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You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>FAST as a Treatment for Obstructive Sleep Apnea <BriefSummary:>The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA). <EligibilityCriteria:>Inclusion Criteria:
* Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured within 12 months prior to the planned procedure
* Age \>/= 20 and \>/= 65
* Body Mass Index ,/= 32 (kg/m\^2)
* Patient offered CPAP and has refused of failed to continue CPAP treatment or is not compliant with CPAP
* Signed informed consent to participate in this study
Exclusion Criteria:
* Prior OSA surgery
* Active systemic infection
* Allergy to any medication used during implantation
* Previous history of neck or upper respiratory tract
* Significant dysphagia or speech disorder
Anatomical
* Identified obvious palatal stenosis
* Enlarged tonsils (3+)
* Anatomy unable to accommodate the implant
Other
* Other medical, social, or psychological problems that , in the opinion of the investigator, precludes the patient from receiving this treatment and the procedures and evaluations pre- and post-treatment
* Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study
* Unable and/or not willing to comply with treatment follow-up requirements
* Pregnancy (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment <Conditions:>Obstructive Sleep Apnea <Interventions:>Encore Tongue Suspension System | 'Age, Categorical', 'Gender', 'Ethnicity (NIH/OMB)', 'Region of Enrollment', 'Body Mass Index (BMI)', 'Prior OSA Surgery' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant <BriefSummary:>The purpose of this study is to learn how effective each of the two dressings, Silverlon® and AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure wound infections. <EligibilityCriteria:>Inclusion Criteria:
* Patients who are scheduled for a CIED implant, generator change, or upgrade at the University of Kansas Hospital
* Able to give informed consent
Exclusion Criteria:
* Patients who are already on antibiotics for another reasons
* Immunocompromised patients such as those on immunosuppressant's and HIV positive patients
* Patients who are post device explant for lead infection
* Patients with an allergy to adhesive, silver or an allergy to the dressing(s) or their components <Conditions:>Infections, Wounds and Injuries <Interventions:>Silverlon®, AQUACEL® AG | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'body mass index (BMI)', 'Diabetes', 'Chronic Kidney Disease (CKD)', 'Oral Anticoagulant (OAC)', 'Platelets', 'Serum Creatinine (Serum Cr)', 'International Normalized Ratio (INR)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Subcutaneous Immunotherapy for Mouse in Adults <BriefSummary:>This is an open label trial of mouse allergenic extract administered by subcutaneous injection in adults with asthma and mouse sensitivity. The study is designed to evaluate:
* the safety of this therapy when given by injection
* biomarkers of the immune response and
* whether the therapy would be effective in treating allergic asthma. <EligibilityCriteria:>INCLUSION CRITERIA
Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed. Participants are ineligible if they:
* Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
* Cannot perform spirometry at Screening;
* Have an asthma severity classification at Recruitment of severe persistent, using the NAEPP classification, as evidenced by at least one of the following:
* Requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid;
* Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months;
* Have been treated with depot steroids within the last 12 months;
* Have been hospitalized for asthma within the 6 months prior to recruitment;
* Have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment.
* Do not have access to a phone (needed for scheduling appointments);
* Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study;
* Have previously been treated with anti-IgE therapy within 1 year of recruitment;
* Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study;
* Refuses to sign the Epinephrine Auto-injector Training Form.
EXCLUSION CRITERIA
Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:
* Do not primarily speak English;
* Plan to move from the area during the study period;
* Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined per protocol;
* Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the participant;
* Are using tricyclic antidepressants or beta-adrenergic blocker drugs (both oral and topical);
* Have not received the seasonal Flu (Influenza) Vaccine if enrolling December through March. <Conditions:>Asthma, Perennial Allergic Rhinitis <Interventions:>Mouse Allergenic Extract | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Mouse-Specific Serum Immunoglobulin E (IgE) Levels', 'Mouse-Specific Serum Immunoglobulin G (IgG) Levels', 'Mouse-Specific Serum Immunoglobulin G4 (IgG4) Levels' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) With/Without Yohimbine <BriefSummary:>The proposed study has three distinct but related research objectives. The first goal is to measure physiological correlates of successful treatment with Prolonged Exposure (PE) therapy for posttraumatic stress disorder (PTSD) in veterans of the Iraq and Afghanistan wars. Individuals with PTSD often experience elevated heart rates and other objectively measurable signs of anxiety when confronted with safe situations that remind them of past dangerous situations. We will measure physiological responses and compare the outcomes to patient's self reported subjective accounts of symptom improvement on traditional measures of PTSD. Developing a way to measure objective gains in symptoms improvement may help researchers who are studying ways to improve PTSD treatment. The second goal of the study is to investigate if yohimbine, a drug found to promote a specific type of learning, will improve treatment outcomes for veterans in PTSD treatment. The third goal is to investigate if ability to get used to loud startling audio tones correlates to baseline PTSD pathology and treatment outcomes for PE. This goal represents an important step forward in understanding characteristics of heritable traits that are related PTSD. It is significant because such research may one day lead to the development of individual responder policies that will assist patients by individualizing treatment plans based on personal characteristics. <EligibilityCriteria:>Inclusion Criteria:
* Subjects must be competent to provide informed consent for research participation.
* Subjects must be male veterans and post deployed active duty male personnel of OEF/OIF.
* Subjects must be between the ages of 18 and 45.
* Subjects must meet DSM-IV diagnostic criteria for PTSD on the CAPS.
* For subjects taking SSRI's, subjects must be stabilized on the current prescribed dose for a period of at least 14 days prior to the trial and remain at that dose for the remainder of the study. Subjects who change their SSRI status or dosage during the study will continue to receive services via the study resources but data generated will not be used in analyses. Subjects will be eligible for the study if they are willing to titrate off potentially confounding agents prior to yohimbine administration (for a period of five half-lives), given that such titration is also clinically appropriate and deemed to be in the patient's best interests.
Exclusion Criteria:
* Subjects with a recent (\< 2 month) history of psychiatric hospitalization or suicide attempt. Recent work with veterans with severe mental illness suggests that a 2-month period of stabilization is sufficient to minimize risk and possible relapse (Frueh, 2005). Subjects with an existing diagnosis of schizophrenia or other Axis I serious mental illnesses (SMI, besides PTSD) will be excluded. SMI will include any severe and persistent mental illness.
* Subjects with a current diagnosis of drug dependence, due to potential interactions with study measurements and treatments. Alcohol use disorders will be allowed given that subjects can pass exclusion criterion 12 without withdrawal symptoms.
* Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
* Subjects with evidence of or a history of clinically significant hematological, endocrine, cardiovascular, hepatic, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses.
* Subjects with SCID-diagnosed panic disorder, as yohimbine may precipitate panic attacks.
* Subjects with an abnormal ECG.
* Subjects with a blood pressure of 140/90 or higher, as yohimbine has been shown to elevate blood pressure.
* Subjects taking Beta blockers, alpha-adrenergic agents, Beta-agonist inhalers, opiates or opiate antagonists and any psychotropic medications other than SSRI's because these may affect test response.
* Subjects who are unwilling or unable to maintain abstinence for three days prior to yohimbine administration from over-the-counter drugs with sympathomimetic properties, e.g., asthma medications, cold medicines with ephedrine, dietary supplements with ephedrine alkaloids, and illegal drugs, e.g., amphetamines, methamphetamine, cocaine, and MNDA as well as alcohol because these may exacerbate the action of yohimbine.
* Subjects taking alpha-adrenergic antagonists, e.g. prazosin for hypertension; and beta-adrenergic antagonists, e.g. propranolol. Because they may attenuate effects of yohimbine. Subjects will be eligible for the study if they are willing to titrate off potentially confounding agents prior to yohimbine administration (for a period of five half-lives), given that such titration is also clinically appropriate and deemed to be in the patient's best interests.
* Asthmatic subjects and subjects on medications for hypertension, due to criteria 9 and 10.
These inclusion/exclusion criteria will allow the majority of veterans treated in the PCT to be study eligible. Accordingly, the sample will be likely generalizable to the population of interest. <Conditions:>Post-Traumatic Stress Disorder <Interventions:>Yohimbine, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Pilot Trial: Postoperative Opioid-free Analgesia <BriefSummary:>North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery. <EligibilityCriteria:>Inclusion Criteria:
Adult patients (\>18 yo) undergoing outpatient surgery
* Abdominal surgery (i.e. cholecystectomies, hernia repairs, ovarian cystectomies, salpingectomies)
* Breast surgery (i.e. lumpectomies, partial and complete mastectomies, axillary node dissections)
Exclusion Criteria:
All patients
* Intraoperative or early postoperative complications (i.e. diagnosed in the Post-Anesthesia Care Unit (PACU)) that require postoperative hospital stay
* Contraindications to any of the drugs used in the trial
* Difficult to be reached after surgery
* Inability to provide written informed consent <Conditions:>Outpatient Surgery, Abdominal Surgery, Breast Surgery <Interventions:>Opioid analgesics, Non-opioid analgesics | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment', 'BMI', 'BMI >= 30.0', 'American Society of Anesthesiology score I', 'American Society of Anesthesiology score II', 'American Society of Anesthesiology score III', 'Risk of opioid abuse score (SD)', 'Risk of opioid abuse score ≥4', 'Pain catastrophizing score, mean (SD)', 'Employed, including self-employed', 'Retired', 'Homemaker', 'Student', 'Unemployed', 'Unable to work, receiving disability pension', 'Current smoker', 'Prerandomization treatment group preference: Unsure or no preference', 'Prerandomization treatment group preference: Opioid medication group', 'Prerandomization treatment group preference: Opioid-free medication group', 'Prerandomization perceptions of opioid-free analgesia: Very Effective', 'Prerandomization perceptions of opioid-free analgesia: Somewhat Effective', 'Prerandomization perceptions of opioid-free analgesia: Not effective', 'Prerandomization perceptions of opioid-free analgesia: No specific expectation', 'Abdominal Surgery', 'Laparoscopic appendectomy', 'Laparoscopic cholecystectomy', 'Laparoscopic inguinal hernia repair', 'Open inguinal hernia repair', 'Open umbilical hernia repair', 'Open incisional hernia repair', 'Breast surgery', 'Partial mastectomy', 'Partial mastectomy with sentinel node biopsy', 'Partial mastectomy with axillary node dissection', 'Partial mastectomy with sentinel node biopsy and reconstruction', 'Total mastectomy with sentinel node biopsy', 'Total mastectomy with sentinel node biopsy and reconstruction', 'Total mastectomy with axillary node dissection and reconstruction', 'Received intraoperative regional analgesia', 'Peripheral nerve block', 'Wound infiltration', 'Duration of surgery', 'Amount of opioids received in the PACU' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers <BriefSummary:>The purpose of this study is to assess the effect of the Naida Link contralateral routing of signal (CROS) device on speech understanding in challenging listening situations and on the quality of life in unilateral CI recipients and their frequent communication partners. We hypothesize that:
1. Unilateral CI recipients will obtain higher speech understanding scores with the CROS device in challenging listening conditions
2. Use of the CROS device will lead to positive changes in ratings on Quality of Life measures for (i) unilateral CI recipients, and (ii) their frequent communication partners
A frequent communication partner (FCP) is an individual (a family member, or a friend, or a care taker, or a significant other, or a colleague, etc.) who has at least two hours of in-person interactions with the CI recipient every week. <EligibilityCriteria:>Inclusion Criteria:
* Unilateral recipients of Advanced Bionics CII/90K/Ultra implants
* Ages 18 years and above
* At least 6 months of CI use experience
* Current users of a Naida CI Q70 or Q90 processor
* Do not currently use a Naida Link CROS device
* Limited usable/aidable hearing in the contralateral ear
* Fluent in spoken English
* Willingness to use the CROS device regularly for the study duration
* Willingness to follow-up on a biweekly/monthly basis
Exclusion Criteria:
* \< 6 months of CI use experience
* \< 30% sentence recognition scores in quiet with unilateral CI
* Inability to participate in speech testing
* Inability to follow and complete questionnaires
* Inability to designate an FC
* not a unilateral recipient of Advanced Bionics CII/90K/Ultra implants
Frequent communication partner (FCP) participants' inclusion criteria:
* Ages 18 years and above
* Fluent in spoken English
* Willingness to participate in the study
* Spends at least two hours of in-person interactions with the recipient of Advanced Bionics CII/90K/Ultra implants every week.
FCP's Exclusion criteria:
* Under the age of 18 years
* Not fluent in spoken English
* Spends less than two hours of in-person interactions with the recipient of Advanced Bionics CII/90K/Ultra implants per week <Conditions:>Hearing Impairment <Interventions:>Naida Link CROS | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer <BriefSummary:>This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered in combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung Cancer (NSCLC).
The sponsor decided to discontinue the development of Sym004. Also the decision was made to discontinue the development of Sym004 in NSCLC indication. The decision to discontinue Sym004 in NSCLC was not related to any safety or efficacy findings regarding Sym004. As a result of the early discontinuation of the trial during the dose escalation part, the expansion cohort will no longer be performed hence the pre-specified secondary endpoints are not analyzed and were removed from the protocol based on protocol amendment 2 dated 31 March 2015. <EligibilityCriteria:>Inclusion Criteria:
* Male or female outpatients (except where inpatient stay is required for medical need at the Investigator's discretion) at least 18 years of age at the time of informed consent
* Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of the lung cancer staging system)
* Eligibility for platinum-based chemotherapy
* Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
* Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
* Previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
* In countries where anaplastic lymphoma kinase (ALK) inhibitors are available for the treatment of NSCLC, subjects need to have been screened for ALK fusion gene rearrangements and excluded if positive, unless previously treated and progressed on an appropriate tyrosine kinase inhibitor (TKI) therapy
* In countries where EGFR TKIs are available for the treatment of NSCLC, subjects need to have been screened for EGFR mutations and excluded if positive, unless previously treated and progressed on an appropriate TKI therapy
* Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
* Known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
* History of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
* Other protocol defined exclusion criteria could apply <Conditions:>Carcinoma, Non-Small-Cell Lung <Interventions:>Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine, Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed, Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel, Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study <BriefSummary:>The single-center, open-label Phase II study has the objective of assess the effect of MD1003 on motor and sensory conduction in patients suffering from demyelinating polyneuropathies in 15 subjects. <EligibilityCriteria:>Inclusion Criteria:
* Male and female aged between 20 and 85 years.
* Patients fulfilling one of the following diagnosis:
* Five patients with chronic inflammatory demyelinating polyneuropathy on both clinical and neurophysiological grounds.
* Five patients with proven genetic diagnosis of CMT1a or CMT1b
* Five patients with anti-MAG polyneuropathy.
* Electrophysiological parameters worsening for the past 3 years
* Available EMG record, performed during the past 6 months to assess variability of NCV parameters
* Signed and dated written informed consent to participate in the study in accordance with local regulations
* Likely to be able to participate in all scheduled evaluation and complete all required study procedures,
* In the opinion of the investigator, the patient will be compliant and have a high probability of completing the study.
* Both male and female subjects who are not either surgically sterile (tubal ligation/obstruction or removal of ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least one year confirmed by a negative hormone panel) must commit to using TWO highly effective method of birth control for the duration of the study and for two months after the treatment termination.
Exclusion Criteria:
* Any general chronic handicapping disease other than peripheral neuropathy
* Impossibility to perform the 10 meters walking test
* Impossibility to assess electrophysiological parameters
* Patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or cancer,
* Patients with hypersensitivity to MD1003 excipients (lactose)
* Laboratory tests out of normal range according to the reference laboratory values. Deviations may be accepted if considered by the investigator as not clinically significant with regards to the study continuation,
* Patients with history or presence of alcohol abuse or drug addiction,
* Patients likely to be non-compliant to the study procedures or for whom a long-term follow-up seems to be difficult to achieve.
* Any new medication for neuropathy initiated less than 3 months prior to inclusion. For CIDP patients, relapse in the past 3 months before inclusion.
* Not easily contactable by the investigator in case of emergency or not capable to call the investigator
* Subjects without effective contraception <Conditions:>Chronic Inflammatory Demyelinating Polyneuropathy, Peripheral Neuropathy, Charcot-Marie-Tooth Disease, Charcot-Marie-Tooth Disease Type 1A, Charcot-Marie-Tooth Disease, Type 1B, Anti-MAG Neuropathy <Interventions:>MD1003 | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment', 'Disease type' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers <BriefSummary:>Study to evaluate the pharmacokinetic and Mass Balance of single dose \[14C\] AZD9291 in healthy male volunteers <EligibilityCriteria:>Inclusion Criteria:
1, Volunteers must be willing to use reliable methods of contraception (condom and spermicide), even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 2. In addition, volunteers must agree to continue to take similar contraceptive precautions until 6 months after the last administration of AZD9291 and avoid procreative sex as well as sperm donation for 6 months.
Exclusion Criteria: 1, Any clinically relevant abnormalities in physical examination, vital signs, hematology,clinical chemistry, urinalysis or ECG at baseline in the opinion of the investigator. 2. Radiation exposure from clinical studies, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. - <Conditions:>Healthy Volunteers <Interventions:>AZD9291 | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus <BriefSummary:>The purpose of this study is to compare standard manual and robotically controlled catheter ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of the CTI is standard treatment for patients with a history of atrial flutter, and those undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation are used in standard clinical practice at The University of California, San Diego (UCSD) for ablation. <EligibilityCriteria:>Inclusion Criteria:
* Must be scheduled to undergo radiofrequency catheter ablation of the cavo-tricuspid isthmus for atrial fibrillation (AF) or atrial flutter (AFL) according to appropriate clinical indications.
* Must be able and willing to provide written informed consent
* Must be at least 18 years old.
Exclusion Criteria:
* Patient's refusal to participate in the study
* Lack of indication for CTI ablation (eg: prior CTI ablation with persistent bidirectional isthmus block)
* Pregnancy <Conditions:>Atrial Fibrillation, Atrial Flutter <Interventions:>Amigo™ Robotic Catheter Manipulation, Manual Catheter Manipulation | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Confirmatory Study of OPC-12759 Ophthalmic Suspension <BriefSummary:>The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients. <EligibilityCriteria:>Inclusion Criteria:
1. Out patient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. Best corrected visual acuity of 0.2 or better in both eyes
Exclusion Criteria:
1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
4. Anticipated use of contact lens during the study
5. Patient with punctal plug
6. Any history of ocular surgery within 12 months
7. Female patients who are pregnant,possibly pregnant or breast feeding
8. Known hypersensitivity to any component of the study drug or procedural medications
9. Receipt of any investigational product within 4 months. <Conditions:>Dry Eye Syndromes <Interventions:>OPC-12759 Ophthalmic suspension, Hyalein Mini Ophthalmic solution | 'Age, Categorical', 'Age Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Double-lumen Tubes (DLT) - Health Economic Study <BriefSummary:>The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both double-lumen tubes are equally cost-effective and the the incidence of fiberoptic bronchoscope use it the same for both tubes. <EligibilityCriteria:>Inclusion Criteria:
* Oral explanation of the investigation and Patient Information has been given to the subject or legal representative
* The subject or legal representative has signed the Informed Consent
* The subject is admitted at Odense University Hospital (OUH), department V
* Subjects evaluated as eligible for single-lung ventilation with the use of a left sided DLT
* Subjects \> 18 years of age
Exclusion Criteria:
* Subjects with known tracheobronchial anatomic anomalies
* Subjects going for emergency procedures
* Subjects with anticipated difficult airways
* Subjects with known tracheal pathology
* Subjects requiring rapid sequence induction
* Surgeries in which other lung isolation devices or techniques may be warranted (e.g. tracheostomy, nasal intubation, bronchial blockers)
* Subjects who cannot be intubated with a double-lumen tube (VivaSight-DL or conventional DLT)
* Subjects requiring a right-sided DLT
* Subjects who had participated in the study before <Conditions:>Single Lung Ventilation, Thoracic Surgery, Anesthesia, Cost-effectiveness <Interventions:>VivaSight double-lumen tube for single-lung ventilation, Conventional double-lument tube for single-lung ventilation | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Height', 'Weight', 'Surgical lung' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664) <BriefSummary:>This is a one year, 2-part study to determine the efficacy and safety of preladenant, an adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to determine if preladenant is effective in the treatment of early Parkinson's Disease. The purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3). <EligibilityCriteria:>Inclusion Criteria:
* Has a diagnosis of idiopathic PD for \< 5 years.
* If receiving amantadine and/or anticholinergics, must have been on a stable regimen of treatment for at least the 5 weeks immediately before Screening. (Note: Participants who are not taking any medications for PD are permitted to enroll in this trial.)
* Must have a UPDRS Part 3 score of ≥10, a Hoehn and Yahr Stage ≤3, be ≥30 to ≤85 years of age, and have results of Screening clinical laboratory tests drawn within 5 weeks prior to randomization, clinically acceptable to the investigator, and not within the parameters specified for exclusion.
* If sexually active or plan to be sexually active, must agree to use a highly effective method of birth control while the participant is in the study and for 2 weeks after the last dose of study drug. A male participant must also not donate sperm during the trial and within 2 weeks after the last dose of study drug.
Exclusion Criteria:
* Must not have a form of drug-induced or atypical Parkinsonism, cognitive impairment (ie, Montreal Cognitive Assessment \[MoCA\] score \<22), bipolar disorder, untreated major depressive disorder, schizophrenia, or other psychotic disorder; history of exposure to a known neurotoxin, or any neurological features not consistent with the diagnosis of PD as assessed by the investigator.
* Must not have had surgery for PD.
* Must not have a history of repeated strokes with stepwise progression of Parkinsonism or head injuries, or a stroke within 6 months of screening; poorly controlled diabetes; abnormal renal function; or a severe or ongoing unstable medical condition.
* Must not have failed to show a therapeutic response if a diagnostic levodopa (L dopa) challenge had been done with a large test dose (\>500 mg) of L dopa (if malabsorption excluded), or failed to respond to an adequate previous treatment with dopaminergic therapy.
* Must not have been treated with L dopa or dopamine agonists for 30 days or more. A participant who has been treated with L-dopa or dopamine agonists for \<30 days will be allowed to enter the study. These participants must stop taking dopaminergic medication 30 days prior to Randomization.
* Must not be at imminent risk of self-harm or harm to others.
* Must not have elevated blood pressure (BP) (systolic BP ≥150 mm Hg or diastolic BP ≥95 mm Hg) that cannot be adequately controlled with antihypertensive medication, as demonstrated by 2 BP measurements meeting acceptable BP criterion at consecutive scheduled or unscheduled visits between Screening and Randomization (a 5-6 week period), one of which must be the Randomization visit.
* Must not have had any clinically significant cardiovascular event or procedure for 6 months prior to Randomization, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure; and a participant must not have heart failure staged New York Heart Association Class III or IV.
* Must not have an alanine aminotransferase (ALT) or aspartate amino transferase (AST) ≥ 3 x the upper limit of normal (ULN) or total bilirubin (T BIL) ≥ 1.5 x ULN.
* Must not have active serologically-confirmed hepatic dysfunction (defined as viral infection \[Hepatitis B, C, or E; Epstein-Barr virus (EBV)\]; cytomegalovirus \[CMV\] or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis, or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis.)
* Must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection.
* Must not have received certain prespecified medications or ingested high tyramine-containing aged cheeses (eg, Stilton) for a prespecified time window before the trial, during the trial, and for 2 weeks after the trial.
* Must not have an average daily consumption of more than three 4 ounce glasses (118 mL) of wine or the equivalent.
* Must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence.)
* Must not have allergy/sensitivity to investigational product(s) or its/their excipients.
* Must not be breast-feeding, considering breast-feeding, pregnant or intending to become pregnant.
* Must not have used preladenant ever, or any investigational drugs within 90 days immediately before screening. <Conditions:>Parkinson Disease <Interventions:>Preladenant 2 mg tablet, Preladenant 5 mg tablet, Preladenant 10 mg tablet, Rasagiline 1 mg capsule, Placebo for Rasagiline 1 mg capsule, Placebo for Preladenant | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Ultrasound Guided Distal Peripheral Nerve Blocks and Postoperative Pain. <BriefSummary:>The aim of this clinical trial is to determinate if distal ultrasound guided peripheral nerve blocks on target nerves (radial and median nerve blocks at the elbow), using low volume and low concentration of long acting local anesthetic provide better postoperative pain control compare with systemic analgesia alone after thumb resection arthroplasty (TRA) due to a prolonged selective sensitive block on the tissue trauma. <EligibilityCriteria:>Inclusion Criteria:
* Age more than 18 years.
* Ambulatory TRA.
* Free acceptance to participate in the study, with informed consent signed by patient, guardian or family member.
Exclusion Criteria:
* Age less than 18 years
* Pregnancy.
* Inability to provide informed consent.
* Allergy to amide local anesthetics/NSAIDs
* Preexisting chronic pain treated with opioids.
* Neuropathy involving the extremity undergoing surgery or neurological-cognitive deficits that may interfere in the assessement.
* Contraindications to dPNBs <Conditions:>Postoperative Pain <Interventions:>Levobupivacaine | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs <BriefSummary:>The goal of this observational study is to test whether surgeries for lenses designed to be implanted in the eye to correct refractive error can be done without the need for using viscoelastic substances that are used routinely nowadays to make it easier to introduce them inside the human eye and protect the inside of the eye during the operation.
The main question it aims to answer is that is it safe to do the surgery without using them? to answer this question researchers will access recorded data of patients that underwent refractive surgeries in a private clinic since 2017 and compare them as two groups: those who underwent the traditional procedures and those who had it without the use of dispersive viscoelastics in regard to their vision before and after surgery, their ocular pressure and biomicroscopic analysis of the inside of their corneas before and after surgery. <EligibilityCriteria:>* Inclusion Criteria:
* patients with refractive errors and stable refraction seeking refractive surgery who are fit for phakic IOL (intraocular lens) implantation and having reasonable improvement of visual acuity with refractive correction.
Exclusion Criteria:
* patients with severe ocular surface disease, unstable refraction, glaucoma, cataract, retinal detachment and uveitis. <Conditions:>Refractive Errors, Myopia, Myopic Astigmatism, Hypermetropia <Interventions:>phakic intraocular lens implantation traditional, phakic intraocular lens implantation reduced OVD | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Anterior Chamber Depth', 'Endothelial Cell Density', 'Corneal endothelial coefficient of variation', 'Corneal endothelial cells hexagonality', 'Central corneal thickness', 'Intraocular pressure', 'Unaided visual acuity', 'Best-corrected Visual acuity' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Pioglitazone for Oral Premalignant Lesions <BriefSummary:>The goal of this clinical research study is to learn how Actos (pioglitazone) may affect oral premalignant lesions (OPLs) and/or the risk of mouth cancer. The safety of this drug will also be studied. <EligibilityCriteria:>Inclusion Criteria:
* STAGE I:
* Males or females with a suspected or histologically confirmed oral premalignant lesion(s) (up to three target lesions may be followed for the purpose of the study) that has a length (longest diameter) of 8 mm or greater and width (diameter perpendicular to greatest length) of 3 mm or greater in size
* If a participant has had a biopsy of the target oral premalignant lesions (OPL) lesion(s) within 6 weeks prior to the screening visit and archival tissue is available and the participant agrees to have archival tissue used for histologic confirmation and biomarker analysis, then NO additional biopsies (of the OPL) need to be performed at the screening visit; the pre-screening biopsy must undergo centralized pathology review before the second stage of registration can be performed; if archival tissue is not available, a waiting period of 6 weeks from the time of the last biopsy must be observed before re-biopsy for study purposes
* If a participant has not had a biopsy of the suspected OPL at the time of the screening visit, then a biopsy of the lesion must be performed during the screening visit; the screening biopsy must undergo centralized pathology review before the second stage of registration can be performed
* The participant's life expectancy is \> 6 months
* The participant has discontinued any other oral cancer chemopreventive therapy at least 12 weeks prior to the baseline visit and all toxicities have been fully resolved; daily aspirin is permitted
* The participant is willing and able to fully participate for the duration of the study
* Women must not be pregnant or lactating; women of child-bearing potential (women are considered not of childbearing potential if they are at least two years postmenopausal and/or surgically sterile) must have used adequate contraception (abstinence; barrier methods such as IUD, diaphragm with spermicidal gel, condom, or others; and hormonal methods such as birth control pills or others) since her last menses prior to study entry; women of child-bearing potential and men must agree to use adequate contraception for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
* Ability to understand and the willingness to sign a written informed consent document
* STAGE II:
* The participant has one or more target lesions histologically confirmed by a biopsy obtained no more than 9 weeks prior to randomization, that is either:
* An EARLY premalignant lesion defined to be at high risk:
* Mild dysplasia of any site
* Hyperplastic leukoplakia of a high-risk site
* Dorsal, lateral or ventral tongue
* Floor of mouth
* An ADVANCED premalignant lesion defined as the presence of at least one of the following:
* Moderate dysplasia
* Severe dysplasia (excluding carcinoma in situ)
* Erythroplakia (due to the high risk for progression associated with erythroplakia, erythroplakia of any histology will be defined as an ADVANCED oral premalignant lesion)
* Hemoglobin levels equal to or above the lower limit of normal
* White blood cells \>= 3,000/uL
* Platelets \>= 125,000/uL
* Total bilirubin =\< 1.5 \* upper limit of normal (ULN)
* BUN and serum creatinine =\< 1.5 \* ULN
* Glucose, serum \< 200 mg/dL
* The participant's Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1
* If the participant is female and of childbearing potential and not lactating she has a documented negative serum pregnancy test within 14 days prior to randomization
* The participant has a baseline EKG that does not show signs of acute cardiac ischemia or cardiac dysrhythmia (except for 1st degree AV block or chronic atrial fibrillation); EKG can be an earlier report within 12 weeks prior to registration
* Participants using the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 3 days prior to starting pioglitazone or placebo on this study; the use of the following drugs or drug classes is prohibited during pioglitazone/placebo treatment: participants taking inhibitors of CYP2C8 (gemfibrozil, ketoconazole, quercetin, trimethoprim), enzyme inducers of CYP2C8 (cortisol, dexamethasone, phenobarbital, rifampin), and CYP3A4 substrate
Exclusion Criteria:
* The participant has active cancer or carcinoma in situ of the head and neck
* The participant has a contraindication to biopsy
* The participant has presence of congestive heart failure (New York Heart Association (NYHA) class II-IV), uncontrolled hypertension (systolic \> 150 or diastolic \> 100), or unstable angina
* The participant has any history of congestive heart failure or history of myocardial infarction within the past 6 months
* The participant exhibits clinical evidence of active liver disease or history of chronic liver disease
* The participant has \> Common Terminology Criteria for Adverse Events (CTCAE) grade 1 edema
* The participant has known diabetes and is on insulin or oral agents; the participant is receiving medical therapy for dysregulated blood sugar
* The participant who currently receives an enzyme inhibitor of CYP2C8 (gemfibrozil, ketoconazole, quercetin, trimethoprim), or enzyme inducer of CYP2C8 (cortisol, dexamethasone, phenobarbital, rifampin), or CYP3A4 substrate will not be eligible for randomization after assessing eligibility in stage two unless he/she will not be eligible for randomization after assessing eligibility in stage two unless he/she is willing to stop these drugs and possibly replace them with alternative therapies
* The participant currently receives pregabalin or thioridazine
* The participant has experienced jaundice with Rezulin (troglitazone)
* The participant has a history of colorectal cancer, familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC)
* The participant has a history of bladder cancer or in situ bladder cancer
* The participant has a history of invasive cancer within the past 18 months (excluding non-melanoma skin cancer and in situ cervical cancer); participants (excluding those with a history of colorectal cancer, FAP, HNPCC, bladder cancer or in situ bladder cancer) who received curative treatment and have shown no evidence of recurrence for 18 months will be eligible <Conditions:>Oral Leukoplakia <Interventions:>Pioglitazone hydrochloride, placebo, laboratory biomarker analysis | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Alcohol Use at Baseline', 'Smoking Use at Baseline' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer <BriefSummary:>This phase I trial studies the side effects and best dose of triapine when given with radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vaginal cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard treatment with cisplatin and radiation therapy may kill more cancer cells. <EligibilityCriteria:>Inclusion Criteria:
* Patient has a new, untreated histologic diagnosis of stage IB2 (\> 5 cm), II, IIIB, IIIC or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan
* Age \>= 18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Life expectancy greater than 6 months
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
* Platelets \>= 100 x 10\^9/L
* Hemoglobin (Hgb) \>= 10.0 g/dL (blood transfusions to reach this amount are allowed)
* Serum creatinine =\< 1.5 mg/dL to receive weekly cisplatin
* If serum creatinine is between 1.5 and 1.9 mg/dL, patients are eligible for cisplatin if the estimated creatinine clearance (CCr) is \> 30 ml/min (for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used)
* Total serum bilirubin =\< 1.5 x upper limit of normal (ULN) (in patients with known Gilbert syndrome, a total bilirubin =\< 3.0 x ULN, with direct bilirubin =\< 1.5 x ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
* Able to take oral medication
* Not pregnant and not breastfeeding; the effects of triapine on the developing human fetus are unknown; for this reason as well as because heterocyclic carboxaldehydethiosemicarbazones and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; patient must have documented negative urine pregnancy test must be resulted within 7 days before initiating protocol therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine, breastfeeding should be discontinued if the mother is treated with triapine; these potential risks may also apply to other agents used in this study
* For HIV and hepatitis B/C (HEPB/C):
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for the dose escalation portion of this trial; for those patients who are enrolled in the HIV positive (+) expansion cohort, they must be HIV infected and be on retroviral therapy with an undetectable viral load within 6 months of enrollment
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured; for patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Able to understand and willingness to sign a written informed consent document
Exclusion Criteria:
* Patient has had a prior invasive malignancy diagnosed within the last three years (except \[1\] non-melanoma skin cancer or \[2\] prior in situ carcinoma of the cervix)
* Patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician
* Patients receiving any other investigational agents
* Patients with known glucose-6-phosphate dehydrogenase deficiency (G6PD) are excluded due to an inability to administer the antidote for methemoglobinemia, methylene blue; pre-registration testing for G6PD is at the investigator's discretion and is not required for study enrollment
* Patients who are taking any medication associated with methemoglobinemia; medication must be discontinued and must have a washout period of 4 halflives or 4 weeks, whichever is shorter
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine or cisplatin
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; known inadequately controlled hypertension; significant pulmonary disease including dyspnea at rest, patients requiring supplemental oxygen, or poor pulmonary reserve; or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =\< 200 mg/dL allowed)
* Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible
* Patients scheduled to be treated with adjuvant consolidation chemotherapy at the conclusion of their standard chemoradiation <Conditions:>Advanced Cervical Adenocarcinoma, Advanced Cervical Adenosquamous Carcinoma, Advanced Cervical Squamous Cell Carcinoma, Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma, Advanced Vaginal Squamous Cell Carcinoma, Stage IB2 Cervical Cancer AJCC v6 and v7, Stage II Cervical Cancer AJCC v7, Stage II Vaginal Cancer AJCC v6 and v7, Stage III Vaginal Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7, Stage IVA Vaginal Cancer AJCC v6 and v7 <Interventions:>Biospecimen Collection, Brachytherapy, Cisplatin, Computed Tomography, External Beam Radiation Therapy, Fludeoxyglucose F-18, High-Dose Rate Brachytherapy, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Pharmacological Study, Positron Emission Tomography, Triapine | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Smoking History', 'Primary Site', 'Histology', 'Stage at Diagnosis', 'Stage', 'ECOG' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia <BriefSummary:>Fostamatinib may improve thrombocytopenia in myelofibrosis patients with severe thrombocytopenia (platelet \<50,000/microL) and allow them to initiate treatment with a JAK2 inhibitor, ruxolitinib. Additionally, fostamatinib monotherapy may also improve myelofibrosis related symptoms and splenomegaly. <EligibilityCriteria:>Inclusion Criteria:
* Confirmed diagnosis of primary myelofibrosis or post-polycythemia vera/essential thrombocythemia myelofibrosis classified as high risk, intermediate-2 risk, or intermediate 1 risk by IPSS.
* Severe thrombocytopenia defined as platelet count \< 50,000/microL (confirmed on at least two measurements over an 8-week period prior to start of study).
* At least 18 years of age.
* ECOG performance status ≤ 2
* Able to swallow pills
* Adequate bone marrow and organ function as defined below:
* ANC ≥ 1000/microL
* Peripheral blood blasts ≤ 10%
* Albumin \> 2.7 g/dL
* Total bilirubin ≤ 1.5 x IULN; patients with Gilbert's syndrome may enroll if direct bilirubin ≤ 1.5 x IULN
* AST(SGOT)/ALT(SGPT) ≤ 1.5 x IULN
* Creatinine clearance \> 30 mL/min by Cockcroft-Gault
* Female subjects must be either post-menopausal for at least 1 year or surgically sterile; or, if of childbearing potential, must not be pregnant or lactating and must agree to use a highly effective method of birth control throughout the duration of the trial and for 30 days following the last dose. Acceptable methods of birth control are defined as: hormonal contraception (pill, injection or implant) used consistently for at least 30 days prior to screening, an intrauterine device (IUD), or intrauterine hormone-releasing system (IUS), or true abstinence (i.e. abstinence is in line with the preferred and usual lifestyle of the subject.). Male subjects do not need to use contraception for fostamatinib because human studies showed minimal R406 in sperm.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
* History of allogeneic stem cell transplant.
* Any solid tumor or hematologic malignancy (other than myelofibrosis) requiring active treatment at the time of study entry
* Currently receiving any other investigational agents.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to fostamatinib, ruxolitinib, or other agents used in the study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, or cardiac arrhythmia.
* Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg, whether or not the subject is receiving anti-hypertensive treatment.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry and prior to the first dose of fostamatinib.
* Known positive status for human immunodeficiency virus (HIV)
* Chronic, active, or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier.
* Treatment with strong CYP3A inhibitors or inducers within 14 days before the first dose of study drug. Strong CYP3A inhibitors and CYP3A inducers are not permitted during the study.
* Ongoing gastrointestinal medical condition such as Crohn's disease, inflammatory bowel disease, or chronic diarrhea that is not well controlled and could interfere with absorption of oral medication or be exacerbated by study medication
* Known hepatic cirrhosis or severe pre-existing hepatic impairment.
* Uncontrolled coagulopathy or bleeding disorder.
* Female patients who intend to donate eggs and male patients who intend to donate sperm during the course of this study or for 4 months after receiving the last dose of study treatment. <Conditions:>Myelofibrosis, Thrombocytopenia <Interventions:>Fostamatinib, Ruxolitinib | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma <BriefSummary:>This is a single-agent, open label, one-arm phase 2 pilot study of avelumab in patients with advanced or metastatic adenocarcinoma of the small intestine. <EligibilityCriteria:>Inclusion Criteria:
* Signed and dated written informed consent.
* Male or female ≥ 18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Histologically confirmed adenocarcinoma of the small intestine that is advanced (not amenable to surgery) or metastatic (clinical stage IV). For the purposes of this study, ampullary tumors are considered a part of the duodenum and are classified as adenocarcinomas of the small intestine.
* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria that has not been previously irradiated and which can be followed by CT or MRI.
* Adequate organ function including:
* Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
* Platelets ≥ 100 × 109/L
* Hemoglobin ≥ 9/g/dL (may have been transfused)
* Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)
* Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft-Gault (CG) equation
* Archival tissue \[paraffin block(s) or unstained slides from paraffin block(s)\] from the primary tumor and/or a metastatic site judged reasonably available prior to initiating treatment, or willingness to undergo fresh pre-treatment tumor biopsy. (Prior to initiating treatment, the screening team must have documentation that an archival or fresh tumor specimen has been requested from a local or outside facility. However, physical possession of requested tissue or waiting for histological analysis or confirmation that an acquired specimen contains tumor tissue sufficient for analysis is not a requirement prior to initiating treatment.) If no archival tissue is available and patient consents to a fresh biopsy, but the patient's lesion is deemed inaccessible to safe biopsy, the patient will be allowed to enroll if otherwise eligible.
* Female patients of childbearing potential and male patients able to father children who have female partners of childbearing potential must agree to use one highly effective method (defined as less than 1% failure rate per year) and one additional effective method of contraception (Appendix 4) from 15 days prior to first trial treatment administration until at least 60 days after study participant's final dose of avelumab.
* Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months without an alternative medical cause). Post-menopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women.
* Male patients able to father children are defined as those who are not surgically sterile (i.e. patient has not had a vasectomy).
* Serum pregnancy test (for females of childbearing potential) negative at screening.
* Re-enrollment of a subject that has discontinued the study as a pre-treatment screen failure (i.e. a consented patient who did not receive avelumab) is permitted. If re-enrolled, the subject must be re-consented. Only the screening procedures performed outside of protocol-specified timing must be repeated.
Exclusion Criteria:
* There is no restriction on the number of prior therapies. However, prior therapy with antibody or drug specifically targeting T cell regulatory proteins, including but not limited to the following is not allowed: Prior immunotherapy with IL-2 or IFN-α, or an anti-PD-1 (including nivolumab), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyteassociated antigen-4 (CTLA-4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
* Within 28 days before first dose of avelumab: Anti-cancer treatment, major surgery requiring general anesthesia, or the use of any investigational agent.
* Within 14 days before first dose of avelumab: Therapeutic or palliative radiation therapy. (Subjects receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before the first dose of avelumab.)
* Current use of immunosuppressive medication, except the following:
* Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intra-articular, intranasal, and inhaled);
* Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent are permitted;
* A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g. CT scan premedication against contrast dye allergy) or for treatment of non-autoimmune conditions (e.g. delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.
* Previous malignant disease other than adenocarcinoma of the small intestine within the last 5 years, with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of avelumab AND additional therapy not required while receiving study treatment).
* All subjects with brain metastases, expect those meeting the following criteria:
* Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment
* No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable.
* Subjects must be either off steroids or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
* Receipt of any organ transplantation including allogeneic stem-cell transplantation.
* Significant acute or chronic infections requiring systemic therapy.
* Known history of testing positive for human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS).
* Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
* Active autoimmune disease with reasonable possibility of clinically significant deterioration when receiving an immunostimulatory agent:
* Subjects with Type 1 diabetes mellitus, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
* Interstitial lung disease that is symptomatic or which may interfere with the detection or management of suspected drug-related pulmonary toxicity.
* Uncontrolled asthma \[defined as having 3 or more of the following features of partially controlled asthma within 28 days prior to starting study treatment: Daytime symptoms more than twice per week, any limitation of activities, any nocturnal symptoms/awaking, need for reliever/rescue inhaler more than twice per week, or known lung function (PEF or FEV1) without administration of a bronchodilator that is \< 80% predicted or personal best (if known)\].
* Current symptomatic congestive heart failure (New York Heart Association \> class II), unstable cardiac arrhythmia requiring therapy (e.g. medication or pacemaker), unstable angina (e.g. new, worsening or persistent chest discomfort), or uncontrolled hypertension (systolic \> 160 mmHg or diastolic \> 100mmHg). Or any of the following occurring within 6 months (180 days) prior to first dose of avelumab: Myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, or serious cardiac arrhythmia requiring medication. (Use of antihypertensive medication to control blood pressure is allowed.)
* Concurrent treatment with a non-permitted drug.
* Requirement of anticoagulant therapy with oral vitamin K antagonists such as Coumadin (warfarin). Low-dose anticoagulants for the maintenance of patency in a central venous access device or the prevention of deep vein thrombosis or pulmonary embolism is allowed. Therapeutic use of low molecular weight heparin is allowed.
* Persisting toxicity related to prior therapy that has not reduced to Grade 1 \[National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03; however, alopecia and sensory neuropathy Grade ≤ 2 is acceptable.
* Known severe (Grade ≥ 3 NCI-CTCAE v4.03) hypersensitivity reactions to monoclonal antibodies, including hypersensitivity to the investigational agent or any component in its formulations, or history of anaphylaxis.
* Vaccination within 28 days of the first dose of avelumab and while on trial is prohibited, except for administration of inactivated vaccines (for example, inactivated influenza vaccine).
* Pregnant or breastfeeding females.
* Known alcohol or drug abuse.
* Prisoners or subjects who are involuntarily incarcerated.
* Other severe acute or chronic medical condition, including colitis, inflammatory bowl disease, pneumonitis, pulmonary fibrosis, or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. <Conditions:>Adenocarcinoma <Interventions:>Avelumab | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients <BriefSummary:>This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy. <EligibilityCriteria:>Inclusion criteria:
* Heart transplantation, 3 months prior to enrollment
* Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral, Certican® and corticosteroids
* Sufficient graft function
* Sufficient renal function
* Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility
Exclusion criteria:
* Multi-organ recipients, re-transplantation, or previous transplant with any other organ.
* Patients who are recipients of A-B-O incompatible transplants
* Cold ischemia time \>6 hours
* Historical or current peak PRA of \> 25% at time of transplantation
* Already existing antibodies against the HLA-type of the receiving transplant Other protocol-defined inclusion/exclusion criteria may apply <Conditions:>Heart Transplantation <Interventions:>Everolimus (EVR), cyclosporine A (CyA), tacrolimus (TAC), Enteric coated mycophenolate sodium (EC-MPS), mycophenolate mofetil (MMF), Corticosteroids | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses <BriefSummary:>The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults. <EligibilityCriteria:>Inclusion Criteria:
* Subjects must have clear intraocular media other than cataract.
* Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
* Subjects must be undergoing primary IOL implantation for the correction of aphakia following central continuous curvilinear anterior capsulorrhexis and phacoemulsification cataract extraction.
* Subjects must require a spherical lens power from 10.00 D to 30.00 D.
* Subjects must be willing and able to return for all scheduled follow-up examinations for each eye from days 1 through 180 following surgery.
* Subjects must have ≤ 1.25 D of preoperative corneal astigmatism.
Exclusion Criteria:
* Subjects with corneal pathology potentially affecting topography.
* Subjects whose fundus cannot be assessed preoperatively.
* Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level worse than 20/30 as verified by OCT.
* Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.
* Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
* Subjects with uncontrolled glaucoma.
* Subjects with previous retinal detachment.
* Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/30 or worse.
* Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.
* Subjects with marked microphthalmos or aniridia.
* Subjects who have had previous corneal surgery.
* Subjects with irregular corneal astigmatism.
* Subjects with amblyopia which reduces potential acuity to worse than 20/30.
* Subjects with optic atrophy.
* Subjects with iris neovascularization.
* Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/30 or worse.
* Subjects with chronic use of systemic steroids or immunosuppressive medications.
* Subjects lacking intact binocular vision. <Conditions:>Cataract <Interventions:>Crystalens AO, SoftPort LI61AO | 'Age, Customized', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta <BriefSummary:>This is an exploratory study to evaluate changes in glycosphingolipid levels and other (exploratory) Fabry disease parameters in male Fabry disease participants who were previously treated with agalsidase alfa (Replagal®) 0.2 milligram per kilogram (mg/kg) every two weeks (q2w) and who are being switched to agalsidase beta (Fabrazyme®) 1.0 mg/kg q2w. <EligibilityCriteria:>Inclusion Criteria:
* The participant and/or his parent/legal guardian is willing and able to provide signed informed consent, and the participant, if less than (\<) 18 years of age, is willing to provide assent if deemed able to do so
* Participant is male and has been treated with agalsidase alfa at 0.2 mg/kg q2w for the 12 months prior to switching to agalsidase beta
* The participant has a confirmed diagnosis of Fabry disease by alfa-galactosidase A (alfa-GAL) activity and/or genotyping per local standards
* The participant when switched to agalsidase beta receives the labeled dose, that is, 0.9 to 1.1 mg/kg (1 mg/kg) q2w, and must be willing to maintain the labeled dose for the duration of the study
Exclusion Criteria:
* The participant is on dialysis or is post renal transplantation
* The participant is in end-stage cardiac failure
* The participant and/or his parent or legal guardian, in the opinion of the investigator, is unable to adhere to the requirements of the study
* The participant has been switched from agalsidase alfa to agalsidase beta and does not have historical blood and urine samples <Conditions:>Fabry Disease <Interventions:>Agalsidase beta | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Duration of Fabry Disease', 'Method of Diagnosis of Fabry Disease' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy <BriefSummary:>CTC levels collected pre-surgery will be correlated with pathological samples. <EligibilityCriteria:>Inclusion Criteria:
* Patients with biopsy-proven NSCLC who are undergoing definitive radiotherapy as a part of their treatment regimen.
* Age 18 or older
* Signed informed consent
* Patients who are incapable of providing informed consent are excluded from participating in this study. <Conditions:>Non-small Cell Lung Cancer <Interventions:>Radiotherapy | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Biopsy-Proven Non-Small Cell Lung Cancer' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma <BriefSummary:>Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment phase, followed by a follow-up phase where subjects will not receive IP. The length of the follow up phase is determined by which study the subject had previously completed. <EligibilityCriteria:>Inclusion Criteria:
* Provision of signed and dated written informed consent
* Negative urine test for female subjects of childbearing potential prior to administration of IP at visit 1
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from screening, and must agree to continue using such precautions for 16 weeks after the final dose of IP.
* Female or male subjects who have not met investigational product discontinuation criteria and have attended the EOT visit in either study D5180C00007 (NAVIGATOR) or D5180C00009 (SOURCE)
To enter the extended follow-up phase of the study, the following inclusion criteria also apply:
* Provision of signed and dated Addendum for Extended Follow-up to informed consent, as well as assent by adolescent subjects where applicable, prior to any mandatory study specific procedures, sampling and analyses before Extended Follow Up.
* Must have entered DESTINATION from D5180C00007 study and have completed IP dosing to Week 100, have not met IP Discontinuation criteria and have attended the EOT Visit.
Exclusion Criteria:
* Any clinically important pulmonary disease other than asthma
* Any disorder, including, but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable
* History of chronic alcohol or drug abuse within 12 months prior to visit 1
* Current malignancy or malignancy that developed during a predecessor study
* Major surgery or planned surgical procedures requiring general anesthesia or inpatient status for \> 1 day during the conduct of the study
* Treatment with systemic immunosuppressive/immunomodulating drugs except for OCS used in the treatment of asthma/asthma exacerbations within the last 12 weeks prior to randomization
* Concurrent enrolment in another clinical study involving an IP
* Any clinically meaningful abnormal finding in physical examination, vital signs, ECG,haematology, clinical chemistry, or urinalysis during the predecessor study
* Pregnant, breastfeeding, or lactating
To enter the extended follow-up phase of the study (which extends from week 104 to week 140), the following exclusion criteria also apply:
* Discontinuation of IP during the treatment period of DESTINATION.
* Entered DESTINATION from D5180C00009 (SOURCE) study. <Conditions:>Asthma <Interventions:>Tezepelumab, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The Effects of Contact Lenses With Experimental Dye on Visual Function <BriefSummary:>This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker. <EligibilityCriteria:>Inclusion Criteria:
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol
3. Between 18 and 65 (inclusive) years of age at the time of screening.
4. Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
5. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.
6. The subject has a best corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria:
1. Currently pregnant or breastfeeding.
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Multifocal, toric or extended wear contact lens correction.
8. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
9. History of binocular vision abnormality or strabismus.
10. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
11. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
12. Any ocular infection.
13. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. <Conditions:>Ametropia <Interventions:>senofilcon A with new UV blocker, senofilcon A | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>What is the Optimal Stiffness and Height of a Running-specific Prosthesis? <BriefSummary:>The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. The investigators will collect biomechanical and metabolic data from participants with unilateral and bilateral below the knee amputations while they run at different speeds on a treadmill. This data will be used to understand the effects of running prostheses. Then, these parameters will be used to develop prosthetic prescription techniques for people with below the knee amputations. <EligibilityCriteria:>Inclusion Criteria:
* bilateral or unilateral transtibial amputation
* at least one year of running experience using running-specific prostheses
* 18-55 years old
* no current problems with their prosthesis or residual limb
* at a K4 Medicare Functional Classification Level
Exclusion Criteria:
* Cardiovascular, pulmonary, or neurological disease or disorder <Conditions:>Amputation, Traumatic, Traumatic Amputation of Lower Extremity, Wounds and Injuries <Interventions:>Otto Bock prosthesis, Ossur prosthesis, Freedom Innovations prosthesis | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Height', 'Weight' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Screen to Save: A Colorectal Cancer Educational Intervention <BriefSummary:>The purpose of this research is to understand if an educational program about colorectal cancer helps improve people's knowledge of colorectal cancer prevention and screening and their intention to get screened for colorectal cancer. <EligibilityCriteria:>Inclusion Criteria:
* Age: 50-74 years old
* Attendee at event where educational module is offered <Conditions:>Colorectal Cancer <Interventions:>Inflatable colon educational module | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Correct Answers on Knowledge Questions' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) <BriefSummary:>This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration. <EligibilityCriteria:>Inclusion Criteria:
* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)
* No prior systemic treatment for ES-SCLC
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end organ function
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
Exclusion Criteria:
* Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
* Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
* Pregnant or lactating women
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Positive test result for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
* Severe infections at the time of randomization
* Significant cardiovascular disease
* Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibody
* History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation. <Conditions:>Small Cell Lung Carcinoma <Interventions:>Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin, Etoposide, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study <BriefSummary:>A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis <EligibilityCriteria:>Inclusion Criteria:
* Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails).
Exclusion Criteria:
* Females who are pregnant, lactating or likely to become pregnant during the study. <Conditions:>Onychomycosis <Interventions:>NVXT topical, Placebo (Vehicle) Topical | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia <BriefSummary:>The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia. <EligibilityCriteria:>Inclusion Criteria:
* History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy, esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of Screening
* History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as documented in the medical record.
* Body mass index (BMI) of up to 40 kg/m2
* If female, must not be breastfeeding and must have a negative urine pregnancy test result
Exclusion Criteria:
* Major surgery within 6 months before randomization.
* History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g., insulin autoimmune hypoglycemia).
* Use of agents that may interfere with glucose metabolism <Conditions:>Acquired Hyperinsulinemic Hypoglycemia <Interventions:>Avexitide | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer <BriefSummary:>RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* Diagnosis of one of the following high-risk hematologic malignancies:
* Chronic myelogenous leukemia meeting one of the following criteria:
* Disease in chronic phase and resistant to available tyrosine kinase inhibitors
* Disease in accelerated phase
* Disease with blast crisis that has entered into a second chronic phase after induction chemotherapy
* Acute myelogenous leukemia meeting the following criteria:
* Marrow blasts \< 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
* Must meet one of the following criteria:
* Disease in second or subsequent complete remission
* Primary induction chemotherapy failure with disease subsequently entering complete remission
* Disease in first complete remission with poor-risk cytogenetics or arising from preceding hematological disease
* Myelodysplastic syndrome meeting at least one of the following criteria:
* Treatment-related
* Monosomy 7 or complex cytogenetics
* International prognostic scoring system score ≥ 1.5
* Chronic myelomonocytic leukemia
* Acute lymphocytic leukemia or lymphoblastic lymphoma meeting the following criteria:
* Marrow blasts \< 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
* Must meet one of the following criteria:
* Disease in second or subsequent complete remission
* Acute lymphocytic leukemia with poor-risk karyotype \[e.g., t(9;22) or bcr-abl fusion, t(4;11), or other MLL translocation\] and in first complete remission
* Chronic lymphocytic leukemia or prolymphocytic leukemia meeting both of the following criteria:
* Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs
* In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy)
* Hodgkin or non-Hodgkin lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse disease) meeting the following criteria:
* Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation
* In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy) NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
* No available matched related or unrelated donor OR a matched related or unrelated donor will not be available in the time frame necessary to perform a transplant
* Availability of a first-degree relative (parent, child, sibling) matched at 3/6-5/6 loci (HLA-A, -B, -DR)
* Donor must be willing to donate mobilized peripheral blood stem cells
* No positive HLA crossmatch in the host-vs-graft direction or high titer donor-specific antibodies
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Bilirubin \< 2 mg/dL (unless due to hemolysis, Gilbert syndrome, or primary malignancy)
* Creatinine \< 2 mg/dL OR creatinine clearance ≥ 40 mL/min
* Not pregnant
* Fertile patients must use effective contraception
* LVEF (Left ventriculr ejection fraction) ≥ 45%
* FEV_1 and forced vital capacity ≥ 50% predicted
* No HIV positivity
* No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No immunosuppressive agents ≤ 24 hours after completion of post-transplant cyclophosphamide (including steroids as antiemetics) <Conditions:>Leukemia, Lymphoma, Myelodysplastic Syndromes <Interventions:>busulfan, cyclophosphamide, fludarabine phosphate, mycophenolate mofetil, tacrolimus, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation | 'Age, Categorical', 'Age Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients <BriefSummary:>This study evaluates the effect of adding fish oil to Fingolimod on some serum cytokines in patients with Relapsing-Remitting Multiple Sclerosis. <EligibilityCriteria:>Inclusion Criteria:
* Patients with relapsing-remitting multiple sclerosis according to McDonald's criteria (2010)
* Age between 18 and 45 years
* Expanded Disability Status Scale (EDSS) between 0-5
* History of at least one relapse during the last year
* Intolerance or serious complications when receiving interferons
* Not receiving interferons in the last two months
* Not having relapse in the last 30 days
* Negative pregnancy test
* History of varicella or varicella vaccination, or positive test for anti-varicella antibodies
* Not to take any medication or dietary complement without permission of the physician
* Filling informed consent
Exclusion Criteria:
* Having chronic and infectious diseases
* History of cardiovascular diseases
* Taking corticosteroids in the last 30 days
* Taking chemotherapy agents such as Cyclophosphamide
* Patients who have taken fingolimod before
* Patients who experience relapse during the study <Conditions:>Multiple Sclerosis <Interventions:>Fingolimod, Fish Oil, Placebo (for Fish Oil) | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment', 'Dietary habits, Categorical (seafood meals per month)', 'EDSS' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel <BriefSummary:>The purpose of this study is to evaluate treatment of advanced Parkinson's Disease (PD) patients on levodopa-carbidopa intestinal gel (LCIG) monotherapy in a routine clinical setting. <EligibilityCriteria:>Inclusion Criteria:
* Participants diagnosed with APD and on LCIG treatment for at least 12 months
* Participant must have been on continuous LCIG treatment for at least 80% of days in the preceding year
* Participants must be treated by the same physician (principal investigator or co-investigator) since the initiation of LCIG treatment
Exclusion Criteria:
* Participation in a concurrent or a previous interventional clinical trial during which the participant was on LCIG therapy
* Lack of motivation or insufficient language skills to complete the study questionnaires <Conditions:>Parkinson's Disease (PD) <Interventions:>No Interventions | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Durvalumab Plus Tremelimumab With Concurrent Radiotherapy for Localized Muscle Invasive Bladder Cancer Treated With a Selective Bladder Preservation Approach <BriefSummary:>Combined-modality treatment of localized muscle invasive bladder cancer including transurethral resection (TUR), radiotherapy and dual checkpoint inhibition immunotherapy could achieve pathological complete response in some patients. These patients could avoid to undergone radical surgery with radical cystectomy and preserve their bladder, without the side-effects associated with chemotherapy and surgery. This study has been design to determine the efficacy of durvalumab plus tremelimumab with concurrent radiotherapy in terms of pathological response rate in patients with localized muscle invasive bladder cancer treated with bladder preservation intent. <EligibilityCriteria:>Inclusion Criteria:
* Patients must have signed the informed consent prior to undergoing any study procedure.
* Patients must be 18 years of age or older.
* Patients must have Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
* A paraffin-embedded tumor sample must be available for the associate molecular study.
* Body weight \>30 Kg.
* Adequate normal organ and marrow function.
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre- menopausal patients.
* Patient is willing and able to comply with the protocol for the duration of the study.
Exclusion Criteria:
* Involvement in the planning and/or conduct of the study (applies to both Sponsor staff and/or staff at the study site).
* Participation in another clinical study with an investigational product during the last 30 days.
* Concurrent enrolment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
* Previous treatment with radiotherapy to the bladder, systemic chemotherapy or immune checkpoint inhibitors. Prior intravesical Bacillus Calmette-Guérin (BCG) treatment for non-muscle invasive bladder cancer is allowed, 28 days prior to study.
* Presence of regional lymph node or metastatic extension of the disease.
* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) \<\<for durvalumab monotherapy and durvalumab + tremelimumab combination studies this criterion can be removed. For durvalumab ±tremelimumab in combination with an agent with pro-arrhythmic potential or where effect of the combination on QT is not known if this criterion should be retained. Patient safety and the cardiac ECG should be consulted as needed\>\>.
* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
* Any concurrent chemotherapy, investigational product (IP) other than studied in this protocol, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
* History of allogenic organ transplantation.
* Active or prior documented autoimmune or inflammatory disorders.
* Uncontrolled intercurrent illness.
* History of another primary malignancy.
* History of active primary immunodeficiency.
* Active infection.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab.
* Receipt of live attenuated vaccine within 30 days prior to the first dose of the investigational medical products (IMP).
* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
* Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study.
* Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
* Known allergy or hypersensitivity to IP or any excipient. <Conditions:>Invasive Bladder Cancer <Interventions:>Durvalumab, Tremelimumab, Radiotherapy | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Eastern Cooperative Oncology Group Performance Status (ECOG-PS)', 'Histology', 'Clinical T stage', 'Previous bladder cancer non-muscle invasive', 'Previous treatment', 'PD-L1 expression' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy <BriefSummary:>The purpose of the study is to compare pain control after robotic hysterectomy surgery using either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are standard of care in these types of surgeries. <EligibilityCriteria:>Inclusion Criteria:
* those who present for elective robotic assisted hysterectomy
Exclusion Criteria:
* non english speaking
* chronic pain
* on opioids greater than 1 weeks
* chronic anticoagulation
* allergy to local anesthetics
* use of spinal or epidural for surgery
* lack of patient cooperation
* contraindication to regional anesthesia <Conditions:>Acute Pain <Interventions:>Bupivacaine, liposomal bupivacaine | 'Age, Categorical', 'Sex: Female, Male', 'Region of Enrollment', 'weight' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Phase 2B Extension Study of Ataluren (PTC124) in Duchenne/Becker Muscular Dystrophy (DMD/BMD) <BriefSummary:>Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b extension trial that will evaluate the long-term safety of ataluren (PTC124) in boys with nonsense mutation DMD/BMD, as determined by adverse events and laboratory abnormalities. The study will also assess changes in walking, muscle function, and other important clinical and laboratory measures. <EligibilityCriteria:>Inclusion Criteria:
* Completion of blinded study drug treatment in the previous Phase 2b study (PTC124-GD-007-DMD).
* Ability to provide written informed consent (parental/guardian consent if applicable)/assent (if less than \[\<\]18 years of age).
* In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during PTC124 administration and the 6-week follow up period.
* Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions.
Exclusion Criteria:
* Known hypersensitivity to any of the ingredients or excipients of the study drug (Litesse® UltraTM \[refined polydextrose\], polyethylene glycol 3350, Lutrol® micro F127 \[poloxamer 407\], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla, Cab-O-Sil® M5P \[colloidal silica\], magnesium stearate).
* Ongoing participation in any other therapeutic clinical trial.
* Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow up would be completed, or could impair the assessment of study results. <Conditions:>Duchenne Muscular Dystrophy, Becker Muscular Dystrophy <Interventions:>Ataluren | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function <BriefSummary:>This study compares the effects of two common hormone medications on the heart and blood vessels of healthy post-menopausal women over the age of 45.
The study will take place over the course of about 5 months. Each subject will take two different medications over two six-week periods. They will be randomized at the beginning of the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the first period, and will receive the other medication the second six-weeks of the study. At the very beginning of the study and at the end of each six-week treatment period, subjects will come to the hospital various tests including non-invasive blood vessel imaging tests, blood draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment periods, there will be a four-week medication-free washout period. <EligibilityCriteria:>Inclusion Criteria:
1. Healthy female postmenopausal volunteers, as defined by absence of menses for at least 12 months and follicle stimulating hormone (FSH) 30 IU/L;
2. Age 45 to 75 years;
3. Systolic blood pressure \<140 and \>90 mmHg and diastolic blood pressure \<90 and \>60 mmHg at the screening visit;
4. No personal history of diabetes;
5. Body mass index \< 30 kg/m2;
6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram).
Exclusion Criteria:
1. Current smoking, defined as smoking within the 12 months before the screening visit;
2. Alcohol intake \>1 beverage per night or history of alcohol abuse;
3. Current or past recreational drug use;
4. Personal history of hypertension, cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), hyperlipidemia, diabetes (defined as a fasting glucose ≥126 mg/dL), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression, or illness requiring overnight hospitalization in the past 6 months;
5. Risk factors for arterial or venous thromboembolism;
6. Personal history of breast cancer or any other type of cancer;
7. Personal history of endometrial hyperplasia, endometrial cancer, or unexplained vaginal bleeding;
8. History of cervical cancer or abnormal pap smear
9. Prescription or herbal medication use, excluding thyroid hormone supplementation;
10. Ischemic changes on resting electrocardiogram;
11. Serum creatinine ≥ 1.3 mg/dL.
12. Serum potassium level \> 5.0 mmol/L;
13. Known hypersensitivity to any of the study drugs;
14. Other active medical problems detected by examination or laboratory testing, except for treated hypothyroidism.
15. Pregnancy <Conditions:>Cardiovascular Diseases <Interventions:>Estradiol+MPA, Estradiol+Drospirenone | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients <BriefSummary:>The aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients. <EligibilityCriteria:>Inclusion Criteria:
* Patients diagnosed with first time ever stroke
* Patients with hemiparesis
* Patients who are between the ages of 18-70
* Patients who has Mini Mental Test score above 23
* Patients whose functional level is less than 4 according to the Modified Rankin Scale
* Patients who has upper extremity spasticity lower than 3 on Modified Ashworth Scale
Exclusion Criteria:
* Hypertension
* Heart disease
* Subluxation and fracture at the shoulder
* Visual impairment
* Limitation in passive normal joint movement in hemiplegic side
* Botulinum toxin administration or surgical operation in the last 6 months patients <Conditions:>Stroke, Hemiparesis <Interventions:>real boxing training, virtual boxing training | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study in Participants With Type 1 Diabetes Mellitus <BriefSummary:>The purpose of this study is:
* To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment.
* To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
* To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment.
* To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment. <EligibilityCriteria:>Inclusion Criteria:
* Have had diabetes mellitus for at least 1 year
* Have an hemoglobin A1c (HbA1c) value less than 12% according to the central laboratory at screening
* Have a body mass index (BMI) less than or equal to 35.0 kilograms per square meter (kg/m\^2)
* Have been treated for at least 90 days prior to screening with the following:
* Insulin detemir, insulin glargine, or human insulin isophane suspension (NPH) insulin in combination with premeal insulin,
* Self-mixed or premixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or
* Continuous SC insulin infusion therapy
* This inclusion criterion applies to female participants:
* Are not breastfeeding
* Test negative for pregnancy at screening and randomization based on serum pregnancy tests
* Do not intend to become pregnant during the study
* Have practiced a reliable method of birth control (for example, use of oral contraceptives or levonorgestrel, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices, partner with vasectomy, or abstinence) for at least 6 weeks prior to screening
* Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
* Capable of and willing and desirous to do the following: adhere to a multiple daily injection regimen, inject insulin with a prefilled pen and perform Self-Monitored Blood Glucose (SMBG) and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above.
Exclusion Criteria:
* Are using twice-daily insulin glargine having been inadequately controlled on once-daily dosed glargine prior to screening
* Have excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 units per kilogram (units/kg) at the time of randomization
* Receiving any oral or injectable medication (other than metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus other than insulins in the 90 days prior to screening
* Lipid-lowering medications:
* Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or are using lipid-lowering medication at a dose that has not been stable for greater than or equal to 90 days prior to screening
* If a participant has not been on a stable dose of lipid-lowering medication for greater than or equal to 90 days prior to screening, the site should wait to screen the participant. If the results of the screening laboratory tests require a change to the participant's current lipid-lowering medication or initiation of lipid-lowering medication, it is acceptable to change the lipid-lowering medication for the participant and to have the participant return greater than or equal to 90 days later to complete some of the screening procedures again
* Have fasting hypertriglyceridemia (defined as greater than 4.5 millimoles per liter \[mmol/L\], greater than 400 milligrams per deciliter \[mg/dL\]) at screening, as determined by the central laboratory
* Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia as determined by the investigator) within 6 months prior to entry into the study
* Have had 2 or more emergency room visits or hospitalizations due to poor glucose control (hyperglycemia or diabetic ketoacidosis) in the past 6 months
* Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
* Renal: Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than 2.5 mg/dL
* Hepatic: Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements as indicated below:
* Total bilirubin greater than or equal to 2 times the upper limit of normal (ULN) as defined by the central laboratory,
* Alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) greater than 2.5 times ULN as defined by the central laboratory, or
* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times ULN as defined by the central laboratory.
* Malignancy: Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
* Allergy: Have known hypersensitivity or allergy to any of the study insulins or their excipients
* Hematologic: Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement
* Glucocorticoid therapy: Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical , intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency
* Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator
* Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing the protocol <Conditions:>Diabetes Mellitus, Type 1 <Interventions:>Glargine, LY2605541, Insulin Lispro | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Systems Biology of Zoster Vaccine <BriefSummary:>The purpose of the study is to better understand how the immune system responds to the new herpes zoster (shingles) vaccine (Shingrix®). The study will be looking at certain markers in the blood after vaccination with Shingrix®. <EligibilityCriteria:>Inclusion Criteria:
1. Subject must be able to understand and provide informed consent.
2. Adults aged 50-60 years, or community dwelling adults aged 70 years and above.
Exclusion Criteria:
1. Inability or unwillingness of a subject to give written informed consent or comply with study protocol.
2. Receipt of immune products:
* Receipt of blood products within 6 months prior of the first dose of the study Zoster vaccine or expected receipt through 6 months after vaccination with the second dose of the study Zoster vaccine.
* Receipt of any vaccine within 4 weeks prior to vaccination with any of the two doses of the study Zoster vaccine or expected receipt within 4 weeks after vaccination with any of the two doses of the study Zoster vaccine.
* Receipt of any Zoster or varicella vaccines at any time prior to study entry.
3. Subject taking any non-topical antiviral therapy with activity against herpes viruses, including but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir 3 days prior to each vaccination or 14 days after.
4. Prior history of shingles.
5. Presence of certain co morbidities or immunosuppressive states such as:
* Chronic medical problems including (but not limited to) insulin-dependent diabetes, severe (at the discretion of the investigator or study physician) heart, lung, liver, or kidney diseases; auto immune diseases; severe gastrointestinal diseases; and uncontrolled hypertension.
* Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C, tuberculosis, organ transplant, cancer, current and or expected receipt of chemotherapy, radiation therapy, steroids \[i.e., \> 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days); (nasal (less than 1mg/day of fluticasone equivalent inhaled corticosteroid is allowable) and topical steroids are allowed)\], antitumor necrosis factor agents, or any other immunosuppressive therapy, anatomic or functional asplenia, congenital immunodeficiency.
6. Conditions that could affect the safety of the subjects such as:
* Severe reactions to prior vaccinations.
* History of anaphylactic/anaphylactoid reaction to any component of the vaccines.
* History of bleeding disorders.
7. Any acute illness, including any fever (\> 100.4 F \[\> 38.0 C\], regardless of the route) within 3 days prior to study entry.
8. Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
9. Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
10. Use of investigational drugs within 12 months of participation.
11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator or study physician, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
12. Women of childbearing potential. <Conditions:>Zoster, Zoster Varicella, Shingles, Chicken Pox <Interventions:>Shingrix® | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs <BriefSummary:>The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs.
Patients intolerant to the most recent TKI therapy must have had BCR-ABL1 ratio \> 0.1% IS at screening and patients failing their most recent TKI therapy must have met the definition of treatment failure as per the 2013 European LeukemiaNet (ELN) recommendations.
Patients with documented treatment failure as per 2013 ELN recommendations while on bosutinib treatment had the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study. <EligibilityCriteria:>Inclusion Criteria:
Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
Patients must meet all of the following laboratory values at the screening visit:
* \< 15% blasts in peripheral blood and bone marrow
* \< 30% blasts plus promyelocytes in peripheral blood and bone marrow
* \< 20% basophils in the peripheral blood
* ≥ 50 x 109/L (≥ 50,000/mm3) platelets
* Transient prior therapy related thrombocytopenia (\< 50,000/mm3 for ≤ 30 days prior to screening) is acceptable
* No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
BCR-ABL1 ratio \> 0.1% IS according to central laboratory at the screening examination for patients intolerant to the most recent TKI therapy
Prior treatment with a minimum of 2 prior ATP-binding site TKIs (i.e. imatinib, nilotinib, dasatinib, radotinib or ponatinib)
Failure (adapted from the 2013 ELN Guidelines Bacarrani 2013) or intolerance to the most recent TKI therapy at the time of screening
* Failure is defined for CML-CP patients (CP at the time of initiation of last therapy) as follows. Patients must meet at least 1 of the following criteria.
* Three months after the initiation of therapy: No CHR or \> 95% Ph+ metaphases
* Six months after the initiation of therapy: BCR-ABL1 ratio \> 10% IS and/or \> 65% Ph+ metaphases
* Twelve months after initiation of therapy: BCR-ABL1 ratio \> 10% IS and/or \> 35% Ph+ metaphases
* At any time after the initiation of therapy, loss of CHR, CCyR or PCyR
* At any time after the initiation of therapy, the development of new BCR-ABL1 mutations which potentially cause resistance to study treatment
* At any time after the initiation of therapy, confirmed loss of MMR in 2 consecutive tests, of which one must have a BCR-ABL1 ratio ≥ 1% IS
* At any time after the initiation of therapy, new clonal chromosome abnormalities in Ph+ cells: CCA/Ph+
* Intolerance is defined as:
* Non-hematologic intolerance: Patients with grade 3 or 4 toxicity while on therapy, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal)
* Hematologic intolerance: Patients with grade 3 or 4 toxicity (absolute neutrophil count \[ANC\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses recommended by manufacturer
Exclusion Criteria:
Known presence of the T315I or V299L mutation at any time prior to study entry Known second chronic phase of CML after previous progression to AP/BC Previous treatment with a hematopoietic stem-cell transplantation Patient planning to undergo allogeneic hematopoietic stem cell transplantation
Cardiac or cardiac repolarization abnormality, including any of the following:
* History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)
* Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
* QTcF at screening ≥450 msec (male patients), ≥460 msec (female patients)
* Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
* Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
* Concomitant medication(s) with a known risk of Torsades de Pointes per www.crediblemeds.org that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
* Inability to determine the QTcF interval
* Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, pulmonary hypertension)
* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
* History of acute or chronic liver disease
* Treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with study treatment
* Moderate or strong inducers of CYP3A
* Moderate or strong inhibitors of CYP3A
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 days after last dose of ABL001 and one month after last dose of bosutinib. Highly effective contraception methods include:
* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
* Female sterilization (have had surgical bilateral oophorectomy (with or without hysterectomy) total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
* Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
* Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception.
* In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking study medication. In the case of oophorectomy alone, women are considered post-menopausal and not of child bearing potential only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. <Conditions:>Chronic Myelogenous Leukemia <Interventions:>Asciminib, Bosutinib | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection <BriefSummary:>This study examined the influence of ribavirin on the initial virological response in treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000 milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon (PEG-IFN) alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously (SC) weekly, for 6 weeks. Following the initial 6 weeks, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin (Copegus®) for 12 weeks. If there was an initial virological response after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks outside of the study. <EligibilityCriteria:>Inclusion Criteria:
* Caucasians, male or female aged between 18 and 70 years
* Indication: serological proof of a chronic hepatitis C infection with positive result of anti-Hepatitis C virus (HCV) test and detectable HCV- Ribo Nucleic Acid (RNA) in serum
* Proven HCV genotype 1 by means of the reverse hybridization assays
* Proven histological infection activity within the liver with or without proven compensated cirrhosis within the last 24 months prior to start of the study (Child-Pugh degree A)
* Participants without previous anti-HCV therapy
Exclusion Criteria:
* Known hypersensitivity to interferon or ribavirin or any of the other component parts
* Pregnant or nursing women, women with child bearing potential and without using a high effective method of contraception. The urine and serum pregnancy test at visit 0 in fertile participants or cohabitants of participants must show a negative result
* Male partners of pregnant women
* Infection with HCV genotype 2, 3, 4, 5, or 6
* Pretreatment with interferon and/or ribavirin
* Immunocompromised participants
* Treatment of systemic anti-neoplastic or immunomodulatoric medication (including supraphysiological doses of steroids or radiation therapy) within the last 6 months prior to the start of treatment and during the complete time interval of study treatment
* Chronic hepatitis due to hepatitis C virus (e.g. haemochromatosis, autoimmunohepatitis, metabolic or alcohol-related liver disease)
* Decompensated liver cirrhosis or liver disease Child-Pugh degree B or C or condition after decompensation
* Signs of a hepatocellular carcinoma within 2 months prior to randomization in case of a cirrhosis or a transition to cirrhosis
* Ascites or esophagus varices with bleedings as documented in anamnesis
* Any medical condition that questions in the opinion of the investigator the participant's enrollment and participation in the trial
* Hemoglobin \<13 grams/deciliter (g/dl) in females and \<14 g/dl in males in screening phase
* Patients with an increased anemia risk (e.g. thalassemia, spherocytosis, etc.) or patients which would be at a particular medical risk in case of an anemia
* Diagnosed neutropenia \<1.500/microliter (mcl) or thrombocytopenia \<90.000/mcl in screening phase <Conditions:>Hepatitis C, Chronic <Interventions:>Pegylated Interferon (PEG-IFN) alfa-2a, Placebo, Ribavirin | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women <BriefSummary:>A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV drugs, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and the safety and effectiveness of oral TDF and oral FTC/TDF compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infections. <EligibilityCriteria:>Inclusion Criteria:
* Willing to provide adequate locator information
* Sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
* Agree to not participate in other research studies involving drugs, medical devices, or vaginal products for duration of study.
* Agree to use effective method of contraception. More information on this criterion can be found in the protocol.
Exclusion Criteria:
* HIV infected
* Known adverse reaction to any of the study products
* Known adverse reaction to latex
* Pathologic bone fracture not related to trauma
* Non-therapeutic injection drug use in the 12 months prior to screening
* Post-exposure prophylaxis for HIV exposure within 6 months prior to enrollment
* Last pregnancy outcome 42 days or less prior to enrollment
* Gynecologic or genital procedure 42 days or less prior to enrollment
* Participation in any other research study involving drugs, medical devices, or vaginal products 30 days or less prior to enrollment
* Currently using spermicide, interferon or interleukin therapy, or certain medications. More information on this criterion can be found in the protocol.
* Any significant uncontrolled active or chronic disease. More information on this criterion can be found in the protocol.
* Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
* Intends to become pregnant in the 24 months after enrollment
* Plans to relocate or travel away from the study site for more than 8 consecutive weeks in the 24 months after enrollment
* Urinary tract infection
* Pelvic inflammatory disease, an STI, or reproductive tract infection requiring treatment
* Grade 2 or higher pelvic exam finding
* Any condition that, in the opinion of the investigator, would interfere with the study
* Pregnant or breastfeeding <Conditions:>HIV Infections <Interventions:>Emtricitabine/tenofovir disoproxil fumarate, Emtricitabine/tenofovir disoproxil fumarate placebo, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate placebo, Tenofovir 1% vaginal gel, Tenofovir placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Some secondary school education or higher', 'Earns own income', 'Live births', 'Currently married', 'At least 2 male sex partners in the past 3 months', 'Episodes of vaginal intercourse in the past 7 days', 'Condom use during last vaginal intercourse', 'Anal sex in the previous 3 months', 'Injectable contraception use', 'Oral pills contraception', 'Infection by Chlamydia trachomatis', 'Infection by Neisseria gonorrhoeae', 'Infection by Trichomonas vaginalis', 'Syphilis infection', 'HSV-2 infection', 'Bacterial vaginosis infection' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis <BriefSummary:>This trial will be a double-blind, randomized, placebo-controlled, safety, tolerability and efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment regimen when administered daily for up to 28 days to patients at least 18 years of age, with atopic dermatitis. <EligibilityCriteria:>Inclusion Criteria:
* Subjects will be included in the trial if they meet all of the following criteria:
1. Are at least 18 years of age
2. Have atopic dermatitis, as determined by an EASI score of ≥5 and ≤50 (Hanifin, 2001)
3. Total treatment area(s) of atopic dermatitis involvement ≥2% and ≤15% today surface area (BSA).
4. Have atopic dermatitis that has been clinically stable for ≥ 30-days prior to the Screening Visit.
5. Are able to obtain written informed consent/ascent in a manner approved by the Institutional Review Board and comply with the requirements of the study.
6. Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the target treatment areas during the treatment period.
7. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
8. Are willing to refrain from exposure to artificial ultraviolet radiation for the duration of the study.
9. Are willing to cover target treatment areas to avoid exposure to natural ultraviolet radiation for the duration of the study.
10. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. i.e. barrier method, hormone or intrauterine device.
11. Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
12. Are willing to refrain from treating areas that are not in the defined treatment area(s), which will be excluded from the IGA assessments and BSA calculation. These areas are as follows: head, neck, soles of feet, palms of hands, axillae, or intertriginous areas.
Exclusion Criteria:
* Subjects will be excluded from the trial if they meet any of the following criteria:
1. Have a sibling or immediate family member already participating in this trial.
2. Currently requires and/or, in the 30 days prior to Screening, has required topical use of a medium or high potency steroid (i.e. \>1%)
3. Atopic dermatitis that, in the opinion of the investigator, is likely to stem from an allergic reaction. (i.e. contact dermatitis)
4. Have \<2% or \>15% total BSA of atopic dermatitis involvement in the target treatment area(s).
5. Have participated in any interventional clinical trial in the previous 30 days to the screening visit.
6. Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances or any member of the Compositae family of vascular plants (e.g., sunflowers, daisies, dahlias, etc.).
7. Have received phototherapy within the 60 days prior to Screening.
8. Have received any systemic medication for atopic dermatitis in the past 2 months that would interfere with the evaluation of atopic dermatitis (excluding antihistamines or leukotriene inhibitors).
9. Have a present condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
10. Are pregnant, breast-feeding or plan to become pregnant at any point for the duration of the trial.
11. Are not willing to practice an approved form of birth control while on the study drug for the duration of the trial. i.e. barrier method, hormone or intrauterine device.
12. Have been treated, with prescription medication for atopic dermatitis, within 60 days prior to the Baseline visit.
13. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years,or any other confounding skin condition.
14. Have undergone treatments with topical atopic dermatitis drug products, other than retinoids or corticosteroids, within 14 days prior to the Baseline Visit, and for therapy containing corticosteroids or retinoids within 28 days prior to Baseline Visit.
15. Have open sores or open lesions in the treatment area(s).
16. Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
17. Require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
18. Have an active infection of any kind at Visit 1 (Baseline)
19. Have an occupation that requires ≥50% of time be spent outdoors, where prolonged exposure to ultraviolet radiation is unavoidable. <Conditions:>Atopic Dermatitis, Eczema <Interventions:>SAN007 5% cream, Placebo, SAN007 10% cream | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Baseline EASI score' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Intravesical Liposomes for Ulcerative Cystitis <BriefSummary:>The objective is to instill liposomes reconstituted with sterile water into the bladder as a compassionate use treatment in one patient with ulcerative interstitial cystitis (IC). <EligibilityCriteria:>Inclusion Criteria:
* Ulcerative IC for at least 6 months documented,
* Negative urine cytology,
* Able to independently complete self administered questionnaires and voiding diaries.
Exclusion Criteria:
* Pregnant or lactating,
* History of bleeding diathesis,
* On anticoagulant therapy,
* Active peptic ulcer disease,
* Obvious neurological impairment,
* Known allergy to liposomes. <Conditions:>Interstitial Cystitis <Interventions:>Liposomes | 'Age, Categorical', 'Gender', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Boston ARCH 4F Intervention to Reduce Fall Risk in People With HIV and Alcohol Use <BriefSummary:>This study is being conducted to assess the acceptability and feasibility of a randomized trial of a 10 week virtual intervention to reduce fall risk in people with HIV who consume alcohol. The hypothesis is that this randomized trial of the fall prevention intervention will be found to be feasible and acceptable in this pilot stage.
Standardized assessments will be administered in-person at Boston University Medical Campus to assess various domains including fall risk, fear of falling, physical performance measures (such as grip strength, balance, and gait speed), substance use, and other related measures. The intervention has 3 main components: home exercises, virtual group sessions and weekly phone check-ins. Home exercise will be customized to match the current fitness level of participants. Participants will be asked to complete assigned exercises 3 times per week. Additionally, there will be a weekly virtual group session led by an Occupational Therapist trained in group facilitation via Zoom. The virtual group sessions will be used to help answer any questions and lead a discussion around challenges related to falls. Finally, a member of the research team will check-in with participants once per week to answer any remaining questions that participants have, provide individual feedback on exercises, and set up reminders for the upcoming week. Reminders will be tailored to the individual participant's needs to remind the participant to complete the intervention's components. <EligibilityCriteria:>Inclusion Criteria:
* Prior or current participant in the Boston ARCH 4F Cohort
* Any alcohol consumption in the last 30 days using Addiction Severity Index
* Deemed a Fall Risk using the CDC STEADI Fall Risk Assessment Form
* Has reliable access to a phone or computer with internet connection
Exclusion Criteria:
* Requires wheelchair for mobility <Conditions:>HIV Infection, Alcohol Consumption, Falls, Accidental, Falls <Interventions:>Fall Prevention Intervention | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Nursing Assistant Intervention to Prevent Delirium in Nursing Homes <BriefSummary:>Delirium is an acute confusion that occurs in one third of hospitalized older adults. As compared to those without delirium, hospitalized patients with delirium have longer hospital stays, higher mortality, and increased risk of nursing home utilization. Substantial attention has been paid to developing, testing, and disseminating interventions to prevent delirium in the hospital but, to date, not in the nursing home setting. In a previous study we used known information on delirium risk factors to develop an intervention that can be delivered at onset of acute illness in nursing home patients. The current study is designed to test the effect of this intervention in a single-site clinical trial. Objectives: 1) to determine, as compared to control, the effect of a multicomponent intervention targeting delirium risk factors on delirium frequency, delirium severity, cognitive and physical function decline, and hospitalization in nursing home patients with acute illness, and 2) to identify features of the intervention associated with occurrence of delirium and other outcomes. Approach: We will screen nursing home patients on 17 long-term care units at a large, urban nursing home who experience onset of a change in condition according to established criteria, and enroll and assign them to intervention or control in a 1:1 ratio. Those assigned to intervention will receive daily visits from an Elder Life Specialist, a mobile Certified Nursing Assistant trained to provide services to counter risks for delirium, including dehydration, immobility, cognitive impairment, undernutrition, and sleep problems, for the duration of the acute illness and for 1 week following. Patients assigned to control will receive usual care from the unit-based nurses and the patient's primary team. Delirium will be assessed 5 days a week by a research assistant. Cognitive and physical function decline and hospital transfer will be ascertained during a 1 month follow-up period. We will compare outcomes between intervention and control, as well as examine associations between outcomes and intervention features such as number and duration of visits. <EligibilityCriteria:>Inclusion Criteria
* Long-term care nursing home resident at The New Jewish Home
* Acute change in condition or just returned from the hospital
* Assent to participate in study
Exclusion Criteria
* Discharge or death expected before 2 months
* Nonverbal or unable to follow simple commands <Conditions:>Delirium <Interventions:>Delirium-prevention, Sham comparator | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Cognitive function' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluation of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together Program <BriefSummary:>Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations at risk due to existing medical conditions. To date, no randomized controlled trials have tested interventions to reduce mental health consequences of contagious disease outbreaks.
Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Systemic Sclerosis can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Many people with scleroderma are at risk of serious complications from COVID-19 if infected due to lung involvement (\> 40% have interstitial lung disease) and common use of immunosuppressant drugs.
The objective of The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate a videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with systemic sclerosis at risk of poor mental health during the COVID-19 pandemic. The trial is a pragmatic randomized controlled trial that will be conducted using an existing cohort of systemic sclerosis patients. We will use a partially nested design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. <EligibilityCriteria:>Inclusion Criteria:
* Classified as having SSc by a physician
* PROMIS Anxiety 4a v1.0 T-score greater than or equal to 55
* Have regular, reliable internet access
* Be fluent in English or French
Exclusion Criteria:
* Receiving counseling or therapy currently
* Having a positive test for the COVID-19 virus <Conditions:>Scleroderma, Scleroderma, Systemic, Systemic Sclerosis <Interventions:>SPIN-CHAT Program | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Education', 'Married or living as married', 'Living alone', 'Working part-time or full-time', 'Time since diagnosis', 'Diffuse disease subtype', 'PROMIS anxiety', 'Patient Health Questionnaire-8', 'COVID-19 Fears Questionnaire', 'Multidimensional State Boredom Scale (MSBS)', 'University of California Los Angeles Loneliness Scale (ULS-6)', 'International Physical Activity Questionnaire - elderly (IPAQ-E)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System <BriefSummary:>The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel. <EligibilityCriteria:>Inclusion Criteria:
Healthy females
* 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
* Regular, consistent menstrual cycles between 25 and 35 days
* Sexually active women requesting birth control
* In good general health, confirmed by medical history, physical (including gynecologic) examination and screening laboratory values
Exclusion Criteria:
* Known or suspected pregnancy;
* Lactating women
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication <Conditions:>Contraception <Interventions:>AG200-15 (cycles 1-13), Lessina crossover to AG200-15 | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants <BriefSummary:>The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment. <EligibilityCriteria:>Inclusion Criteria:
* Genotype 1 hepatitis C infection (confirmed at screening)
* Participant has not received any prior treatment for hepatitis C
* Participant must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
* Must agree to use 2 forms of effective contraception throughout study (both males and females)
Exclusion Criteria:
* Infection with HIV or non genotype 1 hepatitis C
* Liver disease not related to hepatitic C infection
* Hepatic decompensation
* Significant laboratory abnormalities or other active diseases
* Pregnant or planning to become pregnant <Conditions:>Hepatitis C <Interventions:>Placebo, TMC435, Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), Ribavirin (RBV) | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser <BriefSummary:>The objective of this clinical study is to evaluate whether the use of the new CO2 - 9.3μm short-pulsed laser increases the caries resistance of occlusal pit and fissure surfaces in patients in addition to fluoride therapy. This will be quantified by visual exams with the International Caries Detection and Assessment System (ICDAS II), SOPROLIFE daylight and blue fluorescence, and DIAGNOdent Laser Light-induced Fluorescence. This is a randomized, single blind, prospective, split mouth controlled, clinical trial over 12 months. <EligibilityCriteria:>Inclusion Criteria:
* age 6 or older, in good general health
* subject is of moderate or high caries risk according to CAMBRA
* has at least one pair of unsealed molars in at least one jaw with need for a sealant
* teeth with an ICDAS code 0, 1 and 2 with deep grooves and fissures providing an anatomical stick for an explorer
* willing to comply with all study procedures and protocols
* must be able to read and understand English
* have an understanding of the study
* residing in San Francisco or other nearby locales with community water fluoridation (to eliminate water fluoridation as a potential confounding variable)
* patient and parent/guardian able to provide written informed consent in English
* willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research.
Exclusion Criteria:
* show evidence of extremely poor oral hygiene
* subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis),
* taking medications that may affect the oral flora or salivary flow (e.g. antibiotic use in the past three months, drugs associated with dry mouth / xerostomia \[extreme high caries risk\])
* other conditions that may decrease the likelihood of adhering to study protocol
* subjects who will leave the area and are unable to complete the study <Conditions:>Dental Caries <Interventions:>Laser, Fluoride | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor <BriefSummary:>The objectives of this study are to assess the safety and effectiveness of the SENSIMED Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of continuous TF recording.
TF efficacy will be evaluated by demonstrating TF ability to detect:
1. The known phenomenon of increase in IOP when moving from waking state to going to bed, as reflected in pneumotonometer measurements
2. Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).
A screening visit and one 24-hour IOP fluctuation recording session are planned for each patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An ophthalmological examination of the eyes will be done at screening and prior to and following the device recording. <EligibilityCriteria:>Inclusion Criteria:
* Signed informed consent for the investigation
* Diagnosis of primary open angle glaucoma (POAG), including normal tension glaucoma, or healthy subjects, including subjects with ocular hypertension for whom no evidence or suspicion of structural or functional glaucomatous damage exists
* No anti-glaucomatous drug treatment or washed-out for 4 weeks
* IOP symmetry of +/- 3 mmHg between fellow eyes
* Age 18-80 years
* Not more than 4 diopters spherical equivalent on both eyes
* Not more than 2 diopters cylinder equivalent on both eyes
Exclusion Criteria:
* Patients who have had ocular surgery within the last 3 months.
* Corneal or conjunctival abnormality hindering contact lens adaptation
* Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
* Severe dry eye
* Secondary forms of open angle glaucoma (OAG)
* Allergy to corneal anesthetic
* Patients with contraindications for silicone contact lens wear
* Patients not able to understand the character and individual consequences of the investigation
* Simultaneous participation in other clinical research <Conditions:>Primary Open Angle Glaucoma, Healthy Subjects <Interventions:>SENSIMED Triggerfish | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma <BriefSummary:>The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration. <EligibilityCriteria:>Inclusion Criteria:
To be included in this study, you must meet the following criteria:
* Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma
* No previous treatment
* Clinical stage II, III, or IV by the Ann Arbor Staging Criteria
* Age \> 70 years
* ECOG performance status 0, 1, or 2
* Adequate bone marrow, liver and kidney function
* Must give written informed consent prior to entering this trial
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
* Age \< 18 years
* Central nervous system involvement with lymphoma
* Coexistent active malignancies treated within five years
* Active infection precluding the use of combination chemotherapy
* HIV infection
* Pregnant or lactating
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. <Conditions:>Non-Hodgkins Lymphoma <Interventions:>Cyclophosphamide, Mitoxantrone, Vincristine, Prednisone, Rituximab | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Early Feasibility Study to Evaluate the AccuraSee in Correcting Residual Refractive Errors After Cataract Surgery <BriefSummary:>To determine if the intraocular pseudophakic contact lens (IOPCL), referred to as the AccuraSee, corrects residual refractive errors after cataract surgery using a plus powered lens in subjects with ocular pathology previously implanted with a Bausch and Lomb LI61AO or LI61SE monofocal posterior chamber intraocular lens (PCIOL) and to confirm its positional stability and adherence relative to the PCIOL. <EligibilityCriteria:>Inclusion Criteria:
* Subjects who have already had cataract surgery with a Bausch and Lomb monofocal intraocular lens model LI61AO (with lens power from 18.0 diopters (D) to 23.0 D) or model LI61SE monofocal intraocular lens (with a lens power between from18.0 D and 23.0 D), clearly evidenced by photographic documentation with one of the following: (1) patient medical record, (2) clinic chart with labeling attached, (3) surgical record with labeling attached, or (4) patient identification card with make, model, power, and serial number.
* Able to comprehend and sign a statement of informed consent.
* Willing and able to complete all required postoperative visits.
* Subjects who's baseline manifest refraction spherical equivalent (MRSE) is between -0.5D and +3.0D
* Best corrected visual acuity 20/80 or worse.
* Subjects with ≤1.0D 5D of refractive corneal cylinder
* Subjects willing to abstain from pursuing any other surgical vision-correcting procedures for the duration of the study.
* Subject must be at least 22 years or older.
Exclusion Criteria:
* Subjects who have already had cataract surgery with a Toric or multifocal Intraocular Lens.
* Subjects who have already had cataract surgery with a Bausch and Lomb monofocal intraocular lens model LI61AO (with a lens power below 18.0 D and greater than 23.0 D) or model LI61SE (with a lens power below 18.0 D and greater than 22.5 D).
* Subjects who were treated with an IOL off-label.
* Subjects who have MRSE of less than 1.0 Diopter (+1.0 to -1.0 D) and more than +3.0D
* Subjects who have more than 1.5D of refractive corneal cylinder
* Subjects whose continuous curvilinear capsulorhexis was less than 5mm or more than 6.0 mm in size at the time of IOL surgery.
* Subjects who had cataract surgery less than 6 months from the planned date of the IOPCL surgery.
* Subjects with anterior capsule fibrosis and phimosis that in the opinion of the investigator may confound the outcome or increase the risk to the subject.
* Acute, chronic or uncontrolled systemic or ocular disease that in the opinion of the investigator would increase the operative risk or confound the outcome(s) of the study.
* Any corneal abnormality, other than regular corneal astigmatism that in the opinion of the investigator would confound the outcome(s) of the study.
* Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy).
* Microphthalmos.
* Previous retinal detachment.
* Recurrent severe anterior or posterior segment inflammation of unknown etiology.
* Iris neovascularization.
* Uncontrolled glaucoma.
* Aniridia.
* Optic nerve atrophy.
* Damaged or incomplete zonules.
* Known history of pseudoexfoliation.
* Medications that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax)) or other medications with similar side effects (floppy iris syndrome). <Conditions:>Refractive Errors <Interventions:>AccuraSee IOPCL with +3.0D add | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Asthma Link: A Real World Application of School Supervised Asthma Therapy <BriefSummary:>The goal of this study is to assess the feasibility of a clinical trial to evaluate the impact and process of deploying school-supervised asthma therapy in a real-world setting for children with poorly controlled asthma (aged 6-17 years). <EligibilityCriteria:>STUDY INCLUSION/EXCLUSION CRITERIA:
Child Inclusion Criteria:
* Meet the eligibility criteria for Asthma Link (as described below)
* Enrolled in Asthma Link (if randomized to the Asthma Link Condition)
* Able and willing to provide informed assent
Child Exclusion Criteria:
* Unable or unwilling to provide informed assent
* Diagnosis of a serious co-morbid illness during the past 5 years
* Developmental delay that would prevent study participation.
* Planning on moving from primary residence or moving outside of the school district in the next 1 year
* A sibling to a child participating in this study
Parent Inclusion Criteria:
* Parent/guardian to patient
* 18 years or older
* Able to understand and communicate in English or Spanish
* Able and willing to provide informed consent.
Parent Exclusion Criteria:
* Adults lacking capacity
* Prisoners
Medical Provider, School Nurse, Asthma Champion Inclusion Criteria:
• Able and willing to provide informed consent
Medical Provider, School Nurse, Asthma Champion Exclusion Criteria:
• Unable or unwilling to provide informed consent
Child eligibility for children enrolled in Asthma Link:
* children aged 6-17 years (enrolled in grade 1-12)
* prescribed daily inhaled corticosteroid (ICS) for asthma
* 1 or more courses of oral steroids in the past 2 years OR 1 or more hospitalizations or ED visits for asthma in the past 2 years OR 1 or more sick visits for asthma in the past year OR Asthma Control Test (ACT) score \<19
* parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks
* able and willing to assent
* parental permission
* English or Spanish speaking <Conditions:>Childhood Asthma <Interventions:>Asthma Link, Enhanced Usual Care | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa <BriefSummary:>To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/carbidopa 100/25 mg (Sinemet® 100/25) <EligibilityCriteria:>Inclusion Criteria:
1. Availability for the entire study period and willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer prior to participation in the study.
2. Male volunteers.
3. Volunteers of at least 18 years of age but not older than 45 years.
4. Volunteers with body mass index (BMI) greater than or equal to 19 and below 30 kg/m2.
5. Volunteers who are non- or ex-smokers. An ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
6. Volunteers who are healthy as determined by pre-study (at screening) medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
7. Volunteers who have clinical laboratory test results judged clinically acceptable (within the laboratory's stated normal range; if not within this range, they must be without any clinical significance) at screening and admission to first treatment period.
8. Volunteers who have negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.
9. Volunteers who have negative screen of ethyl alcohol and drugs of abuse at screening.
10. Due to unknown risks and potential harm to the unborn fetus, sexually active men must agree to use a medically acceptable form of contraception throughout the study.
Exclusion Criteria:
1. Volunteers who do not conform to the above inclusion criteria, or in case of
2. Volunteers who have a clinically relevant surgical history.
3. Volunteers who have a clinically relevant family history.
4. Volunteers who have a history of relevant atopy.
5. Volunteers who have a significant infection or known inflammatory process at screening or first admission.
6. Volunteers who have acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
7. Volunteers who are vegetarians, vegans or have medical dietary restrictions.
8. Volunteers who cannot communicate reliably with the investigator.
9. Volunteers who are unlikely to co-operate with the requirements of the study.
10. Significant history of hypersensitivity to BIA 9-1067, tolcapone, entacapone, levodopa, carbidopa or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
11. Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
12. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability.
13. Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, lymphatic, musculoskeletal, genitourinary, endocrine, immunologic, dermatologic or connective tissue disease.
14. Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases.
15. Presence of significant heart disease or disorder according to ECG.
16. Presence of suspicious undiagnosed skin lesions or a history of melanoma.
17. Previous history of Neuroleptic Malignant Syndrome (NMS) and/or nontraumatic rhabdomyolysis.
18. Presence or history of significant glaucoma.
19. Use of prescription medications including MAO inhibitors within 28 days before day 1 of the study.
20. Use of over-the-counter (OTC) products within 7 days before day 1 of the study.
21. Maintenance therapy with any drug, or significant history of drug dependency (drug abuse) or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
22. Any clinically significant illness in the previous 28 days before day 1 of this study.
23. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before day 1 of this study.
24. Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study.
25. Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately, inability to understand and to observe the instructions of the physician.
26. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
27. Positive urine screening of ethyl alcohol or drugs of abuse at admission to any treatment period.
28. Any history of tuberculosis and/or prophylaxis for tuberculosis.
29. Positive results to HIV, HBsAg or anti-HCV tests.
30. Participation in any previous clinical study with BIA 9-1067 within 84 days before day 1 of the study. <Conditions:>Parkinson's Disease (PD) <Interventions:>BIA 9-1067, Placebo, Sinemet® 100/25 | 'Age, Categorical', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>TransForm™ Occlusion Balloon Catheter Registry <BriefSummary:>The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures <EligibilityCriteria:>Inclusion Criteria:
1. Subject or legal representative is willing and has provided informed consent.
2. Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
3. Subject is over 18 years of age.
Exclusion Criteria:
1. Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
2. Subject's pregnant <Conditions:>Intracranial Aneurysms <Interventions:>TransForm™ Occlusion Balloon Catheter | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA) <BriefSummary:>The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months. <EligibilityCriteria:>Inclusion Criteria:
* Either one of the following risk factors is sufficient for inclusion (high risk patient)
* Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), \>30 days prior to randomization)
* Previous systemic embolism or at least one of the following risk factors are needed for inclusion: Age ≥75 years
* Symptomatic congestive heart failure
* Impaired left ventricular systolic function
* Diabetes mellitus; Hypertension requiring anti-hypertensive treatment
* In addition to AF the patient must be appropriate for but unable or unwilling to take VKA therapy
Exclusion Criteria:
* Presence of a clinically significant valvular heart disease;; Stroke or TIA and/or systemic embolism within the previous 30 days prior to randomization
* Conditions associated with increased risk of major bleeding <Conditions:>Persistent or Permanent Non-valvular Atrial Fibrillation <Interventions:>AZD0837, Aspirin | 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial <BriefSummary:>This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease - pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study of the REGARD trial.
The aim of this trial is to provide additional data on the factors influencing interferon (IFN) beta response.
This is a Phase 4 trial involving subjects who previously participated in the REGARD trial. To address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected. <EligibilityCriteria:>Inclusion Criteria:
* Was randomized in the REGARD 24735 study
* Is willing and able to comply with the protocol
* Has given written informed consent before performing any trial-related activities
Exclusion Criteria:
* Is unwilling or unable to participate in the study
* Is already included in the initial REGARD 24735 PGx sub-study <Conditions:>Relapsing Multiple Sclerosis <Interventions:>Blood sampling, Blood sampling | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Clinical Evaluation of the Treatment of Spider Veins on the Ankles <BriefSummary:>To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles. <EligibilityCriteria:>Inclusion Criteria:
1. Males or females, 20 to 75 years of age (inclusive).
2. Fitzpatrick Skin Type I - III.
3. Having spider veins on at least 1 ankle measuring 2.0mm or less in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the investigator.
4. Having spider veins on the ankle that are appropriate for laser treatment, as assessed by the investigator.
5. Subject must be able to read, understand and sign the Informed Consent Form.
6. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
7. Wiling to have limited sun exposure for the duration of the study, including the follow-up period.
8. Willingness to have digital photographs taken of ankle spider veins and agree to use of photographs for presentation, educational or marketing purposes.
9. Agree not to undergo any other procedure for the treatment of ankle spider veins during the study.
Exclusion Criteria:
1. Fitzpatrick Skin Type IV - VI.
2. Pregnant.
3. Having an infection, dermatitis or a rash in the treatment area.
4. Having significant varicosities or perforator veins.
5. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
6. Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
7. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
8. In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study. <Conditions:>Spider Veins <Interventions:>Nd:YAG laser | 'Age, Categorical', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies <BriefSummary:>This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103. <EligibilityCriteria:>INCLUSION CRITERIA:
1. Disease
* Patients with histologically or cytologically confirmed solid tumours (breast cancer (triple negative breast cancer \[TNBC\], ER+/-, HER2+/-), gastrointestinal (GI) cancers (resistant to oxaliplatin or irinotecan-based therapy colorectal cancer \[CRC\]), osteosarcoma, adenoid cystic carcinoma (ACC), and malignant glomus tumour) that are surgically unresectable, locally advanced, or metastatic and whose disease has progressed on at least one line of systemic therapy (with the exception of ACC patients who are allowed to be systemic treatment-naïve) and for whom no established therapeutic alternatives exist. Any other solid cancer (including lymphoma) with a confirmed NOTCH1-4 activating mutation or genetic lesion.
* Relapsed or refractory (r/r) T-cell acute lymphoblastic leukaemia (T-ALL) or lymphoma (T-LBL) with a confirmed NOTCH pathway activation. Refractory patients are defined as T-ALL/T-LBL patients with ≥ 5% bone marrow blasts, and/or concomitant extramedullary involvement, who have not achieved a CR after standard induction/consolidation therapy attempt.
2. Demography: men and women ≥ 18 years old
3. Adequate organ function and laboratory results
4. Adequate contraceptive measures
5. Signed informed consent
EXCLUSION CRITERIA
1. Medical History
1. Patients with symptomatic CNS metastases (neurologically unstable or requiring increasing doses of steroids to control their CNS disease)
2. Hypersensitivity to any of the excipients of CB-103
3. Patients with unresolved nausea, vomiting, or diarrhoea of CTCAE grade \> 1
4. Impairment of GI function or presence of GI disease that may significantly alter the absorption of CB-103
5. History of second or other primary cancer with the exception of:
* Curatively treated non-melanomatous skin cancer
* Curatively treated cervical cancer or breast carcinoma in situ
* Other primary solid tumour treated with curative intent and no known active disease present and no treatment administered during the last 2 years.
2. Exclusionary concurrent medical conditions Impaired cardiac function or clinically significant cardiac diseases.
3. Prior Therapy
* In patients with solid tumours cytotoxic chemotherapy within 3 weeks
* In T-ALL/T-LBL patients, prior anticancer therapy less than 2 weeks prior to starting therapy or 5 half-lives (whichever is longer) with exceptions.
* Radiation therapy within 2 weeks of scheduled CB-103 dosing day 1
* Immunotherapy, biological therapies, targeted small molecules, hormonal therapies within 3 weeks of scheduled CB-103 dosing day 1
* Unresolved toxicity CTCAE grade \> 1 from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia), or incomplete recovery from previous surgery. <Conditions:>Breast Cancer, Colorectal Cancer, Adenoid Cystic Carcinoma, Non-hodgkin Lymphoma, Glomus Tumor, Malignant, Hepatocellular Carcinoma, Osteosarcoma, T-ALL <Interventions:>CB-103 | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia <BriefSummary:>RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as etoposide and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving IMRT together with chemotherapy before transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy (IMRT) when given together with etoposide and cyclophosphamide followed by donor stem cell transplant and to see how well they work in treating patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). <EligibilityCriteria:>Inclusion Criteria:
* Patients with acute lymphocytic leukemia or acute myelogenous leukemia who are not in first or second remission (i.e., after failing remission induction therapy or in relapse or beyond second remission)
* All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical sibling who is willing to donate bone marrow or primed blood stem cells or a 10/10 allele matched unrelated donor; a single allele mismatch at A, B, C, DR, or DQ and a KIR mismatch at C will be allowed; all ABO blood group combinations of the donor/recipient are acceptable since even major ABO compatibilities can be dealt with by various techniques
* Prior therapy with VP-16, Busulfan, and Cytoxan is allowed
* A cardiac evaluation with an electrocardiogram showing no ischemic changes or abnormal rhythm and an ejection fraction of \>= 50% established by multi gated acquisition scan (MUGA) or echocardiogram
* Patients must have a serum creatinine of less than or equal to 1.2 or creatinine clearance \> 80 ml/min
* A bilirubin of less than or equal to 1.5
* Serum glutamic oxaloacetic transaminase (SGOT) less than 5 times the upper limit of normal
* Serum glutamate pyruvate transaminase (SGPT) less than 5 times the upper limit of normal
* Pulmonary functioning tests including diffusing capacity of carbon monoxide (DLCO) will be performed; forced expiratory volume in one second (FEV1) and DLCO should be greater than 50% of the predicted normal value
* The time from the end last induction or reinduction attempt should be \>= 14 days
* Signed informed consent form approved by the Institutional Review Board (IRB) is required
DONOR: Any sibling donors who are histocompatible with the prospective recipient will be considered a suitable donor
* Donors will be excluded if for psychological or medical reasons they are unable to tolerate the procedure
* Donor should be able to donate peripheral blood stem cells or bone marrow
Exclusion Criteria:
* Prior radiation therapy that would exclude the use of total-body irradiation
* Patients who have undergone bone marrow transplantation previously and who have relapsed
* Patients with psychological or medical condition that patients physician deems unacceptable to proceed to allogeneic bone marrow transplant
* Pregnancy
* Electrocardiogram (EKG) showing ischemic changes or abnormal rhythm and/or an echocardiogram or MUGA scan showing abnormal wall motion or ejection fraction \< 50% <Conditions:>Leukemia <Interventions:>cyclophosphamide, etoposide, allogeneic bone marrow transplantation, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, intensity-modulated radiation therapy, tomotherapy | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Complementary Food Supplements for Reducing Childhood Undernutrition <BriefSummary:>The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh. <EligibilityCriteria:>Inclusion Criteria:
* Infants 6 months of age <Conditions:>Stunting, Wasting <Interventions:>Wheat Soy Blend (WSB++), Chickpea based complementary food supplement, Rice based complementary food supplement, Plumpy Doz | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors <BriefSummary:>Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia. <EligibilityCriteria:>Inclusion Criteria:
* At least 18 years of age at the time of pre-operative exam
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* Demonstration of refractive stability
* Anticipated post-operative stromal bed thickness of at least 250 microns
* Willing and capable of returning for follow-up examinations for the duration of the study
Exclusion Criteria:
* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Concurrent use of topical or systemic medications that may impair healing
* History of any medical conditions that could affect wound healing
* History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
* Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
* Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course <Conditions:>Hyperopia <Interventions:>LASIK correction of hyperopic refractive errors | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy <BriefSummary:>This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ. <EligibilityCriteria:>Inclusion Criteria:
* The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines for the study treatment and for the pre-entry tumor block submission for HER2 testing and B-43 correlative studies
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory)
* On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) (patients with mixed DCIS and lobular carcinoma in situ \[LCIS\] are eligible)
* The DCIS must be HER2-positive as determined by central testing
* Estrogen and/or progesterone receptor status must be determined prior to randomization (patients with DCIS that is hormone receptor positive or negative are eligible)
* All DCIS must have been resected by lumpectomy
* The margins of the resected specimen must be histologically free of DCIS; for patients in whom pathologic examination demonstrates DCIS present at the line of resection, re-excision(s) may be performed to obtain clear margins (patients who require mastectomy are not eligible)
* If axillary staging is performed, nodal staging must be pN0, pN0(i-), pN0(i+) which is defined as isolated tumor cells =\< 0.2 mm, regardless of the method of detection, i.e., immunohistochemistry (IHC) or hematoxylin \& eosin (H\&E), pN0(mol-), or pN0(mol+); note: axillary staging is not required
* The interval between the last surgery for excision of DCIS (lumpectomy or re-excision of lumpectomy margins) and randomization must be no more than 120 days
Exclusion Criteria:
* Invasive (including microinvasion staged as T1mic) breast cancer (patients with DCIS "suspicious" for microinvasion, but not confirmed, are eligible)
* Nodal staging of pN1 (including pN1mi) (note: axillary staging is not required)
* DCIS present in more than one quadrant (multicentric)
* Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign (if DCIS is found, the patient is eligible if the DCIS was in the same quadrant of the ipsilateral breast and was resected with clear margins)
* Contralateral breast cancer (including DCIS)
* Whole breast irradiation administered before randomization (partial breast irradiation is prohibited)
* Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible)
* Prior anthracycline chemotherapy for any malignancy
* Cardiac disease that would preclude the use of the drugs included in the B-43 treatment regimens; this includes but is not confined to:
* Active cardiac disease:
* Angina pectoris that requires the use of anti-anginal medication;
* Ventricular arrhythmias except for benign premature ventricular contractions (PVCs) controlled by medication;
* Conduction abnormality requiring a pacemaker;
* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and
* Clinically significant valvular disease
* History of cardiac disease:
* Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;
* Documented congestive heart failure; or
* Documented cardiomyopathy
* Uncontrolled hypertension, i.e., systolic blood pressure \[BP\] greater than 180 mm/Hg and/or diastolic BP greater than 100 mm/Hg (patients with hypertension that is well controlled on medication are eligible)
* Other nonmalignant systemic disease that would preclude a patient from receiving trastuzumab or radiation therapy or would prevent prolonged follow-up
* Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin
* Pregnancy or lactation at the time of study entry (note: pregnancy testing according to institutional standards should be performed for women of child-bearing potential)
* Administration of any investigational agent within 30 days before study entry <Conditions:>Breast Ductal Carcinoma In Situ <Interventions:>Laboratory Biomarker Analysis, Trastuzumab, Whole Breast Irradiation | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population <BriefSummary:>The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation (COS) following GnRH treatment. <EligibilityCriteria:>Inclusion Criteria:
* Females aged 21 to 35 years with regular ovulatory menstrual cycles of 21 to 45 days, with a Body Mass Index (BMI) between 18 and 30 kg/m2 who desire pregnancy.
* Subjects must be high responders, defined as subjects who have a serum anti-Müllerian hormone (AMH) ≥5 ng/mL at screening.
* Documented history of infertility (e.g., unable to conceive for at least 12 months or for at least 6 months if receiving donor sperm) with a Day 2 or Day 3 serum FSH level between 1 and 12 IU/L (inclusive), the results of which should be obtained within 6 months prior to randomization.
Exclusion Criteria:
* Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).
* History of recurrent miscarriage not followed by a live birth (recurrent is defined as two (2) or more consecutive miscarriages).
* Previous in vitro fertilization (IVF) or assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of ≤2 mature follicles or history of 2 previous failed cycle cancellations prior to oocytes retrieval due to poor response. <Conditions:>Infertility <Interventions:>menotropin, recombinant FSH | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery <BriefSummary:>RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery. <EligibilityCriteria:>Inclusion Criteria:
* Histologically or cytologically confirmed renal cell carcinoma (any histology) based on prior biopsy or biopsy performed and reviewed at Cleveland Clinic Foundation. This can include pathology read as adenocarcinoma consistent with renal origin.
* Unresectable primary tumor due to any of the following factors or various combinations thereof:
* Large tumor size (\> 15 cm)
* Bulky lymphadenopathy (\> 4 cm or encasement of renal vessels or great vessels)
* Venous thrombosis (high level/invasive disease requiring inferior vena cava reconstruction or hypothermic circulatory arrest)
* Proximity to vital structures (e.g., mesenteric vasculature)
* Any one of these factors may or may not constitute unresectability, but for consideration for this trial, the surgical and medical oncologist must agree that the particular constellation of findings for the patient under consideration would likely entail a low probability (\<50%) that the tumor would be resectable (with negative margins) or that the potential morbidity associated with an attempt at surgical resection would not be clinically acceptable. The numerical thresholds noted above are only a guideline and the clinical judgment of the surgeon and medical oncologist will determine unresectability.
* Patients with history of brain metastases can be enrolled 2 weeks following the completion of gamma knife or whole brain radiotherapy.
* ECOG performance status (PS) 0-1 or Karnofsky PS \>/=70%
* Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 times upper limit of normal (ULN)
* Total Serum Bilirubin ≤ 1.5 times ULN
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
* Serum calcium ≤ 12.0 mg/dL
* Creatinine ≤ 2.5 mg/dL
* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
* The presence of any of the following will exclude a patient from study enrollment:
* Prior systemic treatment for RCC.
* Evidence of bleeding diathesis or coagulopathy. Patients with hematuria from the primary renal tumor are eligible provided all other eligibility criteria are met.
* Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.
* Hypertension that cannot be controlled by medications to \< 160/90 mmHg.
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
* Pregnancy or breastfeeding.
* Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. <Conditions:>Kidney Cancer <Interventions:>sunitinib malate, conventional surgery | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe <BriefSummary:>This will be an open-label, randomized, 2-treatment, 2-period, crossover single-dose study in approximately 134 healthy adult participants. Participants will be randomized into 2 sequences of treatment as described in the following table of Intervention Groups and Duration. <EligibilityCriteria:>Inclusion Criteria:
* Healthy male and/or female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
* Participants will include healthy individuals, with healthy being defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and PR measurement, 12-lead ECG, chest X-ray, or clinical laboratory tests.
* Participants agree to abstain from the use of tobacco- or nicotine-containing products for at least 90 days prior to dosing and have a negative urine screen for cotinine at Screening.
* Participants agree to abstain from alcohol consumption for at least 48 hours prior to Day 1 of dosing in each study period and have a negative screen for alcohol.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* BMI between 19 and 30 kg/m2, inclusive, and body weight of not\<50 kg or \>100 kg.
* Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, injuries to subcutaneous tissue at the injection site).
* Any clinically significant, as determined by the investigator, abnormal laboratory evaluations, including HIVAb, HBVsAg, HBVcAb, HCVAb and liver function taken at Screening. The negative HIVAb status will be confirmed at Screening, and all HIV results will be maintained confidentially by the study site.
* History of malignancy, including current malignancy, with the exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ within 5 years.
* Surgery within the 4 months prior to Screening.
* History of splenic rupture (or participant who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disease, chronic neutropenia, thrombocytopenia, or vasculitis.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* History of biological growth factor exposure, including but not limited to pegfilgrastim, filgrastim and other G-CSFs in the context of treatment, prophylaxis, peripheral blood stem cell mobilization, or previous investigational study setting. This also includes exclusion for history of interferon, epoetin, and IVIG exposure.
* Receipt of live vaccination, or exposure to communicable viral diseases such as chicken pox, varicella, mumps, measles, or COVID-19 within the 4 weeks prior to Screening.
* Use of any prescription medicine (with the exception of contraceptives) within 7 days or at least 5 half-lives, whichever was longer. Use of oral or parenteral anticoagulant or antiplatelet agents and corticosteroids should be specifically queried.
* Administration of a drug by depot injection (with the exception of depot contraception) within 30 days prior to the initial study drug administration or 5 half-lives of that drug, whichever is longer.
* Use of over the counter medications, including aspirin and non-steroidal anti-inflammatory drugs, or natural preparations (dietary supplement or herbal product) within 7 days of the first dose of PF-06881894 or at least 5 half-lives, whichever is longer. Vitamins and calcium supplements are allowed (not to exceed 100% Daily Value). As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect participant safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
* Females using post-menopausal hormone replacement therapy may be eligible to participate in this study if they are willing to discontinue therapy at least 28 days prior to the first dose of study treatment and remain off hormonal therapy for the duration of the study. Hormonal contraceptives that meet the requirements of this study are allowed to be used in participants who are women of childbearing potential.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention (whichever is longer) prior to study entry and/or during study participation. If a participant receives a vaccine or other medical product for the prevention or treatment of COVID-19 authorized under an Emergency Use Authorization, this would not be considered an investigational medical product.
* Hematologic laboratory abnormalities at screening or the Day -5 to Day -4 visit including leukocytosis (defined as total leukocytes \>11,000/μL), leukopenia (defined as total leukocytes \<4000/μL), neutropenia (defined as ANC \<1500/μL) or thrombocytopenia (defined as platelet count of \<150,000/μL).
* A positive urine drug test.
* A positive SARS-CoV-2 infection determined by PCR at screening or Day -5 to Day -4, or determined by a positive COVID-19 antigen test (if performed as part of an investigator site policy).
* Screening supine BP \>= 140 mm Hg (systolic) or \>= 90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is \>= 140 mm Hg (systolic) or \>= 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
* Screening supine 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the participant's eligibility.
* Participants with the following abnormalities in clinical laboratory tests at screening or the Day -5 to Day -4 visit, as assessed by the study specific laboratory will be confirmed by a single repeat test, if deemed necessary. Then the investigator (in consultation with the medical monitor) will determine if the laboratory abnormality is clinically significant and sufficient to exclude the participant from the study.
Lack of adequate hepatic reserve, defined by AST/SGOT or ALT/SGPT \>= 1.5 × ULN of the reference laboratory; TBili \>= 1.5 × ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is \<= ULN.
Lack of renal reserve, defined by serum creatinine of \>= 1.2 × ULN for reference laboratory or eGFR of \<= 80 mL/minute; or known history of glomerulonephritis.
* Drug sensitivity, allergic reaction to, or known hypersensitivity/idiosyncratic reaction to E coli -derived proteins, pegfilgrastim, filgrastim, other G-CSFs or any component of the product or known hypersensitivity to pegylated products or acrylic adhesives. Participants with the rare heredity problem of fructose intolerance are excluded due to the excipient sorbitol.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months of Screening.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* Pregnant female participants, breastfeeding female participants, and male participants able to father children and female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of study intervention.
* Blood donation (including plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing OR had a transfusion of any blood product within 90 days prior to Screening.
* Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol. Male participants with pregnant partners are not to be enrolled in the study, even if the participant is willing to comply with the contraception lifestyle requirements and use a highly effective method of contraception consistently and correctly for the duration of the study and for at least 28 days after the last dose of study intervention.
* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. <Conditions:>Healthy Volunteers <Interventions:>PF-06881894 by on-body injector, PF-06881894 by prefilled syringe | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized', 'Body Mass Index' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial <BriefSummary:>The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and breastfeeding counseling in the peripartum time period <EligibilityCriteria:>Inclusion Criteria:
* Live pregnancy of at least 24 weeks gestation
* Intention to use a contraceptive implant postpartum
* 17 years of age or older
* English or Spanish speaking
* Admission to Labor and Delivery with a plan for delivery (women in both latent and active labor will be eligible)
* The presence of at least one of the following conditions known to be a risk factor for low milk supply:
* Expected delivery prior to 34 weeks
* Obesity (pre-pregnancy BMI \>35)
* Polycystic Ovarian Syndrome
* Diabetes (gestational or pre-gestational)
* Self-reported difficulty with low milk supply in past
Exclusion Criteria:
* Not English or Spanish speaking
* Allergy or Contraindication to contraceptive implant <Conditions:>Contraception, Breastfeeding, Postpartum Contraception <Interventions:>Etonogestrel Contraceptive Implant | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers <BriefSummary:>The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses. <EligibilityCriteria:>Inclusion criteria:
* Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Puls Rate), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
* Age of 18 to 45 years (incl.)
* BMI (Body Mass Index) of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria:
* Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse Rate or ECG - Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy and/or surgery of the gastrointestinal tract (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply <Conditions:>Healthy <Interventions:>BI 655130 (spesolimab), Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563). <BriefSummary:>The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation. <EligibilityCriteria:>Inclusion Criteria:
* Male or female subjects aged 18 to 60 years at the time of the administration of investigational product
* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the US only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
* Physician-diagnosed asthma with a duration of greater than or equal to (\>=) 2 years by medical chart or subject report
* Had an asthma exacerbation requiring urgent care in the year prior to screening
* Meets National Heart, Lung, and Blood Institute (NHLBI) for persistent asthma in the 3 months prior to the current urgent healthcare visit
* Current asthma exacerbation that must have lasted \>= 2 hours prior to arrival to the urgent healthcare setting
* Requires at least 2 treatments of inhaled bronchodilators for the current asthma exacerbation in the urgent healthcare setting or within the emergency medical system (EMS) for \>= 1 hour
* Shows an FEV1 or PEF of not more than 70 percent (%) predicted after 1 hour of treatment of the current asthma exacerbation
* Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual partner) from screening through the end of the study (Day 84; Cessation of birth control after this point should be discussed with a responsible physician)
* Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Day 0 through Day 84
* Otherwise healthy by medical history and physical examination
* A chest x-ray that is normal for an asthmatic population and excludes alternative diagnosis per the investigation
* Ability to complete the follow-up period until Day 168 as required by protocol
* The investigator has determined that the subject is clinically stable and the FEV1, is \>= 30% predicted prior to receiving investigational product on Day 0.
Exclusion Criteria:
* Known history of allergy or reaction to any component of the investigational product formulation
* Acute illness other than asthma at the start of the study
* Fever more than (\>) 38.6 degrees Celsius (C) (\>101.5 degrees Fahrenheit \[F\])
* Current acute asthma attack is due to aspirin-induced asthma
* Current asthma episode is an anaphylactoid/anaphylactic reaction presenting with acute bronchospasm
* Evidence of clinically significant non-respiratory active infection, including ongoing chronic infection
* History or current prolonged diarrhea, abdominal pain, and/or blood and mucus in stools or have minor symptoms and have exposure to stream or lake water, been exposed to someone who has a parasitic infection (like a family member), or study subject has traveled outside the United States of America (USA) and/or Canada within the last year
* Use of immunosuppressive medication (except oral prednisone and inhaled and topical corticosteroids) within 30 days before randomization into the study
* Have received Xolair within 6 months before randomization into the study
* Receipt of immunoglobulin or blood products within 30 days before randomization into the study
* Receipt of any investigational drug therapy within 6 months before the first dose of investigational product in this study through Day 168
* History of primary immunodeficiency
* Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study
* History of clinically significant abnormality on ECG in the opinion of the investigator
* Pregnancy (must have a negative serum pregnancy test prior to the first dose of investigational product)
* Breastfeeding or lactating woman
* History of treatment for alcohol or drug abuse within the past year
* Diagnosis of chronic obstructive pulmonary disease (COPD) by a healthcare professional
* Evidence of any clinically significant systemic disease on physical examination
* History of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy \>1 year prior to entry or other malignancies treated with apparent success with curative therapy \>5 years prior to entry
* Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma
* Any condition (that is, impending ventilatory failure or hemodynamic compromise) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results
* Any employee of the clinical study site who is involved with the conduct of the study
* History of cigarette smoking \>20 pack years
* Previously received benralizumab (MEDI-563)
* Asthma exacerbation due to acute inhalational exposure. <Conditions:>Asthma <Interventions:>Placebo, Benralizumab | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults <BriefSummary:>The investigators developed EM/PROTECT, a behavioral intervention for depressed EM (elderly mistreatment) victims, to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services. PROTECT is built on a model which postulates that chronic stress promotes dysfunction of the cognitive control (CCN) and reward networks, impairing the victims' ability to flexibly respond to the environment and limits their reward activities. PROTECT therapists work with victims to develop action plans to reduce stress, and to increase rewarding experiences. EM/PROTECT has been designed in an iterative process with community EM providers of the New York City (NYC) Department for the Aging (DFTA) to use agencies' routine PHQ-9 depression screening and referral for service. In the current study, the investigators will compare the effectiveness of EM/PROTECT with EM enriched with staff training in linking EM victims to community mental health services (EM/MH). The investigators intend to enroll 50 subjects that will participate in the study for approximately 12 weeks. <EligibilityCriteria:>Inclusion Criteria:
* 55 years of age or older
* Capacity to consent (per Elder Mistreatment staff)
* Significant depression (per Elder Mistreatment staff) as indicated by a score of 10 or above on the Patient Health Questionnaire-9 (PHQ-9), a widely used screening tool routinely administered in Elder Mistreatment (EM) agency settings (the PHQ-9 has a sensitivity of 88% and a specificity of 88% for major depression)
* Need for EM services
Exclusion Criteria:
* Active suicidal ideation (Montgomery Asberg Depression Rating Scale item 10\>4)
* Inability to speak English or Spanish
* Axis 1 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnoses other than unipolar depression or generalized anxiety disorder (by Structured Clinical Interview for DSM-5)
* Severe or life-threatening medical illness
* EM emergency and or referral out of EM agency (per EM staff) <Conditions:>Depression, Depression in Old Age, Elder Abuse, Anxiety <Interventions:>PROTECT with Technology Augmentation | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Clinically Significant Depressive Symptoms, as Measured by the MADRS', 'Assessment of Quality of Life, as Measured by the WHO-QOL', 'Assessment of Stress, as Measured by the PSS', 'Assessment of Meaningful Activities, as Measured by the BADS' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome. <BriefSummary:>The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo. <EligibilityCriteria:>Inclusion Criteria:
* Male, at least 18 years of age
* Has a total NIH-CPSI total score of 15
* Has a NIH-CPSI pain score of 8
* Has had pain in the pelvic region for at least 3 months prior to screening
Exclusion Criteria:
* Has previously participated in a Watson study with silodosin
* Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition
* Has experience ≥2 urinary tract infections within the previous 12 months
* Has any medical condition that in the opinion of the investigator precludes safe participation in the study
* Has any medical condition that could confound the efficacy evaluation
* Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study
* Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation
* Has participated in a study involving the administration of an investigational agent within the past 30 days <Conditions:>Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome <Interventions:>Silodosin 8 mg, Placebo, Silodosin 4 mg | 'Age, Categorical', 'Age Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Phase I Study of Ascending Doses of MMV390048 in Healthy Adult Volunteers <BriefSummary:>This is a first-in-human study of MMV390048. The study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when administered to healthy male volunteers and female volunteers of non-childbearing potential.
In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will be investigated. <EligibilityCriteria:>Inclusion Criteria:
* written informed consent
* Male and female (of non-childbearing potential); age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
* Hematology, clinical chemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant. AST, ALT, lactate dehydrogenase, total bilirubin, haptoglobin and hemoglobin must be within the normal reference ranges
* Body weight at least 50kg and body mass index within 18 to 32kg/m2
* Good peripheral venous access
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* Agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to move away from the study area for the duration of the study
Exclusion Criteria:
* Any acute illness upon admission to the unit on Day -1 or prior to dosing on Day 1
* Use of any other investigational drug within 30 days or five half-lives (whichever is longer) prior to the first dose of MMV390048
* history of hypersensitivity to any drugs
* history of anaphylaxis or severe allergic reaction
* Resting vital signs at either screening or baseline outside the defined ranges
* Orthostatic changes in blood pressure and heart rate measurements greater than: 20 mmHg drop in systolic blood pressure; 10 mmHg drop in diastolic blood pressure; 20 beats per minute increase in heart rate
* history of clinically significant ECG abnormalities, or any of the defined ECG abnormalities at either screening or baseline
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases
* Pregnant or nursing (lactating) women
* Women of child-bearing potential
* males physiologically capable of conceiving offspring UNLESS the volunteer agrees to use condoms and ensure that his partner(s) is either not of child-bearing potential or uses a highly effective method of contraception for the entire duration of the study and for twelve weeks following the last study drug administration
* Smokers (use of tobacco products in the previous three months)
* Use of any prescription drugs, herbal supplements, over--the--counter medication or dietary supplements (vitamins included) within four weeks prior to initial dosing
* Intake of grapefruit, grapefruit juice or other products containing grapefruit within 28 days of the first drug administration of the study drug
* Excessive intake of caffeine drinks or energy drinks within 48 hours before admission defined as more than three 250 ml cups of coffee a day
* Donation or loss of 400 ml or more of blood within eight weeks prior to screening or initial dosing
* Plasma donation (\>100 ml) within 60 days prior to first dosing
* Hemoglobin levels below 12.5 g/dl (males) or 11.5 g/dl (females) at screening
* Haptoglobin levels outside the reference range
* Positive direct anti-globulin test
* Liver enzymes other than ALT, AST and lactate dehydrogenase elevated ≥1.5 x ULN within two weeks prior to initial dosing
* history of autonomic dysfunction within 3 years and/or recurrent history
* History of immunodeficiency diseases, including a confirmed positive HIV test result
* Positive Hepatitis B surface antigen or Hepatitis C antibody test result
* History of recurrent infection
* history of endocrine disease, in particular adrenal disorders such as Cushing's syndrome or Addison's disease, or diabetes mellitus
* history of Gilbert's Syndrome
* history of photosensitivity
* history of any food allergy
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardise the safety of the volunteer or the objectives of the study
* History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or urea values, or abnormal urinary constituents
* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the tests and laboratory assays at screening and/or baseline
* Any clinically significant mental disorder that could limit the validity of informed consent or the volunteer's ability to comply with protocol requirements <Conditions:>Malaria <Interventions:>MMV390048 5mg, MMV390048 20mg, MMV390048 40mg, MMV390048 80mg, MMV390048 120mg, Placebo to match MMV390048 | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Assessing Symptomatic Clinical Episodes in Depression <BriefSummary:>Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD. <EligibilityCriteria:>Inclusion Criteria:
* Currently meets DSM-5 criteria for MDD
* Body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply
Exclusion Criteria:
* Suicide risk
* History of treatment resistance in current depressive episode
* History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
* Additional criteria may apply <Conditions:>Major Depressive Disorder <Interventions:>AXS-05, Bupropion | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use <BriefSummary:>The "Time for Living \& Caring" (TLC) intervention is an online, self-administered intervention, with the purpose of providing informal family caregivers with resources, support, and education to maximize the benefit of their respite time-use (respite is defined as planned time away from caregiving; it can be provided by a formal service provider or informal arrangements within families/networks). The study will use a full-powered pilot sample (anticipated n=150; actual n=166) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention. <EligibilityCriteria:>Inclusion Criteria:
* caregivers to persons with Alzheimer's Disease or Related Dementia (AD/ADRD) (self-identified)
* use formal or informal respite for at least 4 hours per week.
* primary caregiver (self-identified)
* co-residing with the care recipient
* 18 years or older AND
* able to read and write in English.
Exclusion Criteria:
* caregivers to persons with disability or chronic condition, and not Alzheimer's Disease and Related Dementia (AD/ADRD)
* caregivers who do not use respite for at least 4 hours per week
* noncoresidential caregivers
* younger than 18 years
* not able to read and write in English <Conditions:>Anxiety, Burden, Dependency, Caregiver <Interventions:>Time for Living and Caring (TLC) | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Marital Status', 'Education Completed', 'Annual Income' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>AZD1775 in Treating Patients With Advanced Refractory Solid Tumors With CCNE1 Amplification <BriefSummary:>This phase II trial studies how well AZD1775 works in treating patients with solid tumors with CCNE1 amplification that have spread to other places in the body (advanced) and do not respond to treatment (refractory). AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. <EligibilityCriteria:>Inclusion Criteria:
* Patients must have one of the histologically advanced solid tumors harboring CCNE1 amplification: Their diseases are refractory to, or do not have, standard-of-care therapy; or they declined standard-of-care therapy; CCNE1 amplification is defined in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory: CCNE1 amplification \> 7 based on targeted custom Ampliseq panel on the Ion Torrent Personal Genoma Machine (PGM); or CCNE1 amplification on alternate CLIA platforms such as Foundation One, University of Washington (UW)-OncoPlex-Cancer Gene Panel, Memorial Sloan Kettering (MSK)-Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT), Solid Tumor Genomic Assay (Life Technologies), etc. will also be eligible to be treated after principal investigator (PI) approval; patients with known CCNE1 amplification on local or commercial platforms can start treatment after planned biopsy or submission of recent archival sample; central next generation sequencing (NGS) CCNE1 and fluorescence in-situ hybridization (FISH) testing will be performed to confirm the result
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Has read and understands the informed consent form (ICF) and has given written ICF prior to any study procedures; patients with impaired decision making capacity (IDMC) must have a close caregiver or legally authorized representative (LAR)
* Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
* Absolute neutrophil count (ANC) \>= 1500/uL (within 14 days of study drug\[s\] initiation)
* Hemoglobin (HgB) \>= 9 g/dL for mono-therapy (within 14 days of study drug\[s\] initiation)
* Platelets \>= 100,000/uL (within 14 days of study drug\[s\] initiation)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) or =\< 5 x ULN if known hepatic metastases (within 14 days of study drug\[s\] initiation)
* Serum bilirubin \< ULN or \< 1.5 x ULN in patients with liver metastases; or total bilirubin \< 3.0 x ULN with direct bilirubin within normal limits (WNL) in patients with well documented Gilbert's syndrome (within 14 days of study drug\[s\] initiation)
* Serum creatinine =\< 1.5 x ULN, or calculated creatinine clearance (CrCl) \>= 45 mL/min as calculated by the Cockcroft-Gault method or 24-hour measured urine CrCl \>= 45 mL/min (within 14 days of study drug\[s\] initiation)
* Female patients who are not of child-bearing potential and fertile females of childbearing potential who agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 3 days prior to the start of study treatment; male patients willing to abstain or use barrier contraception (i.e. condoms) for the duration of the study and for 3 months after treatment stops
* Willingness and ability to comply with study and follow-up procedures
* Ability to take oral medications without medical history of malabsorption or other chronic gastrointestinal disease, or other conditions that may hamper compliance and/or absorption of the study agent
* No prior treatment with wee1 kinase inhibition
* Provision of an archival tissue block, or 10 formalin-fixed paraffin-embedded (FFPE) slides, if available, and if not available having biopsiable disease and agreeing to pre-treatment biopsies
Exclusion Criteria:
* Use of anti-cancer treatment drug =\< 21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775; for drugs for which 5 half-lives is =\< 21 days, a minimum of 10 days between termination of the prior treatment and administration of AZD1775 treatment is required
* Previous radiation therapy completed =\< 7 days prior to the start of study drugs
* Major surgical procedures =\< 28 days of beginning AZD1775, or minor surgical procedures =\< 7 days; no waiting period required following port-a-cath or other central venous access placement
* Unresolved grade 2 toxicity from prior therapy (except alopecia or anorexia)
* Patient has an inability to swallow oral medications; Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN)
* No other anticancer-therapy (chemotherapy, immunotherapy, hormonal anti-cancer therapy, radiotherapy \[except for palliative local radiotherapy\]), biological therapy or other novel agent is to be permitted while the patient is receiving study medication; patients on luteinizing hormone-releasing hormone (LHRH) analogue treatment for more than 6 months are allowed entry into the study and may continue at the discretion of the investigator
* Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression or hemorrhage for at least 2 weeks after treatment; must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrolment
* Patient has had prescription or non-prescription drugs or other products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks prior to day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug; co-administration of aprepitant or fosaprepitant during this study is prohibited; the use of sensitive substrates of CYP3A4, such as atorvastatin, simvastatin and lovastatin, is also prohibited in this study
* Herbal preparations are not allowed throughout the study; these herbal medications include but are not limited to: St. John's wort, kava, ephedra (ma hung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng; patients should stop using these herbal medications 7 days prior to first dose of study treatment
* Any known hypersensitivity or contraindication to the components of the study drug AZD1775
* Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) \>= class 2
* Unstable angina pectoris
* Congestive heart failure
* Acute myocardial infarction
* Conduction abnormality not controlled with pacemaker or medication
* Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
* Mean resting corrected QTc interval using the Fridericia formula (QTcF) \> 450 msec/male and \> 470 msec/female (as calculated per institutional standards) obtained from 3 electrocardiograms (ECGs) 2-5 minutes apart at study entry, or congenital long QT syndrome
* Pregnant or breastfeeding women
* Serious active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment
* Symptomatic and uncontrolled metastasis in the central nervous system or leptomeningeal or lymphangitic carcinomatosis
* Presence of other active invasive cancers that do not harbor CCNE1 amplification
* Grade 2 or higher peripheral neuropathy
* Human immunodeficiency virus requiring highly active antiretroviral therapy (HAART) treatment due to unknown drug-drug interactions or has known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive or C virus \[e.g., hepatitis C virus (HCV) RNA (quantitative) is detected\]) infection <Conditions:>Advanced Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm <Interventions:>Adavosertib | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Incentives for Oklahoma Tobacco Helpline Engagement in Persistent Poverty Counties <BriefSummary:>The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation counseling and self-reported abstinence at follow-up among Oklahoma Tobacco Helpline (OTH) callers living in persistent poverty counties (PPCs). The study will enroll at least 160 adults who reside in any of the 16 persistent poverty counties in Oklahoma, who are seeking smoking cessation treatment through the OTH. <EligibilityCriteria:>Inclusion Criteria:
1. Contact the OTH seeking smoking cessation treatment
2. Reside in any of the 16 PPCs in Oklahoma (Adair, Caddo, Cherokee, Choctaw, Greer, Harmon, Haskell, Hughes, Johnston, McCurtain, Okfuskee, Payne, Pushmataha, Seminole, Sequoyah, Tillman)
3. Report smoking ≥ 5 cigarettes per day
4. Are ≥ 18 years of age
5. Are able to provide a copy/photo of their ID/driver's license or other documentation of identity and residence
6. Be able to read, speak, and understand English
7. Have no contradictions for NRT <Conditions:>Cigarette Smoking, Nicotine Dependence <Interventions:>Coaching calls, Nicotine replacement therapy, Financial Incentives | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Cigarettes Smoked Per Day (pre-quit)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Tolerance Following Peanut Oral Immunotherapy <BriefSummary:>The unifying objective of this project is to determine whether peanut oral immunotherapy (PN OIT) induced clinical tolerance in the context of food allergy is significantly associated with the expansion of a specific regulatory T cell subset (CD45RA- CD25++ FoxP3++) that is thought to be inducible in the gut-associated lymphoid compartment and associated with immunological tolerance.
The hypothesis of the study is that the induction of Treg cells will be associated with clinical tolerance.
The investigators will measure the change from baseline of induced Treg cells as a frequency of total CD4 T cells during active treatment and compare that between participants who achieve significant clinical tolerance (Tolerance and Partial Tolerance Groups as defined below) and those who do not (Treatment Failure Group). <EligibilityCriteria:>Inclusion Criteria:
* Diagnosis of peanut allergy by a positive skin prick test to peanut (reaction wheal at least 5 mm larger than saline control) and by medical history or Serum peanut-specific IgE \>5 kU/L at screening visit.
* Ara h 2 specific IgE \>0.35 kU/L at screening visit
* Ability to provide informed consent.
* Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy.
* React to less than 443 mg of peanut protein during DBPCFC1
Exclusion Criteria:
* History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 \<92% during reaction), documented hypotension (documented systolic BP \>30% below predicted normal for sex, height, weight or from known baseline), neurological compromise (confusion, loss of consciousness), or incontinence.
* Severe or Moderate asthma as defined using the severity criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/).
* Poorly-controlled asthma as defined by FEV1 \<80% or any of the following symptoms: nighttime awakening \>2 days/week or rescue medication use \>2 days / week.
* Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
* Inability to cooperate with and/or perform oral food challenge procedures.
* Primary Immune Deficiency
* Allergy to oat confirmed by skin prick testing and history
* Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
* Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
* Hemoglobin level less than 12.5 gm/dL at screening. Weight \<23 kg
* Use within the past 6 months of other systemic immunomodulatory treatments including allergen immunotherapy, or use of biologics with an immune target, including omalizumab.
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study. <Conditions:>Peanut Allergy <Interventions:>Peanut Flour, Oat Flour | 'Age, Categorical', 'Age, Continuous', 'Sex/Gender, Customized', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Peanut-specific IgE' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients <BriefSummary:>Malnutrition and underfeeding are major challenges in caring for critically ill patients. Continuous feeding were thought to be better tolerated by patients with the limited absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube clogging and required the patient to be attached to an infusion pump for significant periods of time. Intermittent infusion resembled more physiological feeding process, which allowed greater patient mobility and might reach goal enteral calories earlier, and the latter were considered to effectively decrease the length of stay (LOS)-in-hospital and mortality. However, it also had some previous study found that intermittent infusion had more complications, such as diarrhea, regurgitation than continuous. Some study found that it was an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding intolerance. The primary goal of this was to study whether receiving semi-solidification of nutrients could increase the percent prescribed calories received by improving the feeding intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV). <EligibilityCriteria:>Inclusion Criteria:
(1)14 years and older, who received EN for more than 72 hours, were eligible for inclusion (2) all patients started on EN by nasogastric tube
Exclusion Criteria:
1. received EN \<72 hours
2. received EN prior to ICU admission
3. had acute pulmonary infection
4. had history of Gastrointestinal surgery
5. had contraindications of EN, such as intestinal obstruction (mechanical or paralytic ileus). <Conditions:>Nutrition, Enteral <Interventions:>semi-solid agent with standard enteral feeding, standard enteral feeding | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'NRS 2002' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>TAS-OX for Refractory Metastatic Colon Cancer <BriefSummary:>This study will examine the safety and effectiveness of oxaliplatin in combination with TAS-102 (TAS-OX) for treatment of patients with metastatic colorectal cancer whose cancer has progressed or recurred after FOLFOX chemotherapy. <EligibilityCriteria:>Inclusion Criteria:
1. Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan and oxaliplatin. Patients who could not tolerate standard agents because of unacceptable, but reversible, toxicity necessitating their discontinuation will be allowed to participate.
2. Patients who had received adjuvant chemotherapy and had recurrence during or within 6 months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen.
3. Progression of disease must be documented on the most recent scan.
4. Presence of measurable disease (not required for Phase 1 portion of the trial).
5. Retrovirus-associated DNA sequences (RAS) mutation and mismatch repair (MMR) status must be determined (or tissue availability for testing if not already determined)
6. Age 18 years or older.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
8. Life expectancy of at least 3 months.
9. Patient with adequate organ function:
1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
2. Hemoglobin ≥ 9 g/dL
3. Platelets (PLT) ≥ 75 x 109/L
4. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 5 x Upper limit of normal (ULN)
5. Total serum bilirubin of ≤1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a medical diagnosis of Gilbert's syndrome).
6. Albumin ≥ 2.5 g/dL
7. Serum creatinine ≤ 1.5 x institutional ULN (Cockcroft and Gault formula)
10. Adequate contraception if applicable.
11. Women who are nursing must discontinue nursing prior to enrollment in the program.
12. Ability to take oral medication (i.e. no feeding tube).
13. Patient able and willing to comply with study procedures as per protocol.
14. Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.
Exclusion Criteria:
1. Patients who have previously received TAS-102.
2. Grade 2 or higher peripheral neuropathy.
3. Symptomatic Central nervous system (CNS) metastases requiring treatment.
4. Other active malignancy within the last 3 years (except for non-melanoma skin cancer or a non-invasive/in situ cancer).
5. Pregnancy or breast feeding.
6. Current therapy with other investigational agents.
7. Active infection with body temperature ≥38°C due to infection.
8. Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to drug administration).
9. Any anticancer therapy within prior 3 weeks of first dose of study drug.
10. History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102.
11. Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior 4 weeks.
12. Grade 3 or higher hypersensitivity reaction to oxaliplatin, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication.
13. Unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).
14. Extended field radiation within prior 4 weeks of first dose of study drug or limited field radiation within prior 2 weeks of first dose of study drug.
15. Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.
16. Involvement in the planning and/or conduct of the study.
17. Previous enrollment in the present study. <Conditions:>Colorectal Neoplasms <Interventions:>combined TAS-102 and TAS-OX | 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'ECOG', 'Location of primary tumor, No.', 'Stage at diagnosis', 'Histology', 'High microsatellite instability', 'KRAS/BRAF mutation', 'Number of prior therapies', 'Progression during prior oxaliplatin' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Angiotensin Receptors and Age Related Mitochondrial Decline in HIV Patients <BriefSummary:>This study is designed to evaluate specific factors in mitochondria that may precipitate premature aging and physical weakness in HIV patients. Angiotensin receptors 1 and 2 (AT1R and AT2R) are found in virtually every cell type. This study will evaluate how the relationships among these receptors in immune and skeletal muscle cells change with HIV, and how these changes might trigger mitochondrial dysfunction, declines in muscle strength, and cellular decline in people living with HIV. <EligibilityCriteria:>Inclusion Criteria:
* able to provide informed consent
* able to attend an extended (\~4 hour) Clinical Research Visit
* documented HIV seropositivity
* on a stable anti-retroviral therapy (ART) regimen for at least 12 months
* HIV plasma viral load \< 50 copies/ml for at least 6 months
* Systolic blood pressure \>110
Exclusion Criteria:
* creatinine \> 1.5 ULN (or creatinine clearance \< 60 ml/min)
* anti-hypertensive therapy with ACE-I or AT1R-blockers
* inability to perform functional measures (e.g. non-ambulatory without assistance, requires a prosthesis)
* recent (within 30 days) acute illness requiring medical therapy or hospitalization
* immunosuppressive agents (e.g. \> 20 mg/d x 2 or more weeks of prednisone or equivalent, chemotherapy) in the last 6 months
* cancer requiring treatment w/in 3 yrs (except for non-melanoma skin cancer)
* blood thinning medications such as Coumadin or Plavix or a bleeding disorder such as hemophilia that could cause complications during muscle biopsies
* pregnancy (will provide urine test for females of child bearing potential)
* regular use of non-steroidal anti-inflammatory drugs or other immune modulating agents. <Conditions:>HIV, Aging, Sarcopenia, Angiotensin Receptor Antagonists <Interventions:>valsartan, Placebo | 'Age, Categorical', 'Sex/Gender, Customized', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of Malaria Vaccine RTS,S/AS01E in Plasmodium Falciparum-infected and Uninfected Adults Pre-treated With Anti-malarial Therapy <BriefSummary:>The main goal of this study is to assess the efficacy of RTS,S/AS01E, a candidate vaccine against malaria caused by Plasmodium falciparum (P. falciparum), in adults positive for P. falciparum at the start of the study, but treated with anti-malarial medications to clear the parasite before receiving multiple doses of the vaccine. The goal is to overcome the reduced vaccine efficacy (hypo-responsiveness to the vaccine) reported in actively or chronically infected adults. <EligibilityCriteria:>Inclusion Criteria:
* Provision of signed or thumb printed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female between 18 and 55 years of age, inclusive
* In good general health as evidenced by medical history and clinical examination before entering the study
* Ability to take oral medication and be willing to adhere to the medication regimen
* For females, she must be of non-childbearing potential or use appropriate measures to prevent pregnancy for 30 days prior to vaccination through 2 months after completion of the vaccine series. Non-childbearing potential means she is surgically sterilized or at least one year post-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant or Depo-Provera). Clinical trial site staff will assist with provision of acceptable birth control for study entry and will discuss with volunteer at screening visit.
Exclusion Criteria:
* Planned administration/administration of a vaccine not foreseen by the study protocol from within 30 days before the first dose of study vaccine until 30 days after the last dose of study vaccine.†
† In the context of the COVID-19 pandemic, the administration of the COVID-19 vaccine will be allowed as an exception to this exclusion criteria as follows. The study team will work with the participant to attempt to have any COVID-19 vaccine administration occur 30 days or more before or after study vaccinations. When this is not possible, COVID-19 vaccination will be allowed 10 days or more before or after study vaccination. Intervals shorter than 10 days can be allowed on a case-by-case basis in discussion with the sponsor.
* Any prior receipt of any rabies vaccine or experimental malaria vaccine.
* Confirmed or suspected significant immunosuppressive or immunodeficient condition as determined by the investigator, including clinical stage 3 or 4 human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic reactions, significant immunoglobulin E (IgE)-mediated events or anaphylaxis to previous immunizations.
* History of any neurologic disorders.
* Acute disease (defined as the presence of a moderate or severe illness with or without fever), including acute malaria, at the time of enrolment. All vaccines can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory infection without fever, i.e. Oral temperature \< 37.5°C\*. Individuals excluded with acute disease, including acute malaria, can become eligible again after complete recovery of the illness, including appropriate treatment as applicable, and can be rescreened at a later date. \*Temperature readings may be taken by site staff either using either oral, axillary, or infrared thermal thermometers during clinic or field visits, while subjects enrolled in the reactogenicity cohort will be supplied with oral thermometers for the purposes of recording their own temperature measurements in the memory aid over 7 days after each vaccination.
* Acute or chronic, clinically significant pulmonary, cardiovascular (including cardiac arrythmias) , hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory screening tests.
* History of homozygous sickle cell disease (Hgb SS).
* Any clinically significant laboratory abnormalities as determined by the investigator on screening labs.
* History of splenectomy.
* Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant (i.e. a positive pregnancy test) or lactating female during immunization phase of the study (refer to section 2.3 for rationale). If a woman becomes pregnant after all vaccinations are complete, she will not be excluded from the remainder of the study.
* Female planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase.
* History of chronic alcohol consumption and/or drug abuse.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
* Major congenital defects or serious chronic illness.
* Simultaneous participation in any other clinical trial \[apart from participation in the Health and Demographics Surveillance System (HDSS) network\].
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial. <Conditions:>Plasmodium Falciparum <Interventions:>Malaria Vaccine RTS,S/AS01E, Abhayrab rabies vaccine, Dihydroartemisinin-piperaquine (DHA/Pip), Artemether / Lumefantrine, Primaquine | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>European Sickle Cell Disease Cohort - Hydroxyurea <BriefSummary:>In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease. <EligibilityCriteria:>Inclusion Criteria:
* Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults)
* With symptomatic sickle cell syndrome
* Treated with Siklos®
* Having been informed of the study by the initiating physician and consenting to participate to the cohort. <Conditions:>Sickle Cell Disease <Interventions:>Siklos | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema <BriefSummary:>To investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm. <EligibilityCriteria:>Inclusion Criteria:
The subject must be a breast cancer survivor, at least three years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention.
* Ages 18 to 75 years (inclusive).
* Swelling of 1 limb that is not completely reversed by elevation or compression
* Stage II or greater lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
* Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 8 weeks prior to screening, including use of compression garments for at least 8 weeks without change in regimen
* Willingness to maintain a stable regimen of self-care, with consistent use of compression garments from screening through the entire study duration (through the safety follow-up visit). Self-bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens must remain consistent from screening though the entire study duration.
* Two consecutive measurements of limb volume (LV) in the affected limb taken at least 1 day apart during the screening period must be within 10% of each other. A maximum of 3 measurements can be taken. Affected limb volume ratio \>20% (affected limb compared to unaffected limb); volume measurements will be performed and volume ratio will be calculated at S1 and S2 visit.
* Evidence of abnormal bioimpedance ratio, if feasible based upon unilateral disease: L-Dex \>10 units; bioimpedance performed at S1 and S1
* Willingness and ability to understand and the willingness to sign a written informed consent form document
* Willingness and ability to comply with all study procedures, including measurement of skin thickness using skin calipers.
* Participants must have NED, completed breast cancer therapy 3 years prior to enrollment.
* ECOG 0- 2
Exclusion Criteria:
* Edema arising from increased capillary filtration will be excluded.
* Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
* Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half-life, whichever is longer
* Recent initiation of (≤8 weeks), or intention to initiate, CDPT or maintenance physiotherapy for lymphedema at any time during the duration of the study
* Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis
* Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion)
* History of clotting disorder (hypercoagulable state)
* Chronic (persistent) infection in the affected limb
* Any other infection (unrelated to lymphedema) within 1 month prior to screening
* Current evidence of malignancy or any high risk for breast cancer recurrence (Stage III or IV, ER/PR/HER-2 negative (triple negative) cancer , locally advanced disease, inflammatory breast cancer, \> 3 positive axillary lymph nodes, extracapsular nodal extension, invasive micropapillary breast carcinoma, or if performed, patients with a high risk of recurrence based on multi-gene signatures, e.g. BRCA1, BRCA 2, Oncotype DX (high risk recurrence score) or Mammaprint (poor risk signature)
* Currently receiving chemotherapy or radiation therapy
* Life expectancy \< 2 years for any reason
* Pregnancy or nursing
* Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
* Significant or chronic renal insufficiency (defined as serum creatinine \> 2.5 mg/dL or an estimated glomerular filtration rate \[eGFR\] \< 30 mL/min at screening) or requires dialytic support
* Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels \> 3 × upper limit of the normal range (ULN) and/or bilirubin level \> 2 × ULN at screening
* Absolute neutrophil count \< 1500 mm3 at screening
* Hemoglobin concentration \< 9 g/dL at screening
* Known sensitivity to porcine products
* Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study <Conditions:>Lymphedema, Edema <Interventions:>Biobridge and lymph node transfer | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma <BriefSummary:>This 52 week study will assess the use of intravitreal aflibercept injections in patients with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.
The investigators hypothesize that the neovascularization of the iris and angle present in neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept injection alone and result in increased comfort and preservation of visual field as compared to current standard of care utilizing pan-retinal photocoagulation. The advantages to intravitreal aflibercept injection use could include resolution of NVI/NVA (neovascularization of the iris/neovascularization of the angle) leading to quicker pain relief and quicker lowering of IOP (intraocular pressure). <EligibilityCriteria:>Inclusion Criteria:
* Patients with a diagnosis of neovascular glaucoma (Stage I-II)
* Individuals who are ages 21-90 years old; male or female of any race
* Presence of neovascularization of the iris and/or angle
* At least 90 degrees of "unzipped" anterior chamber angle as noted by gonioscopy. (a "zipped angle is the term used for a drainage angle that is slowly closing due to scar tissue from the neovascularization process)
* Visual acuity of light perception or better in the study eye
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
Exclusion Criteria:
* Use of intravitreal anti-VEGF agents in the study eye in the past 3 months.
* Full PRP in the study eye
* Prior vitrectomy in the study eye
* Prior trabeculectomy or other filtration surgery in the study eye
* Active ocular or periocular infection in the study eye
* Ocular conditions (Cataract or vitreous hemorrhage) that might require surgery in next 12 months
* Allergy to fluorescein dye
* Any past use of systemic anti-VEGF medication
* Myocardial infarction within 6 months prior to study enrollment
* Stroke within 6 months prior to study enrollment
* Pregnant or breast-feeding women
* Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study <Conditions:>Neovascular Glaucoma <Interventions:>Aflibercept | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) <BriefSummary:>The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (\>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period. <EligibilityCriteria:>Inclusion Criteria:
* Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (\>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits
* Severe pruritus was defined as follows on the PP NRS:
1. At the screening visit (Visit 1): PP NRS score was \>= 7.0 for the 24-hour period immediately preceding the screening visit.
2. At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score was \>= 7.0 over the previous week
* Female participants of childbearing potential (that is \[i.e,\], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
Exclusion Criteria:
* Body weight less than \< 30 kg
* Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example \[eg\] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care
* Unilateral lesions of prurigo (eg, only one arm affected)
* History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma \[mycosis fungoides or Sezary syndrome\], chronic actinic dermatitis, dermatitis herpetiformis)
* Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis
* Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis
* Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit
* Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\], hepatitis C (HCV) antibody with positive confirmatory test for HCV (eg, polymerase chain reaction \[PCR\]), or human immunodeficiency virus antibody) at the screening visit <Conditions:>Prurigo Nodularis <Interventions:>Nemolizumab, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia <BriefSummary:>Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).
Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population). <EligibilityCriteria:>Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):
1. Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with:
* AML arising from MDS or another antecedent hematologic disease (AHD).
* AML after previous cytotoxic therapy or radiation (secondary AML).
2. 18 years of age (In Japan, 20 years of age).
3. Adequate Organ Function as defined by the following:
* Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.
* Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).
* Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.
4. QTc interval 470 msec using the Fridericia correction (QTcF).
5. All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines.
* For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.
6. Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.
7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.
8. Female subjects of non childbearing potential must meet at least 1 of the following criteria:
1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
2. Have medically confirmed ovarian failure; or
3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
9. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow \[BM\] assessments).
Exclusion Criteria:
Subjects with any of the following characteristics/conditions will not be included in the study:
1. Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).
2. AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality.
* Complex genetics may include t(9;22) cytogenetic translocation.
3. Subjects with known active CNS leukemia.
4. Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.
5. Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.
6. Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.
7. Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as \<50 bpms.
8. Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.
9. Subjects with left ventricular ejection fraction (LVEF) \<50% are excluded from the Intensive Chemotherapy Study only.
10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.
11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.
12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.
13. Concurrent administration of herbal preparations.
14. Major surgery or radiation within 4 weeks of starting study treatment.
15. Documented or suspected hypersensitivity to any one of the following:
* For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.
* For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.
16. Known active drug or alcohol abuse.
17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
18. Pregnant females or breastfeeding female subjects.
19. Known recent or active suicidal ideation or behavior.
20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study. <Conditions:>Leukemia, Myeloid, Acute <Interventions:>glasdegib, daunorubicin + cytarabine, azacitidine, Placebo, Placebo, glasdegib, cytarabine, HSCT | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Methadone Maintenance for Prisoners <BriefSummary:>This five-year study examines the benefits of methadone maintenance treatment initiated in prison and continued in the community to male offenders who were previously, but not currently, heroin-dependent. It is anticipated that such prisoners will have more favorable outcomes in the year following release with regard to drug abuse, crime, and HIV risk behavior than either prisoners who receive counseling only or begin initiation of methadone maintenance in the community <EligibilityCriteria:>Inclusion Criteria:
* Heroin dependence in the year prior to current incarceration
* 3-6 months left to serve in prison-male pre-release inmate suitability for methadone maintenance as determined by medical evaluation
* Willingness to enroll in methadone maintenance
* Having a Baltimore address
Exclusion Criteria:
* Pending parole hearing
* Pending charges
* Kidney failure
* Liver failure <Conditions:>Heroin Addiction <Interventions:>Counseling Only, Counseling + Transfer, Counseling + Methadone | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin <BriefSummary:>Primary Objective:
* To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus
Secondary Objectives:
* To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
* To compare the incidence and frequency of hypoglycemic episodes
* To assess the safety and tolerability of the new formulation of insulin glargine <EligibilityCriteria:>Inclusion criteria :
* Participants with Type 1 diabetes mellitus
Exclusion criteria:
* HbA1c greater than (\>) 9% (at screening)
* Participants receiving \>0.5 U/kg body weight basal insulin in the last 30 days prior to screening visit
* Participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last 30 days prior to screening visit
* Less than 1 year on any basal plus mealtime insulin
* Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
* Use of an insulin pump in the last 6 months before screening visit;
* Any contraindication to use of insulin glargine as defined in the national product label
* Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening
* Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization
* Initiation of any glucose-lowering agents in the last 3 months before screening visit
* Weight change of greater than equal to (\>=) 5 kg during the last 3 months prior to screening visit
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require laser, surgical treatment or injectable drugs during the study period
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. <Conditions:>Type 1 Diabetes Mellitus <Interventions:>HOE901-U300 (new formulation of insulin glargine), Lantus (insulin glargine) | 'Age, Continuous', 'Sex: Female, Male', 'Body Mass Index (BMI)', 'Glycated Hemoglobin (HbA1c)', 'Duration of Diabetes', 'Basal Insulin Daily Dose', 'Total Insulin Daily Dose' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome <BriefSummary:>Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette Syndrome. <EligibilityCriteria:>Inclusion Criteria:
1. Have a clinical diagnosis of Tourette Syndrome (TS)
2. Have at least moderate tic severity
3. Have TS symptoms that impair school, occupational, and/or social function
4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
5. Be in good general health
6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
Exclusion Criteria:
1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
2. Have a known history of long QT syndrome or cardiac arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening
7. Have a known history of substance dependence, substance (drug) or alcohol abuse
8. Have a significant risk of suicidal or violent behavior
9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study <Conditions:>Tourette Syndrome <Interventions:>NBI-98854, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>HIV+ Substance Users Released From Jail <BriefSummary:>The long-term goal of this project is to improve HIV and substance use outcomes and reduce recidivism for HIV+ substance users released from jail. The overall objective of the proposed R34 project is to develop and pilot test a multi-sector community-clinic collaborative intervention that can subsequently be implemented on a larger scale (as part of a future R01) to achieve this goal. Our central hypothesis is that HIV+ substance users released from jail can successfully overcome obstacles to re-entry and continuity of HIV care with individualized, culturally competent assistance in navigating both social and medical services.
Aim 1: Develop and refine a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.
Aim 2: Conduct a pilot randomized controlled trial comparing the collaborative intervention (n=40) compared to treatment as usual (n=40) in HIV+ substance users released from jail. <EligibilityCriteria:>Inclusion Criteria:
* HIV-infected AND
* ≥18 years old AND
* report or have medical records documenting any opioid (illicit or prescription misuse), stimulant (cocaine, ecstasy, or amphetamines), or heavy alcohol use (as determined by the 3-item Alcohol Use Disorders Identification Test (AUDIT-C) within the past 12 months
* Provide two forms of contact information (address, phone number, email, other locator info) AND
* HIV VL \>200 copies/mL within past 90 days OR
* No HIV visit in 6 months OR Self-reported non-adherence to medications
Exclusion Criteria:
* Unwilling to participate
* Unable to consent
* Does not speak English
* Unwilling to participate
* Unable to consent
* Does not plan to remain in greater Dallas area after release Sentenced to prison or other court-mandated program for ≥6 months
* Does not speak English
* Have an acute medical or psychiatric disorder that would, in the judgment of the PI, make participation difficult or unsafe. <Conditions:>HIV/AIDS, Substance Use Disorders <Interventions:>DOORS-CHW Intervention | 'Age, Continuous', 'Sex/Gender, Customized', 'Race/Ethnicity, Customized', 'CD count' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma <BriefSummary:>A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma <EligibilityCriteria:>Inclusion Criteria:
* Age. 12-80
* Documented physician-diagnosed asthma for at least 12 months
* Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.
* Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
* At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
* Morning pre-BD FEV1 \<80% predicted normal (\<90% for subjects 12-17 yrs)
* Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
* Documented history of at least 2 asthma exacerbation events within 12 months.
* ACQ-6 score ≥1.5 at screening and on day of randomization
Exclusion Criteria:
* Pulmonary disease other than asthma.
* History of cancer.
* History of a clinically significant infection.
* Current smokers or subjects with smoking history ≥10 pack-years and subjects using vaping products, including electronic cigarettes.
* History of chronic alcohol or drug abuse within 12 months.
* Hepatitis B, C or HIV.
* Pregnant or breastfeeding.
* History of anaphylaxis following any biologic therapy.
* Subject randomized in the current study or previous tezepelumab studies. <Conditions:>Asthma <Interventions:>Experimental: Tezepelumab, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial <BriefSummary:>The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment. <EligibilityCriteria:>Inclusion Criteria:
* Subject or legal guardian willing and able to sign and date the Informed Consent Form (and Authorization to Use and Disclose Health Information Form, if applicable)
* Subject indicated for a concomitant surgical repair of the TV
* Subject is willing to return for required follow-up visits to the hospital where the implantation originally occurred
Exclusion Criteria:
* Subject with a degenerative TV condition
* Subject with primary TV regurgitation
* Subject with a previous TV repair or replacement
* Subject indicated for a stand-alone TV repair
* Subject currently participating in an investigational drug or another device study
* Subject with life expectancy of less than one year
* Subject is pregnant or desires to be pregnant within 12 months following implantation
* Subject is under 18 or over 85 years of age
* Subject with active endocarditis
* Subject with valvular retraction with severely reduced mobility
* Subject with a heavily calcified TV <Conditions:>Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency <Interventions:>Contour 3D® implant for tricuspid valve repair, Tri-Ad® implant for tricuspid valve repair | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Internet Self-Management Program With Telephone Support for Adolescents With Arthritis <BriefSummary:>This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL). <EligibilityCriteria:>Inclusion Criteria:
* adolescents 12 to 18 years
* diagnosed with JIA,
* able to speak and read English or French
* able to complete baseline online outcome measures.
Exclusion Criteria:
* cognitive impairment
* major co-morbid illnesses (medical or psychiatric) which may impact their ability to understand and use the web-based program. <Conditions:>Juvenile Idiopathic Arthritis <Interventions:>Teens Taking Charge, Self-Management | 'Age, Categorical', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors <BriefSummary:>To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) <EligibilityCriteria:>Inclusion Criteria:
1. At least 18 years of age
2. Measurable disease as defined by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
4. Agree to provide tumor tissue and blood samples for biomarker assessment
Exclusion Criteria:
1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.
2. Prior therapy with a chimeric antigen receptor T cell-containing regimen
3. History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
4. History of myocarditis regardless of the cause
5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
6. History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
7. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic <Conditions:>Solid Tumor, Unresectable or Metastatic Melanoma <Interventions:>CX-072, Ipilimumab | 'Age, Categorical', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) <BriefSummary:>To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms. <EligibilityCriteria:>Inclusion Criteria:
* Confirmed IBS diagnosis per Rome II for diagnosis of IBS.
* Colonoscopy within 2 years as part of IBS diagnostic evaluation.
* Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.
Exclusion Criteria:
* Symptoms of constipation.
* History of other gastrointestinal diseases.
* Type 1 or 2 diabetes.
* Lactose intolerance not controlled by lactose-free diet. <Conditions:>Non-Constipation Irritable Bowel Syndrome <Interventions:>Rifaximin, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy <BriefSummary:>Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)).
This non-confirmatory Phase 2 study was designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes and nephropathy. <EligibilityCriteria:>Inclusion Criteria:
* Male/female patients, 18-75 years
* Written informed consent
* Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening
* Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at screening while receiving a dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker that is the standard of care as judged by the study doctor.
Exclusion Criteria:
* History of type 1 diabetes mellitus
* Severe renal impairment manifesting as serum creatinine eGFR \< 30 mL/min/1.73 m\^2 at screening
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, unless they are using basic methods of contraception during dosing of study treatment
* Uncontrolled diabetes mellitus at screening
* History or current diagnosis of ECG abnormalities prior to first study dose
* History of kidney disease other than diabetic nephropathy at screening
* Uncontrolled hypertension at screening
* Use of prohibited medications, including but not limited to GLP-1 agonists and SGLT2 inhibitors. <Conditions:>Diabetic Nephropathy <Interventions:>Nidufexor, Placebo, Standard of Care (SoC) | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes <BriefSummary:>Opioid analgesics are the most common postoperative pain medications used among dentists in the United States.Although these medications are highly effective in the postoperative dental pain management, not all patients optimally benefit from this therapy. Many suffer adverse consequences such as nausea, emesis, and psychomotor impairment, and there is a high prevalence of opioid prescription misuse among substance abusers within the dental patient population.
The use of non-opioid analgesics including ibuprofen and acetaminophen in the management of postoperative dental pain has demonstrated equivalent or superior analgesic effects compared to opioid analgesic therapies, typically with significantly less adverse effects.However, despite these results, dentists have encountered a high variability in the success of non-opioid analgesic responses among the postoperative dental pain population.Thus, new strategies for earlier recognition of analgesic responses for pain medications is fundamental in the field of dentistry. Therefore, this study will evaluate the clinical utility of pharmacogenomic testing in acute postoperative dental pain management among healthy adults who undergo extraction of impacted mandibular third molar. <EligibilityCriteria:>Inclusion Criteria:
* Patients who are able to read, comprehend, and sign the consent form, and willing to stay in the study unit for up to 12 hours.
* Patients who are reliable, cooperative, and of adequate intelligence to record the requested information on the questionnaire form(s).
* Women of childbearing potential who are not pregnant, as assessed by a urine pregnancy quick test on the day of the procedure, prior to surgery. Women must be using a method of birth control deemed acceptable by the investigator and continue to use this method during the duration of dosing with study medication
* Patient who develop sufficient levels of pain (rated at 50mm or more out of a 100 mm) on the DPIS within 6 hours post-surgical extraction.
* Patients who agree not to take analgesics other than protocol-defined rescue analgesics during the post-operative treatment period of 6 hours.
* Patients who agree to refrain from alcohol and sedative consumption during the post-operative period of 6 hours.
* Patients scheduled to undergo surgical removal of 3 or more impacted third molars, at least 1 of which must be a bony mandibular impaction. In addition, the sum of the dental impaction scores must be 9 or above, carried out by investigator.
Exclusion Criteria:
Subjects with:
* Known opioids and NSAIDs allergies (or induced asthmatic attacks)
* Known history of opioid abuse
* Recent history of gastrointestinal ulceration
* History of aspirin intolerance/cross-sensitivity
* Recent myocardial disease
* Uncontrolled hypertension
* Patients receiving anticoagulation therapy
* Uncontrolled diabetes
* Pregnant women
* Immunosuppression
* Recent history of opioid or NSAID therapies
* Subjects who do not achieve a qualifying baseline pain threshold of 50mm out of 100mm on the visual analog DIPS within 6 hours of completion of surgery <Conditions:>Pain <Interventions:>Pharmacogenomic Testing, Ibuprofen, hydroxycontin/acetominophen, acetominophen, Oxycontin/acetominophen | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction <BriefSummary:>The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities. <EligibilityCriteria:>Inclusion Criteria:
* Men or women aged 45 years and older
* Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP
Exclusion Criteria:
* Acute decompensated heart failure within the past 4 weeks
* Inability to exercise
* Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF \< 40%) <Conditions:>Heart Failure <Interventions:>Neladenoson bialanate (BAY1067197), Neladenoson bialanate (BAY1067197), Neladenoson bialanate (BAY1067197), Neladenoson bialanate (BAY1067197), Neladenoson bialanate (BAY1067197), Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'LVEF', 'NT-proBNP', 'NYHA class', 'Medical history: diabetes', 'Medical history: Atrial fibrillation', 'Medical history: hypertension', 'eGFR', '6MWD' |