cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Effectiveness of Three Asoprisnil Doses in the Treatment of Women With Endometriosis

The objective of this study is to determine the safety and effectiveness of three doses of asoprisnil, compared to placebo, in the treatment of women with endometriosis.

Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the safety and efficacy of asoprisnil 5, 10, and 25 mg tablets, compared to placebo, administered daily for 12 weeks to women with endometriosis, by assessing whether asoprisnil administration diminishes the pelvic pain, dysmenorrhea, dyspareunia, excessive bleeding, and analgesic use associated with this disease and lessens the subjects' perceived pain symptoms. Otherwise healthy women with surgically confirmed endometriosis will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Surgically confirmed endometriosis
* History of menstrual cycles between 26 and 32 days
* Otherwise in good health
* Age 18-40 years, inclusive
* Subject had pain graded at Screening and Day 1 according to a scale suggested by Biberoglu and Berhman5 in at least one of the following categories:

  1. moderate or severe pelvic pain not related to menstruation, OR
  2. moderate or severe dysmenorrhea, OR
  3. moderate or severe pelvic tenderness elicited on pelvic examination accompanied by non-menstrual pelvic pain.
* Subject agrees to double barrier method of contraception

Exclusion Criteria:

* Any abnormal lab or procedure result the study-doctor considers important
* History of undiagnosed uterine bleeding or gynecological disorder
* Severe reaction(s) to hormone therapy
* History of osteoporosis or other metabolic bone disease
* Subject currently breast feeding
Dynamic and Static Autoregulation After Brain Injury

The aim of the study assesses static and dynamic cerebrovascular autoregulation daily over one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the temporal profile of the autoregulatory status.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury
* Intracranial hemorrhage

Exclusion Criteria:

* Measurement of TCD were impossible
* Injury of the legs (if the both tigh cuffs for dynamic autoregulation could not be fixed)
Prevent Cancer- Greenville

Prevent Cancer-Greenville was created to provide individuals with the opportunity to have their risk of developing cancer studied. Some individuals may be at a higher risk due to their personal lifestyle, family history and/or exposures. If subjects are found to be at high risk for developing a disease, they will be sent to a healthcare provider for further care.

Participants' personal history, lifestyle behaviors and blood, urine, and cheek swab specimens will be used to detect changes or trends that might put them at risk for developing cancer. Some individuals may be at an above average risk of cancer due to lifestyle, family background, personal genetic makeup, or environmental exposures. This will be determined by a process called risk stratification. Risk stratification involves looking at all health-related aspects of a person, determining their individualized risk through screening, and educating them on measures to reduce potential for disease. Participants will complete a yearly health assessment which includes measurements for nutrition, activity, individual risk factors and body composition, including weight height and a special scale which measures fluid and fat.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
Brain Diseases on 7.0T Magnetic Resonance Imaging

This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting brain diseases. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.

7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of brain diseases on 7T MRI.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 and ≤80
* Having brain diseases (eg: brain tumor, cerebrovascular diseases)
* Having no contraindications against MRI or intravenous contrast agent administration
* Clinically stable

Exclusion Criteria:

* Age\<18 or \>80
* Pregnancy and other contraindication to MRI scan
* Informed consent not obtained
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Anxiety

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with anxiety

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages
3. Diagnosis of anxiety based on DSM-V criteria

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors

The primary purpose of this study is to demonstrate the safety and effectiveness of using an intra-operative ultrasound contrast agent(Definity®) for the identification of known liver tumors.

The primary objective of this study is to demonstrate the safety of the use of intra-operative ultrasound contrast (Definity®) administration. The secondary objective of this study is to demonstrate the improved image quality and conspicuity of known liver tumors using contrast enhancement.

Eligibility Criteria:
Inclusion Criteria:

1. Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver tumor:
2. ≥ 18 years of age
3. If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
4. If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits.
5. IRB-approved informed consent, signed by the subject or the subject's legally authorized representative. ≥ 18 years of age

Exclusion Criteria:

1. Not a suitable candidate for operation
Make up for the Epinephrine Autoinjector

Part of the problems related with proper use of epinephrine autoinjector may be related with the design of the autoinjector itself.The aim of the study is to investigate whether minor modifications in the design of currently available epinephrine autoinjector ease its use and abrogate common use errors.

All interns except the ones who previously worked in allergy department in a medical school were invited to the study. Two identical epinephrine autoinjector trainers (Epipen trainer®) were used, one of which was modified by changing gray safety cap to red and placing a yellow arrow pointing to the black injection tip. Written and visual instruction sheet for each trainer was provided. Participants were asked to demonstrate the use of Epipen trainer either with the original or the modified one. They were scored and timed for demonstration. Primary study parameter was the rate of participants correctly demonstrating the use of epinephrine autoinjector. Secondary study parameters were the mean total score, mean time required to administer autoinjector and unintentional self injection of autoinjector into thumb.

Eligibility Criteria:
Inclusion Criteria:We invited all interns in our faculty to inform about the study and included the ones who gave informed consent -

Exclusion Criteria:Interns who previously worked in allergy department were excluded.

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GRID Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors

Palliative radiation therapy represents 40% of the on-going radiation at the Jewish General Hospital. In a traditional palliative radiation treatment to bulky or radioresistant tumors, radiotherapy schema varies from 24 to 30 Gys given in 3 to 10 fractions, depending on the tumor size, tumor location and tumor pathology. However, for many patients this treatment involves considerable toxicity, travel and time spent at the hospital. Spatially fractionated radiation (SFR) is an alternative technique that consists in delivering one single treatment, given through a grid containing holes. The present study is proposing to validate SFR as a safe and effective mean to palliate patients with symptomatic bulky tumors (more than 8 cm) or with tumors known to be resistant to radiation.


Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically or cytologically confirmed malignancy. All malignant histologies/cytologies are eligible.
* Patient with bulky tumor (larger than 8cm), or with a tumor known to be resistant to radiation (eg. Melanoma, hypernephroma, sarcoma), or with a tumor previously irradiated with a palliative intent requiring more than 1 fraction of radiation
* Patient planned to undergo palliative radiation therapy treatments to one of the following 5 sites: extremities, neck, chest, abdomen and pelvis
* WHO performance status of 0-2
* Aged 18 years or older
* Ability to sign and understand an informed consent form

Exclusion Criteria:

* Potentially curable patient
* Previous palliative radiation with hypofractionation
* Tumor located near the spinal cord or in the brain
* Pregnant or nursing woman
ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study

The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.

This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation.
* Subjects who were enrolled, randomized and treated for paroxysmal atrial fibrillation, classified as Modified Intention-to-Treat subjects, and completed the 12-Month Follow-Up in the FARAPULSE ADVENT Trial (CIP CS0934; NCT04612244).
* Subjects or legally authorized representatives who are willing and capable of providing informed consent.
* Subjects who are willing to comply with the protocol requirements.

Exclusion Criteria:

* There are no exclusion criteria for this study.
Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis (RA) Subjects Who Are Sub-Optimal Responders to Etanercept 50 mg Once Weekly (QW)

The purpose of this study objective will be to evaluate the efficacy and safety of etanercept 50 mg BIW in RA subjects who showed a sub-optimal response to standard dose etanercept (50 mg QW) and concomitant methotrexate therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis
* RA with a disease duration \> 6 months
* Current and prior but continuous etanercept (50 mg weekly) treatment for at least 5 months prior to screening
* Subjects must be receiving methotrexate (MTX) at a stable dose \> 15 mg/week at least 4 weeks prior to screening
* Sub-optimal response to etanercept defined by the presence of the following criteria (based on 28 joint count) at screening: 5 or more swollen joints and 5 or more tender joints
* Subjects who are currently receiving oral corticosteroids must be on a dose equivalent to prednisone less than or equal to 10 mg/day at screening
* Subjects who are currently receiving non-steroidal anti-inflammatory drugs (NSAIDs), must be on a stable dose for at least 2 weeks prior to screening
* Subjects who are currently receiving DMARD therapy (including sulfasalazine, hydroxy-chloroquine and leflunomide), must be on a stable dose for at least 4 weeks prior to screening

Exclusion Criteria:

* Nursing mothers, female subjects planning on becoming pregnant, or male subjects planning a pregnancy with their spouse/partner while in the study
* ACR functional class IV
* Receipt of any investigational drug or biologic within 4 weeks of study drug initiation
* Concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent
* History of alcohol or drug abuse within 12 months of screening visit
* Severe comorbidities including: History of cancer (other than resected cutaneous basal and squamous cell carcinoma, and in situ cervical cancer) within 5 years of screening visit. Documentation of disease-free state since treatment required; Diagnosis of Class III or IV congestive heart failure (CHF) or myocardial infarction (MI) within 12 months of screening; Unstable or stable angina pectoris; Uncontrolled hypertension (defined as systolic blood pressure measurement of greater than 180 mm Hg or a diastolic blood pressure of greater than 110 mm Hg); Oxygen-dependent pulmonary disease; Known HIV-positive status or other immunodeficiency syndromes; Chronic hepatitis B (HbsAg) or C (HCV); Systemic lupus erythematosus (SLE); CNS demyelinating events suggestive of multiple sclerosis; Presence of active infection or any underlying diseases that could predispose subjects to infection (e.g., history of recurrent infections, non-healing leg ulcers, advanced or poorly controlled diabetes); Active or prior history of tuberculosis (or known exposure).
* Concurrent treatment with cyclophosphamide
Epidemiological Study to Evaluate Personality Disorders in Prison Populations in Treatment for Hepatitis C

Primary objective: Evaluate the prevalence of personality disorders in patients starting treatment for hepatitis C in the prison and determine their influence on the evolution of the disease.

Secondary objectives:

* Describe the management of patients with personality disorders on treatment for hepatitis C in the prison.
* Describe the characteristics of patients who discontinue the treatment and the reasons for stratifying by the presence of personality disorders.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age.
* Patients with expected prison stay beyond the duration of follow-up period of the study.
* Patients with chronic HCV infection and detectable viral load to initiate treatment with standard therapy.
* Patients their written informed consent to participate in the study.

Exclusion Criteria:

* Patients previously treated with Interferon (IFN) and Ribavirin (RBV).
* Patients can not read or understand a written questionnaire at the discretion of the investigator.
Bioavailability of Anthocyanins of Blue Potatoes as Compared With Bilberries

In this study, the postprandial glycemia and insulinemia caused by boiled potato with blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch, is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids and their metabolites is studied in plasma and urine.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Male
* No regular medication
* No participation in a drug trial or blood donation within 2 months
* Non-smoker
* Signs informed consent
* Body mass index 18.5-27 kg/m2
* Fasting plasma cholesterol \< 5.5 mmol/l
* Fasting plasma triacylglycerols \< 2.6 mmol/l
* Fasting plasma glucose 4-6 mmol/l
* blood pressure \<140/80 mmHg
* hemoglobin\>130 g/l
* Fasting plasma alanine amino transferase (ALAT) \<60 U/l (normal liver function)
* Fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
* Fasting plasma creatinine \<118 µmol/l (normal kidney function)

Exclusion Criteria:

* Regular smoking
* Alcohol abuse
* Regular medication
Muscle Damage and Disuse Atrophy

Limb injury generally requires a period of recovery during which time the limb is often immobilised (e.g. with a cast or brace) resulting in a rapid loss of skeletal muscle. Despite the importance of muscle loss during injury, our understanding of how it occurs is incomplete. Several factors are likely to contribute, including a lack of muscle contraction and injury induced inflammation. In this study, the investigators will recruit healthy volunteers who will spend 7 days in a knee brace to replicate leg immobilisation. Prior to immobilisation, half of the participants will perform a single session of strenuous resistance exercise which is known to cause muscle damage and initiate an inflammatory response. This is designed to replicate the muscle damage and inflammation that occurs with injury. The remaining half of participants will not perform this exercise, allowing us to look at the additive effect of muscle damage and inflammation on muscle loss with immobilisation.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 40
* BMI between 18 and 27
* Healthy, recreationally active, non smoker

Exclusion Criteria:

* Non-removable metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws) or claustrophobia
* Use of nutritional supplements
* Chronic use of over the counter medication
* Any diagnosed metabolic disease (e.g. type 1 or 2 Diabetes).
* Any diagnosed cardiovascular disease or hypertension.
* Anyone with previous motor disorders. Anyone with a current musculoskeletal injury that may impair their use of crutches.
Omega-3 and Aspirin in Periodontal Regeneration

To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis patients.

In this study, we tested the hypothesis that the administration of omega 3 PUFA plus low dose aspirin would augment the results following regenerative therapy of furcation defects in chronic periodontitis patients.

Eligibility Criteria:
Inclusion Criteria:

* suffering moderate to sever chronic periodontitis and displaying at least a single grade II furcation defect according to Glickman's classification 1953, determined by both clinical and radiographic examinations;
* free from systemic diseases known to influence the periodontal condition and not receiving any medication known to affect the periodontal status;
* have not receive any periodontal therapy for a minimum of 6 months prior to the study.

Exclusion Criteria:

* Known hypersensitivity or allergy to one of the used medications
* Pregnancy or lactation
* Heavy smoking (more than 10cigarretes/day)
* History of alcohol abuse
* Participation in other clinical trials
Brief Motivational Interviewing (BMI)

The goal of this research study is to determine if the utilization of brief motivational interviewing (BMI) during continuous care is superior compared to traditional oral hygiene instruction (OHI) to reduce patients' plaque score, bleeding on probing (BOP), and gingival index (GI) longitudinal. An additional goal is to investigate chairside time of implementing BMI.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* ≥ 18 years old
* Periodontal maintenance phase (at least one year)
* Plaque score ≥30% (O'Leary plaque score)
* Minimum of two sites with BOP
* Willingness to fulfill all study requirements
* Patient of Record at the University of Minnesota School of Dentistry

Exclusion Criteria:

* Current smoker or quit smoking less than one year
* Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
* Uncontrolled diabetes (HbA1C \> 7)
* Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS)
* Current use of oral bisphosphonates
* History of IV bisphosphonates
* Require pre-medication or on long-term antibiotics
* Current orthodontic treatment or planning to begin orthodontic treatment during the study
* Unable to comply with the study protocol
Lumbar Plexus Catheter Versus Femoral Nerve Catheter for Postoperative Pain After Anterior Cruciate Ligament (ACL) Repair

Randomized trial comparing lumbar plexus catheter versus femoral nerve catheter (single-shot femoral block as control group) for postoperative pain control after anterior cruciate ligament repair in children (age 11-21). Primary outcome is pain scores for the first 72 hours. Secondary outcomes include opioid consumption, incidence of opioid side effects and quality of recovery (previously validated scale). Our hypothesis is that lumbar plexus catheter will provide superior pain control and overall quality of recovery compared to femoral nerve catheters.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-2
* Age 11-21
* Undergoing anterior cruciate ligament repair

Exclusion Criteria:

* Patient refusal
* Coagulopathy
* Systemic infection or infection at needle insertion site
* Allergy to ropivacaine or opioids
* Taking chronic opioids
* Unavailable by phone
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer

The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 year old
* Confirmed HER2+ metastatic breast cancer
* Prior treatment and progression on trastuzumab
* Patients must have adequate organ functions
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Exclusion Criteria:

* Patients who have had surgery within last 2 weeks prior to starting the treatment
* Patients who receive concurrent therapy for brain metastases
* Impaired heart function or clinically significant heart disease
* Ongoing diarrhea
* Liver or renal disease with impaired hepatic or renal functions
* Concomitant use of any anti-cancer therapy or certain drugs
* Female patients who are pregnant or breast feeding
* Patients not willing to use an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply