cyrilzakka/clinical-trials huggingface dataset:
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants

The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.


Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy male or female participants between 18 and 65 years of age (inclusive) at the time of Screening (Japanese participants must be first-generation Japanese)
2. In good health, determined by no clinically significant findings from medical history, physical examination, ECG, vital signs measurements, and clinical laboratory evaluations
3. Body mass index between 18 and 30 kg/m\^2 at the time of Screening
4. Females of nonchildbearing potential

Key Exclusion Criteria:

1. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease
2. History or current signs or symptoms of cardiovascular disease
3. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in
4. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
5. Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening
6. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in
7. Use of tobacco- or nicotine-containing products within 6 months prior to Check-in
8. Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Screening or Check-in
9. Female participants with a positive pregnancy test at Screening or Check-in
10. Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the end of study (EOS) visit
11. Donation of blood from 3 months prior to Check-in, plasma from 2 weeks prior to Check-in, or platelets from 6 weeks prior to Check-in
12. Unwilling to abide with study restrictions
Clinical Trial Protocol to Evaluate the Efficacy and Safety of Laparoscopic Surgical Systems for Gynaecological Surgery

Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use ingynaecological surgical procedures.

The trial was designed using a prospective, single-centre, single-group target value approach.

For subjects who intend to undergo gynaecological surgery assisted by the Thoracic and Abdominal Endoscopic Surgical System.

To use the Thoracic and Abdominal Endoscopic Surgical System developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. to perform surgery , and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years;
* Body Mass Height Index (BMI) 18\<BMI\<30kg/㎡;
* Patients identified by the investigator as suitable for general, gynaecological and thoracic surgery;
* Written informed consent.

Exclusion Criteria:

* Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.);
* With other malignancies or a previous history of other malignancies.
* Preoperative imaging suggests that the tumour has distant metastases.
* The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment.
* Severe bleeding tendencies or coagulopathic disorders.
* With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
* Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
* With severe allergies and suspected or established alcohol, drug or substance addiction.
* Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
Desflurane vs. Sevoflurane in Endovascular Aortic Repair

Randomized Clinical Trial following the evaluation of the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (Desflurane versus Sevoflurane) on the first 24 hours after surgery.

Randomized Clinical Trial to evaluate the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (Desflurane versus Sevoflurane) on the first 24 hours after surgery.

Secondary Endpoint: Among secondary endpoints we will evaluate clinical variables such emergence and recovery characteristics (time to extubation and time to emergence-open eyes and response to verbal command), the need for postoperative mechanical ventilation, the post-anesthesia recovery score and ICU length of stay.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years undergoing elective endovascular aortic repair
* who have signed informed consent

Exclusion Criteria:

* urgent surgery
* with known hypersensitivity to Desflurane or Sevoflurane.
* Renal failure in hemodialysis
Accuracy Performance Verification of the INVOS™ System in Pediatrics

Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.

The purpose of this study is to verify INVOS™ cerebral oximetry system performance in pediatric and infant patients bycomparing regional oxygen saturation (rSO2) values to reference blood oxygen saturation measurements obtained throughinternal jugular vein and arterial blood convenience sampling according to International Organization on Standards (ISO) 80601-2-85:2021.

Eligibility Criteria:
Inclusion Criteria:

1. Under 21 years of age
2. Meets weight requirement for sensors under study
3. Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
4. Arterial and venous access as part of the planned catheterization procedure

Exclusion Criteria:

1. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\]
2. A skin condition at the sensor site (e.g., rash, abrasion, laceration)
3. Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor
4. A known structural brain lesion beneath the sensor
5. Known hemoglobinopathy
6. Inability to lie supine with neutral neck position during catheterization
7. Cerebrovascular disease
8. An emergent, life threatening condition impacting study conduct
9. Unwillingness or inability to sign informed consent (IC) or assent by the parents/guardians of child
10. Currently receiving phototherapy for bilirubin
11. Arterial or venous anatomy that would preclude obtaining an accurate paired sample
12. Known pregnancy
Accelerated PrEP Access for Black MSM and TW

The investigators will pilot-test an accelerated PrEP initiation approach among young high-risk Black/African American (B/AA) men who have sex with men (MSM) and transgender women (YMSM/TW) at the point of care in community contexts.

The study team will provide a free 30-day supply of HIV pre-exposure prophylaxis (PrEP) to young Black MSM and TW identified as PrEP-eligible and interested in taking PrEP to reduce their risk of HIV acquisition. This intervention is intended to assist youth at high risk for HIV acquisition in successfully initiating PrEP use.

Eligibility Criteria:
Inclusion Criteria:

1. ages 18-24;
2. assigned male at birth, identify as a man (cisgender), transgender woman, or gender non-conforming or genderqueer;
3. identifying as Black, African American, or multiracial with at least one parent identifying as Black or African American;
4. not currently taking PrEP or attending a visit to initiate PrEP;
5. self-report being HIV-negative;
6. reporting one of the following HIV risks in the last 6 months (Hosek, Rudy et al. 2015, Hosek, Rudy et al. 2017): a. condomless anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status; b. anal intercourse with 3 or more male sex partners; c. exchange of money, gifts, shelter, or drugs for anal sex with a male partner; d. sex with a male partner and has had a sexually transmitted infection; e. sexual partner of an HIV-infected male with whom condoms were not consistently used; f. anal intercourse where the condom broke or slipped off

Exclusion Criteria:

* We are excluding those individuals who were assigned female at birth (female birth certificate) and/or cis-gender women (those assigned female at birth and identify as women) from the all phases of this study as this study is intended to explore the HIV prevention behaviors of B/AA young men who have sex with men and young transgender women (assigned male at birth) as these two groups represent the highest risk groups for HIV infection in the US, yet only a small percentage are aware or currently use PrEP for HIV prevention.
Effectiveness of a Multi-Component Evidence-Based Parent Training Program in Reducing Child Maltreatment

This study will determine the effectiveness of a complex parent training program, based on the SafeCare model, in reducing the occurrence of child maltreatment.

Child maltreatment is the general term used to characterize all forms of child abuse, including neglect and physical, sexual, and emotional abuse. These forms of maltreatment can lead to a large number of child developmental, emotional, and behavioral difficulties. As adults, children who are maltreated are more prone to unhealthy behaviors and conditions, such as drug and alcohol abuse, smoking, eating disorders, and depression. A previous study found that Project SafeCare, a treatment program that provides parent training to families with children who were at risk for or victims of maltreatment, resulted in fewer child welfare reports. Participants in Project SafeCare reported improvements in child healthcare, home safety, and parent-child relations. However, the study suggested that the SafeCare program may not be equally effective in decreasing the occurrence of all forms of child maltreatment, particularly child physical abuse. This study will determine the effectiveness of a complex evidence-based practice program, extending upon the SafeCare program, in reducing the occurrence of physical abuse and other forms of child maltreatment.

Participants in this study will receive services from Oklahoma Comprehensive Home-Based Services (CHBS), a program provided to families with issues of child abuse and neglect. Upon entry into the CHBS program, participants will undergo a computerized interview, lasting between 1 and 2 hours. The interview will include questions about family strengths and weaknesses, personal beliefs, substance abuse history, and opinion on CHBS. This computerized interview will be repeated at the end of treatment, approximately 6 to 12 months later. During the first few weeks of CHBS, an agent will make five visits to the homes of participants to observe pretreatment family life. Treatment services will concentrate on improving healthcare skills, parent-child interactions, and safety in homes and will specifically address ways to reduce physical abuse and other identified family issues. Study participation will continue for 12 months after completion of CHBS. Study researchers will obtain child welfare reports from the Department of Human Services (DHS) for up to 10 years after completion of CHBS.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Oklahoma Comprehensive Home-Based Services (CHBS)
* Child referred by Office of Community Services

Exclusion Criteria:

* Primary referral of sexual abuse
* Primary referral goal to maintain permanent placement
A sTudy of Low Dose vs Standard Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients

In this study, the investigates try to confirm the hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in acute coronary syndrome patients with diabetes. Totally 40 ACS patients with diabetes will be divided into 2 groups randomly after PCI for one month. Group 1 will be treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group; Group2 will be treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment. The platelets function will be tested in VASP and TEG methods at 1 and 2 months after PCI as the primary endpoints.The clinical events will be observed 12 months after PCI.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be at least 18 years of age and less than 90 years old
2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome with diabetes mellitus.
3. Subject understand the study requirements and the treatment procedures and
4. provided informed consent before the procedure

Exclusion Criteria:

1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
2. Active bleeding
3. Known hypersensitivity or contraindication to study medications
4. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
5. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
6. Subjects with Cerebral hemorrhage history
7. Subjects with stroke history in half a year
8. subjects with active malignant tumor
9. subjects with whom oral anticoagulants are needed
10. Other conditions which the investigators think not applicable to the study.
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications

The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.

Background: Up to fifty percent of patients do not take their cardiovascular medications as prescribed resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an intriguing and as of yet untested opportunity to adapt behavioral 'nudges' using ubiquitous cell phone technology to facilitate medication adherence.

Objectives: Aim 1: Conduct a pragmatic patient-level randomized intervention across three health care systems (HCS) to improve adherence to chronic CV medications. The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Secondary outcomes include clinical events (e.g., event times for stroke, MI, mortality), utilization of care (e.g., hospitalizations or clinic visits for CV-related reasons), and costs of healthcare utilization. Aim 2: Evaluate the intervention using a mixed methods approach and applying the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. In addition, assess the context and implementation processes to inform local tailoring, adaptations and modifications, and eventual expansion of the intervention within the 3 HCS more broadly and nationally.

Setting: The study will be conducted within three HCS in metro Denver: VA Eastern Colorado Health Care System (VA), Denver Health and Hospital Authority, and UCHealth.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the following cardiovascular conditions and respective medication classes:
* Hypertension (Beta-blockers \[B-blockers)\], Calcium Channel Blocker \[CCB\], Angiotensin converting enzyme inhibitors (ACEi), Angiotensin Receptor Blockers \[ARB\], or Thiazide diuretic)
* Hyperlipidemia (HMG CoA reductase inhibitor \[Statins\])
* Diabetes (Alpha-glucosidase inhibitors, Biguanides, DPP-4 inhibitors, Sodium glucose transport inhibitor, Meglitinides, Sulfonylureas, Thiazolidinediones, or statins Coronary artery disease P2Y12 inhibitor \[Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine\], B-blockers, ACEi or ARB or statins)
* Atrial fibrillation (Direct oral anticoagulants, B-blockers, CCB)

Exclusion Criteria:

* Patients who do not have a mailing address listed in EHR;
* Patients who do not have a landline or cellphone listed in EHR;
* Currently pregnant if denoted in the EHR at the time of the data pull;
* Patients with a mailing address outside of the state of Colorado;
* Patients that do not speak either English or Spanish.
Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 18 years of age, of any ethnic origin
* Type 1 or 2 diabetes mellitus
* Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

Exclusion Criteria:

* Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
* Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.
An Exploratory Study of NBI-34060 Capsules and Next Day Functioning

NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The study will also examine the pattern and extent of nighttime awakenings as reported by the patients, as well as and the patient's sleep experience during treatment.


Eligibility Criteria:
Inclusion Criteria:

* insomnia (DSM-IV diagnosed; at least one month)
* Nocturnal awakenings
* Usual bedtimes between 9:00PM and Midnight.
* Bedtimes that do not vary by more than 2 hours on 5 or more nights per week.
* A usual time in bed of 7 to 9 hours.

Exclusion Criteria:

* no serious concomitant illness
* no other condition that could interfere with sleep
Increasing MAT Engagement With Financial Incentives

The increased prevalence of opioid use disorder (OUD) and associated overdoses and adverse events has led to a substantial increase in the number of patients being seen at emergency departments (ED). Thus, the ED may be an ideal location for identifying patients in need of OUD treatment and can serve as the first touch point in the OUD continuum of care to promote medication assisted treatment initiation. Contingency management (CM) is an effective method for promoting treatment initiation and adherence that has not been thoroughly evaluated for this purpose. The primary aim of the current study is to develop and assess the effectiveness, acceptability, and feasibility of a protocol for delivering CM to increase combined buprenorphine + nalaxone (referred to as BUP hereafter) initiation and continuous adherence for OUD in an existing ED "bridge" program (e.g., Bridge plus CM; B+CM) relative to standard care. Secondary objectives include identifying behavioral and neuropsychological correlates to treatment outcomes, including delay discounting, reinforcer demand, and neurological soft signs.


Eligibility Criteria:
Inclusion Criteria:

1. Participants at least 18 years of age
2. Participants must be newly enrolled in the Bridge program in the Cooper University ED, with their first clinic appointment scheduled to take place at the Cooper Outreach Clinic within one week of enrollment.
3. All subjects must be in good physical health as determined by a physical examination and premenopausal women will have a pregnancy test on the day of the study to rule out pregnancy

Exclusion Criteria:

1. Participants who demonstrate contraindication with Suboxone treatment or who are currently or have recently used other medication-assisted therapies for opioid use disorder.
2. Participants who are currently pregnant or breastfeeding or have been diagnosed with a DSM-5 psychiatric condition that might interfere with treatment delivery (e.g., uncontrolled schizophrenia, bipolar disorder, dementia)
3. Participants who are non-English speaking or cannot otherwise provide valid informed consent.
4. Individuals who are unable to complete the survey assessments, due to literacy or visual impairments.
5. The participant will not be a prisoner
Premature Newborns Treated With Less Invasive Surfactant Administration Under Heated Humidified High-flow

Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP.

Nasal Continuous Airway Pressure (CPAP) or Heated humidified high-flow Air support with nasal cannula (HHHFNC) are among the most commonly used non-invasive respiratory support methods. The purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (PI) and plethysmographic variability index (PVI) values in premature infants treated with less invasive surfactant administration (LISA) under HHHFNC or CPAP. This study was carried out in Hacettepe University Hospital NICU between January and December 2017. Premature newborns who were on noninvazive respiratory support and were diagnosed as RDS within first 72 hours of life, were taken into the study. Noninvasive respiratory support was provided with nasal CPAP or HHHNFC. Pulse oxymetry measurements were obtained before and 5th, 30th, 60th, 120th , 360th minutes, blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration.

Post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. Significance P \< 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.

Eligibility Criteria:
Inclusion Criteria:

* Does not require intubation,
* Diagnosed with RDS
* Premature newborns receiving surfactant therapy in the first 72 hours of life
* Those whose families give written consent

Exclusion Criteria:

* Babies whose families do not give written consent
* Newborns diagnosed with early neonatal sepsis
* Newborns with inotropic requirements
* Neonates with hemodynamically significant PDA
* Babies of diabetic mothers
* Babies with a major congenital anomaly
* Newborns with hemodynamic instability,
* Those requiring endotracheal intubation,
* NEC (Stage 2 or higher),
* Those showing ICH (Stage 2 or higher)
* Babies with perfusion disorders in the first three days