cyrilzakka/clinical-trials huggingface dataset:
Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury

The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Inpatient admission to St. Luke's Rehabilitation Institute for stroke, traumatic brain injury, or non-traumatic brain injury
2. Male or female, 18 to 85 years of age (to match limits of assessment instruments)
3. Able to provide written informed consent or have a legally authorized representative that can provide written informed consent
4. Stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms
5. Normal vision or corrected to normal vision (if glasses or contacts are tinted, willing to remove during light exposure)
6. Normal hearing or corrected to normal hearing
7. Willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment

Exclusion Criteria:

1. History of epileptic or other seizure disorder
2. Cataract surgery in the past 12 months
3. Significant visual impairment affecting light reaching the retina/performance of the retina: cataracts, macular degeneration, diabetic retinopathy, congenital blindness, total blindness, glaucoma, or retinal detachment
4. Endorsement of suicidal ideation on the PHQ-9 depression screen (standard of care admission assessment at St. Luke's)
5. Pre-injury diagnosis of a sleep disorder, including: sleep apnea, insomnia, narcolepsy or periodic limb movement syndrome
6. Neurological disorders other than those attributed to the primary diagnosis, including multiple sclerosis, Parkinson's disease, Huntington's disease, Alzheimer's disease or other dementias, amyotrophic lateral sclerosis)
7. Bipolar diagnosis
8. Females who are pregnant as determined from subject's medical records or who are breastfeeding
9. In active withdrawal from alcohol or street drugs
10. Unwillingness to refrain from wearing tinted glasses or contact lenses during light exposure
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model

This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.

Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to participate in the study, including all assessments, planned inpatient stays and all follow-up visits
* Subject is a healthy, ambulatory volunteer
* Subject meets sleep Qualification criteria

Exclusion Criteria:

* Subject has a medical history of suicidal behavior, epilepsy, eating disorders, sleep disorders, or circadian rhythm disorders
* Subject has worked a night shift or flown \>1 time zone within 30 days prior to Screening
L-tetrahydropalmatine (l-THP) Treatment for Cocaine Use Disorder

Cocaine continues to be one of the most widely used substances of abuse around the world. In the US, an estimated 1.4 million individuals (0.5%) \> 12 years were current (past month) cocaine users in 2011. Currently, no FDA-approved pharmacologic treatments are available for cocaine addiction; thus, this remains a serious public health problem without an effective pharmacological treatment. A promising lead towards an effective treatment comes from a recent finding that pretreatment with oral l-tetrahydropalmitine (l-THP) in rats attenuated the cocaine seeking associated with a cocaine challenge, while having no motor effects. This finding stimulated our group to test the pharmacokinetics and safety of l-THP in a phase I study of people with cocaine use. Preliminary findings show l-THP is safe and well tolerated in cocaine users, with no adverse interactions with cocaine.

This study will test the efficacy and safety of l-THP for abstinence in those with cocaine addiction in a phase II pilot study (N=24). Secondarily, we will examine the effects of these medications on craving.


Eligibility Criteria:
Inclusion Criteria:

* men or non-pregnant/non-nursing women between the ages of 18 and 50 years
* meeting criteria for DSM-5 cocaine use disorder
* self-reported cocaine use (intranasal, IV or smoked) averaging at least weekly for the prior six months positive urine drug test for cocaine in the prior month
* HIV seronegative
* EKG without clinically significant abnormality
* normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and resting heart rate (60-90 bpm)
* ability to adhere to the study restrictions and examination schedule
* women with reproductive potential must agree to the use of one of the following birth control methods (oral contraceptives, condom with spermicide, diaphragm, or intrauterine device) during the study and for 2 weeks after last medication dose.

Exclusion Criteria:

* participation in any investigational drug trial or clinical drug trial within 45 days before study entry
* history of clinically significant adverse reaction or hypersensitivity to cocaine or l-THP
* inability to communicate or co-operate with the investigators
* currently taking any prescribed psychoactive medication, e.g., anti- depressant, anti-psychotic, or mood stabilizer
* current clinically significant medical problem that might interfere with safe study participation. This includes pheochromocytoma, untreated hyperthyroidism, dehydration, fever, coronary artery disease, uncorrected congenital heart defect, seizures, electrolyte imbalance, uncontrolled diabetes mellitus, porphyria variegate, superventricular tachycardia, atrial fibrillation, cardiomyopathy, or uncontrolled hypertension.
* current Axis I Major Depression, Schizophrenia, or Bipolar Disorder.
* score below 10/12 on the Evaluation to Sign Consent (ESC)
Endoscopic Debridement of Chronic Plantar Fasciitis

The aim of the study was to prospectively evaluate the results of endoscopic treatment of chronic plantar fasciitis with resection of the heel spur. Treatment was assessed based on the results of clinical examinations and functional assessment as well as X-ray examination.

Hypothesis: Conducting research on a group of patients will prove that the use of endoscopic technique with heel spur resection for the treatment of chronic plantar fasciitis will improve the functional results of the foot.

Methods: Patients diagnosed with chronic plantar fasciitis will undergo surgical treatment. An inspection is planned before and after 3, 6, 12, 24 and 60 months. During the check-up, the patient will undergo an X-ray examination, medical and physiotherapeutic assessment.

Study plan:

Participation in the research involves arriving at the Rehasport Clinic in Poznań on the dates set by the Chief Investigator (3, 6, 12, 24 and 60 months after the surgical treatment). During the visit, members of the research team ask participants to complete a set of questionnaires, perform a medical examination with a physiotherapeutic assessment described in detail below, and an X-ray examination. The entire examination will last approximately 3 hours.

1. During all visits to Rehasport Clinic, the participant will be asked to complete the surveys ACFAS ankle and foot assessment scale.
2. During the same visits, research team members perform the following tests and examinations:

   1. medical examination - aimed at assessing current ailments and range of motion,
   2. X-ray examination of the foot.

Eligibility Criteria:
Inclusion Criteria:

* symptoms of chronic plantar fasciitis that have persisted for at least 6 months. despite previous conservative treatment, including corticosteroid injections, autologous PRP injections, physiotherapy, use of orthoses and NSAIDs,
* age ≥ 18 years,
* written consent to participate in the study

Exclusion Criteria:

* previous foot surgery,
* advanced diabetes impeding healing,
* significant obesity,
* contraindications to anesthesia
Pancreatic Cancer Early Detection Registry

Identify individuals who are at moderate and high risk or predisposed to developing pancreatic cancer with a familial history in which data collected from this study will be used to identify clinical factors associated with early detection of pancreatic cancer.

Pancreatic cancer is the fourth leading cause of cancer death in both men and women in the United States. In 2015, there were 49,000 new diagnoses with 41,000 deaths . A recent analysis of the pedigrees in the National Familial Pancreatic Tumor Registry found that individuals with a family history of pancreatic cancer in first-degree relatives are at an increased risk of developing pancreatic cancer themselves. There are more than a dozen inherited germline mutations that increase the risk of pancreatic cancer in these family members. In an attempt to lower the number of individuals that develop advanced pancreatic cancer, an early-detection program is created to detect tumors at a stage early enough that treatment is likely to be successful. Numerous treatment options exist such as surveillance, radiation therapy, systemic therapy and surgery. Determining which treatment option will be implemented is based on the stage and grade of the tumor/cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible subjects must be ≥ 18 years of age
2. Meet one of the following criteria:

   * All affected on the same side of the family (maternal/paternal) unless otherwise specified FDR = first degree relative (parent, sibling, child)
   * SDR = second degree relative (e.g., aunt, uncle, grandparent, half-sibling, niece and nephew)
   * TDR = third degree relative (e.g., cousin, half-aunt or half-uncle)

     * 1 FDR with pancreatic cancer \< age 55

       -≥2 FDR, SDR or TDR with pancreatic cancer at any age
     * Genetic syndrome with pancreatic cancer
     * FDR or SDR with pancreatic cancer at any age and Ashkenazi ancestry
     * FDR or SDR with pancreatic cancer at any age and:

       * 1 relative with ovarian cancer at any age or
       * 1 relative with breast cancer ≤50 or
       * 2 relatives with breast, pancreatic or prostate cancer (Gleason score ≥7) at any age
     * Family history of melanoma OR
     * Has previously had genetic testing and has been determined to have a pathogenic gene variant.
     * FDR with a pathogenic gene variant

Exclusion Criteria:

1. Prior treatment of pancreatic cancer including radiation therapy, systemic therapy and/or surgery.
2. Current treatment of pancreatic cancer including radiation therapy, systemic therapy and/or surgery.
A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 45 years of age
* Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease
* Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease
* Receiving evidence-based medical and dietary management of dyslipidemia

Exclusion Criteria:

* Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization
* Uncontrolled hypertension
* Uncontrolled diabetes
* Concomitant treatment with any other drug raising HDL-C
* Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)
Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)

The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure).

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension systolic blood pressure (SBP) \</= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg

Exclusion Criteria:

* Pre-menopausal women
* patients currently taking more than two (2) blood pressure lowering medications
* Body Mas Index (BMI)\>40 kg/m2 (morbidly obese patients)
* History of Alcohol abuse (\<3 Years)
* History of diabetes,chronic kidney disease, Active liver disease, recent heart attack or stroke
Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial

Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: A Randomized Trial

The configuration of culture dishes plays a crucial role in preimplantation embryo development by influencing key culture conditions such as media distribution, oxygen exchange, and embryo spacing, all of which directly impact embryonic growth, fertilization, blastocyst formation, and overall blastocyst quality. Traditional 2D culture dishes provide a flat surface for embryo development, whereas 3D culture dishes create a microenvironment that better mimics in vivo conditions by optimizing nutrient availability and reducing stress from environmental fluctuations. In this study, we compare the effects of two different 3D culture dishes-Dish 1 (Microdrop GPS Dish) and Dish 2 (16-Well BIRR Dish)-on preimplantation genetic outcomes. Using a sibling oocyte split design, oocytes were randomly divided after intracytoplasmic sperm injection (ICSI) and cultured in either dish, ensuring that each patient serves as their own internal control. Embryo development was closely monitored from fertilization to blastocyst formation, to determine whether dish design has a significant impact on preimplantation embryo development.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 35 years or younger
* A minimum of 15 mature oocytes available for ICSI
* Classified as a good prognosis patient

Exclusion Criteria:

* Cases with severe DNA fragmentation
* Patients undergoing FNA or TESE procedures
* Severe male factor infertility
* History of low or failed fertilization in previous cycles
* Any contraindications to gonadotropin stimulation
* Presence of leukocytospermia
A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

The primary objective of the study is to estimate the effects of different strong enzyme (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to determine the safety and tolerability of single-dose PF- 00489791 when it is administered with steady-state itraconazole, diltiazem, or verapamil.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests) with a Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs.) and with a personally signed and dated informed consent document and who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Participating female subjects of non-childbearing potential must meet at least one of the following criteria: achieved postmenopausal status; have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.

Exclusion Criteria:

* Subjects cannot be included in the study if there is: the presence/ history of any disorder that prevents study completion
* Evidence/history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Any surgical or medical condition that may interfere with the absorption distribution, metabolism, or excretion of the study drug
* A positive urine drug screen or history of regular excessive alcohol consumption or use of tobacco-or nicotine-containing products in excess or from 24-hours prior to admission until discharge
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 halflives preceding the first dose of study med.
* Out of range blood pressure including current evidence of orthostatic change in blood pressure
* Abnormal ECG or history or current evidence of clinically important cardiac conduction abnormalities.
* Also excluded are: pregnant or breastfeeding female subjects; male subjects with partners currently pregnant; male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as described in the protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Never taken oral antidiabetic drugs before
* HbA1c greater than 8.5 %
* BMI (Body Mass Index) less than or equal to 35 kg/m\^2

Exclusion Criteria:

* Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
* Taken an investigational drug in another clinical trial within 4 weeks prior to this trial
* Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit
* Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
* Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)
* Impaired renal function
* Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
* Have a clinically significant, active cardiovascular disease, or decompensated heart failure
* Treatment with systemic corticosteroids within the past two months prior to screening
Identification and Characterization of Novel Proteins and Genes in Head and Neck Cancer

Through this study, we hope to learn more about the mechanisms, which may contribute to development and progression of head and neck cancer. The long-term goal of this study will be to develop new strategies and drugs for the diagnosis and treatment of head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

All patients undergoing surgery at Stanford University for head and neck cancer.

Exclusion Criteria:

Non-Stanford patients.