cyrilzakka/clinical-trials huggingface dataset:
Connecting National Guard Service Members Through Education in Crisis Line Facilitation Training

National Guard (NG) are affected by suicide at a much higher rate than civilians. The Military and Veterans Crisis Line (MVCL) is not being used as often as we would expect. The purpose of this study is to find out whether a group-based training session will impact awareness and use of the Military and Veterans Crisis Line (MVCL) among members of the National Guard.


Eligibility Criteria:
Inclusion Criteria:

* Michigan Army National Guard member
* Associated with a unit with more than 25 members

Exclusion Criteria:

- Unable to provide informed consent
Aging, Cognition, and Hearing Evaluation in Elders Study

The investigators will conduct a small pilot study that will randomize \~ 40 70-84 year-old adults with hearing loss to best-practices hearing rehabilitative treatment (hearing assessment, counseling, fitting of amplification devices) versus a successful aging intervention (one-on-one counseling/education sessions on successful aging topics). Participants will be followed for 6 months, and outcomes will focus on communication, quality of life, cognition, and other functional surveys. This pilot study is in preparation for a larger planned trial to investigate if hearing loss treatment can reduce cognitive decline and dementia in older adults.


Eligibility Criteria:
Inclusion Criteria

* Age 70-84 years.
* Community-dwelling.
* Fluent English-speaker.
* Residency. Participants must plan to reside in the local area for the study duration (6 months).
* Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a pure tone average (0.5, 1, and 2 kHz) in the better-hearing ear of ≥ 30 decibels and \<70 dB.
* Word Recognition in Quiet score \>60% bilaterally.
* Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or more
* Willingness to participate. Participants must be willing and able to consent to participate in the study, be willing to be randomized to either the Hearing intervention or to the Successful Aging intervention, and be willing to follow the study protocol for the duration of the trial.

Exclusion Criteria

Potential candidates for enrollment who meet one or more of t he following criteria are excluded from participation in the study:

* Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL)
* Self-reported hearing aid use in the past year (\>5 hours/week).
* Vision impairment (worse than 20/40 on MN Near Vision Card).
* Medical contraindication to use of hearing aids (e.g., draining ear).
* Conductive hearing impairment as determined by a difference in air audiometry and bone audiometry ("air-bone gap") greater than 15 dB in 2 or more contiguous frequencies in both ears.
* Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis
* No participants are excluded based on race or sex
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.
* Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.
* Signed Informed Consent.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities
* Have baseline orthostatic hypotension
* Positive drug screen, excessive alcohol and tobacco use
Bioequivalence Study of Cephalexin Tablets 1g

The objective of this study was to confirm if two formulations of cephalexin tablets are bioequivalent.

Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1 g Cephalexin; Eli Lilly). The single dosage was one tablet.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 26 healthy volunteers, both genders, adults between 18-40 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Healthy, between 18 and 40 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -

Exclusion Criteria:

Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.

Hospitalization for any cause in the seven months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss =\> 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Positive pregnancy test. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study.

-
Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects

This is a single-dose and multiple doses study to assess the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the tolerability of rilzabrutinib in Japanese and Caucasian Healthy Male and Female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese subjects must have both biological parents and all four grandparents of Japanese ancestry and born in a Japanese country of origin.
* Caucasian subjects must have four Caucasian grandparents (Hispanics of white race can be considered Caucasian).
* Healthy adult male or non-pregnant non-lactating females, 18 to 75 years of age (inclusive) at the time of screening.
* Body mass index (BMI) ≥18 and ≤35 (kg/m2), inclusive, and a minimum body weight of 45 kg.

Additional inclusion criteria might apply.

Exclusion Criteria:

* Symptoms consistent with COVID-19 such as fever, cough, and shortness of breath within 14 days before Day 1.
* Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening or check-in (Day -1).
* Known previous COVID-19 infection.
* Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within the 7 days or 5 half-lives, whichever is longer, prior to the first study drug administration. Use of hormonal contraception is allowed prior to and during the study.

Additional exclusion criteria might apply.
Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor

This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit from treatment with everolimus in patients who are eligible for everolimus+exemestane treatment. This trial is not aimed at evaluating a drug activity. Everolimus and exemestane are prescribed within their approved indication as per usual practice and are not part of this trial.

Estrogen hormone receptor-positive metastatic breast cancer who failed to non steroidal aromatases inhibitors in patients who are eligible for everolimus+exemestane treatment

Eligibility Criteria:
Inclusion Criteria:

- Eligible for everolimus+exemestane treatment as required by the marketing authorisation conditions

1. Women (or men) with histologically-proven Estrogen Receptor-positive (ER+) and/or Progesterone Receptor-positive (PR+) / Human Epidermal growth factor Receptor 2-negative (HER2-) metastatic breast adenocarcinoma or locally advanced disease who cannot be treated with surgery and/or radiation therapy
2. Postmenopausal women
3. Asymptomatic if visceral disease
4. Second line hormonotherapy or more for metastatic or locally advanced disease after recurrence or progression following a non-steroidal aromatase inhibitor (in adjuvant or metastatic setting)

   - Eligible for the biopsy
5. Progressive disease under endocrine therapy at the time of inclusion
6. Treatment with everolimus and exemestane not yet started
7. Patients with metastases that can be biopsied, except bone metastases
8. Measurable or evaluable disease
9. Age ≥18 years
10. WHO Performance Status 0/1
11. Provision of signed and dated, written informed consent prior to any protocol specific procedure, including biopsy
12. Patient with social insurance coverage

Exclusion Criteria:

1. Contraindications for everolimus+exemestane treatment
2. Previous treatment with an anti-mTOR therapy
3. More than 1 previous line of chemotherapy in metastatic setting
4. Life expectancy \<3 months
5. Spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug)
6. Haematopoietic function or organ impairment as shown by the following criteria:

   * Polynuclear neutrophils \<1.5 x 10⁹/L
   * Platelets \<100 x 10⁹/L
   * Haemoglobin \<90 g/L
   * Alanine aminotransferase (ALAT) / aspartate aminotransferase (ASAT) \>2.5 x ULN in the absence of or \>5 x upper limit of normal (ULN) in the presence of liver metastases
   * Bilirubin \>1.5 x ULN
   * Creatinine clearance ≤50 mL/min (measured or calculated by Cockcroft and Gault formula)
   * Calcium and phosphate \>ULN
7. Abnormal coagulation or any other medical situation contraindicating biopsy
8. Bone metastases when this is the only site of biopsiable disease
9. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
10. Individuals deprived of liberty or placed under the authority of a tutor
Allogeneic Hematopoietic Stem Cell Transplant For Epidermolysis Bullosa

RATIONALE: In animal models, stem cells have been shown to home to the skin and repair the biochemical and structural abnormalities associated with recessive dystrophic epidermolysis bullosa (RDEB) (collagen 7 deficiency).

PURPOSE: To determine the safety and effectiveness of stem cell infusion in the treatment of RDEB.

OBJECTIVES:

Primary

* Estimate the incidence of detectable donor-derived collagen type VII at day 100 in patients with epidermolysis bullosa by donor.

Secondary

* Determine the incidence of transplant-related mortality at day 180
* Determine the incidence of blood chimerism at days 21, 100, 180, 365, and 730
* Determine the incidence of neutrophil recovery at day 42 and platelet recovery at day 180
* Determine the incidence of acute graft-versus-host disease (GVHD) grade II-IV and grade III-IV at day 100
* Determine the incidence of chronic GVHD at 1 year
* Determine the probability of survival at 1 and 2 years
* Determine the incidence of donor derived cells in the skin
* Determine resistance to blister formation OUTLINE: This is an open-label, pilot study.
* Conditioning regimen: Busulfan intravenously (IV) over 2 hours every 6 hours on days -9 to -4, fludarabine phosphate IV over 1 hour on days -5 to -3, and high-dose cyclophosphamide IV over 1 hour on days -5 to -2.
* Stem cell transplantation on day 0.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: 30 patients

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of epidermolysis bullosa (EB)

  * Documented collagen type VII deficiency by:

    * Antigenic mapping (LH7.2 antibody)
    * Ultrastructure analysis of anchoring fibrils
    * DNA mutation analysis
* Performance status: \>50% Lansky; \>50% Karnofsky
* Adequate organ function

  * Renal: glomerular filtration rate \> 60ml/min/1.73m2 patients aged ≤ 10 years
  * Hepatic: bilirubin, aspartate aminotransferase/alanine aminotransferase (AST/ALT), Alkaline phosphatase (ALP) \< 5 x upper limit of normal 4.2.3 Pulmonary: oxygen saturation \>92% 4.2.4 Cardiac: left ventricular ejection fraction \> 45%.
* Healthy related hematopoietic stem cell donor available and meeting 1 of the following criteria:

  * HLA-A, B, DRB1-identical sibling bone marrow and/or umbilical cord blood donor (first priority)
  * HLA-A, B, DRB1-matched or partially matched related donor (second priority)
  * Donor may be a carrier but must be unaffected by EB
  * 8/8 HLA A, B, C, DRB1 allele level matched unrelated marrow donor (third priority)
  * 7/8 HLA-A, B, C, DRB1 allele level matched unrelated marrow donor or 4/6 HLA-A, B (antigen level), DRB1 (allele level) matched unrelated cord blood donor (fourth priority)

Exclusion criteria:

* Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days)
* Squamous cell carcinoma of the skin
* History of human immunodeficiency virus (HIV) infection
* Prior transplantation with donor skin
Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence

The aim of this study is to assess the efficacy of caffeine compared to placebo as a maintenance treatment for cocaine dependence. Caffeine potentiation with biperiden will be also studied.

Ninety patients with snorted/sniffed cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 10 days in an in-hospital setting.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cocaine dependence, according to DSM-IV-TR criteria
* age between 18 and 60 years
* current cocaine use, confirmed by a positive urine drug screen for cocaine the week prior to admission.
* demonstrated capacity to grant informed consent and sign the pertinent informed consent form.
* place of residence compatible with attendance at the center.
* for women, willingness to use effective contraceptive measures during the study.

Exclusion Criteria:

* diagnosis of a severe medical disorder that could interfere with the study
* presence of an organic pathology for which methylxanthines or biperidene administration is contraindicated
* serum liver transaminase levels 3 times higher than normal values
* pregnancy and breast-feeding
* neuroleptic medication treatment in the past 6 weeks
* current treatment, or anticipation that the patient may need to initiate treatment during the study, with drugs that may interact with study medication.
* current diagnosis of a major mental disorder.
* awareness of a situation that could prevent the patient's participation in the study (e.g. serving a sentence)
* current participation in another research project.
Achieving Blood Pressure Control Together Study

African Americans represent a particularly vulnerable subgroup of persons with hypertension, as they are more likely than Whites to have hypertension, equally as likely to be aware of it and to be treated for it, but less likely to achieve blood pressure control while receiving treatment. African Americans are also more likely than Whites to suffer end organ damage as a result of hypertension. Patients' hypertension self-management behaviors (including adherence to prescribed care, self-blood pressure monitoring, lifestyle changes, and shared medical decision-making) represent a cornerstone of hypertension therapy. Evidence suggests some African Americans with hypertension may experience difficulties carrying out positive self-management behaviors, in part due to cultural beliefs and practices, knowledge and perceptions regarding the nature and consequences hypertension, and lack of systems to support ongoing engagement in prescribed care within their communities. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses.

The goal of this study is to rigorously test the effectiveness of hypertension self-management interventions that engage African American patients, their families, and their community-level resources to improve African American patients' blood pressure.

We hypothesize patients' hypertension control rates may be improved when combining community health worker self-management support with other types of hypertension self-management skills training.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* African American/Black
* English speaking
* Two Blood Pressure values \>=140/\>=90 in 6 months prior
* Seen at East Baltimore Medical Center

Exclusion Criteria:

* 18 years and less
* Non African American/Black
* Not English speaking
* Pregnant
Environmental Treatment for Seasonal Affective Disorder (SAD)

The purpose is to study treatments of Seasonal Affective Disorder (SAD).

This is a multicenter, randomized controlled trial of negative ion generation versus light-emitting diode phototherapy for seasonal affective disorder. Participants appropriate for the study are subjects with a DSM IV diagnosis of Major Depression, with seasonal pattern, winter type. Subjects were seen at Yale University,New Haven,CT University of British Columbia,Vancouver,BC Groningen University Hospital,Groningen, The Netherlands, Royal Ottawa Hospital, Ottawa,Ontario, McGill University, Montreal,Quebec, University Hospital,Saskatoon, Saskatchewan. The trial is 4 weeks in duration.

This trial has now been completed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects meet DSM-IV criteria for major depressive episodes with a seasonal pattern, winter type.

Exclusion Criteria:

* Significant suicidal risk
* Serious medical illness
* Pregnancy
* Other DSM-IV diagnoses
* Taking mood altering medication
* May not travel to a sunny destination during study
Cholesterol Metabolites as Markers for CYP3A Induction

The objectives of this study are:

* To investigate if the endogenous cholesterol metabolite, 4beta-OHcholesterol could be used as a marker for induction of cytochrome P450 (CYP) 3A4.
* To compare 4beta-OHcholesterol with midazolam as a marker for induction of CYP3A4.


Eligibility Criteria:
Inclusion Criteria:

1. Females and males.
2. Age of 18 and above.
3. Caucasians.
4. Healthy as assessed by medical history and examination by principal investigator or delegated personnel.
5. Accept to refrain from herbal drugs, natural preparations, and grapefruit juice 48 hours before and during the study period.
6. Accept to completely refrain from alcohol during day -1 to 1 and R14-R16. During the rest of the study moderate alcohol use is permitted (equal to 1 glass of wine or 1 beer per day).
7. Women of childbearing age should accept using a reliable barrier contraceptive method throughout the study.
8. Women of childbearing age should have a negative pregnancy test at the screening visit.
9. Capable of following given instructions.
10. Has given written informed consent after receiving both oral and written study information.

Exclusion Criteria:

1. Predisposal to allergic drug reactions.
2. Anamnestic and/or visual signs of infection.
3. Women are not allowed to use oral hormone-based contraceptives 2 weeks before start of study and during the study.
4. Participation in another study within one month before entering the present study.
5. Intake of any other drug that can influence the enzyme activity of CYP3A4.
6. Pregnancy.
7. Breast-feeding.
8. A history of liver disease.
Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study

This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease，acute kidney injury, and major adverse cardiac events within 100 days after transplantation，the secondary objective is to observe the high-risk factors for early complications.

This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Baseline characterisitcs of patients, including gender, age, disease type, transplant type, donor gender and age, pre-transplant baseline electrocardiogram, myocardial enzymology, renal function, and other indicators were recorded. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease，acute kidney injury, and major adverse cardiac events within 100 days after transplantation，the secondary objective is to observe the high-risk factors for early complications.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 65 years old;

Gender unlimited;

Normal heart and kidney function before transplantation;

Patients with indications for allogeneic hematopoietic stem cell transplantation.

Exclusion Criteria:

* CREA or BUN higher than the normal upper limit value before transplantation;

Individuals with a history of arrhythmia, heart failure, or PCI stent implantation prior to transplantation;

Patients with mental illness;

Those who are unwilling to sign informed consent.