cyrilzakka/clinical-trials huggingface dataset:
Implementation of a Short Mindfulness-based Program for Young Women in Puerto Rico

The goal of this study is to evaluate the feasibility and acceptability of a revised 4-week mindfulness program among young women with elevated stress and anxiety in Puerto Rico

Women in Puerto Rico (PR) experience a high prevalence of cardiometabolic diseases (CMD), with 38% affected by obesity and 42% by hypertension. These rates are higher than those observed in PR men and non-Latinx White women in the continental U.S. Chronic stress is a key risk factor for CMD, and PR women report higher psychological distress than men, despite facing similar social and environmental stressors. Young adult women are particularly vulnerable, as stress during this life stage can shape long-term health outcomes, highlighting the need for targeted interventions.

Mindfulness-Based Stress Reduction (MBSR) is a structured, evidence-based program designed to reduce stress through techniques such as focused attention, open monitoring, and non-judgmental awareness. MBSR has been shown to lower blood pressure, improve heart rate variability (HRV), and reduce psychological distress, including anxiety and depression. The program's emphasis on group sessions aligns well with PR's collectivist culture, making it a potentially effective approach for this population. However, traditional MBSR programs, which span eight weeks with long session durations and extensive home practice, pose feasibility challenges, particularly in PR, where transportation and time constraints are significant barriers.

To overcome these limitations, researchers have adopted a 4-week MBSR program tailored specifically for young PR women, using shorter sessions and telehealth delivery. Preliminary research has demonstrated good participant retention, satisfaction, and improvements in psychological distress among Latinx women, but no randomized controlled trials (RCTs) have been conducted to evaluate MBSR's impact on PR women's cardiometabolic health. The proposed pilot RCT aims to address this gap by testing the feasibility, acceptability, and effectiveness of the adapted 4-week MBSR program, providing a culturally relevant intervention to reduce stress and improve CMD outcomes in this underserved group.

Eligibility Criteria:
Inclusion Criteria:

* Reporting female sex at birth
* Not identifying as a man, trans man, or trans woman.
* Individuals residing in Puerto Rico
* Spanish speaking
* Currently not pregnant
* Elevated stress (defined as a score \>6 in the Perceived Stress Scale (PSS-4)34) or Elevated anxiety (defined as a score of 5 or more on the GAD-7 scale)
* Willing to undergo research activities.

Exclusion Criteria:

* Male sex at birth
* Identifying as a man, trans man, or trans woman.
* Currently pregnant
* Previous participation in an 8-week MBSR program
* Experiencing moderately severe or severe depressive symptoms (PHQ-9\>15)35)
* Have active suicidal ideation (PHQ-9 item #9)35
* Self-report history of cognitive and psychiatric conditions
* Lack of access to the internet/phone (mode of focus group discussions-via Zoom)
A Proof-of-Concept Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Hemophilic Arthropathy

Repeated joint bleeding leads to hemophilic arthropathy (HA), which manifests with chronic synovitis, cartilage damage and bony destruction. Currently available treatments of HA, including analgesics, NSAIDs, and hyaluronic acid, are predominantly directed toward the symptomatic relief of pain and inflammation, with no or little effect on joint cartilage degeneration. AC201CR, a control released formulation of AC-201, demonstrates anti-inflammatory effects by reducing NLRP3 inflammasome assembly. AC-201 is also unique in that it influences both the anabolism and catabolism of chondrocytes in vitro and has shown cartilage-sparing properties in animal studies. The study is designed to evaluate the joint structure-modifying and symptom-relieving effects, safety, and tolerability of AC-201CR in subjects with HA.


Eligibility Criteria:
Inclusion Criteria:

1. Male age 20 to 65 years, inclusive
2. Diagnosis of Hemophilia A or B
3. Clinical diagnosis of hemophilic arthropathy in the knee(s) for at least 6 months
4. Pettersson score (based on X-ray) of 0 to 4 in at least one knee within 1 year of screening
5. IPSG (2012) overall score of 3 to 9 (based on MRI) in at least one knee at screening
6. Is able to read, understand, and sign the Informed Consent Form (ICF), communicate with the investigator, complete study diaries, and understand and comply with protocol requirements

Exclusion Criteria:

1. Total knee replacement in the primary knee
2. Presence of joint infections in the primary knee
3. Knee surgery within 6 months prior to screening in the primary knee
4. Intra-articular hyaluronic acid (IAHA) or platelet-rich plasma (PRP) injection in the primary knee within 6 months prior to screening
5. Use of any of the following medications after the screening visit:

   1. NSAID injection (oral NSAIDs including COX-2 inhibitors allowed)
   2. Glucosamine or chondroitin
6. History of high responder inhibitory antibodies to factor VIII or factor IX clotting factor, with titer \>5 Bethesda units (BU), OR clinical evidence for presence of factor inhibitor
7. History of rheumatoid arthritis or gouty arthropathy
8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration \>2x the upper limit of laboratory normal range (ULN), or bilirubin \>1.5x ULN at screening
9. Positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or TB
Effects of a Floss Band on Ankle in Stroke

Abstract: Background/Objectives: Stroke patients generally have balance and gait dysfunction due to decreased range of motion (ROM) and muscle strength of the ankle joint. A therapist can apply a floss band to enhance ROM, pain control, jumping performance, strength, myofascial release, and recovery from fatigue. This study compared the immediate effects of floss band application on ankle ROM, balance, and gait ability in stroke patients.; Methods: This study randomized 40 chronic stroke patients to either the floss (n = 20) or sham (n = 20) band group. Outcome measures were ankle ROM, weight bearing lunge test (WBLT) performance, standing balance, and gait ability. Outcome measures were assessed at baseline and immediately after applying the floss or placebo band.

The floss band intervention used the standard floss band technique, wrapping a floss band (lime green Sanctband Comprefloss™, 2" × 3.5 m; PENTEL, Shah Alam, Malaysia) made of natural rubber tightly around the ankle on the affected side. It was started at the fifth metatarsal and wrapped horizontally around the metatarsals twice, in a figure eight to the medial malleolus, over the Achilles tendon and the lateral malleolus three times, and around the medial malleolus again, before being passed twice from the medial mal-leolus over the Achilles tendon to the lateral malleolus, forming an end knot. The participants were instructed to perform low-intensity active exercise involving ankle DF and plantar flexion for 2 minutes after applying the floss band. Then, the floss band was removed and the patient was asked to walk lightly on level ground for about 1 minute to allow reperfusion to normalize blood flow.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ischemic or hemorrhagic stroke
* Chronic patients 6 months after stroke onset
* Able to walk 10 meters independently
* Unable to dorsiflexion the ankle on the affected side
* Modified Ashworth scale (MAS) score \< G2 for the ankle joint
* Adequate cognitive status Mini-Mental State Examination (MMSE) score of ≥ 23

Exclusion Criteria:

* Impaired lower extremity function due to other causes
* Dizziness
* Hemianopia, or other symptoms indicating vestibular dysfunction
* Serious heart disease or use of a pacemaker
* Unable to tolerate the floss band intervention
An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

The goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease


Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfilled the inclusion and exclusion criteria as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.
Open-label, Single Arm, Tumor Imaging and Dosimetry Study of I-124 PGN650 in Advanced Solid Tumors

Tumor Imaging of I-124 PGN65 in Solid Tumors

Up to 12 patients (6 men and 6 women) will be enrolled in this open-label, single-arm, tumor imaging and dosimetry study of I-124 PGN650 in solid tumors. All eligible patients who give written, informed consent and meet all inclusion criteria and no exclusion criteria, and whose laboratory results are within specified limits at the screening visit, will be enrolled. All study subjects will receive a single intravenous (IV) dose of I-124 PGN650. Study subjects will have whole body PET/CT imaging at three different timepoints with all patients having PET/CT at 0 to 60 minutes after injection of I-124 PGN650. Study subjects will then be assigned to either a 3 to 5-hour or 6 to 8-hour timepoint and either an 18 to 26 hour or 42 to 52 hour post-injection timepoint. Tumor and whole body radioactivity distribution will be measured.

Eligibility Criteria:
Inclusion Criteria

1. Signed informed consent form.
2. Male or female, ≥ 18 years of age.
3. Histologically or cytologically confirmed solid tumors at any stage with at least one lesion (primary, metastatic, or recurrent) ≥ 1.5 cm in diameter documented by CT. If the lesion is located in a lymph node, the shortest diameter of the lymph node must be ≥ 1.5 cm as defined by RECIST 1.1. (Note: See Exclusion Criteria #1.)
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5. Adequate baseline hematological and organ function, assessed by laboratory values prior to study treatment as follows: absolute neutrophil count (ANC) \> 1.0 x 109/L; hemoglobin \> 7 g/dL; serum creatinine \< 2 x institutional upper limit of normal (IULN); aspartate transaminase (AST) \< 2.5 x IULN; alanine transaminase (ALT) \< 2.5 x IULN; (if liver metastases are present, ALT and AST \< 5 x IULN); total bilirubin \< 1.5 x IULN.
6. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence), for the duration of study participation (i.e., from dosing day 1 until study day 8). Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
7. Patient must be willing and able to undergo the imaging studies outlined in the protocol.

Exclusion Criteria

1. Only measureable disease (primary or metastatic) is located in or near the thyroid gland, liver, kidney, or urinary bladder.
2. Medical conditions such as ischemic heart or lung disease that may be considered an unacceptable risk.
3. Females who are lactating or pregnant.
4. Persistent acute toxicities from prior anti-cancer therapy.
5. History of hypersensitivity to iodine.
6. Known bladder outlet obstruction.
7. Any condition that would in the Investigator's judgment prevents compliance with the requirements of the protocol.
8. Patients with known history of an autoimmune disease- including but not limited to: celiac disease, Crohn's disease, dermatomyositis, Grave's disease, systemic lupus erythematosus, myasthenia gravis, psoriasis, and rheumatoid arthritis.
Quantitative Pupillometry

The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.

Acute hydrocephalus is an emergency often requiring the insertion of an external ventricular drain (EVD). In the aftermath, the patient is transferred to an intensive care unit (ICU) for close monitoring. Ensuring optimal cerebral perfusion through efficient drainage of cerebrospinal fluid while minimizing drainage duration are the objectives of care.

Assessing pupillary light reflex is a key test for the detection of neurological deterioration. For long, this assessment has been grossly performed via a qualitative approach (present/absence of pupillary light reflex). For a more precise assessment, quantitative pupillometry has been proposed. Pupil size and constriction speed in response to a standard light are recorded by an automatic portable and user-friendly device. This device is increasingly used in the ICU, mostly for prognostication after acute brain injury. We hypothesized that quantitative pupillometry parameters may vary when hydrocephalus occurs.

The aim of this study is to assess whether quantitative pupillometry parameters vary when hydrocephalus occurs. The investigators focused on the early detection of hydrocephalus during the EVD weaning process.

Eligibility Criteria:
Inclusion Criteria :

* Patient older than 18 years old
* Admitted to the ICU
* With an external ventricular drain
* Consenting to participate (or consent from his/her next of kin, if unable to consent).

Exclusion Criteria :

* Patient with pre-existing bilateral pupillary pathology
* Pregnant or breast-feeding patient
* Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment
* Patient with no health insurance
* Patient under guardianship
Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301

This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 in postoperative patients requiring central parenteral nutrition.

This study is a randomized, open-label, phase 3 design. The subject will be assigned to one of the two treatment groups (IN-C006 Peri inj. or RPN301)

Eligibility Criteria:
Inclusion Criteria:

* Age over 19 at the time of obtaining the informed consent form
* Requiring over 3 days of parenteral nutrition via a peripheral vein after an operation
* BMI 16 \~ 30 kg/㎡

Exclusion Criteria:

* Has received parenteral nutrition within 7 days of screening
* Severe dyslipidemia
* Uncontrolled diabetes
* Clinically significant liver disease
* Clinically significant kidney disease
Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations

Single centre, open-label, non-randomized study is planned to proof the concept of safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with constipations

This single-center open-label non-randomized study is planned to proof the concept on safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with irritable bowel syndrome with constipations.

Eligibility Criteria:
Inclusion Criteria:

* willingness to participate (based on signed informed consent form)
* irritable bowel syndrome with predominant constipation, per Rome IV criteria (Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: related to defecation; associated with a change in frequency of stool; associated with a change in form (appearance) of stool - Bristol stool scale types 1 or 2. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis),

Exclusion Criteria:

* pregnant or breast-feeding women;
* intolerance of kombucha or any component of the product;
* history of abdominal surgery;
* the use of concomitant medications able to affect bowel motility;
* general condition of a patient making the appropriateness of his participation in the study questionable;
* chronic decompensated disorders of any organs and systems;
* mean daily caloric intake less than 800 kcal and more than 6000 kcal
* inability to follow standard iso-caloric diet and standard volume of water consumption (1.5-2 litres a day)
Quantification and Repeatability of Magnetic Stimulation

In this project the quantification and the repeatability of responses to rapid bilateral magnetic stimulation of the phrenic nerves will be investigated in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* non-smoking
* normal lung function
* body mass index: 18.5-29.9 kg/m2
* able to communicate in english
* willing to adhere to study rules

Exclusion Criteria:

* acute illness or chronic conditions of the gastrointestinal tract, and health conditions affecting metabolism, the cardiovascular or the respiratory system, or sleep
* intake of medications affecting metabolism, the cardiovascular, the neuromuscular or the respiratory system, or sleep
* any metal or electronics inside of the body
* presence of cardiac pacemaker, implanted defibrillators or implanted neurostimulators
* history of seizures or epilepsy
* tatoos on the stimulation sites
* previous enrolment in this study
* for women: pregnancy, breastfeeding, or intention to become pregnant during the study
A Multicenter Pragmatic Implementation Study of ECG-AI-Based Clinical Decision Support Software to Identify Low LVEF

A prospective, cluster-randomized, care-as-usual controlled trial to evaluate the impact of an ECG-based artificial intelligence (ECG-AI) algorithm to detect low left ventricular ejection fraction (LVEF) on diagnosis rates of LVEF ≤ 40% in the outpatient setting.

The objective of this study is to evaluate the impacts of an ECG-AI algorithm to detect low LVEF and an associated Medical Device Data System when used during routine outpatient care. The study will be conducted in 2 phases: feasibility assessment phase and clinical impact phase.

The study is a prospective, cluster randomized, care-as-usual controlled trial that will be conducted at 6 sites in the USA.

Primary care clinicians and general cardiologists will be invited and consented to participate in the study. For clinicians that accept, practice groups will be randomized to receive access to and education about the Low EF AI-ECG software and encompassing software or to provide care-as-usual in the control group. The study will be conducted in two phases: a feasibility pilot to evaluate integration and usability followed by observational period(s) to evaluate clinical outcomes.

Analyses of the primary and secondary endpoints will be conducted on data from patients that meet the inclusion and exclusion criteria. The expected duration of the study is 12 months, including a feasibility phase (estimated 6 weeks) followed by a 3-month initial observation period with rolling observation count monitoring until the target number of patient encounters is reached, followed by a 90-day follow up period.

At the completion of the feasibility period, we will evaluate quantitative and qualitative outcomes to inform the following observational period(s).

Primary endpoints and exploratory endpoints will be assessed the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years or older (including females who are pregnant, breastfeeding and/or lactating)
* Digital ECG captured or available within site for ECG-AI analysis at point-of-care

Exclusion Criteria:

* Known history of LVEF ≤ 40%
* Known history of systolic heart failure
* Known history of heart failure with reduced ejection fraction
* Opted out of electronic health record-based research
Target Engagement of Terazosin in Healthy Adults

The purpose of the study is to assess the target engagement of Terazosin (TZ) in a single cohort of 6 healthy adult participants. During the study participants will undergo PET/CT scans, 7-Tesla MRI scans, blood draws, and an optional lumbar puncture (LP.)

The study is a single center, 37-day, controlled pilot study to assess the target engagement of Terazosin (TZ) in a single cohort of 6 healthy adult participants (3 men and 3 women.) During the study participants will undergo PET/CT scans, 7-Tesla MRI scans, blood draws, and an optional lumbar puncture (LP.) Participants will have their baseline ATP levels measured (at 0mg TZ.) They will then take doses of TZ at 1mg and will increase their dose on a weekly basis by 1mg until they reach a total dose of 5mg. ATP levels will be assessed on study days 8 and 36. Participants interested in voluntarily donating a sample of cerebral spinal fluid will undergo an optional lumbar puncture on study day 37.

The purpose of the study is to gain a better understanding of the mechanisms in which TZ acts in the brain. TZ was recently discovered to increase energy levels (in the form of ATP molecules) in the brain by enhancing glycolysis. By using different brain imaging techniques, blood assays and cerebral spinal fluid assays, the study will attempt to: 1) quantify the rate of glycolysis in the brain at different dosages of TZ, 2) quantify ATP levels in the brain at different dosages of TZ, 3) quantify ATP levels in blood at different dosages of TZ, and 4) assess the brain permeability of TZ. It is hoped that knowledge gained from the study will help guide future clinical trials using TZ for the treatment of various neurodegenerative diseases such as Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Men or women aged 60-90

Exclusion Criteria:

* History of stroke
* Ineligibility for MRI (e.g. soft tissue metallic implants, clips, cardiac pacemaker, cardiac defibrillator, internal pacing wires, metallic fragments, shrapnel, etc.)
* Current use of more than one of the following classes of medications: beta blockers, ace inhibitors, angiotensin receptor blockers, calcium channel blockers, or diuretics
* Use of any alpha blockers (terazosin, doxazosin, alfuzosin, prazosin, or tamsulosin) in the past year.
* Current use of the over-the-counter supplement yohimbe
* Orthostatic hypotension defined as symptomatic decrease in BP \> 20mmHg systolic or \> 10mmHg diastolic and HR increase \< 20bpm on supine to sitting or standing.
* Alcohol and drug abuse
* Clinically significant traumatic brain injury
* History of Type I diabetes
* Uncontrolled Type II diabetes
* Other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study or increase fall risk
* Use of investigational drugs within 30 days before screening
* History of hemodynamic instability
* For females: pregnancy or breastfeeding