cyrilzakka/clinical-trials huggingface dataset:
Group MDMA-therapy for Veterans With PTSD

This Phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts.

To assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor-investigator is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly open-label MDMA Sessions combined with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary Clinical Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years old.
* Are a U.S. Military Veteran
* Are fluent in speaking and reading the predominantly used or recognized language of the study site.
* Are able to swallow pills.
* Agree to have study visits recorded, including MDMA Sessions, outcome assessments, and non-drug psychotherapy sessions.
* Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
* Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
* If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
* Must not participate in any other interventional clinical trials during the duration of the study.
* Must commit to medication dosing, therapy, and study procedures.
* Have a current PTSD diagnosis at the time of screening.

Exclusion Criteria:

* Are not able to give adequate informed consent.
* Have uncontrolled hypertension.
* Have a marked baseline QTcF interval \>450 milliseconds \[ms\] demonstrated on repeated ECG assessments.
* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
* Have evidence or history of significant medical disorders.
* Have symptomatic liver or biliary disease.
* Have history of hyponatremia or hyperthermia.
* Weigh less than 48 kilograms (kg).
* Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
* Are abusing illegal drugs or alcohol.
Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication

NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 taken twice a day (BID) for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication.

NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 BID for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication.

Eligibility Criteria:
Inclusion Criteria:

* Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities
* Median treadmill peak walking time between 90 and 600 seconds

Exclusion Criteria:

* Symptoms of limb threatening ischemia (ischemic rest pain, ischemic ulceration and/or gangrene)
* Clinically significant pulmonary, neurological or skeletal dysfunction (e.g., lumbar canal stenosis, emphysema, uncontrolled angina, multiple sclerosis, or gait altering amputation) that would directly interfere or limit exercise testing
* Subjects who have had, or will require, a peripheral revascularization procedure within 12 weeks prior to or following treatment initiation.
* A resting blood pressure greater than 150/100 and other clinically significant results.
Acid Lactase in Combination With Yoghurt Bacteria for Improvement of Lactose Digestion in Lactose Malabsorbers

Fermented dairy products, especially real Yoghurt, are often tolerated better by lactose malabsorbers than unfermented dairy products. The intake of dietary supplements containing acid Lactase derived from Aspergillus oryzae with lactose containing foodstuffs is known to reduce/alleviate symptoms of lactose intolerance in lactose malabsorbers. The study aims to compare the effect of the intake of a combination of yoghurt bacteria and acid lactase to the effect of yogurt bacteria or acid lactase alone on the lactose digestion in lactose malabsorbers. It is hypothized that the combination preparation will be more effective and/or will show a more reliable effect than the two mono-preparations.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of African or Asian origin.
* Older than 18 years
* Written informed consent

Exclusion Criteria:

* Participation in a clinical study with a drug or a medical product withing the last 30 days;
* Inability to comply with the study protocol;
* Allergy to milk protein;
* Intolerance against lactase preparations;
* Known metabolic or gastrointestinal diseases which affect the absorption, metabolism or excretion of food components except lactose maldigestion;
* Intake of drugs influencing resorption of food components or gastrointestinal motility;
* Surgery within the last three months which still affect the current status of health;
* Psychiatric diseases
* Epilepsia
* Risk for suicide
* Eating disorders, e.g. anorexia, bulimia
* Alcohol or drug abuse
* Legal incapacity
the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure

The investigators set out to evaluate the effects of the traditional Chinese medicinal mixture under the brand name YangXinShi (YXS) on the prognosis in patients with chronic heart failure when it is combined with the optimal combination drug treatment of heart failure.


Eligibility Criteria:
Inclusion Criteria:

* patients newly diagnosed with heart failure or have been diagnosed with chronic heart failure
* patients classified as NYHA II-IV (New York Heart Association)

Exclusion Criteria:

* with severe liver or renal dysfunction
* with severe systematic conditions such as infection, malignant hypertension etc.
* hemodynamic instability (arrhythmia, acute cardiac infarction, aortic dissection etc.)
* not cooperating due to psychomotor deficiency, or with contraindications for exercise testing
Recovery Rate in Secondary Hypothyroidism

The aim of this project is to assess the rate of recovery of secondary hypothyroidism in patients with pituitary disorders.

The study will be conducted in three stages.

Stage 1 ( Patient identification and enrollment)

We will generate a list of all SHT patients from the HNP database and all patients will be contacted by the principal investigator (or their designate) regarding the study. Those patients who agree to participate in the study will be given a written consent form. We aim to enrol approximately 90 -100 patients for the study. Laboratory samples for serum TSH and T4 levels will be collected to confirm that all patients are adequately replaced for SHT. Those patients who are not adequately replaced and have low T4 will be excluded from the study.

Stage 2 (T4 withdrawal protocol)

Stepwise T4 replacement therapy will be initiated as follows.

Step 1:

* Reduce the dose of T4 therapy by 50% and recheck serum T4 after 2 weeks.
* If serum T4 is normal, go to step 2.
* If serum T4 drops to below normal then resume full T4 replacement (these patients will be considered as having withdrawal failure).

The rationale for testing serum T4 after 2 weeks is that the half life of T4 is up to 7 days and early testing will potentially give false results. Furthermore, serum T3 is not a reliable test in patients taking T4 therapy and will not be requested 6.

Step 2:

* Discontinue T4 therapy altogether and recheck serum TSH and T4 after 2 weeks.
* If serum T4 is normal, go to step 3.
* If serum T4 drops to below normal then resume full T4 replacement (these patients will be considered as having withdrawal failure).

Step 3:

* Recheck serum TSH and T4 after 8 weeks.
* If serum TSH and T4 levels are normal, these patients will be regarded as having successful T4 withdrawal.
* If T4 drops to below normal then resume full T4 replacement (these patients will be considered as having withdrawal failure).

Stage 3 (Analysis)

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of secondary hypothyroidism who are currently taking T4 replacement therapy

Exclusion Criteria:

* uncontrolled cardiovascular disease
* uncontrolled congestive heart failure
* uncontrolled mental health disorder
* not adequately replaced and have low T4 level.
SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults with CD33 And/or FLT3 Blood Cancers Including AML/MDS

This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS.

This is a dose-finding study of SENTI-202, comprised of an initial dose finding using a modified "3+3" study design to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of SENTI-202 when administered after lymphodepleting chemotherapy (Part 1) followed by disease-specific expansion cohorts at the RP2D (Part 2).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with CD33 and/or FLT3 expressing malignancies, including:

  * Relapsed refractory acute myeloid leukemia (AML) with morphologic relapse as defined by ≥5% bone marrow blasts who have received at least 1 prior line, but no more than 3 prior lines of standard anti-AML therapy. Subjects with FLT3-mutated or IDH ½-mutated disease must have received at least one prior targeted therapy.
  * Relapsed refractory myelodysplastic syndrome (MDS) with increased blasts who have received at least 1 prior line, but no more than 2 prior lines of anti-MDS therapy
  * Other hematological malignancies who have received at least 1 prior line of standard of care for the respective disease
  * Documentation of CD33 expression (or FLT3 expression if available) by individual institutional standard of care
* ECOG performance score of 0-1
* Adequate organ function including platelet count \>20x109/L (platelet transfusion is permitted)
* Adequate recovery from toxicities from previous cancer treatments, as described in the study protocol
* Willing and able to provide written informed consent

Exclusion Criteria:

* White blood cell (WBC) count of ≥20×109/L or circulating blasts ≥10×109/L or rapidly progressive/hyperproliferative disease
* Acute promyelocytic leukemia with t(15;17) (q22;q12) or abnormal promyelocytic leukemia/retinoic acid receptor alpha (APML-RARA)
* MDS with fibrosis (MDS-f) or known prior history of constitutional conditions/syndromes with chemo-responsive AML
* Evidence of leukemic meningitis or known active central nervous system disease
* Presence of extra-medullary disease or myeloid sarcoma alone with no morphologic hematologic relapse
* Prior use of certain anti-cancer therapies and/or use within a certain number of days prior to SENTI-202 study treatment, as described in the study protocol
* Hematopoietic cell transplantation (HCT) less than 100 days prior to the first dose of SENTI-202
* Prior NK cell or CAR T cell therapy at any time
* Prior donor lymphocyte infusion (DLI), except if after HCT for MRD+ disease
* Medical conditions or medications prohibited by the study protocol
* Pregnant or breastfeeding female
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.


Eligibility Criteria:
Inclusion Criteria:

* International Prostate Symptom Score (IPSS) ≥ 8
* Gleason Grade Group 1-3
* Prostate-specific Antigen (PSA) ≤20ng/mL
* Cancer stage less than or equal to T2c

Exclusion Criteria:

* Patients with previous surgical treatment of benign prostatic hyperplasia
* MRI evidence of extracapsular extension of cancer
* Any severe illness that would prevent complete study participation or confound study results
Cleveland Kids Run

A 12 month long program focused on making good food choices and exercise directed at 8-12 year olds and their caregivers. The program will consist of monthly educational meetings each teaching a new nutritional and exercise concept. Children will be given weekly exercise schedules and their adherence to the program will be assessed. The study will culminate with an annual children's race in May.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be aged 8-12 years old and enrolled in kindergarten through 6th grade in a Cleveland Public School
* Participants must have at least a B-average or equivalent in the prior academic year
* Participants must have at least one part or guardian who is able to accompany the participant during exercise and educational sessions
* Participants must be willing to participate in the Rite Aid Cleveland Marathon Ringling Bros. and Barnum \& Bailey Red Nose Run® at the end of the study

Exclusion Criteria:

* Children who are younger than 8 years or older than 12 years

  * Children whose parents who are unable or unwilling to provide informed consent,
  * Children whose parents are are illiterate or non-English speaking or reading
  * Children whose parents are unable or unwilling to accompany them to educational and exercise sessions
  * Children with a medical condition that prevents them from unmonitored exercise
  * Children who have not maintained an equivalent of a B-average in the prior academic year
Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation

This study will evaluate the maximum safe dose and duration of regadenoson (Lexiscan) that can be given to people who are having a lung transplant. Regadenoson will be given as a continuous IV infusion. All participants in the study will receive a regadenoson infusion beginning in the operating room during the lung transplant procedure. Participants will be assigned a certain dose of regadenoson to be given over a 12 or 24 hour period.

Lung transplantation currently is one way to treat a variety of serious diseases and conditions such as emphysema, pulmonary fibrosis, and cystic fibrosis. Ischemia Reperfusion Injury (IRI) is a known problem that can happen during the first few days after a lung transplant. IRI can cause swelling of the lungs and low levels of oxygen. The most serious type of IRI can cause the transplanted lung to not work properly, it can even cause death. While new treatments and practices have been put into place to lower the chances of IRI, it is still a difficult problem to overcome after a lung transplant.

Medicines called Adenosine 2A receptors (A2AR) have been studied in animals with IRI for many years. Some of these studies suggest that with the use of A2AR medicines, the chance of IRI may be lowered or prevented. Regadenoson is an A2AR drug.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be undergoing a bilateral lung transplantation for end-stage lung disease and thus meet all criteria to be listed
* Male or female subject, 18 -75 years of age
* Subjects must sign a study specific informed consent prior to study entry
* Subjects must meet all of the following laboratory values:

  1. hemoglobin ≥ 6 g/dL,
  2. platelets \> 75,000/mcL,
  3. aspartate aminotransferase (AST/SGOT)/ alanine aminotransferase (ALT /SGPT) \< 2.5 X institutional upper limit of normal,
  4. serum creatinine \< 1.5 mg/dL,
  5. INR \< 1.5, PTT \< 40 seconds

Exclusion Criteria:

* Subject requires preoperative extracorporeal membrane oxygenation (ECMO)
* Subject has second degree (Mobitz type I or II) or third-degree AV block or sinus node dysfunction
* Subject has history of a bleeding diathesis
* Subject has a history of clinically overt stroke within the past 3 years
* Subject has a history of severe hypertension not adequately controlled with anti-hypertensive medications (Systolic blood pressure ≥ 200 mmHg and/or Diastolic blood pressure ≥ 110 mmHg)
* Subjects who are receiving chronic anti-coagulation or anti-platelet therapy that would preclude surgery (prophylactic aspirin is acceptable)
* Subjects with a history of metastatic cancer
* Subjects with a history of seizure disorder
* Subjects who are receiving or have received within 30 days any other investigational agents
* Subjects who have received theophylline or aminophylline within 12 hours of study dosing
The Effect of Radiofrequency of 448 kHz on Pain and Function

The goal of this trial is to compare the effects 448kHz capacitive resistive monopolar radiofrequency (CRM) with Proprioceptive Neuromuscular Facilitation (PNF) versus only PNF in chronic low back pain patients.

The main questions it aims to answer are:

1. Is there any difference in interventions on reduction of pain.
2. Is there any difference in interventions on reduction of disability.

Participants will in the experimental group will be treated with a combination of:

1. 448kHz capacitive resistive monopolar radiofrequency and,
2. PNF intervention

Participants will in the control group will be treated only using

1. PNF intervention (identical to experimental group)

Researchers will compare experimental and control group to see if there are differences in reduction of pain and disability.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years, chronic low back pain (CLBP)

Exclusion Criteria:

* spinal fractures, radiculopathies, history of spinal surgery, spinal stenosis, history of thrombosis, pacemaker, pregnancy
Dialysis CHW Pilot

To determine the acceptability and feasibility of a community health worker intervention that assists dialysis patients with low socioeconomic status navigate community resources to address health-related social needs. Findings will be used for a future randomized trial that determines the efficacy of the CHW intervention on mental health, quality of life, addressing social needs, and clinical outcomes. This study is intended to be generalizable in all dialysis centers.

The research team will conduct a single-arm 6-month pilot study testing the feasibility of implementing a tailored, health-related social needs intervention among dialysis patients. The research teamwill recruit 30 dialysis (all modalities) patients aged≥18 years with low socioeconomic status to participate in a CHW intervention. The CHW intervention will be modeled after IMPaCT (Individualized Management for Patient-Centered Targets), a 6-month CHW intervention that addresses "upstream" socioeconomic and behavioral barriers to treatment for individuals with chronic diseases, which has been adapted to numerous populations and shown to improve care and reduce hospitalizations. The CHW will identify health-related social needs and help participants navigate community resources to meet needs. All participants will receive the intervention. All participants will also participate in a CHW-led support group, that will occur monthly. The research team will compare outcomes during the 6-months before and during the intervention period. This pilot study aims to (1) assess the feasibility of recruiting dialysis patients experiencing health-related social needs to an intervention trial, and (2) assess the feasibility of implementing the intervention within this population, in a fashion deemed acceptable.

Eligibility Criteria:
Inclusion Criteria:

* Have kidney failure and be receiving dialysis

Exclusion Criteria:

* Live in a nursing facility or institution
* Physically or mentally unable or unwilling to participate
Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder

One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal Affective Disorder(SAD) or so called winter depression is a disturbance of circadian rhythms. Since the circadian system is especially sensitive for the blue portion of the light spectrum, a new light therapy device with more blue light (blue enriched polychromatic light) was tested for its efficacy to treat SAD. In chronobiological terms this light is hypothesized to be more potent in inducing non-visual effects. In the present study fluorescent tubes that emit a high portion of short wavelength light on top of the normal wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients.,In a earlier study it was shown that the therapeutic effect of blue enriched light were equal to standard light treatment using light in both conditions with an intensity of 10 000 lux. In the present study, blue enriched light with an intensity of 750 lux was used, because of the possible saturation effect in the former study. The investigators hypothesise that blue- enriched light with a low intensity improve the therapeutic effects of light treatment leading to a higher response or the same response in a shorter time schedule compared to standard light treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Diagnose of Seasonal Affective Disorder, winter type according to DSM-IV SIGH SAD rating Higher then or equal to 18 on day 1
* No other treatments for mood disorder during the study
* Stay in the Netherlands during the study

Exclusion Criteria:

* Other axis-I disorders according to the DSM-IV
* Acute suicide risk
* Use of psychotropic drugs or photosensitizing drugs
* No other treatments for mood disorder during the study
* Diabetes or epilepsy
* Regular shift work