cyrilzakka/clinical-trials huggingface dataset:
Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder.

The trial will take place with individuals admitted to a residential rehabilitation treatment program. The treatment protocol will consist of 4 preparatory therapy visits, 2 psilocybin sessions (25-30mg), and 8 total integration therapy visits. Primary aims assess acceptability, feasibility, and safety with a primary endpoint at the conclusion of the study intervention. An additional aim assesses preliminary efficacy for methamphetamine use disorder and overall functioning at follow-up assessments 60 and 180 days after discharge from the residential treatment program.

Eligibility Criteria:
Inclusion Criteria:

* United States military Veteran
* Moderate to severe methamphetamine use disorder using the DSM-V diagnostic criteria
* Desire to cease or reduce methamphetamine use

Exclusion Criteria:

* Have uncontrolled hypertension or clinically significant cardiovascular disease
* History of seizure disorder in adulthood
* CNS metastases or symptomatic central nervous system (CNS) infection
* Poorly controlled diabetes mellitus
* Taking certain medications that may interact with psilocybin
* History of any primary persistent psychotic disorder, including schizophrenia, schizoaffective disorder, bipolar disorder with psychosis, major depressive disorder with psychosis, or schizophreniform disorder
* History of bipolar I disorder
* Current eating disorder with active purging
* History of hallucinogen use disorder
* Pregnant or breast feeding
Prospective COVID-19 Cohort Study, Dominican Republic

This project will build on an existing CDC funded cooperative agreement in the Dominican Republic with the Brigham and Women's Hospital (2018-2023) that includes (i) prospective COVID-19 and AFI surveillance at two health facilities and (ii) a nationally representative cross-sectional community-based serological survey of approximately 7,000 healthy adults and children targeting SARS-CoV-2 and other AFI pathogens to be conducted between April and June 2021. This linked study will establish a nested cohort of 2,000 participants enrolled in the national serological survey and prospectively monitor them for COVID-19 symptoms, conduct serial serological testing, implement molecular surveillance for SARS-CoV-2 and sequencing for variants of concern, implement and evaluate WASH mitigation measures, and monitor uptake and perceptions of COVID-19 vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in a linked national community-based seroepidemiological study in the Dominican Republic
* Agreed and consented to be recontacted to participate in additional research studies at the time of enrollment in #1
* ≥2 years of age
* Agree to participate

Exclusion Criteria:

* Ward of the State
Data Registry Following Patients Using Supera Stent in the Femoral Arteries

Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.

This registry follows up to 200 patients for at least 5 years.

The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.

Eligibility Criteria:
Exclusion Criteria:

(Clinical)

* Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
* Rutherford-Becker classification 2 through 5 only
* Patient is at least 18 years of age and of legal age of consent.
* Patient must be willing to participate in the registry for at least 5 years.

(Angiographic)

* Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion
* All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
* All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
* Target lesion length 1-20 cm (visual estimate)
* Target lesion stenosis ≥50% (visual estimate)
* Popliteal artery patent if the lesion is in the SFA
* SFA patent if the lesion is in the popliteal artery
* At least one widely patent (\< 50% stenosis) infrapopliteal artery (for distal run-off)

Exclusion Criteria:

(Clinical)

* Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
* Patient is participating in a clinical study that could confound results
* Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.

(Angiographic)

* Target lesion length \> 20 cm
* Instent restenotic / reoccluded target lesion
* Acute (≤ 4 weeks) thrombotic occlusion
* Untreated ipsilateral pelvic stenosis
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
* Subject must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970).
* Subject agrees to not participate in another study of an investigational agent during the study.
* Other Inclusion Criteria may apply

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study.
* Currently receiving other investigational procedures while participating in this study.
* Subject has known sensitivity to any of the products or components to be administered during dosing.
* Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.

Other Exclusion Criteria may apply
Social Connectedness Group Intervention in Depression

This study evaluates the feasibility of the Groups for Health (G4H) intervention for adults accessing support for depression in the UK. G4H targets improvements in adults' interpersonal functioning in order to reduce feelings of loneliness. The study will adapt the G4H intervention for delivery to adults seeking treatment for depression in the UK and estimate trial parameters (recruitment, retention, missing data and acceptability) of the adapted intervention, prior to a definitive trial. A mixed methods design of interviews and a single group, pre-post study will be employed.

Background: Loneliness is frequently reported amongst adults with depression. Interventions to reduce loneliness in different populations have shown mixed results. The Groups for Health (G4H) programme has been developed according to the social identity approach within social psychology and has demonstrated preliminary efficacy for reducing loneliness in a proof-of-concept study conducted with Australian student sample. The present study will examine whether G4H can be adapted to suit the needs of a clinical population in the context of UK secondary care services.

Objective: Phase 1 - To adapt the G4H intervention for delivery to adults seeking treatment for depression in the UK. Phase 2: To estimate trial parameters (recruitment, retention, missing data and acceptability) of the adapted intervention, prior to a definitive trial; to optimise the adapted intervention for delivery to adults accessing treatment for depression in the UK; to optimise evaluation procedures (candidate outcome measures)

Trial configuration: sequential exploratory mixed methods design. Phase 1: one-to-one interviews. Phase 2: Activity 1 (intervention), single group, pre-post study. Activity 2 (interviews): one-to-one interviews.

Condition: Depression

Interventions: group-based behavioural programme

Eligibility Criteria:
Inclusion Criteria:

Phase 1

Service user participants:

* Aged 18-65
* Accessing treatment for depression
* Loneliness: score 6 or above on the University of California Loneliness Scale (UCLA-3) (Hughes et al., 2004)
* Able to speak/read English
* Ability to give informed consent

Staff participants:

- Clinical practitioner with at least 6 months experience of working with people with depression

Phase 2 Activity 1: intervention

* Aged 18-65
* Accessing treatment for depression
* Loneliness: score 6 or above on the University of California Loneliness Scale (UCLA-3) (Hughes et al., 2004)
* Able to speak/read English
* Ability to give informed consent

Activity 2: interviews

- Attended or agreed to attend Phase 2, Activity 1

Exclusion Criteria:

* None
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Has facial acne vulgaris with:

  * 20 to 50 inflammatory lesions (papules, pustules, and nodules);
  * 25 to 100 noninflammatory lesions (open and closed comedones);
  * no more than 2 nodules on the face; and
  * IGA score of moderate (3) to severe (4)
* Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study

Exclusion Criteria:

* Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations
* Sunburn on the face
* Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
* Abnormal baseline laboratory values that are considered clinically significant
* Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
* Pseudomembranous colitis or antibiotic-associated colitis
Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course

Participants who have signed up to the Watford Football Club Community and Education Trust Weight management programme called Shape Up will be approached to see if they would like to take part in this research study. Their participation in the Shape Up programme will not be affected if they do not choose to opt in to the research component. Fifty participants will be recruited and randomised in to one of two groups. One group will be the control group and they will undertake the Shape Up programme as normal and will be asked to complete some questionnaires in week 1, week 12 and then at 12 weeks follow up. The intervention group will be asked to complete the same questionnaires and will also have a venous blood sample taken at week 1, 12 and then at 12 weeks follow up. This is for measures of cholesterol, sugar, vitamin D, vitamin B12 and iron. The participants will receive a report from a medical doctor in layman terms on these results a week later and will have access to their data on an online portal set up by Medichecks.

The weight management programme is based on a behaviour change programme where the participants attend a 90-minute session for 12 weeks, and they are then supported for another 12 weeks following the end of the supervision. The participants have weight and BMI measured at week 1, 12 and 12 weeks follow up. Each session consists of an education component followed by an exercise component. Initially, the education part is longer and the exercise is shorter, but as the programme progresses the education part becomes shorter and the exercise longer. The education programme includes topics such as healthy eating, increased physical activity and stress. The exercise programme includes whole body activities such as circuit training as well as other group exercise such as football.

The questionnaires will include The Treatment Self-Regulation Questionnaire which will identify the motivation behind the participants' health. A general health questionnaire which is a subjective measure of health (Euro qol EQ-5). The Mental Component Summary of the 12- item Short Form (SF12) which measures emotional quality of life. Physical activity will be measured through the short Active Lives Questionnaire. All these questionnaires have been attached as appendices.

All participants will complete an exit telephone interview from the study to determine qualitative feedback on their experience of the study and to explore whether the biomarkers influenced their motivation to change their lifestyle. Some example questions have been attached.

This is just a feasibility study, therefore no hypothesis testing will be undertaken.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>28
* No injuries

Exclusion Criteria:

* Injury preventing from participating in exercise
* fear of needles
* does not pass a physical activity readiness questionnaire
Effect At 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function.

Long term prognosis of cardiogenic shock is related to the resolution of haemodynamic failure, associated visceral failure and the recovery of an adequate myocardial function. In the immediate aftermath of cardiogenic shock, after catecholamines weaning, there are no recommendations on cardiovascular treatments that would improve this long term prognosis. Indeed, the standard cardiovascular treatments such as inhibitors of the renin-angiotensin and aldosterone system and beta-blockers have hypotensive and negative inotropic effects and may worsen the renal function. In practice, given their side effects, they are not prescribed in the immediate aftermath of cardiogenic shock.

Sodium-glucose co-transporter 2 (iSGLT2) inhibitors are now an integral part of the drug management of chronic heart failure and the EMPULSE-HF trial has just demonstrated a benefit in acute heart failure (PMID: 35228754). Several pivotal clinical trials have demonstrated a significant effect of iSGLT2 on the survival and the risk of re hospitalisation for heart failure (PMID: 32865377, 31535829, 33200892). Our hypothesis is that, in patients in cardiogenic shock, early treatment with Empaglifozin in addition to the standard management could reduce mortality and morbidity (death, transplantation/LVAD and rehospitalisation for heart failure) and improve myocardial function at 12 weeks, compared with standard management alone.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock
* Patient on catecholamine for more than 12 hours and less than 5 days.

Exclusion Criteria:

* GFR\< 20 ml/min/1.73m2.
* Chronic dialysis.
* Patient on SGLT2 inhibitors prior to admission to ICU or CCU.
* Known allergy to SGLT2 inhibitors or to any of its excipients (in particular, patients with hereditary disorders of galactose intolerance, total lactase deficiency or glucose or galactose malabsorption syndrome)
* Patients on lithium.
* Patient in shock for another cause or moribund (SAPS2\> 90).
* Specific cardiogenic shock context:

  1. cardiac transplant patient or on transplant list.
  2. peripartum, adrenergic, valvular, restrictive, post embolic heart disease.
  3. caused by a conduction/rhythm disorder of non-ischemic etiology.
  4. related to cardiotropic drug intoxication.
  5. secondary to a cardiocirculatory arrest with more than 25 min of "low flow" or more than 5 min of "no flow" before recovery of a stable cardiac activity.
* Patient undergoing VA-ECMO at admission (before or in whom implantation is imminent (less than 3 hours)).
* Women of childbearing age without effective contraception.
* Person referred to in Articles 10, 31, 32, 33 and 34 of EU Regulation 536/2014 (Pregnant woman, parturient or breastfeeding mother, Minor (not emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice))
Constraint-induced Movement Therapy and Self-regulation for Children With Cerebral Palsy

This study examines the effect of combining modified constraint-induced movement therapy (mCIMT) and self-regulation (SR) in promoting upper limb function of children with hemiplegic cerebral palsy (CP) studying in a school-based setting.

Children diagnosed with hemiplegic CP are involved. A within-subject design is used with children acting as their own controls. The study is scheduled at three-week intervals. All children undergo conventional occupational therapy (OT) and modified constraint-induced movement therapy plus self-regulation (mCIMT + SR) program in a random order.

Both programs last for three weeks. Each program is followed by a three-week no-treatment period to measure the carry-over effect. The OT program consists of training on unimanual and bimanual tasks for 1 to 2 hours a week with daily home exercise. The mCIMT + SR program involves restraint of the unaffected upper limb of children using a cotton sling for 6 hours per day for 15 days. A one-hour structured task practice with the use of SR is provided during each 6-hour restraint.

The Bruininks-Oseretsky Test of Motor Proficiency, the Jebsen-Taylor Test of Hand Function, the Caregiver Functional Use Survey, a hand dynamometer, pinch gauge, and modified Ashworth scale are used for evaluation. All children are assessed for five times at 3-week interval: once before and twice after the conventional OT; and twice after the mCIMT + SR at 1 week and at 3 weeks.

Before and after the three-week intervention, the children participate in event-related potentials (ERP) sessions with a choice reaction task. Event-related potentials (ERP) technique is used to capture the changes in neural mechanism after intervention.

Eligibility Criteria:
Inclusion Criteria:

* children with diagnosis of hemiplegic CP,
* 6-18 years of age studying at local special school for students with physical handicap (PH),
* intelligence ranging from normal to mild grade mental retardation,
* the ability to extend the wrist at least 20° and the metacarpophalangeal joint 10° from full flexion, and
* no balance problems sufficient to compromise safety.

Exclusion Criteria:

* any health problems that were not associated with CP, and
* severe muscle tone with modified Ashworth scale scored greater than 3.
Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye
* Requires IOP-lowering therapy in both eyes
* Visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

* Experienced significant weight change (over 10 pounds) within 60 days
* History of alcohol or drug addiction
* History of migraines or frequent headaches
* Anticipated wearing of contact lenses during the study
* Required chronic use of ocular medications during study
* Eye surgery within 6 months
* Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
* Use of oral, intramuscular, intravenous corticosteroids within 21 days
* Use of ophthalmic corticosteroids within 2 months
Magnetic Brain Stimulation for the Treatment of Adult Depression

This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance.

Major depression is a type of depression that can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Because people often develop resistances to medications used to treat depression, new treatments are needed. Decreased electrical activity in the prefrontal region of the brain has been linked to some symptoms of depression. Repetitive transcranial magnetic stimulation (rTMS) can be used to influence the brain's electrical activity. This procedure entails attaching electrodes to the head and using a device to pass magnetic energy through coils and into the brain. rTMS has been shown to have antidepressant effects in depressed individuals. However, optimal levels of intensity and treatment duration have yet to be determined. This study will assess the safety and effectiveness of rTMS on the prefrontal region of the brain in depressed adults with moderate treatment resistance.

The treatment phase of this double-blind study will last a minimum of 32 weeks and will consist of 3 phases. In Phase I, participants will be randomly assigned to receive either rTMS or sham stimulation. The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. In Phase II, participants who were unresponsive to Phase I treatment will receive daily rTMS at a lower dose for 3 weeks. Participants who show signs of improvement, but have not achieved remission, may continue Phase II for 4 additional weeks. Baseline magnetic resonance images will be used to determine the optimal stimulus intensity by adjusting for individual differences in cortical to skull distances. Phase III participants will be only those who achieved remission in the first 2 phases. These participants will receive antidepressant medication treatment daily for six months. Participants' functional status and symptoms of depression will be measured using self-report scales and video-recorded interviews at study start date and at the end of each treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depression with a current episode
* Hamilton Rating Scale for Depression score higher than 20
* No response or intolerance to antidepressant medication in the current depressive episode

Exclusion Criteria:

* Current use of antidepressants
* Diagnosis of psychosis or anxiety disorder
* Current substance abuse
* Seizures or history of head trauma