cyrilzakka/clinical-trials huggingface dataset:
Impact of Community-Based Biofeedback Program on Drug Use and Mental Health Among People Experiencing Homelessness

The purpose of this randomized controlled trial was to compare the effectiveness of an HRV-BF intervention versus a health promotion active control intervention focused on improving mental health symptoms among people experiencing homelessness (PEH), who were residing in Skid Row, Los Angeles. In total, 40 PEH were randomized to either the HRV-BF or an active health promotion control group, and received 8 weekly, 30-minute sessions over a two month period, delivered by a nurse-led community health worker team. Dependent variables of HRV, mental health, anxiety, depression and PTSD were measured at baseline, the 8-week session, and/or 2-month follow up.

In this pilot randomized controlled trial, conducted over one year, beginning in April 2021, 40 PEH were recruited from a larger sample of 100 PEH that were participating in a survey on COVID-19. Our outcomes were HRV and symptoms of anxiety, depression and PTSD.

Prior to the intervention, a Community Advisory Board (CAB) met to assess feasibility and acceptability of the HRV-BF program, which was presented in a theater-style approach. The CAB, composed of 6 PEH, and 3 healthcare providers, spoke quite favorably about the program, and provided exceptional feedback in terms of acceptability and feasibility in delivery logistics and cultural sensitivity. PEH shared the high levels of stress and anxiety they were experiencing; how helpful they perceived the program to be, the best timing for delivery, length of time for the intervention (under 60 minutes), and how to minimize attrition. Our study was approved by the Human Subjects Protection Committee at the University of California, Irvine and the University of California, Los Angeles.

Eligibility Criteria:
Inclusion Criteria:

* age 18 and older
* self-reported as residing in a homeless living condition during the previous night
* self-reported having used illicit substances or alcohol during the past year

Exclusion Criteria:

Persons who:

* exclusively spoke languages other than English or Spanish
* were unable to understand informed consent
* had cardiac deficiency, arrhythmias or pacemakers or who took medications affecting autonomic function.
Post Operative Pain Control: Morphine vs Fentanyl

Aim of this study is to compare benefits and disadvantages in using continuous infusion of morphine or fentanyl for post operative analgesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or 2 patients
* undergoing major gynaecological surgery

Exclusion Criteria:

* age \> 60 years
* obesity (BMI\>30 Kg/m2)
* cardiac and respiratory diseases
* renal impairment
* liver disorders
* allergies to any drug used in the study
Clinical Observational Study: IBD Patients With Restless-legs-syndrome and Iron Deficiency Syndrome

Patients with inflammatory bowel disease, such as Crohn´s disease or ulcerative colitis, have recurring episodes of abdominal pain, diarrhea and loss of weight. Besides this other clinical symptoms are possible e.g. deficiency syndromes such as iron deficiency. Iron deficiency usually attended by symptoms like hair loss, pale skin, loss of concentration or fatigue. In some cases iron deficiency can lead to neurological manifestations such as restless-legs-syndrome (RLS). Restless legs syndrome is a neurological disorders which is accompanied by substantial urge to move legs or other parts of the body and unpleasant sensations.

Aim of this study is to to investigate the prevalence of RLS in patients with inflammatory bowel disease and furthermore evaluate the effect of iron supplementation in patients with iron deficiency and concomitant RLS.

Restless legs syndrome (RLS) is a common neurological disease significantly impacting live quality. Two recent studies from North America and Japan revealed a surprisingly high prevalence for RLS in Crohn´s disease and ulcerative colitis (30% and 21%, respectively). The underlying cause for this high prevalence remains elusive at this point.

To address this gap, a cohort of 353 IBD patients from a tertiary IBD centre was prospectively evaluated by our IBD team as well as by the colleagues from neurology. IBD patients (age ≥ 18 years) presenting at our IBD outpatient clinic (tertiary referral center) between February 2014 and February 2015 were prospectively recruited for the study after written consent. The study was approved (16 January 2014) by the ethics committee of the Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin (reference EA4/132/13). Patients were screened for symptoms of iron deficiency (ID) and RLS by a self-developed questionnaire and explored for RLS symptoms by a gastroenterologist. When at least one symptom of RLS was present, patients were referred to a neurologist for RLS or differential diagnosis.

Additionally patients with RLS symptoms were screened for iron-, folic acid- and vitamin B12-deficiency. If a deficiency was detected, patients were substituted. In patients with deficiencies, follow-up visits were scheduled at week 4 and 11 after starting supplementation. Follow-up visits were conducted by the neurologist and the IRLS was performed in all patients at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Written consent
* Age \> 18
* Inflammatory bowel disease

Exclusion Criteria:

* \<18 years
* No written consent
Cryotherapy Effectiveness in Individuals With End Stage Knee Osteoarthritis - a Case Series

The purpose of this case series will be to provide a detailed description of a standardized short-term cryotherapy application protocol using validated functional outcome measures in individuals with end stage KOA

There are no studies determining the efficacy of cryotherapy in pain, function and quality of life for patients with end stage Knee Osteoarthritis (KOA). This case series describes a standardized treatment program for end stage patients with KOA and outcomes over a 12-week period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with knee osteoarthritis based on clinical and radiographic criteria of American College of Rheumatology
* Osteoarthritis signals in at least one of the compartments of the knee joint (tibiofemoral and / or the patellofemoral joint)
* Do not perform regular physical activity
* Grade 4 according to the criteria of Kellgren \& Lawrence knee osteoarthritis radiographic examination scale.
* Minimum score of 4 cm in Visual Analogue Scale (total 10 cm)
* Body Mass Index less or equal to 40 kg/cm2

Exclusion Criteria:

* Physical therapy within 3 months prior to the research project
* Corticosteroid or Hyaluronic Acid injection in the knee (in the previous 6 months)
* Cardiorespiratory, neurological or other rheumatic dysfunctions associated with the diagnosis of knee osteoarthritis.
* Hip, knee or ankle surgery
* Any other type of chronic condition that can lead to pain.
Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19

To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR).
* Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least 1 of the following:

  * Respiratory rate \>30 breaths/minute;
  * Severe respiratory distress, as determined by the Investigator;
  * Oxygen saturation (SpO2) ≤93% on room air.

Exclusion Criteria:

* Participant is intubated/mechanically ventilated.
* In the opinion of the Investigator, participant's progression to death is imminent.
* Treatment with immunosuppressant/immunotherapy drugs, including but not limited to interleukin (IL)-6 inhibitors, tumor necrosis factor-alpha (TNF-α) inhibitors, anti-IL-1 agents and janus kinase inhibitors within 5 half-lives or 30 days prior to Day 1.
* Use of chronic (\>30 days) oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
* Weight \>165 kg or \<40 kg.
Impulse Control in Gilles de la Tourette Syndrome

The study intends to evaluate the role of Mirror Neurons in the determination of gestures, words, and repetitive vocalizations in subjects affected by Tourette's syndrome and to verify if these subjects are faster to assemble sounds, in phonology and morphology, than the non-pathological population.


Eligibility Criteria:
Inclusion Criteria:

TOURETTE GROUP

* Consecutive patients belonging to the Tourette Center
* Caucasian
* Italian mother-tongue
* Age between 6 and 10 years completed
* Male and female 4: 1 (16 males and 4 females)
* Diagnosis of Tourette's syndrome for at least 1 year
* Presence of a value of YGTSS\> 50%

NOT GROUP TOURETTE

* Caucasian
* Italian mother-tongue
* Age between 6 and 10 years completed
* Male and female 4: 1 (16 males and 4 females)

Exclusion Criteria:

TOURETTE GROUP

* Diagnosis of DSA
* Presence of significant psychiatric disorders, with the exception of those belonging to the Tourette Syndrome itself (eg ADHD, OCD).

NOT GROUP TOURETTE

* Diagnosis of DSA
* Presence of significant psychiatric disorders
Study on the Geometric Parameters and Hemodynamic Reference Range of Neonatal Heart.

Perform bedside echocardiography on neonates (term and preterm infants) who were admitted to our neonatal department within 24 hours of birth, and establish a geometric reference range of neonatal cardiac ultrasound and explore the hemodynamic changes of early newborns.

Bedside echocardiography were performed to measure the diameter of each heart cavity and large vessels, velocity of each valve and aorta, wall thickness, left ventricular systolic function, right heart Tei index, Tricuspid Annular Plane Systolic Excursion(TPASE) of term and preterm infants respectively on 0 day, 3d, 7d of life and postmenstrual age of 30 weeks, 32 weeks, 34 weeks and 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 1. Infants with normal hearts (infants with small patent fora-men oval or small patent ductus arteriosus were not excluded).

  2.Healthy preterm infant with no evidence of sepsis, renal failure. 3. Absence of other major congenital anomalies or syndromes 4. Prior written consent was obtained from the parents.

Exclusion Criteria:

* Infants with severe congenital malformations, either cardiac or non-cardiac.
Psychotherapy to Patients With Primary Breast Cancer - Psycho-social and Survival Outcome From a Randomised Trial

The purpose of this study is to determine whether an intervention to breast cancer patients including psycho-education and group psychotherapy can enhance quality of life and survival.

PURPOSE: This randomized study included patients diagnosed with breast cancer who participated in an intervention including education and group psychotherapy lasting 10 weeks after surgery. The purpose of the study was to enhance Quality of Life, coping and social relations and to support the women when going through treatment. PATIENTS AND METHODS: We randomly assigned 210 patients with primary breast cancer to a control or an intervention group. Patients in the intervention group were offered 2 weekly 6-hour sessions of psycho-education and eight weekly 2-hour sessions of group psychotherapy. Participants and nonparticipants were followed up for QoL, coping and social relations after one, six and twelve months post intervention and on vital status 5 years after surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were 18-70 years of age with stage I-IIIA primary breast cancer

Exclusion Criteria:

* Distant metastasis
* Not speaking or understanding Danish
* Over 71 years
* Other life-threatening diseases
* Brain-damaged
Randomized Trial of 2% Chlorhexidine-70% Isopropanol vs 5% Povidone Iodine-69% Ethanol for Skin Antisepsis in Reducing Surgical-site Infection After Cardiac Surgery

Despite completion of more than 9 million procedures each year in France, the best antiseptic solution to be used for preparing the skin to reduce risk of surgical site infection (SSI) remains unknown. 2% Chlorhexidine gluconate (CHG)-alcohol is superior to Povidone Iodine (PVI)-alcohol for short term vascular catheter care (Mimoz O, Lancet 2015; Pages J, Intensive Care Med 2016), but studies comparing both antiseptic solutions for clean-contaminated surgical procedures led to conflicting results.

The present study will be the first large scale multicenter randomized controlled trial adequately powered to compare efficacy and safety of CHG-alcohol over PVI-alcohol in reducing SSI after clean surgery.

A clean surgery was chosen because pathogens involved in SSI mostly originate from skin. Therefore, optimisation of skin disinfection before surgery has the potential to reduce the incidence of SSI. Cardiac surgery was chosen because SSI may be severe, diagnosis of SSI is easy to monitor and to define and infections arise earlier than other frequent clean surgeries using implants such as orthopaedic or vascular surgery.

The incidence of reoperation for any purpose will be used as the main objective because there are easy to track and define and are less susceptible to interpretation in an open trial than superficial SSI. According to CDC criteria, patients will be monitored up to Day 90 because mediastinitis after cardiac surgery may occur after the usual 30-day SSI surveillance period.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years)
* Undergoing any (scheduled) surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy
* Having given their informed consent

Exclusion Criteria:

* Patients with known allergies to CHG, PVI, isopropanol or ethanol
* Surgery for heart transplantation
* Any signs of inflammation or sternal instability at the site of sternotomy or operation for infection (SWI or endocarditis)
* Patients with history of cardiac surgery within 3 months preceding enrolment
* Participation to another clinical trial aimed at reducing SSI
* Patients already enrolled in this study
* Pregnant or breastfeeding women
* Women at age to procreate and not using effective contraception
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis

The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. The investigators will also characterize the impact of FMT on the microbiota of the recipient and determine if it correlates with the microbiota from the FMT donor.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, aged 18-65 years old
* Prior endoscopic confirmation of UC:

Mildly to moderately active UC with Simple Clinical Colitis Activity Index (SCCAI) activity index \>4-9

* Failing standard therapy with:

stable doses of 5-ASA \>2 weeks; thiopurines \>3 months; or is steroid dependent at a dose \<20mg/d; (inability to taper off steroid for longer than 1 week)

* Stable medications dose for at least 2 weeks prior to screening and upon entry into trial
* Ability to understand and willingness to sign informed consent document

Exclusion Criteria:

* Diagnosis of Crohn's disease, indeterminate colitis, or proctitis alone
* Severe or fulminate colitis
* Women who are pregnant or nursing
* Patients who are unable to give informed consent
* Patients who are unable or unwilling to undergo colonoscopy
* Patients who have previously undergone FMT
* Patients who have a confirmed malignancy or cancer
* Patients who are immunocompromised
* Treatment within last 12 weeks with cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide
* Antibiotic use within 2-months of start date
* Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
* Probiotic use within 30 days of start date
* Rectal therapy within 14 days of start date
* Decompensated cirrhosis
* Congenital or acquired immunodeficiencies
* Other comorbidities including:

Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy

* Chronic kidney disease as defined by a GFR \<60mL/min/1.73m2 (40)
* History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia.
* Steroid \>20mg/day
* Positive screening and confirmatory tests for HIV 1 \& 2, Hepatitis A, B, \& C, and Syphilis
Nutrition Intervention in AIDS Wasting

There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Loss of 10% of usual body weight, OR loss of 5% of usual body weight within the previous 6 months, OR BMI20kg/m2. If the candidate is taking a protease inhibitor, he/she must have not regained weight since initiating the medication over a period of at least 4 weeks prior to screening.
* Documented HIV-positive
* Able to eat
* English-speaking
* Compliance with medical regimens
* For heterosexually active women: willingness to use an effective means of birth control
* Patient and physician not planning to start new treatments for HIV infection or weight loss during the 12 weeks of study.

Exclusion Criteria:

* Vomiting 1 time/day or diarrhea 4 times/day on average in the previous week
* Fever 101 F within the previous week
* Receiving induction treatment for one of the following (new diagnosis or recurrence within 4 weeks):

Pneumocystis carinii pneumonia Cryptococcal meningitis Cytomegalovirus retinitis or pneumonitis Toxoplasmosis Mycobacterium avium complex Visceral Kaposi's Sarcoma Lymphoma Pulmonary tuberculosis

* Received corticosteroids, estrogens, progesterones, androgens, oral anticoagulants, or growth hormone within the previous three months
* History of life-threatening reaction to oxandrolone or testosterone
* Currently pregnant
* History of congestive heart failure, myocardial infarction, angina/coronary artery disease, uncontrolled hypertension, cerebrovascular accident, hepatic failure, bleeding disorder, diabetes, nephrotic syndrome, cancer of the breast or prostate, or hypercalcemia
* Milk product allergy
* Current use of injected drugs
* Participation in an exercise program or strength training within the previous 4 weeks
* Any medical condition which renders the participant physically incapable of performing strength exercises
* Serum total testosterone level at least 300ng/ml, unless patient and primary physician prepared to begin testosterone injections concurrent with study enrollment (men only).
Single Dose Study to Determine the Safety, Tolerability, and Pharmacokinetic Properties of Lorcaserin Hydrochloride (BELVIQ) in Obese Adolescents From 12 to 17 Years of Age

The purpose of this study is to evaluate the PK properties, tolerability, and safety of lorcaserin HCL (BELVIQ) in obese adolescent subjects between the ages of 12 to 17 years old

The purpose is to:

1. Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive)
2. Assess the safety and tolerability of a single oral dose of lorcaserin in obese adolescent subjects ages 12-17 (inclusive)

Eligibility Criteria:
Inclusion Criteria:

1. Adolescent subjects aged 12 to 17 years, inclusive at screening
2. a. Eligible female subjects who are sexually active will be:

   * non-pregnant
   * non-lactating
   * agree to continue to use an accepted method of birth control for at least 1 month after study medication administration
3. BMI ≥ 95th percentile for age and gender, but ≤ 44 kg/m21
4. Considered to be in stable health in the opinion of the Investigator.
5. Parent or guardian who can sign written informed consent and subject willing to sign assent

Exclusion Criteria:

1. Clinically significant new illness in the 1 month before screening and any time prior to randomization
2. Significant renal or hepatic disease
3. Secondary (chromosomal, endocrine, or metabolic) causes of obesity
4. Use of medications other than hormonal contraceptives and acetaminophen
5. Use of drugs with serotonergic activity within 1 month before screening
6. Recent treatment with over-the-counter weight loss products or appetite suppressants, or within 3 months of screening and any time prior to randomization with a prescription weight loss drug or lipid dissolving injections or ongoing psychotherapy for weight loss outside of this trial
7. Recent history of alcohol, tobacco, or recreational drug/solvent use
8. Any history of major depression, anxiety, bipolar disorder, schizophrenia, or Axis II psychiatric disease requiring treatment with prescription medication within six months prior to screening
Seoul National University Hospital Systemic Sclerosis Cohort

To establish a new prospective cohort of Korean patients with systemic sclerosis and track the natural history of the disease over time.

To generate new hypotheses for further investigation.

Systemic sclerosis (SSc) is a multisystem and heterogeneous disease characterized by an unpredictable course and high morbidity and mortality. The complexity of SSc requires interdisciplinary diagnostic and therapeutic management and result in a growing burden for all health-care systems. For this reasons, researchers are seeking new diagnostic and therapeutic strategies to improve management of these patients. In order to improve clinical care and to develop recommendations for the diagnosis and treatment of SSc, disease registries are used to capture and track key patient information.

Therefore, SSc research associations and consortiums play a pivotal role to perform ongoing research and data collection to understanding the disease and support research projects. Currently, several national SSc registries in the UK, Germany, USA, Canada, Brazil, Australia and international registry, EUSTAR (European League Against Rheumatism scleroderma trial and research), have been established. However, the natural history of Asian populations are fully evaluated. Therefore, investigators decided to establish SSc cohort in Korean patients.

Eligibility Criteria:
Inclusion Criteria:

* SSc diagnosis according to 1980 or 2013 ACR classification criteria or 2001 criteria for the classification of early systemic sclerosis

Exclusion Criteria:

* When patients refuse to take part in the study