cyrilzakka/clinical-trials huggingface dataset:
Trial of the MEND Childhood Obesity Treatment Program

The number of children who are obese in the UK is steadily increasing with both short and long term consequences for health. The aim of this study is to determine whether the MEND Programme (a new national initiative for the treatment of childhood obesity) is a successful and sustainable treatment for childhood obesity and obesity related health problems.

300 overweight and obese children will be randomly assigned to start immediately on the MEND Programme for 6 months or join a waiting-list control group for 6 months. Measurements of health outcomes will be taken at baseline, and at 6, 12 and 24 months after the Programme. After 6 months of waiting-list time, the control group will follow the same protocol as the immediate starters. The researchers will be unaware (blinded) to which group each child has been assigned to. The study will examine the effects of the MEND Programme on body composition, cardiovascular health and psychological health.

The Study is a Randomised Controlled Trial.

Eligibility Criteria:
Inclusion Criteria:

* Children enrolled in the MEND Programme who are yet to be given a start date for the programme.
* Aged between 7-13 years old.
* Overweight or obese as defined by a BMI which falls above the 91st centile on the boys/girls BMI chart UK cross-sectional reference data:1997/1).
* Clinically well with no known chronic illness.

Exclusion Criteria:

* Age less than 7 years or older than 13.
* Known chronic illness.
Intra-operative Injection of Autologous Conditioned Plasma (ACP) Following Partial Meniscectomy

The aim of the present double blind controlled study is to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of ACP performed at the end of arthroscopic partial meniscectomy.

Patients included in this trial will be randomized in two treatment groups: the first one will receive a single injection of 3-5 cc of ACP (using a dedicated centrifuge) at the end of the arthroscopic meniscectomy, whereas the second group will be treated by surgery alone. In order to ensure the double blinding of the trial all the patients enrolled will undergo blood harvesting before anesthesia, and acp will be produced just for the patients included in ACP group.

All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.

Drugs assumption during the follow-up period will be recorded for each patient. All eventual adverse events occurred during the follow-up period will be registered.


Eligibility Criteria:
Inclusion Criteria:

* chronic symptomatic meniscal tears requiring partial resection;
* healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);

Exclusion Criteria:

* meniscal lesions requiring suture;
* previous surgery on the index knee;
* other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
* history of knee infectious arthritis;
* concurrent rheumatic, metabolic or severe systemic disease;
* Body Mass Index (BMI) \> 30;
* known hypersensibility or allergy to/towards HA ;
* alcohol or other substances abuse/excess.
Optimising Hip Mobility, Hamstring Flexibility and Performance Using Lightback

In athletics, in the sprint and hurdles disciplines, muscle injuries account for a significant proportion of injuries. The hamstrings are particularly vulnerable, accounting for between 12% and 26% of all injuries in these sports. A single-blind study was conducted on 20 hurdler patients with the intention of assessing hip mobility, hamstring flexibility and performance. To collect this data, the research team will conduct examinations and interviews with the athletes in two groups: an experimental group using LightBack and a placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Sprinters and hurdlers aged 18 to 30 years.
* No history of recent (less than 6 months) hamstring or hip injury.
* Signed informed consent.

Exclusion Criteria:

* Cruciate or hamstring tears less than 6 months old;
* Hip and back surgery less than 3 months old;
* Chronic or acute back problems;
* Pregnancy;
* Osteoporosis
* Tumours, bone cancer of the hip and pelvis;
* Direct trauma to the back of the thigh less than 6 months old.
* Orthopaedic or neurological pathologies affecting mobility or muscle activation.
* Participation in another specific training protocol
Development of a Method to Measure mRNA Levels in Skin Samples

The purpose of this study was to develop a non-invasive method to measure mRNA levels using tape stripping on the skin of patients with psoriasis and patients with atopic dermatitis.

Three sequential groups of subjects were recruited in this study for: 1) skin squame collection; 2) tape strip collection; and 3) tape strip and skin biopsy collection in the aim of identifying the most optimal method for measuring the mRNA levels of skin biomarkers in tape strip samples.

Eligibility Criteria:
Inclusion Criteria:

* Subject, male or female, aged 18 years or older at the time of consent.
* Female subjects of childbearing potential had a negative urine pregnancy test at the screening visit.
* Subjects had to be able and willing to provide written informed consent and comply with the requirements of the study protocol. Consent was obtained prior to any study-related procedures.

  \*Special inclusion criteria for volunteers with atopic dermatitis or psoriasis:
* Patient had a history of atopic dermatitis or psoriasis.
* Patient with psoriasis had a Physician's Global Assessment (PGA) score of ≥2 at Day 0.
* Patients with atopic dermatitis had an Investigator's Global Assessment (IGA) score of ≥2 at Day 0.

Exclusion Criteria:

* Female subject was pregnant or breastfeeding.
* Subject was participating in a clinical trial with an experimental drug or device or had participated in a clinical trial with an experimental drug or device within the last 4 weeks of the collection day (Day 0).
* Subject was known to have hepatitis B or hepatitis C viral infection.
* Subject was known to have immune deficiency or was immunocompromised.
* Subject had used systemic medication, medical devices, UVB or PUVA therapy or natural health products to treat atopic dermatitis or psoriasis on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
* Subject had used oral, intravenous steroids, or immunosuppressive medication within 4 weeks of the collection day (Day 0). Subject had used intramuscular or intra-lesional or intra-articular steroids or immunosuppressive medication on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
* Subject had used a biologic within 12 weeks or 5 half-lives of the collection day (Day 0), whichever was longer.
* Subject had used topical medication, natural health products or medical devices to treat atopic dermatitis or psoriasis on the areas to be tape stripped or biopsied within 2 weeks of the collection day (Day 0).

  \*Only for subjects who underwent skin biopsy:
* Subject had a known hypersensitivity/allergy to lidocaine.
* Subject had a history of hypertrophic scarring or keloid formation in scars or suture sites.
* Subject was taking anti-coagulant medication (e.g. heparin, low molecular weight \[LMW\]-heparin, warfarin, anti-platelets \[nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin (equal or lower than 81 mg) were not considered anti-platelets\]) or had a contraindication to skin biopsies.
Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

The purpose of the study is explore the issues that relate to testing a particular dietary treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with which to compare it. In this trial the investigators will look at its effect on symptoms of people with persistent disturbance in their bowel pattern 3 months after an intestinal infection with Campylobacter.

The investigators will also look at the changes in gut bacteria that occur with the diet.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the CERAMIC study (see linked protocol)
* On-going post infective bowel dysfunction (PI-BD) 3 months after confirmation of Campylobacter spp. in stool sample. This is defined as responding 'No' to the question "have your bowels returned to normal since your Campylobacter infection?"
* Will consent to use of data and samples acquired for CERAMIC in the analysis of CEDRIC

Exclusion Criteria:

As for CERAMIC study (so already confirmed)

* Pregnancy declared by the candidate
* History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to: Inflammatory Bowel Disease; Coeliac Disease; Pancreatitis; Gallstone disease (biliary colic, cholecystitis); Diverticulitis; Cancer of the gastrointestinal tract; Irritable Bowel Syndrome
* Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
* Intestinal stoma
* Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
* Use of antibiotics in the preceding four weeks other than for treatment of index infection. Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration
* Inability to complete the symptom questionnaires e.g. cognitive dysfunction, limiting memory and understanding
* Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse

Addition criteria for CEDRIC study:

* Use of antibiotics or prescribed probiotics during the CERAMIC study
* Failure to provide research stool samples during CERAMIC study
* Dietary practice not compatible with safe implementation of the trial diet e.g.veganism
* Medical reasons for pre-existing controlled diet that cannot be safely randomised e.g. end-stage kidney disease, diabetes
Management of Septic Non-union of the Tibia Using the "Induced Membrane" Technique

The aim of the study was to assess clinical and radiological results with the "induces membrane" technique, described by A. C. Masquelet in 1986, in a series of patients with septic non-union of the tibia

Septic tibial non-union is a therapeutic challenge that may even lead to amputation. Treatment often necessitates several chirurgical steps. It is agreed that resection must extend to several tissues (osteitis zone ans macroscopically pathological soft tissue), with associated non-union site stabilization ans effective antibiotic therapy.

In 1986, Pr A. C. Masquelet described a 2-step procedure called the induced membrane technique, to manage bone defects of varying severity. Initial results were encouraging but there have been few large homogeneous series specific to this technique in septic non-union.

Eligibility Criteria:
inclusion criteria :

* Patients with septic non-union of the tibia
* managed using the induced membrane technique between novembrer 2007 and novembre 2014 in Reims University hospital
* Patients who agree to participate to the study
* Major patient

exclusion criteria :

* Patient under law protection
* Minor patient
Frozen Shoulder (Scapular Mobilization Versus Scapular PNF)

This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder.

This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder.

Eligibility Criteria:
Inclusion Criteria:

- All the patients refferd from orthopaedic surgeon with diagnosis of adhesive capsulitis. Patients will be included in this study if they fulfil the following criteria

1. Case diagnosed with adhesive capsulitis, both primary and secondary.
2. Both males and females of the age group 40 to 60 years.
3. Limited active and passive movement of the shoulder joint movements, as well as difficulties with ADLs.

4- The onset of symptoms between 3 to 12 months. 5. Unilateral adhesive capsulitis.

Exclusion Criteria:

* 1. History of shoulder surgery or manipulation under anaesthesia, local corticosteroid injection administration to the affected shoulder within the last 6 months, 2. Neurological deficit affecting the shoulder function during daily activities, 3. Pathology of the shoulder joint other than adhesive capsulitis including rotator cuff tear, tendonitis at the shoulder and neck region, malignancies, history of trauma or accidental injuries of the upper limb.

  4- Other pathological conditions including, a history of stroke, history of mastectomy and coronary artery bypass grafting (CABG).

  5. Rheumatoid arthritis, osteoporosis, or disorders of the cervical spine, elbow, wrist or hand.
Treatment Navigation for Opioid Use Disorder

The investigators will conduct a pilot randomized controlled trial (RCT) study of 100 people with a history of opioid use disorder releasing to WA Department of Corrections (DOC) community corrections supervision in King County. Half of the subjects will receive treatment as usual (e.g. referral to treatment or outpatient drug counseling by DOC community corrections staff) and half will receive 6 months of intervention. The intervention involves treatment decision making, in which the study interventionists help subjects understand treatment choices, decide on the treatment that is best for them, get enrolled in treatment and remain in treatment. The study does not provide treatment, but works with treatment providers to facilitate access to care.

The aims of this study are to determine: 1) whether study procedures can be implemented with as designed, 2) whether offenders can be enrolled and maintained in the study, 3) which medications/treatment options subjects select and their experiences and satisfaction with the interventions, and 4) preliminary intervention effect size on outcomes of interest including recidivism, drug use, hospitalization, and treatment enrollment and retention.


Eligibility Criteria:
Inclusion Criteria:

1. Meets Diagnostic and Statistical Manual (DSM-5) criteria for opioid use disorder (at least 2 criteria) or were receiving treatment for opioid use disorder in the 12 months prior to incarceration.
2. Released to community corrections, not currently incarcerated.
3. Able to understand and provide informed consent.
4. Has access to phone (voice or text) or email to communicate with research staff.

Exclusion Criteria:

1. Under age 18 or over age 70 at time of recruitment.
2. Currently enrolled in an opioid treatment program using medications.
3. Has not used opioids (prescription type or heroin) in the past 6 months prior to incarceration.
4. Unwilling to allow access to medical or drug treatment records, criminal history or criminal activity records.
5. Inability to communicate in English verbally.
6. Inability to provide adequate contact information to assist with follow-up.
7. Not planning on being in King County or reporting to community corrections in King County for 6 months.
8. Violent or overtly hostile/threatening towards research staff.
9. Entering a controlled environment for 31 days or more in the next 6 months.
CeraVe Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of the CeraVe Diabetic Skin Line for the improvement of skin condition in patients with diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women between the ages of 18 and 75 years of age.
2. Willing to provide written informed consent.
3. A diagnosis of diabetes mellitus (DM).
4. DM-related skin changes classified into one or more of the following four categories: i) skin lesions associated with DM; ii) infections; iii) cutaneous manifestations of DM complications; iv) skin reaction to DM treatment.

Exclusion Criteria:

1. History of allergy, anaphylaxis or hypersensitivity to any of the ingredients in CeraVe Hydrating Cleanser or Moisturizing Cream
2. History of allergic contact dermatitis secondary to cleansers or moisturizers.
3. Has a heightened immune response to common allergens, especially inhaled, topical or food allergens (atopy).
4. Has any clinical manifestation in the treatment are(s) or other disorders that, in the investigator's opinion, may affect assessments or the study products.
5. Inability to attend all study visits and follow treatment regimen.
Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2

Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease.

Patients are randomised to surgery or not.

Patients are after staging randomised to neoadj. chemotherapy followed by surgery followed by irradiation or to chemotherapy followed by irradiation.

Endpoint is survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified NSCLC
* Stage IIIA/N2
* age 18-75
* Lung function test allowing surgery
* Mediastinoscopy performed

Exclusion Criteria:

* Prior chemotherapy
* Prior irradiation
The Study in the Correlation Between the Severity of Post-stroke Fatigue and the Severity of qi Deficiency and Blood Stasis

The purpose of the present study was to investigate the correlation between the severity of fatigue, and the severity of qi deficiency and blood stasis.

According to the reports of department of Health, stroke has been the top three ranking in leading ten major mortality causes. Although fatigue is a common symptom after stroke, but it is easy to neglect due to fatigue is a non-specific symptom. Based on the literature review, fatigue symptom is not only common on post-stroke patient and it also has highly correlation with mortality, prognosis and efficacy of rehabilitation. In Traditional Chinese Medicine recording, Wang Qing-ren suggests that the main etiology of stroke is results from qi stagnation and blood stasis, thereafter, the study about qi deficiency and blood stasis became to the main stream for stroke until now. Therefore, the purpose of the present study was to investigate the correlation between the severity of fatigue, and the severity of qi deficiency and blood stasis.

Eligibility Criteria:
Inclusion Criteria:

1. Gender: men or women
2. Age:40\~80 years old
3. Stroke history at least 3 months
4. Hemorrhage or ischemic stoke
5. Conscious clear and can communicate
6. Brief Fatigue Inventory-Taiwan form score ≥ 4
7. Sign informed consent

Exclusion Criteria:

1. Patient with psychotic diagnosis and can't cooperate with researcher
2. Major disease: chronic obstructive pulmonary disease, heart failure, myocardial infarction, chronic renal failure, liver cirrhosis
3. Pregnant women
4. Breastfeeding women
Supplementing Brief Psychotherapy With a Mobile App

Suicide is among the leading causes of death worldwide, and the risk of suicide is highest in the period immediately following discharge from inpatient psychiatric care.1Importantly, despite the enormously elevated risk during this period, nearly 50% of patients do not attend scheduled therapy after discharge. Even among those who do attend therapy, however, the skills learned in treatment may be difficult to use during the highly distressing time leading up to and during a suicide crisis. Most traditional treatments are not designed to be effective during a suicide crisis. In order to reduce the risk of suicidal thoughts and behaviors in general and specifically during the post-discharge period, interventions are needed that: (1) are easily adhered to and (2) are accessible and effective during a suicide crisis. As such, the purpose of this research study is to test an innovative, new intervention in order to develop an effective and accessible intervention for those at high risk for suicide


Eligibility Criteria:
Inclusion Criteria:

* Adult status (18+ years)
* Admission to eligible units in our partner hospital with a reason for admission having to do with suicide risk
* The ability to speak and write English fluently,
* Ownership of and consistent access to an internet-capable smartphone (e.g., an iPhone or Android phone)

Exclusion Criteria

- The presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.
Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?

Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination

our study ıs desıgned as an observatıonal clınıcal study. the purpose ıs to compare the over reserve tests of the patıents before and after vaccıne, to determıne ıf the over reserve and fertılıty of women are affected by the vaccıne.women who applied to the vaccination outpatient clinic for the first dose of vaccine were included in the study.those who have never been vaccinated and have not had covid 19 infection were included in the study.antı ullerıan hormone level ıs the laboratory parameters that best showıng the ovary reserve today. ovarian reserve tests including amh were checked and their fertility was questioned and their information was recorded.

the same tests were repeated after the volunteers received 2 doses of vaccine. ın the power analysis, it was calculated that 104 volunteers should be included in the study.the study will be terminated when 104 volunteers are reached.

Eligibility Criteria:
Inclusion Criteria:

* between 18-45 years old
* have ever had a covid vaccine
* not be infected with covid 19

Exclusion Criteria:

* pregnancy
* diagnosis of any kind of cancer
* oral contraceptive usage
* endometrioma
* PCOS
* menopause
* menstrual irregularity
* premature ovarian insufficiency