cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of VIRTUAL FIBROWALK STUDY

The main objective of this study is to analyse the effectiveness of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of VIRTUAL FIBROWALK treatment in the short- and longterm.

This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU alone and on the comparation of the physiotherapy part of the multicomponent program.

* VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
* Physiotherapy part of VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE) and therapeutic exercise.
* The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance

Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 75 years-old.
* 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
* Able to understand Spanish and accept to participate in the study.

Exclusion Criteria:

* Participating in concurrent or past RCTs (previous year).
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
Study to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome

The purpose of this study is to determine the efficacy and safety of different doses of SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with non-constipation.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed as non-constipation by ROME III.
* Patients who voluntarily signed written informed consent may participate in the study.

Exclusion Criteria:

* Pregnant or lactating female.
* Patients with a history of inflammatory bowel disease.
* Severe neurological or psychological disease
* History of allergic reaction to the medications used in this study
* Use of other investigational drugs within 30 days prior to the study.
* Patients that investigators consider ineligible for this study
Trial Comparing Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings

A multi-center randomized control trial comparing the dressing wear times of two different transparent film dressings when used to secure peripheral intravenous catheters of hospitalized adult patients.

A multi-center, prospective, randomized control trial comparing the dressing wear time, complication rates and cost of two different transparent film dressing when used as intended for peripheral intravenous catheter site protection and securement in five U.S. hospitals.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age, or of consenting age;
2. Admitted or going to be admitted to the hospital;
3. Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer;
4. Has an insertion site in the forearm or hand free of phlebitis, infiltration, dermatitis, burns, lesions or tattoos;
5. Demonstrates cooperation with a catheter insertion and the securement protocol; and
6. Patient or legally authorized representative is willing and able to provide written informed consent and authorization for use and disclosure of Protected Health Information

Exclusion Criteria:

1. Is a current participant or a past participant in this study;
2. If the subject already has a functioning PIV in place, not requiring a replacement catheter
3. If the study PIV catheter site will be placed below an old infusion site;
4. If the study PIV site needs to be immobilized with a splint or other device;
5. Has a documented or a known allergy or sensitivity to a medical adhesive product such as transparent film adhesive dressings, tapes, or liquid skin protectants;
6. Requires the application of a gauze pad, a topical ointment or solution under the dressing in addition to the prep(s) required in the protocol;
7. Will require a power injection through the study PIV catheter for a radiologic procedure during participation in this study;
8. Will require a numbing agent prior to PIV insertion; or
9. Will require the use of ultrasound for the PIV catheter insertion.
Evaluation of a Decision Assisting Tool for Prenatal Testing

This is a randomized study of an interactive, computerized descision-assisting tool for prenatal testing decision making (PT Tool) versus standard educational booklets distributed to all pregnant women by the State of California (control). We hypothesize that, compared to controls, women randomized to view PT Tool will have greater knowledge about prenatal testing and its potential outcomes and better risk comprehension, and that they will be more satisfied with the intervention and have lower decisional conflict.

We will evaluate the tool in a randomized controlled trial among 500 patients receiving prenatal care at one of the obstetrics clinics and practices affiliated with the University of California at San Francisco (UCSF), San Francisco General Hospital (SFGH), Kaiser San Francisco, or California Pacific Medical Center (CPMC). After completing a baseline questionnaire, participants will be randomized to view either a control or intervention group. Patients assigned to the control group will view the computerized version of the age-appropriate educational pamphlet concerning prenatal testing developed by the State of California. Patients assigned to the intervention group will use the computerized decision support tool/educational module which provides important background information about chromosomal abnormalities, and patient-tailored information about the advantages and limitations of diagnostic testing.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant at less than 24 gestational weeks

Exclusion Criteria:

* Not able to speak English or Spanish
Choice of Tube Extremity in Emission of Lowest Radiation Dose in Pediatric Patients

Compare the radiation in pediatric patients thyroid submitted to chest X-ray using the position of the anode and cathode.

The study's primary goal was to compare radiation exposure in two different positions during chest x rays in children. It was conducted from June/2014 to July/2015, and included children from 0 to12 years old staying at the Pediatric Intensive Care Unit at the Instituto de Cardiologia de Porto Alegre, Brazil, with chest x ray requests during ICU stay. They were randomized to two groups: during the x ray, one group was positioned with the thyroid facing the anode end, and the other group was positioned with the thyroid facing the cathode end.

Eligibility Criteria:
Inclusion Criteria:

* Younger than 12 years old
* Admitted to the Paediatric ICU at Instituto de Cardiologia de Porto Alegre
* Chest X ray requested by treating physician

Exclusion Criteria:

* Patients with scans that failed to comply with the technical criteria from the European Community Commission guidelines on quality criteria for diagnostic radiographic images in paediatrics, as evaluated by the radiologist doctors responsible for that exam report.
Effects of Coherent Breathing Breathwork on Health

The investigators are conducting a randomised-controlled trial comparing coherent breathing at \~5.5 breath cycles per minute-bcpm (with equal inhalation/exhalation durations of \~5.5secs each) to a well-designed placebo (paced breathing at 12bcpm with equal inhalation/exhalation durations of 2.5secs each). The metric of 12bcpm is in line with guidance from the British Journal of Nursing, Royal College of Physicians, and Johns Hopkins University which state that the average, healthy bcpm should range from: 12-20bcpm, 12-18bcpm, and 12-16bcpm, respectively, hence the investigators chose the minimum/lower bound for the active placebo control group. The main questions that our study attempts to address are: Does coherent breathing (and placebo coherent breathing) lead to improved mental health and wellbeing in a general population adult sample?

The study will be conducted entirely online through the research platform Prolific, so participant data will be anonymous. The investigators will collect self-reports of mental health and wellbeing before and after the four-week breathwork period, along with a follow-up one-month later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Participants will also be asked how many times they practiced out of the assigned 28 days, to gauge self-reported adherence to the protocol. The investigators can then observe whether self-reported adherence correlates with changes in mental health and wellbeing, if any. Data on the self-reported credibility/expectancy of the breathwork randomly allocated to participants will also be collected, along with open-ended responses on participants' overall experience of the protocol/study.


Eligibility Criteria:
Inclusion Criteria (self-assessed):

* 18+ years of age (18 is the automatic minimum age on Prolific)
* Able to breathe through nose
* Have access to headphones
* The following pre-screeners on Prolific will also be set so only those eligible on Prolific will see the study: Located/living in UK, Fluent in English, approval rate of 98% and at least 20 previous submissions (as recommended by Prolific to increase retention and reduce dropout rates in longitudinal and multi-part studies)

Exclusion Criteria (self-assessed):

* Any problems which affect ones ability to pace their breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, cardiovascular problems, respiratory conditions or diseases (i.e., uncontrolled symptomatic asthma, COPD, lung cancer, etc.), abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea)
* Any other physical/mental health conditions or current life events which impair or affect ones ability to engage in activities involving breath control
Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial

The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.

Objective: To compare pain levels assessed by salivary cortisol and standardized neonatal pain scale among the two most common infant circumcision techniques in uncomplicated pregnancies after a thorough resident-wide education curriculum under attending physician supervision.

The secondary objectives are to assess the operative time, complication rates such as infection and bleeding and short term outcomes including need for re-circumcision among treatment groups.

Hypothesis: The Mogen technique of circumcision is less painful, faster, and associated with less bleeding for newborns when compared to the Gomco technique after a resident circumcision standard teaching curriculum.

Eligibility Criteria:
Inclusion Criteria:

* term infants delivered by cesarean section or vaginal delivery at Good Samaritan Hospital during the time period of the study
* Infants with no blood drawn two hours prior to the circumcision
* Singletons

Exclusion Criteria:

* Infants with congenital anomalies and/or known chromosomal syndromes
* Preterm infants defined as less than 37 / 0 weeks gestation.
* Delivery secondary to non-reassuring fetal heart tracing, defined by the delivering physician
* Infants of diabetic mothers.
* Infants of preeclamptic mothers on magnesium sulfate within 48 hours of delivery.
* Infants delivered by vacuum-assisted or forceps-assisted vaginal delivery.
* Infants of mothers who took steroids for fetal lung maturity within 7 days of delivery. (This may apply to term infants if the mother had no prenatal care and her gestational age was not known on arrival).
* Infants with a 5 minutes apgar score of less than 7
* Infants born to mothers with a history of drug abuse during pregnancy, currently on methadone, or with Hepatitis C or HIV.
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))

A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).


Eligibility Criteria:
Inclusion Criteria:

* Fasting lipoprotein(a) (Lp(a)) 50 mg/dL or more at screening 1
* Fasting Low-density lipoprotein-cholesterol (LDL-C) 100 mg/dL or more at screening 1
* Lipid lowering therapy including statin dose unchanged for at least 8 weeks prior to screening
* Target-to-background ratio (TBR) maximum higher than 1.6 (either right, left carotid or thoracic aorta) on fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT).

Exclusion Criteria:

* Currently receiving, or less than 4 weeks since receiving, treatment in another investigational device or drug study(ies), or participating in other investigational procedures
* Known diagnosis of diabetes mellitus or screening fasting serum glucose ≥ 126 mg/dL or hemoglobin A1C (HbA1C) ≥ 6.5%
* Subject with a history of homozygous familial hypercholesterolemia
* History of a Cardiovascular event
* Subject currently undergoing lipid apheresis
* Known contraindications or limitations to FDG-PET/ CT (scanner weight limit, devices that can cause image artifacts, or carotid/aortic stents/grafts
* Subject has had exposure to investigational drugs targeting Lp(a) within the last 12 months, prior to Screening
* Other Exclusion Criteria May Apply.
Longitudinal Cohort Study Comparing 2 Surgical Techniques in Patients With Class 3 Obesity and Type 2 Diabetes

Wight loss surgery provides good glycemic control in type 2 diabetes. The technique of "Roux-en-Y gastric bypass" is more effective than the "Adjustable Gastric Band" on weight loss.

This longitudinal cohort study will compare the effectiveness of the Roux-en-Y gastric bypass and Adjustable Gastric Banding on glycemic control in type 2 diabetes and explore the responsible mechanisms.

The evaluation will be made preoperatively and 1 year later as assessed by the decline in HbA1c. An evaluation will also be carried out after a weight loss of 10% to indicate whether the observed difference is independent of weight loss.

Type 2 diabetes is a condition often associated with obesity and often difficult to control. In patients with severe obesity, surgical treatment allows a sustainable weight loss and higher than that obtained with other treatments available. In most cases, surgery also reduces significantly the comorbidities of obesity and diabetes in particular. Among the various technical options, adjustable gastric band (AGB) is the simplest and by far the most used in France.

Roux-en-Y gastric bypass (RYGB) is a more complicated intervention combining gastrointestinal malabsorption- duodeno-jejunal and gastric reduction and allows a higher weight loss. Several studies also suggest that the technique has a remarkable efficiency on glycemic control, justifying the extension of its readings/indications. No study controlled, however, has compared these two techniques.

The objective of this study is to compare the efficiency of RYGB vs AGB on glycemic control in type 2 diabetes. Although some studies have compared AGB and RYGB, none have compared their effectiveness on post prandial glucose control in patients with diabetes. It is generally recognized that the effectiveness of RYGB on diabetes is independent of the weight loss, but this has never been demonstrated.

By demonstrating the superiority of RYGB vs AGB, and identifying the responsible mechanisms, the study will expand the indications of RYGB in the treatment of type 2 diabetes. Weight loss surgery offers a unique model for the clinical study of the pathophysiology of type 2 diabetes.

Main objective:

* To compare the effectiveness of RYGB vs AGB on glucose control in obese patients with type 2 diabetes.

Secondary Objectives:

* demonstrate that the better outcome achieved with RYGB is independent of weight loss.
* Identify the mechanisms underlying the better outcome of RYGB

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years AND
* BMI \> 35
* Type 2 diabetes
* Obesity for more than 5 years OR
* normoglycemia
* BMI\< 30

Exclusion Criteria:

* Secondary obesity due to an endocrinopathy
* Chronic pathology (neoplasia, cirrhosis, disease of system)
* Psychosis, alcoholic addiction or narcotics.
* Contre-indications to the anaesthesia
Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen

Atherosclerosis (in particular stroke and heart attack) is the most important health issue in modernized society and high blood pressure is an important predisposing factor. Hypertensive subjects with other chronic disease such as diabetes mellitus or impaired renal function are particularly vulnerable to these atherosclerotic complications in spite of standard antihypertensive therapies.

Danshen and Gegen are commonly used in Chinese materia medica as treatment for cardiac symptoms and atherosclerosis-related disorders.

The objective of this study is to test Danshen and Gegen as an cardiovascular-protective adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.

Danshen and Gegen (D\&G) are two traditional herbal medicines used for cardiac symptoms in ancient Chinese medicinal literature. Recent studies suggest their therapeutic effects in blood pressure and lipid-lowering, anti-oxidation, microcirculation-promoting, foam cells-modulation and have beneficial effects on atherogenic process in coronary patients.

To evaluate the potential of D\&G in primary atherosclerosis prevention in high risk hypertension. Patients with high risk hypertension associated with left ventricular hypertrophy, diabetes mellitus and renal insufficiency were randomized to receive D\&G herbal capsules (2gm/day), or (1gm/day) or identical placebo capsules in double-blind and parallel fashion for 12 months on top of their anti-hypertensive treatments. Flow-mediated dilation (endothelium-dependent dilation, FMD) and nitroglycerin-induced dilation (endothelium-independent dilation, NTG) of brachial artery, and carotid intima-media thickness (surrogate atherosclerosis marker, IMT) were measured by high resolution B-mode ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* High-risk hypertension: Asymptomatic hypertensive (pretreatment BP\>160/95mmHg) subjects, currently blood pressure under control (BP\<140/90mmHg),
* Aged 35-70 years
* With either (i)left ventricular hypertrophy on ECG or echocardiographic criteria, (ii) diabetes mellitus, or (iii) mild renal impairment (plasma creatinine 120-250µmol/l)

Exclusion Criteria:

* Known intolerance to D\&G due to adverse effect, patients with bleeding, disorders or on long-term anticoagulation.
Seroprevalence of Covid-19 in the Staff of the University Hospitals of Strasbourg

The Grand Est region is one of the most affected regions in France during the first wave of the COVID-19 epidemic. A significant increase in the number of patients hospitalized for SARS-CoV 2 infection at the University Hospitals of Strasbourg (HUS) led to a sudden saturation of their capacities. Hospital workers appear to be a population at particular risk for this new infectious agent. The percentage of hospital workers who have been in contact with the virus or have contracted COVID-19 is unknown.

The objective of this work is to determine the prevalence of SARS-CoV-2 positive serologies among hospital staff screened from June 22, 2020 to November 1, 2020 following a screening campaign offering serological testing to all volunteer HUS professionals.


Eligibility Criteria:
Inclusion criteria:

* Adult subject (≥ 18 years of age)
* Hospital staff practicing at HUS who performed SARS-CoV 2 serology in the period from 06/22/2020 to 11/1/2020

Exclusion criteria:

- Subject not meeting inclusion criteria
Human Alcohol Seeking Despite Aversion

Prolonged alcohol use results in drinking despite resultant problems and adverse consequences. The investigators propose to test a laboratory model of human seeking despite aversion to use as an early marker of disease onset, and as a tool for study of its neural functional substrates, and identification of effective treatments.

The long-term goal for this project is to establish a model of alcohol seeking despite aversion (SDA) as a platform for the laboratory testing of novel pharmacologic and behavioral interventions that can be used among those with the highest risk, but who have yet to progress to treatment-resistant drinking. The objective of this application is to test SDA across multiple levels of analysis. The investigators consider SDA as an early marker of alcohol use disorder progression that is related to lifetime drinking history, alcohol use disorder risks, and brain physiology. The investigators have completed a pilot study demonstrating that SDA can be objectively quantified via an intravenous alcohol self-administration task, in which operant work for identical incremental alcohol rewards is paired with aversive stimuli. This preliminary data supports the central hypotheses that behavior in the SDA model is attributable to lifetime alcohol exposure, is related to alcohol use disorder risk factors and phenotypes, and reflects alterations in neural system function. In this project, SDA will be measured along with recent and lifetime drinking history, negative affect-based rash action (i.e. negative urgency, including action with respect to alcohol use), and self-rating of the effects of alcohol. The rationale for this work is that it would lead to the first objective, well-validated measure of SDA in humans.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women age 21-55
* Range of lifetime alcohol drinking history from 25 kg to 500 kg, with preference for extremes, plus recent drinking at least 7 drinks/week (women) and 20 drinks/week (men)
* Able to understand and complete questionnaires and procedures in English
* Willing and able to tolerate iv placement
* Right-handed (for fMRI Arm only)

Exclusion Criteria:

* Pregnant or breast-feeding
* Seeking or in treatment for substance use disorder or under court ordered abstinence
* Medications, medical disorders or conditions that could affect study outcome or subject safety
* Positive urine drug screen for amphetamines/methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine
* Positive breath alcohol (BrAC) reading on arrival at any study visit
* Actively suicidal (within previous year)
* Left-handed or ambidextrous (for fMRI Arm only)
Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania

The long-term objective of the parent study is "to reduce the effects of OPCa through secondary prevention (i.e., early detection, diagnosis and treatment referral)." Consistent with this, this supplement will test HPV-related interventions tailored for Sexual Minority Men (SMM). Acceptability, feasibility and preliminary effectiveness of a smart-phone delivered Oropharyngeal Cancer (OPCA) self-assessment tool will be assessed. Given that homosexuality is stigmatized and criminalized in Tanzania, and that cell phone use is the key way SMM communicate in Tanzania, a self-assessment screening cell phone intervention holds particular promise for SMM in Tanzania but warrants separate evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* gay or bisexual men
* speak Kiswahili or English
* resident in Dar es Salam