cyrilzakka/clinical-trials huggingface dataset:
A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD).


Eligibility Criteria:
Inclusion Criteria:

• Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S).

Exclusion Criteria:

* Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD
* Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
* Have been diagnosed with any eating disorder within the past six months
* Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder
* Have any history of alcohol or substance abuse within 3 months of screening
* Have any history of seizures, including febrile seizures
* Have any history of head trauma associated with loss of consciousness within the past 15 years
Working Memory Training for Dysphoric Students

Depression is associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM impairments depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information. This study explored whether training WM decreases these impairments and reduces clinical symptoms of depression, anxiety and rumination. Sixty-one students with an elevated score on the BDI-II, representing a dysphoric mood state, executed a working memory training (n = 34) or placebo training (n = 27). Before and after training their depression, anxiety, rumination and working memory were assessed. Furthermore, they executed a working memory task while their pupil dilation was measured to assess their fatigue. Moreover, the investigators compared the dysphoric students with a healthy student population on all measures.


Eligibility Criteria:
Inclusion Criteria:

* BDI 10 of higher for dysphoric group
* BDI 5 or lower for healthy control group
First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide

This clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well it works in imaging patients with primary or cancer that has spread to the breast, colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may improve the ability to locate cancer in the body.

PRIMARY OBJECTIVES:

I. To determine the safety, biodistribution and dosimetric properties of 18F-alphavbeta6-binding peptide (BP) in normal tissues and malignancies in cancer patients and correlate concordance with alphavbeta6 expression.

OUTLINE:

Patients receive 18F-alphavbeta6-BP intravenously (IV) and then undergo positron emission tomography (PET) scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.

After completion of study, patients are followed up for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas
* Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
* Will sign the Institutional Review Board (IRB)-approved consent form
* Able to remain motionless for up to 30-60 minutes per scan

Exclusion Criteria:

* Creatinine \> 2 x upper limit of normal
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 x upper limit of normal
* Life expectancy \< 3 months (mo)
* Women who are pregnant or breast-feeding
* Patients who cannot undergo PET/compute tomography (CT) scanning
* Lack of availability for follow-up assessments
* Participation in another clinical trial involving an investigational agent within 4 weeks of enrollment
Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize patients to oral encapsulated FMT or oral Vancomycin.

Patients with primary CDAD will be approached for consent and randomized equally to two arms: oral FMT with oral Vancomycin placebo, or oral FMT placebo with oral Vancomycin. FMT will be prepared from anonymous donors screened according to Health Canada guidelines and stored frozen.

Eligibility Criteria:
Inclusion Criteria:

* life expectancy \> 3 months, 3 or more unformed stools in 24 hours prior to randomization, positive stool test within 72 hours of randomization

Exclusion Criteria:

* pregnancy, previous stool test positive within 12 months, toxic megacolon or ileus, already received \>4 doses of treatment for current episode, inflammatory bowel disease, gastrointestinal surgery within 90 days of randomization (except appendectomy or cholecystectomy), documented aspiration of gastric contents within 90 days of randomization, requirement for treatment with oral probiotics, opiates, loperamide or diphenoxylate during the study duration, anticipated use of antibiotics for any reason during the study duration, known non-CDAD concurrent gastrointestinal infection, concurrent enrollment in another clinical trial for any reason, intolerance or hypersensitivity to Vancomycin, anaphylactic reaction to any food, current induction chemotherapy, HIV infection with Cluster of Differentiation 4 (CD4) count \<200, or any medical or non-medical condition considered by the investigator to preclude participation.
Lifestyle Intervention in Type 2 Diabetes

The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.

Patients with type 2 diabetes using insulin pump therapy are gaining weight within the first months of treatment. This weight gain could counterbalance the metabolic benefice of insulin pump treatment in improving glycemic control and could lead to treatment dropout. Lifestyle intervention aiming at improving physical activity and diet in type 2 diabetes is known to brought body weight reduction and cardiometabolic improvement.

The investigator hypothesized that an intensive, home-based, 6-months diet and physical activity program could prevent the body weight gain associated with insulin pump treatment initiation. The investigator will randomize patients with type 2 diabetes into a "lifestyle intervention" arm or a "usual care" control arm at the time of insulin pump treatment initiation. The primary objective will evaluate body weight change at 6 months after insulin pump treatment initiation. The secondary objectives will evaluate change in glycemic control (HbA1c) and body composition at 6 months. In addition, the retention effect will be assessed on body weight change one year after insulin pump treatment initiation, 6 months after the end of the lifestyle intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adult Type 2 diabetic patients with indication of initiation of insulin pump therapy.
* Patients addressed for the insulin pump follow-up to the home care provider supporting the study.
* Public health care security affiliation.

Exclusion Criteria:

* Breastfeeding or pregnant woman.
* Not willing to participate as assessed by the investigator.
* Patient engaged in another clinical trial with exclusion criteria for other protocol.
* Patients unable to ride a training bike.
* Unavailable in the next 6 months.
* Patient without a medical certificate done in the last 12 months by a cardiologist attesting the ability to participate in a physical activity reinforcement program.
Head to Head Study Against Sevelamer Hydrochloride

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Adults with end stage renal disease who are receiving dialysis

Exclusion Criteria:

* Subjects with significant gastrointestinal disorders
* Subjects who are pregnant or nursing
* Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
* Subjects who are HIV positive
* Subjects with clinical significant liver disease
Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis.

Atherosclerosis (deposition of a plaque essentially composed of lipids on the artery walls) is a frequent condition and is a leading cause of death worldwide. In addition to the long-established risk factors such as age, hypertension, diabetes or sedentary lifestyle, it has been demonstrated that immune cells can participate in the genesis of atherosclerotic plaques through metabolic and mitochondrial reprogramming.

A non-invasive marker of this immune reprogramming has yet to be identified. Through the comparison of a group of atheromatous patients and a group of non-atheromatous patients, this study aims to evaluate this reprogramming phenomenon using a novel non-invasive method.

This monocentric interventional study will take place at the Dijon Bourgogne University Hospital and will include 50 patients divided into 2 groups: "atheromatous coronary patients" and "non-atheromatous patients". The duration of participation in this study is 1 month. This study is based on usually performed procedures. Only blood samples will be taken on a catheter usually used during any cardiac surgery in addition to the medical care that is provided during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

- Person who provides oral consent

Group 1:

- Patient scheduled for cardiac bypass surgery (isolated procedure) with extracorporeal circulation

Group 2:

* Patient scheduled for valve ou ascending aorta surgery with extracorporeal circulation
* No coronary lesion
* No peripheral arterial disease (limbs, carotids, aortic aneurysm)

Exclusion Criteria:

* Person not affiliated with national health care system
* Medication that alters mitochondrial function (Chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil)
* Person under a legal protection measure (curatorship, guardianship, tutorship)
* Pregnant, parturient or breastfeeding women
* Major unable to express consent
* Minor
High-Intensity Interval Training Recuperates Capacity of Endogenous Thrombin Generation in Patients With Heart Failure

Consumptive coagulopathy is associated with increased mortality in patients with heart failure (HF). Physical activity influences the risk of major vascular thrombotic events. This study investigates how high-intensity interval training (HIIT) affects the capacity of endogenous thrombin generation (TG) by modulating circulatory procoagulant microparticles (MPs) in HF patients. Thirty-eight HF patients and 38 age- and gender-matched normal counterparts (NC) were recruited into this study. The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks, whereas the NC group did not receive any form of intervention. Plasma TG kinetics, procoagulant MPs, coagulation-related factors, and oxidative stress/proinflammatory status were analyzed. The results demonstrated that the HF group exhibited (i) less endogenous thrombin potential (ETP) and TG rate, (ii) lower concentration/activity of tissue factor (TF) and counts of TF-rich MPs derived from blood cells, and (iiii) higher vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations, compared to the NC group did. However, HIIT elevated plasma ETP and TG rate, as well as, TF concentration/activity and blood cell-derived procoagulant MP levels in the HF patients. Moreover, the exercise regimen also decreased vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations in patients with HF. Hence, we conclude that HF reduces the capacity of endogenous TG in plasma, which is associated with decreased (or consumed) circulatory procoagulant MP levels. However, HIIT alleviates HF-declined endogenous TG capacity and vascular endothelial damage through recuperating TF-related coagulation activity and suppressing oxidative stress/proinflammatory status.


Eligibility Criteria:
Inclusion Criteria:

* The HF was diagnosed if the patients had a left ventricular ejection fraction (LVEF) \<40%.
* All HF patients were New York Heart Association (NYHA) functional class II or III and had received optimal treatment for at least 12 months according to American Heart Association/American College of Cardiology guidelines.

Exclusion Criteria:

* Patients with the presence of atrial fibrillation/flutter, second/third degree heart block, history of life-threatening ventricular arrhythmias, recent unstable angina, myocardial infarction or coronary revascularization (\<4 weeks), uncontrolled diabetes mellitus, severe chronic obstructive pulmonary disease, or symptomatic cerebral vascular disease within 12 months, collagen vascular disease, alcohol or drug abuse during the previous 12 months or significant renal or hepatic disease were excluded.
Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rct)

One of the most common post-operative deficiencies or complications of bariatric surgery is protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro- and macronutrient deficiencies that can lead to deleterious consequences. A protein-rich diet make a person feel satiety and thereby the consumption will be low in overall energy intake. The objectives of our study are. The aim of this study is to assess the effect of protein supplementation on changes in health parameters such as fat mass, muscle mass, weigh change, protein (total and albumin), Vit B12, Zinc and Magnesium, in Qatari patients post bariatric surgery. Our participants are Qatari aged 18-45 years males and females recruited from the bariatric surgery centers of 2 major HMC hospitals (HGH hospital) and will be randomized to receive either the protein supplement (treatment group) or a dietary advice (control group). All participants will be equally followed and monitored for 3 months and data on the above parameters will be collected, together with other population characteristics, at Baseline, 1 month and 3 month. Data will then be analyzed using the most up-to-date SPSS statistical package to assess the effect of protein supplementation on the parameters of interest. Statistical measures will be carefully chosen to properly assess the difference in the treatment (protein supplementation) effect compared with the control (Dietary advice). Investigators hypothesize that Patients receiving protein supplement (intervention group) Compared with patient not on protein supplement (placebo group) will maintain weight loss and other essential health parameters.


Eligibility Criteria:
Inclusion Criteria:

Study participants must have the following criteria in order to participate in the trial:

1. Qatari males or females.
2. Aged between 18 and 60 year
3. Based at the bariatric surgery list of HMC with their follow up scheduled be at HMC.

Exclusion Criteria:

Patients will be excluded from participating in the trial if they have the following criteria:

1. Any Renal or liver disease because that will affect protein or albumin level in body.
2. Past history of bariatric surgery
3. Patients will be further excluded after starting the trial if they fall into the following categories:

   * Subjects who did not take at least 80% of their intervention product amount per day, or
   * Subjects who did not comply with the treatment (or placebo) for more than 3 days per week.

Also, patients who refuse to participate \& patients with baseline tests showing they are in need for protein supplements will be excluded from the study and given the needed protein supplements per the standard care.
A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).

The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice.

This study is seeking for participants who are:

* Adult Patients who are just confirmed to have Chronic Myeloid Leukemia (CML) defined in Local Product Document (LPD). CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. LPD explains what a medicine's benefits and problems are. LPD also explains how to use the medicine correctly in Korea.
* willing to take part in the study after being informed about the study. All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea.

The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patients newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or CP, AP, BP Ph+ CML with resistance or intolerance to prior therapy
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

- Patients to whom bosulif is contraindicated as per the local labeling- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
Measuring Work-Related Stress in Primary Care in the Covid-19 Pandemic

This prospective cohort study was designed to assess WRS amongst clinical and non-clinical staff in a primary healthcare setting using a validated tool with a view to developing an evidence base to form a historical and comparative record during the Covid-19 pandemic.

Work-related stress (WRS) is the second most common cause of occupational ill health in the United Kingdom. Studies suggest that during the Covid-19 pandemic, an increased prevalence of stress-related disorders was reported amongst healthcare workers. WRS can be assessed using the Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) and is used to compare changes to WRS across six domains over time. Lower scores in domains indicate higher WRS experienced by workers. Increases in the score in subsequent assessments indicate improvements to WRS. The MSIT was distributed to 23 primary care clinical and non-clinical staff in a medical centre in Greater Manchester, United Kingdom in March, 2019. 18 responses were received from 23 staff (78% response rate), establishing a baseline. In May, 2020, the authors decided to reanalyse the effect of the Covid-19 pandemic on WRS upon the same population. The MSIT was redistributed in March 2021, with 14 responses from 20 staff (70% response rate). Microsoft Excel's data analysis was applied to the results. WRS across the practice increased by 7% in demands, 4% in control and 2% in role domains and improved by 3% in support, 3% in relationships and 2% in change domains. The results are in keeping with the global picture of evolving WRS amongst healthcare staff during the pandemic. Monitoring and addressing WRS regularly helps maintain system-wide resilience when faced with unexpected or unprecedented change. Comparing these results with WRS in other healthcare systems would be a useful next step.

Eligibility Criteria:
Inclusion Criteria:

* Primary healthcare staff working at the Gill Medical Centre for at least two months prior to assessment.

Exclusion Criteria:

* Any staff member employed for less than two months, those who were off work due to non- stress related long-term leave or incomplete submissions.
Which is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?

The purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged between 4 and 16 years (inclusive).
* Diagnosis of cerebral palsy.
* Presence of clinical bilateral hip pain (of at least 6 months duration) due to cerebral palsy as defined by the child/young person and/or parents.
* Paediatric Pain Profile score of 25 or greater.

Exclusion Criteria:

* Prior treatment with Botulinum toxin (any serotype, administered anywhere in the body) within 4 months prior to Screening.
* Planned or anticipated requirement for surgery during the study period.
* History of hypersensitivity to the investigational drug or any of its excipients.
* Likely to require treatment during the study with drugs that are not permitted by the study protocol or that in the opinion of the Investigator may interfere with the evaluation of the efficacy or safety of the study medication.