cyrilzakka/clinical-trials huggingface dataset:
Increasing Physical Activity Through a Motivational Online Intervention Using Pedometers in Sedentary Students

The aim of this study is to analyze the effect of a motivational online intervention (MOI) using pedometers to increase physical activity in a sample of sedentary students. It will be compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a pedometer of new generation); MOI condition (access to a MOI and the use of a blinded pedometer); and CONTROL condition (the use of a blinded pedometer).

Regular practice of physical activity (PA) has shown benefits in physical and mental health. However, the levels of PA are low in the general population. Pedometers and motivational online interventions (MOI) have been used to increase PA levels in sedentary population.

In spite of finding positive outcomes on PA levels when theoretical constructs derived from theories of behavior change and Internet have been used to guide pedometer-based interventions, few interventions have incorporated all these variables together and have analyzed the short-term or mid-term results.

The main objective of this study is to analyze the effect of a short self-administered Motivational Online Intervention (MOI) using pedometers to increase PA levels (primary outcome) and to change different theoretical constructs related to the PA behavior (positive decisional balance, self-efficacy, processes of change, stage of change, and enjoyment) (secondary outcomes) in a sample of sedentary students after 3-weeks intervention (post) and after 3-months (follow-up). It will be compared three conditions: MOI+PEDOMETER condition (access to a MOI and the use of a pedometer of new generation); MOI condition (access to a MOI and the use of blinded pedometer); and CONTROL condition (the use of a blinded pedometer). Hence, two conditions will include components of the "Transtheoretical Model of Change" in the intervention, such as the facilitation of the decisional balance, the increase of the self-efficacy, and the use of experiential and behavioral processes of change (e.g., consciousness raising, counterconditioning, reinforcement management, stimulus control), but only one of these condition will receive the feedback of the pedometer that will allow self-monitoring the behavior.

Eligibility Criteria:
Inclusion Criteria:

* to practice less than 30 minutes of moderate-intensity physical activity, three times a week;
* to be sedentary or low active (to walk less than 7500 daily steps during a week
* an age between 18 and 40 years old.

Exclusion Criteria:

* to be already using a pedometer;
* to suffer from a physical and/or a psychological disorder to prevent from practicing physical activity;
* to be already participating in other intervention to practice physical activity; and
* history of drug or alcohol addiction.
Postprandial Blood Glucose and Insulin Levels Following Consumption of Lentil-containing Food Products

This study will recruit 20 healthy adults (male and female) to complete 9 study visits where they will consume different food products (chili, soup and muffin) with or without lentils incorporated into the them. Blood samples will be obtained by finger prick before and for 2 hours after the meal and analyzed for glucose and insulin.

The purpose of the current study is to determine the effects of lentil-containing food products on postprandial blood glucose and insulin levels in healthy premenopausal women and men aged 18-40 years old.This study will use a randomized crossover design. Participants will complete a series of 9 study visits during which participants will consume 9 study treatment meals consisting of muffins, soup and chilli, with and without lentils. Participants will then have their blood sampled for the following 2 hours by finger prick. Participants will remain seated during the test period. All study visits will occur at the Human Nutraceutical Research Unit and be separated by a washout period of 3-7 days. Throughout the study, it will be asked that participants' lifestyle and physical activity remain unchanged. Participants will be instructed to not start any new dietary approaches, and to not start any new natural health products (unless instructed by a physician).

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Age 18-40 years (aiming for equal distribution among 18-29, 30-40 years of age)
* BMI 20-30 kg/m2

Exclusion Criteria:

* Diabetes (fasting blood glucose ≥7.0 mmol/L and/or 2hr blood glucose \>11.1 mmol/L post-75g OGTT) 1
* Impaired Glucose Tolerance (IGT) (Fasting blood glucose 6.1-6.9 mmol/L and/or 2hr blood glucose 7.8-11.0 mmol/L post-75g OGTT) 1
* Blood pressure \>140/90 mm Hg
* Any major medical condition including a history of AIDS or hepatitis
* Medical or surgical event requiring hospitalization within 3 months of randomization
* Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications
* Natural health products (NHPs) used for glycemic control (all other NHPs okay as long as table for 3 months)
* Tobacco use
* Probiotic supplement use
* Dietary fibre supplement use
* Pulse consumption \>4 servings per week
* Food allergy or non-food life threatening allergy
* Alcohol consumption \>14 drinks/week or \>4 drinks/sitting
* Recent or intended significant weight loss or gain (\>4 kg in previous 3 months)
* Elite athletes
* Shift workers
A Single-center, Interventional Diagnostic Study With Minimal Risks and Constraints, Aimed at Longitudinally Evaluating Serum Antibody Levels in Patients With COVID-19 According to the Severity of Their Symptoms.

The COVERT protocol was designed to assess, through a longitudinal analysis, the level of antibodies present in the serum of patients with COVID-19, the duration and the persistence of the humoral response in correlation with the severity of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old,
* Patient whose Covid-19 diagnosis has been confirmed by RT-PCR test (SARS-CoV-2 positive) from a nasopharyngeal swab/broncho alveolar lavage
* Patient whose severity of Covid-19 required hospital treatment
* Patient whose Covid-19 form is defined as moderate (stay in general ward) or severe (stay in ICU), based on the clinical evaluation conducted by the doctor
* Patient agreeing to participate in the study and having signed the informed consent.

Exclusion Criteria:

* Adult person subject to legal protection,
* Pregnant, parturient or breastfeeding woman
* Person not affiliated to a social security scheme or not beneficiary of such a scheme
* Person subject to a safeguard measure
* Person deprived of liberty by a judicial or administrative decision and woman hospitalized without consent under Articles L.3212-1 and 3213-1, which do not fall under Article L.1122-8 of the Public Health Code.
Effects of Resistance Sprint Training With and Without Power Training on Sprint and Agility Performance

This study will be randomized clinical trial will be used to get expected outcomes. Hence under ethical consideration athletes of Pakistan football federation will go under the selection criteria and chosen voluntarily to participate in the study. Data will be collected with non-probability convenient sampling technique and 40 football players will be participated in this study. Participates will be divided into two groups with randomization process. 20 athletes will be in each group. Group A will be treated with squats jumps, change of direction speed, countermovement jump, bench press, Romanian deadlift and barbell squats, resistance band sprints, stair sprints and weighted sled pulls and Group B will be treated with squats jumps, change of direction speed, countermovement jump, resistance band sprints, stairs sprints and weighted sled pulls. These exercises will be given in 3 sets with 10 repetitions in each set. Pre and post interventions measures will be taken on 1st day and at 6th week there will be 3 sessions in a week. SPSS version 25 will be used to analyze the data.

Football is a sport which is of high-intensity intermittent game that requires players to be physically capable of coping with high-intensity movements, having repeated changes of direction, sprints, and accelerations/decelerations, with complex and physically demanding technical different actions Developing and loading strength techniques in football come from knowledge of game performance and its specific components and limitation components. Most of the important factors in football are explosiveness activities such as changing direction, jumping, sprinting, and kicking. Working on these explosive performances have been found after strength training that improved the available force of muscular contraction in appropriate muscle groups. Vertical jump and sprint performances are interlinked with maximal muscular strength in football players and the heavy resistance training can also increase running economy and which ultimately increases the aerobic performance of the athlete

Eligibility Criteria:
Inclusion Criteria:

* Male football players
* Age 18- 40 years
* BMI 18.5-25
* Being volunteered to participate in study
* Being engaged in practice from past 6th month

Exclusion Criteria:

* Athlete with current substance abuse
* Individual diagnose with severe anxiety disorder and psychosis
* History of previous fracture from last 6 months
* Musculoskeletal disorders (sprains, strains, tendinopathies, stress fracture)
DTI in Children With Multiple Sclerosis

This is a prospective, non-randomised, non-blinded, single center study of children and adolescents with multiple sclerosis and clinically isolated syndrome to detect differences or early changes in diffusion-weighted imaging (DTI) by magnetic resonance imaging (MRI).

In children and adolescents with either multiple sclerosis or clinically isolated syndrome an MRI with special DTI-sequences of the brain is performed at timepoint of first manifestation of disease and every 6 months at 3 Tesla MRI according to a specific investigation protocol.

Besides MRI-DTI several clinical data are recorded every 6 months:

1. expanded disability status scale (EDSS)
2. disease activity/ relapse rate
3. lesion load (number of T2-lesions)
4. brain atrophy
5. visual and somatosensoric evoked potentials (VEP, SSEP)
6. neuropsychological examination

Furthermore a complete neurological examination is done every 6 months and particular medication of each patient is recorded in a specific investigator form (case report form, CRF)

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* diagnosis of multiple sclerosis (MS) according to the McDonald criteria 2010 and the consensus recommendations of International Pediatric MS Study Group (IPMSSG) (Krupp et al 2013)
* diagnosis of CIS according to the consensus recommendation of IPMSSG (Krupp et al 2013)
* all types of medication/therapy

Exclusion Criteria:

* pregnancy
* claustrophobia
* allergic reaction of gadolinium (contrast medium)
* implantation of cardiac device
* implantation of neurostimulators
* implantation of cochlea implants
* presence of tattooing (over 20% of body surface)
* presence of permanent-make-up
* presence of permanent transdermal patches
* presence of special catheter systems with temperature probes which cannot be removed
* implantation of metalliferous implants or implants which could contain metal traces
* implantation of artificial heart valves
* implantation of stents or coils
* presence of metal fragments in the eyes
Lung Nodule Intervention Cohort Study

Incident lung nodule is quite common in China. The major treatment method is long-term floolow up without a specific intervention. We aim to investigate the efficacy an safty of a novel transdermal therapy with Chinese herb. The study included two arms: one arm is routine treatment and another arm is routine treatment plus transdermal therapy. The study end point is the change of lung nodule size under CT scan.


Eligibility Criteria:
Inclusion Criteria:

* incident lung nodule patients

Exclusion Criteria:

* severe baseline conditions
Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery

Open, prospective, uncontrolled, observational cohort study.


Eligibility Criteria:
Inclusion criteria:

* patients age 18 years or above undergoing elective total hip or knee replacement surgery
* Written informed consent obtained for data collection and source data verification.

Exclusion criteria:

According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.:

* age of \> 75 years
* renal impairment (creatinine clearance \<50ml/min)
* patients on concomitant therapy with amiodarone or verapamil.
* elevated liver enzymes \>2 upper limit of normal (ULN) and / or hepatic impairment or liver disease expected to have any impact on survival
* anaesthesia with post-operative indwelling epidural catheters
* hypersensitivity to dabigatran etexilate or to any of the excipients
* active clinically significant bleeding
* organic lesion at risk of bleeding
* spontaneous or pharmacological impairment of haemostasis except for the above-included patients groups
* concomitant treatment with quinidine
Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure

The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure


Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure NYHA stage 2 and 3

Exclusion Criteria:

* Valvular disease
* recent decompensation
* Other complaints that might interfere with ergometer exercise
Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ

Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.


Eligibility Criteria:
Inclusion Criteria:

* Haemophilia A (FVIII:C ≤ 2%) based on medical history; at least 100 patients should have severe haemophilia A (FVIII:C \< 1%)
* Male patients of any age
* Previous treatment with a FVIII concentrate for more than 150 EDs
* Availability of detailed documentation (patient diary, log book, etc.) covering either the last 50 EDs or the last 2 years per patient to confirm treatment modality (i.e., prophylaxis, on-demand, recent surgery, or immune tolerance induction)
* Inhibitor negative (\< 0.6 BU) at study entry as confirmed by a recovery test with previous FVIII product and inhibitor test in a central laboratory
* Immunocompetence (CD4+ count \> 200/µL), HIV-negative, or having a viral load \< 200 particles/µL or \< 400,000 copies/mL
* Decision to prescribe Human-cl rhFVIII before enrolment into the study
* Written informed consent by the patient or the patient's parent or legal guardian

Exclusion Criteria:

* Patients treated with any investigational medicinal product (IMP) except FVIII IMP within 30 days prior to the Screening Visit or patients planning to undergo treatment with any IMP other than Human-cl rhFVIII are not eligible for enrolment into the study.
A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa (DEB)

This study is a non-interventional, observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB).

The objective of this study is to characterize the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB). Patients will be followed via remote weekly symptom diaries and monthly questionnaires to assess corneal abrasion symptoms, frequency, and duration.

Eligibility Criteria:
Inclusion Criteria:

1. The subject or their respective legal guardian must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent/Assent Form and must be able to and willing to follow study procedures and instructions.
2. Age 6 months or older at time of Informed Consent/Assent.
3. Prior genetic diagnosis of DEB due to mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty

Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.

Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study.

Eligibility Criteria:
Inclusion Criteria:

* men and women over 60 with the diagnosis rotator cuff massive break (Hamada 2 or more), arthrosis secondary to ruptures of the rotator cuff and primary osteoarthritis with lesion of the cuff, with full Walch B2 type or in patients older than 80 years. Inclusion criteria
* Good functionality of the deltoid muscle.
* Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)
* Accept informed consent

Exclusion Criteria:

* - Review of hemiarthroplasty or anatomical proesis of the affected shoulder.
* Fracture of shoulder in the upper extremity to intervene.
* Central neurological diseases
* Advanced cognitive impairment
* Brachial plexus injuries
* Local or systemic infection.
* Oncological disease
* Treatment with immunosuppressants.
Effect of Music Therapy on Infants with Neonatal Abstinence Syndrome

This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.

The purpose of this exploratory pilot study is to learn what, if any, effects live music therapy interventions have on the pacification, stabilization, and development of infants diagnosed with Neonatal Abstinence Syndrome (NAS). Neonatal Abstinence Syndrome is a group of problems that occur in a newborn who has been exposed to illegal or prescription opiates while in the mother's womb. Participants will receive 6 music therapy sessions over a 14-day period based on a randomized treatment schedule of 6 different interventions.

Eligibility Criteria:
Inclusion Criteria:

Infants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender:

* Admitted to the NICU immediately postpartum
* Gestational age 28 weeks or older
* No identified hearing disorder
* Do not have a diagnosed developmental disability (i.e. Down Syndrome)
* Do not have Fetal Alcohol Syndrome
* Medically cleared to participate in the study by nurse or neonatologist
* Parent or legal guardian able/willing to give consent \& complete the PBQ (Postpartum Bonding Questionnaire)

Exclusion Criteria:

* Admitted to the NICU at any time other than immediately postpartum
* Gestational age \<28 weeks old
* Has an identified hearing disorder
* Has diagnosed developmental disability (i.e. Down syndrome)
* Has Fetal Alcohol Syndrome
* Is not medically cleared to participate in the study by the nurse or neonatologist
* Parent or legal guardian unable/unwilling to give consent
Role of ALBI Score and Sarcopenia As Prognostic Predictors Among Hospitalized Cirrhotic Patients with Hepatic Encephalopathy

To evaluate the role of ALBI score in predicting prognosis and hospital mortality of hospitalized cirrhotic patients with hepatic encephalopathy.

To verify the best scoring system for predicting prognosis and survival among those patients.

To investigate whether the presence of sarcopenia could add to the prognostic role of ALBI score.

Hepatic encephalopathy (HE) is a brain dysfunction caused by impaired liver functions and/or portosystemic shunting. It is one of the most serious complications of liver cirrhosis that leads to a signifcantly impaired quality of life and frequent hospitalizations.

Although the pathogenesis of HE is complex ,accumulation of ammonia ,systemic inflammation, and oxidative stress play a pivotal role .Multiple organs are involved in whole body homeostasis of ammonia, with the liver being a key site .As cirrhosis leads to decline in capacity of liver to detoxify ammonia, skeletal muscle plays a compensatory in ammonia metabolism and clearance .Liver function largely reflect prognosis of liver disease,The ALBI score was originally developed as a measure of liver function in patients with HE.It was developed by putting all of the original components of the Child-Pugh (CTP) score into a multivariable model, the clinical features, (Ascites, Encephalopathy and INR) ,were shown to be redundant in that the entire prognostic value of the CTP score could be explained by just albumin and bilirubin levels in an appropriate formulation derived from multivariable model.As with the CTP and MELD scores, both of which were introduced for specific clinical situation and extended to more general application, the same has happened with ALBI.Increasingly, ALBI score is applied as a preferred measure of liver function due to its objectivity and sensitivity for minor liver function deterioration . In comparison to the MELD score, The ALBI score is sufficiently sensitive of liver function ,thus it might be expected to predict longer-term mortality in patients with cirrhosis, better than the MELD score, which would be expected to predict shorter-term mortality in patients with decompensated cirrhosis or liver failure. A study showed clearly that the ALBI score is the most accurate scoring system in predicting prognosis, followed by CTP, CLIF-SOFA, MELD-Na. Furthermore, it has been shown that the ALBI score is the strongest independent predictor of mortality among other scores. The presence of sarcopenia leads to higher risk of HE. Muscle depletion defined by mid arm circumference is associated with development of covert and overt HE

Eligibility Criteria:
Inclusion Criteria:

* All cirrhotic patients with hepatic encephalopathy admitted to Al-Rajhi liver hospital.

Exclusion Criteria:

* Patients with acute hepatic failure and those with previous portosystemic surgery or TIPS.
* Patients with prior liver or other organs transplantation.
* End stage renal disease(ESRD), and HCC or other solid tumors.
* Patients on marivan for any cause.
* Patients with extra-hepatic biliary obstruction.