cyrilzakka/clinical-trials huggingface dataset:
Protein Supplementation and Endurance Exercise Adaptations

Participants will perform three endurance training sessions weekly for 12 weeks. All participants will be randomly assigned to the protein supplementation group or the placebo (iso-caloric carbohydrate) group. During the 12 weeks endurance training program participants allocated to the protein group (30 g protein per beverage) will receive a protein drink after exercise and prior to sleep at night on training days. On non-training days participants will only receive a protein drink before sleep. Participants allocated to the carbohydrate group (30 g carbohydrates) will receive a carbohydrate drink instead of a protein drink.

In the proposed study, the effects of protein supplementation after training and before sleep on VO2max and performance will be assessed during 12 weeks endurance exercise training in untrained healthy young men. The ready to drink carbohydrate beverage consists of 30g carbohydrate or 30g protein. Previous studies show that the supplementation of 30g protein is in the optimal range to stimulate the muscle protein synthetic response following resistance type exercise. The protein supplementation group in the present study will be compared with an iso-caloric carbohydrate group. In addition, to the pre- and post-intervention biopsies 1 additional muscle biopsies will be taken (in week 6) during the 12 week intervention period. This will create a unique opportunity to establish the timeline of the skeletal muscle adaptive response at functional and mechanistic level following prolonged endurance exercise training, including potential differences between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 18 and 30 years of age
* BMI between 18.5 - 25 kg/m2
* Recreationally active, performing sports on a non-competitive basis
* Maximal wattage of \> 5 watt per kg bodyweight (screening measurement)
* Willing to give muscle biopsies
* Willing to give blood samples
* Having a general-practitioner
* Consumption of alcohol beverages is less than 21 per week
* Able to perform three exercise sessions weekly for 10 weeks

Exclusion Criteria:

* Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease, liver or renal disease, diabetes mellitus type 1 or 2)
* Having a lactose and/or gluten intolerance
* Use of systemic medication (with the exception of antihistaminic medication and the use of occasional painkillers)
* (Chronic) injuries of the locomotor system (e.g. musculoskeletal/orthopedic disorders) that can interfere with the intervention
* Participants who are enrolled in an interventional biomedical research project or have received an investigational new drug or product with the last 30 days prior to screening.
* Smokers and use of illicit drugs
* Blood donor during the study and in the three months before start of the study
* Employed, or intern, or working on a thesis at the department of Human Nutrition at Wageningen University \& Research
* Participating in another scientific study (except EetMeetWeet)
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation

The purpose of this study is to assess the efficacy of Caption LungAI.

After being informed about the study, all patients giving written informed consent will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and one exam conducted by a (non-expert) healthcare provider who is trained on Caption LungAI and will use Caption LungAI to capture images.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-lines.

Exclusion Criteria:

* Patients in extremis/in whom a research lung ultrasound would not normally be performed due to other priorities
Continuous Glucose Monitoring in Prediabetes with Health Education Videos

The objective of this project is to deliver a behavior health education video series that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with prediabetes. The goal is to prevent transition to type 2 diabetes and advanced metabolic complications.

A health education video series, ¡Mi Control!, led by community health workers known as Promotores de Salud (PdS), will be integrated with continuous glucose monitoring (CGM) to support self-monitoring of glucose levels and excursions. Study G2 is a Phase 0 feasibility study enrolling 30 Spanish- and/or English-speaking PdS who test positive for prediabetes via a finger-prick A1c% screening. Participants will wear CGM devices for 20 days, with glucose data masked for the first 10 days and unmasked for the next 10 days. During the unmasked phase, participants will receive daily health education videos on their smartphones. The study will compare the duration of glucose excursions between the masked and unmasked phases to assess the impact of CGM feedback and health education on glucose regulation.

Eligibility Criteria:
Inclusion Criteria:

Pre-diabetes determined by finger prick A1c% Willingness to wear a CGM sensor Community health worker

Exclusion Criteria:

Currently pregnant Diagnosed with any disorder likely interfering with blood glucose levels Influential medical disorder or event affecting ability to participate in the study Incompatible smartphone device not pairing with the Dexcom CGM system
Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™

A multicenter observational study trial validating Quality of Life assessment using EuraHS Quality of Life score and Carolinas Comfort scale™ in patients before and after laparoscopic unilateral inguinal hernia repair.

Depending on the treating physician patients will receive a TAPP or TEP repair for their inguinal hernia and a self-gripping mesh will be used for the repair (Parietex Progrip Mesh).

Primary endpoint will be assessment by the EuraHS-QoL at 1 year after laparoscopic repair of an unilateral inguinal hernia using the Anatomic ProGrip™ Laparoscopic self-fixating mesh.

Secondary endpoints are assessment of the QoL 3 preoperative, 3 weeks and 1 year postoperative, recurrence rate at 12 months, intra-operative and post-operative complications, post-operative hospital stay, operation time and time to place the mesh, VAS (Visual Analog Scale) for pain at several control points, VRS (Verbal Rating Score) for pain at 3 weeks and 12 months, pain medication needed.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient or his/her legal representative
* Primary unilateral inguinal hernia undergoing a preperitoneal laparoscopic repair.

Exclusion Criteria:

* No written informed consent
* Recurrent groin hernia
* Open hernia repair
* Bilateral hernias
* Concomitant repair of another abdominal hernia eg umbilical hernia
* Hernia repair combined with another surgical procedure
* Emergency operations, like incarcerated hernias
* Patients under the age of 18 years and over 80 years
* Pregnant women
* ASA score 4 or more
* Patients unable to perform the QoL assessment, because of language barrier or intellectual incapacity
Rapid Build of HIV Related Protective Barriers

The purpose of the study is to screen the optimal intervention strategies to rapid establish the protective barriers against HIV-infection by maximally decreasing the viremia among HIV- infected patients.

Sexual transmission became the primary route of HIV transmission in China and heterosexual transmission also contributed greatly to HIV epidemic which was mostly reported in South-west rural areas. In past years, Yunnan has experienced powerful campaign of scaling-up the HIV identification as well as antrertroviral therapy.

This study will investigate how to reach the last two of HIV'90-90-90 targets': to provide antiretroviral therapy (ART) for 90% of who diagnosed HIV infection and to achieve viral suppression for 90% of those treated.

The study population consists of participants who received an newly diagnosed HIV infection within the study period. All rerolled participants will be randomized into different study group. In intervention group, medical institutions will provide patients personal involved intervention strategies which guided by frequent viral load detection, and providing of the dosage form of 400 mg EFV in their antiviral therapy.

Main assessment measures are viral suppression rate of HIV-infected patients and treatment coverage .

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive participants who received an newly diagnosed HIV infection within the study period
* Having a current residential address inside of pilot site limits
* Eighteen years old or above
* HIV transmission is heterosexual contact

Exclusion Criteria:

* IDU
* Having severe mental disorder
Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients

This study will evaluate the effects of nebivolol on glycemic control compared with metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus


Eligibility Criteria:
INCLUSION CRITERIA:

* Male or female, 18-85 years of age
* Blood pressure in the range of 130 to 179/80 to 109 mmHg
* Currently using either an ACE inhibitor or an ARB alone or (an ACE inhibitor or an ARB and up to two other drugs for treatment of high blood pressure). (Patients may be on both an ACE inhibitor and ARB, but would need to be taken off one.)
* Stable medication regimen for high blood pressure for at least one month prior to screening
* Stable type 2 diabetes mellitus for at least 3 months prior to screening that is controlled by any or all of the following: diet and antidiabetic medications that may include fixed-dose insulin
* HgbA1c 6.5 to 8.5% (This is measured at the screening visit)

EXCLUSION CRITERIA:

* Use of any beta blocker within one month prior to screening
* Use of clonidine within 3 months prior to screening
* Diagnosis of hyperthyroidism as evidenced by abnormal lab markers
* Any disorder requiring the intermittent or chronic use of systemic corticosteroids
* Diagnosis of hyperthyroidism as determined by lab markers done at screening
* Active liver disease as determined by lab markers
* Kidney impairment; estimated GFR \< 60 mL/min/1.73 m2
* History of heart attack, clinically significant arrhythmia, unstable angina, coronary angioplasty/bypass surgery, stroke, or TIA in 3 months prior to screening
* Chronic heart failure
* Drug or alcohol abuse within 2 years prior to screening
* History of sensitivity to any beta blocker, HCTZ, sulfa drug, or calcium channel blocker
* Participation in another research study within 30 days prior to screening
Study on the Effects of Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older

This study aims to evaluate the efficacy of the oxygen-ozone therapy in the treatment of back pain in subjects aged 65 or older. In particular, the intramuscular injection technique/paravertebral of oxygen-ozone mixture, a minimal invasive treatment with respect to intradiscal infiltration/intraforaminal technique, will be used.

Back pain is a leading cause of disability, including impairment in activities of daily living. In particular, the persistence of low back pain is more frequent in the elderly, associated with functional limitations and difficulties to perform tasks in everyday life. In addition to pharmacological treatments, various non-surgical interventional procedures are used for the treatment of low back pain. Some recent studies have evaluated the interventional oxygen-ozone (O2-O3) therapy in the treatment of back pain. However, these results are based on the technique of intradiscal infiltration / intraforaminal of O2-O3, while the intramuscular injection technique / paravertebral is the most widely used in clinical practice in Italy. In general, minimally invasive treatments such as percutaneous infiltration, are well tolerated and have been shown to produce clinical results, although the number of controlled studies is still scarce and the studies are often not comparable. Taking into account the above considerations, it seems appropriate to try to broaden the knowledge on the use of O2-O3 in the treatment of low back pain, using the technique of intramuscular injection / paravertebral, with particular reference to the elderly population.

The primary objective of this trial is therefore to evaluate the effects of O2-O3 therapy in the treatment of back pain associated with lumbar disc disease using the technique of intramuscular injection/paravertebral. These effects will be evaluated after a 6 weeks treatment period and after a 3 months follow-up period.

The project will include 130 subjects aged 65 or older who will be randomly enrolled in two different types of intervention:

* Oxygen-ozone therapy
* Simulated treatment

fully described below in the section: Interventions

In addition to clinical evaluations, the trial will contribute to the study of biological bases of the O2-O3 therapy as the levels of trace elements, oxidative status and antioxidant capacity in plasma will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 65 or older
* intervertebral disc degeneration
* back pain persistent for at least 6 weeks
* painkillers and anti-inflammatory drugs
* ODI score at baseline between 30 and 80%

Exclusion Criteria:

* heart failure
* favism
* clinically hyperthyroidism
* cancer and concomitant chemo-or radio-therapy
* epilepsy
* asthma
* life expectancy of 6 months or less
* psychotic drugs
* clinical signs of radiculopathy
* polyradiculopathy
* progressive neurological deficit
* lumbar stenosis
* spondylolisthesis
* diabetic neuropathy
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.

This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic kidney disease stage IV not requiring dialysis;
* expected to initiate dialysis within 18 months;
* 15\<=Glomerular Filtration Rate (GFR)\<=29.

Exclusion Criteria:

* failing renal allograft in place;
* acute or chronic bleeding within 8 weeks prior to screening;
* transfusion of red blood cells within 8 weeks prior to screening;
* poorly controlled hypertension;
* immunosuppressive therapy in the 12 weeks prior to screening.
Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)

The objective of this study is to evaluate the safety and efficacy of concurrent administration of influenza vaccine in patients receiving anti-PD1 immunotherapy (nivolumab or pembrolizumab). This will be a prospective observational study, aiming to assess patient tolerance of treatment, adverse events (incidence, grade, need for hospitalization), incidence of influenza infections, and seroconversion rates.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Currently receiving immunotherapy with anti-PD-1 agents (Nivolumab or Pembrolizumab)
* Have not received influenza vaccination prior to study entry date for the upcoming flu season 2016-2017
* No previous contraindication to receiving influenza vaccination
* Histologically proven cancer
* Expected lifetime of at least 12 weeks

Exclusion Criteria:

* Previous cancer
* Autoimmune disease or immunosuppressive treatments
* Corticosteroid treatment
* Those who have a potential indication to change chemotherapy treatment in 42 days following start of treatment
* History of clinically or virologically confirmed influenza infection in the previous six months
* Previous contraindication to receiving influenza vaccination
* Previous allergic/adverse reaction with influenza vaccination
* Have received influenza vaccination prior to study entry date for upcoming 2016-2017 flu season
* Positive anti influenza antibody titers as determined by the baseline blood determination (day 0)
Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children

The purpose of this study is to compare the efficacy and safety of ketorolac sublingual with fentanyl intranasal used in our hospital for pain control in children undergoing bilateral myringotomy with placement of pressure equalization tubes (BMTs).

This prospective, randomized, allocation concealed blinded study is designed to compare ketorolac sublingual vs. fentanyl intranasal vs. the combination of these two medications for pain control after BMTs in children. Bilateral myringotomy and tube placement is an elective operation, mainly in the pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) I-II physical class
* Scheduled for elective BMT
* Mask induction of anesthesia

Exclusion Criteria:

* Allergy to any NSAIDs
* Severe upper respirator infection
* Severe asthma
* Bleeding disorders
* History of GI bleeding
* Renal impairment
* Scheduled for one-sided myringotomy and tube placement
The Effect of Neuro-orthosis on Gait Performer in Post Stroke Subjects

The aim of this study is to verify the effectiveness of foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild, moderate and severe compromise.

The stroke subjects are going to perform the walking training with Foot drop stimulator on the treadmill. All the evaluations will be performed with a foot drop stimulator turned off and on. One month later, that finished the intensive treatment; the participants were also evaluated only without the stimulation of FDS.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with ischemic or hemorrhagic stroke diagnosis.
* Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months)
* Minimal cognitive ability to understand commands
* Able to walk 10 meters unassisted or with minimal assistance

Exclusion Criteria:

* Secondary musculoskeletal disorder involving the lower limb
* Contraindication for electrical stimulation
Hypogonadotropic Hypogonadism in Obese Young Males

Obesity can lead to low testosterone concentrations in young men. This study will study the effects of low testosterone in those men and the result of treating them with clomiphene.

The prevalence of obesity has increased in children over the past few decades. Approximately 20% of adolescent boys are now considered obese. It is well accepted that obese children are at increased risk for high blood pressure, lipid abnormalities and type 2 diabetes. Recent studies have uncovered yet another undesirable effect of obesity. The testosterone levels of obese boys are only half those of lean boys at completion of puberty. Testosterone is important for muscle and bone development. Men with low testosterone are at higher risk of insulin resistance and inflammation, which lead to type 2 diabetes and heart disease. Since testosterone is the major reproductive hormone, these obese boys are at risk of decreased fertility. Men are supposed to achieve their peak testosterone levels at puberty. Thereafter, there is a decline in testosterone levels at the rate of 2% per year for the rest of life. Thus there is a clear need to develop a deeper understanding of low testosterone in these males who are entering their peak fertility years. There are no approved treatments for this disorder. The investigators propose to conduct a randomized placebo controlled trial to evaluate the effect of treatment with clomiphene in obese young men(age 18-30 years) who have low testosterone concentrations. Clomiphene is a drug that increases testosterone concentrations and possibly increases sperm production. In contrast, testosterone replacement therapy decreased fertility and cannot be used in young men. Investigators will study the effect of treatment with clomiphene or placebo tablets for 12 weeks in 30 subjects. The study will evaluate:-

1. testicular function: Testosterone and two proteins secreted by testis(insulin like factor 3 and inhibin B) will be measured in the blood before and after treatment with clomiphene or placebo.
2. insulin resistance: Investigators will measure insulin and glucose levels in the blood.
3. inflammation: Investigators will measure proteins that induce inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Age 18-30 years inclusive will be recruited.

A total of 90 males will be recruited:-

* 30 obese males (defined as BMI ≥30 kg/m2) with HH,
* 30 obese males with normal FT concentrations and
* 30 lean males (defined as BMI \<25 kg/m2) with normal FT concentrations.

Exclusion Criteria:

* Use of androgens, clomiphene, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months
* Hematocrit \> 50%
* Congestive heart failure
* currently suffering from depression
* type 1 diabetes
* Hepatic disease (transaminase \> 3 times normal) or cirrhosis
* Renal impairment (eGFR\<30 ml/min/1.73m2)
* HIV or Hepatitis C positive status
* Participation in any other concurrent clinical trial
* currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
Measurement of Physical Activity in the First Days After Thoracic Surgery

Objective measurement of physical activity has several advantages compared to declarative measures: exemption from memory bias and desirability bias, more precise evaluation, taken into account activities of low intensity, measurement of physical activity and sedentariness profiles (number and duration of periods of activity, number of breaks in sedentary lifestyles).

The aim of this study is to assess the early postoperative mobility of patients who have undergone pulmonary excision by thoracoscopy or robot surgery using ActiGraph GT3X accelerometer. This assessment will serve as a reference element for further studies.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Having to undergo pulmonary excision by thoracoscopy or robotic surgery
* Accepting to wear a belt fitted with an ActiGraph GT3X accelerometer for a maximum of 5 days post surgery
* Affiliated to a Health Insurance plan
* Having given an oral non-opposition

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient unable to move independently (paraplegic, etc.)
* Patient deprived of liberty or under guardianship.