cyrilzakka/clinical-trials huggingface dataset:
Could a Preoperative Feeding Jejunostomy Decrease Sarcopenia for Patients With Oesogastric Adenocarcinoma ?

The study of sarcopenia is a subject that is the subject of numerous research and publications, particularly because of its link with a poor prognosis for many cancers.

In an article published by the digestive surgery team, the role of feeding jejunostomy has been demonstrated: it allowed more patients to reach the 2nd stage of surgery and a better tolerance of chemotherapy.

Investigators wanted to study retrospectively the impact of feeding jejunostomy on radiological sarcopenia. Is the positive effect of jejunostomy in gastric cancers associated with a decrease in sarcopenia?


Eligibility Criteria:
Criteria for inclusion:

* Age 18-80 years
* Sex: H or F
* Subject giving their consent for their participation
* Gastric cancers
* stage\> IB
* whether or not a feeding jejunostomy
* CT scan performed at the HUS, after the end of the courses of chemotherapy and / or before the surgery.

Exclusion criteria:

* antecedent level L3 surgery,
* psoas hematoma
* No CT performed at HUS at the end of chemotherapy and / or before surgery
* Impossibility of giving the subject informed information
* Subject under the protection of justice
* Subject under guardianship or curatorship
Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans

The purpose of this study is to determine whether or not the intake of dietary procyanidins (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans.

Flavanols and their oligomeric derivatives, the procyanidins, are plant-derived compounds normally present in the human diet. Accumulating data demonstrate a causal role for flavanols in mediating the cardiovascular benefits associated with the consumption of flavanol-/procyanidin-containing foods. Evidence for a direct, causal role for procyanidins in this context is far less profound. As this is often based on the poor absorption of procyanidins, it has been proposed that procyanidins may indirectly contribute to the systemic presence of bioactive compounds via derivatives generated from the breakdown or catabolism of procyanidins in the gastrointestinal tract. These postulated 'breakdown products' include: i) flavanols, putatively generated by acid hydrolysis in the stomach, and ii) series of phenolic compounds, including 5-(3,4-dihydroxyphenyl)-gamma-valerolactone, that are produced from procyanidin catabolism by the gut microbiome. Verification or rejection of these suppositions could significantly impact the interpretation of epidemiological-/dietary intervention data, and the design of food-content data bases. To address this question, healthy volunteers will consume specially designed cocoa-based dairy drinks containing flavanols and procyanidins (dimers to decamers) either together or individually.

Eligibility Criteria:
Inclusion Criteria:

* A normal blood chemistry and liver function
* Fasting blood cholesterol and triglycerides \< 300 mg/dl and \< 3.0 mmol/l, respectively
* BMI \< 30 kg/m2 will be considered.
* Volunteers must be able to read and speak English fluently, and thus, fully understand the researchers, research protocols, and their rights as a research volunteer.

Exclusion Criteria:

* A history of cardiovascular disease, stroke, uncontrolled hypertension (\> 160/90 mm), renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
* A history of psychiatric illness or an allergy to peanuts.
Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

The study is trying to answer the following question: "Can we use non-invasive imaging to evaluate the response of atopic dermatitis (eczema) to Dupixent (dupilumab)?"

Participating in this research will allow the subject to undergo a noninvasive imaging alternative to conventional monitoring in response to a biologic. Normally, subjects would undergo a clinical examination, serial photography, and possible biopsies to assess the progression of the disease. This study will get rid of the need for a biopsy but will require multiple scans with non-invasive imaging. This research examines a new approach to monitoring response to a biologic drug used for atopic dermatitis, and can also, be used to grade disease severity without the need for a biopsy.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Atopic dermatitis (AD) affecting ≥10% body surface area (BSA) at baseline
* IGA score ≥3, on the IGA scale of 0-4 at baseline
* Eczema Area and Severity Index (EASI) score of ≥16 at baseline

Exclusion Criteria:

* Prior treatment with Dupilumab (REGN668/SAR231893)
* Treatment with TCS or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
* Bodyweight \<30 kg (65lb) at Baseline
* Known or suspected immunodeficiency including human immunodeficiency virus (HIV) infection
* Pregnancy, breastfeeding or planning to become pregnant or breastfeed during the study
Kanagawa Valsartan Trial (KVT): Effects of Valsartan on Renal and Cardiovascular Disease

The purpose of this study is to prove the hypothesis that the progression of renal and cardiovascular disease is more efficiently prevented when the angiotensin II receptor blocker valsartan is added to conventional antihypertensive therapy.

It is widely recognized that suppression of the renin-angiotensin system ameliorates progression of chronic kidney disease (CKD) and that CKD is an important risk factor for development of cardiovascular disease. However, it has not been fully clarified if amelioration of CKD leads to the lower incidence of cardiovascular disease. The purpose of this study is to determine whether the angiotensin II receptor antagonist valsartan, in combination with conventional antihypertensive therapy, will ameliorate progression of both CKD and cardiovascular disease. The primary outcome is courses of renal and cardiac function. The secondary outcome is a composite of a doubling of serum creatinine concentration, end-stage renal disease, myocardial infarction, coronary revascularization, stroke, hospitalization for unstable angina, hospitalization for heart failure or death from cardiovascular causes.

Eligibility Criteria:
Inclusion Criteria:

* CKD with serum creatinine more than 2.0 mg/dl
* Blood pressure more than 130/85 mmHg
* 20 years old or above

Exclusion Criteria:

* End-stage renal disease with maintenance dialysis
* Polycystic kidney disease
* Collagen disease
* Malignant or accelerated hypertension
Apixaban Prevents Portal Vein Thrombosis After Laparoscopic Splenectomy and Azygoportal Disconnection

The purpose of this study is to determine whether Apixaban is effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy and Azygoportal Disconnection

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. From postoperative day three, patients in apixaban group will receive oral Apixaban 2.5mg bid for six months, and be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. The Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients at baseline, on postoperative months (POD) 7, at postoperative months (POM) 1, 3, and 6. All groups will receive the therapy for six months irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then six months monitoring will be done as per the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
2. Splenomegaly with secondary hypersplenism
3. Bleeding portal hypertension
4. No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
5. Informed consent to participate in the study

Exclusion Criteria:

1. Hepatocellular carcinoma or any other malignancy,
2. Hypercoagulable state other than the liver disease related
3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
4. Child - Pugh C
5. Recent peptic ulcer disease
6. History of Hemorrhagic stroke
7. Pregnancy.
8. Uncontrolled Hypertension
9. Human immunodeficiency virus (HIV) infection
PRolaCT - Three Prolactinoma RCTs

This study aims to investigate if endoscopic trans-sphenoidal prolactinoma resection as a first line treatment, or as an equally valid second line treatment after a short (4-6 months) or long (\>2 years) period of pretreatment with a dopamine agonist is superior to standard care for several outcome parameters. The main objectives are to investigate this for quality of life and remission rate. The secondary objectives are to investigate this for biochemical disease control, recurrence rates, clinical symptom control, tumor shrinkage on MRI, pituitary functioning, the occurrence of adverse reactions to treatment, disease burden, and cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* A history of signs and symptoms compatible with the diagnosis prolactinoma.
* New, recent (PRolaCT-1) or known diagnosis of hyperprolactinaemia, defined as a prolactin level 2 times the local laboratory maximum. At the time of randomization hyperprolactinaemia is still present, or was present \< 12 months before inclusion (PRolaCT-2 and PRolaCT-3).
* No clear alternative explanation for hyperprolactinaemia, e.g. medication use.
* Presence of a clearly identifiable (persisting) pituitary mass on MRI not invading the cavernous sinus and having an optimal chance to be completely resected (generally adenomas with a maximum diameter nog exceeding 25mm). A representative MRI at the time of randomization is required, this MRI should generally not be older than 12 months in PRolaCT-3 and 2 months in PRolaCT-1 and PRolaCT-2.
* Competent and able to fill in questionnaires.
* One of the following, dividing patients in to our three RCTs:

  * PRolaCT-1: no prior treatment for prolactinoma;
  * PRolaCT-2: treatment with a dopamine agonist for 4-6 months; or
  * PRolaCT-3: treatment with a dopamine agonist for at least 2 years.

Exclusion Criteria:

* Contraindication for one of the treatment modalities, e.g. severe side effect of cabergoline, contraindications to surgery, or a clear indication for surgical resection.
* Pregnancy at the time of randomization.
* Clinical acromegaly.
* Prior pituitary gland surgery or radiotherapy to the pituitary gland area.
* Severe renal failure (eGFR \<30 ml/min).
* Insufficient understanding of the Dutch or English language.
* Other medical conditions that to the opinion of the physician are not compatible with inclusion in a trial.

Patients eligible for participation in one of the RCTs, but do not consent to randomisation or in whom there is a clear patient or physician preference for either DA treatment or surgery, are considered for participation in PRolaCT-O.
Comparative Effects of Core Stability Versus Hoping Exercises on Trunk Stability Among Kabaddi Athletes

comparative effects of core versus hoping exercises on trunk stability and balance among kabaddi athlets

Comparative effects of core stability exercises versus hopping exercises on trunk stability and balance among kabaddi athletes

Eligibility Criteria:
Inclusion Criteria:

* Males
* Aged 18-35 years
* Active players training for at least from 6 weeks
* Normal BMI (18.5-24.9 kg/m2)

Exclusion Criteria:

* Any acute inflammatory conditions of the back, spinal fractures, and systemic conditions affecting muscle performance,
* Spinal instability or any musculoskeletal, cardiac issue
* Presence of neurological deficits: history of seizure, headache, spinal cord injury
Urine VOC Investigation in Bladder Cancer Diagnosis

The goal of this study to investigate the volatile organic compounds (VOCs) in the urine samples of both healthy individual and bladder cancer patients, using gas chromatography - mass spectrometry. Researchers aim to find a set of certain VOCs specific to bladder cancer and use this set to construct a diagnostic model that can help diagnosing bladder cancer. Participants will be asked to collect their early morning midstream urine in a predesignated container. Researchers will compare urine VOCs from bladder cancer patients and healthy individuals to see if there is any VOC whose concentration differ significantly among the two groups.

Specifically, participants will be asked to collect 35-45 ml of their early morning midstream urine sample in a predesignated polytetrafluoroethylene bottle. Researcher will collect participants' health information, including their: 1)smoking history; 2)comorbidity; 3) history of past urological procedure; 4)medication; 5)pathology diagnosis after surgery, if participants have bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* bladder tumor confirmed by cystoscopy and radiology
* women of childbearing age with negative urine pregnancy test result
* willing to participate in this trial and sign the informed consent form

Exclusion Criteria:

* patient with 1) uncontrollable urinary tract infection; 2) severe systemic disease; 3) history of malignancy within the past 5 years; 4) pregnancy or lactation
* patient involved in other clinical trials
* other situations researcher considered to be ineligible for this trial
Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults.

The hypothesis is that seafood proteins given in combination with carbohydrates with low GI are superior to seafood proteins in combination with carbohydrates with high GI and meat in combination with both carbohydrates with low and high GI in promoting energy expenditure and satiety. The overall objective of this study is to investigate the acute effects of meals containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Between 18 and 50 years of age
* BMI between 25.0 and 30.0 kg×m-2
* Fasting blood glucose \< 5.9 mmol/L (measured at the screenings visit)
* Non-smoker

Exclusion Criteria:

* Self-reported eating disorders or irregular eating schedule (e.g. skipping breakfast)
* Chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders)
* Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.
* Women who are pregnant, breast-feeding or have intention of becoming pregnant during the study period
* Menopausal women and women with an irregular menstrual cycle
* Food allergies
* Substance abuse
* Vigorous physical activity more than 10 hours/week
* Alcohol intake above the recommendations from the Danish Health and Medicines Authority
* Caffeine intake above 300 mg/day
* Night- or shift work
* Blood donation \<1 month before study commencement and during study period
* Simultaneous participation in other clinical studies
* Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
* Subject's general condition contraindicates continuing the study, as judged by the study personnel or the medical expert
Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease

This is a feasibility and exploratory study consisting of two parts: first, a cross-sectional (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived neurotrophic factor (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in patients diagnosed with Parkinson's Disease (PD) vs. healthy controls matched by age. Second, a prospective, randomized, double blind trial of Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy System (TMS) (real or Sham) and aerobic exercise. This exploratory feasibility study will look at BDNF-TrkB signaling and cortical plasticity.

Twenty-four PD patients (n=24) will be randomly assigned to receive one of two interventions for a duration of two weeks. In Group 1, subjects will participate in daily sessions of sham-rTMS followed by supervised aerobic exercise (Sham rTMS+Aerobic); in Group 2, subjects will participate in a combination of rTMS and supervised aerobic exercise (Real rTMS+Aerobic). Serum BDNF-TrkB signaling in lymphocytes and TMS-based electrophysiological measures of LTP-like plasticity will be measured. A comparison of such measures in a group of patients with PD and in a group of age-matched controls (n=12) will be analyzed to establish the effect of the disease on indices of plasticity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD according to the UK Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders;
* Hoehn and Yahr stage II to III;
* On a stable medication regimen since at least 2 weeks prior the enrolment in the study and, in the view of the treating neurologist, unlikely to require medication adjustments in the following 3-6 months.

Inclusion Criteria (Healthy Controls)

* Male or Female; aged 35-85

Exclusion Criteria (Healthy Controls)

* History of seizure disorder, including febrile seizures;
* Neurological disorder including PD, stroke, traumatic brain injury, fainting spells or syncope of unknown cause(s);
* Major or unstable medical illness;
* Pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed);
* Untreated depression, or score of \>20 on Beck Depression Inventory II;
* Taking any of the following medications within the six weeks prior to the start of the study: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, theophylline, calcium channel blockers, beta blockers, tadalafil, vardenafil, avanafil, and sildenafil;
* Diagnosis of dementia, or Montreal Cognitive Assessment (MoCA) \<20;
* Any clinically significant abnormality on vital signs
* Cardiopulmonary limitations: untreated high blood pressure, history of heart insufficiency (class II-III), coronary vascular disease, angina, arrhythmia, dyspnea on exertion and asthma
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic HCV-infected males and non-pregnant/non-lactating females
* Treatment-naïve or treatment-experienced individuals
* Compensated cirrhosis at Screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients

Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.

Blood flow restriction (BFR) therapy is one such therapeutic tool that has received increasing attention, which involves application of a pressurized tourniquet to the injured limb during rehabilitation that limits atrophy when performing strength training with weight that otherwise would not produce enough of a contraction to prevent muscular atrophy. To date, several studies have been performed on BFR therapy, however, the effect of therapy on ligamentous and tendinous injury in the upper extremity remain unclear as most studies have focused on muscular strengthening in healthy individuals and on lower extremity injuries distal to the tourniquet.

Eligibility Criteria:
Inclusion Criteria:

* injured patient with clinical and magnetic resonance imaging (MRI) consistent with a formal diagnosis of non-operative rotator cuff and/or biceps tendinopathy
* no prior upper extremity ipsilateral procedures or history of deep vein thrombosis
* those willing to be part of the study

Exclusion Criteria:

* patients younger than 18 or older than 55 years of age
* a history of revision surgery or prior ipsilateral upper extremity surgery
* concomitant ligamentous, tendinous, or cartilage injury that would alter postoperative rehabilitation protocol
* inability to comply with the proposed follow-up clinic visits
* patients lacking decisional capacity
JUMP_START - Optimization of Care for Young Cancer Patients with Gastrointestinal Tumors

JUMP_START aims to assess the needs of individuals aged ≤ 50 years with gastrointestinal (GI) tumors and implement a tailored support and counseling program at the University Hospital Heidelberg and the National Center for Tumor Diseases (NCT).

In phase 1A, 12-15 individuals aged ≤ 50 years with GI tumors will be interviewed via telephone using semi-structured interviews to obstain a detailed understanding of the life situation, the burdens, and the care situation within the structures of the NCT Heidelberg.

In phase 1B, the care networks of young patients with GI tumors beyond the NCT, including the analysis of changes and important access routes/possible gatekeepers, will be explored using so-called ego-centered network analyses, in comparison with patients who received a GI tumor diagnosis after the age of 50.

In response to the results of phase 1A and 1B, the care services for young patients with GI tumors will be optimized, and tailored counseling programs will be developed in phase 2.

These project phases will be accompanied by Quality of Life assessments using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires. All patients with GI tumors (regardless of potential inclusion in phase 1A or 1B) will receive the EORTC questionnaires once. In phase 2, Quality of Life will be assessed every 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged ≥ 18 and ≤ 50 years receiving treatment for a GI tumor at the Heidelberg University Hospital
* Sufficient knowledge of the German language
* Capable of providing informed consent
* Additional recruitment for Phase 1B and Quality of Life assessments: Patients with GI tumor aged ≥ 51 years

Exclusion Criteria:

* Individuals with a GI tumor diagnosis after the age of 50 (except in Phase 1B and for Quality of Life assessments)
* Individuals with a GI tumor diagnosis under the age of 18
* Lack of capacity to consent and/or absence of informed consent
* Insufficient knowledge of the German language
* Severe cognitive impairments