cyrilzakka/clinical-trials huggingface dataset:
Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass

Using intravenous and oral administration of stable isotope tracers, we will investigate the importance of altered fat absorption and altered whole body fat metabolism for the reduced postprandial systemic TAG concentrations in non-diabetic patients in weight stable phase after RYGB.


Eligibility Criteria:
Inclusion criteria, RYGB

* Age \> 18 years
* RYGB \> 12 months prior to inclusion
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion

Inclusion criteria, CON

* Age \> 18 years
* No former bariatric surgery
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol, fasting plasma glucose \< 6.1, and no history of diabetes

Exclusion criteria

* Thyrotoxicosis or inadequately treated hypothyreosis
* Haemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy (pregnancy test in fertile woman before enrolment) or breast feeding
* Medication affecting the planned examinations which cannot be paused during the study period.
* Adherence to extreme diets with excessively high or low contributions from certain macronutrients (e.g. ketogenic diet)
* Complications restricting eating behavior (e.g. postprandial hypoglycemia, vomiting or strictures)
* MR contraindications
Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression

The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.

SAMe is a substance that is naturally produced by the body and is also sold as an over-the-counter drug. Although SAMe has not yet been approved for treating depression, evidence suggests that it has antidepressant properties. This study will determine whether SAMe is safe and effective in treating major depression.

This study will last 24 weeks. Participants will be randomly assigned to receive either the antidepressant escitalopram, SAMe, or placebo for 12 weeks. Participants who respond to treatment at the end of 12 weeks will stay on their regimen for an additional 12 weeks. Participants who do not respond to treatment will enter an open treatment phase where they will receive SAMe and escitalopram for 12 more weeks. Depression scales and self-report questionnaires will be used to assess participants. All participants will receive 3 months of follow-up care, including free medication and clinic visits as necessary.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depression
* Score of 25 or higher on the Inventory of Depressive Symptomatology (IDS-C) scale
* Score of higher than 2 on the Clinical Global Impression Improvement (CGI) scale
* Willing to use acceptable methods of contraception

Exclusion Criteria:

* Suicidal or homicidal
* Unstable illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
* Any of the following mental conditions: organic mental disorders; schizophrenia; delusional disorder; psychotic disorders; bipolar disorder; recent bereavement; severe borderline or antisocial personality disorder; panic disorder; or obsessive compulsive disorder
* Substance abuse, including alcohol abuse, within 6 months prior to study entry
* Uncontrolled seizure disorder, or a seizure disorder controlled with psychotropic anticonvulsants
* Psychotic features
* Current use of other psychotropic drugs
* Hypothyroidism
* Have taken 6 weeks or more of either escitalopram or SAMe during the current depressive episode
* Previous intolerance of SAMe or escitalopram
* Investigational psychotropic drugs within 1 year prior to study entry
* Have received two or more antidepressant therapies of adequate doses and duration and failed to respond
* Have received depression-focused psychotherapy
* Bleeding tissue disorder, low platelet counts, a history of GI bleeding, or use of medications that alter bleeding risk
* Long-term aspirin use
* Pregnancy
Catheter System Feasibility Clinical Trial

Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.


Eligibility Criteria:
Inclusion Criteria:

* Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment
* Patients diagnosed with chronic kidney disease classification stage IV or V
* Adequate quality vein \>= 2 mm with confirmed clinically significant outflow based on pre-operative assessment
* Adequate quality radial artery \>= 2 mm based on pre-operative assessment
* Adequate collateral arterial perfusion
* Radial artery-adjacent vein proximity \< = 1.5 mm
* Able to provide informed consent
* Able to travel to institution for follow up examination
* Able to intraoperatively place an .014" guidewire in artery

Exclusion Criteria:

* Suspected skin disease
* Immunocompromised patients (e.g. HIV positive)
* Edema of extremities
* Current diagnosis of carcinoma
* Pregnancy or currently breast feeding
* Diagnosed hypercoaguable state
* Active infection
* Evidence of vascular disease at target site
* Pre-existing vascular disease that could confound study results
* Vessel tortuosity or spasm preventing placement of .014" guidewire
Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease

Randomized placebo-controlled double-blinded interventional trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will reduce vascular calcification in subjects with chronic kidney disease while not decreasing bone mineral density.

Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. Epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in CKD by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and by increasing activity of intracellular anti-calcification enzymes in VSMC. However, there have been concerns that any anti-calcification effect of magnesium might also reduce bone mineral density, in which case there might be an increased risk of bone fractures associated with magnesium supplementation in CKD. We wish to conduct a randomized placebo-controlled double-blinded interventional trial to examine whether oral magnesium supplementation will reduce vascular calcification in subjects with CKD while not decreasing bone mineral density.

Eligibility Criteria:
Inclusion Criteria:

* Estimated glomerular filtration rate between 45 and 15 mL/min for \> 3 months (i.e. CKD stage 3b-4).
* Serum total magnesium \< 0,82 mmol/L and serum phosphate \> 1,15 mmol/L on average of previous measurements.

or Serum total magnesium \< 0,92 mmol/L and serum phosphate \> 1,30 mmol/L on average of previous measurements.

* Life expectancy \> 1 year.
* Expected time until initiation of dialysis or transplantation \> 1 year.
* Women of childbearing age must be actively using contraceptive therapy (p-pills, estrogen depots or intrauterine device) as well as have a negative pregnancy test.
* Written informed consent.

Exclusion Criteria:

* Current hemodialysis or peritoneal dialysis treatment.
* Kidney donor recipient.
* Previous coronary artery bypass graft (CABG).
* Parathyroid hormone \> 600 ρmol/L.
* Previous parathyroidectomy.
* Current treatment with magnesium containing medication or supplements.
* Any condition impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis).
* Active malignancy (basal or squamous cell skin carcinoma, localized prostate cancer and cancer with no signs of reoccurrence after 5 years are exempt from this).
* Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of trial.
* Pregnancy or breastfeeding.
* Allergy towards contents of interventional medication.
* Participation in other interventional trials.
A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.


Eligibility Criteria:
Key Inclusion Criteria:

* Has a confirmed diagnosis of RRMS
* Neurologically stable with no evidence of relapse within 30 days prior to Visit 2

Exclusion Criteria:

* Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
* Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
* History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical trial
* History of a myocardial infarction, including a silent myocardial infarction identified on ECG, or unstable angina

NOTE: Other protocol defined Includison/Exclusion criteria may apply.
The Effects of a Brief Mindfulness Intervention on Emotional Responses and the Moderating Role of Interoception

This study examines the effects of a brief mindfulness intervention (body scan) on emotional responses (e.g., affect, heart rate variability (HRV)) compared to an active control group. Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception on the mindfulness intervention's effects will also be examined.

This 3-armed study examines the effects of a brief mindfulness intervention (audio-guided body scan) on emotional responses (e.g., affect, and heart rate variability (HRV)) compared to an active control group (listening to an audio-book). Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception (i.e., interoceptive accuracy as assessed by the Schandry task) on the mindfulness intervention's effects will also be examined.

Eligibility Criteria:
Inclusion Criteria:

* fluent in the German language
* ability to give informed consent

Exclusion Criteria:

* cardiovascular disease (previous myocardial infarction, hypertension)
* neurological disorders (epilepsy, stroke, multiple sclerosis)
* continuous medication intake (exceptions: contraceptives, nutritional supplements, L-thyroxine for hypothyroidism are allowed)
* pregnancy
The Incidence of Thoracic Disc Herniation in Patients Presenting With Chronic Upper Back Pain

Patients who applied to the Private Medar Hospital between February 2016 and February 2021 with chronic upper back pain and were diagnosed with Thoaracic Disc Herniatin (TDH) (with Thoracic vertebral MRI) and followed up for at least 1 year will be included in the study.

Patients diagnosed with TDH were included in the medical treatment and/or physical therapy program.

Before and after these treatment programs, the pain intensity of the patients was recorded with the visual analog scale (VAS).

The number of patients who applied to the Physical Medicine and Rehabilitation outpatient clinic with chronic upper back pain between February 2016 and February 2021 will be researched, and the demographic characteristics of those diagnosed with TDH will be selected and recorded in their files, their pre- and post-treatment VAS scores, and the results will be analyzed statistically.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* admitted to the Private Medar Hospital Gölcük hospital between February 2016 and February 2021 with chronic upper back pain.
* Diagnosed with TDH as a result of thoracic vertebral MRI

Exclusion Criteria:Patients with

* vertebral fracture,
* developmental spinal deformity,
* spinal infection or tumor,
* chronic widespread pain syndrome such as fibromyalgia,
* diabetes mellitus,
* polyneuropathy
* rheumatological disease
* under 18 years old
* over 65 years old
* who have had previous back and neck surgery
Comparison of the Analgesic Efficacy and Duration of Analgesic Effect of Pericapsular Nerve Group Block Block Application With PENG Block and Pulse Radiofrequency Ablation in Chronic Hip Pain

Comparison of the analgesic efficacy and duration of analgesic effect of PENG block application with PENG block and pulse radiofrequency ablation in chronic hip pain.

Patients with chronic hip pain will be divided into two groups, and after providing the necessary information, informed consent forms will be obtained for inclusion in the study from both groups. The 'Verbal Numerical Rating Scale (vNRS)' will be assessed before the procedure. Patients to undergo PENG block and PENG block with pulse radiofrequency ablation will be monitored prior to the procedure. After the procedure, they will be monitored for 3 hours under observation. At the third hour after the procedure, before leaving the operating room, and at the 1st and 3rd months, patients will be contacted by phone, and the 'Verbal Numerical Rating Scale (vNRS)' will be evaluated. This will allow the comparison of the effects of PENG block and PENG block with pulse radiofrequency ablation on pain management in chronic hip pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hip pain Aged 18-80 ASA I-III patients

Exclusion Criteria:

* Patients with allergies to the medications used, severe cardiac, renal, pulmonary, liver, and endocrine diseases, patients with uncontrolled blood sugar levels (diabetes mellitus), patients who have used anticoagulant medications in the last five days, patients with bleeding or clotting disorders, those with implanted medical devices such as pacemakers and defibrillators, patients with infections at the procedure site, patients with psychiatric disorders or communication difficulties, patients with missing data, and patients who do not wish to undergo regional block are defined as exclusion criteria.
Metabolism Associated With Abdominal Fat Mass Distribution

Objectives:

The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat).

No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.


Eligibility Criteria:
Inclusion Criteria:

* BMI 29-40 kg/m2
* Aged 25-45

Exclusion Criteria:

* Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease, metabolic syndrome
* Pregnancy
* Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study.
* Any therapy (contraception apart) within the run-in period of one week before the test day.
* Subject who cannot be expected to comply with treatments and measures.
* Subject who is affected by any specific eating disorder
* Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
* Subjects having recently undergone a weight loss of more than 3 kilos during the last 3 months
Glycaemic and Insulinaemic Responses After Consumption of FOS.

The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 25.0 kg/m² (included);
* Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit;
* Be used to have breakfast;
* Non-smoker for at least 3 months;
* For the female participant: not being pregnant or breastfeeding and using efficient birth control;
* Signed the consent form;
* Able to follow the instructions of the study;
* Health insured;
* Accepted to be included in the National Registry for biomedical research Volunteers (Fichier VRB, Volontaires Recherches Biomédicales).

Exclusion Criteria:

* Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not);
* Fasting blood cholesterol over 6.35 mmol/L;
* Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma);
* Fasting blood insulin under 20 mU/L;
* Fasting HbA1c under 7%;
* History of hypercholesterolemia, hypertension, diabetes or glucose intolerance treated or not;
* History of dietary allergies or coeliac disease;
* History of digestive system disease susceptible to modify digestion or absorption like Crohn's disease;
* Somatic or psychiatric disorders;
* Renal insufficiency (kidney failure);
* SGOT or ALAT over 52.5 U/L;
* Smoker;
* Consuming more than 3 alcoholic beverage a day;
* Weight varied 3 kg the last 3 months.
A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing

The purpose of this study is to evaluate the short-term efficacy and safety of Fluoxetine in Japanese adult participants with Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Outpatient Japanese participants diagnosed with MDD
* Diagnosis of moderate or greater severity of MDD
* Agree to abstain from sexual activity or to use a reliable method of birth control
* Judged to be reliable (agree to keep appointments for clinic visits and to undergo all tests and examinations required by the protocol)

Exclusion Criteria:

* Have previously been exposed to fluoxetine (LY110140) for any indication in the past
* Significant suicidal risk
* Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder
* Have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine
* Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks
* Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year
* Have had treatment with a Monoamine oxidase inhibitor (MAOI) within 14 days
* Need to use thioridazine or pimozide during the study
* Have previously enrolled, completed, or withdrawn from this study
* Have a positive urine drug screen for drugs with abuse potential
* Female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant
* Have a history of seizure disorder
* Have frequent or severe allergic reactions to multiple medications
* Have a serious or unstable medical illness or condition, or psychological condition
* Participants deemed ineligible by the investigator or sub-investigator for other reasons
Topical Gel Anti-Fungal Agent for Tinea Unguium

The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis).

The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety.

Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of distal subungual tinuea unguium of one great toenail.
* between 20 - 65% infected area for target nail
* 2 mm of clear nail proximally on target nail
* positive dermatophyte culture and positive KOH test
* able to sign informed consent
* understand requirements of study
* females must be post-menopausal or agree to use approved contraceptives throughout the study

Exclusion Criteria:

* patients with nails infected with organisms other than dermatophytes
* patients with proximal subungual tinea unguium
* patients with spikes of disease extending to nail matrix
* patients with more than 5 infected nails
* patients with confounding problems/ abnormalities of target nail
* patients with screening lab values more than 20% of normal
* patients with known hypersensitivity to test material components
* patients requiring systemic medications that may interfere with study
* patients with a poor history of compliance with study requirements
Negative Pressure Wound Therapy in Groin Dissection

This study investigates the use of a negative pressure wound therapy device (PICO™, Smith \& Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.

Patients may develop inguinal lymph node metastases from a variety of cutaneous neoplasms. A number of factors conspire to cause a high rate of wound breakdown and other complications in this patient group. Reported rates of wound healing complications vary in the literature, but tend to affect \> 40% of patients.

A new negative pressure wound therapy device is recommended for use in clean, closed surgical wounds (PICO™ system, Smith \& Nephew Healthcare, UK). Patients will be randomised to receive either PICO™ system for up to seven days, or conventional dressings, and then assessed for wound healing and other outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin

Exclusion Criteria:

* inability to give informed consent for participation
Active Versus Non Active Drainage for the Treatment of Infected Intra-abdominal Collection

The Percutaneous drainage of symptomatic intra-abdominal collection (primary or secondary to surgery)is the treatment of choice in the absence of peritonitis signs. In critically ill patients, this procedure allows to avoid or postpone surgery. In these settings, the percutaneous drain can be either in Active Vacuum Pressure or in Free drainage. However, no prospective trials has assessed the efficiency of these two modalities of drainage in cases of infected intra-abdominal collections. The investigators aimed then to prospectively analyzed the efficiency (in term of infectious control) of drainage under active vacuum pressure vs. free drainage for the treatment of infected intra-abdominal collections.


Eligibility Criteria:
Inclusion Criteria:

* Infected intra-abdominal collection requiring a percutaneous drainage after surgery or due to a primary intra-abdominal infectious disease (e.g. diverticulitis, appendicitis)
* age over 18 years old
* intra-abdominal collections \>5 cm in diameter with signs of infections on imaging

Exclusion Criteria:

* pregnancy
* age\< 18 years
* signs of peritonitis
* Intensive care unit patients