cyrilzakka/clinical-trials huggingface dataset:
Popliteal Plexus Block for Total Knee Arthroplasty

This study aims to assess the analgesic effect of the popliteal plexus block as a supplement to a femoral triangle block in patients undergoing total knee arthroplasty

A femoral triangle block (FTB) effectively anesthetizes the anterior group of nerves innervating the knee (infrapatellar branch of the saphenous nerve, the medial femoral cutaneous nerve and the terminal branch of the medial vastus muscle nerve). However, the posterior group of nerves innervating the knee joint is not covered with an FTB, and therefore most patients complain of significant, opioid-requiring pain despite a successful FTB.

The posterior group consists of the popliteal plexus, which is derived from the tibial nerve and the posterior branch of the obturator nerve. The popliteal plexus is located in the popliteal fossa, where it entwines the popliteal artery and vein. Recent cadaver studies have suggested that an injection into the distal part of the adductor canal will spread to the popliteal fossa (PubMed Identifier (ID): 28937534; PubMed ID: 27442773).

This study aims to assess the analgesic effect of the popliteal plexus block (PPB) as a supplement to a femoral triangle block (FTB) after total knee arthroplasty (TKA).

In the study all patients will receive an FTB with 10 ml bupivacaine-epinephrine (0.5%-1:200,000) with the addition of 0.5 ml Dexamethasone (4 mg/ml).

All patients are postoperatively observed for the development of significant pain (NRS \> 3) in the primary observation period (POP) defined as: a 3-hour observation period starting at the return of completely normal cutaneous sensation (lateral thigh and lateral side of the lower leg) after spinal anesthesia. If the patient reports pain (NRS \> 3) in the POP, the patient will be randomized to the study treatment - a PPB with 10 ml bupivacaine-epinephrine or 10 ml saline.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 50 years of age at screening
* Scheduled to undergo primary total knee arthroplasty in spinal anesthesia
* Normal sensory function at the lateral part of the thigh and lower leg
* American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
* Able to provide informed consent

Exclusion Criteria:

* Unable to cooperate and follow the study protocol
* Communication problems
* Allergic towards any medical product administered in the study
* Diabetes requiring medical treatment
* Pregnancy (a pregnancy test will be conducted on all women of childbearing potential prior to inclusion in the study. A positive test result will result in exclusion from the study)
* Preoperative opioid treatment (dosed \> once daily)
Assessment of Small Intestinal Bowel Epithelial Gaps in Irritable Bowel Syndrome

The study aims to:

1. Determine whether the density of epithelial gaps in terminal ileum of patients with irritable bowel syndrome (IBS) is different from that in inflammatory bowel disease (IBD) patients and normal controls by confocal laser endomicroscopy (CLE).
2. Evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.

Epithelial cells lining the gastrointestinal tract serve as a barrier between the gut lumen and the body. Previous study has shown that epithelium is punctuated by discontinuities named "gaps". Confocal laser endomicroscopy could be used as a useful tool for detecting epithelial gaps in vivo, and epithelial gap density in terminal ileum of IBD patients was elevated compared with normal control using CLE. So this study aims to determine whether the density of epithelial gaps in terminal ileum of patients with IBS is different from that in IBD patients and normal controls by CLE, and to evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Bowel habits alterations meeting IBS Rome III criteria and indications for colonoscopy investigation
* Patients with history of inflammatory bowel disease
* Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
* Patients complained of hemafecia but colonoscopy revealed only haemorrhoid

Exclusion Criteria:

* Patients with known cancers or abdominal surgery
* Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
* Patients who are unwilling to sign or give the informed consent form
* Patients who are allergic to fluorescein sodium
* Patients with impaired cardiac, liver or renal function
* Patients with coagulopathy
* Patients with pregnancy or breastfeeding
Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure

Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions (belly area cuts), by using an endoscope to create a small cut at the most inner layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of the esophagus. The investigators are studying whether subjects who undergo Endoscopic Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar formation and wound infection than with laparoscopic or open surgery.

The purpose of this research study is to find out more about a less invasive way of doing the surgical procedure (esophageal myotomy) to treat Achalasia.

Achalasia is a disease of the esophagus, where the lower esophageal sphincter fails to relax, causing difficulty in swallowing.

Esophageal myotomy (Heller myotomy) is surgically cutting the muscle fibers of the esophageal sphincter to allow passage of food into the stomach.

Esophageal myotomy is routinely done either by laparoscopic or open surgery. Laparoscopic surgery requires several (about 4 to 5) small incisions in the abdomen to allow the camera and surgical instruments to be introduced into the abdominal cavity to perform the myotomy. In open surgery, a 6- to 8-inch abdominal incision is made to gain access to the abdominal cavity to perform the myotomy.

Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions.

The researchers are investigating how safe Endoscopic Esophageal Myotomy is and how well it works. Additionally, the researchers will assess the level of pain and the amount of scarring subjects has after this surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of achalasia
* Age 18-65
* ASA class 1-2

Exclusion Criteria:

* Pregnant women
* Any prior surgical or endoscopic treatment for achalasia except dilation less than 20 mm
* Patients who are taking immunosuppressive medications or are immunocompromised Patients on blood thinners or aspirin or with history of bleeding disorders
* ASA class III patients
Thromboelastometry Guided DIC Prevention After Cesarean Section in Pregnant Women With Placenta Previa

Evaluation of the use of thromboelastometry for early identification of the underlying coagulopathy and to guide individualized transfusion therapy to prevent DIC development during ICU stay after cesarean section in women with placenta previa who require a massive blood transfusion.

Placenta previa is defined as complete or partial implantation of the placenta in the lower segment of the uterus, Patients present with bleeding per vagina occurring usually in the second and third trimester. Bleeding in placenta previa is associated with maternal morbidity and mortality. Transfusion therapy is integral in the acute management of major obstetric hemorrhage. The most important pregnancy related condition leading to bleeding with high mortality and morbidity rates is DIC. Patients exhibit a tendency for severe bleeding associated with the consumption of platelets and coagulation factors. Massive blood transfusions are listed as the main maternal morbidity indicators6.Therefore, early detection of these predictors of DIC and timely intervention of this life-threatening condition is very important. DIC is a clinical-laboratory diagnosis, and laboratory changes need to be interpreted with knowledge of the patient's underlying disorder. Several laboratory parameters are analyzed together as part of a diagnostic algorithm that includes: Prothrombin time (PT), Activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level, and a marker of fibrin degradation, e.g., D-dimer or the soluble fibrin monomer (SFM) 8. None of these markers are taken in isolation, and a combination of results at different time points is particularly helpful in determining the presence of DIC, owing to the multifaceted nature of DIC9, These reasons highlight a strong need for the development of a point-of-care testing system to accurately and reliably diagnose DIC. Thromboelastography (TEM) provides an extended reflection of clot initiation, propagation, and lysis in whole blood. TEM uses three tests: FIBTEM to reveal impaired fibrinogen function, INTEM to reveal coagulation factor deficiency and EXTEM to reveal extrinsic pathway defects

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II
* Age: ≥ 18 years
* Patients with all types of placenta previa
* Eligible for general anesthesia
* Elective cesarean section
* Singleton term pregnancy
* Normal coagulation profile: prothrombin time (PT), activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level

Exclusion Criteria:

* Parturient refusal
* Known coagulopathy
* Women with a history of cardiac, respiratory, renal, neurologic or endocrine diseases.
* Eclampsia and preeclampsia
* Emergency surgeries
* Foetal abnormalities
* Drug induced thrombocytopenia as antibiotics
Effectiveness of Brief Counseling for Weight Management

The purpose of this study is to test the effectiveness of three different methods for delivering weight management information. Two methods utilize an obesity drug and the third method utilizes brief behavioral counseling sessions only.

There is a growing demand for effective obesity treatments that don't require much time to implement especially in a primary health-care setting where time is especially limited. Brief interventions that might provide benefits similar to those produced by more time-intensive and costly lifestyle interventions would be very useful. There is also increasing interest in the efficacy of primary drug therapies for obesity. The purpose of this 12-month study, and 24-month follow-up, is to examine the efficacy of a brief behavioral counseling intervention alone or in combination with a drug already approved for the long-term management of obesity (orlisat)and compare both interventions to a drug alone condition.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index of 30 to 40
* Male or females ages of 25 to 55 years
* Normal blood pressure or controlled with medicine
* Females not lactating, able to get pregnant or using acceptable birth control
* Current allowed medications prescribed at least 2 months prior to study

Exclusion Criteria:

* Pregnant, planning to get pregnant or becomes pregnant
* Insulin dependent diabetes
* Uncontrolled hypertension
* Prescence or history of significant medical conditions that could impact the outcome of the study
* Prescence of active gastrointestinal disorders
* History of mental disorders including eating disorders
* Weight loss greater than 10 pounds in the last 3 months
* History of alcohol or drug dependency
* Use of any weight-loss medication in the last 6 months
* Known allery to orlistat or any of its components
Vortioxetine vs Sertraline in Mexicans

Depression in patients with type 2 diabetes is often undiagnosed and remains untreated, leading to poor therapy adherence and ill health-related outcomes. The aim of study was evaluated the effect of vortioxetine versus sertraline in the treatment of depression, diabetes-related distress and control metabolic in subjects with type 2 diabetes and depression. was included patients who were glycosylated hemoglobin ≥ 7.5%, 18 to 60 years of age and written consent . Pharmacological treatment for depression was assigned randomly: vortioxetine (10 mg/day) or sertraline (75 mg/day) for 8 weeks. Biochemical parameters, anthropometric measures and depression symptoms were evaluated before and at the and at the 8 weeks after antidepressant treatment.

The assessment consisted of an extended face-to-face interview. The patients answered a structured questionnaire used to collect: sociodemographic characteristics (gender, age, education, occupation and marital status) and clinical data (pharmacotherapy, habits, consumed of drugs, diabetes complications and comorbidities). Depression was screened using Hamilton Depression Rating Scale score ≥ 14 (HAM-D), Center for epidemiologic studies depression scale revised in Spanish (CES-DR35), and Problem Areas in Diabetes Questionnaire (PAID-V); anthropometrics measurements were evaluated (weight, waist circumference and body mass index). Besides, blood samples were drawn for the following biochemical parameters: fasting plasma glucose, glycated hemoglobin (HbA1c), cholesterol and triglycerides. Patients who gave informed consent and convened inclusion criteria were attended by a psychiatrist. The pharmacological management were randomly assigned: vortioxetine (10 mg/day) or sertraline (75 mg/day) for 8 weeks, in addition, the patients maintained their established anti-diabetic treatment (oral hypoglycemic or insulin). The study ended at the 8th week, subjects were attended by psychiatrist and blood samples were drawn for evaluated biochemical parameters and the structured questionnaire previously described was applicated.The clinical measures and biochemical parameters were done baseline and after 8-week pharmacological treatment. Finally the effect of both antidepressants were compared.

Eligibility Criteria:
Inclusion Criteria:

* Individuals had to be between 18 and 85 years of age
* Clinical diagnosis of type 2 diabetes mellitus based on the American Diabetes Association criteria,
* They had to receive anti-diabetic treatment, Clinical diagnosis of major depressive episode according Association Diagnostic and Statistical Manual of Mental Disorders, five edition (DSM-V)
* Ratings scale score ≥ 14 by means of Hamilton Depression scale (HAM-D)
* Patients had to give verbal and written informed consent for this study

Exclusion Criteria:

* Neurological illness
* Psychoactive medications
* Type I diabetes
* Active suicidal ideation.
Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

To investigate in renal transplant recipients the potential drug intreaction between Sirolimus, Mycophenolt Mofetil and Fluvastatin

All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks before startin the study were included


Eligibility Criteria:
Inclusion Criteria:

* renal transplant patients (18 - 65 years, inclusive)
* cadaver and living renal transplants(1. Ntx, 2. Ntx)
* Immunsuppression: sirolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months
* writen informt consent by the patient

Exclusion Criteria:

* contraindications for statins
* pregnancy or lactating
* elevated liver or muscle encymes (\> 2x up to normal values: AST, ALT, bilirubine, CPK)
Effects Of Global Postural Re-Education (GPR) On Patients With Non-Specific Neck Pain.

Pain is an "unpleasant sensory and emotional experience (associated with actual or potential tissue damage". Chronic pain is a sensation of hyperalgia to muscles, ligaments and skin on both active and passive movements. Chronic pain has a tendency to prevent people from working and exercising

Neck pain is a very common clinical condition which equals the economic, social cost and level of disability to that of low back pain.Mechanical neck pain that occurs without an identifiable underlying disease and anatomical abnormality is termed as "non-specific" neck pain (NS-NP).Mechanical neck pain commonly arises insidiously and is generally multifactorial in origin.Two most common complains associated with chronic specific and non-specific neck pain are Kinesiophobia (fear of movement) and Postural asymmetry (forward head posture). Medical, surgical and physical therapy treatments are recommended for addressing chronic non-specific neck pain. Within the scope of physical therapy conventional management consist of many different techniques such as therapeutic exercises, electrotherapy, Pilates, yoga and manual therapy. Manual therapy is among the most common used method for treating musculoskeletal conditions including chronic neck pain. Manual therapy consists of stretching techniques, joint mobilization/manipulation, isometric/dynamic strengthening exercises and fascial manipulation or release. Global Postural Re-education (GPR) is an alternative therapeutic strategy based on the concept that postural muscles are organized in the form of 'muscle chains' located on the anterior and posterior aspect of the spine. It involves the global stretching of the anti-gravitational muscles and the kinetic muscle chains.

Eligibility Criteria:
Inclusion Criteria:

* Chronic non-specific neck pain ≥ 3 months.
* No prior medication and Physical Therapy interventions from last 3 months.
* Pain: moderate level (6 on NPRS).

Exclusion Criteria:

* History of any trauma .
* History of any psychological condition.
* Specific causes of Neck Pain (e.g., systemic, rheumatic, neuromuscular diseases).
* Presence of central and peripheral neurological sign.
* Spinal surgery
Multi- Level and Integrated Analysis of Mechanisms Underlying Atrial Dysfunction

Integrated and cross-disciplinary analysis of human physiology and disease provides unbiased and deeply informative insights into human health and disease. In this study the investigators will recruit patients undergoing coronary artery bypass surgery to study the atrium of the heart or the aortic wall that when diseased can cause strokes.

Hypothesis: Systems-level analysis of the left atrium and aorta cells that integrates imaging, histological, cellular and molecular data will identify new mechanism for cardiovascular form and function.

While there are many sub-aims to this study, the overarching goal is to define molecular mechanisms underlying atrial dysfunction. Here the investigator provide a power calculation based on detecting the genetic control points of gene expression (eQTLs) in the human atrial fibroblast. The investigator and many others have shown that tissue-specific eQTLs can be robustly identified at genome-wide significance in segregating populations of \~200. In this study the investigator propose eQTL association analysis in humans, which have previously been successfully performed in cohorts of less than 1000 subjects. The general applicability of this approach has been validated in multiple studies across multiple tissues in cohorts of between 200-1000 subjects.Based on published imaging genetic studies that have been successfully applied in small cohorts (\<500) and the success of echo-based, semi-quantitative studies of ventricular dimensions, the investigator are confident that our quantitative studies of 750 individuals are powered to detect genome wide significant loci for the traits under study.

Despite intensive research there is a critical gap in our knowledge in the mechanisms underlying atrial fibrillation, which is a major cause of stroke and heart failure and increasingly common as it is a disease of the elderly. This project will address this important gap in our knowledge and provide new insights into disease pathogenesis with the goal of stratifying participants to prevent strokes and for treating the underlying substrate.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cardiac bypass surgery during which a sample of right atrial appendage and/or aortic button can be removed.

Exclusion Criteria:

* Infection within 2 weeks preceding the operation or immunosuppressive therapy.
* Patients not able or willing to consent for study.
* Previous atrial intervention.
* Patients who cannot be followed up.
* Exclude patients with significant valvular disease (any planned valvular surgery, MR \> severe, AS \> severe, TR \> severe).
Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device

The principal aim of this study is to evaluate the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis.

The device SENSIUM is a tool to monitor vital signs (respiratory rate, heart rate and temperature) by applying a connected skin patch in order to detect complications early.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. ASA score 1-3
3. Colonic or rectal resection with anastomosis
4. Minimally invasive surgery
5. Patient living close to the hospital (\<1 hour drive)
6. Patient accompanied for 48 hours
7. Body Mass Index \< 40
8. Patient information and signature of consent
9. Patient affiliated to a social insurance plan
10. A pregnancy test must be performed before inclusion in women of childbearing age.

Non-inclusion Criteria:

1. Socially isolated patient and/or no 3G cell signal
2. Severe comorbidities defined as any of these characteristics:

   1. Severe malnutrition (albumin \<30g/l)
   2. Severe anemia \< 80 g/dl
   3. Insulin-dependent diabetes type 1

   e. Patient under anticoagulation f. Severe renal insufficiency
3. History of psychiatric illness with medication requirements
4. Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection)
5. Patient not wishing to enter the study
6. Patient in a period of exclusion from another study or ongoing participation in an interventional study

Exclusion Criteria:

1. Stoma preparation
2. Per operative conversion to laparotomy
3. CHUNG score \> 8