cyrilzakka/clinical-trials huggingface dataset:
Enhanced Recovery After Hepatic Surgery (MultiPAS).

Enhanced rehabilitation programs are based on new therapies and treatment combinations to reduce the length of hospitalization, duration of postoperative convalescence, morbidity, but also the overall cost of care. The operating stress and hypercatabolic conditions surrounding the surgery are sources of complications. In this enhanced rehabilitation approach, the principle is to fight through a series of actions against this surgical stress. Several North American studies, Chinese, Scandinavian or Batavian have shown the feasibility and the interest of enhanced perioperative rehabilitation in liver surgery. Nevertheless, there is not until now French data concerning the assessment of enhanced rehabilitation in liver surgery. The main objective of the study is to compare the effectiveness of the implementation of a multimodal management program after liver surgery in a French university center compared to conventional care. Secondary objectives of the study are to compare an enhanced rehabilitation program in liver surgery versus conventional treatment in terms of morbidity and mortality in the immediate postoperative period and until day 90, length of hospital stay, blood loss and the delay to bowel mobility recovery. Compliance to the program in both groups will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patient to be operated on for hepatectomy in Universitary Hospital of Angers
* No emergency surgery
* No bilio-digestive anastomosis
* Body Mass Index between 18 and 40 kg/m2
* Preoperative morbidity status graded with the American Society of Anesthesiologists (ASA) between I to III
* Affiliated to the national health insurance

Exclusion Criteria:

* Pregnant woman
* Patient who doesn't speack french
* Colorectal surgery combined
* Postoperative stay predictable in critical care unit
* Patient under law protection
Patients With Interstitial Lung Disease

Prospective monocentric collection of data from adult patients with interstitial lung disease (ILD), to provide real-world data on current patient management at the ILD clinic.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Diagnosis of ILD, according to international guidelines.

Exclusion Criteria:

* Inability to give informed consent.
Uterotonics Using to Reduce Bleeding at Cesarean Section

Postpartum haemorrhage continues to be a leading cause of maternal morbidity and mortality worldwide and that is according to the estimates of the World Health Organization in 1998. Average blood loss during delivery progressively increases with the type of delivery, vaginal delivery (500 ml), cesarean section (1000 ml) and emergency hysterectomy (3500 ml) of blood.

A reduction of operative blood loss at cesarean section has a great benefit to the patients in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions. The routine use of oxytocin is associated with a significant reduction in the occurrence of postpartum hemorrhage.

Excessive blood loss as estimated by a 10% drop in the hematocrit value postdelivery or by need for blood transfusion, occurs in approximately 4% of vaginal deliveries and 6% of cesarean births.

Although many delivery units use oxytocin as the first line agent to prevent uterine atony at cesarean section, it may not be the ideal agent for prevention of postpartum haemorrhage especially in compromised patients with preeclampsia, cardiac disease or prolonged labor. Oxytocin and specifically its preservative chlorobutanol increases the heart rate and has negative inotropic, antiplatelet and antidiuretic effects.

Misoprostol, a prostaglandin E1 analogue, has been shown in many studies to be an effective myometrial stimulant of the pregnant uterus which binds to prostanoid receptors.

Misoprostol administration, either by oral or rectal route, has been shown to be effective in prevention of postpartum haemorrhage and is considered as an effective alternative to other conventional oxytocics especially in developing countries as it is cheap and thermostable.

Pharmacokinetic studies suggested that the bioavailability of misoprostol after sublingual administration was higher than those after oral or vaginal administration.

A few studies are now available for the use of sublingual misoprostol in the prevention of postpartum haemorrhage following vaginal delivery and have reported it as an effective and convenient route of administration.

However, none of the studies conducted so far have evaluated the response of sublingual misoprostol for prevention of postpartum haemorrhage during cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age 37-40 wk.
* Elective lower segment cesarean section.
* Under spinal anesthesia.

Exclusion Criteria:

* Anemia (Hb\> 8 g%).
* Multiple gestation.
* Antepartum hemorrhage.
* Poly-hydramnios.
* Two or more previous cesarean sections.
* History of previous rupture uterus.
* Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy.
Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain

This is a 3-arm, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of DR-2001 in endometriosis-related symptoms, primarily nonmenstrual pelvic pain, over a 12-week treatment period.

This multicenter, double-blind, randomized, placebo-controlled study is designed to evaluate the ability of DR-2001 to produce beneficial changes in endometriosis-related symptoms, primarily nonmenstrual pelvic pain, over a 12-week treatment period. The overall study duration for each patient will be about 20 weeks.

Patients who meet all study entrance criteria will be randomly assigned to one of three treatment groups.

The change in endometriosis-related clinical symptoms will be assessed in two ways: through a combined physician/patient assessment and also with a patient self-assessment. Patients will undergo a gynecologic exam at each study visit.

Eligibility Criteria:
Inclusion Criteria:

* Surgically sterilized (patient or partner), willing to use condoms throughout the study, or otherwise not at risk for pregnancy
* Diagnosis of endometriosis within the last 5 years
* Moderate or severe nonmenstrual pelvic pain
* Premenopausal
* Not pregnant or breastfeeding
* Regular (24-35 day) menstrual cycles for at least 2 months

Exclusion Criteria:

* Undiagnosed abnormal genital bleeding
* Any contraindication to the use of hormonal therapy
* Prior surgery for endometriosis
* GnRH analog therapy within 5 months
* Use of estrogens and/or progestins within 2 months
* Pain symptoms unrelated to endometriosis
* Any contraindication to the use of vaginal delivery systems
Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus

The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-79 years of age, inclusive.
2. Diagnosis of type 2 diabetes, at least nine months prior to screening.
3. Stable use of oral hypoglycemic medication for at least two months prior to screening.
4. Body mass index (BMI) ≥25.0 and \<45.0 kg/m2 at screening.
5. Willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial.

Exclusion Criteria:

1. History or diagnosis of type 1 diabetes mellitus.
2. Poorly controlled type 2 diabetes mellitus (HbA1C ≥9.0%).
3. Weight loss or gain \>10 lb (4.5 kg) in the two months prior to screening.
4. Abnormal laboratory test results of clinical importance.
5. History of gastrointestinal surgery for weight-reducing purposes.
6. Poorly controlled hypertension.
7. A clinically important medical or other condition.
8. Any major trauma or major surgical event within three months of screening.
9. Use of injected medications for glucose control within four weeks prior to screening.
10. Use of weight loss medications, supplements, programs, or meal replacement products within two months of screening.
11. Unstable use of foods, dietary supplements, herbals or medications, other than allowed medications, that have the potential to influence carbohydrate or lipid metabolism.
12. Pregnancy
13. Any history of extreme eating habits or an eating disorder diagnosed by a health professional.
14. Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse.
Physical Activity Tracking in Paediatric Elective Tonsillectomy

This pilot study will investigate the feasibility of physical activity tracking in patients aged 4-16 years before and after elective tonsillectomy as an innovative tool in paediatric research. The participating patients will receive a wearable physical activity tracker (CE-certified) that will continuously measure the patients' physical activity before and after an elective tonsillectomy, in addition to their parents' documentation of their child's activity in a conventional diary.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 16 years old, in 2 subgroups (4-7 years, 8-16 years)
* Inpatient surgery at University Children's Hospital Basel (UKBB), Switzerland
* Children undergoing an elective tonsillectomy or tonsillotomy. Children having additional ENT procedures, such as adenectomy, tympanostomy, etc. may be included as well.

Exclusion Criteria:

* Children with mental or physical impairment during daily-life activities.
* Children undergoing additional surgical procedures other than Ear, Nose \& Throat (ENT) procedures impacting the recovery period.
A Comparison of the Retropubic (TVT) With the Transobturator Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence

The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. While the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. Intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). The aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure.

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria:

* Urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra
* With or without concomitant surgery for pelvic organ prolapse
* With or without hysterectomy

Exclusion criteria:

* No informed consent
* No preoperative urodynamic investigation
* Mixed urinary incontinence with predominant overactive bladder
* Recurrent stress urinary incontinence after sling procedure
* Begin of treatment of overactive bladder less then a month ago or non stable condition
* Pregnancy
* Desires future childbearing
* Concomitant incontinence procedure like intravesikal injection of Botulinumtoxin
* Preoperative postvoid residual urinary volume exceeding 100cc
* Coagulopathies
The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients

To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1 plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with initial viral load above 10,000 copies/ml. To study the safety of SPC3 and the kinetics of HIV-1 plasma level changes.

The first five patients receive SPC3 daily for 3 weeks. If that dose is tolerated, the dose is increased and given to the next 5 patients for 3 weeks. The remaining ten patients receive a dose of SPC3 based on response to the previous two dose levels. Patients are followed through day 28.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretrovirals provided regimen has been stable for at least 6 weeks prior to study screening.

Patients must have:

* HIV seropositivity for at least 6 months.
* CD4 \>= 100 cells/mm3.
* HIV RNA PCR (Amplicor) \> 10,000 copies/ml.
* No significant active opportunistic infection or tumor at study entry.

FDA DISCLAIMER:

* The FDA encourages the inclusion of females of childbearing potential in study protocols, but the sponsor of this protocol specifically excludes females of childbearing potential from this study and includes only females who are sterile. Any questions about these inclusion/exclusion criteria should be directed to the study's contact person.

Prior Medication:

Allowed:

* Prior antiretrovirals.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

Inability to communicate with investigator or deemed likely to be noncompliant on study.

Concurrent Medication:

Excluded:

* Any drug that may interact with SPC3 (e.g., suramin).

Patients with the following prior condition are excluded:

History of relevant drug hypersensitivity.

Prior Medication:

Excluded:

* Investigational drug within the past 4 weeks.
Long-Term Follow-Up in Patients With Acute Myocardial Infarction Cohort

AMI Survivors who participated in the project "Construction and key technology research of the whole myocardial protection system for acute myocardial infarction" (project number 2016YFC1301100) and completed the 1-year visit were followed up by telephone at 3 years (within the corresponding follow-up time window) and 5 years after discharge to acquire the patients' medication, health status, and major adverse cardiovascular and cerebrovascular events, including death, heart failure, rehospitalization, re-myocardial infarction, revascularization, stroke, malignant arrhythmia, and bleeding events.


Eligibility Criteria:
Inclusion Criteria:

* AMI survivors who participated in the project "Construction and key technology research of the whole myocardial protection system for acute myocardial infarction" and completed the 1-year visit.
* Telephone to obtain informed consent from the subjects/family members of the subjects.

Exclusion Criteria:

* Not available
Mechanisms of a Dynamic Stability Approach

Background. Arthritis is the leading cause of disability in the United States and osteoarthritis (OA) of the hand affects an estimated 25.6 US residents. OA of the thumb carpometacarpal (CMC) joint is the most disabling form of hand OA. Rehabilitation for persons with thumb CMC OA is recommended as the initial treatment and often involves instruction on joint protection and fitting of a splint to reduce joint stress and pain. More recently, evidence has suggested that specialized exercise may impact a factor linked to this condition, altered joint mechanics. Health records data also suggests that these exercises reduce pain and disability more than what would be experienced by those receiving standard care (SOC) rehabilitation. However, there has not yet been a prospective investigation on how these dynamic stability (DS) exercises alter joint mechanics, improve function, and reduce pain relative to standard treatment. Relatedly, thumb CMC mechanics are most often assessed by physicians through CAT scan and although rehabilitation therapists are not licensed to conduct such assessments, they could benefit from 'real-time' imaging to inform and evaluate the mechanical effects of treatment. Sonography might afford therapists the precision to evaluate mechanical response to treatment yet it is not yet known if thumb CMC sonography corresponds with the gold standard, CAT scan.

Goal and Specific Aims. The long term goal this line of study is to reduce the effects of thumb CMC OA on activity performance and participation through non-invasive and non- pharmacological interventions. We expect to achieve our goals by pursuit of the following two specific aims: 1). Determine if a novel exercise regimen reduces radiographic thumb CMC joint misalignment among persons with thumb carpometacarpal osteoarthritis and 2) Evaluate the accuracy of ultrasound compared with CAT scan (reference standard) for quantifying thumb CMC subluxation

Design and Methods. Specific aim 1 will be addressed through a prospective pre-post interventional study of a 8-week clinic-based dynamic stability program and will undergo a CAT scan before treatment and upon completion of the program (9 weeks) and specific aim 3 will be addressed through a psychometric 'concurrent validity' design.


Eligibility Criteria:
Inclusion Criteria:

* adults with radiographically-confirmed thumb CMC OA

Exclusion Criteria:

* Persons who have had cortisone treatments to the affected thumb within the prior three months, thumb CMC joint replacement, inflammatory arthritis, Ehlers Danlos Syndrome, Marfan's disease, pregnancy or questionable pregnancy, cognitive disorders which would preclude a client from following the testing commands and home program participation, concomitant conditions affecting the arthritic thumb, grade 4 arthritis staging, no ongoing hand rehabilitation (i.e., within prior 6 months), non-English Speaking, and pain which precludes participants from completing testing
Diagnosis of Ascites in Infants and Children

Ascites is the pathologic accumulation of fluid within the peritoneal cavity. Causes of ascites in infants and children :hepatobiliary disorders,serositis, neoplasm, cardiac, genitourinary disorder, metabolic disease and others.

Diagnosis of ascites :history of abdominal distention, increasing weight, respiratory embarrassement, symptoms and signs of (hepatic ,cardiac,renal disease, tuberculosis and malignancy).

lnvestigation:complete blood count, complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test, chest and abdominal plain films,abdominal ultrasound, upper gastrointestinal endoscopy, abdominal paracentesis for ascitic fluid analysis .

Definition : Ascites is the pathologic fluid accumulation within the peritoneal cavity .

causes of ascites in infants and children :

* Hepatobiliary disorders (cirrhosis, congenital hepatic fibrosis, acute hepatitis B,C ,Budd -chiari syndrome, Bile duct perforation)
* Serositis (crohn's disease, eosinophilic enteropathy , Henoch- Shonlein purpura )
* Neoplasm (lymphoma, wilm's tumor ,Glioma, Germ cell tumor, Ovarian tumor,mesothelioma, Neroblastoma )
* Cardiac (Heart failure )
* Metabolic disease
* Gastrointestinal disorder (Nephrotic syndrome, peritoneal dialysis ). Diagnosis of ascites :History of abdominal distention, increasing weight, respiratory embarrassement, jaundice, bleeding (haematemsis, melena, and epistaxis ),Pruritus ,Growth failure ,abdominal pain, fever,Cyanosis, ,dyspnea during suckling, Orthopnea, Buffy eyes, lower limb swelling, Haematrruria .

By examination : Tachycardia ,Tachypnea ,Hypertension ,cyanosis, jaundice, clubbing of fingers ,limb edema ,Hepatomegaly, splenomegaly, dilated abdominal wall veins.

Investigations :

Laboratory tests :complete blood count , complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test.

Imaging studies :chest and abdominal plain films, abdominal ultrasound, upper gastrointestinal endoscopy CT, MR I, Abdominal paracentesis for ascitic fluid analysis :cell count / cytology ,Gram 'stain and culture, Total proteins (albumin /globulin ratio ), Glucose, Amylase, lactase dehydrogenase, Triglycerides,Bilirubin.

Serum ascites albumin gradient (SAAG )is the best single test for classification of ascites into portal hypertensive (SAAG \>1.1g/dl) and non-portal hypertensive (SAAG \<1.1g/dl) causes.

Eligibility Criteria:
Inclusion Criteria:

* age from 1month to 18 year
* infants and children with ascites (hepatic, cardiac, renal, malignant or tuberculous )
* infants and children with peritonitis

Exclusion Criteria:

* age \<1month
* surgical conditions as ruptured viscous or located abscess
Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment

Study Primary Objectives:

To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin.

Study Secondary Objectives :

To compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro:

* Incidence of hypoglycemia
* Change in weight
* Change in serum lipid profile
* Percentage of subjects achieving A1C levels ≤7%

The planned duration of enrollment is 6 months. The study consists of 2 weeks screening phase and a study period that was planned to be 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have given their signed informed consent.
* Males or females between 18 and 79 years of age.
* Diagnosis of type 2 diabetes mellitus for at least one year.
* Patients must have had continuous oral hypoglycemic treatment for at least three months using dosing of: at least half maximally labeled dose of sulfonylurea + at least 1000 mg metformin daily.
* HBA1C ≥ 8 % and ≤11 %, inclusive, as measured at screening (visit 1).
* Patients must have BMI of \> 25 kg/m2 at baseline
* Willingness to accept, and demonstrate ability to inject insulin glargine or 75% insulin lispro protamine suspension and 25% insulin lispro injection therapy.
* Ability and willingness to perform SMBG profiles using a plasma glucose meter at least twice a day.
* Patients must be able to understand and willing to adhere to and be compliant with the study protocol

Exclusion Criteria:

* Patients, who have had stroke, MI, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
* Patients with congestive heart failure requiring pharmacological treatment.
* Patients on non-selective beta blockers (including ocular).
* Patients with impaired renal function, as shown by but not limited to serum creatinine ≥ 1.5 mg/dl (133μmol/L) for males, or ≥ 1.4 mg/dl (124 μmol/L) for females.
* Patients with acute infections.
* Patients with diagnosis of dementia.
* Treatment with systemic steroids or large doses of inhaled steroids.
* Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis.
* Patients with planned radiological examinations requiring administration of contrasting agents.
* Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range.
* Patients with history of hypoglycemia unawareness.
* Pregnant or lactating females.
* Failure to use adequate contraception (women of current reproductive potential only).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.