cyrilzakka/clinical-trials huggingface dataset:
Painless Local Infiltration Anesthesia

The purpose of this study is to assess if a dilution with 1.4% sodium bicarbonate of a 2% mepivacaine+epinephrine solution, can be effective in reducing the pain associated with local infiltration anesthesia, during ambulatory phlebectomy procedures.

The use of local anesthesia by infiltration (LIA), usually prepared with 1% lidocaine or mepivacaine 2%, in combination with epinephrine and diluted with saline solution, it's commonly performed in ambulatory phlebectomy procedures.

Although this kind of anesthesia is among the most effective and safe available, the infiltration of local anesthetic is accompanied by pain in the majority of patients. This can be particularly important in ambulatory phlebectomy procedures, where large areas need to be anesthetized.

Numerous methods have been proposed to alleviate the pain associated with LIA, such as reducing the rate of administration or warming the anesthetic solution.

Sodium bicarbonate added in small concentrations, can also be effective in reducing significantly the pain associated with LIA. A recent trial has confirmed the viability and effectiveness of a solution of lidocaine 1% diluted in sodium bicarbonate 1.4%, in varicose vein surgery.

The purpose of this study is to evaluate the effectiveness in alleviating the pain associated with LIA, of a solution of mepivacaine 2%+epinephrine diluted with sodium bicarbonate 1.4%, compared with an analogous solution diluted with normal saline.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ambulatory phlebectomy

Exclusion Criteria:

* Allergy to amide anesthetics
* Sinoatrial node disease or any degree of atrio-ventricular block
* Acute diseases
* Chronic kidney or liver disease
* Treatment with drugs that alter pain sensitivity (e.g. analgesics)
* Treatment with monoamine oxidase inhibitors or tricyclic antidepressants
* Major psychiatric disorders according to DSM IV-TR diagnostic criteria
* Alcohol abuse actual or recent as described in DSM IV-TR
Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors

Researchers are trying to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18yrs of age with well-differentiated thyroid cancer and self-reported fatigue any time after initial treatment of thyroid cancer.
* English speaking
* Able to provide consent

Exclusion Criteria:

* Pregnant
* Medullary thyroid cancer
* Anaplastic thyroid cancer
* Physical limitations to perform exercise
Situation and Evolution of the Misuse of Alcohol and Other Addictive Behaviors in Obese Patients Being Managed at Nîmes University Hospital

Obesity is a multifactorial pathology in which external (lifestyle, environment) and internal (psychological or biological, especially genetic) factors are involved. These are responsible for a positive energy balance. One of the external factors that can intervene in the genesis of obesity is the existence of eating disorders: bulimic hyperphagia. Some teams consider bulimic hyperphagia as a form of addiction. After bariatric surgery, the appearance of new addictions has been observed.

In connection with Pr Perney's addictology department, the investigators have observed that some patients under treatment for obesity at the endocrinology department subsequently developed other addictions, in particular misuse of alcohol.

The hypotheses of this research are :

There appears to be a transfer from eating disorders to substance misuse addiction in post-treatment of obesity, particularly in patients who have undergone bariatric surgery.

The misuse of addictive substances most concerned by this transfer of addiction in the post-treatment of obesity, particularly after bariatric surgery, seems to be the misuse of alcohol.

This will be the first French cohort study on addictive behaviors in patients undergoing bariatric surgery and the first international study including non-operated obese patients benefiting from medical care alone. This study will improve the multidisciplinary management of these patients by integrating addictologists.


Eligibility Criteria:
* Patient being managed for the first time at Nîmes University Hospital Obesity Clinic ( complete hospitalization, outpatients' or consultation).
* Patient being managed for obesity defined by a body mass index (BMI) of 30 kg.m-² or over
* Patient affiliated to or covered by a health insurance scheme.
* Adult patient (≥ 18 years).

Exclusion Criteria:

* Patient with psychiatric disorder reducing capacity for comprehension.
* Patient in an exclusion period determined by another study.
* Patient under legal guardianship, tutorship or curatorship.
* Patient to whom it is impossible to give clear information
* Patient who is pregnant, about to give birth or breastfeeding.
Laparoscopic Versus Open Repair of Peptic Ulcer Perforation

Although laparoscopic repair (LR) of perforated peptic ulcers (PPUs) has long been accepted, clinical evidence comparing LR versus open repair (OR) remains lacking. The aim of this study is to evaluate the feasibility, safety and outcome of laparoscopic gastric repair and compare it with the outcome open repair by relying on a propensity score matching statistical technique

Despite the evolution of medical management of Gastroduodenal Peptic Ulcer (GPU), complications like bleeding and perforation are still not uncommon in clinical practice. According to the literature in average, 2-14% of peptic ulcers result in perforation, most 215 commonly occurring in females over the age of 60 and chronic NSAID, alcohol or tobacco users.

Management of perforated peptic ulcer entails resuscitation, pharmacotherapy and surgery.

Traditionally, suture with or without omental patch has been considered the 'gold standard' and still is. It is associated with shorter length of stay, lower transfusion needs and has lower morbidity as compared to gastrectomy. In 1992, it has been proposed that laparoscopy should be routinely considered in the management of perforated duodenal ulcer. Nowadays due to the advances in laparoscopic technique, many publications suggest that laparoscopic repair of perforated peptic ulcers could be a superior choice to open repair. These is linked with the advantages of laparoscopic surgery over open surgery such as reduced postoperative pain, lower wound infection rate, decreased length of hospital stay, and earlier functional recovery

Eligibility Criteria:
Inclusion Criteria:

* Patients surgically treated for benign peptic ulcer perforation

Exclusion Criteria:

* Age \< 18 years
* Pregnant and breastfeeding women
* Malignant ulcer perforation
* Gastric resection
* Diagnostic laparoscopy/laparotomy with no further surgical procedures performed
Prospective Evaluation of Idiopathic Pancreatitis: Role of Endoscopic Ultrasonography

The purpose of the study is to determine the best evaluation for patients with idiopathic (unexplained) pancreatitis.

The study evaluates the role of endoscopic ultrasonography, given that the minimally invasive procedures can diagnosis gallbladder disease as well as pancreatitis abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred to the principal investigator for unexplained pancreatitis will be enrolled.

Exclusion Criteria:

* There are no gender nor racial exclusion.
A Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer

The purpose of the research is to determine if blood tests and a CT scan done before surgery can predict how successful the surgery will be. In patients who have cancer of the ovary that has spread, it is hoped that the CT scan will be able to identify the various places where the cancer has spread so that additional surgeons can be available to help with the surgical procedure.

If you have confirmed stage 3 or 4 ovarian, fallopian tube, or primary peritoneal cancer, you may undergo a CT scan of the abdomen and pelvis after the surgery to compare how much cancer the surgeon thought was left after surgery to what is seen on CT scan. A CT scan of the chest will be done if your physician thinks it is necessary.

This study is designed to assess the utility and impact of computed tomography (CT)scanning of the abdomen and pelvis and preoperative serum CA-125 levels in the management of patients undergoing surgery for presumed ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* All patients \> 18 years of age undergoing surgery for presumed ovarian, fallopian tube, or primary peritoneal cancer.
* Patients must be medically and physically able to undergo general anesthesia and possible tumor debulking.
* Patients must read and sign informed consent form after the nature of the study has been fully explained.

Exclusion Criteria:

* Presence of clinically significant disease, allergy, or other disorder precluding the ability to safely perform CT scan of the abdomen and pelvis with oral and intravenous contrast.
* Vulnerable patients (minors, mentally retarded patients, prisoners, etc.)
Effect of Neuromuscular Electrical Stimulation Combined With Blood Flow Restriction on Muscular and Cardiovascular Function

Neuromuscular electrical stimulation (NMES) has recently been combined with blood flow restriction (BFR) in controlled trials and has shown increased muscular strength and size compared with NMES and BFR on their own. However, none have used BFR pressures previously recommended. The first study of my Ph.D. found 40% and 80% BFR pressures to induce acute fatigue and muscle swelling. However, 80% caused higher ratings of pain and perceived exertion. The present study will determine whether NMES combined with either 40% or 80% BFR causes greater structural muscular adaptations and is perceptually easier after 6 weeks of training.

Laboratory testing will take place on 28 separate occasions, 2 familiarisation, 8 testing and 18 intervention sessions. The first session (FAM 1) will serve as a familiarisation trial to the NMES protocol, BFR stimulus and strength testing. It will be conducted 10-14 days prior to the intervention period. The second session (FAM 2) will serve as a second familiarisation trial to the NMES protocol, BFR stimulus and strength testing. This session will take place 7 days prior to the beginning of the intervention period and will serve as a standardised control period prior to the main testing. The third session (PRE) will take place 1 day prior the start of the intervention period and all future sessions will consist of strength, muscle and cardiovascular function outcome measures. The fourth session (MID) will take place the morning following 3 weeks of training. The fifth session (POST1) will take place 48 hours following 6 weeks of training. There will also be post testing sessions after three days (POST2), one week (POST3) and two weeks post intervention (POST4) to assess detraining. Participants will be provided with protein supplementation after every training session. All strength, muscle and hemodynamic measurements will be conducted at St Marys University by Paul Head. Supplements should be avoided for 72 hours prior to experimental measures and throughout the intervention period. All repeated measures will be performed at a similar time of day (± 1 h).

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged between 18 and 45 years old

Exclusion Criteria:

* History of lower extremity surgery, traumatic injuries to the ankle, knee, hip, pelvis and lower back
* Current musculoskeletal condition
* High blood pressure
* Cardiovascular pathology
Repetitive Transcranial Magnetic Stimulation and Intermittent Theta Burst (iTBS) in Schizophrenia

The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and durable effects to the apply traditional rTMS protocols. The aim of this study is to investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms and remission of cognitive functioning in patients with schizophrenia. In a randomized, double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20 sessions. The negative symptoms and cognitive functioning will be assessed before the treatment (pre test) during the treatment (session 10), and after the treatment (post test).QEEG and LORETA apply before and after rTMS in all subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients male and female with the range of 18-50 years of age
2. The diagnosis of schizophrenia according to DSM-IV-TR
3. Completion of consent form
4. Being under supervision of a psychiatrist,
5. Being able to adhere to treatment schedule,
6. Having stable symptoms as defined by not requiring a change in antipsychotic medication for at least 4 weeks or at least 2 weeks for psychotropic agents prior to entering the Study

Exclusion Criteria:

1. The history of rTMS treatment for any reason
2. Cardiac pacemaker
3. Drug pumps
4. Acute heart attack
5. The risk of seizure with any reasons
6. The history of epilepsy or seizure in the first relatives
7. Any metal in head
8. Brain trauma
9. Pregnancy
10. Breastfeeding
11. Drug dependency
Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.

Primary outcome Measure:

To describe Investigational Device performance in term of level of leakage under the skin protector

Secondary Outcome Measure:

* Assessment of the condition of peristomal skin
* Assessment of other performance criteria
* Assessment of AEs for each patient

Eligibility Criteria:
Inclusion Criteria:

* patient is at least 18 years old,
* patient having a colostomy or an ileostomy for at least 1 month,
* patient having a stoma's diameter inferior to 45 mm,
* patient having a flat or flushed or slightly retracted stoma,
* patient using currently a one-piece soft convex or standard ostomy appliance with closed or drainable bags,
* patient using a minimum of 1 product per day with closed pouches or minimum 1 product per two days with drainable pouches
* patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
* patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
* patient agreeing to test investigational product during 14(±3) days.
* patient covered by social security

Exclusion Criteria:

* patient experiencing repeated leakages with his current appliance,
* patient receiving or having received, within the last month, chemotherapy or radiotherapy or corticotherapy,
* patient having a deeply retracted stoma,
* patient currently suffering from peristomal skin complications (bleeding or severe irritation or red and broken skin at the time of inclusion),
* patient already participating in another clinical study or who have previously participated in this investigation,
* pregnant or breast-feeding woman
The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

The primary objective of this study is to evaluate the durability of protection and immuno-persistence of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

This is a follow-up study that is based on phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006). The investigators will recruit people who have participated in phase III clinical study before and to evaluate the durability of protection and immuno-persistence of the bivalent HPV vaccine on 90m and 114m after dose 1.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose;
2. Participants can fully understand the study content and sign an informed consent form；
3. Able to comply with the requests of the study;

Exclusion Criteria:

1. Participants used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study.
2. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
N-methyl Glycine (Sarcosine) for the Treatment of Obsessive Compulsive Disorder (OCD)

Several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of obsessive compulsive disorder (OCD). Sarcosine, also known as N-methylglycine, is an endogenous antagonist of glycine transporter-I (GlyT-I), which potentiates glycine's action at the glycine site of N-methyl-D-aspartate (NMDA) receptors. In this 10-week open-label trial, we examined the efficacy and safety of sarcosine treatment in OCD patients.


Eligibility Criteria:
Inclusion Criteria:

* a primary OCD according to DSM-IV
* at least 1 year's duration of OC symptoms and a minimum severity score of ≥16 on Yale-Brown Obsessive Compulsive Scale
* drug naïve at study entry or
* being free from psychotropic medication for at least 8 weeks at study entry,or
* inadequately responded to ongoing psychotropic medications at study entry (defined by a Y-BOCS score of ≧16 despite treatment with maximum tolerated dose of a SRI medication for at least 8 weeks)

Exclusion Criteria:

* patients with moderate to severe depression defined by a 21-item Hamilton Depression Rating Scale score of \>17,
* a history of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychosis as defined by DSM-IV, or if they were at significant risk of suicide, and
* with clinically significant organic disease including cardiovascular, hepatic, pulmonary, neurologic, metabolic, or renal disease
Time to Hip Fracture Surgery

The purpose of the study is to evaluate how time from hospital admission to start of surgery influence mortality in patients with acute hip fracture. Data on patients with hip fracture surgery will be collected from the hospital's registration system and will be analyzed regarding age, gender, American Society of Anesthesiologists (ASA) Physical Status Classification, type of surgery and time from admission to surgery along with data on mortality.


Eligibility Criteria:
Inclusion Criteria: undergoing

* hip fracture surgery between 2007-2016.
* Over 60 years of age.

Exclusion Criteria:

* Pathological fracture.
* In-hospital falls.
* Diagnostic delay.
PPROM Registry (Preterm Premature Rupture of Membranes)

Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible for 40% of preterm births in the United States. The PPROM Registry aims to identify possible causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care, and to review short term and long term outcomes of affected pregnancies and births.

Detailed Description

Preterm Premature Rupture of Membranes (pProm) is a factor in 40% of preterm births. The earlier in pregnancy pProm occurs, the greater the potential latency period. Threats to the pregnancy include placental abruption, umbilical cord prolapse, infection, and insufficient pulmonary development, and preterm delivery. Management of pProm may include immediate delivery, induction, or expectant management.

It is still unclear what is considered best practice for the course of treatment in pProm pregnancies and post- delivery care of pProm babies in Neonatal Intensive Care Units (NICU), as well as the long term outcomes of pProm survivors. Unfortunately, there are few recent studies available for review and those that exist often do not reflect the current treatments or innovations that have taken place, especially in neonatal care. Many of the studies available focusing on pProm have very small sample sizes, as well as very short follow-up post-delivery, resulting in a wide range of reported outcomes, especially regarding the morbidity and mortality associated with pProm.

The pProm registry is the first of its kind and will provide a large cohort of data for study. The purpose of this registry is to better understand pregnancies and births impacted by pProm. This includes how pProm is managed in pregnancy and in how pProm neonates are cared for in the NICU; identifying trends in expectant management, and to detect short term and long term outcomes of those affected.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with Preterm Premature Rupture of Membranes (PPROM) prior to 37 weeks of pregnancy

Exclusion Criteria:

* Those without a clinical diagnosis or confirmation of PPROM in pregnancy
* Diagnosis of PROM beyond 37 weeks of pregnancy
Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

This study is a double blind randomized controlled trial.

Based on evidence-based literature on vitamins and minerals, there is a cooperation of a manufacturer multivitamin specifically designed for patients with a gastric band and Roux-en-Y gastric bypass (RYGB). These preparations are the proportions adjusted so that the risk of shortages should decrease and on the other hand, excessive levels of nutrients should be avoided. Main objective of this study is to examine whether these new supplements in particular the number of deficiencies in iron, vitamin B12 and vitamin D can be reduced.

Eligibility Criteria:
Inclusion Criteria:

* Patients on the waiting list for RYGB or gastric band and meets
* Age between 18-65 years

Exclusion Criteria:

1. Creatinine \> 150micromol / L
2. Liver enzymes \> 2 times the upper limit
3. Previous surgery on the gastrointestinal tract
4. Intercurrerence disease
5. Gastrointestinal Diseases
6. Psychiatric illness
7. Drugs that affect bone metabolism
8. Known pregnancy