cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Locoregional Anesthesia Protocol by Pudendal Block in Reconstructive Surgery Clitoral

Reconstructive surgery of the clitoris is part of the care offered during a process of care of women victims of MSF. It consists in reconstituting a clitoral neogland after removal of the vulvar excisional scar and recovery of the remaining clitoris. Studies that have monitoring the implementation of this surgery show that it improves the well-being of the patients, brings benefits anatomically, sexual health, personal development, and in the long term decreases chronic pain.

Currently the standard method used in the usual care of the patient is: general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco The pudendal block that the investigators want to evaluate in this research, is a technique that has made proven in several types of surgery, associated with very few complications and easily reproducible.

Reconstructive surgery of the clitoris is part of the care offered during a process of care of women victims of MSF. It consists in reconstituting a clitoral neogland after removal of the vulvar excisional scar and recovery of the remaining clitoris. Studies that have monitoring the implementation of this surgery show that it improves the well-being of the patients, brings benefits anatomically, sexual health, personal development, and in the long term decreases chronic pain. Currently the standard method used in the usual care of the patient is: general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco The pudendal block that the investigators want to evaluate in this research, is a technique that has made proven in several types of surgery, associated with very few complications and easily reproducible. The human clitoris is the most sensitive organ in the human body, with over 8000 endings nervous. All these endings come from the pudendal nerve, itself most often of nerve roots S3. The main hypothesis is that a bilateral anesthetic block of this nerve would reduce postoperative pain in clitoral surgery

Eligibility Criteria:
Inclusion Criteria:

* Major patient,
* With the indication of a clitoral repair surgery
* Having expressed their free and informed written consent
* Affiliated with a social security scheme

Exclusion Criteria:

- Contraindication to the pudendal block technique: notably :

* blood crass disorder
* allergy to Naropein
* infection at the injection site - Poor understanding of the interest of the practice proposed experimental
Fatigability of Lower Limb Muscle in Older Adults: Protective Effects of Strength Training Exercise in Old Men and Women

The proposed studies will assess 1) the mechanisms for the age-related increase in fatigability during dynamic exercise (Aims 1 and 2) and 2) the effectiveness of high-velocity resistance training coupled with blood flow restriction (BFR) in improving muscle power output and fatigability in older adults (Aim 3). The first two aims are cross-sectional studies comparing young (18-35 years old) and older adults (≥60 yrs old) to test our central hypothesis that the greater accumulation of metabolites and increase in fatigability in older adults is due to either age-related impairments in skeletal muscle bioenergetics (Aim 1) and/or vascular dysfunction (Aim 2). These two aims will integrate techniques to assess whole-muscle bioenergetics (31P-MRS) and in vivo vascular function (near infrared spectroscopy; NIRS and doppler ultrasonography) with in vitro assessment of single fiber bioenergetics (epifluorescence microscopy) and vasoreactivity of isolated skeletal muscle arterioles (video microscopy). We will then determine whether bioenergetics, vascular function and fatigability are altered in older men and women in response to 8 weeks of resistance exercise training of the lower limb both with and without blood flow restriction (Aim 3).


Eligibility Criteria:
Inclusion Criteria:

* men and women aged 18-40 years and \>60 years

Exclusion Criteria:

* body mass index ≥40 kg/m2;
* type 1 or type 2 diabetes;
* uncontrolled hypertension;
* active cancer, cancer in remission, or having received treatment for any form of cancer in the previous five years;
* coronary artery disease;
* cardiovascular disease (e.g., PAD, PVD);
* abnormal and untreated thyroid function;
* chronic and/or regular nonsteroidal anti-inflammatory drugs (NSAID) consumption,
* tobacco use (includes smoking);
* any condition that presents a limitation to exercise (e.g., severe arthritis, COPD, neuromuscular disorder, moderate or severe cognitive impairment, Alzheimer's Disease, severe untreated sleep apnea).
* women who are pregnant or likely to be pregnant.
* Subjects will be excluded if they have joint pain in the exercising leg or arm. Medication use. Medications currently taken or in the previous year and known to influence muscle mass (e.g., glucocorticoids, testosterone) and cortical and neuromuscular excitability will be exclusionary, while medications that may be prevalent among older adults (e.g., statins) will be accounted for with a covariate statistical model.
Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy

The aim of this study was to assess the efficiency of the computer-guided interpositional sandwich osteotomy for the vertical bone gain and effects on vital structures (inferior dental nerve bundle) compared to free hand interpositional osteotomies.

in this research a full digital sandwich osteotomy protocol was conducted to be compared with the conventional protocol. the investigators were seeking to determine the significance of using surgical computer software in sandwich interpositional bone grafting at atrophied posterior mandibles and how efficiently can it affect this technique.

Eligibility Criteria:
Inclusion Criteria:

* • Edentulous posterior mandibular ridge with vertical loss of alveolar bone with remaining bone height (4-7 mm) above the mandibular canal

  * Good oral hygiene
  * Highly motivated patients
  * Patients seeking fixed prosthesis at posterior mandibular region.
  * Patients willing for a surgical procedures follow-up with an informed consent
  * Age range 20-65 years

Exclusion Criteria:

* • Smokers

  * Individuals with dentulous posterior mandible ridge
  * Medically compromised patients
  * Patients with local pathosis at the surgical area suggested
  * Previously subjected to reconstructive procedures of the posterior mandible
Estradiol and Fear Extinction in Anorexia Nervosa (AN)

The purpose of this study is to determine whether estrogen may help reduce fear of high calorie-density foods in weight-restored women with Anorexia Nervosa (AN).


Eligibility Criteria:
Inclusion Criteria (AN):

* Previous diagnosis of recent AN with BMI of \<18.5 (within past year)
* Current BMI \> 19.0 and \< 23.0 kg/m2
* Amenorrhea or oligomenorrhea

Inclusion Criteria (Healthy Controls):

* BMI \> 19 \< 23 kg/m2
* Taking hormone-based contraceptives for a period of one month or more
* Eating disorders symptom scores within one standard deviation of healthy controls

Exclusion Criteria (AN):

* Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality
* History of breast cancer, deep vein thrombosis, pulmonary embolism, myocardial infarction or stroke, diabetes, liver disease, known thrombophilic disease
* Currently taking estrogen or progesterone medication
* Tobacco use greater than 1 pack per week
* Use of St. John's Wort, Phenobarbital, phenytoin, carbamazepine, rifampin, and dexamethasone can all decrease plasma estrogen level because they are CYP3A4 inducers. Cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice as these may increase plasma estrogen, potentially increasing the presence of side effects
* Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks)
* Allergy to estradiol or medroxyprogesterone or ingredients in food items used for test meals
* Undiagnosed, abnormal vaginal bleeding

Exclusion Criteria (Healthy Controls):

* Ever diagnosed with an Eating Disorder
* Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality
* Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks)
* Food allergies to items in the test meal
Safety and Efficacy of Heparin Dosing Score Protocol for Polymyxin-B Hemoperfusion

Polymyxin B hemoperfusion (PMX-HP) is mainly used to remove endotoxins in septic shock patients with intra-abdominal infections. Because of the concerns of postoperative bleeding, physicians may hesitate to use anticoagulation in patients with septic shock within a few hours after an abdominal operation. We developed a heparin dosing score protocol for heparin dosage adjustment. The purpose of the study is to examine the safety and efficacy of the heparin dosing score protocol.


Eligibility Criteria:
Inclusion Criteria:

* intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion in National Taiwan University Hospital during October 2013-December 2016

Exclusion Criteria:

* pregnant woman
* patients with do-not-resuscitate declaration
* uncontrolled bleeding within 24hr
Serine Proteases in Gastrointestinal Function and Irritable Bowel Syndrome (IBS)

The proposed pilot project for this seed grant focuses on the role of intestinal serine-proteases in the pathogenesis of diarrhea-predominant IBS (D-IBS). In this study we will further assess serine-protease activity in patients with D-IBS and also explore a possible mechanism by which these proteases can lead to alterations in intestinal physiology and symptoms in these patients.

The general hypotheses for the proposed research are that (A) the levels of fecal serine-protease in patients with D-IBS are abnormally increased (B) this abnormal serine-protease activity leads to/is associated with an abnormal increase in intestinal permeability and therefore enables (C) chronic stimulation and activation of the mucosal immune system in these patients. In addition, it is aim to determine whither periodontal inflammation is associated with intestinal permeability and serine protease activity.


Eligibility Criteria:
Inclusion Criteria:

* Any sex, race, or ethnicity.
* At least 18 years of age (no upper age limit).
* D-IBS patients must meet Rome III criteria for IBS and must have been evaluated by a physician to exclude other diseases that could explain the symptoms. For the latter, patients self statement is acceptable (no official document is required).
* Participation in Dr. Whitehead's 'heterogeneity of IBS' and/or Dr. Ringel's 'intestinal inflammation in patients with D-IBS' research study.

Exclusion Criteria:

* Healthy controls must have no significant or recurring gastrointestinal symptoms.
* Patients and healthy controls should not have a serious, unstable medical condition.
* Patients and healthy controls must have had no gastrointestinal tract surgery other than appendectomy or cholecystectomy.
* Patients and healthy controls must not be pregnant (by self-report). Pregnant women will not be allowed to participate as pregnancy can affect gastrointestinal symptoms.
* Patients and healthy controls must not have a history of inflammatory bowel disease, celiac disease, or other diagnosis that could explain chronic or recurring bowel symptoms in IBS patients or controls.
* Patients and healthy controls should have no history of lactose malabsorption (by self-report).
* Patients and healthy controls should have no history of clinical symptoms of acute infections during the last 8 weeks prior to enrolment in the study.
* Patients and healthy controls should have no history of anti-inflammatory agents including aspirin, non-aspirin, non-steroid anti-inflammatory (NSAID) or steroids in the last four weeks prior to study enrollment.
* Patients should not intentionally consume probiotics or undergo antibiotic treatment during the last 4 weeks prior to enrolment in the study. If the subject consumed any of these medications, a washout period of 4 weeks will be required).
* Patients must have no history of fainting or light headedness during periods of fasting.
* Patients must not have diabetes mellitus, or any similar conditions, that would cause an adverse reaction to the sugar drink.
Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children

The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention.

Insufficient sleep duration is highly prevalent in childhood and is associated with incident obesity, especially among middle school-aged children. Investigators therefore need to identify strategies to increase sleep duration among children for obesity prevention. The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention. This is a single-site study being conducted at the Children's Hospital of Philadelphia (CHOP). Investigators will randomize 325 children, aged 8-12y, with a body mass index (BMI) between the 50th-95th percentile, and who sleep \<8.5 hours per night. Clinical measurements will be acquired at CHOP and sleep will be measured in the home setting. The Way to Health mobile platform will facilitate remote communication and data collection. A validated multi-channel sleep tracker will estimate sleep for 12-months (2-week run-in; 6-month intervention; ≈5.5-month follow-up). A randomized 24 factorial design will assess four components: sleep goal (fixed or modifiable), digital guidance (active or active with virtual study visit), parent incentive (inactive or active), and personalized feedback (inactive or active). The optimal component settings will have to meet the following criteria: increase average baseline sleep duration by ≥30 minutes for ≥75% of intervention weeks and for ≥50% of follow-up weeks. Fat mass will be measured at baseline, 6-, and 12-months using dual energy X-ray absorptiometry (DXA). Total energy intake and the timing and composition of meals will be measured using 24-hour dietary recalls at baseline, 6-, and 12-months. Sociodemographic data will be measured using self-report approaches (e.g., sex, race/ethnicity) and home addresses will be geocoded for geo-spatial analyses.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 8-12 years olds.
2. Insufficient sleep duration (\<8.5 hours per night).
3. Body mass index (BMI) between the 50th and 95th percentile for age and sex.
4. One child per family.

Exclusion Criteria:

1. Diagnosed with a chronic disease.
2. Diagnosed with a behavioral health problem.
3. Diagnosed with a condition that can impact sleep or growth.
4. Diagnosed with a condition affecting physical growth and maturation or dietary intake.
5. Children with a history of cancer, kidney, GI, musculoskeletal, or sleep disorders.
6. Children who will transition to high-school during the study.
7. Children using steroids/hormones.
8. Children regularly taking medications
A Study of the Safety and Pharmacology of MetMAb (PRO143966), a Monovalent Antagonist Antibody to the Receptor C-Met, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors

This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous (IV) infusion in patients with advanced solid malignancies that are refractory to or for which there is no standard of care. The study consists of a dose-escalation stage, an expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation stage testing the combination of MetMAb, at two different doses with bevacizumab at a recommended dose.


Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy
* Disease that is measurable or evaluable by Response Evaluation Criteria In Solid Tumors (RECIST)
* Life expectancy ≥12 weeks

Exclusion Criteria:

* Less than 4 weeks since the last anti-tumor therapy
* Patients receiving erythropoietin products
* Active infection requiring antibiotics
* Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
* Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
* Clinically important history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Known human immunodeficiency virus infection
* Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
Vibration Impact on Parkinson's Tremor

The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson's disease (PD).

Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease (PD) as diagnosed by a movement disorder specialist
* Tremor caused by their Parkinson's disease
* Ability to provide informed consent

Exclusion Criteria:

* Known diagnosis of Parkinson Plus Syndrome
* Dementia
* Other known non-PD cause of tremor
* Other known non-PD cause of limb dysfunction
* Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus
* Non-English speaker
* Prisoners
* Pregnant women
Cognitive-Behavioral Treatment of Gambling

This study will determine the effectiveness of cognitive behavior therapy (CBT) and contingency management (CM) in reducing gambling behaviors and other related problems in pathological gambling.

Study hypothesis: Participants who receive CBT and CM will attend more treatment sessions and show better outcomes than those who receive CBT alone.

Pathological gambling has become an increasingly problematic condition in the United States, often causing serious financial, psychological, and public health consequences. In an effort to treat this growing problem, researchers have evaluated numerous therapies; one such therapy is CBT. CBT has been shown to improve pathological gambling outcomes. However, evidence suggests that adding CM to CBT could result in even more improved outcomes. This study will compare the effectiveness of CBT and CM with that of CBT alone in reducing pathological gambling.

This study will last 12 months. Participants will be randomly assigned to receive either CBT and CM or CBT alone for 8 weeks. CBT will focus on reducing gambling urges and helping patients develop alternative behaviors to gambling. CM will focus on encouraging patients to avoid gambling. Participants in the CBT and CM group will receive voucher incentives for completing homework assignments and engaging in non-gambling social activities. The vouchers will allow participants to take part in non-gambling activities of their choice. Changes in gambling activities and problems will be assessed with self-report scales and interviews at study start and at Weeks 10, 24, and 52.

Participants will be asked to identify at least one person who knows about their gambling and will have regular contact with them over the 12 months of the study. This person will be interviewed at study start and at Months 2, 6, and 12. Contact persons will be asked about participants' gambling behaviors, personal relationships, legal problems, use of health care and mental health services, and how the participant can be contacted if he or she moves.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00158314

http://clinicaltrials.gov/show/NCT00618462

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pathological gambling
* At least 1 gambling episode within 30 days prior to study entry
* Able to read English at a 5th grade level
* Willing and able to comply with all study requirements

Exclusion Criteria:

* Uncontrolled psychiatric conditions
Urdu Version of Fear Avoidance Belief Questionnaire: Reliability and Validity Study

The study aims to translate and culturally adapt Fear Avoidance Belief Questionnaire into the Urdu language and to investigate the reliability and validity in the Pakistani population and check its correlation with Visual Analog Scale , Ronald Morris Questionnaire, Quebec Back Pain Disability Scale and Hospital Anxiety and Depression scale .

As per preceding commendation, Fear Avoidance Belief Questionnaire will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among low back pain population, Fear Avoidance Belief Questionnaire will be conducted in 180 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Fear Avoidance Belief Questionnaire, Hospital anxiety and depression scale, Ronald Morris questionnaire, Quebec pain rating scale and numeric pain rating scale will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 will be used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Fear Avoidance Belief Questionnaire will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients or the ones next to them who gave informed consent
* Participants with complain of low back pain for more than 3 months.
* Age at least above 18 years.

Exclusion Criteria:

* Inability to understand or follow the instructions of the Fear Avoidance Belief Questionnaire.
* Any musculoskeletal pathologies
* Suffering from any cardiovascular pathologies
* Any history of tumor and cancer
* Any history of fracture
* Any histories of infections
* Any history of neurological disorders
* Having any spinal deformity
Reversal of Ventricular Remodeling With Toprol-XL

The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stable asymptomatic heart failure.
* Documented ejection fraction less than 0.40.
* Must be able to comply with all study procedures.

Exclusion Criteria:

* Taken B-blocker therapy for longer than 1 week within 6 months prior to randomization.
* Have heart problems that would not allow B-blocker therapy.
* Receiving B-blockers therapy for any medical reason including topical B-blockers that might cause systemic absorption (e.g., glaucoma).
* Undergone certain heart surgeries, such as, prior heart transplant or cardiomyoplasty.
* Have certain heart diseases.
* Pregnant or breast feeding.
* Unlikely to survive.