cyrilzakka/clinical-trials huggingface dataset:
Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of taurolidine in treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of taurolidine after positive second-look surgery in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. II. Determine the dose-limiting toxicity and safety of this drug in these patients.

OUTLINE: This is a dose-escalation study. Patients receive taurolidine intraperitoneally weekly on weeks 1-3 and 7-9 in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of taurolidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 weeks for 9 weeks.

PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal adenocarcinoma Stage IIC or higher at diagnosis Successfully received prior chemotherapy Undergone initial cytoreductive surgery Evidence of gross disease at second-look surgery

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST and/or ALT less than 3 times upper limit of normal No clinically significant PT/PTT abnormality Renal: Creatinine less than 1.7 mg/dL Other: No known hypersensitivity to taurolidine or its excipients No other clinically significant disease that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drugs
Fit Physicians: Use of Activity Monitors and Activity Integration Program in First Year Medical Students

Using FitBit activity monitors, physical activity levels will be monitored in first year medical students. Body Composition will be measured as well.

Using fitness trackers and exercise testing, it will determine if participating in a novel program that incorporates wellness into the academic term will improve fitness.

An estimate, 120 students will enroll in this study. Men and women aged 18-55 years of age that are just entering medical school. Students who are currently pregnant will not be allowed to participate in this study.

Participation will involve 2 visits at the start of the academic school year, and two visits at the end of the academic school year.

These visits will entail you undergoing a body composition scan measured by an duel energy x-ray absorptiometry (iDEXA) machine. The scan takes approximately 15 minutes. Subjects may be asked to perform an exercise stress test on a treadmill. The exercise test is approximately 40 minutes. Subjects may be asked to participate in a fitness program 2x a week, and may be asked to wear a Fitbit Flex™ activity tracker on the wrist for the duration of the school year. Investigators will be accessing academic grades to use for statistical purposes only. Subject names will never be given to any other party other than the investigators involved.

Eligibility Criteria:
Inclusion Criteria:

* First year medical students
* Must have smartphone

Exclusion Criteria:

* Medical conditions that prohibit exercise
* pregnancy
ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension

The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:

* If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner
* If the changes in lipid profile are in a dose-response manner

Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks


Eligibility Criteria:
Inclusion Criteria:

* Men and women with Grade I Hypertension (systolic blood pressure between 130 and 139 mmHg; and diastolic blood pressure between 80 to 89 mmHg) without taking any antihypertensive drug

Exclusion Criteria:

* Acute or chronic kidney disease including dyslipidemia due to nephrotic syndrome.- -
* Hypothyroidism
* Having previously suffered a myocardial infarction or stroke
* Pharmacological treatment with insulin, sulfonylureas, protease inhibitors
* Chronic gastrointestinal disease
* Pregnancy or intention to become pregnant during the study period.
* Breastfeeding
* Allergy or intolerance to garlic
* High alcohol consumption (\>14 units per week)
* Smokers
Treatment of Acetaminophen Toxicity With N-acetylcysteine

Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to CHMCA between June 1, 2004 to May 31, 2008 with a qualifying ICD-9 diagnosis code for the following APAP overdose situations; poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0)
* Serum APAP concentrations ≥ 150 g/mL at 4 hours or a serum concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained \> 4 hours post ingestion
* Between the ages of 0-21 years

Exclusion Criteria:

* Serum APAP concentrations are not actually documented
* Patient did not receive oral or IV NAC treatment
* Patient has a preexisting liver disease such as cirrhosis or hepatitis C
* Patient \> 21 years of age
Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee

The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

This randomized, double-blind, placebo controlled prospective study will assess the safety and effectiveness of a single intra-articular injection of Monovisc® in providing symptomatic relief of pain caused by idiopathic osteoarthritis (OA) of the knee as compared to a placebo comparator injection of sterile saline.

Eligibility Criteria:
Main Inclusion Criteria:

* Male or Female
* Age 35 to 75 years
* Body Mass Index (BMI) 20 to 40 kg/m2
* Willing and able to provide informed consent
* Willing to limit analgesic use to acetaminophen 7 days prior to and 12 weeks after injection
* Not pregnant or lactating
* Previous conservative treatment regimen for osteoarthritis (OA)
* Diagnosis of idiopathic OA of the index knee
* OA symptoms for \>= 6 months
* Index knee Kellgren-Lawrence (K-L) grade of II or III
* Index knee Baseline Summed WOMAC Pain Score \>= 200mm and \< 400mm after NSAID washout
* Contralateral Knee K-L grade 0, I or II
* Contralateral Knee Baseline WOMAC Pain Score \< 150mm after NSAID washout

Main Exclusion Criteria:

* Joint disorders which could interfere with treatment effectiveness
* Joint disorders which could interfere with study assessments
* Arthroscopy of either knee within 3 months of screening
* Open surgery of index knee within 12 months of screening
* Open surgery of contralateral knee within 3 months of screening
* Injection of Hyaluronic Acid (HA) in either knee within 6 months of screening
* Injection of steroid in index knee within 3 months of screening
* Any pre-treatment contraindication for injection or aspiration of the index knee, including cutaneous infection, intra-articular infection, knee deformity or condition which may jeopardize sterility or delivery of injection
* Synovial fluid aspirate volume \> 20 milliliters (mL)
* Visual appearance of synovial fluid that contraindicates injection
* Index knee range of motion \< 90 degrees
* Subject participation in other research study within 30 days of screening
* Subject unwilling to maintain active lifestyle, exercise program and body weight similar to that during 3 months prior to screening for duration of study
* Unwilling to maintain constant dosage of oral glucosamine or chondroitin sulfate for duration of study, if applicable
* Other medication or treatments that could interfere with study injection or assessments
* Allergy to gram positive bacterial products or intolerance of acetaminophen
* Active fibromyalgia
* Peripheral neuropathy severe enough to interfere with evaluation of either knee
* Vascular insufficiency severe enough to interfere with evaluation of the subject
* Hemiparesis involving either lower extremity
* Systemic bleeding disorder
* Other conditions which may adversely affect the success of the procedure
Communicating Veins Between Adjacent Hepatic Veins: an Intra-operative Ultrasound Study

The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its rationale from living donor liver transplantation (LDLT). Parenchymal sparing procedures although HVs are resected suggest that probably their presence is underestimated.

Taking profit from new improvements in ultrasound technology the investigators aim to better estimate the rate of CVs in a consecutive series of patients in whom resection of one HV at caval confluence is needed.

The search for communicating veins (CVs) between adjacent hepatic veins (HVs) has drawn its rationale from the need of reducing the risk of incomplete blood outflow in the medial portion of the hemiliver without the middle hepatic vein (MHV) in living donor liver transplantation (LDLT). However, only 24% of patients seems having CVs based on the findings of color-Doppler intraoperative ultrasound (CD-IOUS) exploration. On the other hand the safety of parenchymal sparing procedure despite HV resection let suppose that CVs are probably more frequent than expected.

Certainly, better in vivo knowledge of the rate of CVs and their direct detection would consolidate and probably further expand parenchymal sparing techniques. Taking profit from new advancements in ultrasound technology we have carried out the present study with the aim of better estimating the rate of CVs in a consecutive series of patients in whom resection of one HV at caval confluence was needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for being enrolled in the present study were those carriers of primary or metastatic tumour with direct contact or invasion of one HV at the caval confluence.

Exclusion Criteria:

* N/A
Ischemic Strokes While on NOAC - How Compliance Matters

This study is aimed to depict the epidemiological trend, aetiologies, clinical characteristics, treatment options of IS-NOAC in face of the rapidly increasing NOAC usage. Knowledge on this ischaemic stroke entity will define clinical characteristics, identify preventable causes and inform resource allocation on the evaluation modalities, reperfusion strategies and forecast future burden of IS-NOAC.

Data will be retrieved from the stroke registry of Prince of Wales Hospital which recorded all in- and out-patients with stroke or transient ischaemic attack (TIA). All consecutive adult patients with known AF who developed ischaemic stroke or TIA in 2010, 2012, 2014, 2016 and 2018 (i.e. 5 full yearly time-points) and categorize the patients according to their anticoagulation status (elaborated below) with the inclusion and exclusion criteria stated will be recruited.

All demographic data, blood results, imaging and assessment data will be retrieved from electronic patient record (CMS system) and stroke registry. All-cause mortality at 1 year will be verified via CMS system too.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who were ethnic Chinese
2. Patients with known AF
3. Patient who suffered from ischaemic stroke

Exclusion Criteria:

1. Patient who are non-ethnic Chinese
2. Patient who suffered from haemorrhagic stroke
Pilot Study of AVT16 in Healthy Adult Subjects

This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged between 18 and 55 years old inclusive
* Medical history without evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety
* Haematology and biochemistry tests within normal range

Exclusion Criteria:

* History of relevant drug and/or food allergies
* History of hypersensitivity to vedolizumab, AVT16 of their constituents
* Past or concurrent medical conditions that could potentially increase subject's risks or interfere with study evaluations
Per-operative Ultrasonographic Assessement of the Placement of the Mesh in Laparoscopic Sacral Colpo/Hysteropexy

This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.

Genital prolapse is a very common functional pathology that affects 30% of women. The functional impact of prolapse is highly variable and may lead patients to consider surgery. Surgery for laparoscopic genital prolapse (laparoscopy) is a common practice. The placement of prostheses on the anterior and posterior walls of the vagina is sort of "estimated", performed without any quality control . This technique is associated with a high rate of patient satisfaction (90% satisfaction), but a risk of anatomical recurrence in 20-30% of cases and a risk of reoperation for relapse in 3% of cases. It is likely that the lower the intervesico-vaginal prosthesis, the lower the risk of cystocele relapse is important.The postoperative ultrasound visualization of prostheses placed in promontofixation is possible: they appear hyperechoic. In particular, in anterior, where a prosthesis is placed between the vagina and the bladder, it is possible to verify that this prosthesis supports the entire bladder base.Thus, it may be possible to check the correct position of the prostheses intraoperatively. If studies were conducted postoperatively, to the best of our knowledge, no study has been conducted on the value of an intraoperative ultrasound control.

Eligibility Criteria:
Inclusion Criteria:

* Adult women (\>18 years-old)
* patient who undergo laparoscopic sacral copopexy/hysteropexy
* Affiliation to a public health insurance system
* Written and informed consent given by the patient

Exclusion Criteria:

* Pregnancy, breast-feading
* woan involved in an interventional research
* Patient under tutorship or curatorship
* Pregnancy and breast feeding
Effect of Pelvic Floor Muscle Electrophysiologic Therapy on Enhanced Recovery After Gynecologic Surgery

This study is to evaluate the effect of pelvic floor muscle electrophysiologic therapy on enhanced recovery after gynecologic surgery,to solve muscle soreness and retention of urine after laparoscopy, and endometrial repair after electrosurgical resection of intrauterine adhesions.

Pelvic floor muscle electrophysiologic therapy is widely used in the treatment of pelvic floor dysfunction diseases at home and abroad. Electrical stimulation can also relieve depression and anxiety and play a sedative effect. In recent years, some studies have shown that pelvic floor electrophysiological therapy can improve the intimal blood flow resistance index of thin endometrium. Therefore, whether or not the pelvic floor electrophysiological therapy can relieve the muscle soreness caused by carbon dioxide retention after endoscopic surgery, reduce the postoperative urinary retention, shorten the postoperative anus exhaust time, and repair the endometrium after the intrauterine adhesion. we expect this electrophysiologic therapy can solve some common postoperative complications and difficult problems, such solve muscle soreness and retention of urine after laparoscopy, and endometrial repair after electrosurgical resection of intrauterine adhesions. Hope to help patients recover quickly after surgery.

Eligibility Criteria:
Inclusion Criteria:

.After electrocision of intrauterine adhesions;

.Or after common gynecologic laparoscopic surgery，patients occurred muscle pain or patients occurred urinary retention.

Exclusion Criteria:

* Pregnancy;
* Suspected acute inflammation of the genitourinary system;
* Postoperative persistent vaginal bleeding;
* Patients have vaginal stenosis;
* Patients have implantation of a pacemaker with a cardiac pacemaker;
* Patients have a malignant pelvic organ tumor; .Patients have nervous system disease (dementia or unstable seizures),who cannot actively cooperate with the treatment.
USING THE ACCUVEIN DEVICE FOR PATIENTS WHO ARE DIFFICULT TO PERFUSE

Prior to any examination related to the clinical investigation, the investigator (IDE) will check the eligibility criteria of the person undergoing the research, and will inform and obtain the free, informed and written consent of the person undergoing the research.

The patient will then be randomised into one of two groups (insertion of a intravenous route with the AccuVein device vs. insertion of a VVP without the AccuVein device). After randomisation, the TEC or qualified person starts the stopwatch as soon as the tourniquet is applied.

The nurse makes a first attempt to perfuse the patient. The TEC or the qualified person will stop the stopwatch when the nurse checks the patency of the first attempt at perfusion and signals its success, or when the nurse withdraws the needle if the first attempt is unsuccessful. The pain felt by the patient will be assessed by the nurse using the self-assessment scale from 0 to 10 at the end of the first attempt.

If the first attempt at VVP insertion fails, the choice of conditions and personnel involved in carrying out further attempts will be left to the discretion of the nurse.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients who are difficult to infuse according to the nurse's subjective assessment after the tourniquet has been applied; this may particularly concern patients who are obese, dark-skinned, multi-drug users, sickle-cell anaemia sufferers, drug addicts, elderly with fragile skin and subcutaneous haematomas
* Patients with a medical prescription for intravenous route
* Patients affiliated to a social security scheme
* For women of childbearing age: effective contraception (oral contraceptives, intra-uterine devices or condoms) or post-menopausal women (no menstrual period for 12 months).
* Patient has read and understood the information letter and signed the consent form

Exclusion Criteria:

* Contraindication to fitting a intravenous route (burns to all four limbs, etc.)
* Extreme urgency to have a intravenous route, incompatible with the study, because of a loss of chance due to loss of time
* Patients unable to consent to participation in research
* Pregnant or breastfeeding women or women in labour
* Person deprived of liberty by administrative or judicial decision or person placed under court protection/guardianship or curatorship
Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea

Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most cases, a child born before 24 years of age is stillborn, but in about one in three cases, it shows signs of life such as heartbeat, breathing, gasps or limb movements.

With these too small children showing signs of life, three attitudes are possible: doing nothing and waiting for this life to stop by themselves, setting up palliative care to ensure the child's comfort, or administering a medication to shorten his or her life. The attitude to have is not univocal and the feeling of the teams confronted with their management is difficult even if the goal of the caregivers is always to act as best as possible.

The main objective of the study is to describe the clinical state of the child and the practices implemented in the birth room at the Nice University Hospital when children showing signs of life before 24 weeks of amenorrhea are born.

The secondary objective is to describe caregivers' experiences, their experiences of these situations and attitudes towards children and their parents, and to identify ethical dilemmas in these situations.

This study is an observational cohort study including all births of live children before 24 weeks of amenorrhea at Nice University Hospital for 12 months. It consists of two parts: a quantitative study describing the child's condition and caregiving practices, and a qualitative study of caregivers' experiences and the determinants of their attitudes towards the child.

The investigator will coordinate the collection of the data necessary to conduct the quantitative study, and then conduct individual semi-directive interviews with each of the caregivers present at the birth of the child. The qualitative study will be based on the analysis of these interviews.


Eligibility Criteria:
Inclusion Criteria:

* Child born before 24 weeks of amenorrhea (term estimated by echographic dating or by the date of the last menstrual period in the absence of ultrasound)
* Inscription in the birth register (so from 15 weeks of amenorrhea)
* Non-opposition of the parents

Exclusion Criteria:

- Child transferred to neonatal intensive care unit.
Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa

The purpose of this study is to investigate areas of the brain responsible for self-regulation in adult women who have never had an eating disorder with women who have bulimia nervosa. More specifically, investigators are interested in changes in brain activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and regulating emotions. Data collection will rely on a technology called functional magnetic resonance imaging (fMRI).


Eligibility Criteria:
General Inclusion Criteria:

* Female
* Right-handed
* Between the ages of 18 and 35 years

  \*For Women with Bulimia Nervosa:
* Binge eating (i.e., eating a large amount of food while experiencing a sense of loss of control)
* Purging via self-induced vomiting (other methods may also be endorsed)

General Exclusion Criteria:

* Current significant medical illness or condition (e.g., diabetes, thyroid disease)
* Pregnancy, planned pregnancy, or lactation during the study period
* Non-removable metallic objects in the body
Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone

Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management of kidney stone by topical administration of drugs? In order to secure fewer complications in ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human to determine its potential of lowering intrarenal pressure.


Eligibility Criteria:
Inclusion Criteria:

* Indication for RIRS procedure
* Age \> 18 years
* Normotensive
* Capable of understanding information given

Exclusion Criteria:

* Previous myocardiac infarct
* Daily use of alpha- og beta- blocking medicine og calcium antagonists
* Use of NSAID the last 2 days
* Stone in the ureter
* Declared
* Known malignant disease in urinary tract
* Bladder disease
* Nephrostomies inserted
* JJ-catheters inserted
* Prisoners
* Pregnant
* Nursing mothers