cyrilzakka/clinical-trials huggingface dataset:
Cryolipolisis for Abdomen and Flank Fat Reduction

Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion Cryolipolysis. The region will be treated according to the individual need, in the region of abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60 and 90 days after randomization. Blood collections will also be performed at baseline and between 14 and 21 days after randomization for evaluation of lipid profile and liver function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Body mass index \> 29.9 Kg/m2

Exclusion Criteria:

* Pregnancy
* Diabetes
* Cancer
* Vascular diseases
* Heart diseases
* Liposuction or other surgical procedures for body contouring
* Active infection
* Wounds
* Paroxysmal cold hemoglobinuria
* Cold urticaria
* Significant weight changes in the past 3 months or during treatment
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain

The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of cancer pain.

This study will evaluate the safety of the matrix fentanyl patch. The study will be conducted in opioid-tolerant patients with moderate to severe cancer pain currently taking an around-the-clock opioid. Patients will discontinue their current opioid regimen and begin using ZR-02-01 as soon as possible under the direction of the physician investigator upon entry into the study. Patient's dose of ZR-02-01 will be determined by the investigator using sponsor-provided conversion. Pain therapy will be under the supervision of the physician investigator.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 and no older than 75 years of age at the time of screening
* Patient has a diagnosis of cancer
* Patient has moderate to severe pain that is related to cancer or its treatment and is expected to last indefinitely and is currently taking an around-the-clock opioid to treat his/her pain
* Patient is already receiving opioid therapy, has demonstrated opioid tolerance
* A responsible adult caregiver is available in the event of an emergency at home

Exclusion Criteria:

* Patient has uncontrolled or rapidly escalating pain as determined by the investigator
* Patient has a history of substance abuse or has a substance abuse disorder
Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer

Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.

Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population

The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment.

The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy.

200 randomized patients are required.

The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).

Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven non resectable pancreatic adenocarcinoma
* Indication of palliative chemotherapy
* Life expectancy ≥ 3 months
* Eastern Cooperative oncology group (ECOG) - Performance status ≤2
* Age ≥18 years old
* At least one measurable lesion as assessed by CT-scan or MRI (Magnetic resonance Imaging)
* Identified Accompanying partner Adapted Physical Activity (AAPA)
* Signed and dated informed consent
* Registration in a National Health Care System (CMU included for France)

Exclusion Criteria:

* Previous Cerebrovascular accident or myocardial infarction \<6months
* Uncontrolled hypertension.
* Severe cardiovascular or respiratory disease
* Severe cognitive or psychiatric disorder
* Severe motor and/or sensory neuropathy
* Rheumatologic or orthopedic problem or bone lesions with a fracture risk
* Others comorbidities contra-indicated physical exercises
* Patient protected by the law - Guardianship and trusteeship
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure

The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction.

The purpose of this study was to evaluate the effect of sacubitril/valsartan in improving erectile function in male patients with chronic heart failure (NYHA II) and reduced ejection fraction (HFrEF) and erectile dysfunction (ED). Data from this study was intended to provide a thorough understanding of the impact of sacubitril/valsartan on male sexual function and therefore quality of life.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients with a diagnosis of chronic heart failure (NYHA class II) and reduced ejection fraction (LVEF \< 40%)
* Patients must be living in a stable and sexually active heterosexual partnership for at least 6 months prior study start
* Patients must have a mild to moderate erectile dysfunction (determined by using the IIEF-5 questionnaire)
* Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior study start
* Patients must be literate in German

Key Exclusion Criteria:

* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes, ACEIs, ARBs or NEP inhibitors, as well as known or suspected contraindications to the study drugs
* Previous history of intolerance to recommended target doses of ACEIs or ARBs
* Known history of angioedema
* Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
* Symptomatic hypotension
* Impaired renal function
* Penile anatomical defects and Peyronie's disease
* Diabetes mellitus Type I or insulin-dependent Type II
* Known prostate cancer
Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma

The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.

The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria:
* Willing to sign ICF
* Above 18 years
* KPS score≥70
* Expected survival time more than 90 days
* Subjects with EGFR overexpression (2+ or 3+ in IHC)
* With target lesions in spiral CT or MRI examination within 30 days
* Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and Paclitaxel agent.
* Lab test of baseline meet following criteria
* Hemoglobin higher than 9.0g/dL
* Neutrophil higher than 1,500/mm3
* PLT higher than 10.0 104/mm3
* Bilirubin lower than 1.5 times of upper limit of normal range
* AST,ALT,ALP lower than 2.5 times of upper limit of normal range
* Creatinine lower than upper limit of normal range
* When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range

Exclusion Criteria:

* Patients who have received irinotecan
* Patients who are allergic to irinotecan or nimotuzumab.
* Other active malignancy within the last 5 years
* Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
* Investigator judge not eligible to this trial
Detection of Methylated Reprimo in Plasma for Asymptomatic Gastric Cancer

In this proposal the investigators aim to develop a commercial kit to be used in primary screening and non-invasive triage for early detection of gastric cancer. This kit will be cost-effective and more accessible to the general population. In addition, the investigators would like to expand our current patent already submitted to INAPI (National Institute for Intellectual Property) and propose royalties to biomedical diagnostic companies for the use of our product at international level.

Gastric cancer is the first cause of death in Chile and the second worldwide. Currently, no screening methods are available for early detection of gastric cancer at population level. The only available test is serum levels of pepsinogen I/II for gastric atrophy, a precursor lesion only for intestinal type with low risk to progress to gastric cancer. The investigators' previous work, supported by FONDECYT (National Council for Research and Technology) and FONIS (National Council for Research and Development of Human Health) both from the Government of Chile led us to discover a potential biomarker for early detection of gastric cancer, Reprimo, a tumor suppressor gene related to p53 in the arrest of G2-M of the cell cycle (Clin Cancer Res. 2008;14:6264-9). Here, the investigators propose to evaluate plasmatic detection of Reprimo in conjunction with gastric atrophy markers and H.pylori detection to establish a novel screening and triage strategy for early detection of gastric cancer. The aims are i) to determine sensitivity and specificity for Reprimo in the detection of gastric cancer in a high-risk population evaluated by upper gastrointestinal endoscopy (1,000 males, 30-74 y.o. low income, symptomatic or asymptomatic) and ii) to characterize at clinical, pathological and molecular level cases of gastric cancer identified and non-identified by direct detection of Reprimo along with atrophy, H.pylori and clinical markers. With this information, the investigators will develop an algorithm for screening and triage evaluating predictive values of plasmatic detection of Reprimo versus atrophy \& H.pylori detection and clinical data in a general population (3,000 male/female, 40-70 y.o.) from a high-risk area for gastric cancer in Chile. In this step the investigators will evaluate also acceptability, efficacy and efficiency of the proposed algorithm. In this proposal the investigators aim to develop a commercial kit to be used in primary screening and non-invasive triage for early detection of gastric cancer. This kit will be cost-effective and more accessible to the general population. In addition, the investigators would like to expand the investigators' current patent already submitted to INAPI and propose royalties to biomedical diagnostic companies for the use of the investigators' product at international level.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age 40-70 y.o.

Exclusion Criteria:

* Gastric Cancer
* Dyspepsia
* Bleeding disorders
Internationally Adopted Children Quality of Life

This study evaluates the global quality of life of foreign born adopted children, one to seven years following their arrival in France. Investigators will assess global health, behavior, school integration for each child who arrived in France between 2008 and 2013, through an online anonymous survey. Investigators, then, will identify variables associated with a lower quality of life in order to improve the support offered to the children.

Investigators will use a known and official quality of life score: the PedsQL®. This score has never been used in this population so investigators will first have to test its internal validity, so that investigators cannot use it in their global evaluation. The second stage will consist of identifying variables associated with a lower quality of life, as previously determined. Investigators will send letters to each family through the adoption department of each area enrolled in our study, to ensure data. Parents and children will be required to login to a safe, anonymous, controlled website in order to input their data. The data will be recorded on the internal server of Nantes University Hospital. This study has been accepted by both the Computing and Liberties Commission (CNIL) and Nantes University Hospital's Ethics group in the field of Health (GNEDS) comities.

Eligibility Criteria:
Inclusion Criteria:

* All international adopted children, who arrived in France between 2008 and 2013, living in four French districts (Loire-Atlantique, Ille et vilaine, Maine et Loire and Finistère) and accepting to fill the on-line questionnaire of the study

Exclusion Criteria:

* Children born in France.
* Children or adoptive parents refusing to participate.
The ReTAVI Prospective Observational Registry

Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure.

The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations.

Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year.

Between 1.4 and 2.8% of all patients undergoing transcatheter heart valve (THV) implantation require a second THV implanted into the previously implanted THV because of clinically significant aortic regurgitation \[1-3\]. 90% of THV-in-THV implants were considered successful although the mortality in the redo-TAVI group was higher at similar STS risks as in those with a successful first implant.

Redo-TAVI may also be a promising treatment strategy in degenerated THVs, but there is insufficient knowledge which strategy and valve design may result in the best outcomes \[4\]. Evidence so far reported is based on case reports and small case series, but not on a prospective, multicenter documentation.

Currently, \~ 5% of THV are implanted in degenerated surgical bioprosthetic valves. With the expanded use of THV for treatment of lower risk patients with severe aortic stenosis (sAS), it is estimated that the number of patients requiring re-treatment for THV failure is likely to rise within the next years.

Eligibility Criteria:
Inclusion Criteria:

Consecutive patients fulfilling the following criteria:

1. Consenting adult patient (≥18 years)
2. Procedural success of the first TAVI
3. TAVI device failure of the index THV, irrespective of SVD severity
4. Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
5. The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI
6. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)

Exclusion Criteria:

1. Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
2. Life expectancy below 12 months
3. Patients with largely incomplete data with respect to the aims of the project
4. Pregnant women at the time of the redo-TAVI

Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.
Prospective Trial for Clinical Validation of "QOCA Disposable BLE Thermometer "

The purpose of this trial is to evaluate the accuracy and safety of the "QOCA Disposable Body Temperature Patch" (Q-temp-w1).

Q-temp-w1 is a contact type body temperature patch developed by Quanta Computer Co., Ltd. It is mainly used to measure the body temperature of the human body. It can be used for general body temperature measurement, home temperature measurement records and medical tracking. Both the European Union and the US FDA state that the clinical test methods of the temperature patch must comply with ISO 80601-2-56. Therefore, this test plan will follow the ISO 80601-2-56 criteria to evaluate the accuracy of the temperature patch and follow it. The sampling age range and the fever/non-fever ratio are stratified, and clinical efficacy analysis is performed based on the measurement results. The main evaluation indicators include clinical bias, limits of agreement, and clinical repeatability.

Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female aged between 0-100 years.
* 2. Patient agrees to participate in the trial and sign informed consent.

Exclusion Criteria:

* 1. Those who have any broken skin or skin diseases on the part of the body which is the test site of the BLE thermometer, Including the underarms and the back of the body.
* 2. Those whose test site of the BLE thermometer are known to be contaminated by uncle arable body fluids, or lead to the inaccurate of the BLE thermometer.
* 3. Those who have restlessness or other conditions that make them unable to tolerate the temperature measurement procedure.
Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin

Our study evaluates the efficacy of IGIV treatment in PPS on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with PS at Montpellier's Hospital

Patients are admitted to a multidisciplinary consultation (neurologist, PMK) to validate the indication of treatment with IGIV. Realization of a pre-therapeutic evaluation in the department of MPR on the criteria of judgment, then the patient is admitted in a service of neurology to benefit from the cure of IGIV. The patient is then re-admitted to a PMR service for post-treatment evaluation.

Collection of data retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PPS
* Pre- and post-therapeutic evaluation carried out
* Data transcribed in the computerized patient file

Exclusion Criteria:

* No walking patient
Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole in Lower Third Molar Removal

The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal anti-inflammatory drugs (NSAIDS). The present study aims to evaluate in a double blind, randomized and crossover manner the clinical efficacy of ketoprofen (immediate release - 100 mg) and ketoprofen in association with omeprazole (modified release - 200 mg ketoprofen with 20 mg omeprazole) in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. After collection, data will be analyzed by means of graphs and tables to allow the appropriate analyses. Paired t-test will be used to compare the duration of surgeries. Nonparametric Wilcoxon test will be used for the analysis of "rescue medication" and postoperative pain parameters (visual analog scale). Data of "mouth opening" and "swelling" will be statistically analyzed through analysis of variance (ANOVA) followed by Tukey's test for multiple comparisons. Statistical significance will be set at 5%. Results will be presented as mean ± standard deviation of the mean.

Studies have shown that NSAIDS exert their therapeutic effect by the inhibition of cyclooxigenases (COX) 1 and 2, which determines the inhibition of prostaglandins production whose effects potentiate the action of many inflammatory mediators. The protocol for the administration of these formulations will involve the administration of a tablet of the immediate release product (100 mg) every 12 hours, and one capsule of the modified release product (200 mg ketoprofen with omeprazole) every 24 hours, during 4 days.

The following parameters will be analyzed:

1. subjective postoperative pain evaluation, with the aid of a visual analogue scale,
2. mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal),
3. beginning and duration of the surgery after anesthetic administration,
4. incidence, type and severity of adverse reactions,
5. total amount of rescue analgesic medication (paracetamol),
6. facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery).

Eligibility Criteria:
Inclusion Criteria:

* Need of lower third molar surgeries in similar positions

Exclusion Criteria:

* Presence of systemic diseases;
* Presence of local inflammation and/or infection;
* Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration;
* Cardiovascular, kidney or hepatic diseases;
* Patients who are making use of antidepressants, diuretics or anticoagulants;
* Asthma and allergy to aspirin, naproxen or any other nonsteroidal antiinflammatory drug;
* Regular use of any nonsteroidal antiinflammatory drug, pregnancy or breast feeding.