cyrilzakka/clinical-trials huggingface dataset:
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]

The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use

Treatment of the metastatic renal cell carcinoma (mRCC) has experienced fundamental changes within a very short period of time. In the past few years, introduction of various new substances for the treatment of mRCC has therefore resulted in new scientific research questions. Temsirolimus and sunitinib are current standard therapies in the first-line treatment of mRCC. Inlyta® is a new substance that was developed for the treatment of mRCC after failure of sunitinib or cytokines.

Since August 2009, Torisel® is available as another treatment option for patients with mantle cell lymphoma (MCL). In addition, Sutent® is used for patients with non-resectable / metastatic gastro-intestinal stroma tumors (GIST) after failure or intolerability of imatinib.

The routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials. Therefore, the purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use.

Therefore, the following information is of particular interest in the course of the investigation:

* Efficacy (best response, overall survival, progression-free survival)
* Tolerability of the therapy (assessed by the physician)
* Safety profile (overall incidence of adverse events as well as side-effect rate) of subjects with mRCC, rMCL, and GIST under treatment with Torisel®, Sutent®, and/or Inlyta®
* Profile, comorbidities, and characteristics of subjects treated with Torisel® Sutent®, and/or Inlyta®
* The sequence of using the systemic therapies for RCC, MCL, and GIST
* Patient survey on the quality of life of mRCC patients

Eligibility Criteria:
Inclusion Criteria:

* Patients with proven tumor of RCC, MCL or GIST by histology.
* Informed consent signed by patient.

Exclusion Criteria:

* Pregnancy
Patient Specific Optimized Therapy (PSOT)

Data collection from atrial flutter patients before, during and after undergoing catheter-based electrophysiological (EP) intervention in order to develop a patient specific optimized therapy (PSOT) to improve specific patient's arrhythmia treatment for Atrial Flutter.

Prospective, single-center, non-randomized, open label, single arm study. Consented subjects who are scheduled to undergo ablation due to atrial flutter will be enrolled in the study. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 3 months.

KODEX - EPD™ system will be used in all procedures during treatment of cardiac arrhythmias.

Anonymized data will be stored in an EPD database and will be used to train and test predictors for personalized optimized therapy.

Data will be collected on paper and/or electronic forms and saved in the EPD Database.

Advanced data analysis will be used to map patient specific demographics, history, current ailment, intervention to patient outcome. The technology to be utilized will help develop a method to identify the personalized treatment for a given patient (defined by: patient's demographic, history, current ailment and intervention information to achieve optimal outcome).

Data will be anonymized by removing patient protected health information, only initials will be used. The data will be integrated to an EPD data base and will be used to train and test predictors for personalized optimized therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject signed a written Informed Consent form to participate in the study, prior to any study related procedures.
* Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
* A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
* Subject is deemed amenable to therapeutic ablation for atrial flutter.

Exclusion Criteria:

* Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
* Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
* Patient had experienced previous stroke (TIA or CVA).
* Thrombi detected in the heart.
* Known marked valvar insufficiency.
* Life expectancy less than 12 months.
* Known severe renal insufficiency.
Mater-Bronx Rapid HIV Testing Project.

In the M-BRiHT study we aim to implement a programme of opportunistic HIV screening in the Emergency Department, Mater Misericordiae University Hospital. We hypothesize that such a programme will be acceptable in an Irish setting. We also wish to study the factors that influence test completion or acceptance. We will utilise informative interactive video media via a touch-screen tablet device to provide pre-test counselling and then offer rapid minimally invasive testing with a cotton-bud type swab of the buccal mucosa. In doing so we will to determine absolute numbers of those attending the ED who consent to watching the interactive information video about rapid HIV test screening. We will describe the absolute number and proportion of those who watch the interactive video who subsequently proceed to have the rapid HIV test. The primary aim is to determine the cultural, gender and ethnic factors which influence the completion of such rapid HIV testing with the future objective of maximising test completion in this crucial public health area.


Eligibility Criteria:
Inclusion Criteria:

* All adults greater than 18 years of age who present to the Emergency Department, Mater Misericordiae University Hospital
* Must have capacity to consent to watch an interactive video tablet device about HIV and HIV screening test.

Exclusion Criteria:

* HIV positive patients (known previous HIV positive patients).
* Acute intoxication in which capacity is impaired
* Critically unwell patients who require active or intensive resuscitation.
* Acute psychiatric disturbance in which capacity is impaired
Effectiveness of an Adapted Physical Activity Program on Improving the Health-related Quality of Life of Women with Endometriosis in Martinique

There is no specific treatment for endometriosis, because the pathophysiology is poorly understood.

Adapted physical activity (APA) is recognized as a beneficial supportive care for patients suffering from chronic pathology. Adapted physical activity can play a role in managing endometriosis symptoms. Studies have shown that regular physical exercise can help reduce pain, improve quality of life and alleviate symptoms related to chronic diseases.

However, it is known that few women with endometriosis have regular physical activity because of pain, chronic fatigue that lead to activity limitation or even disability.

This study provides an opportunity to evaluate the impact of regular APA practice on improving the quality of life and symptoms of women with endometriosis in Martinique.

Based on this, APA could be included in the endometriosis care pathway in Martinique.

The investigators' hypothesis is that APA improves the overall quality of life of women with endometriosis and also has a positive impact on pain, functional abilities and sleep. The effectiveness of the proposed adapted physical activity program also improves the psycho-social and professional impact of the disease in the daily lives of patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult woman of childbearing age,
* Clinico-radiological or clinico-histological diagnosis of endometriosis: laparoscopy with biopsy or MRI,
* History of endometriosis symptoms before diagnosis,
* Walking without technical assistance,
* Able to read and write,
* Patient wishing to improve her health by optimizing her lifestyle,
* Patient affiliated or beneficiary of a social security scheme,
* Patient having given free, informed and written consent.

Exclusion Criteria:

* Acute or terminal illness,
* Recent fracture of the upper or lower limbs (\< 3 months),
* Other chronic unstable or orthopedic illness that could interfere with the ability to participate in a physical activity program,
* Resting ECG at inclusion outside the normal range,
* Patients who practice moderate to intense physical activity for more than 150 minutes per week,
* Absolute contraindication to physical activity linked to severe co-morbidities,
* Patient placed under legal protection, guardianship or curatorship,
* Pregnant or breastfeeding woman.
Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects

This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study.

A screening will be used to determine subject suitability for inclusion in the trial. Subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Phenylephrine suppositories at various doses) will be administered at pre-determined intervals.

This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject suitability for inclusion in the trial. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Phenylephrine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Phenylephrine analysis.After determining baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 1 Coated Suppository per study. 60, 120 and 240 minutes after the coated suppository insertion amnometric studies will be performed: The first 2 subjects in the study will receive 40 mg phenyephrine coated suppositories. If significant (\> 15%) increase in the resting anal pressure will occur with this dose, the rest of the study subjects will receive the same dose. If the raise in the resting anal pressure will not be significant AND no adverse events was observed, than the following subjects will receive 80 mg phenylehprine coated suppositories.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Male or female subjects 18 to 55 years of age.

Exclusion Criteria:

* Active or chronic disease.
* In need of chronic use of medication, with the exception of birth control medications.
* Currently uses medication for acute illness.
* Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin, Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
* Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
* Receipt of any investigational treatment (drug or device) within 90 days prior to screening.
Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries

Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (T group and F group). Using computer generated randomization table; each group consists of 51 patients:Group (T) (n=51): Patients will receive preemptive intravenous infusion of tramadol plus paracetamol .

Group (F) (n=51): Patients will receive preemptive intravenous fentanyl.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for day case surgeries.
* Patient acceptance to be included into the study.
* Both sex.
* Patients with ASA physical status I, II.
* BMI 25 - 30 kg m-2.
* Duration of surgery from 1-2 hours

Exclusion Criteria:

-Uncooperative patients and patients with psychological problems.-

* Patients with liver or renal impairment.
* Patients with history of allergy to drug used in the study.
* Patients with chronic pain.
* Patient on pain therapy.
Evaluation Of New Onset Postoperative Atrial Fibrillation

This is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, CABG procedures compared to subjects that do not undergo pericardial closure. This trial will be conducted at up to 20 clinical sites in the U.S.

The objective of this prospective clinical trial is to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures as compared to subjects who did not undergo pericardial closure. Safety will be established by demonstrating that the composite clinical event rate for the ECM treatment group is not worse than the control group that did not undergo pericardial closure. The efficacy will be established by demonstrating a reduced incidence of new onset postoperative atrial fibrillation in the ECM treatment group as compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* The subject is 18 years of age or older
* This cardiac operation is the subject's first or primary cardiac operation
* The subject must be undergoing an isolated CABG procedure using a median sternotomy approach
* The subject must possess the ability to provide written Informed Consent
* The subject must express a willingness to fulfill all of the expected requirements of this clinical protocol

Exclusion Criteria:

* Prior history of atrial fibrillation
* Prior history of open heart surgery
* Prior history of pericarditis
* Prior history of anti-arrhythmia drug treatment (e.g., amiodarone, dronedarone or sotalol) in the past six months
* The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers)
* Concomitant procedure planned
* In the investigator's opinion, the subject may require prophylactic treatment with anti-arrhythmia drugs or temporary pacing postoperatively
Vascularity of the Ulna and Its Association With Forearm Nonunion

Non-union after operative treatment of an ulnar fracture is very uncommon. There are severely disabling and challenging to treat. Multiple factors have been associated with the establishment of this non-union. Many non-unions are associated with soft tissue damage, fracture site vascularity, persistent instability, infection, and the surgical treatment technique. This study analysed the systemic conditions and local factors associated with the failure of bone fracture healing The aim of our study was to identify the risk factors for ulnar nonunion

In the anatomical study we investigated the extraosseous and intraosseous blood supply in fourteen specimens from the Department of Human Anatomy. We correlated the areas with a low vascularity with the usual areas that patients have ulnar nonunion.

In the clinical study we retrospectively reviewed a cohort of ulnar fractures treated surgically with open reduction and internal fixation (ORIF), during a period of 10 years (2007-2016). We identified 211 ulnar fractures. All patients had a minimum follow-up of 1 year. We defined non-union if there was no radiological consolidation of the fracture after this period, and we classified them according to Weber classification. We assessed risk factors like: fracture site vascularity, surgical treatment technique, biological factors of the patient, and the fracture's mechanism. We correlated data and associated risk factors from the anatomical and the clinical studies.

Data were analysed using SPSS software system version 21. Multivariate regression analysis was performed to assess independent risk factors of ulnar non-union. Chi square test or Fisher exact test was used to compare categorical measurements. Statistical significance was considered as p less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 90 years old
* Forearm ulnar nonunion

Exclusion Criteria:

* Children
* Other types of forearm fractures
A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to complete the micturition diary and questionnaires correctly
* Patient has symptoms of overactive bladder for ≥ 3 months
* Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
* Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period

Exclusion Criteria:

* Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
* Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Patient has an indwelling catheter or practices intermittent self-catheterization
* Patient has diabetic neuropathy
* Patient has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Patient receives non-drug treatment including electro-stimulation therapy
* Patient has severe hypertension
* Patient has a known or suspected hypersensitivity to YM178, other beta-adrenoreceptor (ß-AR) agonists, or any of the other inactive ingredients
* Patient has been treated with any investigational drug or device within 30 days
* Patient had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period
* Patient has serum creatinine of \>150 μmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x upper limit of normal range (ULN), or Gamma glutamyl transferase (γ-GT) \> 3x ULN
* Patient has a clinically significant abnormal electrocardiogram (ECG)
Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD).

The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.

The TMF-Allo study is a prospective, open-label, multi-center, parallel, randomized phase II clinical trial comparing a group patients with FMT and a control group of patients without FMT.

The main objective of this study is to assess the effect of allogeneic FMT versus no treatment on Graft-versus-host disease and Relapse-Free Survival (GRFS) at one year in adult patients treating with myelo-ablative allo-HSCT for haematologic malignancy.

The secondary objectives are to evaluate :

* Overall survival, progression-free survival at 1 and 2 years,
* The haematological evolution,
* The evolution of infections,
* The tolerance and safety of the TMF carried out in post-transplant,
* The evolution of the composition and diversity of the microbiota in allograft patients receiving TMF or not.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over
* Men and women
* Patients affiliated with a social-security organization
* Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood)
* Signed and dated informed consent

Exclusion Criteria:

* Status of tumor progression at the time of allo-HSCT
* Inability to understand the protocol (linguistic barrier, cognitive difficulties)
* Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma)
* Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis)
* Fecal incontinence
* Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of GvHD, or studying the effectiveness of a FMT in another indication.
* Pregnant women
* Patient under guardianship, curatorship or protection of justice