cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation

The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking.

Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

* non tobacco cigarettes consumption
* chronic use of marijuana
* pregnancy, breastfeeding
* any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change
7 Year Follow up Analysis on the Speed of Progression of Tooth Wear Using 3D Subtraction

Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and 1, 3 5, and the 7-year recall digital 3D scans will be made, which will be compared and subtracted.

Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and the 5-year recall digital 3D scans will be made, which will be compared and subtracted. Per tooth the loss of material is measured in maximum loss in height (µm) and volume (mm3) per year, using best fit alignment and 3D subtraction.

The loss of tooth material will be analyzed using descriptive statistics and possible effects of jaw type, tooth type and cusp type will be analyzed using multi level regression models.

The use of index teeth will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Generalized tooth wear
* A minimum of three posterior teeth (premolars and molars) per quadrant
* A maximum of one edentulous space in need for treatment, with a maximum span of one tooth-width

Exclusion Criteria:

* ASA 4
* Edentulous space has a span exceeding 1 tooth-width, or more than one space
* Functional problems (mouth opening \<5cm, Temporomandibular Dysfunction)
* Severe periodontitis
* Strong gag reflex
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs

Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).

The study analyzed the risks that the IUD was expelled or perforated the womb for the following group comparisons:

* Women who were breastfeeding at the time of IUD insertion and within 52 weeks postpartum versus women who were not breastfeeding at the time of IUD insertion and within 52 weeks postpartum.
* Women who had a first observed IUD insertion within different time periods after childbirth (i.e., ≤ 6 weeks, \> 6 weeks and ≤ 14 weeks, \> 14 weeks and ≤ 52 weeks) versus women who had their first observed IUD insertion more than 52 weeks after childbirth, including women without a recorded delivery within the past 52 weeks. An additional analysis involved 5-level postpartum timing (i.e., 0 to 3 days, 4 days to ≤ 6 weeks, \> 6 weeks to ≤ 14 weeks, \> 14 weeks to ≤ 52 weeks) versus the \> 52 week postpartum group.

The study also analyzed the risks that the IUD was expelled or perforated the womb for different types of IUDs. In addition, the study aimed to assess the following interactions:

* The extent to which the type of IUD (IUDs releasing the hormone LNG versus Copper IUDs) modified the risk that an IUD was expelled or perforated the womb in relation to breastfeeding and/ or in relation to the point in time when the IUD was inserted after childbirth.
* The extent to which the breastfeeding status modified the risk that an IUD was expelled or perforated the womb in relation to the point in time when the IUD was inserted after childbirth.


Eligibility Criteria:
Inclusion Criteria:

* Women with evidence in the database of insertion of an IUD (e.g. levonorgestrel-releasing, copper) during the study time window for each site
* Enrolled in the database with electronic medical records available for review for at least 12 months before the IUD insertion

Exclusion Criteria:

- Women with more than 50 years of age at the time of the IUD-insertion
Timing And Typology of ConducTIon disturbanCes During TAVI

The TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational. The registry is planned to continue until the calculated sample size is achieved.

All patients since February 2023 treated successfully with TAVI until the study endpoint will be deemed suitable for inclusion in the registry. The registry will:

1. collect the baseline clinical features of the study population.
2. evaluate the electrocardiogram (ECG) and contrast tomography (CT) scan parameters.
3. collect procedural characteristics including type and timing of any conduction disturbance
4. collect follow-up data including post-procedural ECG, echocardiographic and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

Patients successfully undergoing transcatheter aortic valve implantation for native severe aortic stenosis.

-

Exclusion Criteria:

1. Presence of previously implanted permanent cardiac pacemaker.
2. Valve-in-valve procedures.
3. No pre-procedural electrocardiogram is available.
4. No pre-procedural contrast CT TAVI is available.
5. Enrollment in another clinical trial.
6. Patients aged less than 18 years old.
7. Patients who do not consent for their data to be included in the registry.
8. Failed transcatheter aortic valve deployment. -
Expiratory Muscle Function in Critically Ill Ventilated Patients

Inspiratory muscle weakness develops rapidly in ventilated critically ill patients and is associated with adverse outcome, including prolonged duration of mechanical ventilation and mortality. Surprisingly, the effects of critical illness on expiratory muscle function have not been studied.

The main expiratory muscles are the abdominal wall muscles, including the external oblique (EO), internal oblique (IO) and transversus abdominis muscles (TRA). These muscles are activated when respiratory drive or load increases, which can be during e.g. exercise, diaphragm fatigue, increased airway resistance, or positive airway pressure ventilation. The abdominal wall muscles are also critical for protective reflexes, such as coughing. Reduced abdominal muscles strength may lead to decreased cough function and thus inadequate airway clearance. This will lead to secretion pooling in the lower airways, atelectasis, and ventilator associated pneumonia (VAP). Studies have shown that decreased cough function is a risk for weaning failure and (re)hospitalization for respiratory complications. Further, high mortality was found in patients with low peak expiratory flow.

Considering the importance of a proper expiratory muscle function in critically ill patients, it is surprising that the prevalence, causes, and functional impact of changes in expiratory abdominal muscles thickness during mechanical ventilation (MV) for critically ill patients are still unknown.

Ultrasound is increasingly used in the ICU for the visualization of respiratory muscles. In a recent pilot study the investigators confirmed the feasibility and reliability of using of ultrasound to evaluate both diaphragm and expiratory abdominal muscle thickness in ventilated critically ill patients (manuscript in preparation). Accordingly, the primary aim of the present study is to evaluate the evolution of abdominal expiratory muscle thickness during MV in adult critically ill patients, using ultrasound data.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Invasive mechanical ventilation \< 48 hours
* Expected duration of mechanical ventilation \> 72 hours

Exclusion Criteria:

* Past medical history of neuromuscular disorders
* Mechanical ventilation \> 48 hours within the current hospital admission
* Pregnant women
* Open abdominal wounds at proposed location of the ultrasound probe, due to recent abdominal surgery
Uro-DNA Collection for Expanded Genome-Wide Association Study (GWAS) of Renal Cell Carcinoma (RCC)

In the last decade, investigators from the Department of Cancer Epidemiology and Genetics (National Cancer Institute, USA) have conducted genome-wide association (GWAS) studies of renal cell carcinoma.

Dr. Mark PURDUE and Dr. Stephen CAHNOCK (Department of Epidemiology of Cancer and Genetics, NCI) propose to expand their genome-wide association study (Expanded GWAS) by genotyping approximately 10,000 additional cases of kidney cancer patients, in collaboration with US institutions, South-American and European.

This study describes the participation of the French Kidney Cancer Research Network (UroCCR) in the Expanded GWAS research, under the coordination of Professor BERNHARD (Bordeaux University Hospital).

The aim of the Expanded GWAS study is to better understand the role of common genetic variants in susceptibility to renal cell carcinoma (RCC).

The participation of the French UroCCR network consists in completing the bio-collection of the UroCCR cohort by preserving constitutional DNA and to provide DNA samples to the US NCI team.

This will increase the number of samples for meta-analysis and contribute to better identify clear cell kidney cancer susceptibility loci.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18,
* Confirmed cases of renal cell carcinoma (any RCC histology) of European or African origin,
* Patients included in the UroCCR study,
* Free, informed, written and signed consent by the participant and the investigator (at the latest on the day of inclusion and before any investigation required by the research) for specific blood collection for the purpose of DNA extraction,
* Programmed or ongoing management for kidney tumor,
* Constitutional DNA available (whole blood) for selected cases,
* Affiliated person or beneficiary of a social security scheme.

Exclusion Criteria:

* Patients below 18,
* Refusal of consent or participation.
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk

This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.


Eligibility Criteria:
Key Inclusion Criteria:

* Cohort 2: Confirmed medical history of LVH based on American College of Cardiology (ACC)/American Heart Association (AHA) guidelines and NYHA Class I at screening
* Cohort 3: Confirmed medical history of HF consistent with current ACC/AHA guidelines and NYHA Class I at screening
* Cohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines and NYHA Class I or II at screening

Key Exclusion Criteria:

* Active neurological disorder, such as uncontrolled seizure disorder.
* Current diagnosis of cancer or other known acute chronic infection, such as hepatitis B or hepatitis C, by medical history or an active infection requiring interventional therapy at screening.
* Shortness of breath, fatigue, heart palpitations, pain, or other limitations of physical activity
Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention

Preventing foot ulcers in people with diabetes can reduce costs and increase quality of life. Despite availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesise that a multimodal approach incorporating a variety of orthotic interventions that matches an individual person's need can reduce ulcer recurrence with beneficial cost-effectiveness and cost-utility.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 1 or 2
* Age 18 years or above
* Loss of protective sensation based on the presence of peripheral neuropathy
* A healed plantar foot ulcer or foot amputation in the preceding 4 years until two weeks before study inclusion
* In possession of custom-made orthopaedic shoes, defined as "Orthopaedic shoes type A" or "Orthopaedic shoes type B" , or Orthopaedic Provision in Regular Footwear (OVAC), according to the Dutch healthcare system
* Ability to provide informed consent

Exclusion Criteria:

* Foot ulcer or open amputation site(s)
* Active Charcot's neuroarthropathy
* Foot infection, based on criteria of the PEDIS classification
* Amputation proximal to the metatarsal bones in both feet
* Healed ulcer on the apex of digitus 2-5 as the only ulcer location in the past 4 years, as surgical intervention (flexor tenotomy) is a more likely and guideline-recommended treatment for such patients, rather than the multimodal care under investigation
* Severe illness that would make 12-months survival unlikely, based on the clinical judgment by the physician
* Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on clinical judgment
A Study of Tazemetostat on Safety in Participants With Relapsed or Refractory Follicular Lymphoma With Enhancer of Zeste Homolog 2 (EZH2) Gene Mutation in Japan

The primary purpose of the study is to investigate the safety of tazemetostat in participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation under daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation
2. Participants treated with tazemetostat

Exclusion Criteria:

1. Participants with a history of hypersensitivity to any ingredient of Tazverik
Surgical Outcomes for Proliferative Diabetic Retinopathy by Preoperative Glycemic Control and Renal Function

The surgical outcomes of 25-gauge vitrectomy for proliferative diabetic retinopathy has been evaluated by preoperative glycemic control and renal function

The purpose of this study is to evaluate the surgical outcomes of 25-gauge vitrectomy for proliferative diabetic retinopathy by preoperative glycemic control and renal function.

Eligibility Criteria:
Inclusion Criteria:

* The patients had25-gauge vitrectomy for proliferative diabetic retinopathy

Exclusion Criteria:

* The patients had hemodialysis , followed up less than 6 months, had vitrectomy for diabetic macular edema and macular ration but not macular detachment.
Effects of Bandaging and Kinesiotaping® in Patients With Total Knee Arthroplasty

The study aimed to compare the effectiveness of elastic bandaging, Kinesio taping, and short stretch bandaging techniques on postoperative pain, edema, and functional level in the early stage after total knee arthroplasty.

The study was conducted on 30 volunteer subjects who underwent unilateral total knee arthroplasty surgery. Thirty participants who underwent unilateral total knee arthroplasty were divided into the Elastic Bandage Group (n=10), Kinesio Tape group (n=10), and Short Stretch Bandage group (n=10). All treatments were stopped on the eighth day. All measurements taken preoperatively were repeated postoperative 1st, 3rd, 5th, 8th, 14th, 28th days, 6th week, and 3rd month. The functional level was measured in the sixth week and third month.

Eligibility Criteria:
Inclusion Criteria:

* 60 years or older patients who had undergone unilateral TKA surgery for primary knee osteoarthritis, rheumatoid arthritis, and posttraumatic arthritis.

Exclusion Criteria:

* Body mass index greater than or equal to 35 kg/m2,
* Having a neurological or peripheral vascular disease,
* Having a contraindication condition for compression application (e.g., acute cellulitis, arterial insufficiency, unstable heart disease, acute deep vein thrombosis), and kinesio taping application (e.g., presence of active infectious, lymphedema and/ or cancer history)
Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis

Acute necrotizing pancreatitis is a frequent and potentially lethal disease, especially in case of infected pancreatic necrosis (IPN). IPN usually occurs after the first week of evolution. The step up approach is now widely recommended for the management of IPN. In fact, in case of suspicion of IPN, a drainage percutaneous or transgastric is recommended at first, supported by probabilist antibiotherapy. 1/3 of patients won't require any other interventions. For 2/3 of patients, an additional necrosectomy is necessary. Necrosectomy was formally realized by open laparotomy. Since de last decade, mini-invasive technics have emerged: transgastric necrosectomy, video-assist retroperitoneal debridement. laparoscopy and permitted a decreased of morbidity and mortality. Recently, Hollemans et al. developed a nomogram based on 4 variables (sex, multi-organ failure, % of necrosis and collections heterogeneity) which are negative predictors for success of catheter drainage in IPN with an receiver operating characteristic (ROC) curve at 0.76. The aim of this study is to validate on a large retrospective cohort Hollemans nomogram in predicting catheter drainage success. Secondary aims are to evaluate possible others predictors for success of catheter drainage in IPN and to evaluate the impact of antibiotherapy on microbiological results and on the need for an additional necrosectomy regarding its type and duration, as well as the emergence of multiresistance organism.

Using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of acute necrotizing pancreatitis admitted to digestive liver disease unity or ICUs at the Nantes University Hospital, Rennes, Angers and Brest University Hospital from January 1, 2012, to december 31, 2017. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to success of catheter drainage or failure of catheter drainage, and the differences of these characteristics between two groups were evaluated. The Hollemans nomogram is evaluate and potential risk factors will be collected and studied by using multiple logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>18 years) with acute necrotizing pancreatitis
* IPN proven or highly suspected (proven=positive cultures on pancreatic collections or gas on CT, highly suspected= sepsis without any others infection)
* The need for a catheter drainage

Non inclusion Criteria:

* patients under 18 years
* lack of radiologic evidence to diagnose acute necrotizing pancreatitis,
* no suspicion or confirmation of IPN
* no need for a drainage
* unable to receive a drainage
* pregnancy
COMPARISON of the EFFECT of TWO DIFFERENT ANALGESIS TECHNIQUES in ABDOMINAL HYSTERECTOMY

Hysterectomy is one of the most commonly performed surgical procedures after cesarean section in many countries worldwide, especially among women of reproductive age. Postoperative pain is typically managed with oral and parenteral narcotics. Patient-controlled analgesia (PCA) is an effective pain management method that provides advantages such as faster pain relief, better dosage control, and elimination of the need for timer adjustments. Facilitating the recovery process and optimizing postoperative pain management are crucial components of perioperative care. To minimize systemic opioid requirements and opioid-related side effects, multimodal analgesia combining local anesthesia, peripheral, and non-opioid analgesics has become increasingly popular.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 65 years classified as ASA 1 and ASA 2.

Exclusion Criteria:

* Patients with allergies to the active substance, those with severe liver or renal insufficiency, a history of long-term nonsteroidal anti-inflammatory drug (NSAID) and opioid analgesic use, a history of gastrointestinal bleeding, peptic ulcer or inflammatory bowel disease, a history of diabetes or other neuropathic conditions, preoperative atrioventricular block and bradycardia, underlying serious respiratory diseases, a history of psychiatric disorders, patients classified as ASA stage 3 or higher, patients weighing less than 40 kg, patients unable to use the patient-controlled analgesia (PCA) device, and patients who need to discontinue the study medication during surgery for any reason will be excluded from the study
Novel Methods to Reduce Children's Secondhand Smoke Exposure II

The overall aim of the current study is to determine if the use of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing children's secondhand smoke exposure.


Eligibility Criteria:
Inclusion Criteria:

In order to be included in the study, participants must:

1. be the primary caregiver(defined as a person who spends the most time with the child and spends a minimum of 4 hours per day in the presence of the child) of a child between the ages of 3-11 (if caregiver has more \> 1 child between 3-11 years, we will include the youngest),
2. smoke at least 10 cigarettes per day for the past year,
3. indicate that they smoke around their child or in the car or home at least one time per week\],
4. have no intention of quitting smoking in the next 12-weeks,
5. aged 18-65 years,
6. be fluent in English,
7. have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension),
8. not currently pregnant, planning to become pregnant, or breastfeeding,
9. do not use non-cigarette tobacco (cigars, chewing tobacco)
10. have no prior use of any potential reduced exposure product,
11. have no major psychiatric impairment, including psychosis, suicidality, and/or any current alcohol/drug abuse or dependence

Exclusion Criteria:

Does not meet all of the requirements of inclusion criteria