cyrilzakka/clinical-trials huggingface dataset:
PREEMIE: Study for Treatment of PDA in Premature Infants

This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Subject is age ≥5 days at time of enrollment.
* Subject has a diagnosis of a hemodynamically significant patent ductus arteriosus (PDA) requiring closure.
* Subject has a PDA is ≤4.0 mm in diameter.
* Subject has a PDA is ≥5 mm in length.
* Subject's weight is between 600-2500 grams at time of enrollment.

Exclusion Criteria:

* Subject has pre-existing coarctation of the aorta.
* Subject has pre-existing left pulmonary artery stenosis.
* Subject has an Intracardiac thrombus that may interfere with the implant procedure
* Subject has other known hemodynamically significant congenital heart disease conditions at time of enrollment requiring intervention, e.g., valvular atresia, Tetralogy of Fallot, atrial septal defect, ventricular septal defect, transposition of the great vessels, etc.
* Subject has an active systemic infection at the time of enrollment.
Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea

This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or respiratory comorbidities/disorders.


Eligibility Criteria:
Inclusion Criteria:

* Subject with newly diagnosed OSA (5≤AHI≤30 ev/h) or for whom treatment has failed (CPAP, mandibular repositioning device), or patients with snoring only (5\<AHI)
* BMI≤30kg/m²
* Patient with good motivation to use the nasal device,
* Informed consent signed,
* Patient with social protection.

Exclusion Criteria:

* Cardiovascular comorbidities (resistant hypertension, recurrent atrial fibrillation, left ventricular failure, coronary heart disease and stroke),
* Respiratory comorbidities (respiratory failure, chronic obstructive pulmonary disease (COPD),
* Patient with one or more documented contraindication to use Nastent™,
* no regular partner,
* contraindication for sleep endoscopy,
* Psychiatric or neurological disorders (epilepsy),
* Progressive cancer or chronic inflammatory disease,
* AHI including more than 5 central apnea per hour,
* Allergy to one component of Nastent™.
Autophagy in Paediatric Crohn's Disease

Crohn's disease is a multifactorial complex disease resulting in a between microbiota and immune system. Indeed, GWAS (Genome-Wide Association Studies) association study pinpointed polymorphisms as genes susceptibility on more than 200 loci. Among them genes coding for proteins involved in autophagy machinery (i.e: ATG16L1, IRGM et NDP52). Autophagy is a ubiquitous intracellular mechanism mandatory for protein and microorganism recycling.

So far, the role of autophagy in gut inflammation and intestinal homeostasis in Crohn's disease patients is partially understand. Then, investigators plan to evaluate, on native cells, the autophagic flux in pediatric patients suffering of a Crohn's disease compare to controls.


Eligibility Criteria:
Inclusion Criteria:

For Crohn's Disease group :

* Age between 6 and 17 inclusive
* Patients with a weight \> 25 kg at the time of inclusion
* Patients with Crohn's disease requiring ileocolonoscopy (diagnosis or follow-up)
* Mild to severe Crohn's disease consistent with PCDAI disease activity score
* Patients on nutritional therapy (Modulen/Modulife), corticosteroids, salicylic derivatives, immunosuppressants, biotherapies (anti-TNF, vedolizumab and ustekinumab) or without treatment
* Consent form signed by the patient or the holder(s) of parental authority.
* Affiliation to a social security scheme or beneficiaries of a similar scheme.

For Control group:

* Between 6 and 17 years old included
* Presenting a weight \> 25 kg at the time of inclusion
* Without a diagnosis of Crohn's disease
* Requiring evaluation by ileoendoscopy
* Consent form signed by the patient or the holder(s) of parental authority.
* Affiliation to a social security scheme or beneficiaries of a similar scheme.

Exclusion Criteria:

* Refusal to participate in the protocol
* Intercurrent infection
* Ongoing antibiotic treatment
* Patient involved in another interventional study protocol including an exclusion period still in progress at pre-inclusion
* Pregnant, parturient or breastfeeding women (on questioning)
* Persons deprived of their liberty by a judicial or administrative decision
* Persons subject to psychiatric care
* Persons admitted to a health or social establishment for purposes other than research
Randomized Control Trial for Overweight Employees in Worksites

Impact of lifestyle intervention in at-risk Asian Indians at worksite remains largely unexplored. The aim of this study was to assess impact of the multi-component interventions on body weight, body fat patterning and cardio-metabolic risk factors in overweight individuals working in corporate worksites in New Delhi, north India.

A randomized open label clinical trial is planned in 4 worksites. The total study duration is 18 months. Four workplace sites will be divided into two active intervention and two control sites. Intensive awareness generation activities for overweight and obese employees and a general awareness health, nutrition and physical education programme for the rest of the employees. The study subjects will be part of awareness sessions which will be conducted in the 6 month intervention period. Besides group sessions individual diet charts will also be worked out by a trained nutritionist. Physical activity advice will be provided to them keeping their specific requirements in mind. Pedometers will be provided to them and they will be encouraged to walk for 15 minutes in pre-lunch period. Leg movements at the desk will also be encouraged.

Eligibility Criteria:
Inclusion Criteria:

* Overweight (≥23kg/m 2 ) individuals in the age group 25-55 years
* Individuals who are willing to participate in the study

Exclusion Criteria:

* Previously diagnosed diabetics and patients with coronary artery disease.
* Have received any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, (e.g. metformin, thiazolidinediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors
* Pregnant and lactating women
* Severe end organ damage or chronic diseases:renal/hepatic failure, any malignancy, major systemic illness etc.
* Known case of HIV infection
* Unwillingness to participate in the study
Prospective Cohort of Transitional Urology Patients

A transitional Urology database was created in parallel with National Spina Bifida registry to follow patients with complex congenital urogenital anomalies and be able to prospectively evaluate them. The investigators obtained the standardized questionnaires to collect long-term data regarding patients' genitourinary status including urine and fecal continence, sexuality, fertility, and pelvic health.

The care and management of pediatric patients with congenital genitourinary anomalies transitioning to adolescents and later adults is undergoing a period of profound transformation. Due to improvements in surgical and nonsurgical interventions, children with diverse congenital disease affecting the genitourinary tract are surviving into adulthood at far higher rates than in the past. As an example, up to 70-75% of children born with a myelomeningocele and consequent neurogenic bladder are living past the age of twenty. These new expectations, especially in the areas of sexual function, fertility and reproductive health, are creating previously unseen challenges for health care providers attempting to transition adolescents from pediatric to adult care. As this patient population continues to grow, the transitional process for urological care of congenital anomalies is progressively becoming a topic of vital importance.

We plan to advance adolescence clinical and research care and pioneering a unique and novel opportunity in transitional care.

This database will help us: 1. To develop and revise (as necessary) standards of care and treatment best practices for patients transitioning to adolescents with congenital genitourinary malformation. 2. To share evidence-based information between physicians across the country, advancing best practices for the secondary conditions of spina bifida, exstrophy, neurogenic bladder and bowel, and hydrocephalus. 3. To implement benchmarks to improve care in transitional urology clinics. 4. Evaluate the clinical cost-effectiveness of care offered.

Eligibility Criteria:
Inclusion Criteria:

- Primary diagnosis of congenital genitourinary abnormality leading to neurogenic bladder such as myelomeningocele, exstrophy, cerebral palsy, posterior urethral valve, congenital cardiac anomalies, chromosomal abnormalities, etc.

Exclusion Criteria:

- Non congenital neurogenic bladder
Impact of Robotic Approach Compared to VATS and Open Approach on Quality of Life in Patients With Lung Cancer

The aim of the study is to compare quality of life and early and late post-operative pain after anatomical lung resection (lobectomy or segmentectomy) performed by a robotic approach compared to the videothoracoscopic approach (VATS) and the thoracotomic approach antero-lateral in patients with early stage lung cancer.


Eligibility Criteria:
Inclusion Criteria :

* known or suspected lung cancer clinical stage T1-T2;
* N0-N1 candidates for surgery lobectomy or anatomical segmentectomy;
* ASA-1-2-3;
* not severe heart disease;
* no alcohol;
* no renal impairment (creatinine \<2);
* not obese (BMI \<30);
* no evidence of other serious comorbidities in the opinion of the investigator.

Exclusion Criteria:

* severe heart disease;
* renal impairment (creatinine \>2.5);
* evidence of any serious comorbidities according to the investigator;
* malignant tumor in the previous 2 years;
* previous chest surgery.
Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening

Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.

Primary Objectives:

The overall purpose of this protocol is to evaluate the feasibility and acceptability of CHW-delivered selfsample HPV testing (CHW-SS) to increase cervical cancer screening among women in RGV and other low- resource communities in Texas.

The specific aims of this protocol are to:

Specific Aim 1: Determine the feasibility of CHW-SS in the RGV and other low-resource communities in Texas (i.e., reach, screening uptake, notification of test results).

Specific Aim 2: Assess the acceptability and experiences of CHW-SS among under screened persons in rural, persistent poverty communities in the RGV and other low-resource communities in Texas.

Secondary Objectives:

Exploratory Aim 3: Assess attendance for clinical follow-up among individuals who participate in CHW-SS and test positive for HR-HPV.

Exploratory Aim 4: Evaluate contextual fit of the intervention.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

* Provision of signed and dated informed consent form
* Currently resident in RGV or other low-resource community in Texas
* Stated willingness to comply with all study procedures
* Females; Age ≥25 years
* Have no history of hysterectomy with removal of the cervix
* Have no history of cervical cancer or high-grade dysplasia
* Have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Unable to communicate in English or Spanish
* Lack valid telephone contact information
* Report being currently pregnant.
Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients

The primary objective of this study is to assess the activity on breathing parameters of 4 escalating doses of AVE0657 in comparison to placebo in patients with Cheynes-Stokes Breathing Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Presence of Congestive heart failure (CHF) defined as ejection fraction ≤40% by history of echocardiography data and New York heart Association (NYHA) class II-III and of typical cyclic crescendo and decrescendo change in breathing amplitude AHI ≥10 and \<60 and majority of the apneas to be ≥60% central in origin.

Exclusion Criteria:

* Subject on supplemental oxygen

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Seeing Red: Clinical Assessment Tools for Clinical Trial Decision Support

This research aims to assess the utility and validate the inter-rater reliability of the new nursing documentation tools for commonly encountered moisture-associated skin damage including (incontinence-associated dermatitis (IAD) and intertrigo (ITD)) at Valley Regional Hospital.

This is an exploratory study to assess the utility and accuracy of a structured documentation tool for IAD and ITD in hospitals. Current documentation involves a mostly verbal description of the location, size, and general features of the rash. Without a standardized approach to documentation, it can be challenging to accurately evaluate the evolution of the rash and the response to treatment from day to day and from different nurses. The reliability of the documentation tool will be assessed by comparing the results of the bedside assessment tool with that completed by wound care experts using standardized digital live photographs. The utility documentation tool from a nursing perspective will also be assessed using a structured questionnaire. Analysis of digital live photographs using a standard algorithm will be done to determine whether such an analysis can objectively and accurately track the healing of moisture-associated skin damage.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Intertrigo (ITD) and or incontinence-associated dermatitis (IAD)
* Expected length of stay of seven (7) days
* life expectancy greater than one week
* written informed consent by the patient or his/her representative including explicit consent to take daily photographs of the rash associated with MASD.

Exclusion Criteria:

* known allergy to standard MASD treatments
* life expectancy less than seven days
* complex skin disorders
Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea

This study was designed to evaluate the anti-hypertensive efficacy of lacidipine in hypertensives with Type 2 diabetes and effectiveness on endothelial cell function in Korean population.


Eligibility Criteria:
Inclusion criteria:

* Newly diagnosed as essential hypertension or not treated in the past 2 weeks(If the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week -2) assessments)
* Mean seated SBP at screen visit = 130mmHg (as measured by a mercury sphygmomanometer)
* Type 2 diabetes (American Diabetes Association criteria 2004) and HbA1C \<11%
* Agree to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken if the subject a female of child-bearing potential
* Provide written informed consent

Exclusion criteria:

* Mean seated SBP of \> 180 mmHg
* Known or suspected secondary hypertension
* Anemia defined by haemoglobin concentration \< 10.0 g/dL
* Hemoglobinopathy or peripheral vascular disease
* Clinically significant renal or hepatic disease (i.e., subjects with serum creatinine = 2.0 mg/dL; Alanine aminotransferase, Aspartate aminotransferase, total bilirubin, or alkaline phosphatase \> 2.5 times the upper limit of the normal reference range)
* Unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment
* Chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e. only use of topical, inhaled or nasal corticosteroids is permissible)
* Female who is lactating, pregnant, or planning to become pregnant
* clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory tests, or electrocardiogram etc.)
* Acute or chronic metabolic acidosis or a history of diabetic ketoacidosis
The 4-SITE Field Following Study (4-SITE FF)

The purpose of this study is to evaluate and document appropriate clinical performance of the new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable cardioverter defibrillator (ICD) PGs (Models F103; F111), the COGNIS 100 HE 4-SITE cardiac resynchronization therapy ICD (CRT-D) PG (Model P108) when connected to any of the RELIANCE Quadripolar (4-SITE) defibrillation leads.

Appropriate clinical performance of system components of the 4-SITE systems other than the new 4-SITE header / lead interface has been evaluated and documented already in the previously conducted COGNIS and TELIGEN 100 HE FIELD FOLLOWING STUDY, The COGENT-4 Field Following Study.

Data collected may be used to support international regulatory submissions including the FDA and the Japanese Ministry of Health, Labour and Welfare.

The following devices will be used (all are CE-marked):

* TELIGEN 100 HE 4-SITE (Single and Dual Chamber ICD)

  * Model Number: F103 (Quadripolar, VR);
  * Model Number: F111 (Quadripolar, IS-1, DR)
* COGNIS 100 HE 4-SITE (CRT-D)

  o Model Number: P108 (Quadripolar, IS-1, IS-1)
* RELIANCE 4-SITE leads (12 different model numbers in total as shown in the table below)

Eligibility Criteria:
Inclusion Criteria:

Study Specific:

* ICD / CRT-D Indication according to normal clinical practice
* Patients receiving:
* a single or dual chamber 4-SITE compatible ICD
* or a 4-SITE compatible CRT-D
* one of the RELIANCE 4-SITE defibrillation leads
* Patients currently implanted with a pacemaker
* upgraded to a 4-SITE compatible ICD or CRT-D (4-SITE header)
* one of the RELIANCE 4-SITE defibrillation leads

General:

* Willing and capable of providing informed consent for
* undergoing a 4-SITE system implant,
* participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
* Geographically stable patients who are available for follow-up at a study centre
* Age 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

Study Specific:

* ICD and CRT-D Patients scheduled for a device replacement
* CRM Patients who have or who would need an lead adaptor
* All patients who have an active or non-active defibrillation lead other than 4-SITE

General:

* Not willing and not capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation (including VT/VF shock conversion) at an approved clinical investigational centre and at the intervals defined by this protocol
* Patients who were in NYHA Class IV during the last 3 month
* Patients with pre-existing diseases, which may confound study results
* Patients currently requiring dialysis,
* Cancer patients
* Patients with drug and/or alcohol abuse history
* Life expectancy \< 12 months (or expected heart transplant within 12 months)
* Patients on a Heart Transplant List
* Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion.
* Enrolled in any other concurrent study
Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery

The objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy.

This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy.

Breast reductions are common procedures. One of the main difficulties related to this surgery remains the healing, wide at the peri-areolar level, vertical at the sub-areolar level and in the sub-mammary fold. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloidal healing, especially in young subjects.

On This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result without scarring in the context of the reduction of medium volume breast hypertrophy.

Ultimately, the results of this study may serve as a basis for further research by proposing:

* Prophylactic mastectomies and immediate breast reconstruction without lateral scar and with a less visible sub-breast scar.
* A breast reduction in young patients before the skin undergoes the effects of the heaviness of the breasts.

Eligibility Criteria:
Inclusion criteria :

* Women over the age of 18.
* Category 1 or 2 according to the Regnault classification.
* C cup breast size or larger.
* Areola "looks ahead" i.e. a distance between point A (at the top of the areola) at the median suprasternal point of approximately 16 cm to 24 cm.
* Ptosis (distance between the lowest part of the breast and the submammary fold) of a maximum of 7cm (measured in a seated position).
* Expected correction of half ptosis with decrease of 1 to 3 cup sizes.
* Patient has good quality thick skin.
* Social security scheme.
* Patient requesting breast reduction.
* Patient having signed the free and informed consent.

Non inclusion criteria :

* Areola "look down"; point A more than 25 cm.
* Ptosis greater than or equal to 8 cm.
* Thin skin.
* Smoker.
* Patient under effects of anti-coagulant.
* Patient participating in another clinical study.
* Protected patient: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, lactating woman.