cyrilzakka/clinical-trials huggingface dataset:
Comparing Diet and Exercise Approaches in Women

The purpose of this study is to determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves fitness program promotes stepwise reductions in body weight, improvements in body composition and/or improvements in markers of fitness and health better than following the Weight Watchers Momentum Program for the same time period.

The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women. The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day). The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone. Researchers in the Exercise and Sport Nutrition Lab at Texas A\&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program. Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness. The Weight Watchers program is another popular weight loss program. It provides a systematic approach to diet and exercise throughout the weight-loss process. Consequently we are interested in comparing the efficacy of both programs to one another. The purpose of this study is to determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves fitness program promotes stepwise reductions in body weight, improvements in body composition and/or improvements in markers of fitness and health better than following the Weight Watchers Momentum Program for the same time period.

Eligibility Criteria:
Inclusion Criteria:

* Participant is female
* Participant is between the ages of 18 and 45
* Participant is sedentary and overweight (BMI \> 27)

Exclusion Criteria:

* Participant has any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism;
* Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
* Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
* Participant has been pregnant or lactating within the past 12 months or are planning to become pregnant during the next 12 months;
* Participant is involved in a planned exercise program (\> 30 min./d. 3 d./wk.) within 3 - 6 months prior to the start of the study;
* Participant has taken any weight loss medications and/or dietary supplements that may affect muscle mass or body weight during the three month time period prior to beginning the study;
* Participant has a recent history of weight change (+/- 7 lbs. within the last 3 months).
Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing

The goal of this prospective non-randomised study is to test the feasibility of leadless conduction system pacing using the WiSE-CRT device in patients with an indication for Cardiac Resynchronisation Therapy.

The main question\[s\] it aims to answer are:

1. What is the safety profile of leadless conduction system pacing?
2. What is the success rate of leadless conduction system pacing?
3. What are the electrical and haemodynamic effects of leadless conduction system pacing.

Participants will undergo pre-procedural cardiac CT, and post-procedure electro-anatomical mapping and haemodynamic assessments.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
* Patients meeting European Society of Cardiology Criteria for Cardiac Resynchronization Therapy (CRT) with Class 1 or 2a recommendation:

  * Dyssynchronous Heart Failure: Left Ventricular Ejection Fraction (LVEF) ≤35%, QRS duration \>150ms or \>130ms in presence of left bundle branch block (LBBB). Also included here are patients with EF ≤35%, an existing pacing system and an RV pacing burden of \>20%.
  * BLOCK HF population: Patients requiring pacing for atrioventricular (AV) block with an LVEF ≤50%
  * AV node ablation (AVNA) population: Patients planned for AVNA with EF ≤50%.

Exclusion Criteria:

* Any contraindication to LV endocardial pacing.

  * LV thrombus
  * Contra-indication to heparin
  * Contra-indication to anti-platelet agents
* Failure of acoustic window screening
* Septal wall thickness \<5mm (minimum required wall thickness at any target implant site)
* Myocardial infarction within 40 days prior to enrolment.
* Cardiac surgery or coronary revascularisation procedure within 3 months prior to enrolment or to be scheduled for such procedures within the following 7 months.
* Participation in other studies with active treatment/investigational arm.
* Pregnant or planning to become pregnant in the next 7 months.
High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study

This study intends to explore the therapeutic effect of PCSK9i Evolocumab on atherosclerotic plaques in cerebral arteries (including carotid and vertebral arteries) compared with intensive statin treatment, and monitor the pathological properties of carotid/vertebral artery plaques with OCT technology. At the same time, three-dimensional ultrasound and high-resolution magnetic resonance are used to explore the new mechanism of pathological changes of cerebral atherosclerotic plaques in a multidimensional manner.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, regardless of sex;
2. Cerebrovascular angiography examination was performed, and the imaging characteristics were consistent with: 1) The stenosis degree of internal carotid artery (starting from C1 segment) or vertebral artery (starting from vertebral artery to V4 segment) was 20%-69%; 2) The target vessel for imaging has not undergone or intends to undergo revascularization and must be available for OCT imaging catheter;
3. Participants who understand and sign the informed consent form voluntarily.

Exclusion Criteria:

1. Intolerant to both atorvastatin and rosuvastatin;
2. History of major surgery or endovascular treatment within 3 months prior to the screening period;
3. Arterial stenosis or occlusion not caused by atherosclerosis, such as arterial dissection, moya-moya disease, vasculitis, radiation vascular disease, or fibromuscular dysplasia;
4. Abnormal liver function (ALT \> 3 times the upper limit of normal);
5. Renal dysfunction (glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 at screening);
6. Thrombocytopenia (PLT\<100G/L);
7. The expected survival time is not more than 6 months;
8. Other known serious life-threatening disease (such as hematologic disease, malignancy), unstable vital signs or need for continuous monitoring, or moribund state during screening;
9. Patients have been included in other studies that conflict with this study;
10. Known sensitivity to any of the products or components to be administered during dosing;
11. Pregnant, breastfeeding or planning pregnancy, and other conditions that the investigator considers the patient unsuitable for enrollment;
12. Other conditions that the investigator considered inappropriate for enrollment.
Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.

The overall aim of this clinical trial is to evaluate an at scale version of 'Happy Talk' in a large scale effectiveness study (examining inputs, outputs and outcomes) based on a sample of children from socially disadvantaged areas. Researchers will compare Happy Talk to usual care and children's allocation to the programme will be decided on randomly.

The investigators also aim to

* complete a pre-trial process evaluation to inform intervention implementation - examining factors which promote parental engagement and partnership between SLTs and educators and incorporating these into SLT training and future rollouts of the programme.
* complete a concurrent process evaluation from a realist perspective to examine how the mechanisms underpinning Happy Talk are influenced by the implementation context and therefore what would need to be considered for successful implementation across varied settings. Our SWAT is embedded in this process evaluation and addresses the Trials Methodology Research Network methodological priority questions 1 and 5 https://priorityresearch.ie/priority-one-questions/
* Complete an economic evaluation in which compare the costs and benefits of Happy Talk are compared to standard pre/school care.

The study aims to answer the following research questions:

When implemented at scale

1. Does 'Happy Talk', a targeted selective intervention focused on increasing parent and early educator responsive interaction, improve language and quality of-life (QoL) outcomes in socially disadvantaged preschool and young school-aged children?
2. Does Happy Talk enhance responsiveness and language promoting behaviours in home and pre/school contexts?
3. What programme features support successful real-world application of 'Happy Talk' including factors which promote parental engagement; partnership between SLTs and educators; and fidelity of implementation?
4. How do contextual factors influence Happy Talk implementation /outcomes?
5. How can trials become part of routine care?
6. Is Happy Talk cost effective compared to usual care?

Intervention: The programme is informed by general systems theory and is embedded in the preschools, and homes of socially disadvantaged children with the aim of effecting change in parent and educator behaviour. There are both parent and preschool staff components to the programme.


Eligibility Criteria:
Inclusion Criteria for pre/schools:

* Those falling within the Health Services Executive Community Healthcare Organisation (CHO) area for which support has been offered.
* Those attached to DEIS schools (Delivering Equality of Opportunity in Schools i.e., those including a high concentration of students from socioeconomically disadvantaged backgrounds)
* Child and Family Resource centres (established in Ireland for children from disadvantaged backgrounds)

Exclusion Criteria:

* Pre/schools outside of supported areas.
* Schools that are not defined as DEIS schools.
* Preschools not attached to DEIS schools.
Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

To detect by sonography relapse of disease activity prior to clinical symptoms in RA patients treated by rituximab.


Eligibility Criteria:
Inclusion Criteria:

* failure to at least one TNF-blocking agent

Exclusion Criteria:

* pregnant or childbearing woman
* Rituximab contraindication
* woman unable to use contraceptive means
The ProVerum First in Man PROVE Study

A clinical evaluation to assess the safety and performance of the ProVeeTM Urethral Expander System, designed to alleviate the symptoms of Benign Prostatic Hyperplasia (BPH).


Eligibility Criteria:
Inclusion Criteria:

* Males ≥ 50 years of age
* Moderate-to-severe symptomatic BPH
* IPSS of \> 15
* Peak urinary flow rate (Qmax) of \<12 mL/s
* Prostate volume of ≥ 30 and ≤80 cc
* Prostatic urethral lengths ≥ 4cm

Exclusion Criteria:

* A prostatic urethral length of less than 4cm
* A prostatic volume \<30cc or \>80cc
* An obstructing intravesical prostatic median lobe
* Urinary incontinence due to an incompetent external sphincter
* Urethral pathologies that may prevent insertion of delivery system
* A current symptomatic urinary tract infection
* Current significant visible haematuria
* Patients with known allergy to nickel or titanium
* History of significant medical co-morbidity or prior surgery that may confound the results of the Study
* Another medical condition that would pose an unacceptable patient risk
* Known or suspected urological condition that may affected voiding function
* Neurogenic bladder and/or sphincter abnormalities
* Patients with cognitive disabilities unable to understand and give informed consent to the research study
Individual Differences in Diabetes Risk: Role of Slow WaveSleep

This study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers age 18-20 with a BMI \< 27kg/m2 in women and \< 28 kg/m2 in men with normal findings on clinical examination, routine laboratory tests and EKG
* only subjects who have regular life styles (no shift work, no travel across time zone during the previous 4 weeks)
* habitual bedtimes between 7.0-8.5 hours/night
* do not take medications will be recruited

Exclusion Criteria:

* women taking hormonal contraceptive therapy and pregnant women will be excluded
* individuals with a history of psychiatric, endocrine, cardiac or sleep disorders will be excluded
* other exclusion criteria will be: tobacco use, habitual alcohol use of more than 1 drink per day, excessive caffeine intake of more than 300 mg per day
Distraction Method on Pain and Anxiety During Circumcision

Circumcision is a common procedure in infants, children and young people around the world for cultural, religious or medical reasons. Since this is a painful procedure, it is performed under local anesthesia or general anesthesia. It is recommended to perform this procedure under local anesthesia if there is no risk. Although local anesthesia is used during the procedure, pain and anxiety levels of children may increase. Distraction methods are commonly used and effective methods to reduce pain and anxiety during painful procedures. The aim of this study was to evaluate the effect of tablet playing during circumcision on pain and anxiety in school age children.

Circumcision is a common procedure in the worldwide. To our knowledge, although there have been several randomized controlled trials using video and game techniques, which are distractions to reduce pain and anxiety during painful procedures, no randomized controlled trials using playing the game with Tablet to reduce pain and anxiety during circumcision have been found. Non-pharmacological studies, such as play therapy, are needed to reduce pain and anxiety in school-age children undergoing circumcision under local anesthesia. The aim of this study is to provide evidence about the effectiveness of playing the game with Tablet used to reduce pain and anxiety during circumcision, and to contribute to nursing care in pain management.

Eligibility Criteria:
Inclusion Criteria:

* being between 7-12 years
* male gender
* circumcision with local anesthesia
* agreeing to participate in the study

Exclusion Criteria:

* presence of any contraindication for circumcision (hemophilia, bleeding disorders, urinary anatomical disorders-hypospadias, epispadias etc.)
* any analgesic used 24 hours before circumcision
Complement Activation in the Lysosomal Storage Disorders

The lysosomal storage disorders (LSDs) are monogenic disorders associated with inflammation affecting multiple organs, and early death. Few treatments are available that can modify the disease course, and there is an urgent need to identify new steps in pathogenesis that can be targeted therapeutically. The complement system is novel and highly plausible as a primary driver of inflammation and cellular injury in the LSDs. This study assesses the complement activation state in patients with Fabry disease (FD), Gaucher disease (GD) and Niemann-Pick disease, type C (NPC), with comparison to healthy controls. This has the potential for immense clinical benefit through targeted complement inhibition across the full spectrum of lysosomal storage disorders, in which key pathophysiological processes including the inflammatory response to lysosomally 'stored' materials are shared.

This is a single-centre, cross-sectional observational study in patients \>16 years of age diagnosed with FD, GD or NPC. The research hypotheses of this study are:

1. That complement is excessively activated, including at the specifically complement C5 level, in patients with the lysosomal storage disorders FD, GD and NPC.
2. That complement activation drives tissue injury in the LSDs via downstream effector mechanisms including membrane attach complex (MAC/C5b-9)-mediated cytotoxicity and C5aR-mediated inflammation.

The study aims to show enhanced complement activation, including at the C5 level, in patients with FD, GD and NPC compared to healthy controls.

The research assays for this study include the primary outcome measure of plasma soluble C5b-9 (sC6b-9) levels measured using ELISA. This assay measures the degree to which ongoing C5 activation Is occurring in vivo based on sensitive detection in plasma of the key activation product C5b-9. The assay would be expected to show elevated plasma sC5b-9 levels in patients with the glycosphingolipidoses compared to disease-free controls, as was previously demonstrated in patient cohorts of atypical haemolytic uraemia syndrome (aHUS) and C3 glomerulopathy (C3G). Additional complement activation products will be assessed as secondary endpoints including plasma C3a and C5a levels by ELISA, and intracellular leukocyte C5a concentration as a marker of systemic C5a generation and C5aR1 expression.

Eligibility Criteria:
Inclusion Criteria:

* All consenting patients with a prior diagnosis of FD, GD or NPC will be included in the study. Control participants will be healthy volunteers.

Exclusion Criteria:

* Patients who are unable to provide consent or to perform a blood or urine test will be excluded.
A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adolescents 12 to less than 18 years of age
* Recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment
* Receiving a stable regimen of a calcineurin inhibitor (CNI), with mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil (EC-MPS/MPA), with or without daily corticosteroids for ≥ 30 days prior to randomization
* Clinically stable renal function during the 12-week period prior to screening, in the opinion of the investigator and based on protocol-defined criteria for proteinuria and estimated glomerular filtration rate (eGFR)
* Serologic evidence of past exposure to Epstein-Barr virus (EBV) and current absence of EBV DNA replication at or prior to renal transplantation and during the Screening period
* Completion of an initial course of SARS-CoV-2 vaccination per local standard of care, a minimum of 6 weeks prior to enrollment

Exclusion Criteria:

* Recipients with EBV serostatus negative or unknown at screening or at transplant
* Treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6 calendar months prior to enrollment
* Biopsy-confirmed antibody-mediated acute rejection at any time with the current allograft
* Banff 97 grade IIA or higher acute cellular rejection (or equivalent), or treatment with plasmapheresis or rituximab for any acute rejection at any time with the current allograft
* Current evidence or past history of active or inadequately treated latent tuberculosis (TB) infection
* Previously treated with belatacept or previously enrolled in a belatacept trial with their present allograft

Other inclusion/exclusion criteria apply
Phase I Clinical Trial of DA-6886 in Healthy Male Subjects

DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* 20 \~ 45 years old
* 27kg/m2 ≥ BMI ≥ 20kg/m2
* Healthy Male
* Informed consent

Exclusion Criteria:

* Clinically significant medical history
* smokers
* Clinically significant hypersensitivity of Drugs
* Clinically significant cutaneous disorder
* QTcB \> 450msec
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
LimPrOn: Limburg Pre-eclampsia Investigation

Background:

Multiple adaptations at the cardiovascular system occurs during pregnancy. In the pregnancy condition pre-eclampsia (PE), this adaptations are abnormal. Five to eight percent of all pregnant women worldwide will develop PE.

PE is a pregnancy condition which is characterized with a high blood pressure (\>140/90 mm Hg) and the occurrence of proteinuria (\>3g/dl/24h) after 20 weeks of gestation. When untreated, this condition can have severe complications for both mother and child. It's important to monitor women with a high risk for developing PE for an early detection and treatment of this condition.

For this reason, a multicenter study is set up with the following applications:

1. NICCOMO and Maternal Venous Doppler Echography: impedance cardiograph and an echography of the heart and veins.
2. Maltron: bio-electronic impedance analyze
3. Remote monitoring of the high risk patients to become a more intensive follow-up

Number of inclusions: 2000 pregnant women from the prenatal consultations of eight different hospitals:


Eligibility Criteria:
Inclusion Criteria:

* \> 10 weeks of pregnancy, primipara and multipara

Exclusion Criteria:

* \< 10 weeks of pregnancy and congenital malformations of the fetus
Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery

This study represents the first step for testing this device in patients in real-life situations to evaluate the technological capacities and usability by the patient


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old and less than 80 years old
* The patient is undergoing orthopedic (shoulder, foot, knee), digestive (gallbladder) or gynecological (uterus-ovary) adjustment outpatient surgery
* The patient has sufficient cognitive and intellectual ability to use the system
* The patient must undergo a training test during consultation to use the tablet and perform the measurements
* The patient must have access to 4G at home.

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant
* The patient needs emergency surgery
* The patient has a level 4 or 5 ASA psychological class
* Patient cannot have outpatient surgery for medical reasons (decompensated medical pathology), or social reasons according the the SFAR (société française anesthésie réanimation) criteria. Patient alone at home and geographically far from a hospital \>30km (or \>45 minutes by car).