cyrilzakka/clinical-trials huggingface dataset:
Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF

This is a prospective randomized trial to compare the use of AFC and serum AMH as the basis for gonadotrophin dosing in in-vitro fertilization treatment.

The hypothesis is that the use of serum AMH as the criterion for determination of gonadotrophin dosing in IVF treatment results in more optimal ovarian response than AFC.

Patients undergoing the first-time IVF treatment cycle using either conventional insemination technique or intracytoplasmic sperm injection at Queen Mary Hospital will be invited to participate in this study. Participating subjects will be randomized into either (i) AFC or (ii) AMH group, where the gonadotrophin dosing will be determined based on the baseline AFC and serum AMH respectively as assessed one month before the IVF treatment. Randomisation will be performed according to a computer-generated list which will be read by an independent research nurse. That research nurse will assign the initial gonadotrophin dose according to the study protocol.

In the AFC group, starting dose of gonadotrophin will be determined based on serum AMH concentration as follows:

AFC \<= 5: 300 IU daily AFC \>5 and \<=15: 225 IU daily AFC \>15: 150 IU daily

In the AMH group, starting dose of gonadotrophin will be determined based on serum AMH concentration as follows:

AMH \<= 1.0 ng/ml: 300 IU daily AMH \>1.0 and \<=3.3 ng/ml: 225 IU daily AMH \>3.3 ng/ml: 150 IU daily

The clinician and patient will both be blinded to the randomization throughout the course of treatment. The proportion of subjects having appropriate ovarian response, defined as the number of oocytes retrieved being 6 to 14 inclusive, will be compared between the two arms.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing the first IVF cycle during the study period.

Exclusion Criteria:

* Body mass index \>=30 kg/m2
* Subjects in repeated IVF cycles
* Subjects undergoing IVF treatment using donor oocytes
* Subjects undergoing pre-implantation genetic diagnosis
Use of Extracorporeal CO2 Removal in Case of Moderate to Severe ARDS to Apply an Ultraprotective Mechanical Ventilation Strategy

The extracorporeal CO2 removal (ECCO2R) has been recently proposed in case of Acute Respiratory Distress Syndrome (ARDS) in order to reduce pulmonary injuries induced by the mechanical ventilation. A reducing of tidal volume and/or respiratory rate is thus expected using this extracorporeal respiratory support. However, most of existing devices of ECCO2R can apply only a limited extracorporeal flow, often less than 1L/min, which limits the CO2 exchanges and does not allow to reach an ultraprotective ventilation. An extracorporeal flow higher should logically maximalize CO2 removal and allow reducing intensity of mechanical ventilation. Works focused on high-flow ECCO2R (2-3 L/min) in setting of ARDS are therefore mandatory to better understand apprehend the phenomena of gazes changes with this device and confirm the added-value in management of these specific patients.

This is a prospective interventional study focused on a cohort population.

The included patients will be those affected by a severe ARDS (Berlin definition) requiring an aggressive mechanical ventilation and whom a high-flow ECCO2R was implemented.

The high-flow ECCO2R will be proposed in all patients with inclusions criteria with the 15 first days following their admission. The day of initiation of the high-flow ECCO2R will considered as Day 0 in our study.

A data collection will be focused on the respiratory parameters, clinical complications until ICU discharge and outcome, extracted from medical records.

The main endpoint will be the perrcentage of patients whom an ultraprotective ventilation could be applied successfully during more than 12h. Ultraprotective ventilation is defined in our work as follows: Tidal volume ≤ 3 mL/kg and respiratory rate ≤ 16/min associated with a PaCO2 ≤ 45mmHg and a PaO2 ≥ 55 mmHg.

The secondary endpoints will be durations of mechanical ventilation, ICU stay and hospitalization, as well as rheological behavior of extracorporeal circulation, respiratory parameters under high-flow ECCO2R, specific complications and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 years old
* Patient suffering from ARDS including the 3 following parameters during more than 12 hours:

PaO2/FiO2 ≤200 Driving Pressure ≥15 cmH2O, Tidal Volume = 6 mL/kg PIT Respiratory rate ≥ 28/min

- Or patient hospitalized for severe bronchospasm or COPD exacerbation associating a persistent capnia ≥ 50 mmHg despite maximal mechanical ventilation (Vt = 6mL/kg PIT, respiratory rate ≥ 24/min)

Exclusion Criteria:

* Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique)
* Consent refusal from the patient or his/her next of kin and the impossibility to enrol using the emergency procedure
* Pregnant or breast feeding patient
* Absence of a French Health Care Insurance coverage
Effects of a PA Intervention for Fatness and Fitness in Adolescents With Intellectual Disability

The proposed study will be a 12-week school-based physical activity (PA) program with a 2-armed randomized controlled trial (RCT) design. It will target overweight and obese children with intellectual disability (ID). The primary outcomes will be both fatness-related and fitness-related outcomes. In addition, the effect of the intervention on blood pressure will be evaluated as the secondary outcomes.

Childhood obesity and lower HRPF levels are major threats to public health. The previous research finds that children with ID are more vulnerable to be obesity and lower HRPF levels than general pediatric population. In addition, the transition from adolescence to young adulthood is recognized as a particularly high-risk period for weight gain. However, Interventions to reduce obesity and improve HRPF levels among adolescents with ID are scarce. The main purpose of this study is to implement and evaluate a fun game-based PA program to reduce overweight/obesity and improve health-related physical fitness (HRPF) levels among adolescents with ID (aged 12-18 years old).

The study consists of a 3-month intervention and a 3-month follow-up. Totally Forty-eight overweight/obese adolescents with mild intellectual disability (ID) will be recruited from special schools in China and then randomly assigned into two groups (n=24 for each group). Selection criteria for participants are: (1) children with mild ID; (2) aged 12-18 years old; (3) being overweight or obese; (4) without physical disability and other relevant health conditions. Participants in the experimental group will receive a fun game-based PA program (60 min/time, 2 sessions/week, 24 sessions totally) at school. No intervention will be provided to participants in the control group.

All participants in the two groups (N=48) will undertake repeated measurements on a set of study outcomes for three times. All measurements are non-invasive and no potential consequences are expected. In addition, questionnaires will be used to collect each participant's information of socio-demographic characteristics, physical activity level and eating habits (about 15 minutes).

The investigators expect the findings from the study would make up the knowledge gap and help eliminate existing health inequities among children with ID. It would serve as an example for use of other researchers, policy-makers, and the public to tackle off obesity among adolescents with ID in a global scale. If effective, this program would be welcomed and adopted by other special schools in the future. In addition, the effective model can also be extended to reach students with ID in normal schools.

Eligibility Criteria:
Inclusion Criteria:

* children with mild ID;
* aged 12-18 years old;
* overweight or obese;
* at least one family member who is able to attend the program with them.

Exclusion Criteria:

* with physical disability;
* with a medical predisposition towards obesity (such as genetic syndrome) that could interfere with the results of the study;
* with contraindications for PA (e.g. severe heart disease).
Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery

The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical closure of LAA in patients undergoing aortic valve replacement. This randomized, prospective, open-label international multicenter trial will enroll 1040 patients undergoing aortic valve replacement with CHA2DS2-VASC score ≥2 but without an indication for anticoagulation at the time of enrollment. Patients will be randomized in 1:1 fashion to standard therapy + surgical closure of LAA vs. standard therapy alone. The duration of the study is five years (plus additional 10 years).

Previous studies have concluded that ≥90% of AF related left atrial thrombi are located in the left atrial appendage (LAA). Surgical closure of LAA can be performed using ligation, stapler or other devices designed for this purpose during cardiac surgery. However, current evidence for surgical closure of LAA is scarce and no large scale randomized prospective clinical trials addressing this issue have been published. American College of Cardiology (ACC)/ American Heart Association (AHA) guidelines state that LAA exclusion should be considered in patients with recurrent and persistent AF who remain symptomatic with heart rate control and where antiarrhythmic medication is not tolerated or no longer effective. Current European Association of Cardiothoracic Surgery (EACTS) guidelines conclude that there is no proven benefit of surgical LAA exclusion in terms of stroke reduction or mortality benefit (level of evidence 2a B), and if exclusion is contemplated, devices designed for appendage exclusion should be used rather than a cut-and-sew or stapling technique. These guidelines are based on small poorly designed descriptive trials and only one small randomized trial.

LAA-CLOSURE trial aims to assess efficacy and safety of prophylactic surgical closure of LAA in patients undergoing aortic valve replacement.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing aortic valve replacement (+/- coronary bypass AND/OR mitral valve surgery) according to clinical indications (ESC guidelines for the management of valvular heart disease)
2. Age ≥18 years
3. No indication for long term anticoagulation at the time of enrollment.
4. Patients with CHADS-VASC score ≥2
5. Patient is willing to comply with specified follow-up evaluations
6. Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics committee or Institutional Review Board.

Exclusion Criteria:

* Age \< 18 years
* Expected survival \< 1 year
* Chronic atrial fibrillation
* Indication for long term anticoagulation therapy before the index procedure
* Mechanical valve implantation previously or at the index procedure
* Any significant medical condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
Study of External Beam Radiotherapy to Thyroid Carcinoma

The primary objective of this study is to estimate the 5 year locoregional control rate after External Beam Radiotherapy (EBRT) in the patient with locally advanced differentiated thyroid cancer. In a prior retrospective trial for this same group of patients, the 5 year locoregional control rate was 85% in EBRT group and 70% in no EBRT group. For the total number of patients to detect a minimum of 20% improvement in 5 year locoregional control rate with 80% of statistical power and the 5% significance level, the table for sample size planning given by Makuch and Simon was chosen. Forty-three patients are required for this regimen to regard as worthy of further investigation. Considering 15% follow up loss, 50 eligible patients will be enrolled.

The standard approaches to the treatment of differentiated thyroid cancer include surgical resection, radioactive iodine treatment, and thyroid-stimulating hormone suppression. The role of external beam radiotherapy (EBRT), however, remains controversial.

The purpose of this phase II study is to evaluate the impact of EBRT on the locoregional control in locoregionally advanced or recurrent differentiated thyroid cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed differentiated thyroid cancer
* Patient with locally advanced tumor (T4a, tumor of any size extending beyond the thyroid capsule to invade subcutaneous soft tissues, larynx, trachea, esophagus, or recurrent laryngeal nerve or T4b, tumor invades prevertebral fascia or encases carotid artery or mediastinal vessels or N1b, unilateral, bilateral, or contralateral cervical or mediastinal lymph node positive), or locoregionally recurrent tumor
* All patients must have radiographically assessable disease
* No previous irradiation to the planned field
* Age of ≥ 18 years
* Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
* Required Entry Laboratory Parameters WBC count ≥ 1,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; creatinine ≤ 3.0 mg/dL
* Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.
* Signed informed consent form prior to study entry

Exclusion Criteria:

* Patient with anaplastic carcinoma (focal anaplastic change associate with differentiated thyroid cancer is not excluded)
* Age of \<18 years
* Previous history of RT adjacent to planned field
* Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
* Pregnant or breast feeding status
* Previous history of uncontrolled other malignancies within 2 years
Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure

Age-related macular degeneration (AMD) and glaucoma are among the leading causes of blindness in the western world. Elevated intraocular pressure (IOP) is a well known major risk factor for glaucoma. In addition, there is growing evidence that vascular factors, including arterial hypertension and hypotension, may play a role in the pathogenesis of AMD and glaucoma. To gain more insight into these mechanisms in humans is the primary goal of the present study.

Optical coherence tomography (OCT) delivers three dimensional, volumetric reflectivity information through transparent media in vivo. Moreover, the images show a high choroidal penetration and a resolution comparable to an histologic examination when infrared light sources are used. Because of its non-invasive character, OCT provides an ideal method for diagnosis and monitoring of retinal and choroidal abnormalities.

The present study aims to investigate whether choroidal thickness is temporarily altered by changes in IOP or systemic hemodynamic parameters. IOP will be increased by the use of a suction cup technique, mean arterial blood pressure will be altered by intravenously administered Phenylephrine or Sodium-Nitroprusside.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Men and women will be included in equal parts
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia less than 1 diopter

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks History of hypersensitivity to the trial drugs or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* History of migraine
* Pregnancy
Incidence of Respiratory Depression in Cesarean Section

This study is designed to determine the incidence and severity of respiratory depression in elective cesarean section patients who have received a spinal or epidural narcotic called duramorph for management of postoperative pain. A monitoring device called a capnograph as well as a device called a pulse oximeter is placed on the patient once in the recovery room after delivery. The capnograph monitors the carbon dioxide level that the patient breathes out as well as their respiratory rate. The pulse oximeter is a device that is taped on the patient's finger and measures their oxygen saturation level. The monitoring is maintained for 18-24 hours after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Are female \>= 18 years of age and \<=55 years of age with ASA class I-III
* Schedule for cesarean surgery
* Are willing and able to sign informed consent form for this study
* Are willing and able to follow the instruction in this study protocol

Exclusion Criteria:

* Have known contraindication/allergy to neuraxial anesthesia or morphine.
* Have an ASA class \> III
* Age \> 55 years
The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries

The purpose of the study is to determine the role of blood flow restriction (BFR) + neuromuscular electrical stimulation (NMES) in improving post-operative physical therapy and recovery after ankle fracture surgery. We expect to see improved muscle strength, less muscle wasting, and improved functional recovery after surgery when making these additions to routine post-operative (postop) physical therapy protocols.

Few studies have examined BFR in patients sustaining operative foot and ankle injuries. Due to the weight bearing limitations and prolonged immobilization following these injuries, patients often experience increased time away from work and delays with return to sport. These factors are responsible for the rapid muscle atrophy that occurs in the immediate post injury period because of immobility and disuse. Recently, blood flow restriction (BFR) therapy has been shown to be effective in improving muscle strength and preventing atrophy when combined with low load resistance training physical therapy programs.7,8 Neuromuscular electrical stimulation (NMES) is an adjunctive agent that has been show to augment the effects of BFR alone.4 The null hypothesis is that a 2 week BFR + NMES + low load resistance training program in patients age \>= 18 recovering from foot and ankle surgery will have no effect on short term (2 weeks postop) lower extremity muscle hypertrophy or atrophy, patient pain and satisfaction, or functional recovery after foot and ankle surgery.

Eligibility Criteria:
Inclusion Criteria:

* isolated, closed low-energy rotational ankle fracture without prior surgery or implants to injured area

Exclusion Criteria:

* history of Deep Vein Thrombosis in affected extremity
* history of significant cardiac disease defined as a recent stent placement in past
* history of peripheral arterial disease
* history of sickle cell disease
* history of coagulopathy
* presenting to surgery \>14 days after injury
Relationship Between Dysfunctions of Movement in the Lower Back and Pelvis With Overuse Injuries in Handball Players

The aim of this study is to assess the relationship between the presence of overuse injuries and failure to control of movement in those areas. For this, participants will perform some tests related to movement dysfunction lumbar-pelvic area to check for faults in one or more movement planes.

Handball is considered a high intensity sport even though the 70% of the time the game is standing or walking. The large number of repetitions of high intensity activities such as sprinting or jumping, associated with physical contact with opposing players, make this sport in a physically demanding activity. Furthermore, overuse injuries have been widely described but poorly quantified. In addition, is necessary to know the influence of static lumbar-pelvic position in low back pain and its correlation with stability. Not only strength is important for a good quality of movement, there should also be a specific muscle activation in order for a correct motor pattern. This coordinated action must be I just by the action of muscles agonists, antagonists and synergists.The aim of this study is to assess the relationship between the presence of overuse injuries and failure to control of movement in those areas. For this, participants will perform some tests related to movement dysfunction lumbar-pelvic area to check for faults in one or more movement planes.

Eligibility Criteria:
Inclusion Criteria:

* Players from the first team
* Without injury that does not allow movement tests

Exclusion Criteria:

* Spinal cord injury or tumor, myelopathy, neuropathy and spondylitis and spondylolisthesis in the lumbar spine.
* Tumors or major injuries in the knee or hip.
Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses

Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload.

A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study.

The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses.

Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 12-40 years
* Patellofemoral pain syndrome
* Patient affiliated to a social protection regime
* Patient who signed an informed consent
* For teenagers with no complete growth and muscular maturation, failure of appropriate rehabilitation during minimum 2 months
* Patient informed of the results of the prior medical examination
* Normality (no sign of osteoarthritis) of the knee radiographs
* Ability to read and understand French

Exclusion Criteria:

* Knee osteoarthritis
* Systemic disease
* Inflammatory rheumatism disease
* Unstable knee
* Prior patellofemoral dislocation
* Osteochondrosis
* Referred pain from a hip or spine disease (particularly proximal femoral epiphysiolysis in the teenagers)
* A history of patellar trauma
* A history of knee surgery
* Meniscus, ligament or osteochondral pathology
* Knee tendinitis or bursitis
* Neurologic disease
* Pregnancy
* Antidepressant therapy or behavioral disorder
* Patient unable to comply the required maximum observance
* Impossibility to give enlightened information to the patient
* Patient under guardianship