cyrilzakka/clinical-trials huggingface dataset:
Physical Activity Intervention for Gestational Diabetes

Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM). The increased risk associated with having GDM is compounded by excess weight retention. Therefore, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM. The long-term goal is to prevent T2DM among women with GDM. This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM.

Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM). The increased risk associated with having GDM is compounded by excess weight retention, a common issue after any pregnancy. Considering excess weight is the best predictor of developing T2DM, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM. The long-term goal is to prevent T2DM among women with GDM. This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM in a parallel two-arm randomized controlled trial (n=80 women/arm, N=160). The intervention uses ankle weights (2.5 pounds \[1.1 kg\]) worn on each ankle during routine daily activities (e.g., cleaning, cooking, child care) to increase energy expenditure. The central hypothesis, based on existing literature and preliminary data, is that postpartum women with GDM will adopt an intervention that requires minimal additional time outside of their daily activities. We anticipate that this will result in additional weight loss that is clinically significant when compared with controls who only receive standard information on recommended physical activity. The rationale for the proposed research is that once an intervention that both improves T2DM factors and is easily adopted by women with GDM is known, early intervention specific to this restricted timeframe can be implemented.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years
* Diagnosed with GDM in current pregnancy
* English language ability adequate for participation
* Plan to remain in the area for study duration
* Ability to provide informed consent

Exclusion Criteria:

* Prior Type 1 or Type 2 diabetes
* Pregnant with multiples (e.g., twin, triplets, etc.)
* Premature infant \[\<35 completed weeks gestation (assessed after delivery, before randomization)\]
* Heart disease, serious illness, or conditions that may impede or prohibit participation in either study arm
* Pre-pregnancy BMI \<18.5 (underweight)
* Live outside 35 mile radius of Ohio State University
* Woman is an appointed surrogate
* Infant will be adopted after delivery
A Brief Parent-based Sleep Intervention for Children With Autism Spectrum Disorder

Sleep problems are very common in children with ASD, with a prevalence rate as high as 78%, and often pose significant challenges and stress to the families. Sleep problems in children with ASD are strongly associated with the exacerbation of daytime symptoms, and poor parental sleep quality and mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ASD (aged 3-6). Eligible participants will be randomised to either intervention (three consultation sessions and four follow-up phone calls) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), and one-week after the intervention (post-treatment).


Eligibility Criteria:
Inclusion Criteria:

* Parents/caregivers (aged 21 or above) of preschool children (aged 3 to 6 years old) with a clinical diagnosis of ASD attending paediatric developmental clinic or clinical psychology service at the Duchess of Kent Child Assessment Centre (DKCAC)
* Clinical diagnosis of ASD would be made by either a Pediatrician or a Clinical Psychologist, using at least one of the following diagnostic tools: Childhood Autism Rating Scale, Second Edition (CARS-2), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Autism Diagnostic Interview-Revised (ADI-R) and clinical interview based on diagnostic criteria of ASD depicted in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

Exclusion Criteria:

- Parent/caregiver of children with diagnosed co-morbid neurological, psychiatric or medical conditions which could have affected their sleep, such as obstructive sleep apnea, epilepsy, childhood anxiety disorder
Investigation on Home Care Needs of ALS Patients and Their Caregivers

The research target

1. To investigate the home nursing knowledge needs of ALS patients;
2. Investigate the needs of ALS caregivers for home nursing knowledge;
3. To compare the differences between patients and caregivers in the knowledge needs of patients' refusal to care, so as to provide patients and caregivers with targeted care, meet the needs of patients, improve the quality of life of patients, and extend the survival period.

The research target

1. To investigate the home nursing knowledge needs of ALS patients;
2. Investigate the needs of ALS caregivers for home nursing knowledge;
3. To compare the differences between patients and caregivers in the knowledge needs of patients' refusal to care, so as to provide patients and caregivers with targeted care, meet the needs of patients, improve the quality of life of patients, and extend the survival period.

Assessment indicators

1. Scale: Self-designed questionnaire "Questionnaire on the Degree of Home Nursing Knowledge Needs of ALS Patients or Their Families";
2. Amyotrophic lateral sclerosis function rating scale (ALS FRS)

Eligibility Criteria:
Inclusion Criteria:

* confirmed and suspected patients of ALS diagnostic criteria revised by E1 Escorial in 1998;Conscious and stable vital signs;Signing the informed consent;

Exclusion Criteria:

* patients with severe medical diseases, such as severe cardiovascular and cerebrovascular diseases, liver and kidney failure, etc.The existing resources cannot complete the questionnaire to fill in the exclusion of patients, but the caregivers can fill in the questionnaire;
Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker

Eligibility Criteria:
Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

* Symptomatic macular pucker with retinal edema
* Age 18 years and older
* Scheduled vitrectomy and internal limiting membrane peel
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study:

* Patients under the age of 18
* Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Obstructed nasolacrimal duct in the study eye (s)
* Hypersensitivity to dexamethasone or prednisolone eye drops
* Patients being treated with immunomodulating agents in the study eye(s)
* Patient being treated with immunosuppressants and/or oral steroids
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition

To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry.

The specific aim of this study is to validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry. Combined videofluoroscopic swallowing studies with pharyngeal manometry are commonly used in the evaluation of dysphagia. However, no published study has compared the results of simultaneous pharyngeal manometry with objective timing and displacement measures on videofluoroscopy. These objective measures, such as the pharyngeal constriction ratio, were developed here at UCD and are not yet routinely used by other practitioners. A secondary aim of this study will be to corroborate recent data in the literature suggesting that the presence of feeding tube through the upper esophageal sphincter does not affect the oropharyngeal phase of deglutition. This topic is currently under hot debate in the speech language pathology realm and has important implications for the evaluation of hospitalized patients with dysphagia.

Eligibility Criteria:
Inclusion Criteria:

* undergone pharyngeal manometry with simultaneous videofluoroscopy during the period 1/1/06 to 4/30/07

Exclusion Criteria:

* those who do not meet the inclusion criteria; pregnancy
Evaluation of an Adapted Formula on Atopic Dermatitis.

The aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis.

The study is double blind randomized where the new formula is compared to a placebo during 3 months followed by a period of 3 months optional. During this period of time, all infant include in the study will be fed with the study formula.

Eligibility Criteria:
Inclusion Criteria:

* Aged below 18 month
* Having an atopic dermatitis diagnosed according to the United Kingdom Working Party - Having an Eczema Area Severity Index (EASI) between 7.1 and 50.0
* Whose parents gave their informed consent

Exclusion Criteria:

* systemic corticotherapy
* antihistamine
* use of dermocorticoide and/or antibiotics within 15 days
* symptoms of cutaneous infection
* Past anaphylactic shock
* cow's milk, soya or fish allergy
* Exclusive or predominant breast feediing (more than one feeding/day)
* Consumption of less than 500 ml per day
* Participation to another trial.
Assessment of the Learning Curve of Total Thoracoscopic Mitral Valve Repair

Total thoracoscopic mitral valve plasty (MVP) is characterized by minimal trauma, minimal bleeding, and short postoperative recovery time. The learning curve of any new procedure needs to be evaluated for learning and replication.Using Cardiopulmonary bypass (CPB) time and Aortic clamping (AC) time as evaluation variables, we visualized the learning curve for total thoracoscopic MVP using Cumulative sum analysis. We also analyzed important postoperative variables such as postoperative drainage, duration of mechanical ventilation, ICU stay and postoperative hospital stay.

The retrospective study comprised 150 consecutive patients who underwent total thoracoscopic MVP from October 2017 to July 2021.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years who underwent total thoracoscopic MVP without concurrent cardiac Surgery

Exclusion Criteria:

* data miss greater than 10%
Swimming Immediately After Having a Meal

Many believe that it is unsafe to swim immediately after having a meal and that it is preferable to wait at least 30 minutes. The fear is that swimming can cause stomach cramps and muscle cramps with discomfort and potentially drowning.

With this randomized controlled trial, the aim was to investigate whether there was any hold in this belief and what could potentially happen by swimming with the stomach full immediately after a meal.

All volunteers will be adults. Participants will receive both oral and written information about the trial prior to giving consent for participation.

Participants will act as their own control over two days. On the first day, participants will be randomized to either swim immediately after they have eaten their usual lunch or 30 minutes after the last bite. They will do the opposite on the second day. The randomization will be done by throwing a dice.

Prior to swimming, participants will fill out the following:

* Visual analogue scale (VAS) about their well-being
* Questionnaire about their mood state

After swimming, participants will fill out the following:

* Visual analogue scale (VAS) about their well-being
* Questionnaire about their mood state
* Adverse events

Prior to swimming and afterwards, the participants' blood pressure, pulse, and blood oxygen levels will be measured.

Sample size: Convenience sample.

Withdrawal and dropout criteria: All participants will be informed that they can withdraw their consent at any point during the trial without having to explain any reasons.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Healthy volunteers
* Otherwise, no restriction since each participant acts as their own control

Exclusion Criteria:

* Smoking one hour prior to swimming
* Participants who cannot swim
Electroconvulsive Therapy in Clozapine Refractory Schizophrenia

This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.

ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of schizophrenia according to DSM-IV criteria
* Duration of illness 2 years or greater
* Resistance to at least 2 antipsychotics
* Clozapine resistance
* Capacity to give informed consent
* For women of childbearing capacity, a negative pregnancy test and patient agreement to use a medically accepted form of contraception
* Brief Psychiatric Rating Scale score of at least a 4 on one of the four psychotic items on the psychotic sub-scale or a score of 12 on these 4 items combined.
* Clinical Global Impressions (CGI) - severity rating of at least moderate (score of 4)
* Receiving at least two 400 mg doses of chlorpromazine equivalents for at least 4 weeks (may include newer antipsychotics)
* Having substantial psychotic symptoms despite at least 12 weeks of treatment (at least 8 weeks at a consistent dose)

Exclusion criteria

* schizoaffective disorder; bipolar disorder;
* current affective episode;
* Electroconvulsive Therapy (ECT) within the past 6 months
* history of epilepsy; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than tardive dyskinesia or neuroleptic-induced parkinsonism); psychoactive substance dependence (other than nicotine or caffeine) within 1 month prior to entering the study
* a score of less than 18 on the 24-item Hamilton Depression Rating Scale (HAM-D)
* clinical determination that mood stabilizers were necessary and therefore could not be discontinued.
* pregnancy.
* affective disorders and prominent depressive symptoms because ECT is well known to be effective in those situations, and we wanted to avoid contamination of our results by improvement solely driven by the treatment of the affective symptoms.
Phenotypic and Transcriptomic Description of Megakaryocytes in Sickle Cell Patient

Sickle cell disease is the most common inherited blood disorder in the world. Chronic hemolysis induces platelet activation and chronic inflammation. Platelets and megakaryocyte, as medullar platelets precursors, are known to play a role in innate immunity. Little is known about the role of megakaryocytes at basal state and during acute complication in sickle cell disease patients. The aim of this study is to evaluate the role of megakaryocytes in sickle cell disease.

Sickle cell disease is the most common inherited blood disorder worldwide. It is a hemoglobinopathy characterized by a chronic hemolysis, vaso-occlusion, endotheliopathy, coagulation activation and chronic inflammation. It is a multisystemic disease leading to acute (Vaso-occlusive crisis, acute chest syndrome) and chronic complications with multiorgan damage. Platelets are activated and release pro-inflammatory mediators in sickle cell disease patients. Less is known about megakaryocytes, precursors of platelets, in sickle cell disease. Nevertheless, it recently has been shown that megakaryocytes, are also produced in the lung and can displayed a pro-inflammatory transcriptomic signature depending on local conditions. An increase in pulmonary megakaryocytes has been described in vascular diseases associated with excessive coagulation, in acute respiratory distress syndrome, and infections demonstrated that during severe SARS-CoV2 pneumonia, there was an increase in circulating megakaryocytes characterized by a pro-inflammatory transcriptomic signature. Acute chest syndrome represents the first cause of mortality in patients with sickle cell disease, characterized by an acute respiratory failure whose pathophysiology includes vaso-occlusive phenomena, infection and inflammation. Given a pro-inflammatory and pro-thrombotic state in sickle cell disease, particularly in acute chest syndrome, we suggest that the megakaryocyte may be involved in the pathophysiology of sickle cell disease. The aim of this study is to evaluate the role of megakaryocytes by peripheral blood sampling from 10 sickle cell disease patients at rest since at least 1 year, 10 sickle cell disease patients at rest and 20 patients during acute complications (10 sickle cell disease patients during vaso-occlusive crises, 10 sickle cell disease patients during acute chest syndrome).

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease SS or S-béta° thalassemia
* Patient at steady state since at least 1 year or at steady state (without crisis), or during vaso-occlusive crisis or during acute chest syndrome
* Age \> 18 years old

Exclusion Criteria:

* Patient objects to take part in the study Hematologic disorder (leukemia, myeloma, myelodysplasic syndrome, myeloproliferative syndrome)
* Immune thrombocytopenia, Immunosuppressive or anti-inflammatory (biotherapies, corticosteroids, non steroidal anti-inflammatories drugs) Page 12 sur 23
* Anti-platelets agents
* Red blood cell exchange or transfusion \< 3 months
Analyze Sleep Stages by Portable ECG Device

Sleep is a fundamental need for human and is associated with the working performance and the disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more important recently. In clinical settings, the analysis of daily sleep quality depends on actigraphy and sleep log. However, the uses of actigraphy and sleep log are not really convenient for patients. In this trial, the investigators will measure the subjects' ECG signal and movement using a portable ECG device with motion sensor. On the other hand, the sleep stages are also obtained from the current wide-established measurement- polysomnography. The ECG signals, movements, and sleep stages will be analyzed by our algorithm of artificial neural network. Then, the investigators can obtain the preliminary analysis of sleep quality can be obtained by using ECG device with our algorithm. It is helpful for doctors to realize the patent's sleep quality quickly


Eligibility Criteria:
Inclusion Criteria:

* OSA: OPD OSA patients; Healthy: no OSA

Exclusion Criteria:

* heart disease
* arrhythmia
Evaluation of Membrane Lung Function in High-altitude Regions

Over the last 20 years, extracorporeal membrane oxygenation (ECMO) has been used to support adult patients with respiratory or cardiac failure who are unlikely to survive conventional treatment methods. ECMO circuit, pump, and oxygenator technology improvements permit safer perfusion for extended periods. The prolonged use of an ECMO circuit increases the risk of membrane lung (ML) dysfunction. The ML is responsible for taking in oxygen and removing carbon dioxide. The non-biologic surface of the ML triggers inflammatory and coagulation pathways, resulting in the formation of blood clots, breakdown of fibrin, and activation of white blood cells, which ultimately leads to ML dysfunction. Coagulation and fibrinolysis activation can cause systemic coagulopathy or hemolysis, and the deposition of blood clots can block blood flow. Moreover, the accumulation of moisture in the gas phase and the buildup of protein and cellular debris in the blood phase may contribute to shunt and dead-space physiology, respectively, impairing the exchange of gases. These three categories-hematologic abnormalities, mechanical obstruction, and inadequate gas exchange-account for most ML exchanges. Worsening oxygenation during ECMO should prompt quantification of oxygen transfer. ML exchange is indicated when the ML can no longer meet the patient's oxygen demand. The partial pressure of Post-ML arterial oxygen less than 200 mmHg is the most important consideration in this decision. In some high-altitude regions of China, ECMO treatment is also routinely conducted. The experiences above are derived from low-altitude areas, and whether they apply in high-altitude regions is still being determined. This study aimed to explore the significantly lower membrane lung oxygen uptake in high-altitude regions compared to low-altitude areas.


Eligibility Criteria:
Inclusion Criteria:

* Receiving ECMO support

Exclusion Criteria:

* Unable to obtain post-membrane blood gas
* Pregnancy
* Patients cannot receive anticoagulation
* Refusal to participate in the trial
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)

To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.

MEGA Study is the first prospective, randomized, controlled trial conducted in Japan to evaluate the primary preventive effect of pravastatin against CHD in daily clinical practice. Because the dose of pravastatin used in the MEGA Study was 10-20 mg/day, which is consistent with the approved doses in Japan and lower than the doses used in previous large-scale clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* TC:220～270mg/dl
* Male: 40-70 years old/ female: postmenopausal-70 years old
* \<40kg in weight

Exclusion Criteria:

* FH
* History of CHD(angina, MI, post-PTCA/CABG, etc.)
* History of CVA(stroke, TIA, etc.)
* Underlying malignant tumor
Aripiprazole in Patients With Acute Mania

The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Acute Bipolar I Mania

Exclusion Criteria:

* Patients with a DSM-IV diagnosis other than Bipolar I Mania