cyrilzakka/clinical-trials huggingface dataset:
Effect of Supine or Prone Position After Caesarean Birth

Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by Caesarean birth.

This study hypothesizes that when the infant is prone they will have postural drainage, better dorsal lung expansion, less vagal response from suctioning and less agitation secondary to the righting reflex.

This study will compare 1033 term babies divided by randomization into two groups prone and supine. During the study, care givers will monitor and record incidence and severity of Respiratory Distress, Use of FiO2 or respiratory support, admissions to NICU.

Eligibility Criteria:
Inclusion Criteria:

\* Any woman not in labor who are undergoing elective Cesarean birth at term, 37 to 41 completed weeks gestation.

Exclusion Criteria:

* any woman with prior rupture of membranes
* diabetes mellitus, gestational diabetes,
* any woman receiving sedation
* using medication such as Demerol, magnesium sulfate or general anesthesia
* any woman who has a known drug history
* any known macrosomia
* known congenital anomalies or meconium stained fluid
* any woman with illnesses such as maternal fever, chorioamnionitis, severe neonatal distress
* any woman with compromised infant at delivery
* oligohydramnios
* history of antenatal steroids.
Effect of High Versus Low-level Laser Therapy in Patients of Lumber Radiculopathy

To Compare the effects of high-level laser therapy (HLLT) and low-level laser therapy (LLLT) on pain in patients with lumbar radiculopathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders male and female will be included.
* Patients aged 40-65 years will be included.
* Patients with a diagnosis of lumbar radiculopathy confirmed by clinical evaluation by a physician or physiotherapist.
* Patients with a history of radicular leg pain and/or numbness or tingling sensation in the leg.
* a positive score on the Straight Leg Raise (pain between 35 degrees and 75 degrees), pain limiting functional ability, and scores at least 3/10 on the VAS, restricted lumbar range of motion - 25% flexion, 20% extension.
* Patients who have not received any form of treatment for lumbar radiculopathy within the past 3 months

Exclusion Criteria:

* Patients with a history of spinal surgery in the last 2 years or spinal deformity.
* Patients with a history of fracture or dislocation of the lumbar spine.
* Patients with a diagnosis of any other neurological disorder or neuropathy.
* Patients who are pregnant or breastfeeding.
* Patients with any other medical condition that may interfere i.e. inflammatory rheumatic disease, cardiac pacemaker, continuing that may interfere with the study outcomes or put them at risk with the study outcomes or put them at risk.
Comparative Evaluation of an Electrical Impedance Device Versus Digital Radiography in Estimation of Remaining Dentin Thickness

The research question was that in patients with carious posterior permanent teeth, would the electrical impedance device be as valid as digital radiography in estimation of remaining dentin thickness? The proposed hypothesis was null.


Eligibility Criteria:
Inclusion Criteria:

* Participants eligible for this study were those aged from 18 y to 28 y,
* willing to join the study
* with clinically detectable occlusal or proximal carious vital permanent molar teeth with closed apex and healthy periodontal supporting.
* The minimum extension of the carious cavity should be at least 1 mm in width to accommodate with the probe of the prepometer

Exclusion Criteria:

* Excluded participants were those with poor oral hygiene,
* severe medical complications,
* showing signs and symptoms of irreversible or necrotic pulp pathology also when the affected tooth was with extended buccal or lingual caries, extending clinically beyond ¼ dentin thickness or previously restored.
Multimodal Psychotherapy Training for Chinese Medical Students

Providing evidence-based, well-designed psychotherapy teaching to train them to get a basic understanding of psychotherapy and to gain required skills for clinical practice would be fundamental to medical students, residency. This study will be a two-arm randomized controlled trial (RCT) to evaluate the effectiveness of multimodal psychotherapy training program for medical students in China.

Background and aims: Providing evidence-based, well-designed psychotherapy teaching for medical students and residents is urgently needed. The aim of this project is to measure the effectiveness of a newly multimodal psychotherapy teaching program for medical students and residents in China.

Design: This study will be a two-arm randomized controlled trial (RCT). The intervention group will receive a two-day multimodal-based intensive educational intervention with 8 weeks follow-up (supervision based online teaching). The wait-list control group will not receive the intervention until the end of the study. Both groups will be followed up to 8 weeks.

Setting: This trial will be conduct at the Sir Run Run Shaw Hospital.

Participants: This study aims to recruit about 160 medical students and residents, with approximately 80 in each group.

Measurements: The primary outcome measure is the changes of the Facilitative Interpersonal Skills task (FIS) scores. Secondary outcome measures include: training program acceptability; trainees' psychotherapy knowledge; utilization of psychotherapy; and self-reported self-efficacy and self-reported motivation for psychotherapy.

Comments: If this CBT-based brief and short-term psychotherapy skill training program is proven effective, the mental health impact of its expansion nation-wide could be enormous.

Eligibility Criteria:
Inclusion Criteria:

1. Medical student, residents, health care providers
2. 18 years of age or older
3. Expressing an interest in psychotherapy
4. Willingness to received randomization
5. Willing to provide informed consent to participate in the study

Exclusion Criteria:

1. Not health care providers
2. Below 18 years old
3. Unwilling to be randomized
4. Unable to provide informed consent
Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology

This is a single-center study of 80 subjects with asthma including those with obesity and metabolic dysfunction (MD), those with obesity and without metabolic dysfunction, those with severe asthma and mucus plugging and those with severe asthma and without mucus plugging. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria will participate in a cardiopulmonary exercise testing (CPET) visit to compare lung function markers and change in oxygen saturation between obese patients with and without MD and severe asthma patients with and without mucus plugging.

The mechanism of poor exercise tolerance in patients with severe asthma is poorly understood. In preliminary data, the investigators have identified increases in air trapping in patients with obese asthma and metabolic dysfunction and patients with asthma and mucus plugs. The investigators have also found air trapping on CT (Computerized Tomography) scans of severe asthma patients with mucus plugs. Therefore, the investigators hypothesize that obese patients with metabolic dysfunction (MD) and severe asthma patients with mucus plugs develop changes in lung function during exercise.

To test this hypothesis, this protocol will plan for cardiopulmonary exercise testing in patients with obesity or severe asthma. The analyses will compare dynamic hyperinflation, expiratory flow limitation, and the RV/TLC ratio (ratio of residual volume to total lung capacity) before and after exercise between obese patients with and without MD and severe asthma patients with and without mucus plugs.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years old at Visit 0
2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
3. History of physician diagnosed asthma
4. Evidence of bronchodilator reversibility (12% improvement in FEV1 after albuterol administration) or positive methacholine challenge PC20 or PD20. Historical evidence is accepted.
5. Meets criteria for obesity or severe asthma a. Obesity: BMI≥30 i. Metabolic dysfunction is defined as presence of either:

1. IL-6 high: Plasma IL-6 \> 3.0 pg/mL 2. Insulin resistance: HOMA-IR \> 3 mass units b. Severe asthma: Requires treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy.

i. Mucus Plugging is defined as mucus plug score ≥ 4

Exclusion Criteria:

1. Asthma exacerbation or URI within the previous 6 weeks.
2. History of smoking

   1. If \<30 years old: Smoked for ≥5 pack-years
   2. If ≥30: Smoked for ≥10 pack years
3. Pregnancy
4. Absolute or relative contraindication to exercise testing per ATS criteria
5. Any other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician of record.
Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine

Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine

Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine

Eligibility Criteria:
Inclusion Criteria:

* Painful mucositis
* Child from 5 to 18 years.
* Presenting mucitis induced by chemotherapy or a conditioning of graft hematopoïetic.
* A pain not controlled by systematic paracetamol (10mg/kg/4h) or a the propacetamol (20mg/kg/4h).
* Not presenting a neurological or psychological difficulty at the use of the PCA or a EVA.
* First morphine amount going back to less 48h, and lass administration dating of more than 4h at the time of the beginning of the perfusion of Ketamine/placebo (EVA \> 30 after stop morphine).
* Assent signed by the parents and each time possible by the child.

Exclusion Criteria:

* The child was already included in the study.
* The age of psychomotor development is lower than 5 years
* Presence of a depression or a major depressive episode according to definition DSM IV.
* Hepatic or renal anomaly major (rank 3 or 4 of the scale of toxicity NCI CTC v2.0)
* Bilirubin\>3N
* Gamma WP\>3N
* SGOT or SGPT \>5N
* Creatinin\>3N
Use of Animations Movies to Increase Response in a National Health Survey

The aim of this study is to examine the potential for animation movies to improve response rates and sample composition in an embedded randomized controlled trial in the Danish National Health Survey 2021. The overall research question is whether cover letters including an animation movie can perform better than generic letters.

The aim of this study is to examine the potential of animation videos to improve response rates and sample composition in an embedded randomized controlled trial in the Danish National Health Survey 2021 (DNHS-2021). The overall research question is whether digital cover letters including an animation video can perform better than digital letters without animations. The proposition is that such letters should increase the willingness of some sample members to participate by means of increased motivation and reduced complexity, and that this will be reflected in higher response rates. In addition to examining whether it can be advantageous for overall response rates to use cover letters including animation videos, this study also examines the effect of different versions of the animation videos across sample subgroups in order to identify how to best target potential non-respondents in future surveys.

Eligibility Criteria:
Inclusion Criteria:

* Aged 16 years or older and living in Denmark at January 1th 2021.
* Able to receive an invitation through a secure electronical mail service (Digital Post).
Prognostic Value of Cardiac and Renal Markers in Ischemic Stroke and Transient Ischemic Attack

Patients with stroke or transient ischemic attack (TIA) are at high risk of poor outcome, recurrence of cardiovascular events or vascular death.Until now, no reliable predictive biological marker could be identified in the acute phase of stroke.We hypothese that, in the acute phase of ischemic stroke or TIA, the increase of cardiac ( brain natriuretic peptide, BNP) or renal markers (albuminuria, cystatin C)might predict recurrence of cardiovascular events or vascular death. We want to assess which one of these markers has the best prognosis value , in a prospective study of 300 stroke patients followed during 3 years.

Patients with ischemic stroke or TIA will be included in the 48 hours following the onset of symptoms, in 3 university hospitals.For each patient will be collected

* 1 blood sample for the BNP measure in pg/ml
* 1 blood sample for the Cystatin C measure in mg/l
* 2 urinary samples to measure the albumine/creatinine ratio, at inclusion and 5 days after the inclusion, and to study the variation of albuminuria in micrograms/min.

The clinical follow-up will be organized during 3 years. The following events will be notified: poor outcome (defined with the Barthel and Rankin scores), recurrence of cardiovascular or cerebrovascular events, vascular death.

After adjustment on the main clinical prognosis factors, we want to determine wich one of these markers has the best prognosis significance and allows to identify in the acute phase the "high-risk" patients, in order to intensify individual treatment and secondary prevention.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke or TIA in the first 48 hours following the onset of symptoms

Exclusion Criteria:

* Patient unable to give an informed consent
* Urinary sample impossible to collect
Influence of Polishing After Bleaching on Color Change and Enamel Morphology

This trial evaluated the influence of polishing on enamel color change after in-office bleaching treatment. It also evaluated the influence of polishing on tooth morphology and sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 to 30 years old of both sexes;
* With good oral hygiene;
* With no sensitivity to tactile and evaporative stimuli;
* Who have not undergone previous bleaching treatment, and with no caries lesions.

Exclusion Criteria:

* patients undergoing fixed orthodontic treatment;
* patients allergic to the bleaching product;
* drug users or pregnant women;
* patients with carious lesions, defective restorations and/or periodontal disease, patients with systemic diseases, pulpitis or patients using analgesics.
Emotion Regulation in Binge Eating and Purging Among Adolescents

The study will examine the neural and behavioral correlates of emotion regulation in adolescents engaging in binge eating and/or purging and healthy adolescents. Furthermore, it will look at the influence of executive function on emotion regulation in this population. This study will allow us to gain further understanding of the neural basis of emotion regulation in this age group. Moreover, this study supports the need to develop new treatment approaches based on a better understanding of the brain processes associated with eating disorders.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 14-18
* with or without current binge eating and/or purging behaviors

Exclusion Criteria:

We exclude patients of clinically significant low weight (\<85% ideal body weight using CDC norms for height, age, and gender) and those with contraindications for MRI (e.g., orthodontia, metallic implants). Participants also will be without evidence of current or past major neurological (e.g., seizures, psychosis, head trauma) or major sensory deficit.
A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.

HIV-1-infected patients who are currently receiving stable antiretroviral therapy add tenofovir DF to their regimen. Study participation lasts for approximately 48 weeks. Interested patients should contact their physicians.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have a viral load greater than or equal to 10,000 copies/ml.
* Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.)
* Are at least 18 years old.
* Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward.
* Have a life expectancy of at least one year.

Exclusion Criteria

You will not be eligible for this study if you:

* Have a history of a serious kidney or bone disease.
* Have severe nausea, vomiting, or trouble taking medications by mouth.
* Are pregnant or breast-feeding.
* Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine.
* Are taking any medicines that interfere with kidney functions.
Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

This is a pilot single-blind placebo-controlled randomized trial to establish experimental feasibility. We plan on enrolling a pilot cohort of 40 patients, with up to 5 patients in treatment phase 0 and the remaining in treatment phase I. During Phase I, the remaining participants will be assigned to either treatment or control group using dynamic block randomization balancing on sex, age group, and disease histology.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years old
* Diagnosis of stage III colon cancer
* Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.

Exclusion Criteria:

* Allergy or sensitivity to probiotic supplementation
* Diagnosis/history of:

Non-colon GI cancer or chronic GI-related disease or disorders such as gastric ulcer, irritable bowel syndrome, inflammatory bowel disease, or intestinal malabsorption syndrome Cognitive impairment, such as dementia, or developmental disorder that would affect ability to give consent or comply with study procedures

* Current treatment of cancer other than non-melanoma skin cancer, including metastases and recurrences
* Current participation in another interventional study of medication(s)
* Major changes in eating habits within the past 3 months, such as stopping or starting a restricted diet
* BMI ≥40 kg/m2 or ≤17 kg/m2
* Unexpected change in weight of ˃4.5 kg within the past 6 months
The Role of Bifidobacterium Animalis Ssp Lactis DR10 Supplementation in Women During Pregnancy and Lactation on Breast Milk IL-8 and Gut Mucosa Integrity in Infant

Hopefully this research can help to provide the optimal nutrition management from pregnancy so that the babies wiil born with better quality of health and reduce the morbidity and mortality.

Until now, there is no data regarding probiotics in Indonesien breastmilk and the role of probiotics supplementation on pregnant women to the baby especially from inflammation pathways. The investigators hope the result of this research can help reducing infant morbidity and mortality rate in Indonesia, also has a benefit for future research.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women ,gestation age 32-34 weeks, normal pregnancy, plan to deliver spontaneously, no antibiotic
* tend to give exclusive breastfeeding
* want to join the research
* well doing baby

Exclusion Criteria:

* pregnant women with pre-eclampsia,bleeding,infection,premature rupture of the membrane or other chronic disease
* plan to deliver by caesarean section
An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to assess safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of adenocarcinoma of the prostate
* Evidence of stage IV disease on previous bone, CT, and/or MRI scan
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
* Mandatory plasma and fresh or archival tumor tissue must be submitted

Exclusion Criteria:

* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
* Participants with active brain metastases
* Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment

Other protocol defined inclusion/exclusion criteria could apply
The China Longitudinal Aging Study of Cognitive Impairment

Alzheimer's disease (AD) and Vascular dementia (VaD) have become common diseases in the elderly. The burden of dementia is rising in China, with major medical, social and economic impacts. To address this important public health problem, cohort study on elderly cognitive disorders should be carry out. The methods of early prevention, early diagnosis and early treatment the cognitive disorders in elderly should be found to reduce the burden of the social and economic issue due to dementia. At present, the international corresponding guidelines have taken gene and brain imaging biomarkers as important indicators of dementia pathogenesis research, accurate diagnosis and targeted intervention. Based on the above understanding, the study carry out the population cohort study based on accurate diagnosis and construct the high standard information and sample bank. The study will establish the standard and quality system of geriatric cognitive disorders cohort study (unified standards and norms). The study will integrate the standard biological samples stratified acquisition function module (homogeneity and precision) of elderly cognitive disorders, and complete the construction of biological samples bank and clinical diagnosis and treatment information database. The study will apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. The study will evaluate whether peripheral nerve degeneration can predict central nervous system degeneration based on the large cohort of elderly study. In addition, The study will make an effective supplement the sample bank construction of Shanghai Mental Health Center.

The neuropsychological test battery are used to access the cognitive function of subjects in the study. The brain MRI and biochemical examination will be done in the screening period. The samples such as plasma, serum, urine and faeces et al. of the subjects will be collected in the study.

Eligibility Criteria:
Inclusion Criteria:

* registered residents in the community;
* ≥ 60 years;
* without schizophrenia or mental retardation;
* be able to communicate and accept physical and cognitive examinations

Exclusion Criteria:

* blind
* deaf mute