cyrilzakka/clinical-trials huggingface dataset:
Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS

This study assesses the clinical effectiveness of mammalian target of rapamycin (mTOR) inhibition with rapamycin in minimizing or decreasing the severity of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in participants infected with mild to moderate COVID-19 virus.

This is a single center, double-blind, placebo-controlled, randomized clinical trial in which each participant, after admission to hospital with a diagnosis of mild to moderate COVID-19 infection, will be administered either a dose of rapamycin or the placebo daily. Each subject will receive the assigned treatment until hospital discharge or death. Evaluations will be performed at the beginning of the clinical trial and then daily up to 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Over 60 years of age clinically judged to require hospitalization
2. SARS-CoV2 infection documented by positive RT-PCR nasopharyngeal swab
3. Mild to Moderate clinical status defined as clinical symptoms with or without pneumonia on imaging, with or without fever who are judged to require hospital admission

   1. Elevated ferritin
   2. Lymphopenia
   3. Bilateral opacities on chest x-ray
   4. Low pro-calcitonin
   5. Clinical signs suggestive of symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea or moderate illness with CoVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute.

Exclusion Criteria:

1. Known or suspected allergy to RAPA
2. High pro-calcitonin
3. SARS-CoV2 documented by negative RT-PCR nasopharyngeal swab
4. Treatment with contraindicated concomitant medications: currently receiving immunosuppressants, including steroids, prior to enrollment, or with immunomodulators or immunosuppressant drugs, including but not limited to Inter leukin (IL)-6 inhibitors, Tumor necrosis factor (TNF) inhibitors, anti-IL-1 agents and Janus kinase (JAK) inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization.
5. Currently receiving immunosuppressants, including steroids, prior to enrollment
6. Serious underlying disease including but not limited to cardiac, pulmonary, renal, hepatic (bilirubin \>1.5x Upper normal limit (ULN) or Aspartate Aminotransferase (AST)\>ULN but bilirubin ≤ ULN), endocrine (diabetes) or psychiatric disorders judged to be at risk in participating by the inpatient attending physician or team
7. Suspected or confirmed history of alcohol or substance abuse disorder
8. Having participated in other drug trials in the past month
9. Deemed otherwise unsuitable for the study by researchers
10. Clinically judged to not require hospital admission
Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years of age or older
2. Qualifying voiding diary
3. Have a diagnosis of UUI for at least 6 months
4. Failed and/or are not a candidate for conservative therapies.
5. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol
6. Willing and able to provide signed and dated informed consent

Exclusion Criteria:

1. Have primary stress incontinence
2. History of a prior implantable tibial neuromodulation system
3. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
4. Previous pelvic floor surgery in the last 6 months
5. Women who are pregnant or planning to become pregnant during the course of the study
6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section

This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent

Exclusion Criteria:

* • Women not willing or women not able to provide consent

  * Women who have a classical caesarean section
  * Women younger than 18 years of age
  * Women with any of the following conditions will be excluded (ergometrine contra-indicated in patients with these conditions).
  * Pre- eclampsia
  * Eclampsia,
  * Uncontrolled hypertension (hypertension defined as systolic blood pressure more than 140 mm Hg and diastolic blood pressure more than 90 mm Hg)
  * Any cardiac lesion
  * Impaired liver function
  * Impaired kidney function
  * Hypersensitivity to any of the active ingredients of the preparations that will be used (Syntometrine® or Syntocinon®)
  * Occlusive vascular disease
  * Autoimmune vasculitis
Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy

Severe CTEPH leads to an impaired physical capacity and a restricted quality of life and poor prognosis.

Pulmonary endarterectomy represents the best choice as therapy, when the thrombi are located in the central pulmonary vessels and therefore can be operated. By this operation the pulmonary artery pressure can be normalised and the patients' survival improved. Up to now, after successful endarterectomy patients only receive anticoagulation.

Despite operation many patients remain symptomatic and are restricted in their physical capacity. Therefore a hypothesis of this project is that most of the patients, even after successful operation, show peripheral vascular remodelling with a ventilation-perfusion mismatch and elevated pulmonary pressure during exercise.

In this study we aim to analyse how many patients with CTEPH after endarterectomy show elevated pulmonary artery pressures at rest or during exercise and are limited in their physical capacity, hemodynamics, oxygen uptake and quality of life and need further therapy.

Another aim is to examine whether exercise and respiratory therapy may improve the patients postoperatively.

Therefore 30 patients with CTEPH \> six months after endarterectomy, with ongoing restricted exercise capacity shall be included. After baseline examination in the University hospital Heidelberg the patients receive exercise and respiratory therapy for three weeks. The patients will receive further examinations at the end of rehabilitation after 3 weeks and after 15 weeks. All examinations include medical history, family history, physical examination, ECG and echocardiography at rest and during exercise, cardiopulmonary exercise testing, assessment of the respiratory muscle strength, the SF-36 questionnaire for quality of life, laboratory testing and MRI.

Rehabilitation will be conducted in the clinic for rehabilitation Koenigstuhl, Heidelberg. Participants will be randomised into two groups, a control group receiving a conventional therapy for three weeks, in which physical exertion is to be avoided and a training group with additional exercise and respiratory therapy.


Eligibility Criteria:
Inclusion Criteria:

* A Screening

  1. Informed consent
  2. Men and women 18 - 75 years
  3. Patients ≥ 6 months after endarterectomy because of chronic thromboembolic pulmonary hypertension (CTEPH)
* B Training

See A + all patients who showed a restricted physical capacity in the screening:

* Latent pulmonary hypertension
* Restricted physical capacity

Exclusion Criteria:

1. Pregnancy or lactation
2. Change in medication during the last 2 months
3. Patients with signs of right heart decompensation
4. Disease which affects the gait
5. Unclear diagnosis
6. Acute illness, infection, fever
7. Severe lung diseases with FEV1 \<50% and TLC\< 70% of reference
Social Groups for Australian Children on the Autism Spectrum

This study evaluates the KONTAKT social skills group training in Australian children on the autism spectrum compared to an active control group which is a group Art class

KONTAKT is a manualized Social Skills Group Training program designed for children and adolescents with ASD which aims to improve communication, social interaction skills, reduce the severity of ASD symptoms, improve the ability to empathise and adapt in a group setting. A large randomized controlled trial in Sweden found that adolescents who participated in KONTAKT demonstrated improvements in social skills, behaviour, reduced stress and improved overall functioning as reported by parents immediately following and at three months after the program. However, social skills are at least in part influenced by social cultural contexts and there is a need to understand the feasibility, acceptability and effectiveness of KONTAKT in an Australian context. Moreover, in the previous studies, the social skills groups were compared to treatment as usual groups. Therefore, this study evaluates the KONTAKT social skills group training in Australian children on the autism spectrum compared to an active control group which is a group art class

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 8 to 12
* Clinical consensus diagnosis of ASD as defined by DSM-5 and confirmed by the Autism Diagnostic Observation schedule-2
* IQ scores \> 70 as measured by the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)

Exclusion Criteria:

* Existing prior comorbid externalizing behaviours as assessed by the Childhood Behaviour Checklist (CBCL).
* Clinically assessed self-injurious behaviour • Low intrinsic motivation to participate in a social skills training group
* Insufficient English language skills
The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection

This study aims to explore the association between RA and osteoporosis and highlight the risk factors that RA patients have that may cause or affect osteoporosis progress.

Rheumatoid arthritis (RA) is an autoimmune chronic connective tissue disease that produces persistent systemic inflammation, with joint inflammation leading to function loss and joint destruction. It can finally lead to some serious systematic disorders, such as cardiovascular, pulmonary, skeletal, and psychological disorders.

One of the most severe comorbidities of RA is osteoporosis (OP), which is a chronic metabolic skeletal disease leading to an increased risk of low trauma fracture, and many factors can play a role in increasing this association including treating RA patients with glucocorticoid over a long duration, chronic joints inflammation, calcium malabsorption, age of the patients, and genetics.

Osteoporosis is characterized by microarchitectural deterioration of bone tissue and low bone mass. The most commonly used measurement for OP is bone mineral density (BMD) and DEXA (dual x-ray absorptiometry) Scans.

Osteoporosis can result in devastating physical, psychosocial, and economic consequences. Still, it is often overlooked and undertreated, in large part because it is clinically silent; there are no symptoms before a fracture occurs.

Epidemiological studies indicate that about 60-80% of RA patients have a comorbidity of OP.

These two kinds of complex diseases may share some common genetic mechanisms and biological processes. For example, proinflammatory cytokines including TNF-α, IL-17, IL-6, and IL-1 have been reported to be closely associated with OP, and they also play important roles in the development of RA. Also, the inflammation in the joints increases bone absorption and makes RA patients susceptible to bone loss and osteoporosis development.

One of the primary drugs recommended for the treatment of RA is a corticosteroid, glucocorticoid (GC). Both systemic corticosteroid and intraarticular corticosteroid are proven to be risk factors for developing secondary osteoporosis and osteoporotic fracture. The risk increases with the long duration of use and using a high dose. Longer duration and severity of RA were also indicated as independent risk factors for vertebral fractures. The American College of Rheumatology (ACR) recommended increasing the awareness of RA patients about BMD and getting DXA done for identifying a patient at risk of osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient more than 18 years old classified as rheumatoid arthritis based on ACR/EULAR 2010 Classification criteria.

Exclusion Criteria:

* Patients with other clinical conditions that causes secondary osteoporosis as Diabetes Mellitus, renal, liver diseases, thyroid and parathyroid disorders.
Light Needle Positioning Robot Under MRI Guidance

This study aim is to evaluate the needle positioning precision, compared to the real path planned by the physician on healthy voluntaries, by positioning a fictional needle, without inserting it.

Additionally, this study will evaluate:

* the robot precision,
* the robot detection robustness,
* the software and device ergonomics,
* the device security.


Eligibility Criteria:
Inclusion Criteria:

* person over 18 years old,
* person with height is under 1m90,
* person with abdomen height is under 28 cm,
* person with abdomen width is between 26 cm to 50 cm,
* person able to hold his breath during 30 seconds,
* person affiliated to social security or similarly regime,
* signed consent for participation in the study.

Exclusion Criteria:

* person with a contraindication for abdomen MRI,
* claustrophobic person,
* protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Oxygen Saturation and Caffeine Post-Discharge

This study aims to determine normative values of oxygen saturation in late preterm infants, and evaluate the frequency of hypoxic events in infants requiring caffeine at discharge and those not requiring it.

Apnea of prematurity is a common morbidity among premature infants. Recent studies suggest an association between apnea and neurodevelopmental impairment. Our objectives are to determine normative values of oxygen saturation in late preterm infants -reference group. In infants born 28-35 weeks requiring caffeine- study group and infants born 28-35 weeks not requiring caffeine-control group we will be evaluating the frequency of hypoxic events. Recruitment time: February 2015 until December 2016.

After consent a pulse oxymeter will be placed on the infant's right wrist. For those infants that will receive caffeine prior to discharge, this medication will be instituted after 12 hours of the initiation of the study and continue for the remaining of the hospitalization. For all other infants, the pulse oxymeter will be done continuously until discharge. After discharge, the recording will be done at home once a week until 46 weeks corrected age in the three groups.

All the data will be reviewed by a blind observer to the groups from which that data comes. The data will be analyzed by a statistician.

Normative values will be developed on the reference group until 46 weeks post conceptional age.

Any medical problems encounter by the patients while on the study or in the following 6 months will be recorded to establish the safety of caffeine use at home and its discontinuation at 44 weeks post conceptional age.

Eligibility Criteria:
Inclusion Criteria of infants admitted to NICU:

1. Gestational age at birth of \< or = 35 weeks
2. Families of infants that live in Calgary
3. Infants discharged home from PLC or South Health Campus (SHC)
4. Decision of treating team to start caffeine
5. No episodes of clinically significant apnea for a period of 3 to 5 days prior to discharge
6. Infant has access to reliable post-discharge follow up

Exclusion Criteria of all infants:

1. Active serious medical conditions other than apnea (Congenital Heart Disease (CHD), Chronic Lung Disease (CLD), symptomatic anemia).
2. Congenital disorders like Trisomies, genetic syndromes, midline defects, metabolic disorders.
The Effectiveness of Group-Delivered Guided Written Exposure Therapy for CPTSD Symptoms Among Adolescents : A Multi-centered Randomized Controlled Trail

This study aims to examine the effectiveness of group-delivered Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among Chinese adolescents through a randomized controlled trial. A total of 120 participants will be recruited, with 60 randomized to the GWE-C group and 60 randomized to the supportive therapy (ST) group. The GWE-C intervention will consist of 7 to 10 group sessions. The primary outcome, assessed by the International Trauma Questionnaire (ITQ), will be measured at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 10 and 18 years;
* Meet the diagnostic criteria or subclinical criteria for Complex PTSD (C-PTSD) , defined as missing either one symptom from the PTSD clusters, or the DSO cluster;
* Possess sufficient literacy and language skills to complete writing-based tasks;
* Be able to understand the study procedures and complete the required assessments;
* Provide written informed consent, with consent also obtained from their legal guardians.

Exclusion Criteria:

* Presence of a severe psychiatric disorder or neurodevelopmental disorder, such as schizophrenia, bipolar I disorder, autism spectrum disorder, intellectual disability, or other severe psychiatric conditions that would interfere with study participation;
* Presence of a severe physical illness that would impair the ability to engage in the intervention;
* Suicidal ideation within the past six months;
* Ongoing exposure to traumatic events;
* Currently receiving other trauma-focused psychological treatments.
Prognostic Implications of AccuFFRangio-guided PCI in STEMI

This is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. The aim of this study was to evaluate the diagnostic accuracy and prognostic implications of AccuFFRangio in patients with ST-segment elevation myocardial infarction (STEMI).


Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* STEMI patients with primary percutaneous coronary intervention within 24 hours with at least 1 non-IRA
* Diameter stenosis of 50%-90% by visual estimate
* Reference vessel size \> 2 mm in stenotic segment by visual estimate

Exclusion Criteria:

* LVEF ≤ 40%
* eGFR \< 60 mL/min
* Allergy to contrast media, adenosine
* Prior CABG
Methionine Metabolism in Enterally Fed Pediatric Sepsis

Critically ill children have abnormal utilization of nutrients such as glucose, lipids and protein. Protein synthesis is increased mainly in the form of immune and signaling proteins, while muscle and structural protein synthesis is decreased. The metabolism of sulfur amino acids through the splanchnic area and specifically methionine and cysteine have not been investigated in critically ill septic children, despite that sulfur amino acids have important roles in thiol, antioxidant and epigenetic reactions. Methionine metabolism in sick children will be influenced by its rate of utilization through different pathways. Our study aims to investigate the metabolism of methionine and cysteine when both amino acids are given by the enteral route in critically ill septic children. The investigators are focused on the rates of transmethylation, remethylation and transsulfuration in critically ill septic children, and if the current standard nutrition maintains methionine nutritional balance and functional requirements in critically ill children fed by the enteral route.

This is a prospective, translational study on the splanchnic metabolism of methionine to determine the rates of the different pathways and synthesis rates of glutathione when critically ill children are fed by the enteral route, and the difference among various age groups. The study size will include 45 critically ill septic, pediatric patients (15 infants at 1 month-3 years of age, 15 children at 4-12 years of age and 15 adolescent at 13-19 years of age), males and females admitted to the pediatric intensive care unit (PICU) at Children's Medical Center, Dallas. The minimal subject's weight will be 4 kg. The number of subjects includes an expected drop out rate of about 20%, in order to obtain 15 patients with complete data in each group. Patients will receive nutritional support as per standard care. This study will yield important knowledge and may lead in the future to changes in the current practice on the management of critically ill pediatric patients in the PICU.

Eligibility Criteria:
Inclusion Criteria:

1. Children age 1 month-19 years
2. Diagnosis of severe sepsis diagnosed as clinical sepsis syndrome (requires two of the following criteria):

   * Source of infection
   * Fever or Hypothermia
   * Leukocytosis or Leucopenia
   * Poor organ perfusion (such as delayed capillary refill or decreased urine output or hypotension)
   * Bacteremic sepsis demonstrated by positive blood culture
3. Weight greater or equal to 4.0 kg
4. Need for enteral nutrition by a nasogastric/nasoduodenal tube
5. Presence of central and/or arterial venous access as per clinical indication

Exclusion Criteria:

1. Patients with metabolic diseases (i.e. Insulin dependent diabetes mellitus, urea cycle disorders, cystinuria, etc.)
2. Pregnancy
3. Primary liver failure
4. Primary renal failure
5. Patients unable to tolerate enteral feedings
6. Weight less than 4.0 kg