cyrilzakka/clinical-trials huggingface dataset:
About Oral and Gut Microbiota in Intensive Care Unit : SARS-CoV-2 (COVID-19) Infection Impact.

The objective of the present study is to describe the negative impact on oral and gut microbiota of a severe acute respiratory syndrome SARS-CoV-2 infection in patients hospitalized in intensive care units (ICU). The study would like to compare their microbiota to the microbiota of ICU patients, non-infected by the SARS-CoV-2.

Gut microbiota in ICU patients is sorely distorted, there is an important loss of diversity which can be traduced by a decrease of commensal bacteria and an increase of pathogens. The virulence, infectivity, and transmissibility of the emerging SARS-Coronavirus 2 is a reason for us to find strategies and therapeutics to curb the epidemic. Gut mucosa is very probably a target for the virus and it seems likely that feces are a way of transmissibility. It suppose too that gut microbiota is more weathered in patients with a SARS-CoV-2 infection, moreover if they have to be hospitalized in ICU. For this reason, the present study would like to collect oral and rectal swab from patients hospitalized in ICU for a serious SARS-CoV-2 infection and from patients hospitalized in ICU for another reason that a SARS-CoV-2 infection at day 1, each 7 days and at the end of their ICU stay. Other objectives are to know if this distorted microbiota is a risk factor for poor outcomes in our ICU patients, if antibiotics and artificial nutrition are too a risk factor of weathered microbiota and finally if we can connect oral and rectal dysbiosis to use the oral dysbiosis to predict the rectal dysbiosis in view of the ease to collect oral sample.

Eligibility Criteria:
Inclusion Criteria:

Controls:

- Hospitalized patient with non-SARS-CoV-2 hypoxemic pneumonia

Patients COVID 19:

- Patient hospitalized for SARS-CoV-2 hypoxemic pneumonia

All:

* Patient hospitalized for less than 48 hours in a general intensive care unit
* Patient who has given free, informed and express (oral) consent to participate in the research (or a close relative or trusted person of the patient if the patient cannot express himself/herself)
* Patient covered by a social security system or equivalent
* Expected hospitalization of more than 48 hours

Exclusion Criteria:

* gut inflammatory disease
* recent gut surger
* ostomy
* recent antibiotics
* artificial nutrition in the long term
Characterization of the Melanoma-Specific Immune Response

The aim of this study is to study T-cells. Blood will be collected and the samples will be used to generate T cell clones. Two separate blood draws will be required at the maximum.

The aim of the study is to in-vitro characterize and expand T cells specific for melanoma-derived antigens. Peripheral blood with be collected from 20 volunteers with biopsy proven melanoma and 10 age matched controls. Blood will be collected prior to the initiation of chemotherapy. There will be no more than two blood draws per patient. Most patients will receive a single blood draw; however, some participants may be asked to return for a single additional blood draw if investigators were unable to isolate melanoma-specific immune cells after the first blood draw. Two separate blood draws will be the maximum. The interval between these blood draws will be a minimum of 3 months apart. Blood samples will be used to determine the patient's HLA haplotype via PCR and DNA sequencing. After the patient's haplotype has been established melanoma-specific T cell clones will be generated from the peripheral blood samples and expanded in-vitro. These clones will then be assayed for specificity against commercially available melanoma cell lines. The T cell clones will also be assayed for reactivity to melanocyte differentiation antigens such as MART-1 and gp100. If the volunteer requires a palliative resection of a melanoma tumor then the patient's own tumor cells may also be used to test the specificity of the isolated T cell clones. All experiments will be conducted in-vitro.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy diagnosis of malignant melanoma
* Have had a biopsy diagnosis of malignant melanoma in the past

Exclusion Criteria:

* Patients taking immunosuppressive medications
Magnetic Resonance Imaging of Brain Development in Autism

The purpose of this study is to investigate brain development in autism by longitudinally assessing children with autism, as well as typically developing controls, using advanced MR techniques. We will use longitudinal diffusion tensor imaging (DTI) measures to investigate the protracted development of long-range white matter fibers in autism. In addition, we will investigate the effect of autism risk genes on brain development.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 6 - 18 years at initial MRI

Inclusion criteria for subjects with autism

1) DSM-IV (APA, 1994) diagnosis of autism, according to ADI-R interview

Inclusion criteria for controls

1. no DSM-IV (APA, 1994) diagnosis, according to DISC interview
2. no scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)
3. IQ \> 70

Exclusion Criteria:

1. major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
2. presence of metal objects in or around the body (pacemaker, dental braces)
3. history of or present neurological disorder
4. for individuals over 12 years of age: legal incompetence, defined as the obvious inability to comprehend the information that is presented by the investigator and is outlined in the Information letter and on which the decision to participate in the study is to be based
Current Pharmacological Practices in Severe COVID-19

The investigators aim to understand the variation in pharmacological therapies for the management of severe coronavirus disease 2019 (COVID-19) in India and compare it to the recent available evidence.

The ongoing pandemic of COVID-19 has proven to be the greatest medical emergency of recent times. The evidence on the therapeutics has evolved significantly in last few months after initial use of re-purposed drugs.

The objective of this study is to understand the current practices in the management of adults severe COVID-19 in India.

The ongoing pandemic of COVID-19 has proven to be the greatest medical emergency of recent times. The response of the medical world to this crisis has been unprecedented. The healthcare workers are caring for patients at the frontline while, scientists and researchers are discovering vaccines or effective treatment in shortest possible duration. The scale and effect of pandemic in India, being second most populous country of the world is enormous. As of December 30, 2020, India has crossed 10 million cases and 148,000 deaths from COVID-19. India has second most number of cases only after United States of America (USA) and with third largest number of deaths. The Ministry of Health and family Welfare (Under Government of India) has given periodical clinical management guidelines, with last updated on July 5, 2020 (version 5).

In adults, severe COVID-19 is defined as presence of any of the following dyspnea, a respiratory rate of 30 or more breaths per minute, a blood oxygen saturation (SpO2) of 93% or less, a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (Pao2:Fio2) of less than 300 mm Hg, or infiltrates in more than 50% of the lung field while Critical COVID-19 is defined as presence of acute respiratory distress syndrome (ARDS), sepsis or septic shock. The mortality in critical COVID-19 is reported to be 25-49% in different studies. The evidence on the therapeutics for COVID-19 has evolved significantly in last few months after initial use of re-purposed drugs. There are no recent guidelines available based on the current evidence for clinical management of COVID-19.

The investigators are planning for nation-wide multicentre cross-sectional survey on understanding participating physicians practices on choice of different pharmacotherapeutic agents available in India as of January 2021.

The objective of this study is to understand the current practices of participating physicians in the management of adult patients with severe COVID-19 in India and to determine future priorities.

Eligibility Criteria:
Inclusion Criteria:

Physicians who are involved in management of adult patients with severe COVID-19 in India

Exclusion Criteria:

Pediatrician Physicians who are not managing severe COVID-19 patients or refused to participate.
Atrial Fibrillation Patient Preference Study

The main research question of this patient survey is to assess AF patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban).

VKA (Waran®) will be compared to Rivaroxaban.

The objective of this study is to investigate the following research questions in a cross-sectional survey of Swedish AF patients being treated either with a VKA or with a NOAC:

* Which attributes of a medication to prevent stroke do AF patients view as important?
* Do AF patients have a preference regarding the attributes of the medication options VKA or NOAC and, in case of NOACs, with regards to rivaroxaban attributes?
* Are there subgroups of AF patients whose preference for one of the medication options appears above or below average?
* What is the quality of life of Swedish AF patients? Are there subgroups with differences in their quality of life (for example: subgroups of patients with different CHA2DS2-VASc scores)?
* Which burden do Swedish AF patients experience in association with their anticoagulation therapy? Are there differences in the burden of treatment (ACTS) between patients treated with VKA or with NOACs?

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for AF patients in both the NOAC and the VKA groups:

* Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),
* Age of at least 18 years at time of study inclusion,
* Generally willingness (informed consent) and ability to fill out a survey on satisfaction with treatment and quality of life, and to conduct a structured phone interview (approx. 20 - 30 min) in Swedish language.

Additional inclusion criterion for Group 1 (NOAC):

* Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke \& systemic embolism for at least the previous 3 months.

Additional inclusion criterion for Group 2 (VKA):

* Continuous anticoagulation with a VKA for prevention of Stroke \& systemic embolism for at least the previous 3 months.

Exclusion Criteria:

Exclusion criteria for both groups:

* Participation in another
Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever

The aim of the study is to investigate comparison the effectiveness of online aerobic dance exercises versus physical activity counselling in patients with Juvenile Familial Mediterranean Fever.


Eligibility Criteria:
Inclusion Criteria:

* To be under colchicine treatment for at least 3 months
* Being in an attack-free period

Exclusion Criteria:

* Attack in the last 2 weeks
* Having any systemic chronic disease except Familial Mediterranean Fever
* Presence of amyloidosis
* Having arthritis that may prevent participation in exercise
Prednisone for Heart Failure Patients With Hyperuricemia

Hyperuricemia is a very common finding in patients with heart failure. It is usually related to diuretic use and deteriorated renal function. The recently evidence showed that prednisone and allopurinol may have similar effect on uric acid (UA) lowering in symptomatic heart failure patients with hyperuricemia, but prednisone may be superior over allopurinol in renal function improvement. Thus the investigators design this randomized head to head study to test their hypothesis that prednisone is superior over allopurinol in renal function improvement despite their similar effect on UA lowering in heart failure patients with hyperuricemia.

Hyperuricemia in heart failure (HF) is linked to renal impairment, hemodynamic compromise, and inflammation. Hyperuricemic HF patients are characterized by worsening of renal function and fragile volume state, both of which restrict the use of non-steroidal anti-inflammatory drugs (NSAIDs) when treating concurrent inflammatory diseases. Recent small studies suggest that steroidal anti-inflammatory drug, prednisone, may have renal protective, UA lowering, and potentiating diuretic effects in hyperuricemic HF patients. However, general acceptance of prednisone as a treatment option for anti-inflammation therapy in patients with hyperuricemic HF requires more safety data. We therefore designed a randomized study to compare the safety and renal protective effects of short-term use of prednisone with allopurinol, a widely used xanthine oxidase inhibitor with a well-established safety profile in HF, in hyperuricemic HF patients.

Eligibility Criteria:
Inclusion Criteria:

* chronic congestive heart failure
* 18-80 years old
* NYHA Class II-IV
* Serum uric acid \> 7mg/dl
* left ventricular ejection fraction ≤ 45%

Exclusion Criteria:

* Acute gouty arthritis;
* Any condition (other than heart failure) that could limit the use of prednisone or xanthine oxidase inhibitors;
* Acute decompensated heart failure;
* Any concurrent disease that likely limits life expectancy;
* Active myocarditis, or an hypertrophic obstructive or restrictive cardiomyopathy;
* Myocardial infarction, stroke, unstable angina, or cardiac surgery within the previous 3 months;
* Indication for hemodialysis
* Creatinine\> 3.0 mg per deciliter at admission to the hospital
* Uncontrolled systolic blood pressure \> 140 mmHg
* Known bilateral renal artery stenosis
* Complex congenital heart disease
* Any signs of infections
* Enrollment in another clinical trial involving medical or device-based interventions
68Ga-FAPI PET/CT in Patients With Various Types of Cancer

To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure in the pulmonary blood vessels due to Pulmonary Arterial Hypertension (PAH) and due to Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Pulmonary hypertension is characterized by the elevation of pressure in the pulmonary arteries (PAP) and of the pulmonary vascular resistance (PVR) leading to increased workload of the right chamber of the heart to eject blood against this elevated resistance. The goal of this study is to measure the safety and tolerability of the drug as well as the reduction of the PVR at different doses

In Part A patients without specific treatment for PH (untreated patients) will be tested. In Part B also patients stably pre-treated with specific PH drugs will be studied in combination with the new inhaled drug


Eligibility Criteria:
Main Inclusion Criteria:

* Patients with PAH or CTEPH undergoing medically indicated routine invasive diagnostics
* Men and women aged 18 to 80 years

Part A:

- Untreated patients: Therapy-naïve patients (defined as off treatment with PDE-5 inhibitors, endothelin receptor antagonists, prostanoids, or other sGC stimulators/activators) with PAH or CTEPH or patients pre-treated with these medications who have to undergo a drug specific wash-out period at the discretion of the investigator for least 24 h prior to Day -1 if medically safe

Part B:

* Untreated patients with PAH or CTEPH:

  -- Group 1 (total will be summed up with corresponding dosage group from Part A)
* Pre-treated patients with PAH or CTEPH:

  * Group 2: Pre-treated patients with any kind of monotherapy\* for PAH/CTEPH
  * Group 3: Pre-treated patients with any kind of double combination therapy\* for PAH/CTEPH \* patients receiving inhaled Iloprost, and patients who are known responders to iNO are excluded

Main Exclusion Criteria:

- Medical history indicating a different cause for PH than PAH or CTEPH according to the guidelines of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), such as significant left heart disease, valvular disease, or structural heart defects, as assessed by the investigator, significant pulmonary disease or clinical suspicion of pulmonary venoocclusive disease
Capturing Infectious COVID-19 Asymptomatic Cases in Singapore

This study is being conducted to assess the performance of the BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2, used in serial testing, in identification of infectious, asymptomatic individuals. This information may be used to inform development of an effective testing strategy by policy makers.

This multi-center, prospective, observational, diagnostic evaluation study is designed to assess the performance of the BD Veritor System in the detection of SARS-CoV-2 in asymptomatic individuals compared to viral culture and a commercially available RT-PCR assay over multiple testing time points. The study will enroll a minimum of 150 asymptomatic, adult participants who test positive for SARS-CoV-2 during community/traveler screening procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥21 years of age at the time of informed consent
2. Has a positive screening test for SARS-CoV-2 by RT-PCR
3. Is asymptomatic for COVID-19 on the day of their positive screening test (may have symptoms on the actual day of study enrollment)
4. Is expected to remain at the study site for the full 6-day study period
5. Willing and able to complete all study required procedures
6. Provision of signed and dated informed consent form

Exclusion Criteria:

1. History of frequent or difficult to control nosebleeds within the 14 days prior to study participation
2. If, at the discretion of the Investigator, involvement in the study is likely to jeopardize the subject's health or their current or future medical treatment
Brachial Plexus Birth Palsy: Reinforcement Paradigm to Augment Recovery

Infants who sustain an injury to the brachial plexus in the perinatal period are at high-risk for long-term neuromuscular deficits and prehensile dysfunction. If recovery is delayed because of slow axonal regrowth, disuse atrophy and secondary musculoskeletal deficits may develop. The investigators' hypothesis is that early, intensive intervention designed to foster muscle activation is essential to optimize outcomes after brachial plexus injury and may supplement rehabilitation and microsurgery. This proposal targets infants who are non-surgical candidates. Yet, future studies will examine whether the investigators' experimental intervention can hasten recovery from microsurgery and will examine which post-operative time-point is best to employ it. The investigators' intervention shows promise to increase muscle activation and improve arm function in infants with brachial plexus birth palsy (BPBP) through contingent reinforcement based on a pilot study.

The investigator's study objectives are to (1) test the feasibility of a parent-lead in-home 2-week intervention for infants with BPBP; and (2) determine the effect size for the primary outcome measure(s) in preparation for a future definitive randomized controlled trial (RCT). In this feasibility RCT, the investigators will compare two in-home interventions in 3 to 12-month-old infants with upper trunk BPBP; n=12 per group: (1) experimental; and (2) dose-equivalent active control. For the experimental intervention, infants will trigger a musical toy to move and play via biceps contraction above a preset individual threshold. For the control intervention, toys will be available to play with, yet, there will be no reinforcement for biceps activation.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 3 to 12 months with upper trunk brachial plexus birth palsy confirmed by an attending Hand and Upper Extremity Surgeon;
2. Full-term at birth;
3. A minimum score of '1' (0-7 scale) in elbow flexion of affected arm (isometric contraction) based on the Active Movement Scale (AMS);
4. Score ≥ 25th percentile on the motor subtest of the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSITD-III®);
5. Ability to sustain attention/arousal for a 10 minute training period based on criteria from the Neonatal Behavioral Assessment for an awake-alert state.

Exclusion Criteria:

1. Visual/auditory deficits;
2. Nerve repair/shoulder surgery;
3. Excessive crying during session(s);
4. Shoulder, elbow, or wrist joint contractures \> 20° in the affected arm;
5. An inability to trigger the musical-toy to play at baseline.
Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome

The aim of this study is to better understand the effects of transcranial photobiomodulation (tPBM) on neural oscillations of individuals diagnosed with Down syndrome.

This study will compare the effect of tPBM to sham tPBM on gamma neural oscillations in the brain as assessed by EEG, and on language, attention and memory as assessed by neuropsychological testing. Participants will be randomized to either tPBM with near-infrared light (tPBM-NIR) or tPBM-Sham and will undergo 18 treatments (3 treatments per week for 6 weeks) in addition to baseline, short-term and long- term follow up visits.

Eligibility Criteria:
Inclusion criteria for this study include:

1. adult men and women between the ages of 16 and 35
2. diagnosis of DS (i.e., clinical diagnosis of Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21)

Exclusion criteria for this study include:

1. diagnosis of seizure disorder
2. diagnosis of dementia
3. inability to complete study procedures
4. English as a second language
5. speech as the secondary mode of communication
6. speech of less than two-word utterances
7. changes in medications, augmentative devices, and other intervention two weeks prior to baseline testing and throughout study completion at PI's discretion
8. untreated obstructive sleep apnea (OSA)
9. Participation in other clinical research trials that may influence affect primary outcomes or adherence to the proposed study, as assessed by the PI and the Co-Is
10. candidates who have a current diagnosis of cancer and/or are currently undergoing treatment for cancer
11. history of migraine with an aura in the past 6 months
12. current pregnancy