cyrilzakka/clinical-trials huggingface dataset:
Cold Stress Stimulate the Browing of Subcutaneous White Adipose in Healthy Adults

Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT), play an essential role in regulating whole-body energy homeostasis. Recent studies also reveal the presence of a subset of cells in WAT that could be induced by environmental or hormonal factors to become ''brown-like'' cells, and this ''beigeing'' process has been suggested to have strong antiobesity and antidiabetic benefits. More recently, same studies showed that cold stress stimulate the browning of subcutaneous white adipose. However, to the investigators knowledge, there are no direct data that clearly show that cold stress can promote the browning of subcutaneous white adipose.

Individuals have cold exposure at 15C for 2 hr everyday for one week.Biopsy for subcutaneous white adipose was performed before and after one week cold exposure programme under local anesthesia. Measure the brown fat characteristics of biopsy samples. The expression levels of uncoupling protein-1 (UCP-1), peroxisome proliferator-activated receptor (PPAR)-r, peroxisome proliferator-activated receptor r coactivator 1 a (PGC1a) , growth factor receptor binding protein-10 (Grb10), PR domain containing 16 (PRDM16) will be determined before and after cold stress programme from the biopsy samples. In addition, a combination of PET and computed tomography (CT) - with the glucose analogue 18F-fluorodeoxyglucose (18F-FDG) as a tracer will be performed for brown adipose tissue before and after cold stress programme.

Eligibility Criteria:
Inclusion Criteria:

* healthy men
* 18-60 years old
* BMI 20-28 kg/m2

Exclusion Criteria:

* BMI \< 20 kg/m2
* BMI \> 28 KG/M2
* Female
Feasibility of Virtual Reality Delivery of Pain Neuroscience Education

Randomized Clinical Trail (RCT) for patients already planned to attend physical therapy for chronic low back pain. Patients will be randomized to receive Physical Therapy (PT) as usual or PT plus pain education delivered via virtual-reality headset.

There is an increasing emphasis in physical therapy and healthcare in general on enhancing patients' ability to self-manage spinal pain as a strategy to reduce disability for impacted individuals and escalating healthcare costs. This change in emphasis requires a paradigm shift on the part of practitioners and patients alike in how they conceptualize and respond to pain. PNE is a promising education strategy that has been shown to influence patient-reported outcomes in those with chronic pain and has been shown to influence the provider's beliefs about pain. However, the delivery of this education has proven difficult for providers in terms of comfortability and time-efficiency. A standardized delivery a PNE by experts in the field could prove efficient and effective.

STUDY DESIGN The investigators' overall goal is to determine the feasibility of VR-delivered pain neuroscience education (PNE). Secondarily, the investigators would like to see if these interventions are best targeted to specific individuals. To accomplish these goals, the investigators will conduct a randomized clinical trial, randomly assigning participants to receive virtual reality (VR) education in addition to usual care or usual care with no additional education.

Eligibility Criteria:
Inclusion Criteria:

* i. Age 18-75 at time of first physical therapy session ii. Primary reason for physical therapy is low back pain iii. History of low back pain \>/= 12 weeks

Exclusion Criteria:

* i. Age \>75y/o or \<18 y/o ii. Red flag condition that prohibits participation in physical therapy:

  * Systemic metabolic disorder
  * Neurological or muscular degenerative disorder (including Epilepsy)
  * Systemic infection
  * Cardiopulmonary or pulmonary disorder with contraindication to physical exercise iii. Recent spinal surgery (\<12 months) iv. Specific spinal pathologies, such as severe stenosis or spondylolisthesis or fracture v. Acute radiculopathy or compromised nerve root vi. Currently known to be pregnant
Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI

This study aims to evaluate the beneficial effect of heart rate reduction of oral ivabradine in patients presenting with non ST-segment elevation myocardial infarction (NSTEMI) during acute stage post percutaneous coronary intervention versus conventional treatment.

Materials and methods: A total of 100 patients admitted to the emergency department, National Heart Institute, Cairo, Egypt were randomized into two groups as follows: Group A: 50 patients with NSTEMI treated with ivabradine (5mg twice daily) in addition to the conventional treatment; Group B: 50 patients with NSTEMI treated with the conventional treatment only. Demographic data, detailed history, clinical examination, chest pain onset, blood pressure, heart rate (HR), temperature and respiratory rate, electrocardiogram (ECG) as well as echocardiography and laboratory investigations were recorded. Patients were monitored for a period of 3-5 days (acute stage).


Eligibility Criteria:
Inclusion Criteria:

* Patients with NSTEMI with normal sinus rhythm and heart rate (HR) more than 70 beats per minute (bpm) and systolic blood pressure (SBP) \>90 mm Hg undergoing PCI

Exclusion Criteria:

* Patients needing urgent cardiac surgery, IV inotropic agents or had a HR less than 60 bpm without any medication.
Consumer Evaluation of Intermittent Catheter Product Modifications

This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.


Eligibility Criteria:
A. Inclusion Criteria for Arm 1

Subject who:

1. is male and at least 18 years of age
2. has been performing unassisted, self-catheterizations, with a Hollister standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month

B. Exclusion Criteria for Arm 1

Subject who:

1. is currently undergoing chemotherapy, radiation or steroid therapy
2. has a symptomatic urinary tract infection (UTI)
3. is currently using a coude intermittent catheter product to perform catheterization
4. performs non-urethral catheterization

C. Inclusion Criteria for Arm 2

Subject who:

1. is male and at least 18 years of age
2. has been performing unassisted, self-catheterizations, with a non-standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month

D. Exclusion Criteria for Arm 2

Subject who:

1. is currently undergoing chemotherapy, radiation or steroid therapy
2. has a symptomatic urinary tract infection (UTI)
3. is currently using a coude intermittent catheter product to perform catheterization
4. performs non-urethral catheterization
5. is unable to use a Hollister standard with tip hydrophilic intermittent catheter
A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects.

The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and age is between 18 and 55 years, inclusive;
* All female subjects must have negative results for pregnancy tests performed;
* If male, subject must be surgically sterile or practicing at least 1 of the following methods of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug;
* If male, subject agrees to abstain from sperm donation through 90 days after administration of the last dose of study drug;
* Body Mass Index (BMI) is ≥ 18 to ≤ 31 kg/m2, inclusive;
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG), as judged by the investigator.

Exclusion Criteria:

* Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator;
* Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
* Requirement for any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis;
* Recent (6-month) history of drug or alcohol abuse;
* Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to study drug administration;
* Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day -1;
* Consumption of alcohol within 72 hours prior to study drug administration;
* Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or Seville oranges within the 72-hour period prior to study drug administration;
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration;
* 17.10. Current enrollment in another clinical study.
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.

We will investigate whether levels of blood proteins in children with well-functioning hearts with one ("single") ventricle are similar to levels of these blood proteins in children with two ventricles. For children with hearts with a single ventricle, we will examine blood proteins at various levels of heart function. To assess blood protein levels, we will collect small (6 mL) samples of blood. Heart function will be determined by existing clinical scoring systems. Enrolled patients will receive an echocardiogram, which is a dynamic ultrasound picture of the beating heart.

Eligibility Criteria:
Inclusion Criteria:

* Children with a structurally normal heart and a patent ductus arteriosus.
* Children with single ventricle physiology.

Exclusion Criteria:

* Children must not have chromosomal abnormalities. Small deletions, such as that which produces DiGeorge syndrome, are permissible.
* Children with acute intercurrent non-cardiac inflammatory illness (such as post-operative wound infection) are ineligible, as such conditions may cause elevated blood levels of the proteins under study.
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

This study will help determine which types of drugs that may interact with Lu AF35700


Eligibility Criteria:
Inclusion Criteria:

* Body weight at least 50 kg and Body Mass Index 19 - 30 kg/m2
* Good general health ascertained by a detailed medical history, laboratory tests and physical examination

Exclusion Criteria:

-Pregnant or lactating women

Other protocol defined inclusion and exclusion criteria may apply
Flu Vaccine Responses in the Setting of Melanoma Treatment

Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. We are conducting a prospective unblinded study of influenza vaccine recipients.

Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. In particular, immune responses following influenza vaccination have not been studied in the setting of advanced melanoma and in the context of various anti-tumor treatments. In this study, we will look at the immune response of subjects receiving vaccination.

Eligibility Criteria:
Inclusion Criteria:

* adults capable of providing consent
* have a diagnosis of locally advanced or metastatic melanoma

Exclusion Criteria:

* are allergic to influenza vaccination
* have received influenza vaccination within the past 6 months
* require prednisone, methotrexate, or other immunosuppressing medications
* have HIV infection
* have a history of solid organ or bone marrow transplant
* require combination immunotherapy
* are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study
Egg-Banking and Ovo-donation

Egg-banking would considerably simplify the logistics and means by which oocytes could be donated. These banks would make it easier to immediately provide oocytes that would be compatible to the recipient, shortening or even eliminating the problem of long waiting lists. Egg-banking would also allow the oocytes to be effectively quarantined, drastically diminishing the risk of transmission of infectious diseases in a fashion analogous to semen banks. The most essential prerequisite for a successful egg cryo-banking program is to have an efficient oocyte cryopreservation technology. Recent studies, including our own experience, have indicated that vitrified oocytes preserve intact their potential to fertilize and further develop into competent embryos, giving high clinical results as well as high survival rates. The aim of this study is to evaluate impact of the establishment of an egg-banking in our ovum donation program. Oocyte cryopreservation is carried out by Cryotop method. The study includes oocyte donation cycles conducted with fresh and vitrified oocytes. Recipients are allocated randomly into each group ("fresh vs. vitrified cycles"). Main outcome measures include survival, fertilization, embryo development and clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Receptors

  * Women receiving donor oocytes and whose partners without seere pathology of semen.
  * BMI \< 25

Donors:

Inclusion Criteria:

18 - 35 years oldaños.

* Normal Response (8-15 follicles)to long protocol of ovarian stimulation with hCG
* Donors with normal menstrual cycles ( 21-35 day duration).
* Donors with Body Mass Index (BMI) between 18-25 Kg/m2

Exclusion Criteria:

* Donors with +/= two previous miscarriages'
* Polycystic Ovary Syndrome
* Donors with antecedents of poor embrionary quality not attributed to masculine factor.
* Donors with decline of Estradiol Hormone of more than 10% or Estradiol Hormone plateau.
* Donors with a high response \>20 ovocitos and/or levels above 3000pg/mL of Estradiol the day of the administration of Chorionic gonadotropin (hCG.
Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS): Clinical Characterization and Prospective Course

This study is a brief (3 month) longitudinal study following children between the ages of 4-16 years old who have been diagnosed with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). Parents and children (who are at a 2nd grade reading level) will complete questionnaires online or in person weekly for 3 months. Additionally, parents will track their child's symptoms 3 times/week using a mobile application for 3 months. The investigators are hoping to begin to characterize the longitudinal trajectory of neuropsychiatric symptoms in children with PANS. Additionally, the study will seek to identify baseline demographic and clinical characteristics (e.g., gender, recent onset versus chronic course, GAS versus other triggers) that predict severity of baseline neuropsychiatric symptoms and predict change in symptoms over time.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking boys and girls ages 4-16 years
* Abrupt onset of OCD or severely restricted food intake
* At least 2 equally abrupt-onset concurrent neuropsychiatric symptoms from the following 7 categories: anxiety, emotional lability/depression, irritability/aggression/severely oppositional behaviors, behavioral/developmental regression, deterioration in school performance, sensory or motor abnormalities (e.g. tics), somatic symptoms (e.g., urinary, sleep)
* Neuropsychiatric symptoms are not better explained by a known neurological or medical disorder.

Exclusion Criteria:

- Too unstable psychiatrically or medically to participate safely in the protocol, per clinical judgment of the Principal Investigator or Co-Investigator
Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation

The proposed study will be the first to examine whether changes in blood flow patterns within the brain account for the possible cognitive benefits of CR. A clearer understanding of this possibility may provide key insight into the way CVD affects the brain, help identify effective treatments, help a greater number of patients return to work, and improve quality of life.

Based on recent patient referrals, we expect that 30 participants will subsequently enroll in CR and 30 will not. CR patients will complete standardized neuropsychological tests (45-60 minutes) and Transcranial Doppler (30-40 minutes) during their first and last week in the CR program. Patients who do not enroll in CR will undergo testing at similar intervals to serve as a matched control group. Standard medical records will be collected for participants in both groups to obtain demographic and medical information. CR-specific medical records will also be collected to obtain information about possible mechanisms for cognitive benefits (e.g. improved stress test performance, reduced blood pressure, etc.). All participants will be compensated for their time.

Eligibility Criteria:
Inclusion Criteria:

- 50 to 85 years of age, able to communicate in English, history of heart disease

Exclusion Criteria:

- history of significant neurological disorders, such as stroke, Alzheimer's disease, or severe head injury significant psychological problems such as schizophrenia or bipolar disorder
Evaluation of Clinical Characteristics and Outcome of COVID19 Pneumonia in Assiut University Hospital

* Evaluation of the clinical presentation of COVID 19 pneumonia.
* Identification the risk factors of severing COVID 19 pneumonia.
* Evaluation of the outcome of the disease.

Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China. It was initially reported to the WHO on December 31, 2019. On January 30, 2020, the WHO declared the COVID-19 outbreak a global health emergency.On March 11, 2020, the WHO declared COVID-19 a global pandemic, its first such designation since declaring H1N1 influenza a pandemic in 2009. The incubation period for coronavirus disease 2019 (COVID-19) is believed to extend to 14 days, with a median time of 4-5 days from exposure to symptomatic onset. In one study, 97.5% of symptomatic patients developed symptoms within 11.5 days of becoming infected. Most patients with coronavirus disease 2019 (COVID-19) will experience the following (in descending frequency): Fever, Cough, Fatigue, Anorexia, Shortness of breath, Sputum production, Myalgia.

Atypical presentations have been described, and older adults and persons with medical comorbidities may have delayed presentation of fever and respiratory symptoms.

Less common symptoms (\< 10%) include headache, confusion, rhinorrhea, sore throat, and hemoptysis. Some patients have experienced gastrointestinal symptoms such as diarrhoea and nausea prior to developing fever and lower respiratory tract signs and symptoms. anosmia may precede the onset of respiratory symptoms. The most common serious manifestation of COVID-19 upon the initial presentation is pneumonia. Fever, cough, dyspnea, and abnormalities on chest imaging are common in these cases. Bilateral distribution of ground-glass opacities (GGO) with or without consolidation in posterior and peripheral lungs was the cardinal hallmark of COVID-19. However, with further analysis of increasing cases, a diversity of interesting CT imaging features were found, including crazy paving pattern, airway changes, halo sign, Pleural changes including pleural thickening and pleural effusion, Vascular enlargement, Air bubble sign, Lymphadenopathy, etc, which may shed light on the possible mechanism of lung injury in COVID-19. On the laboratory aspect leukopenia, leukocytosis, and lymphopenia were common among early cases. Lactate dehydrogenase and ferritin levels are commonly elevated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COVID 19 PCR positive

Exclusion Criteria:

* Patients less than 18 years of age .
A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA patients who currently use a nasal or nasal pillows mask will be recruited

This study will involve a baseline (Visit One) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.

The mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea.

Neither the investigators nor the participants will be blinded to the study.

Eligibility Criteria:
Inclusion Criteria:

* AHI ≥ 5 from diagnostic PSG night
* Aged 22 and over (FDA defined as adult)
* Either prescribed APAP, CPAP or Bi-Level PAP for OSA
* Existing nasal or nasal pillows mask users (preferable 70%:30% split)
* Fluent in spoken and written English

Exclusion Criteria:

* Inability to give informed consent
* Patient intolerant to CPAP therapy
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or think they may be pregnant