cyrilzakka/clinical-trials huggingface dataset:
Does eNOS Gene Polymorphism Play a Role in the Maintenance of Basal Vascular Tone in the Choroid or Optic Nerve Head?

Nitric oxide (NO) is a potent endothelium-derived vasodilatator that plays a major role in the control of ocular blood flow. Endothelial NO synthase (eNOS) is one of three isoforms of NOS producing NO through hydroxylation of L-arginine. The eNOS gene is located on the long arm of chromosome 7, and different polymorphic variations have been identified. These single nucleotide polymorphisms (sNP´s) have the ability to change transcription activity and therefore enzyme levels. Recent data indicate that the T -786C polymorphism (especially the homozygous variant) is associated with reduced eNOS activity and consequently impaired NO production.

In the present study the investigators want to investigate if the T -786C eNOS gene polymorphism determines choroidal and optic nerve head blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Homozygous variants of the T -786C genotyping (CC or TT)
* Normal ophthalmic findings, ametropia less than 3 diopters

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
NSAID Use in Postpartum Hypertensive Women

Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and deliver an infant via vaginal delivery will be placed into two groups in the postpartum period. One group will receive Ibuprofen for pain control and the other group will be given Tylenol. Blood pressures during the postpartum period will then be collected and compared in order to see if NSAIDs use increases blood pressure.

The patients who have a vaginal delivery and have the diagnosis of hypertension in pregnancy will be randomized to either Ibuprofen use or acetaminophen use during the postpartum period. Standard blood pressure monitoring in the postpartum period will be followed to help determine if there is a significant rise in the women who use NSAIDS in the postpartum period versus those that use acetaminophen.

Groups will be divided into women with chronic hypertension, women with chronic hypertension with superimposed preeclampsia, women with preeclampsia without severe features, women with preeclampsia with severe features, women with gestational hypertension without severe range blood pressures, and women with gestational hypertension with severe range blood pressures.

Recruitment will last 36 months. Patients will be monitored during their postpartum stay (typical 2 days) with blood pressure measurements. An additional 12 months will be needed for data analysis and publication.

Eligibility Criteria:
Inclusion Criteria:

* vaginal delivery
* diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
* preeclampsia without severe features
* preeclampsia with severe features gestational hypertension without severe range blood pressures
* gestational hypertension with severe range blood pressures
* singleton pregnancies

Exclusion Criteria:

* Cesarean Delivery
* no diagnosis of hypertensive disorder
* chronic or acute renal disease
* allergy to ibuprofen or acetaminophen
* lupus
* multiple order pregnancies (twins, triplets)
* Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs
Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD

All measurements are performed on two consecutive days at the beginning of a pulmonary rehabilitation program in a randomized cross-over study design. On the first day, each patient is randomly assigned to perform either the 2 minute walk test or the 6 Minute walk test. On the second day each patient performs the test that was not performed on the first day. All walk tests are performed by the same investigator on the same track and time of day, following the 2002 guidelines of the American Thoracic Society.

Patients wear a mobile pulse oximeter that continuously records heart rate and oxygen saturation during testing. Baseline values of oxygen saturation, heart rate and ratings of perceived exertion on the modified Borg scale (0 to 10) for dyspnea and leg fatigue are recorded at rest after 10 minutes of sitting.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of chronic obstructive lung disease stage III or IV according to the Global Initiative for chronic Obstructive Lung Diseases definition
* ability to read and understand the German language and study procedures.
* written informed consent

Exclusion Criteria:

* severe acute exacerbation of chronic obstructive lung disease
* severe respiratory failure (partial Oxygen pressure at rest lower than 55 millimeter mercury)
* non compliance to the study protocol.
Benson Relaxation Technique Combined With Music Therapy for Fatigue, Anxiety, and Depression in Hemodialysis Patients

This study carried out in the HD unit of a large-scale training and research hospital, and at a dialysis center associated with this hospital located in Ankara, Turkey. Participants will be randomized to one of two study arms.

Arm 1: Intervention group Arm 2: Control group Hypothesis 1. The HD patients in the 8-week intervention of BRT combined with music therapy will report lower fatigue scores than those in the control group.

Hypothesis 2. The HD patients in the 8-week intervention of BRT combined with music therapy will perceive lower anxiety and depression than those in the control group.

Patients undergoing hemodialysis treatment are susceptible to many complications. The inadequate stress-coping strategies render them vulnerable to high symptom burden and impaired quality of life. Patients are given conventional treatments to stop or slow down the progress of nephron destruction and prevent complications associated with uremia. However, previous studies observed that these therapies may be limited in alleviating fatigue, anxiety, and symptoms of depression, and may pose severe side effects. Therefore, in recent years patients have shown enhanced tendency to use complementary and integrative approaches including aromatherapy, acupuncture, massage, music, and relaxation to provide better control on their health and treatment process, feeling better physically, and emotionally, and as well as improve quality of life. The present study investigates the effects of Benson relaxation technique combined with music therapy in two-centered, 2-arm, assessor blinded randomized, controlled study of 61 hemodialysis patients.

Arm 1: Benson relaxation technique combined with music therapy ; Arm 2: control. The investigators hypothesize that Benson relaxation technique combined with music therapy will decrease severity of fatigue, anxiety, and depression.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were 18 years and older,
* Capable of communicating in Turkish,
* Had received HD in last three months,
* Undergone HD at least two times in a week,
* Showed a willingness to participate in this study.

Exclusion Criteria:

* Patients with aggravated conditions who would not be able to continue with the study,
* Other accompanying diseases that significantly affect the fatigue like COPD, advanced,
* Heart failure, asthma, and malignant tumors,
* Diagnosed with major depression,
* Could not communicate in Turkish,
* Used another complementary and integrative approach within the study period.
Max COVID19- Study

In view of the increasing cases of COVID-19 in India and the possibility of the exponential rise of the cases, this study has been designed to collect data of the healthcare workers of Max Hospital and the general population. Our objective is to identify individuals with flu-like symptoms in suspicion of COVID-19 and follow them weekly up to 8 weeks until the pandemic resolves. The data will be collected through an online questionnaire circulated via Emails or WhatsApp.

The primary objective of this study is to screen and identify individuals with flu-like symptoms and follow-them up weekly. In the study, baseline data will be collected online and then weekly follow up will be done with the participants for 4 weeks via opted communication method. There will be no physical contact and we are also avoiding the use of papers so as to avoid possible transmission. Participation in this study will be entirely voluntary and the questionnaire will be accessible to the participants only when they mark "Agree" on the form.

The data collection form is available in English and Hindi.

The study questionnaire includes questions related to general health status, clinical symptoms, Food security, and job security.

Eligibility Criteria:
Inclusion Criteria:

* Indian males and females currently living in India, OR
* All the employees of Max Super Speciality Hospital, New Delhi, India

Exclusion Criteria:

* Anyone who has filled the questionnaire once per household
Decoding and Selective Modulation of Human Memory During Awake/Sleep Cycles

The proposed project seeks to elucidate memory processes and consolidation during sleep by leveraging the unique capability of direct recordings from the human brain at multiple levels of resolution-single neurons, localized neuronal assemblies, intracranial local field potentials-during rich behavioral tasks with real-life narratives and extracting neural features that relate to different aspects of episodic experience. The investigators will further probe causal mechanisms of consolidation by application of auditory and electrical stimulations during sleep and its effect on modulating memory processes.


Eligibility Criteria:
Inclusion Criteria:

* All epilepsy patients between the ages of 18 and 65 who undergo depth electrode placement for clinical purposes
* Eligibility is determined by the epilepsy surgery team (based on neuropsychological testing and on psychiatric evaluation)
* Willing to provide informed consent and participate the study

Exclusion Criteria:

* Neurological or psychiatric issues, other than epilepsy, that would put the patient at risk
* Patient is younger than 18 or older than 65 years of age
* Unwilling to provide informed consent
Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters

The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on cardiovascular parameters and sympathovagal balance in healthy subjects. It is investigated if auricular vagal nerve stimulation affects heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the site of stimulation in the auricle, whereas four distinct stimulation points are tested.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged 20 to 50 years

Exclusion Criteria:

* participation in a clinical trial in the last 5 weeks
* diseases which may affect the autonomous nervous system (e.g., diabetes mellitus)
* confounding medical treatment with known effects on the autonomous nervous system (e.g., beta blocker)
* drug abuse
* active implanted devices
* pregnancy or nursing
Osteoporosis and MRI Study in Hemophilia

The purpose of this study is to evaluate bone mineral density in adult subjects with hemophilia versus a comparator population without hemophilia (non-hemophilia age- and gender-matched database) by using the following diagnostic means: dual-energy X-ray absorptiometry (DXA) scanning, clinical scales, quality of life (QOL) scales and biomarkers. In addition to this osteoporosis study, hemophilic arthropathy of the knee with respect to loss of knee cartilage will also be explored by using magnetic resonance imaging (MRI substudy). No investigational product will be dispensed.


Eligibility Criteria:
Inclusion Criteria:

* Male and at least 25 years old at the time of screening
* Moderately severe or severe hemophilia A or B (factor VIII or factor IX \<= 2% by chart documentation)
* Ambulatory (ie, not wheel chair dependent)
* Performance status - ECOG of 0 or 1 (= out of bed at least 75% of time)
* Willing and able to comply with the requirements of the protocol and is able to give informed consent

Additional inclusion criteria for MRI Substudy:

* Baseline knee joint space width is \>= 3mm at the medial or lateral aspect of either knee as measured by weightbearing fixed flexion PA X-ray
* Able to undergo 1.5 or 3T MRI

Exclusion Criteria:

* Inability to position properly for DXA
* Presence of orthopedic hardware or other artifact in the lumbar spine (L1-L4) or either proximal femur
* Prior documentation of being HIV positive
* Radiosynovectomy or surgical synovectomy within the last 6 months
* Current or past treatment with bone active drugs
* Long-term corticosteroid use \[defined as 7.5-mg prednisone daily (or equivalent) for \>= 3 months\]
* If subject is family member or employee of the investigator

Additional exclusion criteria for MRI Substudy:

* Any contraindication or relative contraindication to MRI
* Less than 3mm knee joint space width at the medial and lateral aspect of both knees on baseline X-ray evaluation
* Knee bleed within 30 days of informed consent
* Prior total knee arthroplasty (TKA)
Multi-drug Resistant Gram-negative Bacteria and Veno-venous Extracorporeal Membrane Oxygenation (ECMO)

Veno-venous extracorporeal membrane oxygenation (VV-ECMO) is a life-support technique used in patients with most severe acute respiratory distress syndrome (ARDS). ARDS is a life-threatening form of respiratory failure associated with a mortality rate of approximately 40-45%.Despite several studies confirming a real benefit of the use of ECMO in patients with ARDS who are unresponsive to conventional management, ECMO is still a complex and costly treatment that can be exposed to potential complications, such as nosocomial infections (NI).

Noteworthy, the most frequent NIs occurring during VV-ECMO are pneumonia (\>40%) and, secondly, blood-stream infections (3-18%). The situation is more challenging for Gram-negative bacilli: more than one-half of the Escherichia coli and more than one-third of the Klebsiella pneumoniae isolates were resistant to at least one antimicrobial group. Of note, an alarming increase in carbapenem resistance has been reported in several species, including K. pneumoniae (7.9% of isolates), P.aeruginosa (16.5% of isolates) and A. baumannii (\>30% of isolates).

In fact, the isolation of MDROs has been shown to be an independent risk of death and of subsequent infections not only in critically ill patients but also in those patients requiring VV-ECMO (mortality rate between 56-68%). However, data are still conflicting about the exact incidence of multidrug resistant organisms (MDRO) during VV-ECMO and the impact on short- and mid-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ARDS
* VV-ECMO

Exclusion Criteria:

* pregnancy
* age \< 18
* uncompleted records
* survival \< 24h after ECMO connection
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation

The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7 to 10 days of life time will improve lung function in premature infants, allowing a decrease in required oxygen concentration and ventilator settings.

Pulmonary surfactant is required for normal lung function. Preliminary data from previous trials suggest that more than half of chronically ventilated premature infants, greater than 1 week of age, have at least one episode of surfactant dysfunction, as measured in vitro, associated with a low surfactant protein B content. We propose to enroll premature infants less than 1250 gm birthweight, between days 5 and 21 of life who are intubated, mechanically ventilated, with a respiratory decompensation, defined as a severity score (mean airway pressure x FIO2) rising from a baseline of \< 1.8 to \> 3.5, sustained for \> 24 hours. Infants will receive two doses of Infasurf surfactant, 12-24 hours apart, at the standard dose of 3 ml/kg. Primary outcome is the change in respiratory severity score at 72 hours post surfactant treatment compared to pre-treatment. Sample size is 31 infants, study duration is 3 years, and recruitment of study patients will occur at the Hospital of the University of Pennsylvania, and Women and Children's Hospital of Buffalo.

Eligibility Criteria:
Inclusion Criteria:

* Less than 1250 gm birthweight
* Day 5-21 of life
* Intubated and mechanically ventilated, with respiratory decompensation, defined as the majority of daily severity scores (calculated every 6 hr from average of respiratory settings over 3-4 hour period) rising from baseline \< 1.8, to \> 3.5, sustained for \>24hr. Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.

Exclusion Criteria:

* Serious congenital malformations
* Life expectancy \< 7 days from enrollment
* Patent ductus arteriosus at time of decompensation
* Pulmonary hemorrhage as cause of respiratory decompensation
* Active air leak syndrome at time of decompensation
* Postnatal steroid therapy for lung disease
Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms

To study the effects of probiotic supplement in children with Attention-deficit hyperactivity disorder (ADHD),40 patients will be randomly allocated to two groups of intervention and placebo. The intervention and the placebo group will be prescribed with 1 capsule of probiotics and placebo for 8 weeks, respectively. Treatment efficacy will be assessed via administrating the Conners's rating

Both probiotics and placebo groups will receive medication with Ritalin in a dose-dependent manner, starting at the onset of the study and simultaneous with probiotic supplementation. Children weighed 30 Kg or less receive 0.3 mg/kg of Ritalin in 3 separate intervals and after four weeks the dosage will increase to 0.5mg/kg. Those who weighed more than 30 kg receive 0.5 mg/kg with the same pattern that reaches the highest point of 0.7 mg/kg by week four. Each dosage will be administrated trice a day with breakfast, lunch, and dinner. In the middle of the study patients who consumes less than 80% of their supplements will be omitted from the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Attention Deficit Hyperactivity Disorder
* Having an Intelligence quotient more than 85 based on Wechsler test for children
* Willing to participate in the study

Exclusion Criteria:

* History of any other mental and psychological disorder such as depression, chronic motor tic disorder, communication disorder, learning disability
* Taking any stimulant, sedative, anti-anxiety and anti-psychotic medications
* History of any chronic disorders, requiring long term medication (such as cancers, Cirrhosis, autoimmune disorders, metabolic disorders ) or, chronic neurological disorders (such as epilepsy)
Life Study: Lifestyle Intervention in Fibroid Elimination

The study will evaluate a lifestyle, nutrition, and exercise program to assess whether this program is acceptable and feasible for patients..Researchers will examine if the LIFE program can modify fibroid recurrence.

This prospective cohort pilot study will enroll asymptomatic, post-surgical patients who underwent a laparoscopic, open, robotic myomectomy, or other procedure ie Sonata, Accessa for fibroid removal. Patients will be offered enrollment into a lifestyle, nutrition, supplement, and exercise program to assess whether this program is acceptable and feasible for patients. Surveys will be collected at 3-6 month intervals.

Eligibility Criteria:
Inclusion Criteria:

* Participants ages 18-50, who are seeking care at the Center for Fibroid Care at NYU
* Participants who have had a procedure or surgery performed to removed fibroids within the last 3 months and are now considered "fibroid free."
* Be English speaking and be able to read/write in English
* Visit with PCP within the last 3 months with labs

Exclusion Criteria:

* Currently Pregnant
* Use of any medication, hormonal or GNRH agonists, that would affect fibroid growth
* Postmenopausal women
* Non-English speaking
* Fibroid procedure or surgery outside of the 3-month window
* Women who are physically incapable of following a physical activity regimen
* Women with multiple dietary restrictions that would impact their ability to follow recommended dietary plan. (ie. GI disorders)
Mitral Valve in Hypertrophic Cardiomyopathy

The purpose of the study is to assess the role of mitral valve apparatus in the development of outflow tract obstruction in patients with hypertrophic cardiomyopathy and to identify the best surgical treatment modality to relieve outflow tract obstruction in such patients

It is well-known that mitral valve plays an important role in the development of left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. In order to further investigate this phenomenon, the following study aims to compare mitral valve geometry indices, as assessed by transthoracic echocardiography, two- and three-dimentional transesophageal echocardiography and mitral valve quantification analysis, and papillary musles' function, as assessed by 2D speckle tracking imaging, in patients with hypertrophic obstructive cardiomyopathy, patients with arterial hypertension and left ventricular hypertrophy and people without structural heart disease. This will provide information on the geometric characteristics of mitral valve that predispose to the development of obstruction. Futhermore, patients with hypertrophic obstructive cardiomyopathy that are eligible for the surgical relief of obstruction will be randomised into four groups according to the modality of intervention. These groups are as follows: 1) isolated extended septal myectomy; 2) extended septal myectomy + edge to edge mitral valve repair; 3) extended septal myectomy + posterior lealfet sliding plasty; 4) extended septal myectomy + secondary chordae transection. After surgery, said indices will be reassessed and the degree of outflow tract obstruction relief noted, in order to elicit which geometrical changes are produced by each type of intervention. Patients will be followed long-term, up to 5 years, in order to define whether the addition of the intervention on mitral valve helps abolish the residual gradient more effectively, and whether it translates into any survival benefit.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Signed informed consent to participate in the study
* For patients with hypertrophic cardiomyopathy only: resting or latent peak left ventricular outflow tract gradient \>50 mmHg, NYHA class III-IV
* For patients with arterial hypertension only: hystory of arterial pressure increase \>140/90 mmHg, increased left vantricular wall thickness (\>10 mm) and myocardial mass indexed to BSA (\>95 g/m2 for women and \>115 g/m2 for men), as assessed by 2D transthoracic echocardiography

Exclusion Criteria:

* Age \< 18 years
* Persistent form of atrial fibrillation
* Intrinsic mitral or aortic valve disease
* Coronary artery disease
* Reduced left ventricular ejection fraction
* For control group only: presence of any structural heart disease