cyrilzakka/clinical-trials huggingface dataset:
Health Literacy in Adults With Congenital Heart Disease

Currently, both oral and written health education make certain assumptions about the health literacy of patients and their parents. The prevalence of health literacy issues is unknown in the adult congenital heart disease (CHD) population. Having a better understanding of a patient's and/or their parents' health literacy will help us develop appropriate education and teaching tools to meet the patient's and their parents' needs.

When providers speak with patients regarding their congenital heart disease, they currently have no assessment of the patient's basic health literacy. If providers are aware of the level of their patients' health literacy, they will be better equipped to provide care on the level the patient best understands.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age and older with congenital heart disease.

Exclusion Criteria:

* Developmentally delayed subjects.
* Any subject not meeting inclusion criteria.
Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients

The purpose of the study is to investigate the effects that Osteopathic Manipulative Medicine has on lower extremity muscle characteristics in PD. Muscle stiffness, range of motion, and gait will be measured.

Participants will be asked to attend one in person session at the NYIT Academic Health Care Center. Participants will be randomly assigned to a control or experimental group. After a visit with the treating physician, both groups will have muscle stiffness tested using a myotonometry meter via a MyotonPRO device, gait measured while walking on a treadmill for 2 minutes before and after treatment, and range of motion tested using a goniometer. One week after the visit, participants will be asked to complete a brief survey over the phone with one of the study investigators.

Parkinsonism, most commonly caused by Parkinson's disease (PD), is a syndrome characterized by rest tremor, rigidity, bradykinesia, and postural instability. Gait speed and endurance directly inhibit the independence and community engagement for those with Parkinson's disease (PD). Pain was ranked as one of the most troublesome nonmotor symptoms associated with PD. Rigidity is commonly associated with pain in patients with PD. Osteopathic medicine treats somatic dysfunction which is the impaired function of body components including the somatic, skeletal, myofascial, vascular, lymphatic, and neural systems. Osteopathic manipulative treatment (OMT) will be applied to the lower extremity (LE), specifically muscle energy technique (MET) to the hip, knee, and ankle bilaterally. A sham control group will receive passive range of motion (PROM) joint movement of the hip, knee, and ankles bilaterally without reaching joint physiologic barrier. Muscle and gait parameters, ROM, Timed Up \& Go (TUG) and LE functionality will be assessed and juxtaposed. Based on preliminary results of muscle measurements, stiffness and relaxation improved in a patient with PD before and after LE OMT and demonstrated to be feasible. Investigators intend for the patients who receive OMT to improve LE muscle quality, gait, ROM, TUG, and daily functionality. Through this research Investigators hope to demonstrate that OMM as a supplemental treatment regimen can improve quality of life in those living with PD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease as per a neurologist, a severity of 2-4 on the Hoehn and Yahr (H-Y) Scale
* Able to receive OMM
* Able to be in a supine and prone position for MyotonPRO measurements
* Able to ambulate for gait measurements
* Have musculoskeletal complaints of leg pain/cramping or gait abnormalities due to their PD

Exclusion Criteria:

* Presence of severe fasciculations based on clinical judgment due to interference with measurements
* Gait disorders not attributed to PD
* Presence of other medical neurologic diagnoses that can affect outcome measures such as muscle tone/stiffness and ambulation (ie stroke, multiple sclerosis)
tDCS in Pediatric Acquired Brain Injury

In this preliminary study, we will examine the safety, tolerability, and feasibility of transcranial direct current stimulation (tDCS), in the setting of dosage escalation, as a candidate intervention for children with Acquired Brain Injury (ABI).

Previous studies have demonstrated that transcranial direct current stimulation (tDCS) is safe and effective in adults with chronic Acquired Brain Injury. Limited data have established the safety of tDCS in children with neuropsychiatric and neuromotor disorders. However, these tDCS safety paradigms may not be relevant to children with ABI due to their abnormal brain structure and function, decreased ability to communicate, variable symptomology, and time-consuming care needs that exist in this population.

In this open-label, single-group, dosage escalation study, investigators aim to assess the safety, tolerability, and feasibility of incrementally higher tDCS currents in 10 pediatric patients with ABI on an inpatient rehabilitation unit. The study will include up to three sessions of tDCS (sham, 1mA, and then 2 mA) either over the left dorsolateral prefrontal cortex or over the primary motor cortex based on the goal to evaluate change in either cognitive or motor function. We will also explore whether tDCS improves consciousness in pediatric DOC. Mozart classical music, as a concurrent intervention, will be played during sham, 1 mA, and 2 mA tDCS applications.

Eligibility Criteria:
Inclusion Criteria:

* Age 5 through 17 years
* History of acquired brain injury.
* Currently inpatient at the Kennedy Krieger Rehabilitation Unit.
* Parent and child proficient in English.

Exclusion Criteria:

* Patients with extensive focal lesions in the left dorsolateral prefrontal cortex (DLPFC) and bilateral primary motor cortex as determined by review of imaging and/or imaging reports obtained as part of clinical care.
* Youth with known seizures in the month prior to study enrollment.
* Participants with non-convulsive seizures and/or interictal epileptiform discharges observed on study screening extended EEG.
* Females with confirmed pregnancy on urine test.
* Youth with history of craniotomy surgery, metallic cerebral, cochlear or electronic implant in the head or neck area, or ventricular shunt or pacemaker.
* Patients requiring daytime mechanical ventilation.
* Children with head circumference less than 43 cm
* Bilateral severe or profound hearing loss
* Presence of hairstyle interfering with tDCS application and/or high quality EEG signal
* Youth in foster care.
Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate

Urinary tract infections are among the most prevalent microbial diseases and their financial burden on society is substantial. The use of bacteriophages against bacterial pathogens has gained over the last years a renewed interest, because of the continuing increase in antibiotic resistance worldwide. Thus, the aim of this study is to investigate the efficacy of intravesical bacteriophage treatment to normalize urine culture compared to intravesical placebo or standard antibiotic treatment in a randomized controlled trial following a pilot phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients with urinary tract infections who are scheduled for transurethral resection of the prostate with urine culture (taken by mid-stream urine; or from the existing transurethral or suprapubic catheter) ≥104 colony forming units /mL of predefined uropathogens, including Enterococcus spp., Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus spp., and Streptococcus spp. and lower urinary tract symptoms such as urgency, frequency, dysuria, increased number of incontinence episodes
* Written informed consent.

Exclusion Criteria:

* Fever \>38°C
* CRP \>100mg/L
* Acute prostatitis
* Concomitant fungal urinary tract infection
* Current antibiotic treatment or antibiotic treatment within the last 7 days (exceptions: subjects with an active catheter associated urinary tract infection who have received prior antibiotics may be enrolled provided a minimum of 48 hours has elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for catheter associated urinary tract infection who present signs and symptoms consistent with an active new catheter associated infection may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture)
* Any rapidly progressing disease or immediately life-threatening illness including but not limited to: acute hepatic failure, respiratory failure, and septic shock
* No informed consent
Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts

The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).

The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).

Data from all patients with LHC treated in Sahloul Hospital, between January 2000 and December 2019, were retrieved from a retrospective database. To minimize selection bias, propensity score matching (PSM) was performed, based on variables representing patient characteristics and operative risk factors.

RS especially total pericystectomy had fewer postoperative complications and lower recurrence rate compared to CS. RS may be the preferred procedure for LHC if the expertise is available.

Eligibility Criteria:
Inclusion Criteria:

* age over 14 years old.
* Patients presenting liver hydatid cyst .

Exclusion Criteria:

* age less than 14 years old.
* Patients presenting other localization of hydtic cyst , than the liver.
* calcified cysts.
* patients with incomplete medical records.
* patients who were lost to follow up.
Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis


Eligibility Criteria:
Inclusion Criteria:

* Subjects at least 18 years old with severe CKD (defined as creatinine clearance \< 30 mL/min at both screening assessments) and CKD requiring hemodialysis
* Additional inclusion criteria apply

Exclusion Criteria:

* Subjects must have calcium, phosphate, and magnesium levels appropriate for their condition and must not have other uncontrolled co-morbidities.
* Additional exclusion criteria apply
Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy

This is a multi-center, randomized, double-blind, placebo-controlled food challenge to be conducted in infants or children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a physician diagnosis of IgE-mediated Cow's Milk Allergy (CMA) based on a clinical history of a reaction resulting in characteristic immediate hypersensitivity symptoms within 2 hours of oral exposure or immediate hypersensitivity symptoms according to physician's observation
* Participant is willing to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:

  1. Documentation of milk-specific serum IgE \>15 kIUA/L or \> 5 kIUA/L if younger than 1 year.
  2. Documented cow's milk skin prick test mean wheal \>10mm
  3. Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
* Participant agrees to stop oral steroid use within 14 days and antihistamine use within 7 days of confirmation of diagnosis and food challenges.
* Participant had followed a strict cow's milk protein-free diet prior to enrollment.
* Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* Participant is exclusively breastfed at the time of enrollment.
* Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula.
* Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases or abnormalities other than CMA, immunodeficiencies, unstable asthma, asthma treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema.
* Previous severe anaphylactic reaction to cow's milk within the last two years.
* An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test.
* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent.
* Participant is routinely consuming baked milk products.
Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease

The purpose of this study is to assess the Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease patients.

In total, 50 patients with interstitial lung disease (ILD) are going to recruited.The patients are studied at the afternoon in a semirecumbent position. After the application of topical anaesthesia (2% xylocaine), the patient will be asked to swallow two balloon-tipped catheters and the multi-pair esophageal electrode catheter through the nose into the their right position.

At the first period, the stable signals of unassisted spontaneous breathing (about 10min) were chosen to be recorded. The Esophageal and gastric balloon-catheters are used to detect the intra-thoracic and abdominal pressure.The diaphragm electromyogram (EMGdi) will be recorded from a multipair esophageal electrode.The baseline data of the respiratory muscle activity will be detected by these catheters and electrode.p0.1 (the negative airway pressure generated during the first 100 ms of an occluded inspiration) will be also meassured.

After the first period, the nonvolitional tests on respiratory muscle function and strength (twitch mouth and transdiaphragmatic pressure during bilateral magnetic phrenic nerve stimulation (TwPmo and TwPdi) will be done.

After the second period,the patients will be ask to perform different maneuvers, including maximal inspiration against a closed valve ,maximal inspiration to total lung capacity (TLC),maximalexpiration at the total lung capacity (TLC) against a closed valve and maximal sniff from functional residual capacity(FRC).Each maneuver will repeated more than three times with an interval of 30 s or more. Inspiratory capacity(IC),global maximal inspiratory pressure (PImax), maximal sniff nasal pressure (SnPna) and maximalexpiratory pressure will be meassured with the balloon-catheters.The maximal value of the diaphragm electromyogram (EMGdi) will be recorded during these maneuvers.

Eligibility Criteria:
Inclusion Criteria:

* Interstitial lung disease patient meet the diagnose criteria of interstitial lung disease

Exclusion Criteria:

1. Severe Cardiovascular disease
2. Pneumonia
3. Neuromuscular and chest wall deformity
4. Respiratory arrest
5. Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
6. Change in mental status; uncooperative patient
Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition

Galantamine Hydrobromide Tablets, Bioequivalence study of Dr. Reddy's under Fed condition.

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories, ltd. and Janssen Pharmaceutical Products, l.P. (Reminyl®)4 mg Galantamine HBr Tablets in Healthy Adult Male Volunteers under Fed Conditions

Eligibility Criteria:
Inclusion Criteria:

Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the studyI unless otherwise specified:

* Healthy adult male volunteers, 18-55 years of age;
* Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Ufe Insurance Company, 1983);
* Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs;
* Give voluntary written informed consent to participate in the study.

Exclusion Criteria:

Subject candidates must not be enrolled in the stUdy if they meet any of the following criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
* In addition, history or presence of:
* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to galantamine or other anticholinesterase inhibitors;
* asthma and seizures.
* Subjects who tested positive at screening for HIV, HbsAg or HCV.
* Subjects whose PR interval is \>200 msec at screening and prior to dosing.
* Subjects whose QTc interval is \>450 msec at screening and prior to dosing.
* Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
* Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
* Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
* Subjects who, through completion of the stUdy, would have donated in excess of:

  500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
* Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania

This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety for bipolar mania. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).

Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT).

Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. In Addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. As a consequence, MST are able to generate focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;
2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
3. the positive and negative syndrome scale (PANSS) score ≥ 60;
4. informed consent in written form.

Exclusion Criteria:

1. diagnosis of other mental disorders;
2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
4. failure to respond to an adequate trial of ECT lifetime;
5. are pregnant or intend to get pregnant during the study;
6. other conditions that investigators consider to be inappropriate to participate in this trial.
eMurmur ID - Clinical Performance Evaluation

The differentiation between innocent and pathologic murmurs through traditional auscultation can often be challenging, which in the end makes the diagnosis strongly dependent on the clinitians experience and clinical expertise. With the development of technology it is now possible to help diagnose heart murmurs using computer aided auscultation systems (CAA). eMurmur ID is an investigational CAA system (not FDA cleared) and the investigators hypothesize that it can distinguish between AHA class I (pathologic murmurs) and AHA class III heart sounds (innocent murmurs and/or no murmurs) with a sensitivity and specificity not worse compared to a similar FDA cleared CAA system on market.


Eligibility Criteria:
Inclusion Criteria:

* All age groups of patients will be included from 1day old
* Patients who are being followed for known congenital heart disease and are returning for follow up
* Patients referred for a suspected heart murmur

Exclusion Criteria:

* Mismatch between the expert physician's diagnosis (auscultation based) and the diagnosis resulting from echocardiography (independently read by a cardiologist blinded to the auscultation results). Note: both, the expert physician and echocardiography results must independently reach the same diagnosis, which is then accepted as the gold standard reference diagnosis to which both devices are compared to. This is necessary because not every pathology visible on an echocardiogram causes an audible murmur, and not every murmur heard by a medical expert might correlate to pathology.
* Patient whose behaviour does not allow for a standard auscultation by the physician (e.g. a screaming fit).
Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas

The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.


Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older
* Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
* Diagnosis of FFKC
* History of Radial Keratotomy with fluctuating vision
* Ability to provide written informed consent
* Likely to complete all study visits
* Minimum corneal thickness of at least 300 Measured by ultrasound or Pentacam
* At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)

Exclusion Criteria:

* Severe corneal scarring that markedly affects vision
* Contraindications to any study medications or their components
* Pregnancy or breast feeding
* Active Herpes Corneal Disease