cyrilzakka/clinical-trials huggingface dataset:
Comparing Transcranial Direct Current Stimulation Montages in Stroke

40 acute subjects will be split into 5 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal, extracephalic or placebo.

Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.

Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test

40 acute subjects will be randomized and split into 5 groups.

Each group will receive one of the following tDCS montages :

Anodal : Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder Placebo : anode montage but current is ramped up over 15 secondes, then ramped down.

Subjects will receive, in addition to conventional rehabilitation (±1.5h/weekday), 2mA for 20 mins of their attributed tDCS, 5 times a week.

Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test

All researchers, therapists, data analysis and patients are blinded by a code system implemented in the tDCS machine

Eligibility Criteria:
Inclusion Criteria:

* First Ever Stroke
* Motor or sensory deficit
* Understands and follows orders
* Signed inform consent

Exclusion Criteria:

* One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
Predictors and Prognostic Factors on the Acute Ischemic Stroke

Through 5 years continuous observation of acute ischemic stroke patients in Neurology Department of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, clinical data about emergency treatment (neurological score, examination and treatment), medical data after admission (neurological score, inspection, examination and treatment) and long-term prognosis (neurological score) was collected. The outcomes were set as the score scale, all blood test index and examination index of the research objects at specific period after illness. Through statistical analysis and comparison of different in-hospital clinical data in predicting the outcome of the patients, our study will provide more evidence-based solutions for the treatment and prediction of acute ischemic stroke.

The research is designed as registrated, prospective, open-labeled, blind-endpoint, and the research objects are continuously recorded. The final subgroups are blind to neurological evaluators, data inputers and statisticians.

The research is a continuous observational exploratory study. All patients with ischemic stroke admitted to Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology from April 1, 2017 to December 31, 2021 will be included. According to the current situation, it is expected to enroll approximately 5000 of eligible patients for long-term follow-up observation.

We'll use multiple linear regression analysis model to study factors and confounding factors and their interaction. And we will control the confounding factors, and make a quantitative description of the relationship between factors and outcome variables.

Missing cases will be treated as censored values, and the ratio of missing cases will be recorded. All samples will be analyzed by Intent-to-Treat (ITT) analysis. In the analysis, if the results are statistically significant, the missing cases in the exposed group will be deleted, and the missing cases in non-exposure group be added. If the results are still statistically significant, then the missing cases are defined as not affecting the analysis results.

If the heterogeneity of data is large, the objects will be analyzed in subgroups according to age or sex.

If the missing rate is greater than 20%, it is necessary to analyze the sensitivity of the whole sample.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old, of either sex
* Confirmation by CT scan
* Willingness to participate in the study and comply with its procedures by signing a written informed consent

Exclusion Criteria:

* Cerebral hemorrhagic infarction confirmed by CT scan
* Patients with severe systemic disease who are expected to survive for no more than three months
* Unwilling to participate in the study
Musical-animated Toys and Audio Books in Pediatric Palliative Care.

The aim of this study was to determine the effect of audio book and musical-moving toy on fear, anxiety and pain in tracheostomy care of children in palliative clinic.

In children with receiving palliative care will be randomly divided into two groups: audiobook group and musical-moving toy. Interventions will be applied for 2 days, 1 times a day (2 sessions). No intervention will be applied to both groups besides audiobook or musical-moving toy intervention. The children will be assessed before, during and after. Pain, fear and anxiety due to tracheostomy care procedure will be evaluated using the Wong Baker Facial Pain Scale, Child Anxiety Scale-Stateness and Children's Fear Scale . In addition, the heart rate, respiration, blood pressure and SPO2 values of the children will be measured with the help of a bedside monitor.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 6 months and 18 years
2. Receiving inpatient treatment in paediatric palliative care service
3. No visual and hearing abnormalities

Exclusion Criteria:

1. The family's desire to leave research.
2. Deterioration of the child's condition
Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant

The purpose of the study is to determine whether cinacalcet, used in patients with secondary hyperparathyroidism to control excessive parathyroid hormone, can normalize low blood phosphorus that is commonly seen in patients who have had a kidney transplant.

Secondary hyperparathyroidism (SHPT), common in ESRD, persists following renal transplantation resulting in profound hypophosphatemia. This can lead to hemolysis, congestive heart failure, rhabdomyolysis. Phosphate repletion is difficult in view of the persistent SHPT: oral phosphate supplementation can lead to hypocalcemia, reduced 1,25-OH Vitamin D production, hypercalcemia and further hyperparathyroidism. In addition, phospho-soda has been associated with phosphate nephropathy and renal failure.

Cinacalcet HCl is a calcimimetic agent that has recently become a standard therapy in the treatment of SHPT in ESRD. It suppresses PTH secretion by acting as a modulator of the Calcium-sensing receptor on the PTH cell, causing the PTH cell to decrease production of parathyroid hormone. It is a very effective agent, producing significant reduction of PTH as well as improvement in calcium and phosphate metabolism in the dialysis patient. The drug is well-tolerated with minimal adverse effects. Cinacalcet has also been used to control hypercalcemia in renal transplant patients with persistent hyperparathyroidism. Short-term cinacalcet given for 2 to 4 weeks has normalized serum phosphorus and decreased urinary phosphate wasting in renal transplant recipients with stable graft function.

We hypothesize that Cinacalcet HCl will normalize the hypophosphatemia of early renal transplant by reducing the effects of PTH on the proximal renal tubular transport of phosphorus, thereby allowing phosphate reabsorption and decreasing urinary phosphate wasting.

Eligibility Criteria:
Inclusion Criteria:

* renal transplant within last 3 months
* serum phosphorus less than 2.0 mg/dl
* serum creatinine less than 2.0 mg/dl

Exclusion Criteria:

* sensitivity to cinacalcet
* use of amitryptiline, desipramine, itraconazole, ketoconazole
* pregnancy
Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine

This study aims to compare the effects of transcranial direct current stimulation on the clinical and cognitive function in patients with chronic migraine.

The patients will be randomized into 1 of 3 groups: active tDCS for 15 minutes, active tDCS for 15 minutes, with an interval of 20 minutes and more 15 minutes os stimulation, sham tDCS for 15 minutes. The tDCS will be applied for 10 days over 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* females
* clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta).

Exclusion Criteria:

* headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease
* use of central nervous system modulating drugs
* pregnancy
* metallic head implants
* use of a cardiac pacemaker
Urinary Excretion of Enteroviruses From Children With a Presumed Enteroviral Infection

Enteroviruses can infect most human organ systems, especially the heart, nervous system and pancreas. Whether Enteroviruses can also affect the kidneys is not known yet. Therefore we will analyze urine of children with a suspected enteroviral infection for enteroviruses and signs of kidney infection.

Enteroviruses have been shown to cause mesangioproliferation and glomerulonephritis in mice (especially coxsackievirus B4). In some cases, large amounts of IgA are deposited in the mesangium, resembling human IgA-nephropathy. In humans, case reports indicate the propensity of certain enteroviruses to cause kidney infections.

Our project aims to analyze urine of children with suspected enteroviral infections (e.g. meningitis, myocarditis, sepsis of the newborn etc.) to identify cases suspicious of concomitant enteroviral kidney affection. To achieve this aim, enterovirus-PCRs will be performed and microhematuria searched for.

Eligibility Criteria:
Inclusion Criteria:

* children, suspected of suffering from an enteroviral infection
Combined Agent Randomized Trial of Induction of Labor

To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.

This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: \>36 weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's score \<6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate oxytocin. Primary outcome measure was the rate of vaginal delivery \<24 hours. Secondary outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non reassuring fetal status (NRFS) and rate of uterine hyperstimulation.

Eligibility Criteria:
Inclusion Criteria:

* \> or = to 36 weeks of gestation
* Singleton fetus
* Cephalic presentation
* Intact membranes and an unripe cervix (Bishop score \<6)

Exclusion Criteria:

* Multifetal gestation
* Rupture of membranes
* Ripe cervix (Bishop score \>6)
* Active labor
* Contraindication to vaginal delivery
* Previous uterine surgery
* Non-cephalic presentation
* Fetal macrosomia
Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mg

The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg.

This will be an open label, randomized, single dose, 2-treatment, 2-period crossover study in healthy volunteers.Study treatments will be administered under fasting conditions.

Blood samples for the analysis of tacrolimus in blood will be obtained as follows: Predose(immediately prior to dosing), and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Eligibility Criteria:
Inclusion Criteria:

* Signed the informed consent from prior to screening test
* Between 19 years and 55 years in healthy male subject
* Have not any congenital or chronic disease and medical symptoms
* Body mass index(BMI) of 18 to 30 and a total body weight ≥ 55kg
* Appropriate subject for the study judging from investigator

Exclusion Criteria:

* Evidence or history of clinically significant hepatic, renal, neurologic, immune system, respiratory system, endocrine
* Any condition possibly affecting drug absorption (e.g. gastrectomy)
* Subject with hypersensitivity to tacrolimus or any excipient
* Administration of cyclosporin or bosentan
* Administration of potassium-sparing diuretics
* Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* SBP\<90 mmHg or DBP\<50 mmHg, SBP\>150 mmHg or DBP\>100 mmHg at least 3 minutes of rest
* A positive HBsAg, HCV Ab, HIV Ab, RPR
* AST, ALT \> 1.5\*upper limit of normal range at the screening test
* Subject with a history of drug abuse or a positive reaction for drug abuse at the screening test
* Taking ETC medicine including oriental medicine within 14days before the first hospitalization or taking OTC medicine, vitamin within 7days
* Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initiation test
* Participating in a bioequivalence study or other clinical study within 3 month preceding the first hospitalization
* Blood donation or more within 2 month or component blood donation within 1 month prior to the first hospitalization
* Continued to be drinking(alcohol\> 21 units/week, 1 unit=10g of pure alcohol) or during clinical trials can not be drunk
* Severe heavy smoker(cigarette\> 10 cigarettes/day) during 3 months or can not be smoking during the clinical study
* Continued to be taking caffeine or can not be taken caffeine
* Continued to be taking grapefruit or can not be taken grapefruit
* Not use of contraception during the clinical study
* An impossible one who participates in the clinical trial by investigator's decision including for reason of laboratory test result
Palliative and Oncology Care Intervention: Symptom COACH

The investigators propose to conduct the first pilot trial of a collaborative palliative and oncology care intervention for HNC patients receiving CRT to assess the feasibility and acceptability of the intervention. The intervention will incorporate weekly palliative care visits into standard oncology care targeting coping, mood, and symptom management.


Eligibility Criteria:
Inclusion Criteria:

1. adult patients (≥18 years) with a diagnosis of HNC for which they are undergoing CRT
2. receiving all oncology care at Fox Chase Cancer Center (FCCC)
3. able to speak and read in English or with assistance from an interpreter

Exclusion Criteria:

1. patients with prior history of HNC for which they underwent CRT
2. patients with uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease which the treating clinician believes prohibits informed consent or participation in the study
3. patients enrolled on other supportive care intervention trials
Ammonia Levels and Cognitive Impairment

The purpose and objective of this study is to determine the prevalence of elevated ammonia levels in subjects with cognitive impairment, and to observe if treating the cause of the elevated ammonia level improves mental status. This study does not include any imaging, treatment,or interventions, other than the blood draws. The blood draws will be taken to assess blood ammonia level and liver function. If the the ammonia level is not elevated, no further lab draws will occur. If the ammonia level is elevated, liver function is normal, and a cause for the high ammonia level is revealed with a plan for clinical treatment by the subjects' physician, then two more blood draws will occur; one prior to treatment, and one 3 months after treatment. The main risk to subjects is related to the blood draw (i.e. momentary discomfort, bruising, infection, bleeding, clotting or fainting), and there is a potential loss of confidentiality. A paired student t test will be done with the two later blood to compare objective data.


Eligibility Criteria:
Inclusion Criteria:

* cognitive decline (suspected or documented)
* able to get blood drawn

Exclusion Criteria:

* liver disease/cirrhosis
Mindfulness Meditation for Insomnia

This is a pilot study evaluating the feasibility and acceptability of a non-pharmacological, mind-body intervention to improve sleep quality, including a preliminary evaluation of neurophysiological signals. The study involves 4 weeks of guided mind-body practice at home using a smartphone app during bedtime and pre/post in-lab sleep study visits.


Eligibility Criteria:
Inclusion Criteria:

* 1. age 20 - 50 years\*
* 2. chronic insomnia (defined by Diagnostic and Statistical Manual Diploma in Social Medicine, DSM-V or International Classification of Sleep Disorders - Third Edition, ICSD-3) with sleep latency \>20 minutes
* 3. speak and understand English
* 4. have a smart phone for mobile app installation

Exclusion Criteria:

* 1. sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, sleep deprivation, jet lag, etc)
* 2. shift worker or routine night shifts
* 3. women with pregnancy or breast feeding
* 4. history of head trauma or surgery
* 5. regular (defined as twice a week or more) practice of mind-body interventions
* 6. neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.)
* 7. current use of neurologic, psychiatric, or cardiovascular medications that have expected neuropsychiatric or cardiovascular effects (i.e., beta-blockers, hypnotics, antidepressants).
The Effect of Tramadol on Interscalene Brachial Plexus Block

The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine local anesthetic solution in interscalene brachial plexus block for shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder surgery

Exclusion Criteria:

* patients on opioids
* diabetes mellitus
* interscalene block contraindicated
* patient refusing regional anesthesia techniques
Role of Preservation of Scarpa's Fascia in Abdominoplasty

The purpose of this study is to determine whether leaving a thicker layer -which preserves the tissue called Scarpa's fascia -intact during an abdominoplasty (tummy tuck) decreases the damage to the lymphatic system.

In order to investigate the effect of leaving a thinner or slightly thicker layer intact during a tummy tuck, patients who are already planning to undergo the surgery, and who agree to participate, will be randomly assigned to two groups in a manner similar to flipping a coin. The first group will have their abdominoplasty performed with a thinner layer of abdominal wall left in place while the second group will have the surgery with a slightly thicker layer left in place. Both methods of doing a tummy tuck meet acceptable standards of care, and the aesthetic outcomes will not be negatively impacted by either of the options.

Before and after the surgery, a procedure called lymphoscintigraphy will be performed. Lymphoscintigraphy is a special type of imaging where a dye, called a radiotracer, is injected and then detected by a special camera. The pictures provided by the lymphoscintigraphy allow investigators to look at the lymphatic system, which is a small network similar to blood vessels that helps drain extra fluid. The lymphoscintigraphy will help investigators to know what method of performing the tummy tuck leaves the lymphatic system most intact.

In addition, photographs of each patient's abdomen will be taken using a special camera that allows investigators to put the photographs in the computer and compile a 3-dimensional image. Investigators will be able to look at the volume changes from swelling after the surgery using these pictures. Finally, an ultrasound will be used to help identify any seromas, or fluid collections, that may form after the surgery.

The lymphoscintigraphy, photographs and the ultrasound combined will help determine whether or not leaving a thicker or thinner layer during a tummy tuck helps preserve the fluid draining lymphatic system and whether or not that effects recovery after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* all patients ages 18-65 years who are planning to undergo elective abdominoplasty

Exclusion Criteria:

* patients with contraindications to lymphoscintigraphy
* patients with contraindications to abdominoplasty
* previous abdominal surgery or traumatic perforation
Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease

This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.

DENV infections can cause self-limited but incapacitating acute illness lasting four to seven days. The illness is characterized by fever, headache, severe pain in muscles, joints, pain behind the eyes, and a rash. DENV infection can be complicated by the development of hemorrhagic fever (DHF) or shock syndrome (DSS), which is manifested by plasma leakage and a bleeding diathesis or frank hemorrhage. DHF is fatal in at least 0.5% of pediatric cases but rarely in adults. People, particularly children, living in hyper-endemic areas who have antibodies from an earlier dengue infection with one serotype are at increased risk for DHF if subsequently infected by another dengue virus serotype.

Currently, no specific anti-viral therapy exists. Therapy is largely supportive. Mosquito control has failed to prevent dengue transmission; therefore, prevention of dengue through vaccination is an important objective of the World Health Organization (WHO) and many national governments, including the United States.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age or the legal age of consent (whichever is greater) to 50 (inclusive) years of age
* Negative screening laboratory test against dengue, Japanese Encephalitis, West Nile, and Yellow Fever viruses
* Healthy
* All subjects must agree to use contraception or to abstain from sex from enrollment through trial completion
* Able to provide informed consent and able to be followed throughout the trial period

Exclusion Criteria:

* History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, West Nile virus, Yellow fever, and dengue
* Have a known or suspected hypersensitivity or adverse reaction to vaccines
* Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0
* Are pregnant or breastfeeding
* Known HIV, Hepatitis B and/or Hepatitis C infection
* Have any acute illness, including an oral body temperature greater than 100.4°F at the day of vaccination
* Have any occupational, social, or medical concerns that would impact subject safety, interfere with protocol adherence, or affect a subject's ability to give informed consent
* Have been using immunomodulatory therapy (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) within the past 6 months; medications or nutritional supplements known to or which potentially could affect organ function within 30 days prior to the initial injection
* Have received an investigational drug or vaccine or participated in a drug product or vaccine study within a period of 30 days prior to Day 0
* Have received or donated blood or plasma within 90 days of Day 0 (or plan on receiving or donating blood or plasma during the study)