cyrilzakka/clinical-trials huggingface dataset:
Hand Rehabilitation Study for Stroke Patients

The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. The ultimate goal is to some day design an effective long-term training program to help someone recovery their ability to use their hands and function independently at home and in society. In order to know how to apply electrical nerve stimulation to produce a good long-term effect on hand dysfunction, we first need to know how to make it work best in the short-term, and improve our understanding of for whom it works and how it works.We will use a commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently apply electrical nerve stimulation over the skin of the affected arm. This is a portable, safe and easy to use device designed for patients to operate in their homes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years, has residual hand motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to enrollment.

Exclusion Criteria:

* Pregnant; uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease; active cancer; significant hand joint deformity or other diagnosis with major effect on hand function besides stroke; severe alcohol or drug abuse within the past year; untreated or inadequately treated major depression; spasticity score \>3 on the MAS; lack of finger range of motion of at least 10 degrees; severe aphasia or other communicative, behavioral or cognitive impairment that significantly interferes with the participant's ability to comply with the protocol or provide informed consent. In addition, patients will be excluded if they have a pacemaker.
Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression

Carpal tunnel syndrome is caused by compression of the median nerve at the wrist. The hypothesis is that ultrasound imaging can be used to visualize nerve compression in carpal tunnel patients during hand activity, and normal subjects will not demonstrate any nerve compression.

Two patients with carpal tunnel syndrome underwent nerve testing to document that they had median nerve abnormality at the wrist. They subsequently had ultrasound imaging of the wrist at rest and during a stress test using hand activity. Two control subjects had nerve testing to prove that they had no nerve abnormality at the carpal tunnel. The carpal tunnel syndrome patients demonstrated nerve compression on the ultrasound images during the stress tests and the normal subjects showed no nerve compression.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have symptoms consistent with carpal tunnel syndrome and electrodiagnostic testing that demonstrates abnormal median nerve function at the wrist, consistent with carpal tunnel syndrome.
* Normal subjects must have no upper limb symptoms to support carpal tunnel syndrome and normal nerve testing.

Exclusion Criteria:

* Patients excluded if nerve testing was not consistent with carpal tunnel syndrome.
* Normals excluded if nerve testing demonstrated any median nerve abnormality.
Transducer Selection in the Speed and Quality of Image Acquisition in FAST Exams

The Focused Assessment of Sonography for Trauma (FAST) is a rapid point-of-care ultrasound exam performed on blunt and penetrating trauma patients who are too critically injured to be transported to a CT scanner. Low-frequency ultrasound is used to image the abdomen and pericardium in these patients, using either a curvilinear transducer or a phased-array transducer. Whether the use of one transducer or the other is better for this application is not well studied. In this study, physician ultrasound operators will perform the FAST exam on healthy non-injured volunteers to determine if the speed or quality of images between the two transducer types is different.

The Focused Assessment of Sonography for Trauma (FAST) is a rapid point-of-care ultrasound exam performed on blunt and penetrating trauma patients who are too critically injured to be transported to a CT scanner. In performing this exam, time to acquisition of adequate images is crucial to clinical decision-making as patients undergoing this exam have a high probability of deteriorating if not intervened on appropriately.

Low-frequency ultrasound is used to image the abdominal cavity and pericardium in these patients, using either a curvilinear transducer or a phased-array transducer. Both of these transducers are capable of acquiring the images necessary to interpret a FAST exam, but it has not been well studied whether using one transducer instead of the other improves time to image acquisition or image quality.

In this study, physician ultrasound operators are asked to perform FAST exams on healthy non-injured volunteers for the purpose of determining if there is a difference in the time to acquisition or quality of images between phased-array and curvilinear transducers.

Eligibility Criteria:
Inclusion Criteria:

Study's ultrasound operators must be emergency medicine residents or PA/NP fellows currently enrolled in an emergency medicine training program between the ages of 18 - 64 years who are not pregnant.

Study's healthy normal volunteers must be emergency medicine faculty, fellows, or PA/NPs aged 18-64 with no anatomic abnormalities, prior surgeries, or significant chronic medical conditions.

Exclusion Criteria:

Pregnant women

Prisoners

Anyone below the age of 18 or above the age of 64 years old

Individuals with abnormal/thoracic anatomy (such as individuals with situs inversus) and individuals with chronic medical conditions that would limit their ability to participate in the study or have ultrasound images taken of them.
Teaching Medical Students How to Suture: Standard Simulation vs in Situ

The purpose of this project is to compare in situ simulation with standard lab simulation. To do this, 30 pre-clinical medical students will be randomized into the lab or ER and taught how to suture a simple laceration. To do this, a synthesized 'skin' will be placed over a volunteer's arm and will have an incision of a predetermined length.

For this study, 30 first and second year students will be equally randomized to either a standard simulation lab or the ER department to learn the skill of suturing. These students will not have any knowledge of suturing prior to this study. Each group will have 15 students. Each student will be given access to the same suturing learning video. They will each attempt 15 sutures on a lab generated skin placed over a volunteer's arm. Each incision length will be predetermined and of the same length. The student will have the opportunity to re-watch the video in between each suture attempt. The volunteer will record the student's number of attempts and whether or not they had to review the video. The idea behind this, is that students should began to plateau with their learning after about 8-9 attempts and most will no longer require the video beyond that.After the 15 attempts, the student will immediately practice 6 sutures on a second skin over the volunteer's arm, again of a predetermined incision length. At this point the students will only be allowed to practice the suturing skill and will not have access to the learning video. At this point, the student's hands will be video recorded to assess the accuracy of the skill.One week after the learning session, regardless of the environment they initially learned in, the student will be brought to the ER and again allowed to practice 6 sutures on a simulated skin placed over a volunteer's arm. The incision will be the same length as the incision in the previous practice session. Again, the student's hands will be video recorded while practicing the 6 sutures.Afterward, the student will be given a questionnaire regarding which environment they practiced in and how prepared they felt to practice in the insitu environment without learning aids.

Eligibility Criteria:
Inclusion Criteria:

* Pre clinical medical students (year one or two)

Exclusion Criteria:

* Medical students not in first or second year training
* Extensive knowledge or background with suturing
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)

The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.

There were two parts in the study, Part A and Part B.

Part A was an assessment of 4 weeks of dosing with patiromer in the treatment of hyperkalemia; Part B was a randomized, placebo-controlled, 8-week assessment of the withdrawal of patiromer in participants with a baseline serum potassium at the beginning of Part A ≥ 5.5 mEq/L who responded to the 4 weeks of treatment with patiromer during Part A.

All participants received patiromer during Part A; Part B participants were randomized to continue patiromer or switch to placebo. Total study participation was up to 14 weeks (including up to 2 weeks of follow up).

The dose of patiromer could be titrated based on participant's serum potassium response.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 18 - 80
* Chronic kidney disease (CKD) - eGFR 15 to \< 60 mL/min/1.73m2 at screening
* Hyperkalemia, defined as a serum potassium value of 5.1 to \< 6.5 mEq/L at screening
* Taking either an Angiotensin-Converting Enzyme (ACE) Inhibitor, an Angiotensin II receptor blocker (ARB), or an aldosterone antagonist (AA) medication
* Informed consent given

Exclusion Criteria:

* Participants with auto-immune related chronic kidney disease such as lupus nephritis or renal scleroderma/scleroderma renal crisis, or mixed connective tissue disease with renal involvement
* Participants with uncontrolled Type 1 diabetes, defined as or a HbA1c \> 10.0 %, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months within the previous 6 months in participants with Type 2 diabetes
* Participants with severe heart failure, defined as NYHA (New York Heart Association) class IV
* Participants with major surgery including thoracic and cardiac, in the past 3 months, or participants with heart or kidney transplant
* Participants with significant cardiovascular or cerebrovascular events in the past 2 months, such as cardiac arrest, myocardial infarction, or stroke
* Participants with BMI ≥ 40 kg/m2
Effect of Intravenous Hyoscine Butylbromide Injection on First Stage Labour in Primigavidae

A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed

A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 - 35 years old
2. Primigravdae.
3. Gestational age between completed 37- 41 weeks + 6 days.
4. Uncomplicated cephalic singleton pregnancy occipto-anterior position.
5. Established spontaneous active labour (defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation three to four centimeters) with cervical effacement not less than 50%.
6. Intact amniotic membranes.

Exclusion Criteria:

1. Multigravidae.
2. Multiple fetus.
3. Malpresentation.
4. Patients with indications of elective caesarean section.
5. Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus.
6. Contraindications for hyoscine butylbromide which include known allergy to hyoscine or other atropinics (e.g., atropine, scopolamine), myasthenia gravis, megacolon or glaucoma.
7. Patients presented to causality with spontaneous rupture of membranes.
8. Spontaneous rupture of membranes during the active phase of first stage of labour.
9. Oxytocin induction or augmentation.
10. Patients who underwent epidural anesthesia or other types of analgesia.
Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients

The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.
* Body mass index between ≥19 and ≤42 kg/m2.
* Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.

Exclusion Criteria:

* History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.
* Systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg at screening
* Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma

The purpose of this study is to test see the combined effects of the study drug called Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also cause side effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
* Patients must have high-risk NB (MYCN-amplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age).
* Patients must be in first CR/VGPR
* Patients must have a negative human anti-hu3F8 antibody (HAHA) titer

Exclusion Criteria:

* Existing major organ dysfunction, i.e., renal., cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3, with the exception of hearing loss and hematologic toxicity.
* Active life-threatening infection.
* Inability to comply with protocol requirements
Study to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease

This study is a single-arm study initiated to evaluate the efficacy and safety of CM310 in subjects with recurrent IgG4-related disease.

This study includes three stages: screening period, treatment period and safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years, male and female.
* With IGG4-related disease.

Exclusion Criteria:

* Inoculate live vaccine within 4 weeks before screening.
* Treponema pallidum antibody positive in screening period.
* Active hepatitis in screening period.
* With a history of solid organ or cell transplantation within 6 months before screening.
* With other medical or non-medical conditions that are not suitable for the study by the investigator.
A Meditation Intervention on Subconcussive Head Impacts

The purpose of this research is to explore potential methods of rehabilitating changes observed from repetitive head impacts. Participation in this study will involve functional magnetic resonance (fMRI) imaging, aerobic testing, heart rate variability (HRV) wrist monitor, hypercapnia challenge, a meditation rehabilitation intervention, and filling out survey information concerning subjective well-being.

COLLEGE ATHLETES:

At each study visit, participants will undergo an fMRI-cerebrovascular reactivity (CVR) challenge scanning session as well as an aerobic exercise test on a stationary bike. During the CVR-fMRI scan, the participant will wear a mask that will deliver a blend of oxygen and nitrogen at varying amounts while lying in an MRI scanner. During the aerobic stationary bike assessment, the participant will pedal at a steady state against applied resistance for 10 minutes while wearing an ECG heart rate monitor to observe heart rate. A Biostrap heart rate variability (HRV) wrist monitor will be provided which will be worn daily. The data from the monitor, concerning HRV and sleep, will be collected. The participant will answer a brief survey concerning the previous night's sleep. After the conclusion of the sport's season, there will be a follow up scanning session. After the post-season scan, the participant will participate in a breath work meditation intervention over the following two months, twice a week for a 30 minute meditation session.

HIGH SCHOOL ATHLETES:

Participants will be given a Biostrap HRV monitor which will be worn daily. The data from the monitor, concerning HRV and sleep, will be collected. The participant will answer a brief survey concerning the previous night's sleep. High school athletes will be randomized into one of two study groups, the control group or the intervention group. The intervention group will receive guided meditation over 2 months (twice a week for 30 mins each session), and will ride a stationary bike at 3 time points. The control group will proceed about their lives normally.

Eligibility Criteria:
Inclusion Criteria:

* Participants recruited for this study will be comprised of adolescent and young adult athletes (age-range 13-25) engaged in high school or college contact athletics who are enrolled in an ongoing NIH funded study of subconcussive head impact exposure (Whitlow: R01 NS091602), which acquires pre- and post-season MRI scans and cognitive testing.

Exclusion Criteria:

* Athletes will be excluded from the study if they suffer a concussion over the sports season or during the course of the proposed mediation intervention study. Athletes will be excluded if they experience claustrophobia entering an MRI scanner.
International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia

This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years.
2. Ability to provide informed consent or assent.
3. Prior successful participation in a tolvaptan hyponatremia trial termination with evidence of continued need or desire for therapy.

Exclusion Criteria:

* A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient.
* Hyponatremia which is acute, reversible, artifactual or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy.
* Hyponatremia due to reversible medical condition or therapy
* Conditions associated with an independent imminent risk of morbidity and mortality
* Conditions which confound the assessment of endpoints.
Sleep and Health Outcomes in Women With Heavy Menses

This study will evaluate subjective sleep over three consecutive menstrual cycles (menses and non-menses) in females reporting heavy menstrual bleeding. Following a baseline phase of one menstrual cycle, study subjects will use a standardized nighttime feminine product during menstruation for their second cycle. For the third cycle, subjects will continue to use the standardized menstrual product with behavioral modification that includes refraining from those sleep behaviors used to avoid nighttime menstrual leakage.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-50 years old
* Generally healthy (self-assessed; no significant underlying disease)
* Premenopausal patients with regular menstrual cycles every 21 to 35 days
* Patients with at least 3 days and no more than 7 days of bleeding during menstruation
* An intact uterus and at least one ovary
* Ability and willingness to provide written informed consent
* Willingness to adhere to study procedures
* Menstrual pads are the primary form for nighttime menstrual protection needs
* Will maintain a daily schedule that allows normal or typical sleep habits (ie, not a night-shift worker; \>5 hours of sleep).
* Women will self-report that they have heavy flow and perform at least one of the following compensatory behaviors:

  * Set an alarm or plan to get up in the middle of the night to check or change the pad
  * Add additional disposable absorbent products for extra leak protection of coverage (e.g. extra pads or liners)
  * Use pillows or other means to limit sleep positions (to prevent moving at night)
  * Use something extra on top of my bedding (such as a towel) to sleep on
  * Wear an extra pair of pants/shorts
  * Wear tighter clothing than they typically would, like yoga pants

Exclusion Criteria:

* Currently pregnant or intending to imminently attempt pregnancy
* Any condition (social or medical) that, in the opinion of the primary care giver or study staff, would make trial participation unsafe or complicate data interpretation
* Difficult sleeping environment due to:

  * Frequently involved in activities requiring nighttime awakenings (eg, taking care of an infant or loved one).
  * Disruptive bed partners (i.e., snoring, children, pets, etc)
  * Diagnosed sleep disorders (i.e. insomnia, sleep apnea, restless leg disorder, breathing disorder, etc)
* Use of an Intrauterine Device (IUDs) unless copper IUD.
* Regular use (\>1 day per week) of sleep aids and/or sedating medications, including over the counter products like melatonin.
Improvement of Appendix Identification and Appendicitis Diagnosis in us After Administration of Oral Contrast Medium

Rate of appendix localization on ultrasound is not high. We suggest a way to improve it's localization by oral administration of iodinated contrast material.

The administration of oral iodinated contrast material might facilitate identification of the appendix and accurate diagnosis of appendicitis. When indicated will shorten time to CT examination.

Eligibility Criteria:
Inclusion Criteria:

* patients in emergency department with right lower quadrant pain

Exclusion Criteria:

* patients under 18 years old
* pregnant women