cyrilzakka/clinical-trials huggingface dataset:
Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug

The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.


Eligibility Criteria:
INCLUSION CRITERIA:

* Weigh at least 13kg.
* Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
* Currently being treated with an antiepileptic drug(s) (AED).
* Benzodiazepines are allowed with some frequency restrictions.
* Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study.
* History of primary generalized tonic-clonic seizures with no focal onset.
* Have at least 1 primary generalized tonic-clonic (PGTC) seizure during the 8 consecutive weeks prior to the baseline period of the study.
* Have at least 3 PGTC seizures occur anytime during the 8-week baseline phase of the study.
* Females must agree to acceptable form of birth control.

EXCLUSION CRITERIA:

* A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
* Have Lennox-Gastaut syndrome.
* Currently using or has previously used the drug being studied.
* Is abusing alcohol and/or other substance(s).
* Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during the study.
* Is receiving chronic (long-term) treatment with any medication that could influence seizure control.
* Follows the ketogenic diet.
* Is planning surgery to control seizures during the study.
* Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality.
* Has any clinically significant heart, kidney, or liver condition, or a condition that affects how drugs are absorbed, distributed, metabolized, or removed from the body.
Analysis of Cases of Sexual Assault in Taiwan

The aim of this study was to analyze victims, assailants, assaults, evidentiary examinations and treatment characteristics of cases of sexual assault sought emergency care at Far Eastern Memorial Hospital、National Cheng Kung University Hospital、Taoyuan General Hospital, Department of Health, Executive Tuan, R.O.C.、National Taiwan University Hospital Yun-Lin Branch、Hospital and National Taiwan University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* all cases

Exclusion Criteria:

* nil
A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults

The objectives of this study are to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple doses of ABT-436 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Age is between 18 and 55 years, inclusive.
2. If female, subject must be postmenopausal for at least two years or surgically sterile.
3. Females must have negative results for pregnancy tests prior to study drug administration.
4. If male, subject must be surgically sterile or agree to be sexually inactive or agree to use a barrier method of birth control.
5. Body Mass Index is 18.0 to 29.9 kg/m2 (2 = superscript number), inclusive.
6. A condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram.
7. Must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

1. History of significant sensitivity or allergy to any drug.
2. Use of known inhibitors or inducers of CYP3A within 30 days prior to the first dose of study drug and through the end of the study.
3. Requirement for, or use of within the 2-week period prior to study drug administration, any over-the-counter or prescription medication, vitamins, minerals or herbal supplements on a regular basis.
4. Receipt of any depot drug by injection within 30 days prior to study drug administration.
5. Positive screen for drugs of abuse or alcohol, or recent (6-month) history of drug or alcohol abuse.
6. Use of tobacco or other nicotine-containing products within the six-month period preceding study drug administration.
7. Donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first dose of study drug.
8. Receipt of an investigational product within a time period equal to 10 half-lives, if known, or a minimum of 6 weeks prior to study drug administration.
9. Has a clinically significant abnormal diastolic blood pressure (\< 45 or \> 90 mm Hg), systolic blood pressure (\< 85 or \> 140 mm Hg) or heart rate (\< 45 or \> 100 bpm).
10. HbA1c \> 6.0%.
Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope

The fiberoptic bronchoscope (FOB) has been the preferred instrument for many years in the management of difficult tracheal intubation, and it is considered as a gold standard. The disposcope endoscope (DE) is a medical device for endotracheal intubation used in clinical practice recently.This study compares FOB and DE for awake orotracheal intubation in obese patients with anticipated difficult airway.

Forty obese patients with anticipated difficult airways were randomised to undergo awake orotracheal intubation by FOB(group F) or DE(group D) after conscious sedation. The conditions of orotracheal intubation, the time needed to view the vocal cords and to complete the orotracheal intubation, the hemodynamic changes and the adverse events including bradycardia, respiratory depression during orotracheal intubation, throat pain, hoarseness and memory after surgery were recorded. The ease of view the vocal cords and passing the tracheal tube through the glottis were also evaluated by using a visual analogue scale (VAS) by operator.

Eligibility Criteria:
Inclusion Criteria:

* ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.

Exclusion Criteria:

* Exclusion criteria included age younger than 18 yr,
* ASA class IV or V,
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
Effect of Dietary Amino Acid Profile on Lipoprotein Metabolism, Vascular Reactivity and Inflammatory Markers

The aim of this study is to explore the significance of the Lys:Arg ratio on responses of lipids and lipoprotein concentrations to dietary proteins and to evaluate the effects of dietary Lys:Arg on cardiovascular disease risk factors and endothelial function.

Findings from early studies in a variety of experimental models of atherosclerosis on the effect of dietary protein suggested that proteins from vegetable sources are less cholesterolemic and atherogenic than proteins from animal sources. Throughout the later part of the 20th century there has been sporadic interest in the effect of protein type and amino acid profiles on blood lipid concentrations and atherosclerosis. A major focus for this evaluation has been to compare proteins based on their amino acid profile, often expressed as lysine (Lys) to arginine (Arg) ratio (Lys:Arg). While animal studies have provided important information regarding the significance of the Lys:Arg in determining the cholesterolemic response to a dietary protein, interpretation of these data must be done with caution since most of the studies have been conducted in animal models that have a different lipoprotein distribution and metabolism than humans. Moreover, the mechanistic insights of this response are yet to be determined. While the favorable effects of Arg on endothelial function appear to be consistent when Arg is administered using a supplement, the effects of dietary Arg naturally present in protein rich foods has yet to be determined. The aim of this proposal is to explore the significance of the Lys:Arg ratio on responses of lipids and lipoprotein concentrations to dietary proteins and to evaluate the effects of dietary Lys:Arg on cardiovascular disease risk factors and endothelial function.

Eligibility Criteria:
Inclusion Criteria:

* Age: 50-85 years
* LDL-C concentrations \>120 mg/dL

Exclusion Criteria:

* Use of medications known to affect lipid metabolism
* Established cardiovascular disease
* Renal disease
* Liver disease
* Thyroid disease unless controlled with medication for at least 6 months
* Type I and II diabetes
* Irritable bowel syndrome
* Chronic use of prescription anti-inflammatory medications
* Smoking
* Alcohol intake \>7 alcoholic drinks per week
* Unwillingness to maintain body weight during participation in the study
* triglyceride (TG) \> 400 mg/dL
* Unwillingness to adhere to diet and study protocol
* Weight gain or loss of more than 15 lb within 6 months prior to enrollment
Foley Catheter Versus PGE2 for Labor Induction at Term: a Pilot Study

Induction of labor is one of the most common interventions in obstetrics. In the past decade, the rates of labor induction at term have doubled from approximately 9% to 23% in the United States and from 10% to 20.4% in China. The majority of women undergoing labor induction requires cervical ripening for the unfavorable cervixes. As globally, it is still required to explore an optimal induction method. Foley catheter was among the oldest mechanical approaches, while prostaglandin E2 vaginal suppository (PGE2) one of the most popular pharmacological agents for cervical ripening. There were studies reporting similar cesarean section rates between these two methods. However, there are no randomized control trials (RCTs) with adequate power to compare their frequencies of severe perinatal complications. The investigators aim to compare the effectiveness and safety of Foley catheter versus PGE2 for induction of labor among term pregnant women with an unfavourable cervix.

The investigators propose a single center, open-label, randomized controlled clinical trial (1:1 treatment ratio) in Guangzhou Women and Children's Medical Center. Women with a term pregnancy, an indication for induction of labor, and a live singleton fetus at cephalic presentation, intact membranes, an unfavorable cervix, no prior cesarean section or contraindication to vaginal delivery, are eligible to participate. After informed consent, they will be randomized to undergo induction of labor by Foley catheter or PGE2.

Our primary outcomes will be (I) a composite of severe perinatal complications and (II) vaginal delivery. Before the formal recruitment of this RCT, a pilot study with a sample size of 200 pregnant women will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for induction of labor.
* Women aged ≥ 18 years old
* ≥ 37 weeks of gestation
* Live singleton pregnancy in cephalic presentation
* Intact membranes
* Cervical Bishop score \< 6
* Informed consent.

Exclusion Criteria:

* Contraindications for vaginal delivery.
* Prior cesarean section
* Known hypersensitivity for Foley catheter or PGE2
* Non-reassuring fetal status
* Lethal fetal congenital anomaly
Factors and Outcomes Associated With Postpartum Cabergoline Use

Cabergoline is frequently being requested by many postpartum women with a live newborn to suppress lactation. The aim of the study is to investigate which women desire such an intervention, and what side effects they are experiencing.

Cabergoline is a dopamine receptor agonist. Outside of the United States, it is occasionally used to suppress lactation, most commonly after a pregnancy loss or stillbirth. However, the investigators noted that the patient population in Israel has been requesting cabergoline for administration after healthy births, for immediate lactation suppression.

Use of cabergoline after delivery comes with many concerns. One primary concern is that this medication can increase the risk of venous thrombotic events, particularly during postpartum when thrombosis risk is already elevated. Secondly, it may have effects that alter mood, which are similarly concerning during a vulnerable period when postpartum depression and other mental health disorders are common.

Finally, of course, is the issue that so many women are requesting lactation suppression immediately after birth, and therefore will not accrue the neonatal and maternal benefits of lactation.

The investigators want to understand the characteristics, demographics and other factors that lead these women to make this choice, as well as assess their risk of medical and psychological adverse effects from cabergoline used in the postpartum period.

During this study, the investigators will not be prescribing cabergoline or in any way affecting its use. The study will be recruiting as subjects women who requested and received cabergoline prescriptions independently, as is common practice throughout the country.

The study will involve three questionnaires with these subjects: one in the hospital, after birth; one a week after birth; and one 6 weeks after birth. The questionnaires will involve medical history, a validated lactation questionnaire, as well as demographic data. All data will be held in a private, password-locked database.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women
* After a live birth
* Requesting cabergoline for lactation suppression

Exclusion Criteria:

* those who request cabergoline for lactation suppression after a stillbirth or pregnancy loss
Physiological Changes Induced Through MEP Conditioning in People With SCI

The study team is currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. After spinal cord injury, brain-to-muscle connections are often interrupted. Because these connections are important in movement control, when they are not working well, movements may be disturbed. Researchers have found that people can learn to strengthen these connections through training. Strengthening these connections may be able to improve movement control and recovery after injuries.

Research participants will be asked to stand, sit, and walk during the study sessions. Electrodes are placed on the skin over leg muscles for monitoring muscle activity. For examining brain-to-muscle connections, the study team will use transcranial magnetic stimulation. The stimulation is applied over the head and will indirectly stimulate brain cells with little or no discomfort.

Participation in this study requires approximately three sessions per week for four months, followed by two to three sessions over another three months. Each session lasts approximately 1 hour.


Eligibility Criteria:
Inclusion Criteria:

* Neurologically stable (\>1 year post SCI)
* Medical clearance to participate
* Ability to ambulate at least 10 m with or without an assistive device (except for parallel bars)
* Signs of weak ankle dorsiflexion at least unilaterally
* Expectation that current medication will be maintained without change for at least 3 months; stable use of anti-spasticity medication is accepted

Exclusion Criteria:

* motoneuron injury
* known cardiac condition (e.g., history of myocardial infarction, congestive heart failure, pacemaker use)
* medically unstable condition
* cognitive impairment
* history of epileptic seizures
* metal implants in the cranium
* implanted biomedical device in or above the ches (e.g., a cardiac pacemaker, cochlear implant)
* no measurable MEP elicited
* unable to produce any voluntary TA EMG activity
* extensive use of functional electrical stimulation to the leg on a daily basis
* pregnancy (due to changes in weight and posture and potential medical instability)
Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training

The goal of this clinical trial is to compare the effects of protein consumption before sleep or immediately after exercise during 12 weeks of resistance exercise training in older adults. The main questions it aims to answer are:

Are there differences in muscle growth or strength during 12 weeks of resistance training when 40 grams of protein is consumed either before sleep or immediately after exercise? Are there differences in cognitive performance during 12 weeks of resistance training when 40 grams of protein is consumed either before sleep or immediately after exercise?

This study is a randomized double-blind placebo-controlled study. Participants will be randomly allocated into 1 of 3 groups. All three groups will perform the same 12-week resistance exercise training program two times per week and consume 40 g of protein: 1) Immediately post-exercise, 2) 30 minutes prior to sleep, or 3) no supplemental protein (control). Test of muscle growth and strength, and cognitive performance will be measure before, during, and after the exercise training program.

Researchers will compare the 3 conditions to determine if consume protein after exercise or before sleep during 12 weeks of resistance exercise training affects muscle growth and strength, and cognitive performance.


Eligibility Criteria:
Inclusion Criteria:

* Male between 60-75 years old at the time of enrollment.

Exclusion Criteria:

* Diagnosis of cardiac or peripheral vascular disease
* Stroke, kidney dysfunction
* Metabolic disease
* Uncontrolled hypertension
* Orthopedic limitations
* Skeletal muscle complications
* Milk allergy
* Psychiatric conditions
* Use of psychotropic drugs
* Cognitive impairment (scoring 26 points or less on the Montreal Cognitive Assessment)
* Participation in a structured regular exercise program within the past 6 months
* Actively attempting to increase or decrease body mass
* Body mass index (BMI) of ≥ 35 kg/m2
The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy

There are different techniques of interscalene brachial plexus block, we aimed to evaluate the effectiveness of 3 of them as analgesia during shoulder arthroscopy surgery under general anesthesia.

Prospective randomized controlled study

There were 4 groups included in our study:

Group N: nerve stimulator guided interscalene brachial plexus block was done Group U: ultrasound guided interscalene brachial plexus block was done Group NU: dual guidance (using both nerve stimulator and ultrasound) Group C: control group We assessed in each group: heart rate, noninvasive blood pressure, time needed for block, onset of sensory and motor power loss and their offset, and finally patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years old.
* Sex: Both sexes.
* ASA I \& II.

Exclusion Criteria:

* - Patient refusal.
* Bleeding disorders.
* Damage or disease of the brachial plexus.
* ASA more than II.
* Pre-existing peripheral neuropathy.
* Patients with neuromuscular diseases.
* Patients with known hypersensitivity to drugs of the study.
* Patients with local skin infection at the site of injection.
* Psychiatric diseases interfering with evaluation of the block.
Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) is under-diagnosed and is associated with increased cardiovascular morbidity and mortality. Laboratory-based overnight polysomnography (PSG) is the gold standard in clinical practice to diagnose OSA but has availability, cost, and resource limitations. In the last decade, an alternative diagnostic strategy, Portable Monitoring (PM) has emerged with the goal of reducing expense and delays in clinical management. In contrast to PSG, PM maybe performed unattended in homes, utilize different neurophysiologic and cardiorespiratory parameters, and may synthesize these data differently. PM is feasible and is approved by Centers for Medicare and Medicaid Services (CMS) in the United States. However, the diagnostic utility of PM in minority and underserved populations is not defined.

African-Americans are more severely affected by hypertension and cardiovascular disease (CVD) than other ethnic groups and OSA is more common in this population. OSA is a treatable cause of hypertension. Despite this the impact of timely interventions for OSA on health outcomes and risk reduction specific to African Americans is unknown.

Purpose of this research: In view of the vulnerability of this population and the potential for improvement in healthcare access for OSA with home-based diagnosis, this study aims to establish the feasibility and identify the potential advantages and limitations of home-based diagnosis of OSA in a high-risk urban African-American population including veterans with frequently limited access to healthcare.

Hypothesis: The investigators hypothesize that home-based PM is not inferior to standard laboratory-based PSG in effectively diagnosing OSA in urban African Americans.

Hypothesis: The investigators hypothesize that home-based PM is not inferior to standard laboratory-based PSG in effectively diagnosing OSA in urban African Americans.

The specific aims of this project are:

Primary Aims: Aim 1. To compare the validity of a comprehensive and current PM technology to standard in-laboratory full PSG

1a) to measure and compare diagnostic accuracy of home-based PM with laboratory-PSG

1. b) to measure and compare diagnostic accuracy of simultaneous laboratory-based PM with laboratory-PSG Aim 2. To test the reliability and examine the applicability of PM in the home-setting
2. a) to compare diagnostic accuracy of home-based PM with laboratory-based PM

2b) to examine factors associated with technical reliability (data failure rate) of home-based PM 2c) to compare patient satisfaction and preference of testing in home-setting to laboratory-setting

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female African-Americans (age ≥18 years)
2. Berlin Questionnaire
3. Ability to understand written and verbal English

Exclusion Criteria:

1. Past treatment of OSA (medical, dental, or surgical)
2. Other primary sleep disorder(s) by history
3. Active uncontrolled medical conditions/immobility
4. Current drug or significant alcohol use
5. No current residential address or contact phone number