Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for acute repetitive seizures.

Conditions: Seizures; Epilepsies, Partial; Epilepsy, Complex Partial; Epilepsy, Generalized; Epilepsy

Summary: to evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. in addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration.


Eligibility criteria:
key inclusion criteria for patient: * older than 2 years of age and between 6 and 136 kg body weight * recipient of clinical diagnosis of epilepsy, taking a stable antiepileptic drug regimen for at least 2 weeks, and requiring intermittent medical intervention to control episodes of acute repetitive seizures (ars) * experienced at least 2 episodes of ars in previous year, one of which occurred in previous 6 months * has episodes of ars that include complex partial or generalized seizures * has a responsible caregiver available to participate * is not pregnant or lactating and is practicing an acceptable method of birth control. for caregiver: * age of 18 years or older and has demonstrated responsibility as a caregiver through training to: * recognize an episode of repetitive seizures for which the injection was intended, * administer study drug * count and record seizures and respiratory rate in the patient diary, * monitor the patient and record observations in the patient diary for 12 hours following study drug treatment * recognize the need for immediate medical attention. key exclusion criteria for patient: * petit mal status or petit mal variant status * history of ars consistently progressing to status epilepticus * history of failure to respond to benzodiazepine treatment * hypersensitivity to diazepam * acute narrow angle glaucoma * alcohol and/or other substance abuse * has taken another investigational drug in previous 30 days * acute or progressive neurologic or severe psychiatric disease or severe mental abnormality.

Keywords: acute repetitive seizures ars diazepam cluster seizures
stria gravidarum and olive oil for pregnancy women

Conditions: Striae Gravidarum; Pregnancy Related

Summary: the aim of this study was to investigate the clinical efficacy of olive oil on the severity and progression of striae gravidarum. this randomized controlled clinical trial included 156 primipara women who were early third trimester. they were randomly allocated into two groups: an experimental group and a control group. women in the experimental group applied olive oil to their abdomen twice a day in the morning and evening. the control group had no intervention.

the development of striae is one of the most common skin changes in pregnancy. the aim of this study was to investigate the clinical efficacy of olive oil on the severity and progression of striae gravidarum. this randomized controlled clinical trial included 156 primipara women who were early third trimester. they were randomly allocated into two groups: an experimental group and a control group. women in the experimental group applied olive oil to their abdomen twice a day in the morning and evening. the control group had no intervention.data were collected using maternal information form, fitzpatrick skin type scale and davey's severity score.

Eligibility criteria:
inclusion criteria: * being in the age group of 20-30 years, early third trimester (being at the 28th week of gestation), having a singleton pregnancy, being primiparous, and volunteering to participate in the study. exclusion criteria: * having a chronic disease (such as diabetes or hypertension), having striae (before 28th gestation week), having traces of scar tissue from adolescence, using cortisone cream or another kind of topical cream, having polyhydramnios, having threatened preterm labor or preterm delivery, having any disease of the skin, taking any medication regularly, having a problem preventing communication, using pharmacological or non-pharmacological methods (undergoing pharmacotherapy) to reduce nausea, and undergoing psychiatric treatment (psychotherapy).

Keywords: striae gravidarum primipara women pregnancy olive oil
investigation of the effects of the technology-based cardiac rehabilitation program in coronary artery patients

Conditions: Coronary Artery Disease; Physical Inactivity

Summary: this study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.

cardiovascular diseases constitute one of the most critical health problems of today's society due to the loss of workforce, morbidity, mortality, and high hospital expenses. this study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease * access to the online program * volunteering to participate in the research * having an ios or android operating system compatible phone exclusion criteria: * having a musculoskeletal problem * having uncontrolled hypertension * having chronic heart failure (nyha iii-iv) * a history of acute coronary syndrome or surgical revascularization less than 12 months ago * more than 50% occlusion on the main coronary artery * having arrhythmia

Keywords: cardiac rehabilitation exercise training
clinical and genetic investigation of the association between primary aldosteronism and thyroid cancer

Conditions: Thyroid Cancer, Papillary; Primary Aldosteronism

Summary: aldosterone excess can cause oxidative stress leading to dna damage in vitro and in vivo. single case reports demonstrated a coincidence of primary aldosteronism (pa) with different malignancies. a higher prevalence of thyroid nodules and non-toxic multinodular goiter was described in patients with pa compared to those with essential hypertension (eh). a single study showed an association between pa and papillary thyroid cancer (ptc), but without a paired control group. objective: to assess pa prevalence in a transversal cohort of patients with ptc and eh compared to a paired control group with ht.

primary aldosteronism (pa) is the most frequent cause of endocrine hypertension, with an estimated prevalence of 20% among individuals with resistant hypertension. pa is associated with an increased risk of malignancy, probably due to aldosterone effects in promoting cell proliferation. recently, a high prevalence of pa was demonstrated in patients with essential hypertension (eh) and papillary thyroid cancer (ptc), similarly to the prevalence of pa among individuals with resistant eh. in addition, abnormalities in thyroid ultrasound (non-toxic multinodular goiter) are more common in pa patients when compared to controls. despite of this initial evidence, the link between pa and ptc remains to be elucidated. then, the aim of this study is to investigate the clinical and genetic aspects of the association between pa and ptc. the specific aims are: 1) to evaluate the prevalence of pa in a transversal cohort of patients with eh and pct; 2) to investigate thyroid ultrasonography abnormalities in pa patients; 3) to perform exome sequencing (blood dna) in patients with pa and ptc paired with tumor tissue; and 4) to conduct functional studies of the novel genetic variants identified by exome sequencing. to achieve this goal, the investigators will employ the following techniques: next-generation sequencing, bioinformatic analysis, real-time pcr and immunohistochemistry. in this project, the investigators expect to establish the prevalence of pa among patients with eh and ptc, and to identify new genetic targets involved in the association between pa in ptc.

Eligibility criteria:
inclusion criteria: * all patients with ptc and eh regardless of hypertension severity exclusion criteria: * patients who were using medications that secondarily increase blood pressure levels were excluded * did not agree to participate
characterization of clonal b cell populations in hcv infection

Conditions: Hepatitis C

Summary: the purpose of this study is to investigate the mechanism of autoantibody production during chronic hepatitis c virus (hcv) infection. 10-50% of individuals with hcv have symptoms of mixed cryoglobulinemia (mc). by studying the b cells from hcv-infected individuals with and without mc, as well as from healthy controls, we hope to gain insight into the mechanisms of autoantibody production and develop new strategies for treatment of mc.

hepatitis c virus (hcv) infects approximately 170 million people worldwide. about 10-50% of persons with hcv have mc. mc is associated with the development of autoimmune symptoms and b cell proliferative disorders. we plan to study b cells from individuals chronically infected with hcv as well as from healthy controls. we sort b cells into different types, and we analyze these types for differential levels of gene expression. we are testing the hypothesis that certain types of b cells from subjects with mc have increased expression of genes that allow for increased cell survival. people interested in participating in this study will have a complete history and general medical examinations before beginning the study. following the screening, you will have a procedure called leukapheresis, in which white blood cells are removed, but your own red blood cells are returned. the procedure takes approximately 3 hours and is similar to blood donation. the leukapheresis is done during a same day admission to the hospital by an outside blood collection company with trained nurses and certified equipment. some aspects of this study are experimental which means the fluid and cells collected will be studied and analyzed to determine more precisely how your body's immune system is responding to the virus. these tests are experimental in that they are not part of the usual routine care of patients.

Eligibility criteria:
inclusion criteria: * at least 18 years of age. * ability to give informed consent. * wbc greater than 3,000/mm3. * platelets greater than 80,000/mm3. * hb at least 9.5 g/dl. * inr less than 1.5. * biologic therapy: greater than 6 months post-rituximab therapy. * greater than 6 months post ifn- alpha and ribavirin therapy. exclusion criteria: * decompensated cirrhosis. * serious uncontrolled medical illness. * receipt of immune modulators or suppressors within 30 days prior to study entry, including, but not limited to, interferons and thalidomide. * psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements. * alcohol or drug use or dependence that, in the opinion of the investigator,would interfere with adherence to study requirements.
two way bioequivalence study under fed conditions

Conditions: Healthy

Summary: the purpose of this study is to assess the single dose bioequivalence of ondansetron odfs 8mg with zofran odt® (containing ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions. the purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

an open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron orally dissolving filmstrip (odfs) 8mg with zofran orally disintegrating tablets \[odt® (containing ondansetron 8 mg)\] in 48 healthy, adult, human study participants under fed conditions. volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. study participants were fasted for 10 hours prior to dosing in both periods. dosing was conducted as per the randomization schedule in each period under fed conditions.a washout period of 7 days was observed between the two periods.

Eligibility criteria:
inclusion criteria: * provide written informed consent. * healthy adult within 18-45 years of age (inclusive). * body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg. * systolic blood pressure with upper limit of less than 140 mmhg and lower limit of more than or equal to 90 mm hg. * normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1. * normal ecg, chest x-ray and vital signs. * if study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study. exclusion criteria: * the study participants were excluded based on the following criteria: * incapable of understanding the informed consent. * history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug. * evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function * volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma . * smokes regularly more than ten cigarettes daily * taken over the counter or prescribed medications * history of any psychiatric illness, which may impair the ability to provide written, informed consent or full participation. * history of alcohol or substance abuse within the last 5 years. * clinically significant abnormal values of laboratory parameters. * positive urine screen for drugs of abuse at the time of admission check-in for each period.
qudexy xr for the prevention of migraine in children 6 to 11 years old

Conditions: Migraine Disorders

Summary: a phase 4 study to evaluate qudexy xr for the prevention of migraine in children 6 to 11 years of age.


Eligibility criteria:
inclusion criteria: 1. subject is a female or male 6 to 11 years of age, inclusive, at visit 1 (screening) 2. subject weighs at least 17.0 kg and less than 50.0 kg at visit 1 (screening) based on 95 percentile weight for the age range.11 3. subject has at least a 6-month history of headaches consistent with a diagnosis of migraine with or without aura (international classification of headache disorders, 3rd edition \[ichd 3\]). 4. subject had ≥8 self-reported headache days in the 28 days prior to screening. 5. subject has a pedmidas score \>10, indicating at least mild disruption in daily activities, and \<140, indicating extreme disability that may require more comprehensive, multi component therapy. exclusion criteria: 1. subject has continuous migraines, defined as an unrelenting headache for a 28-day period. 2. subject is currently receiving treatment or has used botulinum toxin (botox®) within 3 months prior to visit 1 (screening). 3. subject is currently receiving migraine prevention medication and has initiated or changed the dose within 28 days of screening or is unwilling to avoid making a change during the duration of the study. 4. subject has previously failed an adequate trial of topiramate (at least 3 months duration at a clinically appropriate dose) for prophylaxis of migraine headache due to lack of efficacy or aes. 5. subject has previously failed an adequate trial of \>3 migraine preventative medications. 6. subject has a known history of allergic reaction to topiramate or any excipient in qudexy xr. 7. subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug. 8. subject is currently using an investigational drug or device or has used such within 30 days prior to visit 1. 9. subject has begun menses and any of the following: 1. subject has tested positive for pregnancy; or 2. subject is pregnant, planning pregnancy, or lactating; or 3. subject is taking an oral hormonal contraceptive (either combined \[estrogen and progestogen containing\] or progestogen-only) and is unable or unwilling to switch to an alternative highly effective contraceptive method.
school-based intervention to increase physical activity among adolescent females

Conditions: Cardiovascular Diseases; Obesity

Summary: physical inactivity is a major public health problem in the united states. research has shown that physical activity levels decline during adolescence, and the decline is greater in females than males. the purpose of this study is to evaluate a life-skills oriented physical activity intervention at increasing activity levels and decreasing cardiovascular risk factors in adolescent females.

physical activity levels decline dramatically during adolescence, particularly among females, with the decline most apparent among african americans. the health benefits of regular physical activity are well-known; individuals who are active have lower rates of obesity and less incidence of cardiovascular disease. because physical activity behaviors often develop during childhood, it is important to develop programs specifically for adolescents to encourage them to adopt and maintain a physically active lifestyle. unfortunately, few programs have been developed that specifically focus on adolescents, and the long-term effectiveness of these programs is unknown. this study will evaluate the effectiveness of a life-skills oriented comprehensive physical activity program (cap) at increasing activity levels in adolescents. participants in the cap program will develop new behavioral skills, which will assist them to continue a physically active lifestyle once the program ends. the purpose of this study is to compare cap versus a standard physical education (pe) class at increasing physical activity levels and decreasing cardiovascular risk factors in adolescent african american and caucasian females. this study will enroll 9th grade female students who attend a high school in baltimore, maryland. they will be randomly assigned to participate in either a standard pe class or cap. participants in the cap program will also receive support from a family member to ensure that they receive encouragement for engaging in exercise. baseline assessments will include physical activity level; cardiorespiratory fitness; cardiovascular risk factors, including blood pressure, lipoproteins, and body mass index (bmi); and psychosocial factors. participants will attend follow-up visits at the end of each school year in the 9th, 10th, and 11th grades.

Eligibility criteria:
inclusion criteria: * enrolled in 9th grade at the participating high school in baltimore, maryland exclusion criteria: * has a chronic medical disorder * currently taking medications that affect the cardiovascular or metabolic systems (e.g., beta adrenergic blockers) * excused from the state of maryland's pe requirement * planning on leaving the area prior to the end of the study * has a sibling enrolled in the study * pregnant or breast-feeding

Keywords: physical inactivity
relationship between hamstring length and gluteus maximums in mechanical low back pain

Conditions: Mechanical Low Back Pain

Summary: the aim of this study was to determine the correlation between hamstring length and gluteus maximus strength with and without normalization in patients with mechanical low back pain

seventy-three patients diagnosed as mechanical low back pain. firstly, gluteus maximus (gm) strength was measured isometrically as a force (kg) and then converted to torque (nm). gm strength was normalized for body weight and height using the following formula: % (body weight × h) = torque (n × m) ×100 / body weight (n) × h (m), then assessment of hamstring length flexibility using the active knee extension method. data was collected and the correlation was determined.

Eligibility criteria:
inclusion criteria: * patients diagnosed as mechanical low back pain (mlbp) with very high grade mechanical inflammatory low back pain (mil) index. * age ranged from 18 to 40 years. * body mass index ranged from 25 to 30 kg/m2 exclusion criteria: * history of previous fractures, surgeries, malignancies, trauma, rheumatoid arthritis, spondylosis, and spondylolisthesis. * history of lower limb injuries in the last six months before the study. * inability to correctly produce maximal gluteus maximus contraction in a pain-free rom.
an exploratory study of telaprevir in treatment-naive participants with chronic genotype 4 hepatitis c virus infection

Conditions: Hepatitis C

Summary: the purpose of this study is to evaluate the activity and safety of telaprevir on hepatitis c virus (hcv) genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.

this is a phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on hcv early viral kinetics in treatment-naive participants who are chronically infected with hcv genotype 4. the study consists of 4 parts: screening period (6-week); investigational treatment period (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo); standard treatment period (consists of 46 or 48-week standard treatment); and follow-up period (24-week). the activity of telaprevir will be evaluated by early viral kinetic parameters along with viral response and pharmacokinetic assessments during the investigational treatment phase. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: - participant has chronic genotype 4 hepatitis c infection * plasma hepatitis c virus (hcv) ribonucleic acid (rna) level greater than 10,000 international unit per milliliter (iu/ml) at screening * participant never received treatment for hcv * participant was to be in good health (besides hcv infection), in the opinion of the investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram \[ecg\]), with any chronic medical conditions under stable medical control * participant had to be willing to refrain from the concomitant use of any medications or substances exclusion criteria: - participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with study procedures * participant has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection * female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding * participant has hypersensitivity to tartrazine * participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months

Keywords: hepatitis c telaprevir pegylated-interferon-alfa-2a pegasys ribavirin copegus