Kornimate/medical-research-clean huggingface dataset:
choline supplementation as a neurodevelopmental intervention in fetal alcohol spectrum disorders

Conditions: Fetal Alcohol Spectrum Disorders

Summary: this is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with fetal alcohol spectrum disorders (fasd). the primary outcome measures are cognitive measures.

this project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with fetal alcohol spectrum disorders (fasd). pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). this study will evaluate the effects of daily choline supplementation vs. placebo for 9 months. outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. the study will also continue to collect safety and tolerability data.

Eligibility criteria:
inclusion criteria: 1. ages 2 years to 5 years of age 2. available parent or legal guardian capable of giving informed consent for participation. 3. documented prenatal alcohol exposure (self-report, social service records, or adoption records). 4. modified institute of medicine (iom) criteria for fetal alcohol syndrome (fas), partial fetal alcohol syndrome (pfas), or alcohol-related neurodevelopmental disorder (arnd) (hoyme, may, et al., 2005). exclusion criteria: 1. known history of a neurological condition (ex. epilepsy, traumatic brain injury) 2. known history of a medical condition known to affect brain function. 3. known history of other neurodevelopmental disorder (ex. autism, down syndrome) 4. known history of very low birthweight (\<1500 grams)
extract of ginkgo biloba and tardive dyskinesia

Conditions: Tardive Dyskinesia; Schizophrenia

Summary: the purpose of this study is to determine whether extract of ginkgo biloba is effective in the treatment on tardive dyskinesia

tardive dyskinesia(td) is a common complication of conventional antipsychotic treatment in subjects with schizophrenia. there is no established treatment for td patients.this disorder remains a significant clinical problem for both patients and physicians for the foreseeable future.

Eligibility criteria:
inclusion criteria: * male or female aged 18 to 60yrs * meeting diagnostic and statistical manual of mental diseases, fourth edition(dsm-iv) criteria for schizophrenia or schizo-affective disorder * abnormal involuntary movement scale (aims) score ≥2. * patients from whom informed, written consent is obtained. * patients who have been on a fixed dose of antipsychotic medication for at least 4 weeks prior to trial entry. exclusion criteria: * significant neurological disorder other than td * substance abuse * significant other medical illness * psychiatric disorder not stabilised * pregnancy or lactation * take antioxidants(such as vitamin c)

Keywords: tardive dyskinesia schizophrenia extract of gingko biloba
a study of capecitabine (xeloda) as first-line chemotherapy in participants with metastatic nasopharyngeal cancer

Conditions: Nasopharyngeal Cancer

Summary: this study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (iv) cisplatin in participants with metastatic nasopharyngeal cancer. participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. the anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.


Eligibility criteria:
inclusion criteria: * adults 18 to 75 years of age * histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer with at least 1 measurable lesion which has not been irradiated * ability to swallow and retain oral medication exclusion criteria: * previous cytotoxic chemotherapy except adjuvant, concurrent, or neoadjuvant treatment completed at least 6 months before enrollment * clinically significant cardiac disease * history of other malignancy within the last 5 years except cured basal cell cancer of the skin or cured cancer in situ of the cervix * radiotherapy within 4 weeks of treatment start or any prior radiotherapy performed to the indicator lesion(s) being measured in the study
evaluation of long-term isokinetic training of knee joint

Conditions: Knee Injuries and Disorders

Summary: the goal of this clinical trial is to assess the effectiveness of isokinetic rehabilitation training under optimal stiffness in patients undergoing knee joint rehabilitation. the main questions it aims to answer are: * does isokinetic training under optimal stiffness lead to greater force exertion compared to traditional bodyweight training? * what are the long-term (6-week) effects of isokinetic training under optimal stiffness on joint flexibility and muscle strength? researchers will compare the effects of isokinetic training under optimal stiffness to traditional bodyweight training to see if isokinetic training produces superior improvements in muscle strength, flexibility, and overall functional recovery. participants will: * perform regular training sessions using a portable knee joint isokinetic trainer, customized to their optimal stiffness for maximum force exertion. * engage in a 6-week rehabilitation program, with assessments at the beginning, and end of the study to evaluate changes in muscle strength, and functional recovery.


Eligibility criteria:
inclusion criteria: 1. age between 20-60 years. 2. patients with unilateral anterior cruciate ligament (acl) rupture, with or without meniscus injury. 3. postoperative period of 3-6 months. 4. no restriction in knee extension or flexion movements. exclusion criteria: 1. patients with major diseases or conditions such as coronary heart disease, myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage, or malignant tumors. 2. pregnant or breastfeeding women and other special populations. 3. patients who refuse to sign the informed consent form or are unable to complete the entire study process. 4. patients currently infected with human immunodeficiency virus (hiv), or with a history of infectious hepatitis b or c. 5. patients with concurrent medical issues, including but not limited to: (1) uncontrolled hypertension (systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥95 mmhg), congestive heart failure (new york heart association functional classification of stage iii or iv). (2) patients with mental incapacity or an inability to comprehend the study requirements.
effect of grape juice consumption on the parameters of oxidative stress and muscle fatigue in judo athletes

Conditions: Oxidative Stress; Muscle Fatigue; Polyphenol; Free Radical Oxidation of Tissue

Summary: this project aims to evaluate if after 14 days of grape juice ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in judo fighters. the study will be a randomized, blind, crossover clinical trial of 20 judo athletes. judo wrestling simulations will be performed on 3 different days.

grape juice has a high concentration of phenolic compounds and is capable of modulating biochemical parameters and oxidative stress. by naturally containing carbohydrates grape juice can help acutely minimize fatigue during exercise as well as long-term oxidative stress parameters in athletes. this project aims to evaluate if after 14 days of grape juice ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in judo fighters. the study will be a randomized, blind, crossover clinical trial of 20 judo athletes. judo wrestling simulations will be performed on 3 different days. each exercise session will consist of four 7-minute bouts, with 14-minute rest between them. the athletes will perform a first fight simulation without ingestion of any beverage (control group 1), and then will be randomized to determine the order of participation in the groups: maltodextrin (group 2 placebo) and grape juice (intervention group 3). analyzes of oxidative stress; muscle strength and fatigue; perceived effort rate; lactate; heart rate; analysis of food consumption and body composition.two-way anova will be used to evaluate the relation of the intervention and physical exercise, besides parameters of strength and fatigue. the level of significance adopted will be 5% and for the analysis, the spss summer 23 statistical program will be used.

Eligibility criteria:
inclusion criteria: * judo athletes, federated, who hold state, federal and international competitions of both sexes, aged between 15 and 24 years and any weight category of the sport, except free weight. exclusion criteria: * recent injury (last 3 months) that prevents training or competition; * food restriction on grape juice; * being in the phase of fast weight loss in pre competition..
study of two formulations of cyclosporine ophthalmic emulsion in healthy volunteers and in patients with dry eye

Conditions: Dry Eye Syndromes

Summary: this study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). the parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (restasis®) in patients with dry eye.


Eligibility criteria:
inclusion criteria: parallel-group phase: * weigh at least 110 lbs * 18 to 45 years old paired-eye phase: * dry eye disease in both eyes exclusion criteria: parallel-group phase: * use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study * has donated blood within 90 days * significant weight change (over 10 lbs) within 60 days * previous use of restasis® parallel-group and paired-eye phases: * anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days * consumption of alcohol products within 72 hours paired-eye phase: * previous ocular surgery * use of restasis® within 30 days
post-approval study of the nexstent carotid stent system and the filterwire ez embolic protection system: sonoma

Conditions: Carotid Stenosis

Summary: the primary objective of the sonoma registry is to confirm the safety of the nexstent® carotid stent system and filterwire ez™ embolic protection system in routine clinical practice and to identify rare or unanticipated device-related events that might occur.

the sonoma registry will enroll approximately 300 subjects at a maximum at 78 study centers.

Eligibility criteria:
inclusion criteria: * candidates must be indicated for carotid stent placement as per nexstent carotid stent labeling located in the directions for use (dfu). exclusion criteria: * subjects with contraindications as outlined in the dfu should be excluded from this registry.

Keywords: nexstent filterwire ez boston scientific carotid artery carotid endarterectomy carotid revascularization
fmri of stress and addictive disorders

Conditions: Cocaine Dependence; Opioid Dependence; Alcoholism; Pathological Gamblers; Adolescents

Summary: the purpose of this study is to explore whether frontal brain activation in response to stress varies as a function of the presence or extent of early trauma and whether or not this effect is greater in women compared to men. to examine the effect of stress on thinking and remembering. to examine the separate and interactive effects of stress, addiction, withdrawal, and genetics; and to examine fmri brain activation associated with stressful, reward-related-cue and neutral/relaxing audiotaped scripts,visual images and emotional video clips in addicted individuals and in healthy controls.


Eligibility criteria:
inclusion criteria: * between ages 13-50 years old (adolescents 13-17 years old) * able to read and write. * cocaine dependent subjects: meet dsm-iv criteria for cocaine dependence; report current cocaine use of at least once a week or more; confirmation of cocaine use via positive urine toxicology screen during initial assessments and upon admission to the cnru. * opioid dependent subjects: meet dsm-iv criteria for opiate dependence and are participating in substance abuse treatment including pharmacotherapy for opioid dependence. * alcohol dependent subjects: meet dsm-iv criteria for alcohol dependence and are currently abstinent from alcohol as documented by substance abuse treatment participation. * healthy controls: negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use. * healthy adolescent boys and girls, with no medical or psychiatric conditions; * women: have a regular menstrual cycle. exclusion criteria: * controls: lifetime or current history of any substance abuse/dependence (excluding nicotine). * regular use of any psychoactive drugs including anxiolytics and antidepressants. * any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded. * any subjects with foreign ferromagnetic metal objects in their body or other mr contraindications will be excluded including subjects who work as welders. * women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states). * iq below 75
analysis of muscle oxygen saturation and functional variables during physical capacity assessments in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Muscle Oxygenation; Exercise; Respiratory Physiotherapy

Summary: this experimental pre-post intervention study aims to evaluate the effect of a respiratory physiotherapy and combined strength and cardiovascular training program on muscle oxygen saturation and functional capacity in patients with chronic obstructive pulmonary disease (copd). oxygenation of the intercostal, quadriceps, and triceps surae muscles will be assessed using near-infrared spectroscopy (nirs) during standard physical performance tests (6-minute walk test and 30-second chair stand test). additional functional parameters and quality of life will be recorded pre- and post-intervention. the results will contribute to optimizing rehabilitation programs and monitoring intensity and progress through muscle oxygenation data.

this experimental pre-post study investigates the effects of a combined respiratory physiotherapy and physical training program on muscle oxygen saturation and functional capacity in patients diagnosed with chronic obstructive pulmonary disease (copd). copd is a highly prevalent condition with a progressive impact on functional capacity, muscle performance, and quality of life. it is associated with systemic repercussions, including skeletal muscle dysfunction and oxygen transport limitations, which impair tolerance to physical activity. the study will evaluate the acute and cumulative effects of a structured, supervised intervention including respiratory physiotherapy techniques, cardiovascular training, and progressive resistance training. measurements will be taken before and after the intervention period to assess changes in muscle oxygen saturation-measured using near-infrared spectroscopy (nirs) devices (moxy monitor)-in key muscle groups (intercostal, quadriceps, and triceps surae). functional capacity will be assessed using the 6-minute walk test (6mwt) and the 30-second chair stand test (30cst). additional variables including inspiratory and expiratory pressures, pulmonary function (fev1/fev6), heart rate variability, dyspnea, lower limb fatigue, and quality of life (copd assessment test) will also be recorded. the intervention consists of 20 hospital-based sessions over four weeks (five sessions per week). the protocol is designed to reflect real clinical settings and aims to provide evidence for the feasibility, safety, and functional relevance of combining respiratory and musculoskeletal rehabilitation strategies in copd patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years * clinical diagnosis of copd * medically cleared for physical exercise exclusion criteria: * decompensated heart failure or exercise-limiting comorbidities * cognitive impairment or legal incapacity to consent * inability to perform physical tasks
self-help video for insomnia in college students

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to test the effectiveness of a 1-session abbreviated cognitive-behavior therapy for insomnia among college students. the investigators will examine the following hypotheses in the present study: 1) viewing the treatment video will produce an increment in sleep knowledge relative to baseline and minimum treatment control; and 2) viewing the treatment video will result in improved sleep relative to baseline and minimum treatment control. students who self-identify as having insomnia will be recruited from the university of alabama's psychology subject pool. students who enroll in the study will receive a link to the demographic and screening questionnaire. individuals who have a history of other sleep disorders or who currently present with symptoms strongly suggestive of sleep disorders, such as obstructive sleep apnea or narcolepsy will be excluded. individuals who are shift-workers and those with a history of severe mental illness will also be excluded. participants who meet criteria for this study will then be directed to complete a measure of sleep knowledge. once they have completed the measure of sleep knowledge, they will be directed to complete the consensus sleep diary (csd) for 14 days as soon as possible after awakening in the morning. during the second week of completing the csd, participants will be directed to complete the insomnia severity index and the patient-reported outcomes measurement information system sleep disturbance and sleep-related impairments short forms on the last day they complete a csd. participants will be randomized to a treatment group or a minimum treatment control group upon completion of these baseline measures. those in the treatment group will be emailed the following components of the insomnia treatment: a link to the treatment video, an mp3 file with a relaxation recording, and a pdf file of a brochure reviewing the information presented in the treatment video. participants will be asked to view the treatment video and begin practicing the relaxation technique presented in the mp3 file as soon as possible. participants in the minimum treatment control group will receive a link to a sleep education video. two weeks after participants have viewed the videos, they will be asked to complete post-treatment measures in the same sequence as they did at baseline. one month after the post-treatment measures have been completed, both groups will be asked to complete the same measures again for follow-up.


Eligibility criteria:
inclusion criteria: * must be a student at the university of alabama * must be 18-24 years old * must have a complaint of insomnia exclusion criteria: * history of sleep disorder other than insomnia * symptoms strongly suggestive of sleep disorders other than insomnia * shift-work * history of severe mental illness (e.g., psychotic disorders, bipolar disorder, severe depression, or personality disorders)

Keywords: sleep initiation and maintenance disorders cognitive therapy
acoustic stimulation during restricted sleep after sleep deprivation

Conditions: Sleep Deprivation; Sleep Restriction; Acoustic Stimulation; Performance; Alertness

Summary: the purpose of this study is to determine if brief sounds or tones presented within a restricted period of recovery sleep after a period of sleep deprivation will enhance restorative properties and improve performance during a subsequent period of wakefulness.


Eligibility criteria:
inclusion criteria: * healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive) * must demonstrate adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz. individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. individuals who fail the comprehension assessment for the second time will be disqualified. exclusion criteria: * you must have learned english as your first language * you must have a body mass index (bmi) below 30 (this is a mathematical calculation of your height and weight) * you must not have current or a history of sleeping problems (for example, insomnia or sleep apnea), or symptoms that indicate a potential sleep disorder * you must get an average of 6-9 hours of sleep per night and maintain a normal sleep/wake schedule * you must not drink excessive amounts of caffeine, alcohol, or smoke cigarettes regularly * you must not be on certain medications (determined on a case by case basis) * you must test negative for illicit drugs * women must not be pregnant or nursing * you must not be participating in another ongoing clinical trial * you must have a social security number or tax identification number in order to be paid for screening and participation in the study * you cannot have a history of the following conditions: cardiovascular disease, a neurologic disorder, pulmonary disease requiring inhaler use, kidney disease or kidney abnormalities, liver disease of liver abnormalities, a history of psychiatric disorder requiring hospitalization or medication within the last two years or for a continuous period of more than 6 months in the last ten years
long-term remote ischemic preconditioning improve the prognosis of myocardial infarction patients with emergency reperfusion therapy

Conditions: Myocardial Infarction, Acute

Summary: patients with acute myocardial infarction (ami) are in critical condition. when primary percutaneous coronary intervention (pci) was performing, no-reflow, reperfusion injury，heart failure, heart rupture, malignant arrhythmia maybe happen. it was reported remote ischemic preconditioning (ripc) may play an effective endogenous cardiac protection. this study will investigate whether once ripc before primary pci or long-term ripc can improve ami patients short-term and long-term (1 year) prognosis. 400 stemi patients undergoing primary pci were randomly divided into 3 groups: long-term ripc group (once preoperative ripc and once ripc/day after pci), preoperative ripc group (once preoperative ripc), control group (without ripc). cardiac troponin (tni), high-sensitivity c-reactive protein (hscrp), adenosine, vascular endothelial growth factor (vegf), hypoxia inducible factor-1 (hif-1), echocardiography and magnetic resonance （mr）were detected 1 day, 1 month and 1 year after pci. patients will be followed up by telephone at the end of one year. the major adverse cardiovascular events (mace) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.


Eligibility criteria:
inclusion criteria: * age between 18-80 years; * st segment elevation myocardial infarction (stemi); * plan to primary percutaneous coronary intervention. exclusion criteria: * age more than 80; * renal failure with creatinine \>2 mg/dl; * reject taking part in the study.

Keywords: remote ischemic preconditioning acute myocardial infarction