Kornimate/medical-research-clean huggingface dataset:
long term effects of nutritional supplementation on final height

Conditions: Growth Disorders; Low Weight; Short Stature

Summary: the proposed study is an extension study to two ongoing double blind, randomized, placebo-controlled studies evaluating the effect of gender-specific nutritional supplementation on growth of short and lean adolescent boys and girls. the aim of the current study is to extend these short term double blind, randomized, placebo controlled studies (one in boys and one in girls) and to add an extension study, which will evaluate the long term effect of the gender specific nutritional supplementation on final height. patients completing the ongoing studies will be offered to continue treatment with the study formula until final height. patients reluctant to continue to consume the study formula will be offered to continue followup only during the extension study without any intervention.


Eligibility criteria:
inclusion criteria: * participation in the former double blind, randomized, placebo controlled study to evaluate the effect of nutritional supplementation on growth of short and lean adolescent boys (protocol no. 0676-14) and girls (protocol no. 0002-15). * completing at least the double blind phase of the previous studies (protocol no 0676- 14 or 0002-15) * signing informed consent forme exclusion criteria: * diagnosis of growth hormone deficiency or treatment with growth hormone * any known chronic disease or dysmorphic syndrome including: bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems * any known gastrointestinal disease including malabsorption * any known organic reason for growth retardation * any chronic treatment with medication that might affect appetite, weight or growth
preanesthetic analgesia/nociception index (ani) and propofol injection pain

Conditions: Pain, Acute; Analgesia; Nociceptive Pain

Summary: recently, analgesia nociception index (ani) has been evaluated for objectively measuring peri-operative pain and to guide intra-operative opioid administration during various surgeries. propofol injection pain (pip) is a common problem and can be very distressing to the patient.

this study aimed to the association of preanesthetic ani scores and pip in patients who scheduled for general anesthesia. before propofol administration in remifentanil group, preanesthetic ani values (instant and mean) were checked after remifentanil to a target ce of 4 ng/ml. control group received the same volume of saline as remifentanil group. heart rate and bispectral index were checked as ani. point biserial correlation and roc curve were analyzed.

Eligibility criteria:
inclusion criteria: * male patients who scheduled for general anesthesia * cognitive patients who could understand this study exclusion criteria: * patients receiving β-receptor blockers, ketamine, clonidine, or any vasoactive substance (i.e. metaraminol, ephedrine) and patients receiving neostigmine, atropine or glycopyrrolate.
safety study of melatonin in stroke patients

Conditions: Acute Ischemic Stroke

Summary: the purpose of the study is to evaluate the effect of melatonin (in a dosage of 14mg daily) for a better clinical outcome in the period three days post stroke.

stroke is the third most common cause of stroke. the cascade of event is separated into hyperacute,,acute,sub-acute and chronic. in the acute, sub acute state there are mechanisms of inflammation apoptotic death and effect of free radicals. melatonin was proved to effect these mechanisms and to have a favourable effect in different diseases. the aim of the study is to prove that the use of melatonin in a higher dosage may have a anti-destructive effect in stoke.

Eligibility criteria:
inclusion criteria: * within 72hours of ischemic stroke * age 18-80 * both gender * ability to sign consent form exclusion criteria: * intra-cerebral bleeding * tumour of brain * multiple sclerosis * s/p craniotomy * known allergy to melatonin
trial of a physical activity intervention for ra fatigue

Conditions: Rheumatoid Arthritis

Summary: the major goal of this project is to conduct a randomized, controlled trial of the impact of a practical, low cost physical activity intervention on fatigue among persons with rheumatoid arthritis (ra). fatigue has been identified as a major concern for individuals with ra, and is considered a core outcome measure for ra. our recent study of the sources of fatigue identified physical inactivity as a primary predictor of fatigue. studies have examined the impact of exercise interventions on ra outcomes, but most of these interventions have focused on pain or function as outcomes. the few exercise studies examining fatigue suggest that increasing physical activity reduces fatigue, but the interventions have been resource-intensive, requiring specially trained personnel to administer them, highly structured activities, and/or attendance at classes or a specified facility. each of these components increases the cost and barriers to implementation of an intervention. pedometers have been shown to be an effective means of increasing physical activity, and could form the basis of a simple means to increase physical activity. this project will test the effect of a simple pedometer-based intervention, with two incremental degrees of guidance, on increasing physical activity and decreasing fatigue. three groups (n=40 in each) will be studied: a control group with an educational pamphlet only, a pedometer-only intervention group, and a pedometer group with step targets. both intervention groups will keep step-count diaries. groups will be followed over 20 weeks. we expect that (1) the pedometer-only intervention group will increase activity more than the education group, and the group with step-count targets will demonstrate even greater increases in activity; and (2) greater increases in activity will be associated with greater decreases in fatigue. secondary outcome measures will include depressive symptoms, self-reported sleep quality, and body composition. our overall goal is to demonstrate an effective, yet simple and low cost, physical activity intervention to decrease fatigue that could be broadly accessible and have the potential for wide implementation.


Eligibility criteria:
inclusion criteria: * physicians' diagnosis of ra * english verbal fluency * residence in the greater san francisco bay area * score ≥20 on 10-item promis fatigue scale, or at least one item rated "often" * bmi ≥ 20 kg/m2 exclusion criteria: * currently engaging in regular exercise * non-ambulatory or presence of a condition or comorbid disease that would limit the ability to engage in walking (e.g., foot deformities, lower extremity joint surgery upcoming or in past 6 months, myocardial infarction in past 6 months, stroke, congestive heart failure, severe chronic obstructive pulmonary disease).

Keywords: rheumatoid arthritis fatigue physical activity
a community-university approach to preventing hiv

Conditions: HIV/AIDS and Infections; Drug Abuse; Adolescent Behavior; Drug Usage; Alcohol Use; Mental Health; Tobacco Use; HIV Testing

Summary: examine the feasibility and acceptability of delivering the s4e intervention to 20 african-american youths between the ages 16-21 in flint, michigan. the investigators will examine the preliminary efficacy of the s4e intervention in improving the uptake of hiv self-testing immediately post-intervention.

hiv is a significant public health concern in the us, and african american youth (defined as the adolescent and young adults 16-21 years of age) are disproportionately affected. furthermore, hiv risk behaviors, including substance use and sexual risk behaviors are prominent. despite the disproportionately high rates of hiv infection and risk behaviors in youth, few youth report having ever been tested for hiv and many are not routinely screened for asymptomatic stis as recommended by the center for disease control. to address these significant public health concerns, a mobile-health (mhealth) intervention, storytelling 4 empowerment (s4e) was developed for health clinic settings. s4e has demonstrated high feasibility, acceptability, and preliminary efficacy among youth in clinic settings. the proposed research will determine the feasibility and acceptability of delivering s4e via near peers, as well as determine the preliminary efficacy of s4e to improve hiv self-testing immediately post-intervention in a community sample (n=20) of at-risk youth ages 16-21 living in flint, michigan by conducting a phase i, one-arm pilot study to examine the feasibility and preliminary efficacy of s4e in improving the uptake of hiv self-testing immediately post-intervention. a university-community approach was taken to employ principles of community based participatory research (cbpr) to determine the accessibility and acceptability of s4e when delivered by near peers.

Eligibility criteria:
inclusion criteria: * 16-21 years of age * sexually active * african american * live in flint michigan exclusion criteria: * report of prior psychiatric hospitalization by adolescent * visible cognitive impairment due to drug use

Keywords: mhealth prevention intervention primary health care
safety and tolerability of combined treatment with nilotinib and ruxolitinib in cml and ph+ all patients

Conditions: Chronic Myeloid Leukemia

Summary: in this study it was the rationale to evaluate the safety and tolerability of the combined administration of nilotinib and increasing dose of ruxolitinib in patients with chronic myeloid leukemia and patients with philadelphia positive acute lymphoblastic leukemia.


Eligibility criteria:
inclusion criteria: patients of the first stratum must have chronic myeloid leukemia receiving nilotinib first-line therapy or receiving second-line or subsequent-line treatment with nilotinib. patients of the second stratum must have cml in ap/bc or relapsed/refractory ph+ all, or be ph+ all patients with mrd with or without prior nilotinib pretreatment; patients must have adequate end organ function, as defined by: * creatinine \< 2.0 x upper limit of normal (uln) * total bilirubin \< 1.5 x uln (\< 3.0 x uln if related to disease or polymorphism, such as mb. gilbert) * alt and ast \< 2.5 x uln (\< 5.0 x uln if related to disease) * serum lipase ≤ 1.5 x uln * alkaline phosphatase ≤ 2.5 x uln (\< 5.0 x uln if related to disease); patients must have the following electrolyte values within normal limits or corrected to within normal limits with supplements prior to the first dose of study medication: * potassium * magnesium * phosphate * total calcium (corrected for serum albumin); female patients of childbearing potential (wocbp) must have a negative serum pregnancy test within 7 days before initiation of study drug. all wocbp must use highly effective contraceptive methods throughout and during 3 months after study; patient has an eastern cooperative oncology group (ecog) performance status of ≤ 1 for patients in cp, ≤ 2 for patients in ap/bc or with relapsed/refractory ph+ all or with ph+ all with mrd; patient has the following laboratory values within 7 days of starting study drug: - for cml and ph+ all patients: platelet count \> 75 x 109/l and anc \> 1.0 x 109/l exclusion criteria: patient must not have evidence of active malignancy other than the existing cml or all patient must not receive drugs that interfere with coagulation or inhibits platelet function, with the exception of aspirin ≤ 150 mg per day or low molecular weight heparin. patient must not have history of platelet dysfunction, bleeding diathesis, and/or coagulopathy in the 6 months prior to screening; patient must not require treatment with any strong cyp3a4 inducer or inhibitor patient must not have history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes and their excipients; patients must not take other investigational drugs within 28 days prior to screening; patient must not be pregnant or lactating at screening and/or baseline; patient must not have impaired cardiac functions other protocol-defined inclusion/exclusion criteria may apply

Keywords: cml, ph+ all
effect of remote ischemic conditioning on vascular health in stroke patients

Conditions: Stroke, Lacunar

Summary: the main aim of the current study is to assess cardiovascular effects of remote ischemic conditioning in patients who have suffered from stroke. a group of stroke patients will be subjected to four weeks of daily remote ischemic conditioning and four weeks of placebo and vascular function is assessed as a primary outcome.

remote ischemic preconditioning (ric) has been shown to reduce myocardial damage in association with a myocardial infarct but less is known about the potential effects on vascular function in patients who have suffered a stroke. ric is a procedure by which blood flow to a limb is repeatedly occluded during a short period by an inflatable cuff. this project evaluates the effect of a two week period with ric on vascular function and cerebral blood flow velocity as well as on factors associated with blood clot formation in patients who have suffered a stroke. the study also aims to provide mechanistic insight into the beneficial effects of the ric procedure. subjects are patients who within the past five years have suffered from lacunar infarct. the study is of a cross-over design with two weeks of homebased ric treatment and two weeks of control period in a randomized order. before and after the experimental periods the subjects undergo a number of tests assessing general health status, vascular function and cerebral blood flow velocity. skeletal muscle samples are obtained for the determination of selected proteins related to vascular function and angiogenesis and blood samples are obtained for the determination of platelet function. .

Eligibility criteria:
inclusion criteria: * clinical symptoms and corresponding computer tomographytomography/magnetic resonance (ct/mr)-scanning results for lacunar infarct within past five years. * small vessel disease stroke (lacunar infarct) is defined by the toast criteria exclusion criteria: clinical significant carotid stenosis. cardioembolic stroke * clinically significant chronic diseases other than lacunar infarct and associated factors * current or past smoker within the past ten years * current treatment with beta-blockers, peroral steroids or nsaids * alcohol- or drug-addiction. * pregnant or lactating. * inability to understand the content of the study information provided.
subjective and objective performance of systane complete multi-dose pf versus walgreen's lubricant balance

Conditions: Dry Eye

Summary: single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. subjects will be assessed at a screening visit, and 2 follow-up visits. clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.


Eligibility criteria:
inclusion criteria: subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * subjects who currently have mild to moderate symptoms of dry eye as defined by a screening sande score of 20-55 inclusive (equivalent to osdi score of 12 -32).2 * subjects between the ages of 18-65. * subjects willing to comply with the prescribed regimen and schedule of eye drops. * subjects willing to attend all study visits. * subjects willing to discontinue any current artificial tear use 24 hours prior to the baseline study visit. exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * ocular anterior segment infection, inflammation, abnormality, or active disease. * history of herpetic keratitis or ocular surgery. * recent (within 1 year) thermal meibomian gland expression procedure including lipiflow, ilux, or tearcare. * recent (within 1 year) blepharitis debridement procedure including blephex. * screening sande score \> 55 (equivalent to osdi score of \>32).2 this is indicative of a severe dry eye. * screening sande score \< 20 (equivalent to osdi score of \<12).2 this is indicative of a clinically normal eye. * screening non-invasive tbut \ 10 seconds.3 * screening nafl score \ 10 (severe dry eye).4 * pregnant or lactating. * current use of contact lenses. * any change in eye drop regimen, whether otc or rx in the last 90 days. the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
covid-19: post-covid olfactory disorders assessment

Conditions: Olfaction Disorders

Summary: covid 19 cause an olfactory loss in more than 80% of cases. this loss most often regresses but leaves 20% of patients with an olfactory complaint, particularly with regard to the quality of daily life. the neuro-cognitive implications involved with covid19 and the consequences of persistent olfactory loss remain unknown. the effectiveness of therapeutic management, in particular olfactory re-education, has not yet been clarified. objectives are the assessment of patients olfactory disorders, psychiatrics and neurocognitives specificities after a covid, before and after treatment or specific cares.


Eligibility criteria:
inclusion criteria: * adults patient, * anosmia during a covid19 acute infection (pcr+) and persistant olfactive disoders at least 6 weeks after symptoms disappeared. exclusion criteria: * preexisting smell loss.
a single dose study in japanese and western healthy subjects to investigate the safety, tolerability and pharmacokinetics of pf-04991532

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders

Summary: this study is to investigate the safety, tolerability and pharmacokinetics of single ascending oral doses of pf-04991532 in japanese healthy subjects. the secondary objective is to investigate the pharmacokinetics and safety of single ascending oral doses of pf-04991532 in western healthy subjects and to compare the pharmacokinetics between japanese and western healthy subjects.

safety/tolerability and pharmacokinetics

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non-childbearing potential, between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs). * japanese subjects must have four japanese grandparents who were born in japan. * mean body weight and the body weight range of western subjects must be within ±10% of the japanese subjects. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * screening supine blood pressure \>=140 mm hg (systolic) or \>=90 mm hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest. * any condition possibly affecting drug absorption (eg, gastrectomy). * history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening. * treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. * 12-lead ecg demonstrating qtc \>450 msec or a qrs interval \>120 msec at screening. if qtc exceeds 450 msec, or qrs exceeds 120 msec, the ecg should be repeated two more times and the average of the three qtc or qrs values should be used to determine the subject's eligibility. * pregnant or nursing females or women of childbearing potential.

Keywords: pf-04991532 safety and tolerability pk japanese and western population
comparison of skinlink with suture for ed patients

Conditions: Wounds and Injuries; Lacerations

Summary: the purpose of this study is to determine whether suture using the device of "leukosan skinlink" is more faster and safer than that of "nylon" in the treatment of simple wound for ed patients.


Eligibility criteria:
the inclusion criteria were age 18-75 years,presence of a partial thickness laceration, generally good health without systemic abnormalities,agreement to return for a 14-day follow-up, and written informed consent. the exclusion criteria were previous diagnosis of diabetes mellitus, peripheral vascular disease, or bleeding disorders; history of keloid formation or scar hypertrophy; and allergy to cyanoacrylate compounds or formaldehyde
study of mt1013 injection for the treatment of secondary hyperparathyroidism (shpt) patients with chronic kidney disease undergoing maintenance dialysis

Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis

Summary: this is a multi-center, open, single-arm phase iib clinical study comprising 2 parts, which part a will enroll about 110 subjects, and part b will enroll about 190 subjects to investigate long-term efficacy and safety of mt1013 after treatment.the treatment duration for part a mad study is 52 weeks and the duration for part b study is 26 weeks.


Eligibility criteria:
inclusion criteria: * 1. subject capable of understanding written information ,willing to participate in, and provide a written informed consent; 2.male or female subjects must be at least 18 years old when signing the informed consent; 3.the subjects must undergo maintenance hemodialysis three times a week or five times two weeks for at least three months； 4.dialysate calcium concentration≥1.25 mmol/l (2.5 meq/l); 5.diagnosed of secondary hyperparathyroidism (shpt); exclusion criteria: * 1.primary hyperparathyroidism; 2.refusal to discontinue cinacalcet, etelcalcetide, or other calcimimetics during the study; 3.has used rankl inhibitors such as denosumab within 6 months before screening. 4.diagnosed with gastrointestinal bleeding within 6 months prior to screening; 5.subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmhg and/or diastolic blood pressure\>110 mmhg, despite optimal drug treatment prior to enrollment; 6.the subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy during the study; 7.subjects are allergic or intolerant to any component of the investigational drug； 8.history of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
efficacy of acupuncture for prophylaxis of intrathecal morphine induced pruritis in patients undergoing caesarean delivery

Conditions: Acupuncture; Morphine Induced Pruritis

Summary: intrathecal morphine is commonly used for pain relief in caesarean delivery. side effects such as itch (pruritis) and nausea \& vomiting are common and have been shown to be the most common cause for dissatisfaction. the incidence of pruritis is 74% even with current available medications. acupuncture has been shown to be effective for morphine related side effects but has not been evaluated for prophylaxis of itch in pregnant population. primary objective: acupuncture at li 11 reduces the incidence of pruritis after elective caesarean section under spinal with intrathecal morphine


Eligibility criteria:
inclusion criteria: * asa i \& ii patients undergoing elective caesarean delivery under spinal with intrathecal morphine exclusion criteria: * patient refusal * asa iii \& iv patients * pre-existing pruritis * eczema * bleeding tendencies * known allergy to any of medications used * any contra indication to spinal anaesthesia

Keywords: caesarean delivery pruritis intrathecal morphine acupuncture at li11