Kornimate/medical-research-clean huggingface dataset:
study of tranilast alone or in combination with febuxostat in patients with hyperuricemia

Conditions: Gout; Hyperuricemia

Summary: this is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (pk) and pharmacodynamics (pd) and to evaluate the effect of febuxostat on tranilast pk and pd as measured by reduction in serum uric acid levels.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 70 * subjects with hyperuricemia who are otherwise healthy exclusion criteria: * pregnant or nursing * known history of gout * clinically significant infection at screening * known sensitivity to tranilast or febuxostat

Keywords: gout hyperuricemia
the effect of alpha-lactalbumin on microbiota composition

Conditions: Alpha-lactalbumin; Microbiota; Dysbiosis

Summary: to evaluate the effects on microbiota composition after the administration of an oral supplementation based on alpha-lactalbumin in subjects with dysbiosis.


Eligibility criteria:
inclusion criteria: * condition of dysbiosis exclusion criteria: * antibiotic treatment within 1 month * probiotic or prebiotic treatments * concomitant inflammatory intestinal diseases * pregnancy * neoplastic diseases * allergy to milk protein (alpha-lactalbumin) * substance abuse
french registry of acute coronary syndrome with or without st elevation 2010

Conditions: Myocardial Infarction; Acute Coronary Syndrome

Summary: the observatory fast mi 2010 proposes to establish a cohort of 3500 patients recruited prospectively over a period of 2 months. patients will be followed up at 1 month and then followed annually for 10 years. patients should have agreed to participate in the study, participation in the protocol, or refusal to participate will not affect the therapeutic approach of the physician. the study of genotypic or phenotypic characteristics will not change the therapeutic approach of health care teams.

this is a multicenter observational study, given to 300 prospective medical facilities, chu, chg, chr, health facility of the army, including a clinic or intensive care unit entitled to receive emergency acs. (see attached list 10-6) a questionnaire will be sent to each center before the recruitment center on the type and number of beds (appendix 10-5) patients will be recruited consecutively in the ciau member during a period of 2 months. the 1-month follow-up will be done by the referring physician of each isb, by mail or telephone contact with the treating physician and / or patient. annual follow-ups will be conducted during 10 years of clinical research technicians of the french society of cardiology, mail and / or telephone contact with the municipalities of birth, treating physicians and patients.

Eligibility criteria:
inclusion criteria : * patients over 18 years old * admitted patient for a myocardial infarction (mi) of less than 48 hours, characterized by the typical rise and fall of troponin or cpkmb associated with at least one of the following: symptoms of myocardial ischemia or appearance of pathological q waves or repolarization disorders related to ischemia (in addition to or nstemi) * patient who consented to participate in the study exclusion criteria: * refusal of consent * mi occurring within 48 h after a therapeutic intervention (angioplasty or coronary bypass or other surgery) * diagnosis of sca reversed in favor of an alternative diagnosis
fermented soybean supplementation among active pulmonary tuberculosis patients with standard therapy in indonesia

Conditions: Pulmonary Tuberculosis; Body Weight Changes; Motor Activity

Summary: tuberculosis (tb) patients often have a lower body mass index (bmi) and experience wasting. wasting reduces lean body mass and may cause physical function impairment. this study aimed to determine the efficacy of fermented soybeans (tempeh) as a food supplement on body weight and physical function changes among active pulmonary tuberculosis patients with standard therapy.

this study was carried out at the outpatient department building, lung hospital surabaya, indonesia. as a national health referral system in tb program, the hospital was related to four local sub district health centers that were involved in the recruitment of participants in the study. patients with newly diagnosed pulmonary tuberculosis were randomly assigned into two groups, namely intervention group, which consisted of 65 participants and control group which had 64 participants. randomization was carried out using sealed, unmarked opaque envelopes that are allocated to participants in this study. a minimum sample size of per group (n=64) was determined by windows version g\*power 3.1.5 software to identify a mean difference in body weight change of ≥1.1 kg between intervention and control groups. the intervention group obtained the standard therapy of tb and an additional 166.5 grams of boiled tempeh daily for two months. the control group obtained only standard tb therapy. patients in the intervention group were instructed to divide one cake tempeh into three pieces and eat them three times in a day. consumption frequencies of supplements were recorded in a logbook by an enumerator during random visits once a week. one of the patient family members was asked to help to supervise compliance. the participants were assessed before and after the intervention period for both groups. body weight of the participants was evaluated by measuring the change in body weight. the change of physical function was assessed by handgrip strength using a digital dynamometer and 6-minute walk test (6mwt). protein and caloric intakes were estimated twice, measured during the first and second months using 24-hour dietary recall method during the intervention period.

Eligibility criteria:
inclusion criteria: * newly diagnosed adult male and female tb active patients * having clinical evidences of active tb symptoms * positive or negative sputum smears * having positive chest x-ray that compatible with a diagnosis of tuberculosis * no history of previous anti tuberculosis treatment * give a written informed consent and basic contact data exclusion criteria: * heavy smoker (\> 20 cigarettes per day) * pregnancy and lactation * extra pulmonary tb * known allergy to soybean * having clinical evidences of any underlying disease

Keywords: tempeh body weight handgrip strength 6mwt supplementation wasting
anchoring patients pain scores in the emergency department

Conditions: Abdominal Pain; Chest Pain; Headache; Joint Pain; Muscle Pain; Back Pain; Neck Pain

Summary: the proposed research will be a prospective, observational study to test the hypothesis that anchoring will affect verbal pain scores in the emergency department. there will be a small retrospective aspect to this study to obtain patient satisfaction ratings.

the investigators will evaluate a convenience sample of patients presenting to the ed with a complaint of pain. patients will be consented for participation and will fill out a brief survey concerning the current visit in the ed. there will be two forms of the survey. participants will be randomly assigned to one of the two survey forms. participants will first be asked if their pain score for this visit is greater than or less than an anchor number provided. in this survey, the investigators will use 20 and 80 as our anchoring numbers. the participants will then have a follow up question asking them to estimate their pain score on a 0-100 scale. investigators will then perform a chart review to determine patient satisfaction scores for that specific visit to determine if the anchoring effect has any input on patient satisfaction scores.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * presenting to the ed with a chief complaint of any type of pain exclusion criteria: * under 18 years of age * refusal to consent * incarcerated patients * pregnant patients * unable to complete survey secondary to clinical instability, severe pain, or disorientation determined by a study physician

Keywords: emergency room
virtual reality versus balance beam on spastic hemiplegic cerebral palsy

Conditions: Balance Problems in Spastic Hemiplegic Children; Walking Performance in Spastic Hemiplegic Children

Summary: is there any difference between the use of virtual reality and balance beam on walking performance in children with spastic hemiplegic children?

to compare the effect of virtual reality and the traditional physical therapy program based on neurodevelopmental technique with spastic hemiplegic children. to compare the effect of balance beam and the traditional physical therapy program based on neurodevelopmental technique with spastic hemiplegic children. to compare the effect of virtual reality and balance beam on walking performance in children with spastic hemiplegic children.

Eligibility criteria:
inclusion criteria: * age ranges from 7 to 11 years old, from both genders. * modified ashworth scale adopted from, (bohannon and smith,1987) was used to select the patients with grade 1 and 1+ of spasticity. * they were able to stand and walk. * gross motor function measure scale gmfm (level i \&ii). (russell et al. ,2013). * children with good mentality to understand the evaluation steps. exclusion criteria: * children who have orthopedic surgery or botulinum toxin-a injection in the last 6 months. * children who have any spinal deformities. * children with severe muscle contracture.
immobilization in external rotation after first time anterior shoulder dislocation

Conditions: Shoulder Dislocation

Summary: comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.

the purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.

Eligibility criteria:
inclusion criteria: * 14 to 30 years of age * willing to participate in follow-up for at least two years * acute, first-time, traumatic, isolated anterior dislocation of the shoulder exclusion criteria: * previous instability of the affected shoulder * a history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder * inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments * incompetent or unwilling to consent * a medical condition making the patient unable to wear a sling * significant associated fracture (exception hill sachs of \>20% or bony bankart lesions\>10%) * neurovascular compromise of the affected limb * concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
study of nnz-2566 in patients with traumatic brain injury

Conditions: Brain Injuries

Summary: the purpose of this study is to determine whether nnz-2566 is safe and effective in the treatment of traumatic brain injury (tbi).

moderate to severe traumatic brain injury frequently results in persistent problems with memory, attention span, mood and more complex brain functioning such as planning and organizing. there are currently no drugs available to reduce the brain damage or the persisting symptoms that result from tbi. the longer term goal of this study is to provide physicians with a safe and effective treatment for tbi.

Eligibility criteria:
inclusion criteria: * non-penetrating tbi. * male. * age 18-70 years. * admission to hospital. * post resuscitation gcs 4-12. * have at least one reactive pupil. * randomization within 7 hours of injury with the ability to receive investigational product within 8 hours of injury. * hemodynamically stable after resuscitation (systolic blood pressure (sbp) \>100 mm hg). * willing to undergo all neuropsychological and activities of daily living (adl) testing (i.e. understand english, able to read, write, have sufficient motor dexterity and, be available for follow-up visits at 4-6 weeks and 12-14 weeks post injury). exclusion criteria: * penetrating brain injury. * spinal cord injury. * presence or known history of prior cerebral injury requiring hospitalization that would, in the opinion of the investigator, interfere with or bias the assessment of efficacy. * non-traumatic brain injury. * known history of any medical or psychiatric disorder, or any severe concomitant disease, that in the opinion of the investigator would interfere with or bias the assessment of efficacy. this includes the following: schizophrenia; bipolar disorder; major depressive disorder; post traumatic stress disorder (ptsd); generalized anxiety disorder; attention deficit hyperactivity disorder; neurodegenerative diseases (alzheimer's, parkinson's, huntington's disease, vascular dementia, diffuse lewy body disease); stroke; brain tumor; multiple sclerosis (ms); seizure disorders; chronic pain disorder; alcoholism or substance abuse. * significant non-central nervous system (cns) injuries sustained at the time of the tbi that in the opinion of the investigator would interfere with or bias the assessment of efficacy. * weight \>150 kg. * participation in another clinical trial within the previous 4 weeks. * clinical state requiring greater than 6 l colloid or crystalloid fluid resuscitation prior to randomization. * inability to obtain informed consent from legally acceptable representative. * prior enrollment in this study. * qtc exclusions. the study will use the exclusion criteria as defined in ich guideline e14 to exclude patients with a risk of qt/qtc prolongation, as follows: * a marked baseline prolongation of corrected qt/qtc interval \>450 ms. * history of risk factors for torsade de pointes (e.g. heart failure, hypokalemia (serum potassium at screening (\<3.0 mmol/l)or family history of long qt syndrome).
cards is designed to show if lowering cholesterol with atorvastatin in type 2 diabetics without cv disease reduces the risk of cv events

Conditions: Major Coronary Event; Cerebrovascular Accident; Coronary Artery Bypass Graft; Angina, Unstable; Revascularization

Summary: a study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (niddm) who have a history of either hypertension, retinopathy, microalbuminuria, macroalbuminuria, or who currently smoke, but who do not have established corornary heart disease or other macrovascular disease.


Eligibility criteria:
inclusion criteria: patients must have a documented history of at least one of the following: * hypertension (defined as systolic blood pressure 140 mmhg or a diastolic blood pressure 90 mmhg (defined as the disapperance of all sound \[korotkoff phase v\] or receiving anti-hypertensive treatment. blood pressure should be measured after sitting the patient quietly for 3 minutes). * retinopathy (defined as any of the following; non-proliferative retinopathy, pre-pre-proliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease or history of photocoagulation). * microalbuminuria (defined as either, albumin creatinine ratio \> than = to 2.5 mg/mmol, or albumin excretion rate on a timed collection \> than = to 20 mcg/min (\> than = to 30 mg/24hrs) on two successive occasions, or a positive micral or other strip test). * macroalbuminuria (defined as either; albustix or other dipstick evidence of gross proteinuria, albumin creatinine ratio \> than = to 25 mg/mmol; or albumin excretion rate on a timed collection \> than = 200 mcg/min (\> than = 300 mg/24hrs) on two sucessive occasions). * current smoker exclusion criteria: * type i diabetes mellitus * any major coronary event prior to entry into the study
study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of cyh33 in patients with pik3ca-related overgrowth spectrum (pros) and pik3ca-related vascular malformations (prvm)

Conditions: PIK3CA-Related Overgrowth Spectrum (PROS); PIK3CA-related Vascular Malformations (PRVM)

Summary: this study is a multi-center, open-label, single arm, phase i/ii study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of cyh33 in patients with pik3ca-related overgrowth spectrum (pros) and pik3ca-related vascular malformations (prvm)


Eligibility criteria:
inclusion criteria: * the patient or the patient's guardian (if applicable) voluntarily signs the informed consent form. * at the time of signing the informed consent, the age of adult patients should be ≥ 18 years, and the age of adolescent patients should be ≥ 12 years and \< 18 years of age. * patient diagnosed with pik3ca-related overgrowth spectrum (pros) or pik3ca-related vascular malformation (prvm). * patients should be tested to have adequate organ and bone marrow function, within 28 days of the screening period. exclusion criteria: * patients who have received any prior treatment with pi3k or akt inhibitors. * received a blood transfusion or platelet transfusion within 2 weeks prior to the administration of the investigational drug. * patients with clinically significant cardiovascular disease.
come as you are - assessing the efficacy of a nurse case management hiv prevention and care intervention among homeless youth

Conditions: Behavior, Risk

Summary: the purpose of this study is to to determine the efficacy of the nurse case management hiv (ncm4hiv) intervention on hiv prevention compared to usual care among youth experiencing homelessness (yeh).


Eligibility criteria:
inclusion criteria * youth engaged in high-risk sexual activity or intravenous drug use * speak english * homeless * not planning to move out of the metro area during the study exclusion criteria: * youth with very low literacy * severe acute mental symptoms

Keywords: hiv prevention homeless
characteristics of hospitalized patients with community-acquired pneumonia

Conditions: Community-acquired Pneumonia

Summary: at present, the epidemiological characteristics and the distribution of pathogens of community-acquired pneumonia in shandong province are not clear. in order to understand the characteristics of community-acquired pneumonia, the distribution of pathogens and the risk factors of complications in shandong province, it is necessary to carry out investigation and study, which will provide the basis and support for the future prospective cohort study of pulmonary infection.


Eligibility criteria:
inclusion criteria: * age \> 14 years. * in the community. * chest x-ray showed patchy, patchy infiltrative shadows or interstitial changes with or without pleural effusion (in or out of hospital) . * pneumonia-related clinical manifestations: 1) recent cough, expectoration or respiratory disease symptoms aggravated, and the emergence of purulent sputum, with or without chest pain. 2) fever: armpit temperature ≥37.3℃ or hypothermia: armpit temperature \ 10 × 10\^9/l or \< 4 × 10\^9/l with or without left shift of nucleus. comply with 1,2,3 above plus any one of 4 above. exclusion criteria: * the patients were initially diagnosed with pulmonary neoplasms, tuberculosis, non-infectious interstitial disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil granulocyte infiltration and pulmonary vasculitis. * human immunodeficiency virus. * the patient was readmitted within 72 hours of discharge and was classified as a single hospitalization.
predictors of postoperative pain

Conditions: Postoperative Pain

Summary: the purpose of the study is to prove that pain scores generated from painful stimuli applied preoperatively may help identify the inter-individual variability in pain perception.

psychological factors and experimental pain models such as as electrical, pressure, heat, or cold stimuli have been identified as predictors of pain intensity and opioid consumption postoperatively. this study will investigate, in addition to the factors described above, the ability of pain scores generated from painful stimuli postoperatively in predicting postoperative pain.

Eligibility criteria:
inclusion criteria: * patients undergoing abdominal hysterectomy through a pfannenstiel incision * american society of anesthesiologists (asa)class i-iii exclusion criteria: * patients with a history of psychiatric disease * diabetic or alcoholic patients who may have impaired sensation due peripheral neuropathies * chronic opioid or nonsteroidal antiinflammatory drug use * chronic pain conditions

Keywords: pain quantitative sensory testing
a study of aln-hbv in healthy adult volunteers and non-cirrhotic patients with chronic hepatitis b virus (hbv) infection

Conditions: Hepatitis B; Chronic Hepatitis B; Hepatitis B, Chronic; Hepatitis B Infection; HBV

Summary: the purpose of this study is to determine the safety, tolerability and pharmacokinetics of aln-hbv in healthy adult volunteers and patients with chronic hepatitis b virus (hbv) infection. in addition, the study will assess antiviral efficacy of aln-hbv in patients with hbv.

the study has 3 parts. part a is a single ascending dose (sad) study in healthy volunteers. part b is a single ascending dose study (sad) in patients with hbv infection. part c is a multiple ascending dose study (mad) in patients with hbv infection.

Eligibility criteria:
inclusion criteria: all subjects: * 18 to 65 years inclusive * women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception * agrees not to donate blood during the duration of the study * willing to comply with the study requirements and to provide written informed consent additional inclusion criteria for patients with hbv infection: * body mass index (bmi) ≥18.0 kg/m2 * must be on a stable regimen of entecavir or tenofovir exclusion criteria: all subjects: * any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk * subjects with a history of serious mental illness * active infection with human immunodeficiency virus (hiv) infection, hepatitis a virus (hav), or hepatitis c virus (hcv) infection and/or a history of delta virus hepatitis * known hypersensitivity or contraindication to any medication or history of allergic reaction to an oligonucleotide or n-acetylgalactosamine (galnac) additional exclusion criteria for healthy volunteers: * evidence of liver disease

Keywords: rnai therapeutic hepatitis b chronic hepatitis b hepatitis b, chronic hepatitis b infection hbv