Kornimate/medical-research-clean huggingface dataset:
backup with combivir or single dose (sd) truvada in order to avoid non-nucleoside reverse transcriptase inhibitor (nnrti) resistance after sd nevirapine for the prevention of mother-to-child transmission (pmtct)

Conditions: HIV Infections

Summary: the aim of the study is to find short course alternatives to single dose (sd)nevirapine for the prevention of mother-to-child hiv-transmission with the same or better degree of transmission protection than sd nevirapine but with less nnrti resistance development.

randomised open study comparing zidovudine from 28 weeks gestation, single dose nevirapine + 1 week of combivir with zidovudine from 28 weeks gestation, single dose nevirapine + single dose of truvada for the mothers during birth. in both arms the infants will receive one dose of nevirapine within the first days after births as well as 7 to 28 days zidovudine. n = 450. the study will be conducted at ngamiani and makorora health centres and bombo regional hospital in tanga, tanzania as a cooperation between rigshospitalet, denmark, university of copenhagen and national institute of medical research, tanzania.

Eligibility criteria:
inclusion criteria: * hiv infected, antiretroviral naive, not fulfilling national tanzanian criteria for haart treatment, giving informed consent, consenting to homevisit-follow-up in case of no-show for scheduled hospital visit. exclusion criteria: * cd4 less than 350 x10(6)/l, suffering from systemic diseases in need of medical treatment e.g. tb, renal or liver failure etc. * creatinin higher than 1,5 mg/dl, alanine aminotransferase above 140 u/l

Keywords: mother-to-child-transmission pmtct hiv resistance nnrti
randomized clinical trial of bococizumab (pf-04950615; rn316) in subjects with hyperlipidemia or mixed dyslipidemia at risk of cardiovascular events

Conditions: Hyperlipidemia

Summary: this study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of bococizumab (pf-04950615;rn316) to lower ldl-c.


Eligibility criteria:
inclusion criteria: * treated with a statin. * fasting ldl-c \> 70 mg/dl and triglyceride \<=400 mg/dl. * high or very high risk of incurring a cardiovascular event. exclusion criteria: * pregnant or breastfeeding females. * cardiovascular or cerebrovascular event of procedures during the past 30 days. * congestive heart failure nyha class iv. * poorly controlled hypertension.

Keywords: mixed dyslipidemia high risk of cardiovascular events multiple cardiovascular disease risk factors
premature infants receiving milking or delayed cord clamping: premod2

Conditions: Intraventricular Haemorrhage Neonatal; Death; Neonatal

Summary: this study is being done to find out whether umbilical cord milking (ucm) is at least as good as or better than delayed cord clamping (dcc) to reduce bleeding in the brain or prevent death in premature newborns. the investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either ucm or dcc. \* the trial was stopped by the dsmb for safety in the small strata. they subsequently allowed for continuation of the trial in infants 29-32+6 wk ga.

aim 1. compare the incidence of severe intraventricular hemorrhage (ivh) and/or death in premature newborns \<33 weeks gestational age (ga) delivered by c/s receiving ucm to those receiving dcc. hypothesis1: first demonstrate infants in the ucm group are not inferior to the dcc group (reject h10). hypothesis2: if h1 is true, demonstrate lower incidence of severe ivh and/or death in ucm infants compared to dcc. aim 2. compare the safety and efficacy profiles of premature newborns \<33 weeks ga delivered by c/s receiving ucm vs. dcc during their hospitalization. hypothesis3: ucm group will have a decreased need for resuscitation interventions with no differences in bilirubin or polycythemia compared to dcc. hypothesis4: ucm group will have improved blood pressures in the first 24 hours of life compared to dcc. aim 3 (exploratory). to compare the outcomes of premature newborns \<33 weeks ga delivered by c/s (cesarean section) (from aims 1 and 2) with those born by v/d (vaginal delivery) receiving ucm or dcc.

Eligibility criteria:
inclusion criteria: * 23 to 32 +6 gestational age (currently enrolling 29 to 32+6 weeks) * multiples without twin-to-twin transfusion syndrome (ttts) exclusion criteria: * congenital anomalies * major cardiac defects * placental abruption or previa with hemorrhage * cord prolapse * hydrops * bleeding accreta * monochorionic multiples with evidence of ttts * fetal or maternal risk (i.e. compromise) * parents declined study * unlikely to return for 2 yr follow up

Keywords: premature infants umbilical cord milking delayed cord clamping intraventricular hemorrhage death
quality of life and sexual function of vaginal operation in the treatment of previous cesarean scar defect

Conditions: Quality of Life; Sexual Activity

Summary: the aim of this study is to further demonstrate the safety , validity and quality of (sexual)life of vaginal operation for previous cesarean scar defect resection.

collect all the patients'clinical information,use two questionnaire (the hrqol and fsfi)to estimate patients' general healthy and sexual function before surgery and postoperation in 1 month,3 months and 6 months

Eligibility criteria:
inclusion criteria: * preoperative diagnosed as pcsd * hemodynamic stability exclusion criteria: * irregular menstrual cycle * using iud * complicating other disease also causing vaginal bleeding,such as endometrial polyp,submucous myoma and functional uterine bleeding.

Keywords: uterine scar from previous cesarean delivery previous caesarean scar deficiency transvaginal resection quality of life sexual activity
protein plus: improving infant growth through diet and enteric health

Conditions: Stunting; Malnutrition; Protein; Enteric Pathogens; Campylobacter Infections

Summary: this cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens.

stunting a major public health problem in bangladesh, where 36% of children under the age of five are too short for their age. while dietary data indicate that protein intakes of infants and young children are largely in line with requirements, the extent to which requirements derived for healthy infants and young children are relevant in the context of frequent infections remains an important research question. recent investigations indicate widespread pathogen carriage among bangladeshi infants, with virtually all having at least one detectable pathogen in nondiarrheal stools by six months of age. campylobacter and pathogenic e. coli predominate in this setting. enteric pathogens can compete with the host for available nutrients or alter nutrient metabolism. acting via environmental enteric dysfunction, they can alter both digestion-through loss of digestive enzymes-and absorption of nutrients. microbial translocation may further alter specific amino acid requirements. even in the absence of acute diarrheal disease, enteric pathogen carriage is strongly associated with linear growth faltering. combining the effects of high pathogen burden and poor diet, as indicated by low energy and protein from complementary foods, observational evidence suggests that the potentially preventable length-for-age z-score deficit may be as high as 0.98. the present trial will test the combination of a) protein supplementation in the form of a protein-rich blended food or an egg, both fed daily to infants 6-12 months of age, and b) azithromycin treatment for enteric pathogens. the primary outcome will be change in length-for-age z-score from the 6 to 12 months. biochemical, microbiological and clinical intermediates will be measured to inform our secondary aims.

Eligibility criteria:
inclusion criteria: * born to women enrolled in ongoing community trial (nct02909179) over a one-year period exclusion criteria: * born to women not registered as part of the ongoing community trial (nct02909179)

Keywords: linear growth infant feeding environmental enteric dysfunction
vancomycin resistant enterococci in patients awaiting liver transplantation at the university of michigan: prevalence, risk factors, natural history and outcome of colonization

Conditions: Liver Diseases

Summary: enterococci, especially vancomycin resistant enterococci (vre), are increasing in prevalence in many hospitals in the united states. patients undergoing liver transplantation are at particular risk for developing infection due to vre. the effect of prior colonization with vre on the outcome of liver transplantation is unknown. this prospective study will ascertain the prevalence of gastrointestinal colonization with vancomycin resistant enterococci among patients awaiting liver transplantation at the university of michigan health system. risk factors for acquisition of the organism, natural history of colonization and outcome in colonized patients will also be determined. all patients currently listed on a priority waiting list for liver transplantation at umhs will be invited to participate. patients will receive a standardized letter from their primary gastroenterologist describing the rationale for the study. patients will be contacted by telephone by a member of the study team in order to arrange an appointment in the gcrc at the time of their regularly scheduled transplant clinic appointment in order discuss their potential participation in the study. patients who give informed consent, will be interviewed using a standard interview questionnaire. demographic and historical data relevant to the risk of vre colonization will be collected during the interview. a sample will be obtained via rectal swab for culture. rectal swabs for culture and collection of information on the standardized questionnaire will be repeated every six months while the patient is awaiting liver transplantation. when a patient undergoes liver transplantation, a culture will be obtained at the time of admission and weekly after post-operatively until discharge. all patients will be followed for 60 days after transplantation to assess several primary outcomes, including operative and post-operative complications, vre infection and mortality. rectal swabs will be the only procedure performed for the purposes of this study. culture results will not be made available to the transplant team in order to avoid bias in clinical care. all data will be entered into an electronic database. gcrc statisticians will assist in the analysis of risk factors and outcome analysis.


Eligibility criteria:
inclusion criteria: * all patients 18 years or older currently listed on a priority waiting list for liver transplantation at the university of michigan will be invited to participate.

Keywords: liver transplantation vancomycin resistance
massage of the low back muscles assessed with ultrasound scanning

Conditions: Myofascial Pain Syndrome

Summary: the aim of the study is to use diagnostic ultrasound to compare the thickness of soft tissues in the low back in a group of patients with chronic low back pain treated with massage to a control group of non-treated patients. it is hypothesized that on average, soft tissue thickness in the lumbar region will change in the group receiving massage compared to the control group.

a specialized form of massage designed to reduce fascial restrictions will be compared to a no-treatment control group based on a change in thickness of the lumbodorsal fascia as determined by ultrasound imaging.

Eligibility criteria:
inclusion criteria: * history of chronic low back pain far at least 3 months * able to read and write english * between 18-64 years of age exclusion criteria: * prior lumbar surgery * infected or broken skin over the lumbodorsal fascia * major structural spinal deformity * specific cause of low back pain, such as tumor, infection, fracture * bleeding disorders or use of anticoagulant medications * pregnancy * litigation for low back pain * systemic infection

Keywords: myofascial pain trigger points
laboratory, cellular and molecular determinants of clinical success in diabetic patients with critical limb ischemia

Conditions: Diabetes Mellitus; Critical Limb Ischemia; Critical Lower Limb Ischemia; Diabetic Foot

Summary: the ecad-cli is an investigator-driven, prospective, single-center study. the aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in patients with diabetes mellitus and critical limb ischemia.

all consecutive patients admitted to maria cecilia hospital will be enrolled in the ecad-cli study. according to interventional management of the patient the following data and samples will be prospectively collected and related to outcome: * medical history, cardiovascular risk factors, clinical presentation * information related to angiography of peripheral arteries. an independent core-lab will review angiographies to assess extent and severity of peripheral artery disease * information related to medical treatment, including antithrombotic agents, antimicrobics and any treatment to permit wound healing * blood sample to obtain dna, rna and serum * patient undergoing surgery and/or debridement for wound/ulcer due to diabetic foot disease will receive biopsy for specimen collection * atherosclerotic plaque sample in patients undergoing atherectomy for the treatment of the peripheral artery disease all clinical variables and information obtained from blood/tissue samples will be related to outcome. any adverse events will be judged by an independent blinded committee.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus in treatment with oral agents and/or insulin * diagnosis of critical limb ischemia requiring medical and/or interventional treatment exclusion criteria: * dialysis * diagnosis or suspicion of malignancy * life expectancy \<1 year * inability to guarantee clinical follow-up
child-parent familial hypercholesterolemia screening

Conditions: Familial Hypercholesterolemia

Summary: child-parent screening for familial hypercholesterolemia has been proposed to identify children and their parent who are carrier of mutations and with high risk for inherited premature coronary artery disease. the investigators assessed the efficacy and feasibility of such screening in primary care practice. key scientific questions: 1. the 95th and 99th percentile of finger blood tc in children of 2 years old. 2. mutations that contribute to high tc status ( serum tc \>99th percentiles) compared with international fh48 panel for fh genetic screening.

familial hypercholesterolemia (fh) is an inherited condition resulting in high levels of low-density lipoprotein cholesterol (ldl-c) and increased risk of premature coronary artery disease in men and women. child-parent screening for familial hypercholesterolemia has been proposed to identify persons who are carriers of fh mutations and with high risk for inherited premature coronary artery disease. the investigators will conduct a cross-sectional community-based screening in children of 2 years old to detect fh children cases using finger blood tc test first and followed by serum tc test and mutation test, and to identify and diagnose their affected parents. this study aims to established the child-parent screening program and technique issues for early diagnosis of familial hypercholesterolemia families for future early intervention. child-parent screening strategy in our study consists three steps: i. capillary blood total cholesterol test of children aged around 2 years; ii. re-test for children with cholesterol\>95th percentile in the first step; iii. wes (whole exome sequencing) test for \>p99 in the first two steps. iv: tc test and mutation test to the parents of the child fh cases. the investigators will determine fh families based on the program. children's hospital of fudan university will provide treatment further.

Eligibility criteria:
inclusion criteria: * receive routine child care * aged 1 - 3 years old ( date of investigate minus date of birth) exclusion criteria: * it is up to the researcher to decide whether it is suitable to participate in this research
azacitidine plus pd-1 therapy for r/r hodgkin lymphoma

Conditions: Relapsed Classic Hodgkin Lymphoma; Refractory Classic Hodgkin Lymphoma

Summary: the goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with pd-1 therapy in treating patients with relapsed/refractory classic hodgkin lymphoma.

the investigators will evaluate response rate, progression free survival (pfs), overall survival (os), and toxicity of azacytidine combined with pd-1 therapy in classic relapsed/refractory hodgkin lymphoma.

Eligibility criteria:
inclusion criteria: * pathologically confirmed hodgkin lymphoma according world health organization (who) classification. * patient is ≥ 18 years of age at the time of signing the informed consent form (icf). * patient must understand and voluntarily sign an icf prior to any study-specific assessments/procedures being conducted. * patient is willing and able to adhere to the study visit schedule and other protocol requirements. * relapsed (after partial or complete response) or refractory aitl after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below). * meet the following lab criteria: absolute neutrophil count (anc) ≥ 1,5 x 10\^9/l (≥ 1 x 10\^9/l if bone marrow (bm) involvement by lymphoma); platelet ≥ 75 x 10\^9/l (≥ 50 x 10\^9/l if bm involvement by lymphoma); hemoglobin ≥ 8 g/dl. * anticipated life expectancy at least 3 months. exclusion criteria: * active or uncontrolled infections requiring systemic treatment within 14 days before enrollment. * any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy. * pregnant or lactating women.
physical training in patients with idiopathic inflammatory myopathies

Conditions: Idiopathic Inflammatory Myopathies; Physical Activity

Summary: physical training may improve physical capacity and health parameters in various systemic autoimmune diseases, including idiopathic inflammatory myopathies. therefore, the present study will assess the role of an exercise training program in patients with idiopathic inflammatory myopathies.

to assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.

Eligibility criteria:
inclusion criteria: * diagnosis of dm / pm according to the criteria of bohan and peter (1975) * both genders and age ≥ 18 years * use of prednisone ≤ 0.5 mg/kg/day in the last three months. the dose of prednisone will be kept fixed throughout the study * physically inactive exclusion criteria: * disease relapsing * neoplasia associated-myositis * overlapping myositis * use of lipid-lowering drugs * smoking * diabetes mellitus
proprioception and brace training in knee osteoarthritis

Conditions: Osteoarthritis Knees Both

Summary: knee osteoarthritis is common joint disorder in older adults. the prevalence of osteoarthritis is increasing in the elderly population and due to obesity.the aim of this study to compare improvement in balance between brace and proprioceptive training in knee osteoarthritis and to compare mobility level between proprioceptive and brace in knee osteoarthritis

knee osteoarthritis is common joint disorder in older adults. the prevalence of osteoarthritis is increasing in the elderly population and due to obesity. balance disorder generally disturbed equilibrium and increase risk of fall. there is lack of proprioceptive sensation in patients with knee osteoarthritis. the aim of this study to compare improvement in balance between brace and proprioceptive training in knee osteoarthritis and to compare mobility level between proprioceptive and brace in knee osteoarthritis. randomized control trial study of 8 week follows up. sample size will be 22. the patients will be divided into 2 groups brace and proprioceptive training. the patients will get training section for 3 days per week for 8 weeks. the measurement will be taken at base line, after 8 weeks. study duration will be 6 months. individuals of age 50-70 year, mini-mental state examination (mmse) 20 or higher, berg balance scale (bbs) 30-45 points, experience of at least one fall during the previous 12 months, both males and females will be include. patients will be excluded if they exhibited history of cardiovascular or musculoskeletal diseases, previously used medication for the central nervous system, occurrence of lower limbs lesions or fractures in last six months. assessment tools will be mmse, berg balance scale, tug, ctsib, 6 minute walk test. data will be analyzed through spss 20. data will be check for its normality, within groups comparison paired sample t-test, between groups independent sample t-test will be used

Eligibility criteria:
inclusion criteria: * age 50-70 years. * both males and females * knee osteoarthritis unilateral and bilateral (12). * american college of rheumatology (acr) criteria for diagnosing osteoarthritis of knee joint is presence of pain in knee joint plus any three of six factors listed below (13). * age more than 50 y * presence of crepitus on active motion * less than 30 min of morning stiffness * bony tenderness * bony overgrowth * no palpable warmth of synovium * mini-mental state examination (mmse) 23 or higher (14). * berg balance scale (bbs) 30-45 points (4) exclusion criteria: * history of stroke during the previous 12 months * history of cardiovascular or musculoskeletal diseases, * previously used medication for the central nervous system. * presence of lower limb lesions or fractures in the last six months

Keywords: proprioception training, balance, bbs,
training and calibration of dental examiners

Conditions: Dental Plaque

Summary: training and calibration of dental examiners


Eligibility criteria:
inclusion criteria: * male or female volunteers 18-65 years of age * good general health * must sign informed consent form * minimum of 20 natural uncrowned teeth (excluding third molars) must be present. * no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. exclusion criteria: 1. subjects unable or unwilling to sign the informed consent form. 2. medical condition which requires pre-medication prior to dental visits/procedures 3. moderate or advanced periodontal disease or heavy dental tartar (calculus). 4. 2 or more decayed untreated dental sites at screening. 5. other disease of the hard or soft oral tissues. 6. impaired salivary function (e.g. sjogren's syndrome or head and neck irradiation). 7. use of medications that can affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants). 8. use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. 9. pregnant or nursing women. 10. participation in any other clinical study within 1 week prior to enrollment into this study. 11. allergy to chlorhexidine 12. use of tobacco products 13. subjects who must receive dental treatment during the study dates. 14. current use of antibiotics for any purpose. 15. presence of an orthodontic appliance. 16. history of allergy to common dentifrice ingredients. 17. immune compromised individuals (hiv, aids, immuno suppressive drug therapy)