Kornimate/medical-research-clean huggingface dataset:
pilot rct of an obesity intervention for primary care pediatrics: helping hand

Conditions: Childhood Obesity

Summary: this is a feasibility study to evaluate a 6-month obesity treatment intervention (helping hand: health activity and nutrition directions) for pediatric primary care clinics. the program targets 5-8 year old children and their parents to change the child's lifestyle behaviors and the associated parenting practices to improve the child's weight status. four community clinics participated. families were recruited from clinics and after informed consent and baseline data have been obtained, the families were randomized into one of two groups: (1) the treatment group who immediately participated in helping hand or (2) the wait list control group, who started the program 7 months later. data were gathered on all the participating children and their parents at three time points: baseline, post the intervention (month 7) and post the wait list control group completing the intervention (month 14). this was a pilot study to test the feasibility of an obesity prevention plus program delivered in the child's primary care clinic. the primary outcome was family attendance to the 3 data-collection meetings with research staff and the 6 prevention plus intervention sessions with a trained health advisor.


Eligibility criteria:
inclusion criteria: * 1) child: healthy 5 to 8 year old child who is overweight (bmi =/\>85%), but not morbidly obese (bmi\<99%) * 2) child attends one of 4 tcpa clinics * 3) child is texas children's health plan member/participant * 4) parent who is child's primary care taker able and willing to participate * 5) parent and child willing to attend and participate in 6 month intervention sessions and 3 measurement time points over 14 months * 6) only one child per family will be eligible to participate. exclusion criteria: * 1) parent unable to read or write in english or spanish. * 2) parent or child unable to participate in counseling sessions in english or spanish * 3) child with bmi =/\> 99%tile * 4) child with medical consequences of obesity (such as hypertension, hypercholesterolemia, insulin resistance, type 2 diabetes) that would require treatment and not prevention. * 5) child on medications (such as oral steroids, stimulants, or anti-psychotic medications) that can affect their weight status * 6) child with medical problems that could influence their diet or physical activity or make it difficult for that child to participate in a behavior change program (such as mental retardation, neurologic disorders, severe food allergies or severe cardiac or pulmonary disease that restricts their activities). * 7) parents who participated in interviews during the developmental phase of helping hand * 8) family currently participating in other weight treatment of prevention programs

Keywords: child primary care treatment parenting lifestyle behaviors
observation in patients with early-stage vulvar cancer undergoing sentinel lymph node dissection

Conditions: Stage I Vulvar Cancer; Stage II Vulvar Cancer; Stage III Vulvar Cancer; Vulvar Squamous Cell Carcinoma

Summary: this research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.

primary objectives: i. to prospectively observe patients who receive radiation +/- chemotherapy immediately after lymph node dissection to confirm the safety of this procedure. outline: patients receive standard therapy including sentinel lymph node dissection. patients are then observed to collect information about treatment and outcomes every 2 months for 2 years.

Eligibility criteria:
inclusion criteria: * patients must have squamous cell carcinoma with a depth invasion \> 1 mm * patients must have t1 or t2 tumors (international federation of gynecology and obstetrics\[figo\] staging), \< 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes * localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible * preoperative imaging do not show enlarged (\< 1.5 cm) suspicious nodes * patients must sign informed consent exclusion criteria: * inoperable tumors with diameter \> 4 cm * patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (\> 1.5 cm) suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases * patients with multifocal tumors * patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
safety study of spc3649 in healthy men

Conditions: Hepatitis C

Summary: a placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of spc3649.


Eligibility criteria:
inclusion criteria: * healthy volunteers * bmi: 19-28 kg/m2 * no clinically significant disease/disorder * screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion * following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out. exclusion criteria: * heavy exercise within the past 7 days * alcohol intake\> 21 units weekly * regular smoker * received experimental drug within 30 days of study entry * planned participation in any experimental study during the study period * hiv-ab, hbsag and/or hcv ab positive * history of specific allergy * current use of any drug or narcotics.

Keywords: antisense microrna antagonist anti-mir-122 safety in healthy volunteers hepatitis c
safety, tolerability, pharmacokinetic and pharmacodynamic effect of pth134 at increasing doses in healthy postmenopausal subjects

Conditions: Postmenopausal Osteoporosis

Summary: this study is designed to investigate the safety and tolerability of pth134 in healthy subjects and to assess the exposure from pth134.


Eligibility criteria:
inclusion criteria: * healthy postmenopausal female subjects, 40 to 70 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening * body mass index (bmi) within the range of 19 to 32. exclusion criteria: * smokers who report cigarette use of \>= 5 cigarettes per day. * use of any prescription drugs or over-the-counter (otc) medication (vitamins, herbal supplements, dietary supplements) started within the last month prior to screening. * previous osteoporosis treatment * history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse other protocol-defined inclusion/exclusion criteria may apply

Keywords: osteoporosis parathyroid hormone pharmacodynamic pharmacokinetic
gestational diabetes: the prevention

Conditions: Pregnancy

Summary: to assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to gestational diabetes. and to assess if excessive maternal weight gain is an influence in the diagnostic.

a clinical, randomized controlled trial was used. 342 pregnant women without obstetric contraindications accepted informed consent for inclusion in the study. finally, 257 were studied, 101 in intervention group (ig, n= 101) and 156 in control group (gc, n= 156). a physical exercise program three times per week during pregnancy was developed. the duration of session was 60 minutes and 50 minutes in land and water, respectively.

Eligibility criteria:
inclusion criteria: * healthy pregnant women * at week 8-14 * adherence 80% (minimum) until the end of pregnancy exclusion criteria: * contraindications appointed by american college of obstetricians \& gynecologists (acog) * no adherence

Keywords: pregnancy, exercise, gestational diabetes
study of ins50589 intravenous infusion in subjects undergoing coronary artery bypass grafting (cabg) involving cardiopulmonary bypass

Conditions: Coronary Disease

Summary: the purpose of this trial is to identify a dose or doses of ins50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.


Eligibility criteria:
inclusion criteria: * are scheduled for primary cabg by median sternotomy involving cardiopulmonary bypass * willing to receive allogeneic blood product transfusions during and after surgery exclusion criteria: * have had previous cardiac surgery * have had previous median sternotomy * have tendency for bleeding or family history of bleeding * have an abnormally low platelet count * have received certain anticoagulant or antiplatelet medications within a specified time period prior to the scheduled cabg surgery

Keywords: coronary artery bypass graft surgery involving cardiopulmonary bypass
timing of estrogen support during the luteal phase of in vitro fertilization (ivf)/intracytoplasmic sperm injection (icsi) cycle

Conditions: Infertility

Summary: to test the hypothesis that adding estradiol (e2) to progesterone supplementation later in the luteal phase of in vitro fertilization (ivf)/intracytoplasmic sperm injection (icsi) cycles, rather than earlier in the luteal phase, improves clinical pregnancy rates (prs).

several studies reported that elevated e2 may have a detrimental effect on endometrial receptivity and embryo. this conflict was the starting point of our study. the investigators thought that this luteal decrease in e2 level could be prevented by adding estradiol just before the receptivity window is open, instead of adding earlier in the luteal phase which could result in defective embryo implantation.

Eligibility criteria:
inclusion criteria: * all patients on long gnrh agonist protocol with controlled ovarian hyperstimulation who were seen in our ivf clinic between february and november 2008, and who have e2 levels on the day of hcg administration \>2500 pg/dl exclusion criteria: * presence of azoospermia requiring testicular sperm extraction procedure * endometriosis greater than stage ii * unilateral oophorectomy, polycystic ovarian syndrome (pcos) * secondary infertility * age greater than 40 yrs and a basal follicle stimulating hormone (fsh) level higher than 12 miu/ml were exclusion criteria

Keywords: luteal phase support estradiol supplementation ivf/icsi clinical pregnancy rate
prospective, single-arm, multicenter study for evaluation the safety and effectiveness of the alex stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease

Conditions: Stable Angina; Unstable Angina; Myocardial Infarction

Summary: to evaluate the safety and effectiveness of the alex stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

prospective, multicenter, non-randomized study designed to enroll up to 60 subjects to evaluate the safety and effectiveness of the cobalt-chromium sirolimus eluting coronary stent alex in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Eligibility criteria:
inclusion criteria: clinical inclusion criteria: * \> 18 years of age * patient must provide written informed consent prior to procedure using a form that is approved by the local ethics committee * clinical diagnosis of stable angina, unstable angina or myocardial infarction without st elevation (nstemi) or myocardial infarction with st elevation provided the expiry of 72 hours of the onset of symptoms and stable clinical and hemodynamical condition the patient with patent postinfarcion artery (timi 3) and indications for pci and next stage of revascularization in the other vessels * earlier effective supply of others lesions in others vessels in case of multivessels disease * female of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for 12 months after enrolment angiographic inclusion criteria * target lesion stentosis must be \> 70% (visual estimate) * patient eligible for pci treatment with the alex stent system (vessel diameter in range of 2.5 to 4.0 mm and length of lesion that allows to cover a single stent with maximum length of 30 mm in visual evaluation) exclusion criteria: clinical exclusion criteria * anticipated inablility of the patient to comply with 12 months of antiplatelet treatment (e. g. elective non-cardiac surgery following stenting, drug intolerance etc.) * acute or chronic renal failure (serum creatinine \> 2 mg%, gfr \< 60 ml/min/1.73m2) * left ventricular ejection fraction (lvef) \< 40% * cardiogenic shock * short life expectancy (\< 1 year) * any significant medical condition which in the investigator's opinion may interference with the patient's optimal participation in the study * current participation in another drug or device clinical trail in which there no be reached the primary endpoint or which clinically interferences with trail's enpoints angiographic exclusion criteria * chronic total occlusion * calcified lesion which cannot be successfully dilated * location of lesions in the winding vessels where there is no possibility of oct imaging * target stenosis located in venous or arterial bridge * unprotected left main coronary disease with \> 50% stenosis

Keywords: alex coronary stent cobalt-chromium sirolimus oct
metformin use and vitamin b12 deficiency

Conditions: Vitamin B12 Deficiency; Type 2 Diabetes Mellitus

Summary: the primary objective is to determine the incidence of vitamin b12 deficiency in patients on metformin therapy for diabetes.


Eligibility criteria:
inclusion criteria:age 20-80; diagnosed with type 2 diabetes for at least 30 days exclusion criteria:known vitamin b12 or folate deficiency; pernicious anemia; on vitamin b12 therapy; hematological malignancy; methotrexate use; alcohol intake greater than two drinks per day; vegetarian diet; previous gastric surgery; inflammatory bowel disease

Keywords: metformin vitamin b12 type 2 diabetes methylmalonic acid deficiency
somatosensory evoked potentials from the lower urinary tract

Conditions: Neurogenic Lower Urinary Tract Dysfunction

Summary: spinal cord injury and other systemic neurological diseases (multiple sclerosis, parkinson's disease) affect the integrity of lower urinary tract (lut) function, leading to neurogenic lower urinary tract dysfunction (nlutd). the urodynamic investigation is the current "gold-standard" for evaluating lut function. nevertheless, the sensory situation of the lut cannot be investigated objectively. furthermore, the current classification of the severity of the nlutd due to spinal cord injury (sci) does not represent the sensory situation of the lut. additional investigations therefore need to be established for assessing the sensory situation of the lut. somatosensory evoked potentials (seps) are an established method for investigating the processing of sensory nervous activity. however, seps from the lut of sci individuals have not yet been investigated. a novel technique, i.e. diffusion tensor imaging (dti), allows to process magnetic resonance images (mri) in order to visualize nerve fibers. using dti, the innervation of the bladder after sci can be visualized. the structural presentation of bladder innervation will be compared with the functional results, i.e. the sep of the lut in sci individuals. the primary objective of the proposed study is to elicit and characterize (latency, amplitude) the somatosensory evoked potentials (seps) from the bladder in individuals suffering from neurogenic lower urinary tract dysfunction as a result of spinal cord injury. furthermore, the seps from the bladder will be compared with the seps from peripheral nerves (n. tibialis, n. pudendus, n. medianus). moreover, the latency and amplitude of the seps from the bladder of individuals with somato-sensory complete spinal cord injury will be compared with those from the bladder of individuals with somato-sensory incomplete spinal cord injury. finally, the structural innervation of the bladder after sci will be compared with the remaining sensory function.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * chronic sci of a minimum of 1 year * aetiology of sci: traumatic exclusion criteria: * age \ 70 years * aetiology of sci: non-traumatic * history of bleeding disorder * history of chronic neuropathic pain * intravesical botulinum toxin injections \< 12 months ago * bladder management using indwelling catheters (suprapubic, transurethral) * bladder augmentation * sacral deafferentation * sacral neuromodulation * acute, symptomatic urinary tract infection * pregnancy * urolithiasis * bladder cancer * exclusion criteria for mri (cardiac pace maker, implanted metal etc.)
sleep device testing to promote sleep in infants

Conditions: Insomnia Chronic

Summary: infants often have sleep challenges. most of these challenges in otherwise healthy children and due to behavioral insomnia. the goal for infants is to become independent sleepers by learning the process of self-soothing. this study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.


Eligibility criteria:
inclusion criteria: 1. age between 2-12 months. 2. meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the international classification of sleep disorders manual. exclusion criteria: 1. diagnosed comorbid health problem that may disrupt sleep. 2. history of birth prior to 37 weeks gestational age.
safety of sch 530348 in subjects undergoing non-emergent percutaneous coronary intervention (study p03573)

Conditions: Arterial Obstructive Diseases; Coronary Disease

Summary: the object of the study is to determine whether different doses of sch 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding. a secondary objective is to determine whether patients treated with sch 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.


Eligibility criteria:
inclusion criteria: * a person who is 45 years or older and is mentally competent to provide a signed written informed consent. * a person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention. * if a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control. exclusion criteria: * pregnancy * recent stroke * active internal bleeding or a history of a bleeding disorder * increased risk of bleeding * severe high blood pressure * liver or kidney disease * low platelet count * condition such as alcoholism, mental illness, or drug dependence * ongoing chest pain * planned or ongoing treatment with a blood thinning medication * a serious condition or illness that would interfere with participation in the study

Keywords: platelets platelet aggregation inhibitors protease-activated receptor 1 hemorrhage
screening study to identify patients with complement factor i deficiencies

Conditions: Previous Diagnosis With a Complement-mediated Disease and/or With Clinical Manifestations Reasonably Associated With Complement Factor I Deficiency

Summary: this is screening study to identify patients with complement factor i deficiencies. the primary objective is to identify participants with cfi deficiencies and assess the prevalence in the screened population.


Eligibility criteria:
inclusion criteria: an individual must meet all the following criteria to be eligible to participate in this study: 1. a male or female ≥6 months of age who has been diagnosed with a complement-mediated disease in which a reasonable etiological association with cfi deficiency has been reported 2. affirmation of participant's informed consent or lar's willingness to provide informed consent with signature confirmation before any study-related activities. (study-related activities are any procedures that would not have been performed during normal clinical management of the participant.) the participant (if a minor) must be willing to give written informed assent if the minor is within the age groups 7 to 11 years old and 12 to 17 years old. exclusion criteria: 1) diagnosis of age-related macular degeneration that is complement-related with no concurrent systemic complement involvement
management and outcomes of perioperative care among european diabetic patients

Conditions: Diabetes Mellitus; Postoperative Complications

Summary: the incidence of diabetes is increasing globally, including within europe. there is an estimated 20million diabetic patients in europe, which is likely to increase, thereby adding to societal demands on european health services. diabetic patients are more likely to have surgical interventions than the general population. there are plausible pathophysiology and clinical mechanisms that diabetics are at increased risk of postoperative complications. when postoperative complications occur in the general population, they increase mortality or increase risk of major adverse cardiovascular events (myocardial infarction, cerebrovascular accident, pulmonary embolism) at 30-days and up to one year later. in addition, diabetes is an independent risk factor for surgical site infections. there is variation in practice guidelines in different countries in the perioperative management of diabetic patients undergoing major surgery, but this has not been documented on a large scale. given the multiplicity of guidelines and differing recommendations, it is unsurprising that variability of 'real-world' clinical practice with regard to perioperative management of oral antihyperglycemic medications and insulin therapy has been noted in audits such as the national confidential enquiry into patient outcome and death (ncepod). further, although it is recognised that diabetic patients are at increased risk of postoperative complications, this has not been recently evaluated, especially in light of ongoing developments in perioperative care, such as enhanced recovery programmes. while a quality improvement intervention study has shown that maintaining tight preoperative glycaemic control improves postoperative glycaemic control, it is not known if this reduces postoperative morbidity overall. further, whether certain anaesthetic techniques may be associated with better or worse outcomes after major non-cardiac surgery is unknown.

see brief summary

Eligibility criteria:
inclusion criteria: * diabetic patients (all classes except gestational diabetes) undergoing surgery (defined as requiring any general anaesthesia technique or any specific regional anaesthetic technique or a combination) * ambulatory, elective or emergency surgery and patients who receive postoperative care in intensive care or high dependency units will be included. exclusion criteria: * patients who are not diabetic * patients with gestational diabetes * patients undergoing minor surgery

Keywords: diabetes mellitus surgery postoperative complications