Kornimate/medical-research-clean huggingface dataset:
infants fed an amino acid-based formula

Conditions: Food Allergy

Summary: to observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.


Eligibility criteria:
inclusion criteria: * subject is judged to be in good health as determined from subject's medical history * subject is from a full-term birth with a gestational age of 37-42 weeks * subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.) * subject has been documented to have cmpa and/or multiple food allergies, fpies or gastrointestinal eosinophilic disorders. * subject is experiencing persistent feeding intolerance symptoms including any of the following: regurgitation/vomiting associated with feeding (within 1 hour), constipation, diarrhoea, hematochezia (blood in the stool), crying, gassiness (wind), and/or skin rash/eczema. * parent(s) confirm their intention to feed their infant study product during the study period. * parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrolment through the duration of the study, unless instructed otherwise by their healthcare professional. * infant using medications (otc medications for gas \[wind\]), home remedies (such as juice for constipation), herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gl tolerance may not be enrolled unless the parent agrees to discontinue the use of these agents prior to enrolment or a healthcare professional recommends their continued use. * subject's parent(s) has voluntarily signed and dated an icf, approved by an iec/irb and provided applicable privacy regulation authorisation prior to any participation in the study. exclusion criteria: * subject is receiving steroids or antibiotics * subject is tube-fed * subject has received an amino acid-based formula * subject has been diagnosed with: short bowel syndrome, inflammatory bowel disease, pancreatic disease, protein maldigestion (malnutrition), mast cell disorder * subject is participating in another study that has not been approved as a concomitant study by an
vaccine therapy for patients with stage iv melanoma

Conditions: Malignant Melanoma

Summary: this is a phase iii study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. the purpose of this study is to evaluate the ability of the cancervax™ vaccine to prevent or slow the recurrence of melanoma.


Eligibility criteria:
* must have stage iv melanoma * must have had all clinically-detectable disease surgically removed * cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. some corticosteroids, and certain types of radiation therapy) * cannot have hiv or hepatitis a, b, or c
vitamin d supplementations as adjunct to anti-tuberculosis drugs in mongolia

Conditions: Vitamin D Supplements; Tuberculosis; Sputum; Cytokines; Immunity

Summary: hypothesis that improving vitamin d status among tb patients will speed the pace of bacteriological cure, and will enhance immune responses to tb infection

tuberculosis (tb) will be the world's largest single cause of death from infection for the 30-year period between 1990 and 2020. more than 95% of tb cases, and deaths due to tb, occur in developing countries. mongolia is one of the countries with the highest tuberculosis burdens in the western pacific region. in addition, vitamin d deficiency is endemic in mongolia. we propose to determine the efficacy of vitamin d supplements, as an adjunct to multidrug therapy, in enhancing the anti-microbial immune response to tb, a finding that could lead to the development of shorter drug regimens, and thus more efficient and effective tb treatment protocols. we propose to conduct a double blind, placebo controlled, randomized clinical trial to test the effect of a daily vitamin d supplementation on the ability of subjects to control tb infection. the primary endpoint: the primary endpoint will be: time to sputum culture conversion from positive to negative. the number of days to sputum conversion will be measured, in both the intervention and control groups, starting on the date that treatment is begun. sputum samples will be collected and cultured every two weeks thereafter. the date of conversion from positive to negative, for each subject, will be the date halfway between the date of the last culture-positive sputum and the first culture-negative one. secondary endpoints: bacteriologic secondary endpoints, cell-mediated immune function endpoints and bmi.

Eligibility criteria:
inclusion criteria: * sputum positive tb patients exclusion criteria: * we will exclude those with abnormal lfts at baseline (2.5 times upper limit of normal), as they will be at higher risk of developing drug-induced hepatitis
safety and efficacy study of femara(letrozole) as an extended adjuvant treatment in breast cancer patients

Conditions: Breast Cancer; Letrozole

Summary: title of study: an observational, multicenter study on the safety and efficacy of femara® (letrozole) as an extended adjuvant treatment in breast cancer patients who completed adjuvant tamoxifen or toremifen treatment objectives: the major objective of the study is to assess safety and efficacy of femara® in women who had undergone resection of a primary breast cancer and subsequently received prior adjuvant tamoxifen or toremifen therapy for 5 years in real-life condition. the study aims at the following objectives: 1. to identify unknown adverse reactions, especially serious adverse reactions 2. to evaluate incidence and descriptions of adverse reactions under the routine drug use 3. to identify factors that may affect the safety of femara® 4. to identify factors that may affect the efficacy of femara® methodology: this will be an open-label, multi-center, single-arm, observational phase iv study. number of centers \& patients: approximately 610 (planned no. of patients for total study period) patients from 4 centers will be enrolled in this study. population: postmenopausal early breast cancer patients who have finished adjuvant treatment with tamoxifen or toremifen for 5 years after curative surgery as "indications" described in local product labeling. investigational drug: femara® will be administered orally as described in "dose \& administration" of local product labeling up to 3 years. study duration: fpfv may. 2006, lpfv dec. 2011. study drug will be administered for up to 3 years with renewal of contract on yearly basis.


Eligibility criteria:
inclusion criteria: * written informed consent form * postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study * age ≥50 years with cessation of menses and age \<50 years postmenopausal status defined by one of the following: * fsh level \> 30-40 iu/l * cessation of menses over the past 1 year * are/become amenorrheic due to either chemotherapy or lhrh, are/become amenorrheic due to surgical ovarian ablation * the tumor was to be er and/or pgr-positive or the receptor status could have been unknown * no evidence of recurrence of the disease at entry * patient must be accessible for follow-up exclusion criteria: * those patients known to have had receptor-negative primary tumors * any concurrent malignancy * patients who previously received hormone replacement therapy (hrt) during 5 years of adjuvant therapy with tamoxifen or toremifen * patients who are currently receiving other aromatase inhibitors, or chemotherapy * patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results * life expectancy \< 12 months
assess the safety & reactogenicity of dtpa-ipv/hib vaccine administered at 3, 4, 5 & 18 mths of age, in healthy infants

Conditions: Diphtheria; Tetanus; Poliomyelitis; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines

Summary: to assess the safety and reactogenicity of the dtpa-ipv/hib vaccine as primary and booster vaccination. the dtpa-ipv/hib vaccine given at 3 and 4 months of age is co-administered with gsk biologicals' rotavirus vaccine or placebo. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

single group study. subjects in gsk biologicals' rotavirus study (rota-028) in singapore will be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months

Eligibility criteria:
inclusion criteria * subjects must have been enrolled in the rota-028 study. * a male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol exclusion criteria * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
continuous passive motion versus heterotopic ossification

Conditions: Traumatic Brain Injury; Spinal Cord Injuries; Stroke

Summary: the investigators hypothesize that heterotopic ossification (ho) formation can be suppressed if the application of a continuous passive motion (cpm) device can be performed for a substantial amount of time. the investigators will use the following study design: a pilot study with 10 icu patients receiving cpm and 10 matched cases which will follow a conventional physiotherapy program at the time of the conduction of the study. the comparison between the treatment and referent groups of the outcomes will prove the prophylactic power of cpm against ho.

the aim of this study is to formally evaluate whether the investigators can indeed prevent ho by the timely and painless use of cpm in neurogenic intensive care unit (icu) patients with stabilized medical conditions, suffering from neurological insults either traumatic brain injury (tbi), stroke, or spinal cord injury (sci). the investigators hypothesize that ho formation can be suppressed if cpm can be performed for a substantial amount of time. the investigators will perform a pilot study with 10 icu patients receiving cpm and 10 matched cases which will follow a conventional physiotherapy program at the time of the conduction of the study. the primary outcomes will be the ct appearance of ho in the hip or knee joint and the degree of rom limitation in the given joint at baseline and at the end of the clinical trial. a secondary outcome that will be measured, will be the glasgow coma scale (gcs) at the beginning and at the end of the cpm program. the comparison between the treatment and referent groups in terms of these outcomes will prove the prophylactic power of cpm against ho.

Eligibility criteria:
inclusion criteria: 1. patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (tbi), stroke, or spinal cord injury. 2. a negative triplex ultrasound in order to rule out deep venous thrombosis (dvt) 3. a positive three-phase bone scan with tc99. (will be obtained as soon as ho symptoms are onset.) 4. patients with verified ho formation on the knee or hip joint will undergo a ct to show the extent of the lesion. exclusion criteria: 1. life-threatening conditions that render continuous passive motion (cpm) application difficult. 2. ho detected in another location than the hip or knee joint. 3. concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (ap) level. 4. patients not reacting to painful stimuli

Keywords: ossification, heterotopic continuous passive motion (cpm) zoledronic acid range of motion (rom) prophylaxis
cardiometabolic benefit of reducing iatrogenic hyperinsulinemia using insulin adjunctive therapy in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus; Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY); MODY2 Diabetes; Healthy Volunteer

Summary: this study aims to understand the heart and blood sugar health benefits of using an adjunctive therapy to lower high insulin levels in people with type 1 diabetes. the investigators will also look at people with a specific type of diabetes called glucokinase-maturity onset diabetes of the young (gck-mody) and those without diabetes to help interpret the results. the investigators will use a medication that helps the body get rid of sugar, called and sglt2 inhibitor, with the goal to reduce the body's insulin requirements. the investigators believe this could lead to better heart and blood sugar health, including a better response to insulin and more available nitric oxide, a gas that helps blood vessels function well. the investigators will compare heart and blood sugar health risk factors in participants with type 1 diabetes, participants with glucokinase-maturity onset diabetes of the young (gck-mody), and non-diabetic healthy volunteers under two conditions: high insulin levels typical of type 1 diabetes and normal insulin levels typical of the other two groups.


Eligibility criteria:
inclusion criteria: age: 18-60 years bmi: 18-28 kg/m² weight: ≥ 50 kg t1dm participants: duration of t1dm: 1-30 years hba1c: 5.7-7.5% insulin therapy: using automated insulin delivery gck-mody participants: hba1c: 5.7-7.5% genetic confirmation: positive gck sequencing control participants: hba1c: less than 5.5% \*\* exclusion criteria: severe hypoglycemia: ≥1 episode in the past 3 months comorbidities: * any hospital admissions for diabetic ketoacidosis in the past 6 months * sbp greater than 140 mmhg and dbp greater than 100 mmhg * egfr by mdrd equation of less than 60 ml/min/1.73 m² * ast or alt greater than 2.5 times uln * hct less than 35% medications: * any antioxidant vitamin supplement within 2 weeks before the study * any systemic glucocorticoid * antipsychotics * atenolol, metoprolol, propranolol * niacin * any thiazide diuretic * any oral contraceptive pill with greater than 35 mcg ethinyl estradiol * growth hormone * any immunosuppressant * antihypertensive * any antihyperlipidemic other: * pregnancy * tanner stage less than 5 * peri- or post-menopausal women * active smoker t1dm participants: medications: any diabetes medication except insulin c-peptide: greater than 0.7 ng/ml (fasting) gck-mody participants: none specific

Keywords: type 1 diabetes mellitus with glucokinase-maturity onset diabetes of the young (gck-mody) nitric oxide sodium-glucose cotransporter-2 inhibitors (sglt2i) healthy volunteer insulin sensitivity flow-mediated vasodilation (fmd)
lipid lowering effect of plant stanol ester in a drinkable non-dairy product

Conditions: Hypercholesterolemia

Summary: the aim is to determine the effect of investigational products on serum ldl cholesterol.


Eligibility criteria:
inclusion criteria: * signed written informed consent * mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l) * plasma triglyceride levels ≤ 4.0 mmol/l * age 18-65 years exclusion criteria: * intolerance to oats or other ingredients of the test products * severe obesity (bmi ≥ 32 kg/m2) * consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, pcsk9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. statin treatment is allowed at stable dose. * consumption of plant stanol or plant sterol containing food products or supplements or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample) * history of malignant diseases like cancer within five years prior to recruitment * history of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (cabg), percutaneous transluminal coronary angioplasty (ptca) within the previous 6 months * diagnosed type 1 or type 2 diabetes requiring medical treatment * celiac disease * medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. orlistat, victoza) * alcohol abuse (\> 4 portion/per day) or recreational drug abuse * pregnancy or planned pregnancy or lactating * clinically significant abnormalities in screening labs * participation in another clinical trial in the preceding 3 months
a clinical investigation of new ostomy appliances

Conditions: Leakage

Summary: this is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. every patient is to test two new ostomy appliances each for two weeks. during the test a questionaire is to be filled out and interviews will take place. primary parameter is leakage. a study nurse will visit the participants in their homes every two week during the test.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years. 2. have had an ileostomy for more than 3 months. 3. have used convex products for the last 1 month. 4. has given written informed consent. 5. have an ileostomy with a diameter between 15 and 33 mm. 6. have inward peristomal area exclusion criteria: 1. have loop ostomy 2. pregnant or breastfeeding. 3. known allergy towards any of the product components or ingredients. 4. currently receiving or have within the last 2 months received radio- and/or chemotherapy. 5. currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area. 6. currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
trial ii of lung protection with azithromycin in the preterm infant

Conditions: Bronchopulmonary Dysplasia

Summary: the hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of bpd. the purpose of this study is to determine if azithromycin treatment is beneficial for prevention of bronchopulmonary dysplasia in preterm infants.

the survival of preterm infants has increased dramatically and has been associated with an increase in bpd. the incidence of bpd among extremely low birthweight infants ranges from 45% to 90%. development of bpd is associated with both antenatal (maternal chorioamnionitis often due to ureaplasma is related to bpd) and postnatal complications (oxygen toxicity, barotrauma, late onset infections). these insults appear to lead to an inflammatory response with resultant arrest of normal alveolar and vascular development. multiple human studies support the role of inflammation in the development of bpd. evaluating a medication that could decrease the inflammation in bpd, with minimal side effects, could significantly improve the morbidities of prematurity and the financial burden incurred by parents. macrolide antibiotics (erythromycin and azithromycin) have been shown to have anti-inflammatory properties that are independent of their antimicrobial properties. azithromycin has the potential to decrease the severity of ventilator-induced pulmonary inflammation that is commonly seen in bpd.

Eligibility criteria:
inclusion criteria: * birthweight less than 1250 grams admitted to uk nicu * mechanical ventilation within the first 72 hours of life exclusion criteria: * confirmed sepsis by blood culture * multiple congenital anomalies or known syndromes * intrauterine growth retardation with birthweight less than 10%ile for gestational age * rom for \>7 days

Keywords: premature infant respiratory distress syndrome mechanical ventilation
coronary screening in a high risk subset

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to test the hypothesis that the incidence of coronary heart disease and cardiovascular mortality could be accurately predicted by the presence of coronary calcific deposits detected by cardiac fluoroscopy.

background: because of its low cost and non-invasive nature, fluoroscopy was thought to be a potentially powerful screening tool for coronary heart disease if its efficiency could be demonstrated. the utility of exercise testing for screening had been limited by its relatively low sensitivity since it could only detect atherosclerotic plaque large enough to significantly impede coronary flow. design narrative: asymptomatic high risk subjects were screened with cardiac fluoroscopy and exercise testing at baseline and followed for six years with annual visits. the sensitivity and specificity of fluoroscopy in relation to the incidence of coronary heart disease and the incidence of cardiovascular mortality was determined and compared at 3.5 and 6 years of follow-up. the predictive utility of fluoroscopy and exercise testing, in relation to the incidence of coronary events, was assessed by logistic regression analysis. multivariate analysis was also performed on baseline risk factors. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria