Kornimate/medical-research-clean huggingface dataset:
glycemic and satiety response to fiber and glycemic index of meals in diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to assess the post-prandial response of four breakfast with different content of dietary fiber and glycemic index on glycemic response and satiety in patients with type 2 diabetes.

design study: single-blind crossover randomized clinical trial hypothesis: a meal with high gi and high fiber content determines a lower glycemic response compared to a meal with high gi and low fiber content (fiber beneficial effect on glycemic response independent of glycemic index. test meals: four test meals isocaloric and with the same proportion of macronutrients will be evaluated (5 kcal/kg, 17% of energy provided by protein, 58% of energy provided by carbohydrates, and 25% of energy provided by fat): test meal a:high glycemic index (gi= 60.3%) and high fiber content(5.88g) test meal b:high glycemic index (gi= 62.8%) and low fiber content(2.05g) test meal c:low glycemic index (gi= 37.0%) and high fiber content(5.75g) test meal d:low glycemic index (gi= 38.4%) and high fiber content(1.91g) outcomes: glycemic response: serum glucose and insulin satiety response: serum ghrelin and subjective assessment of satiety by a specific scale for measurement of appetite in single test meal studies. logistic: patients will undergo a clinical, nutritional and laboratory evaluation for confirm the inclusion criteria and will be request to give their written informed consent. all participants will test each meal with a mean of seven days separating the individual test days.a 12h fast will precede all the study visits.pre-and postprandial blood samples will be draw to determine the concentrations of serum insulin and plasma glucose, and ghrelin through an antecubital cannula before and 15, 30, 45, 60, 90, 120 and 180 min after the test meals. the vas scale will be applied in these times.

Eligibility criteria:
inclusion criteria: * type 2 diabetes, * hba1c \< 9%, * bmi \< 35kg/m², * metformin and/or diet as treatment for diabetes exclusion criteria: * use of insulin as diabetes treatment * digestive disease with malabsorption * diabetes neuropathy with gastroparesis

Keywords: fiber glycemic index glycemic response diabetes ghrelin
study of ds-8201a for participants with advanced solid malignant tumors

Conditions: Neoplasm Metastasis

Summary: her2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (her2). her2 promotes the growth of certain cancer cells. this study will test an experimental drug called ds-8201a that has not been approved by the health authorities yet. ds-8201a will be tested for safety in patients with advanced solid malignant tumors that test positive for her2. it also will test how ds-8201a moves within the body (pharmacokinetics).

the expected time from the first subject's enrollment until the last subject's enrollment is approximately 8.5 months. the screening period is 28 days and each cycle of treatment is 21 days. the data for the primary analysis will cutoff after all subjects have either discontinued the study or completed at least 3 cycles, whichever comes first. after the primary analysis, the main study will be closed and transition to the extension period. depending on the preliminary results of cohort 1, sponsor may decide whether cohort 2 will be opened or not. the number of treatment cycles is not fixed in this study. subjects who continue to derive clinical benefit from the study drug in the absence of withdrawal of consent, progressive disease (pd), or unacceptable toxicity may continue the study drug.

Eligibility criteria:
inclusion criteria: * has a pathologically documented unresectable or metastatic solid malignant tumor, with her2 expression \[immunohistochemistry (ihc) 3+, 2+, or 1+ and/or in situ hybridization (ish) +\], next generation sequencing, or other analysis techniques as appropriate\] that is refractory to or intolerable with at least one prior systemic chemotherapy regimen, or for which no standard treatment is available * has a left ventricular ejection fraction (lvef) ≥ 50% * has an eastern cooperative oncology group performance status (ecog ps) score of 0 or 1 exclusion criteria: * has a contraindication for receiving ritonavir or itraconazole according to the prescribing information * has a medical history of myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure

Keywords: unresectable or metastatic solid malignant tumors solid malignant tumors oncology her2 antibody drug conjugate adc
pain levels and opioid usage in three nerve block cohorts in primary tka

Conditions: Knee Arthropathy

Summary: the primary objective of this study is to compare effect of combined block of acb (adductor canal block) with ipack (interspace between the popliteal artery and the capsule of the posterior knee) block and/or intra-articular block in immediate postoperative and early postop rehabilitation and pain management in patients undergoing primary tka. the secondary objective is to review both in-hospital and post-discharge pain levels and narcotic usage of primary tkas, with a minimum 6-week postoperative follow-up.


Eligibility criteria:
inclusion criteria: 1. patient is indicated for a primary, unilateral tka secondary to osteoarthritis. 2. patient age is 22-89 at time of tka surgery. 3. patient agrees to participate as a study subject and signs the informed consent and research authorization document. 4. patient is able to read and speak english. exclusion criteria: 1. patient is under the age of 22 or over the age of 89. 2. patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis). 3. patient is scheduled to undergo a bilateral tka surgery. 4. patient is unable to read and speak english.
central hypothyroidism, a novel laboratory measurement

Conditions: Central Hypothyroidism

Summary: medical management of central hypothyroidism is controversial due to lack of reference for evaluation of pituitary negative feedback. therefore, titration of medical treatment is based on t4 levels, measured with variable laboratory methods. patients who have central hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which they need replacement therapy such as steroids, testosterone and growth hormone. this combined hormone deficiency makes clinical and laboratory evaluation challenging among these patients. symptomatically, central hypothyroidism is relatively mild and lack non-specific and it might be overlooked due to other hormonal deficiencies. replacement therapy for central hypothyroidism is titrated by arbitrary target free t4 levels of above 50th percentile of normal. the goal of our study is to compare the standard results from well known measure methods to a new method for measuring ft4 using liquid chromatography - tandem mass spectrometry.


Eligibility criteria:
inclusion criteria: * clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as acth, lh, fsh exclusion criteria: * primary hypothyroidism

Keywords: central hypothyroidism, hypopituitarism, eltroxin
a multisite trial of acquirec therapy

Conditions: Hemiparetic Cerebral Palsy

Summary: a multisite trial to testing different dosage levels of a systematic form of pediatric constraint-induced (ci) therapy called acquirec therapy. the high dosage treatment involved 6 hours of daily therapy services for 21 days. this was compared to a moderate dosage level of 3 hours of daily therapy services for 21 days. it was hypothesized that children receiving the higher therapy dosage would have greater and more clinically significant benefits from acquirec therapy but that both groups of children would benefit from the therapy services.


Eligibility criteria:
inclusion criteria: * children 3-6 years of age * hemiparetic cp exclusion criteria: * no prior ci therapy treatments * no botox for 6-months

Keywords: pediatric ci therapy acquirec therapy dosage occupational therapy physical therapy cerebral palsy hemiparesis
pemafibrate to reduce cardiovascular outcomes by reducing triglycerides in patients with diabetes (prominent)

Conditions: Type2 Diabetes; Dyslipidemia

Summary: the primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of: * nonfatal myocardial infarction (mi) * nonfatal ischemic stroke * coronary revascularization; or * cardio vascular (cv) death.

a multi-regional clinical trial with participating sites in the following countries. india is being conducted under a previous protocol version due to regulatory requirements. * argentina * brazil * bulgaria * canada * colombia * czech republic * denmark * france * germany * hungary * india * israel * japan * mexico * netherlands * poland * romania * russian federation * slovakia * south africa * spain * ukraine * united kingdom * united states

Eligibility criteria:
inclusion criteria: 1. fasting tg ≥ 200 mg/dl (2.26 mmol/l) and \< 500 mg/dl (5.65 mmol/l) at visit 1 (screening/enrollment visit) or visit 1.1 (retest) 2. hdl-c ≤ 40 mg/dl (1.03 mmol/l) at visit 1 (screening/enrollment visit) or visit 1.1 (retest) 3. type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated hba1c (≥ 6.5% \[48 mmol/mol\]), elevated plasma glucose (fasting ≥ 126 mg/dl \[7.0 mmol/l\], 2-hour ≥ 200 mg/dl \[11.1 mmol/l\] during oral glucose tolerance testing, or random value ≥ 200 mg/dl with classic symptoms, or currently taking medication for treatment of diabetes; and either 1. age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); or 2. age ≥ 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following: * i. prior mi or ischemic (non-hemorrhagic) stroke * ii. coronary angiographic lesion of ≥ 60% stenosis in a major epicardial vessel or ≥ 50% left main stenosis * iii. asymptomatic carotid disease with ≥ 70% carotid artery stenosis * iv. symptomatic carotid disease with ≥ 50% carotid artery stenosis * v. symptomatic lower extremity pad (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing \[eg, toe-brachial index, angiogram, or other imaging study\]) * vi. prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy) exclusion criteria: 1. current or planned use of fibrates or agents with ppar-α agonist activity (eg, saroglitazar) within 6 weeks (42 days) of visit 1 (screening/enrollment visit). note: ppar-γ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed 2. known sensitivity to ppar-α agonists or tablet excipients 3. initiation of, or change in, current tg-lowering therapy within 12 weeks of visit 1 (if applicable). note: tg-lowering therapy is defined as niacin \> 100 mg/day or dietary supplements or prescription omega-3 fatty acids \> 1 g/day 4. type 1 diabetes mellitus
effects of the pilates method versus home exercise in individuals with chronic non-specific back pain

Conditions: Chronic Low Back Pain

Summary: the aim is to compare the effectiveness and cost-effectiveness of a pilates program versus home-based exercises in individuals with chronic non-specific low back pain. this is a randomized controlled trial with economic evaluation. participants will be sequentially enrolled and randomly allocated into two groups: 1) pilates: mat pilates sessions, supervised by a physiotherapist (2x/week for 6 weeks); 2) home-based exercise: face-to-face familiarization (two sessions), supervised by another physiotherapist. after familiarization, the exercises will be prescribed using a booklet containing descriptions of sets/repetitions, as well as guidelines and precautions, to be performed during 6 weeks (2x/week) and monitored in a diary. participants will be supervised by the physiotherapist (telephone/text messaging). participants will be evaluated in three different moments: 1) baseline (pre-intervention); 2) at the end of the intervention (post-intervention, 6 weeks); and 3) after six months follow-up (from post-intervention). primary outcomes: pain intensity and disability. secondary outcomes: perception of recovery, postural balance, and quality of life. concurrently, a cost-effectiveness study will be conducted comparing the pilates vs home-based exercise, from the perspectives of public healthcare and society. in the first perspective, only costs incurred by the public healthcare system will be included (direct costs related to consultations, medications, tests, hospitalizations, and professional fees). in the second perspective, private health care expenses, costs incurred by patients (transportation and support by caregivers, when applicable), as well as indirect costs (missed workdays and loss of productivity) will be included. the incremental cost-effectiveness ratios for the primary outcomes and cost-utility ratios will be calculated for both perspectives. the cost-utility ratio will express the incremental costs per quality-adjusted life year (qaly). in addition, the absolute and incremental net monetary benefit will be calculated. sensitivity analyses will be conducted. data normality assumptions will be evaluated using the shapiro wilk test. if confirmed, a mixed model will be used, for the comparisons between groups and moments. it is hypothesized that the pilates will be more cost-effective compared to the home-based exercise program.


Eligibility criteria:
inclusion criteria: * presence of chronic non-specific back pain for more than 12 consecutive weeks; * not having attended pilates or physiotherapy sessions for at least 6 months prior to enrollment. exclusion criteria: * history of trauma or fractures in the spine;; * diagnosis of osteoarthritis, disc herniation or spondylolisthesis; * referred pain (visceral, abdominoplasty, appendicitis, abdominal and pelvic surgeries); * previous surgery on the spine; * presence of root symptoms; * pregnancy.

Keywords: physical therapy therapeutic exercises low back pain
diabetes prevention program

Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Glucose Intolerance

Summary: the diabetes prevention program is a nationwide clinical study to answer the question: can type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? the study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the united states. it is sponsored by the national institute of diabetes and digestive and kidney diseases of the national institutes of health, and other institute and corporate sponsors. researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying type 2 diabetes in persons with impaired glucose tolerance (igt). each person in the study will be followed for 3 to 6 years.


Eligibility criteria:
inclusion criteria: * impaired glucose tolerance (fasting plasma glucose 95-125 mg/dl and 2hr plasma glucose 140-199 mg/dl) * bmi \>= 24 kg/m2 exclusion criteria: * underlying disease likely to limit life span and/or increase risk of interventions * conditions or behaviors likely to effect conduct of the dpp * diabetes or disordered glucose metabolism * suboptimally treated thyroid disease * fasting triglyceride level \< 600 mg/dl * exclusions related to medications

Keywords: clinical trial multi-center niddm niddk diabetes prevention program (dpp) diabetes risk factors diabetes glycemia cardiovascular risk factors quality of life physical activity and nutrition occurrence of adverse events insulin secretion and sensitivity prevention abnormal glucose metabolism lifestyle intervention drug intervention
study of flavocoxid (limbrel) vs naproxen in subjects with mod-severe osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.

this will be a randomized, double blind, placebo controlled, parallel group, multi-center study in subjects with moderate-severe oa. subjects will be randomized to receive flavocoxid 250 mg bid, flavocoxid 500 mg bid, naproxen 500 mg bid or placebo in a 2:2:2:1 ratio. subjects will take study materials twice daily for twelve (12) weeks. after the 12 week visit subjects in the placebo arm will be re-randomized to the two flavocoxid arms. all subjects will then continue on the study for an additional 12 weeks. subjects will keep a diary noting date of onset of symptom change (better or worse), adverse events and cost of all aspects of medical care related directly or indirectly to osteoarthritis. laboratory studies for inflammatory markers will be drawn and archived at baseline and at the 12 week visit. in addition, a subgroup of subjects will have arthrocenteses performed at baseline and the 12 week visit and the synovial fluid archived for study of intra-articular inflammatory markers.

Eligibility criteria:
inclusion criteria: * oa of the knee * k-l grade 2-3 * positive response to nsaids exclusion criteria: * k-l grade 1 0r 4 oa of the knee * history of gi bleed within past 5 years * chronic bleeding disorder
comparison of efficacy and ocular surface assessment between bridin-plus and combigan in glaucoma or ocular hypertensive

Conditions: Glaucoma; Ocular Hypertensive

Summary: comparison of efficacy and ocular surface disease assessment between bridin-plus eye drops and combigan eye drops in glaucoma or ocular hypertensive patients : phase 4, parallel group design, investigator-blind, active-control, randomized, multi-center trial

the purpose of this clinical trial is to prove lower negative effects on ocular surface disease and higher patient compliance of a single-use formula bridin-plus® eye drops group, comparing to a multi-use formula combigan® eye drops after 12 weeks of administration to glaucoma or ocular hypertensive patients.

Eligibility criteria:
inclusion criteria 1. male or female adults who are 19 years or older with a diagnosis of glaucoma or intraocular hypertension 2. a person who has completed an appropriate washout period if glaucoma treatment medication has been used 3. intraocular pressure measured by goldman applanation tonometer at visit 2 is 15mmhg or above and less than 40mmhg 4. a person who has signed the written consent form by himself/herself or by a legal representative exclusion criteria: 1. a patient with primary close angle glaucoma, congenital glaucoma, secondary glaucoma caused by steroids 2. best corrected visual acuity of both eyes measured by snellen acuity charts is 20/80 (decimal 0.25) or less 3. a patient with progressive intraocular inflammation 4. central corneal thickness is less than 470um or greater than 591ums 5. a patient who has had lacrimal punctual occlusion done within the last 3 monthds or who has eye surgery plan during the clinical study 6. pregnant or lactating women 7. other cases if investigators judge the patient is difficult to participate the clinical trial
clinical study to evaluate the pharmacokinetics and safety of bdp hfa nasal aerosol

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 bmp - the active metabolite of bdp) after intranasal administration of bdp hfa with the systemic levels of 17 bmp after administration of orally inhaled bdp hfa in healthy volunteers.


Eligibility criteria:
inclusion criteria: * informed consent * male or female subjects 18-45 years of age * general good health exclusion criteria: * history of physical findings of nasal pathology (within 60 days prior to screening visit) * participation in any investigational drug study 30 days preceding screening visit * history of respiratory infection/disorder with 28 days preceding screening visit
daclizumab versus thymoglobulin in renal transplant recipients with high immunological risk

Conditions: Renal Transplantation

Summary: to compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either atg or the anti-il2r mab daclizumab.

the objective of this randomized, multi-center trial is to directly compare the atg, thymoglobulin, with the anti-cd25 mab, daclizumab, in a high-risk, hla-sensitized renal transplant population, in order to elucidate whether there is any significant difference in the incidence of acute rejection after one year. eligible patients were randomized (1:1) to receive either atg (1.25 mg/kg/d from day 0 to day 7) or daclizumab (1 mg/kg at days 0, 14, 28, 42 and 56). maintenance immunosuppression comprised tacrolimus, mmf and prednisone. the study's primary endpoint was the incidence of biopsy-proven acute rejection at one year.

Eligibility criteria:
inclusion criteria: 1. third or fourth renal graft or 2. current anti-hla antibodies above or equal to 30% at the last evaluation or 3. peak anti-hla antibodies above or equal to 50% at the last evaluation or 4. a second graft if the first was lost within 2 years because of rejection. 5. patients who gave their informed consent and are able to understand the scope of the study exclusion criteria: 1. transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft. 2. transplantation from a non-heart beating donor 3. transplantation of two kidneys from the same donor 4. patients with generalized infection at the time of transplantation 5. women in child-bearing age who do not plan to use efficient contraception

Keywords: renal transplantation immunisation acute rejection induction therapy thymoglobulin daclizumab rejection in sensitized renal transplant recipients