Kornimate/medical-research-clean huggingface dataset:
chronic obstructive pulmonary disease (copd) and osteoporosis

Conditions: Pulmonary Disease, Chronic Obstructive; Osteoporosis

Summary: the main objective is to study important factors in the patho-physiology of osteoporosis in patients with copd. therefore, the investigators will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data.

rationale: chronic obstructive pulmonary disease (copd) is defined as a preventable and treatable disease with significant extrapulmonary effects. osteoporosis is recognized as one of these extrapulmonary consequences. it results in increased risk of fracture and thereby an increased morbidity and mortality. nowadays it is believed that the patho-physiology of osteoporosis is multi-factorial. however, which factors are most important in patients with copd is still not clear. objective: the main objective is to study important factors in the patho-physiology of osteoporosis in patients with copd. therefore, we will study biological markers in plasma and urine and correlate them to markers of bone turnover and clinical data. study design: the present study will be an observational, cross-sectional study.

Eligibility criteria:
inclusion criteria for the copd patients: * aged 50 years or older; * women have to be postmenopausal (amenorrhea for 12 months or more) * copd global initiative of obstructive lung disease (gold) i, ii, iii and iv according to the american thoracic society (ats) guidelines; * ≥ 12 pack years; * no respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study; * no use of oral corticosteroids for at least 4 weeks before the study; * no use of anti-osteoporotic medication (calcium, vitamin d, biphosphonates) before inclusion; * capable to provide informed consent. exclusion criteria for the copd patients: * malignancy in the last 5 years; * lung fibrosis; * inflammatory bowel disease; * rheumatoid arthritis; * alcohol abuse; * bronchiectasia; * auto immune diseases; * hypothyroidism or hyperthyroidism based on blood sampling for thyroid hormone (tsh, ft4).

Keywords: copd osteoporosis pathophysiology mechanism bone markers bone turnover protein turnover ageing endocrinology vitamin d
gingival depigmentation using diode laser 940nm versus 980nm

Conditions: Gingival Pigmentation

Summary: is study aimed to evaluate the effectiveness of two diode lasers of different wave lengths 940nm and 980nm for the treatment of physiologic gingival melanin hyperpigmentation.


Eligibility criteria:
inclusion criteria: * patients of both sexes diagnosed clinically with physiologic gingival pigmentation. * pigmentation extending from canine to canine in either upper or lower arch. exclusion criteria: * smokers. * patients with uncontrolled metabolic disease. * immuno-compromised patients. * patients with renal disease. * patients having coagulation disorders. * pregnant and lactating women. * evidence about the relation of pigmentation with malignancies. * history of previous treatment of gingival pigmentation.
topical-rapa use in inflammation reversal and re-setting the epigenetic clock

Conditions: Aging; Epigenetics; Inflammatory Mediators

Summary: topical rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited.

rapamycin 8% ointment will be applied topically to one of the participant's forearms and matching placebo to the opposite forearm daily for a total of 6 months. after consenting, screening and randomization of arms, the participants will be monitored at monthly visits until study completion.

Eligibility criteria:
inclusion criteria: * 65-95 years of age. * good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable. * selected subjects will be in good health (per the world health organization, good health will be defined as complete physical, mental, and social well-being and not merely the absence of disease or infirmity). * all diseases or infirmities will be clinically stable whether managed by medications or not. * clox score of 10 or greater * women will be postmenopausal * postmenopausal women taking hormone replacement will be included if they have been on a stable dose for ≥6 months * live within a 20 mile drive of the uthsa campus (7703 floyd curl drive, san antonio, tx) exclusion criteria: * diabetes. * history of skin ulcers or poor wound healing, or keloid formers. * smoking. * liver disease. * coumadin anti-coagulation. * treatment with drugs known to affect cytochrome p450 3a (diltiazem, erythromycin, etc. - due to role in rapamycin metabolism). * treatment with an immunosuppressant (prednisone, etc.) within 6 months. * history of recent (within 6 months) myocardial infarction or active coronary disease. * hypersensitivity to rapamycin or petrolatum (ointment vehicle) * arm tattoos or scars in application area

Keywords: epigenetic clock
can whey protein improve glycemic control in type 2 diabetes?

Conditions: Type 2 Diabetes Mellitus; Hyperglycemia

Summary: the purpose of this study is to investigate whether intake of protein supplement just before meals lowers the blood sugar levels after the meals. it is believe that pre-meal administration of a high-protein supplement can effectively improve glycemic control in type 2 diabetes (dm).

11.3% of the population aged 20 years or older (25.6 million individuals) has diabetes. in the population aged 65 years or older, the prevalence of diabetes reaches to 26.9%. type 2 dm is caused by insulin resistance accompanied by insufficient compensatory insulin response. therefore insulin secretagogues are a significant component of the therapeutic armamentarium. insulin secretagogues, such as sulphonylureas and meglitinides, are routinely prescribed to lower post prandial glucose levels in type 2 dm. however, these medications are cleared by the liver and the kidneys and cannot be used in the presence of relevant co-morbidities. these medicines can also cause side effects, including hypoglycemia. limitations of these medicines are likely to lead diabetic patients and their health care providers to seek alternate methods to treat postprandial hyperglycemia. thus, our research which aims to identify an alternate insulin secretagogue is important and timely. whey protein (wp), a rich source of essential and branch chain (bc) amino acids (aa), is a potent insulin secretagogue. although it is well known that protein and/or aa intakes stimulate insulin secretion, protein supplements are not being used clinically in order to lower post-prandial glycemia. wp can be a satisfactory alternative to the pharmaceutical insulin secretagogues.

Eligibility criteria:
inclusion criteria: * men and women with type 2 dm; age: 25 to 70y; bmi: 25 - 40 kg/m2; on no drug treatment or on metformin alone; hgba1 6.5 - 8.5%; urinary microalbumin \< 30 mg/g cr. exclusion criteria: * systemic disease (liver, renal, untreated hypothyroidism, etc); in the last 2 mo: \> 5% weight change, smoking, alcohol intake \> 4 /wk; restricted diets; medications or herbals affecting insulin secretion/sensitivity . pregnant women, prisoners, individuals who cannot provide informed consent.

Keywords: whey protein protein supplement diabetes type 2 dm hyperglycemia insulin secretagogue
symbicort turbuhaler 30/60 clinical experience investigation

Conditions: Bronchial Asthma

Summary: the purpose of this study is to confirm the safety (adr related to beta stimulant drugs, unexpected adrs) and efficacy of symbicort in daily practice and the control status on bronchial asthma and patient satisfaction


Eligibility criteria:
inclusion criteria: * patients treated with symbicort for the first time due to bronchial asthma exclusion criteria: -

Keywords: bronchial asthma symbicort
lactate clearance in hospital-acquired pneumonia

Conditions: Pneumonia; Mortality; Lactate; Prognosis

Summary: there is no clear consensus on the use of pneumonia severity index (psi) developed for community-acquired pneumonia in hospital-acquired pneumonia cases. in another aspect, psi is a relatively difficult scoring system that includes many parameters. this study evaluated whether lactate clearance could be used as a mortality marker instead of psi in hospital-acquired pneumonia. as a result, lactate clearance was lower in the mortal group and when the diagnostic statistics were evaluated, it was seen that the sensitivity and specificity rates were significantly higher. in conclusion, lactate clearance has been evaluated as a strong predictor of mortality in hospital-acquired pneumonia.


Eligibility criteria:
inclusion criteria: * 18 and over age, hospital-acquired pneumonia, emergency department admissions exclusion criteria: * patients who are pregnant or lactating, under 18 years of age, in the healthcare-associated pneumonia group, had mechanical ventilation at the last hospitalization, whose lactate level could not be studied for any reason at admission and 6th hour, had missing data used in pneumonia severity index calculation and/or who did not accept to participate in the study
tbtc study 23a: pharmacokinetics of intermittent isoniazid and rifabutin in hiv-tb

Conditions: HIV Infections; Tuberculosis

Summary: primary objectives: 1) to determine the proportion of patients with hiv-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin. secondary objectives: 1. to determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin. 2. to evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy. 3. to evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of tb therapy. 4. to define and correlate phenotypic inh acetylator status with the results of genotypic acetylator data obtained in the parent trial.

this study will seek to enroll every eligible patient enrolled in tbtc study 23. consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-oh desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).

Eligibility criteria:
inclusion: 1. patient enrolled in tbtc study 23 2. informed consent exclusion: 1. severe anemia (hct \<25%)

Keywords: tuberculosis tb
the impact of time restricted feeding in crohn's disease

Conditions: Crohn's Disease (CD)

Summary: time-restricted feeding (trf) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. trf has been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. this proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active crohn's disease. if time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.


Eligibility criteria:
inclusion criteria: * subjects has active crohn's disease of the ileum and/or colon. the diagnosis should be confirmed by endoscopic or radiological evidence. * active inflammation on colonoscopy performed as evidenced by an ses-cd ≥ 6 (or ≥ 4 for isolated ileal disease) or c-reactive protein ≥ 1.0 mg/l or fecal calprotectin ≥ 250 μg/g. any or all of these results must be from within 180 days of study entrance. * subject should have bmi of \>18.5 and \<40 exclusion criteria: * subjects who decline to provide informed consent * subject with a history of an eating disorder, major gastrointestinal surgery within the past 3 months. * subject with a history of antibiotic use within 4 weeks. * subject with a history of bowel obstruction within the past 12 months * subject with a history of diabetes requiring medication * subject who is currently pregnant or breastfeeding will be excluded * subjects with current antibiotic use. in order to participate, subjects will be required to have a 2-week wash-out period.

Keywords: fasting time restricted feeding intermittent fasting inflammatory bowel diseases (ibd) ibd cd
comparison of diclofenac vs. nepafenac ophthalmic drops: patient comfort

Conditions: Post Surgical Management; Pain Management; Inflamation Management

Summary: in this study we test diclofenac and nepafenac and compared patients experience and comfort following administration of these ophthalmic drops.

in this study we will compare the ocular tolerability between preservative-free diclofenac and nepafenac drops. using a standard comparative scale we will measured discomfort, itching, burning and pain in intervals of 1 sec, 5 sec, 1 min and 5 min post-administration. the results may aid both doctors and patients in decision regarding the post surgical anti-inflammatory treatment.

Eligibility criteria:
inclusion criteria: * patient facing cataract surgery exclusion criteria: * under 18 * cognitive decline
vitamin d deficiency in adults following a major burn injury

Conditions: Vitamin D Deficiency; Burns

Summary: this is a single site double blind randomized controlled trial of replacing vitamin d for vitamin d-deficient burn patients at a current recommended dose (400 iu daily) versus a higher dose (4000 iu daily). capsules will be made in a compounding pharmacy and will look identical. randomized controlled trial. people who meet the selection criteria will be randomized to either low or high dosage of vitamin d. treatment arm is high dose vitamin d (4000 iu), and control is low dose vitamin d (400 iu). main outcome variables include promis-29 measures of physical health, mental health and social health, the veterans rand 12 item health survey (vr-12), and the 4-d itch scale. secondary outcome variables include subject demographics, injury demographics and characteristics.


Eligibility criteria:
inclusion criteria: 1. adults, 18 years of age or older, who have completed 6 months from time of their burn injury 2. ≥ 10% tbsa, ≥ 65 years of age and burn surgery for wound closure 3. ≥ 20% tbsa, 18 - 64 of age and burn surgery for wound closure 4. electrical high voltage / lightning and burn surgery for wound closure 5. hand burn and/or face burn, and/or feet burn and burn surgery for wound closure 6. may speak english or spanish 7. vit. d deficiency exclusion criteria: 1. patients with parathyroid disease, severe liver dysfunction, sever kidney dysfunction, which are not caused by the burn injury 2. patients with malignant tumors 3. patients not meeting the inclusion criteria
immunogenicity & safety study of gsk biologicals' combined measles-mumps-rubella-varicella vaccine 208136

Conditions: Measles; Varicella; Mumps; Rubella

Summary: this phase 3b study is being conducted for the purpose of registration of the gsk208136 vaccine in korea.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including 11 and 24 months of age, at the time of the vaccination. * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis a or b vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose. * previous vaccination against measles, mumps, rubella and/or varicella. * history of measles, mumps, rubella and/or varicella/zoster diseases. * known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start. * 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(s), including systemic hypersensitivity to neomycin. * major congenital defects or serious chronic illness. * acute disease at the time of enrolment. * rectal temperature ≥ 38°c or axillary temperature ≥ 37.5°c at the time of vaccination. * residence in the same household as a high risk person e.g.: * new-born infants (0-4 weeks of age) * pregnant women who have a negative history of chickenpox * persons with known immunodeficiency

Keywords: second year of life one-dose schedule varicella rubella measles mumps
passive mobilisation of region of shoulder joints for hemiplegic patient

Conditions: Hemiplegia

Summary: hemiplegia is a high prevalence pathology with 1 per 1000 habitants in france. one of these complications is shoulder pain which affects about 35 to 70% of cases. the medical care of this complication is critical because it affects the patient's quality of life and also hinders participation in rehabilitation sessions slowing the recovery of independence in activities of daily living. literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his attitude pronounced lateral rotation. but no data to confirm that passive mobilization reduce shoulder pain. because no data available to permit us to determine the sample size we set-up this preliminary study to check if efficiency found in these preliminary data are consistent with an estimable real efficacy in a randomized trial feasible.


Eligibility criteria:
inclusion criteria: * hospitalized in physical medicine and rehabilitation at centre hospitalier universitaire réunion (site of le tampon) * having made a cerebrovascular accident between 30 and 3 days before inclusion * with pain in the upper limb whose score with visual analogue scale is greater than or equal to 20 mm * able to understand the question: "do you have arm pain?" exclusion criteria: * with visual analogue scale score lower than 20 mm at the inclusion * with aphasia of comprehension * with medical contraindication for passive shoulder mobilisation (shoulder fracture, dislocation,...) * opposing to any mobilization * with shoulder pathology previously known * history of cerebrovascular accident prior 30 days before inclusion
usefulness of chromoendoscopy in diagnosing microscopic colitis

Conditions: Chronic Diarrhoea; Lymphocytic Colitis; Collagenous Colitis

Summary: the purpose of this study is to determine whether chromoendoscopy using indigo-carmine dye spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due to chronic watery diarrhea.

microscopic colitis is a common disease found in 10% to 20% of cases having chronic watery diarrhea. obvious endoscopically identifiable changes of the mucosal surface are usually absent, thus diagnosing microscopic colitis relies on multiple biopsy sampling from all segments of the colon. chromoendoscopy using indigo-carmine dye spray might, however, unravel mucosal changes in microscopic colitis (suzuki 2011). the aim of this study is to investigate if chromoendoscopy using indigo-carmine 0.2-0.5% in patients with chronic watery diarrhea is useful in diagnosing microscopic colitis.

Eligibility criteria:
inclusion criteria: * patients with chronic non-bloody diarrhea for at least one month exclusion criteria: * patients who decline to participate * unable to give informed consent

Keywords: microscopic colitis intestinal diseases inflammatory bowel diseases
bi 836826 dose escalation in patients with relapsed or refractory non-hodgkin lymphoma (nhl)

Conditions: Lymphoma, Non-Hodgkin

Summary: the purpose is to investigate the maximum tolerated dose (mtd), safety and tolerability, pharmacokinetics and efficacy of bi 836826 monotherapy in patients with relapsed or refractory non-hodgkin lymphoma with at least prior treatments.


Eligibility criteria:
inclusion criteria: 1. patients with relapsed or refractory non-hodgkin lymphoma of b cell origin (mature b cell lymphoma according to who) not considered candidates for intensive anti-lymphoma therapy 2. patients must have either aggressive nhl and received at least one prior anti-cd20 containing immunochemotherapy or indolent nhl and received anti-cd20 therapy and at least two prior therapies 3. measurable disease on computed tomography (ct) scan with involvement of one clearly demarcated lesion =2 cm or two or more clearly demarcated lesions of \>1.5 cm at longest diameter (this criterion applies only for the expansion cohort) 4. relapse or progression of disease with an indication for therapy as per investigator's judgement 5. life expectancy of =3 months 6. eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: 1. primary central nervous system (cns) lymphoma or known cns involvement 2. prior history of malignancy other than a mature b cell neoplasm according to who classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix or breast treated with curative therapy) unless the subject has been free of disease and without treatment for at least 5 years 3. last chemotherapy \<4 weeks prior to visit 1 4. last anti-cd20 therapy (non-radiolabelled) \<4 weeks prior to visit 1 5. last corticosteroid \<2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent 6. high-dose therapy with stem cell support \<6 months prior to visit 1 7. radio-immunotherapy \<3 months prior to visit 1