Kornimate/medical-research-clean huggingface dataset:
opus study: effect of roflumilast on exacerbation rate in patients with chronic obstructive pulmonary disease (by217/m2-111)

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Summary: the purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
main inclusion criteria: * fev1/fvc ratio (post-bronchodilator) ≤70% * fev1 (post-bronchodilator) ≤50% of predicted * current smoker or ex-smoker * clinically stable copd indicated by no exacerbation and no change in copd treatment of within 4 weeks prior to baseline * availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline main exclusion criteria: * copd exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline * lower respiratory tract infection not resolved 4 weeks prior to baseline * diagnosis of asthma and/or other relevant lung disease * known alpha-1-antitrypsin deficiency * need for long-term oxygen therapy defined as ≥16 hours/day

Keywords: roflumilast chronic obstructive pulmonary disease copd
randomized study of alendronate in adult patients with cystic fibrosis related osteoporosis

Conditions: Osteoporosis; Cystic Fibrosis

Summary: objectives: i. determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis. ii. assess the safety and efficacy of this treatment regimen in improving osteoporosis in this patient population.

protocol outline: this is a randomized, double blind study. patients will be stratified according to sex (male vs female) and osteoporosis disease severity (mild vs severe). patients are randomized to one of two treatment arms. patients undergo bioavailability assessment to confirm the ability to absorb alendronate. arm i: patients receive calcium and vitamin d supplements with a placebo daily for one month. arm ii: patients receive calcium and vitamin d supplements with oral alendronate daily for one month. treatment continues if differences are seen in bone mineral density between the treatment arms. patients are followed for biochemical response at week 6, 12, and 52. bone mineral density is measured at 1 year and 2 years. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of cystic fibrosis mild to moderate lung disease * at least one site specific (spine or femur) bone mineral density representing low bone mass or osteopenia (greater than 1 standard deviation below peak bone mass) --prior/concurrent therapy-- * endocrine therapy: at least 3 months since prior corticosteroids --patient characteristics-- * performance status: ambulatory * renal: creatinine no greater than 3 mg/dl no renal failure * other: no history of esophagitis no allergies to alendronate not pregnant fertile female patients must use effective barrier contraception or progestin only oral contraceptives (e.g., norethindrone) ability to comply with treatment no intestinal problems other than cystic fibrosis

Keywords: cardiovascular and respiratory diseases cystic fibrosis disease-related problem/condition genetic diseases and dysmorphic syndromes osteoporosis rare disease
assessment of efficacy and safety of tegaserod treatment and placebo in women with dyspepsia

Conditions: Dyspepsia

Summary: this study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. tegaserod will be evaluated at 6mg twice daily and placebo.


Eligibility criteria:
inclusion criteria: * female patients, 18 years and older * self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia; for at least 12 weeks, not necessarily consecutive, during the previous 12 months. exclusion criteria: * abnormal esophago-gastro-duodenoscopy (egd) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an edg exam performed with 12 weeks prior to baseline. * current or history of erosive esophagitis confirmed by egd * heartburn occurring 3 or more days a week. other protocol-defined inclusion/exclusion criteria may apply

Keywords: dyspepsia, gastrointestinal, tegaserod
femoral artery block for reduction of tourniquet induced hypertension

Conditions: Tourniquets; Anesthesia, Conduction; Anesthetics, Local; Hypertension

Summary: a randomised controlled trial to assess the impact of femoral artery block on the incidence of tourniquet hypertension in patients receiving cruciate ligament surgery with \> 30 minutes of tourniquet under combined anaesthesia (balanced general anaesthesia and femoral nerve blocks).


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i to iii * receiving cruciate ligament surgery with \> 30 minutes of tourniquet * combined anesthesia (balanced general anesthesia and femoral nerve block) exclusion criteria: * nerve block contraindications (block site infection, allergic to local anesthetic) * tourniquet contraindications (peripheral vascular disease or neuropathy, previous arterial bypass graft) * tourniquet inflation time \< 30 min * patient refusal * pregnant patients * patients with a active psychiatric disease.
molecular imaging of inflammation with 18f-pbr06 to identify unstable carotid plaques in patients with stroke

Conditions: Stroke

Summary: evaluating an innovative molecular imaging technique to visualize inflammation of the atherosclerotic plaque in patients with a recent ischemic stroke (\ 50%, by performing a positron emission tomography-computed tomography (pet-ct) with pbr06 18f, a tracer for translocator protein (tpso).

more than one third of cerebral ischemic events are related to an atheromatous plaque. inflammation, through a key player, the macrophage, is associated with increased metabolic activity of atherosclerotic plaque and its possible rupture. inflammation within the plate is thus a marker of instability. these data underscore the importance of a prospective evaluation of inflammation with specific imaging with pet tracers inflammation.

Eligibility criteria:
inclusion criteria: * man with transient ischemic attack or recent ischemic stroke (\<15j) in the carotid territory, confirmed by mri * man with carotid stenosis\> 50% on the side of stroke * male candidate for carotid endarterectomy * subject affiliated or beneficiary of a social security scheme * informed written consent exclusion criteria: * women * chronic inflammatory disease in progress (cancer, vasculitis, ...) * patient with infection within 7 days * a person placed under judicial protection, guardianship * incapable of giving consent * low affinity binder for tspo

Keywords: positron emission tomography carotid plaque inflammation stroke
effects of a program of physical exercise and electrotherapy on muscle strength in subjects of the fourth age

Conditions: Geriatric Assessment; Muscle Strength; Postural Balance; Body Mass Index

Summary: the purpose of this study is to determine whether neuromuscular electrical stimulation, strengthening exercises, or combination of both over lower limbs are effective in the improvement of the stability fundamentally against falls, greater independence and, therefore, better quality of life in elderly over 75 years.


Eligibility criteria:
inclusion criteria: * age above 75 exclusion criteria: * mental disorder * previous electrotherapy treatments * pacemakers * lower limbs prosthetics * major coronary diseases

Keywords: aged strength balance electrotherapy quality of life
comparative effects of backward treadmill walking and lower extremity cross training among stroke patients

Conditions: Stroke

Summary: stroke is one of the high rated neurological disorders, induced by disruption of brain's blood flow. stroke can alter the level of consciousness, motor and cognitive skills, sensory perception and language; it all depends on the extent of injury and the region of brain that is affected. even though all the rehabilitation given to the "stroke" patients, but still 25-30% of the survivors still have gait and balance problem and they require complete physical support before their discharge from the hospital. backward treadmill walking has reported numerous benefits in improving balance, motor function and gait. cross training is a technique which is applied to healthy limb of the individual to increase muscle strength and muscle activity.so the aim of this study is to find the effects of backward treadmill walking and lower extremity cross training on gross motor function and balance among stroke patients. the study will be randomized clinical trials, participants will be randomly allocated into two groups each group will have 13. this study will be conducted in safi teaching hospital faisalabad. group a will be treated with backward treadmill walking and group b will be treated with lower extremity cross training. all participants will receive conventional physical exercises which includes general mobility and functional activities. in this study, the 40-minute training programs for both groups will be occur 5 times a week for 6 weeks, with 5 minutes being allocated for warm up, 30 minutes devoted to the main exercise, and 5 minutes for cool down. outcome will be measured before and after giving treatment by using tinetti performance oriented mobility assessment and lower extremity functional scale. the results will be calculated by using spss version 25. frequencies and mean standard deviation will be measured, parametric and non-parametric tests will be applied


Eligibility criteria:
inclusion criteria: * hemiplegic stroke patient diagnosed within last 6 months to 1 year * age 55 to 75 years * cognition score on mini-mental state examination \> 24 * able to independently walk 10 m without walking aids * able to understand instructions exclusion criteria: * who will have visual or vestibular injury * patients having history of orthopedic surgery or having an orthopedic condition * who will have \>grade 2 on modified ashworth scale (mas)
whole milk versus whey protein supplement and resistance exercise

Conditions: Muscle Development

Summary: the purpose of the study is to examine the effects of consuming protein supplement (whey) compared to whole milk immediately after bouts of resistance training on muscular strength and body composition.


Eligibility criteria:
inclusion criteria: * healthy * currently working out at least 3 times per week exclusion criteria: * taken any ergogenic aid/sport supplements in the last 2 months

Keywords: lean tissue strength condition protein amino acid
the endocarditis aumc data collection

Conditions: Endocarditis; Coagulation Disorder; Valve Disease, Heart

Summary: the investigators will compare patients with and without infective ndocarditis undergoing valve surgery and evaluate factors that may help optimise perioperative care of these high-risk patients.

the aim of this study is to examine the differences between patients with and without endocarditis who undergo cardiothoracic (valve) surgery. in addition, the investigators will look at the differences between endocarditis patients who undergo surgery, and those who are treated conservatively. the investigators will look at incidence and degree of perioperative coagulation abnormalities, as well as transfusion and coagulation factor requirements, heparin resistance, bleeding scores, predictive endocarditis mortality scores, vasopressor-inotrope scores, and relate these where possible to the pathogen causing ie. the investigators will also look at perioperative complications, in particular, thromboembolic events and mortality at 30 and 90 days, and at 1 year. these outcomes may help optimise perioperative care for high-risk endocarditis patients, and in particular those undergoing valve surgery.

Eligibility criteria:
inclusion criteria: * patients \> 18 years * dutch or english speaking * all patients with infective endocarditis admitted to amsterdam umc in the study period * all patients with infective endocarditis scheduled for cardiac valve surgery compared to a matched cohort of patients scheduled for similar surgery due to non-infectious indication in amsterdam umc in the same period exclusion criteria: * previous history of coagulation disorders
physical activity intervention for gestational diabetes

Conditions: Gestational Diabetes

Summary: gestational diabetes mellitus (gdm) portends an immediate, increased risk for type 2 diabetes mellitus (t2dm). the increased risk associated with having gdm is compounded by excess weight retention. therefore, the weeks and months immediately after a gdm-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay t2dm. the long-term goal is to prevent t2dm among women with gdm. this study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with gdm.

gestational diabetes mellitus (gdm) portends an immediate, increased risk for type 2 diabetes mellitus (t2dm). the increased risk associated with having gdm is compounded by excess weight retention, a common issue after any pregnancy. considering excess weight is the best predictor of developing t2dm, the weeks and months immediately after a gdm-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay t2dm. the long-term goal is to prevent t2dm among women with gdm. this study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with gdm in a parallel two-arm randomized controlled trial (n=80 women/arm, n=160). the intervention uses ankle weights (2.5 pounds \[1.1 kg\]) worn on each ankle during routine daily activities (e.g., cleaning, cooking, child care) to increase energy expenditure. the central hypothesis, based on existing literature and preliminary data, is that postpartum women with gdm will adopt an intervention that requires minimal additional time outside of their daily activities. we anticipate that this will result in additional weight loss that is clinically significant when compared with controls who only receive standard information on recommended physical activity. the rationale for the proposed research is that once an intervention that both improves t2dm factors and is easily adopted by women with gdm is known, early intervention specific to this restricted timeframe can be implemented.

Eligibility criteria:
inclusion criteria: * age 18+ years * diagnosed with gdm in current pregnancy * english language ability adequate for participation * plan to remain in the area for study duration * ability to provide informed consent exclusion criteria: * prior type 1 or type 2 diabetes * pregnant with multiples (e.g., twin, triplets, etc.) * premature infant \[\<35 completed weeks gestation (assessed after delivery, before randomization)\] * heart disease, serious illness, or conditions that may impede or prohibit participation in either study arm * pre-pregnancy bmi \<18.5 (underweight) * live outside 35 mile radius of ohio state university * woman is an appointed surrogate * infant will be adopted after delivery
influence of probiotics on atopy with focus on respiratory allergic diseases- follow-up to 7 years

Conditions: Asthma; Allergic Rhinitis

Summary: the investigators had conducted an initial double-blind, placebo-controlled clinical trial (nct00318695) to study the effects of probiotic supplementation from birth to 6 months of age in the incidence of atopic diseases at 2 years old. this is then further investigated up to 5 years of age in a follow-up study nct00365469 to assess the longer term beneficial effects. this current study intends to follow-up for another 2 years until 7 years of age as this is critical in the evaluation of respiratory allergies in the form of clinical asthma and allergic rhinitis.

this study intends to continue the initial double-blind, placebo-controlled randomized clinical trial (nct00318695) which involved 253 subjects with a first degree family history of allergic disease. the infants received at least 60ml of commercially available cow's milk based infant formula with or without probiotic supplementation (bifidobacterium longum \[bl999\] 1×10\*7 colony-forming unit (cfu)/g and lactobacillus rhamnosus \[lpr\]2×10\*7 cfu/g) daily from the first day of life for the first 6 months. a follow-up study (nct00365469) up to 5 years of age is currently in process. this current study plans to continue the follow-up for a further 2 years till the cohort reaches 7 years of age. this study will only involve telephone calls which will be conducted every 3 months to ascertain for symptoms and incidence of respiratory allergic disease.this is critical in the evaluation of asthma and allergic rhinitis which tend to develop later in life and this step-wise, temporal development of respiratory allergies has been described as "atopic march".

Eligibility criteria:
inclusion criteria: * subject has completed the both nct00318695 and nct00365469 studies. * parent(s) / guardian consent to the subject's participation in the study. * subject and the parent(s)/ guardian are willing to comply with the study procedures exclusion criteria: * the parent is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained. * the parent is unable/ unwilling to comply with study procedures

Keywords: probiotics asthma allergic rhinitis
evaluation of pregnancy outcome with usage of drug-free in-vitro activation of follicles ovary

Conditions: Infertility (IVF Patients); Infertile Females or Females with Ovarian Insufficiency

Summary: this study is the pilot study to evaluate the effect of drug-free in vitro activation to improve the outcomes of ivf in poor responder women

first, patients who are poor responders based on poseidon criteria 1, 3 (women under 35 years of age who either have abnormal ovarian reserve tests or have not had an adequate ovarian response in an ivf cycle) are included in the list of poor responders and are consulted after a complete evaluation by a physician. the patient has a history of poor response in previous ivf cycles. after obtaining the patient's consent, the patient undergoes laparoscopy. the laparoscopy procedure will be performed at milad infertility center, which is equipped with a laparoscopy operating room and a laboratory nearby. the procedures will be performed by a single surgical team that includes laparoscopy and infertility flowsheets. after general anesthesia and pre- and post-operative care, double puncture laparoscopy will be performed. two minor trocars will be placed, which will be held in place by an ovarian grasper. with scissors, a part of the ovarian cortex is first separated from the underlying medulla and strips of cortex 1 to 2 mm thick and 10 mm long are removed. they are immediately transferred to the adjacent laboratory. a 1 x 5 mm sample from the removed piece is used for histological examination and determination of the number of remaining follicles. the tissue is then divided into 1 x 1 x 1 mm pieces. the removal site will be sutured in case of bleeding. the preparation of the ovary into small pieces will be performed by a single physician for all patients. the prepared pieces are immediately transferred to the operating room. then the surgeon places the prepared pieces in the tunnel between the cortex and medulla in the opposite ovary and then sutured. the patient is then followed up and immediately treated with fsh (sinagene company, tehran, iran) at a maximum dose of 300 units, and then the dose is adjusted according to the ovarian response. when a 12 mm follicle is observed, 0.25 mg of sterotide (merck serono, mississauga, canada) is started. when the size of 1 or 2 follicles reaches 16, 10,000 units of hcg (puyish daru company, tehran, iran) and two ampoules of deca (decapeptyl 0.2 mg, ferring, germany) are given together for triggering. ovulation is performed 36 hours later under transvaginal ultrasound guidance.

Eligibility criteria:
inclusion criteria: * women under 35 years of age who have one of the following characteristics: or poor response to gonadotropins in a previous ivf cycle (fewer than 3 oocytes in a previous ivf cycle) or ovarian reserve test amh less than 1.1 exclusion criteria: * unwillingness to continue working with the researcher during the procedure
blueberry intake and infant gut health

Conditions: Infant Development

Summary: the objective of this project is to investigate the effects of blueberries on gut microbiota, inflammation and innate immunity in breastfed infants during early complementary feeding (\~5 to 12 months of age).

some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.

Eligibility criteria:
inclusion criteria: * generally healthy * full term (gestational age ≥ 37 weeks) * no prior exposure of solid foods * exclusively breastfed (\< 2 weeks of cumulative formula exposure) * willing to consume blueberry/placebo powder exclusion criteria: * having health conditions that would affect normal growth * pre-term * consumed formula for more than two weeks * not willing to consume the blueberry/placebo powders

Keywords: blueberries gut microbiota inflammation innate immunity early complementary feeding
virtual sailing simulator in individuals with spinal cord injury

Conditions: Spinal Cord Injury

Summary: the research is being done to look at the benefits of a recreational and therapeutic program for people with spinal cord injury using the vsail-access sailing simulator.

the vsail-access is the first sailing simulator available for people with disabilities. the vsail-access simulator is a variation on the vsail where the cockpit is fitted with a seat. the vsail simulator is a generic sailboat cockpit powered by a pneumatic ram and custom designed software. the sailor sails the simulator around virtual courses displayed on a computer screen in the same way as a real sailboat on water. electronic sensors provide real time feedback to match the movements of the virtual sailboat displayed on the screen with those of the simulator. sailors can select wind strength and conditions to suit their ability. adults with spinal cord injury may take part in this study.

Eligibility criteria:
inclusion criteria: * males and females, age 18-65 years, all ethnic groups. * spinal cord injury. * chronic injury, \> 6 months from the injury. * all asia neurological levels (c1-s1) * all asia impairment scale a-d . * subjects are able to comply with procedures and follow-up. * subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues. exclusion criteria: * cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke nyha class iii or iv, history of arrhythmia with hemodynamic instability. * uncontrolled hypertension (resting systolic bp \> 160mmhg, or diastolic bp \> 100mmhg consistently). * severe hypotension (systolic bp \< 80 mmhg, or diastolic bp \< 55 mmhg). * ventilator dependent subjects. * significant cognitive impairment. * history of epileptic seizures. * unstable long bone fractures of the extremities. * subjects having stage iii or greater skin ulcerations. * active sailor. * active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

Keywords: spinal cord injury virtual sailing vsail