Kornimate/medical-research-clean huggingface dataset:
effects of acapella vs chest physiotherapy in post-operative cabg patients

Conditions: CABG

Summary: coronary artery bypass grafting (cabg) is a surgical procedure that is performed to improve blood flow to the heart by bypassing blocked or narrowed arteries. cabg is a major surgery that is associated with significant postoperative complications, including pulmonary complications such as atelectasis and pneumonia. chest physiotherapy is commonly use to prevent and treat these complications, but its effectiveness in post-operative cabg patients is not well established. the purpose of this study is to evaluate the effects of acapella device vs chest physiotherapy on pulmonary function, airway clearance and dyspnea in post-operative cabg patients. the group a will receive (baseline treatment aerosol therapy, acbt, mobilization, breathing with arm elevation with addition to using acapella), while the group b will receive base line treatment. aerosol therapy, acbt, mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute the primary outcome measures of the study will be pulmonary function tests, including forced vital capacity (fvc), forced expiratory volume in one second (fev1), and fev1/fvc, and modified borg dyspnea scale . the secondary outcome measures will be the amount of sputum cleared. the study will be conducted over a period of 6 months after approval of synopsis. the study will be conducted in a tertiary care hospital in lahore, pakistan. patients who have undergone cabg surgery will be screen for eligibility and those who meet the inclusion criteria will be enroll in the study. patients who have a history of chronic lung disease, smoking, intubated patient or other respiratory conditions will be exclude from the study


Eligibility criteria:
inclusion criteria: * both gender * patients aged between 55-70 years * vitally stable * extubated post-cabg day 01 patients * patient undergone for the 1st time cabg exclusion criteria: * with a history of chronic obstructive pulmonary disease or asthma patient * intubated patient * surgical complication after cabg * with a history of smoking * patients who have undergone thoracic surgery in the past * patients with a history of neuromuscular disorders * patients with a history of heart failure * vitally unstable or on ventilator post cabg patients

Keywords: cardiac surgery cabg pulmonary function airway clearance dyspnea post-operative complications pneumonia atelectasis
this research hypothesizes that the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.

Conditions: Diabetic Foot; Diabetic Foot Ulcer

Summary: this research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. the hypothesis of the research is the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetic patients regardless of the pharmacotherapy that they receive. * adult patients of both sexes. * peripheral neuropathy patients. * patients without wounds or ulcers at the examination time. * patients with a foot ulcers history. * patients with or without minor amputation prior to the inclusion time in the present study. * patients who don´t need gait support mechanisms such as walking sticks, crutches, splints or any other devices which interferes with the autonomous development of the gait. exclusion criteria: * patients with mayor amputation. * patients with rheumatic disease that affect the feet. * patients with peripheral neuropathy of different etiology to diabetes mellitus. * patients with several critical ischemia criteria, defined by tacs ii guideline.
collection of tumor tissue, blood and spinal fluid from patients with brain or spine tumors

Conditions: Primary or Metastatic Central Nervous System (CNS) Tumor

Summary: the purpose of the study is to collect samples of brain or spine tumors. memorial sloan-kettering cancer center would then store them for use by researchers who study brain or spine cancer and try to find better ways of treating it. we will also collect blood and spinal fluid from patients with brain or spine tumors. the blood and spinal fluids are also used for research studies of cancer and its treatment.

the main objective of the protocol is the establishment of a repository of central nervous system (cns) tumors or metastases to the cns and related tissues as an invaluable resource for current or future research studies of the etiology, pathogenesis and treatment of human central nervous system tumors. the database will be established through the intra-operative acquisition of brain or spine tumors as well as the collection of blood and spinal fluids from consenting cns tumor patients.

Eligibility criteria:
inclusion criteria: * for acquisition of intra-operative brain or spine tumor specimens, blood specimens and spinal fluid specimens, all patients who undergo surgery for resection or biopsy qualify for inclusion in this protocol. * if spinal fluid is not accessed as part of the operative procedure, it will not be collected. * all patients must be under the care of one or more members of the mskcc cns disease management team at the time of tissue acquisition. patients may have been previously diagnosed and/or treated at another institution. * subjects are eligible regardless of sex, age or race. * parental or guardian consents will be obtained in the case of minors (less than 18 years of age) exclusion criteria: * patients or their guardians, in case of a minor, may choose to be excluded at any time. * if a patient, or guardian, decides to withdraw after some or all of the tissues have been collected, such tissues will be destroyed at their request. * patients or their guardians will be counseled at the time of obtaining their consent, of the possibility of withdrawing from the protocol.

Keywords: central nervous system (cns) tumor tissue collection
interrogating the pathophysiological mechanisms of constipation in patients with systemic sclerosis

Conditions: Systemic Sclerosis; Constipation; Gastrointestinal Motility Disorder; Autonomic Dysfunction

Summary: the purpose of this study is to determine whether transcutaneous electrical acustimulation (tea) alters systemic sclerosis (ssc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ans) function. the study will examine the effects of tea on slow colonic transit (sct) and rectal hyposensitivity (rh), to examine whether tea improves autonomic dysfunction and modulates inflammatory pathways.


Eligibility criteria:
inclusion criteria * patients with ssc-constipation from aim 1 of the study * patients with sct (\>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the sitzmark capsule or patients with rh (defined in aim 1) * patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to tea. exclusion criteria -patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
a study of guselkumab in participants with moderately to severely active crohn's disease

Conditions: Crohns Disease

Summary: the purpose of this study is to evaluate the safety of guselkumab in participants with crohn's disease.


Eligibility criteria:
inclusion criteria: * have crohn's disease (cd) or fistulizing cd of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * have moderate to severe cd as assessed by cdai components of stool frequency (sf), and abdominal pain (ap) scores, and endoscopic evidence * have screening laboratory test results within the protocol specified parameters * a female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline * demonstrated intolerance or inadequate response to conventional or to biologic therapy for cd exclusion criteria: * has complications of cd, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation * unstable doses of concomitant crohn's disease therapy * receipt of crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol * prior exposure to p40 inhibitors or p19 inhibitors * any medical contraindications preventing study participation
lcar-b4822m-02 cells in treating relapsed/refractory (r/r) multiple myeloma

Conditions: Refractory or Relapsed Multiple Myeloma

Summary: this is a single arm, open-label, phase 1 study, to determine the safety and efficacy of lcar-b4822m car-t cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r mm).

multiple myeloma (mm) is a usually incurable malignancy of plasma cells. current therapies for multiple myeloma often cause remissions, but nearly all patients eventually relapse, there is an unmet clinical needs for these patients. b-cell maturation antigen (bcma) is a protein expressed by normal plasma cells and the malignant plasma cells of multiple myeloma, and it was supposed to be a promising target for r/r mm.

Eligibility criteria:
inclusion criteria: - patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated imwg criteria. patients with refractory multiple myeloma. clear bcma expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry. refractory disease：1) at least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors. relapse criteria in nccn clinical practice guidelines in oncology: multiple myeloma (2016.v2) exclusion criteria: - women of child-bearing potential or who are pregnant or breastfeeding. have any active and uncontrolled infection: hepatitis b, hepatitis c, hiv, or other fatal viral and bacterial infection. systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen. patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder. patients with cns metastases or symptomatic cns involvement (including cranial neuropathies or mass lesions and spinal cord compression). history of allogeneic stem cell transplantation. have active acute or chronic graft-versus-host-disease (gvhd), or require immunosuppressant medications for gvhd, within 6 months of enrollment. patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.
fractional flow reserve (ffr) versus intravascular ultrasound (ivus) in intermediate coronary artery disease

Conditions: Coronary Artery Stenosis

Summary: this study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of intravascular ultrasound (ivus) versus fractional flow reserve (ffr) guided percutaneous coronary intervention (pci) with intermediate coronary artery lesion.

this trial is a prospective, randomized, open label, two arm designed multi-center trial. when diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, ivus and/or ffr will be performed in order to decide pci or defer by 1:1 randomization. the patients would be followed up to 2 years clinically.

Eligibility criteria:
inclusion criteria: clinical indication: * patients with angina or patients with documented silent ischemia * patients who are eligible for intracoronary stenting * age \> 18 years old, \< 75 years old angiographic indication: * intermediate coronary artery disease (30-70% diameter stenosis) by visual estimation * reference vessel diameter ≥ 3.0mm by visual estimation exclusion criteria: * acute or old myocardial infarction * previous coronary artery bypass graft * left main disease (≥ 50% stenosis) * in-stent restenosis lesion * chronic total occlusion * low ejection fraction (\< 40 %) * graft vessel lesion * history of bleeding diathesis or coagulopathy * limited life-expectancy (less than 1 year) due to combined serious disease * contra-indication to heparin, everolimus * contraindication to aspirin, clopidogrel or cilostazol * pregnant

Keywords: intravascular ultrasound fractional flow reserve
a study on m2a magnum total hip arthroplasty

Conditions: Degenerative Joint Disease; Avascular Necrosis

Summary: the purpose of this study includes the investigation of metal-ion release and renal function analysis in m2a total hip arthroplasty.

there are no clinical studies conducted on its performance in asian population. furthermore clinical data is required to support marketing and validate design of m2a magnum.

Eligibility criteria:
inclusion criteria: * patients suitable for primary total hip replacement * patients aged over 20 * patients with limited co-morbidity- asa i-iii * patients must be able to understand instructions and be willing to return for follow-up * patients willing to provide blood and urine samples for metal ion analysis at follow-up exclusion criteria: * pre-existing metal implants * infection, sepsis, and osteomyelitis * uncooperative patient or pt with neurologic disorders who are incapable of following directions * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, or neuromuscular disease * pregnancy
efficacy and safety of mm-ii for treatment of knee pain in subjects with symptomatic knee osteoarthritis

Conditions: Osteoarthritis of Knee

Summary: this is a phase iib, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of mm-ii in subjects with symptomatic knee oa as compared to matching placebo.


Eligibility criteria:
inclusion criteria: 1. subject is able to provide written consent, understand study requirements, is prepared to complete study procedures and is able to independently communicate meaningfully with study personnel 2. presence of index knee pain for at least 6 months prior to screening 3. men or women ≥ 40 years of age at the time of screening 4. radiographic evidence of knee osteoarthritis exclusion criteria: 1. pain in the contralateral knee with a severity of ≥ 30 mm on a 100 mm vas 2. presence of ≥ 40 mm on a 100 mm vas pain in any other joints 3. concomitant moderate or large size synovial fluid effusion of the index knee at screening . 4. known diagnosis of infection in the index knee in the past five years prior to screening
potential effect of topical imiquimod on atrial ectopy in patients with actinic keratosis

Conditions: Actinic Keratosis

Summary: the purpose of this study is to determine the potential effect of topically applied 3.75% imiquimod cream on atrial ectopy in actinic keratosis (ak) patients. the primary endpoint is the change in the 24-hour supraventricular premature beat count. the secondary endpoint is the change in 24-hour supraventricular premature couplet and run counts and atrial fibrillation (% time); change in 24-hour mean heart rate; change in 24-hour ventricular premature beat count, ventricular premature couplet and run counts.

this study is a double-blind, randomized, placebo-controlled, 2-way crossover study designed to assess the potential effect of topically applied 3.75% imiquimod cream on atrial ectopy in actinic keratosis (ak) patients. candidates for study participation will begin screening procedures up to 28 days prior to enrollment. qualified subjects shall be admitted to the cru on day -1 for baseline evaluations and will be randomized to one of two possible treatment sequences. each subject will receive both the active 3.75% imiquimod cream and the matching placebo in a randomized crossover fashion with a 2-week washout in between each treatment. the application area is the entire face (exclusive of nares, vermilion, periocular areas and ears) or balding scalp. atrial ectopy will be monitored for 24 hours at baseline (day -1; prior to the first dose of study medication), and at the conclusion of each 14-day treatment period using a continuous 12-lead digital holter recorder. adverse events, concomitant medication use, study medication accountability, and subject compliance will be reviewed at each visit.

Eligibility criteria:
inclusion criteria: * male and female ak patients with at least 5 typical visible or palpable ak lesions on face or balding scalp * ak patients in otherwise good general health age 18 years and above * female subjects of childbearing potential must be non-pregnant and non-lactating exclusion criteria: * previous clinical study participation within 30 days (drug or device) * evidence of clinically significant diseases * history of drug or alcohol abuse * subjects with uncontrolled systemic hypertension, nyha heart failure classification class \> ii, or a history of atrial fibrillation or atrial flutter * subjects using imiquimod or interferon within 30 days prior to the first dose of study medication * have known allergies to any excipient in the study cream * have melanoma anywhere on the body

Keywords: actinic keratosis atrial ectopy
a research study to evaluate the safety and effectiveness of mk0686 for the treatment of postherpetic neuralgia (also known as phn or post shingles pain) (0686-005)

Conditions: Neuralgia, Postherpetic

Summary: the purpose of this study is to test the safety and effectiveness of mk0686 in relieving neuropathic (chronic) pain as experienced by patients with postherpetic neuralgia (also know as phn or post shingles pain). this is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * diagnosis of postherpetic neuralgia with pain having lasted at least 6 months * able to complete study questionnaires, patient diary, and comply with daily study medication * patient is not satisfied with current treatment for pain control exclusion criteria: * pregnant or nursing female * history of evidence of a condition that in the opinion of the investigator, may interfere with the study results (e.g., diabetic neuropathy of fibromyalgia) or pose undue risk to undergo the course of medication required by the study (e.g., unstable heart disease, morbid obesity, kidney or liver disease)
a study to investigate the safety and metabolism of gsk376501 in overweight subjects

Conditions: Type 2 Diabetes Mellitus

Summary: this study represents the first administration of gsk376501 in humans and the goal is to evaluate its initial safety and tolerability. the way the human body processes gsk376501 will also be determined.

a single-blind, randomized, placebo controlled, ascending single and repeat dose study with once daily dosing to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of gsk376501 and to evaluate food effects and the relative bioavailability of a tablet formulation compared to the powder for reconstitution formulation in healthy overweight and obese subjects (dix109177)

Eligibility criteria:
inclusion: * healthy * non-smoking * overweight or obese subjects with a bmi between 27 and 35. exclusion: * women who are pregnant, lactating, or are of child-bearing potential

Keywords: gsk376501, first time in human, single dose, dose escalation, healthy overweight/obese volunteer
autoimmune hepatitis study

Conditions: Hepatitis, Autoimmune

Summary: the purpose of the study is to determine the role special antibodies play in possibly identifying autoimmune hepatitis through the following: identify the response of specific t cells to antibodies and monitor the response of the cells that regulate the immune system

the object of this protocol is to characterize and monitor auto antigen-specific t cell responses in blood and liver biopsies of patients with anti-sla/lp or anti-lkm-positive autoimmune hepatitis. the results will provide insight into the pathogenesis of autoimmune hepatitis and the monitoring of auto antigen-specific t cell reactivity in correlation to disease exacerbation and therapy.

Eligibility criteria:
inclusion criteria: male or female subjects,all ethnic groups, over 18 years of age, anti-sla/lp or anti-lkm-positive autoimmune hepatitis exclusion criteria: subjects with a hematocrit of \<25

Keywords: aih, autoimmune hepatitis
a dose-ranging trial of opc-131461 in cardiac edema (congestive heart failure [chf])

Conditions: Cardiac Edema (CHF)

Summary: to investigate the dose response in respect of weight decrease following repeated oral administration of opc-131461 at 1, 2, 5, and 10 mg or placebo in patients with chf with volume overload despite having received diuretics other than vasopressin antagonists


Eligibility criteria:
inclusion criteria: * subjects with chf with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload. * subjects undergoing any of the following diuretic therapies * loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule * concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses * concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses * subjects who were currently hospitalized or who are able to be hospitalized exclusion criteria: * subjects with acute heart failure * subjects with an assisted circulation device * subjects who cannot sense thirst or who have difficulty in ingesting water
mycosis culture collection from dermatological isolated

Conditions: Onychomycosis; Resistant Infection; Nail Diseases

Summary: this pilot, prospective, observational drug study aims to evaluate the efficacy, tolerability and safety of topical and oral antifungals in the treatment of onychomycosis caused by yeasts, dermatophytic moulds and non-dermatophytic moulds as well as correlate the scores in the maldi-tof method for the 'identification of genus and species of higher fungi utilizing the comparison between identification in direct optical microscopy, culture examination and optical microscopy and macroscopic and onychoscopic clinical aspects. furthermore, an optional substudy will evaluate the drug resistance of clinical isolates using molecular or genetic methods.


Eligibility criteria:
inclusion criteria: * patients with clinical suspicion of onychomycosis. exclusion criteria: * patients deemed unsuitable by the investigator * patients with documented sensitivity to study drugs such as azoles, allylamine, and ciclopirox olamine. * failure to adhere to topical or oral therapy; * replacement of the therapy reported in the study protocol; * voluntary decision by the patient

Keywords: onychomycosis resistant infection nail diseases