Kornimate/medical-research-clean huggingface dataset:
effects of inspiratory muscle training in patients with bronchiectasis

Conditions: Bronchiectasis

Summary: the purpose of this study is to determine whether inspiratory muscle training could improve and/or prevent the deterioration of inspiratory muscle strength, clinical cardiopulmonary outcome, systemic immunologic responses and quality of life in patients with bronchiectasis.

inspiratory muscle training is reportedly beneficial in patients with diverse chronic cardio-pulmonary diseases. it can increase inspiratory muscle strength and endurance, improves exercise capacity and quality of life (qol), and decreases the perception of dyspnea (pod) for adults with stable chronic obstructive pulmonary disease (copd). though the pathophysiology in copd and bronchiectasis are different, there are some similarities in clinical presentation. in copd patients, lung hyperinflation induces functional weakness of the inspiratory muscle and increases elastic load to breathing and intrinsic positive end expiratory pressure. patients with bronchiectasis shows reduced ratio of fev1/fvc, reduced fev1, and normal or slightly reduced fvc, which indicate that airways are blocked by mucus. however, there has been no study that used imt as a training modality to determine its effect in bronchiectasis. the clinical relevance of increased respiratory muscle strength per se by imt alone is unknown. this study tried to evaluate the feasibility and effectiveness of home-based threshold training and examined if the effects of imt extends to clinical outcomes such as activities of daily living and qol in bronchiectasis patients.

Eligibility criteria:
inclusion criteria: * bronchiectasis confirmed by clinical history, pulmonary function test, and high resolution computed tomography exclusion criteria: * had recent exacerbation within six weeks * use of corticosteroid * with poor consciousness level * have cerebro-vascular or neuro-muscular disorders
neural correlates of working memory training for hiv patients

Conditions: HIV Infection

Summary: despite potent combination antiretroviral therapy, cognitive (memory and concentration) problems continue to occur in up to 50% of hiv-infected individuals, especially in older infected individuals, and those who abuse alcohol, marijuana or psychostimulants. since no effective treatments are available to these individuals with cognitive problems, conservative estimates indicate that the cost of care for these patients could double in the next two decades. to address this urgent problem, this study will use a comprehensive approach (cognitive tests, functional mri and several biomarkers) to evaluate whether a novel computer-based training program would improve the brain function, especially working memory and attention, in hiv-infected and infected individuals.

the overall goals are to perform a double blind placebo-controlled study using cogmed™ to determine whether this adaptive wm training program will benefit hiv-infected individuals, and whether the investigators can identify individuals who might benefit most from the working memory (wm) training. lastly, the investigators will explore how brain activation, neuroinflammation and cerebrospinal fluid (csf) monoamine levels might be related to wm function before and after the training.

Eligibility criteria:
inclusion criteria for hiv-infected participants : 1. men or women of any ethnicity, ages\>18 years and able to provide informed consent, 2. hiv seropositive (with documentation from medical records), 3. stable on an antiretroviral regimen for 6 months or will remain without antiretroviral treatment during the duration of the study. inclusion criteria for seronegative (sn) healthy participants : 1. men or women of any ethnicity, ages \> 18 years and able to give informed consent, 2. seronegative for hiv exclusion criteria : 1. confounding co-morbid psychiatric illness 2. confounding neurological disorders 3. abnormal screening laboratory tests (\>2 sd) that might indicate a chronic medical condition (e.g. diabetes, severe cardiac, renal or liver disorders) 4. medications that might influence outcome measures 5. current or history of drug dependence within the past two years 6. positive urine toxicology screen 7. inability to read at an 8th grade level 8. other contraindications for mr studies

Keywords: human immunodeficiency virus (hiv) working memory training brain function functional magnetic resonance imaging (fmri)
chicgb vs beam in high-risk or r/r lymphomas

Conditions: Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell

Summary: high-dose chemotherapy (hdt) with autologous stem cell transplantation (asct) plays a vital role in treating high-risked or relapsed/refractory lymphoma. our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (chicgb) as conditioning therapy improved the survival of these patients. so we designed this trial to verify if chicgb were better than bcnu, etoposide, cytarabine, and melphalan (beam). patients with diffuse large b cell or extra-nodal nk/t cell lymphoma who consent to this study will be randomized into the trial group who receive chicgb or the control group whom receive beam. patients will be followed for up to 2 years after the hematopoietic cell transplantation (hct).


Eligibility criteria:
inclusion criteria: * patients with primary refractory or recurrent diffuse large b cell lymphoma or extra-nodal nk/t cell lymphoma that do not qualify for treatment protocols of higher priority. * relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment. * adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dl. * adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (sgot) and/or serum glutamate pyruvate transaminase (sgpt) \</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 x upper limit of normal. * adequate pulmonary function with forced expiratory volume at one second (fev1), forced vital capacity (fvc) and diffusing capacity of lung for carbon monoxide (dlco) \>/= 50% of expected corrected for hemoglobin. * adequate cardiac function with left ventricular ejection fraction \>/= 50%. no uncontrolled arrhythmias or symptomatic cardiac disease. * performance status 0-1. 10. negative beta diffusing capacity of the lung for carbon monoxide (hcg) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization exclusion criteria: * central nervous system lymphoma * patients relapsed after autologous stem cell transplantation * bone marrow was involved by lymphoma * patients with active hepatitis b or c(hbv dna \>/=10,000 copies/ml). * active infection requiring parenteral antibiotics * hiv infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and a normal cluster of differentiation 4 (cd4) counts * evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis c or positive hepatitis c serology. * patients with a corrected qt interval(qtc) longer than 500 ms
evaluation of hepatic impairment on ag-013736 pharmacokinetics

Conditions: Hepatic Insufficiency

Summary: this study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of ag-013736.


Eligibility criteria:
inclusion criteria: * diagnosis of reduced hepatic function (child pugh classification a or b) * body mass index of 18-32 kg/m2 exclusion criteria: * history of febrile illness within 5 days prior to first dose * any condition possibly affecting drug absorption (e.g. gastrectomy) * positive urine drug screen

Keywords: hepatic impairment
68ga-psma-11 pet/ct in patients with various types of cancer

Conditions: Prostate Cancer; Positron-Emission Tomography

Summary: to evaluate the potential usefulness of 68ga-psma-11 positron emission tomography/computed tomography (pet/ct) for the diagnosis of primary and metastatic lesions, efficacy assessment and recurrence monitoring in various types of cancer.

subjects with various types of cancer underwent 68ga-psma-11 pet/ct either for an initial assessment or for recurrence detection. tumor uptake was quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy of 68ga-psma-11 pet/ct were calculated.

Eligibility criteria:
inclusion criteria: (i) adult population (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include mri, ct, tumor markers and pathology report); (iii) patients who had scheduled 68ga-psma-11 pet/ct scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the clinical research ethics committee. exclusion criteria: (i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
nopho-aml 2004 study for children with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the overall objective is to improve the cure rate of children with newly diagnosed acute myeloid leukemia (aml) who undergo risk-adapted therapy. stem cell transplantation (sct) is reserved to high-risk patients defined by cytogenetics and response to chemotherapy. the efficacy and toxicity of gemtuzumab ozogamicin (go, mylotarg) will be evaluated.

the overall objective is to improve the cure rate of pediatric patients with newly diagnosed acute myeloid leukemia (aml). the specific aims are as follows: 1.1 therapeutic aims to improve the event-free survival (efs) of aml patients who undergo risk-adapted therapy. to improve the overall survival (os) by reserving stem cell transplantation (sct) to high-risk patients based on cytogenetics and response to induction therapy. to compare the outcome of sct using hla-matched sibling donor (msd) or hla-matched unrelated donor (mud). to assess the efficacy and toxicity of gemtuzumab ozogamicin (go, mylotarg) as post consolidation therapy. 1.2 biologic aims to study minimal residual disease (mrd) levels in blood and bone marrow (bm) at defined time points and to study the prognostic impact of mrd. to test in vitro cellular drug resistance at diagnosis and relapse, and correlate these data to background factors and clinical outcome. to secure storage of biological material from diagnosis for future biologic studies

Eligibility criteria:
inclusion criteria: * aml as defined by the diagnostic criteria, * age \< 19 years at time of study entry, * written informed consent exclusion criteria: * previous chemo- or radiotherapy, * aml secondary to previous bone marrow failure syndrome, * down syndrome (ds), * acute promyelocytic leukemia (apl), * juvenile myelomonocytic leukemia (jmml), * myelodysplastic syndrome (mds), * fanconi anemia, * positive pregnancy test

Keywords: aml children gemtuzumab ozogamicin stem cell transplantation
study assessing the efficacy and safety of octreotide acetate in patients with acromegaly, with micro or macroadenomas

Conditions: Acromegaly

Summary: the purpose of this study is to evaluate the efficacy of octreotide acetate to decrease gh and igf-i levels in acromegalic patients, with microadenomas (≤ 10 mm) or macroadenomas (\> 10 mm).


Eligibility criteria:
inclusion criteria: * male or female patients aged 18 - 80 years. * newly diagnosed or previously treated acromegalic patients. * lack of suppression of gh nadir to \<1.0 microg/l, after oral administration of 75 g of glucose (ogtt). * igf-i levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender). exclusion criteria: * requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass. * no evidence of pituitary adenoma on magnetic resonance imaging (mri). * symptomatic cholelithiasis. * unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction within the three months preceding study entry. * liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent alt, ast, alkaline phosphatase 2 x \> upper limit of normal, or total bilirubin 1.5 x \> upper limit of normal. * female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. medically acceptable methods include oral birth control pills, intrauterine devices, or mechanical methods (e.g. vaginal diaphragm, vaginal sponge or condom with spermicidal jelly). if oral contraception is used, the patient must have been practicing this method for at least two months prior to the screening visit and must agree to continue the oral contraceptive throughout the course of the study, and for one month after the study has ended. * history of immunocompromise, including a positive hiv test result (elisa and western blot). other protocol-defined inclusion/exclusion criteria may apply

Keywords: microadenoma macroadenoma
evaluation of the efficacy and safety of naft-600 in subjects with tinea pedis

Conditions: Tinea Pedis

Summary: this is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group phase 3 study of naft-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.

this study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening koh, and a positive culture.subjects will be evaluated at day 1 (baseline), week 2, week 4, and week 6 (follow-up). adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. efficacy assessments will include koh and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and investigator's global assessment.

Eligibility criteria:
inclusion criteria: * males or non-pregnant females, ≥12 years of age, of any race or sex. females of child-bearing potential must have a negative urine pregnancy test. * for minors (less than 18 years), the parent/legal guardian must complete the informed consent process and the subject must complete the assent process and sign the appropriate form (if age appropriate). * presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s). exclusion criteria: * subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina or myocardial infarction) within the last 6 months. * subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results. * subjects with a known hypersensitivity to study drugs or their components. * subjects who have a recent history or who are currently known to abuse alcohol or drugs. * uncontrolled diabetes mellitus. * hemodialysis or chronic ambulatory peritoneal dialysis therapy. * current diagnosis of immunocompromising conditions. * foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis. * severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection. * extremely severe tinea pedis (incapacitating). * female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.

Keywords: fungal infection athlete foot
clinical trial of the femtosecond laser system visumax for refractive correction of hyperopia by means of lenticule extraction

Conditions: Hyperopia

Summary: this is a feasibility and clinical evaluation study of the visumax femtosecond laser for refractive correction of hyperopia using the small incision lenticule extraction (relex smile) method. in relex® the visumax femtosecond laser creates two interfaces that define a refractive lenticule of stromal tissue. in relex® flex, the upper interface is converted into a lasik flap by the creation of a sidecut. the lasik flap is lifted and the lenticule can be removed to correct the refractive error by tissue subtraction. in relex® smile, the lenticule is dissected and removed through a small 2-3mm incision without the need to create a whole flap. the aims are i) to optimize the visumax settings for lenticule separation ii) to optimize the lenticule geometry iii) to assess the safety, efficacy and stability of the treatment


Eligibility criteria:
inclusion criteria: * older than 21 years of age, * maximum hyperopic meridian between +1.00d and +7.00d * astigmatism up to 6d * cdva of: 1. 20/200 or worse in the eye(s) being treated for phase i 2. between 20/200 and 20/100 in the eye(s) being treated for phase ii 3. between 20/40 and 20/60 in the eye(s) being treated for phase iii 4. 20/25 or better for phase iv * total uncut stromal thickness of more than 300 µm * no previous refractive surgery, * no ocular disease, * normal corneal topography, * contact lens wearers have to stop wearing hard contact lenses at least 4 weeks and soft contact lenses 2 weeks prior to pre-examination, * willing to attend follow-up examinations within the scope of the clinical investigation, * able and willing to sign the informed consent exclusion criteria: * patients who are not being able to lie flat in a horizontal position, * patients who are not being able to understand and give informed consent, * pregnant or nursing women (or women who are planning to became pregnant during the clinical investigation), * diagnosis of an autoimmune disease (e.g. aids), connective tissue disease or diabetes, * treatment with medications such as steroids or immune-suppressants, * herpes simplex or herpes zoster keratitis, * all standard medical exclusion criteria for lasik

Keywords: femtosecond laser small incision lenticule extraction (smile)
a study investigating the effect of montelukast in patients with seasonal allergic rhinitis (mk-0476-192)(completed)

Conditions: Seasonal Allergic Rhinitis

Summary: a study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. loratadine is included in the study as an active control.


Eligibility criteria:
inclusion criteria: * patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season * patient is a non-smoker * patient is in good mental and physical health exclusion criteria: * patient is hospitalized * patient is a woman who is \<8 weeks postpartum or is breast feeding * patient intends to move or vacation away during the study * patient is a current or past abuser of alcohol or illicit drugs
near infrared spectroscopy and transcutaneous oxygen pressure in critical limb ischemia before and after treatment

Conditions: Peripheral Vascular Disease; Critical Limb Ischemia

Summary: comparison of two non-invasive methods for measuring tissue oxygenation. one is transcutaneous oxygen pressure (tcpo2) and the other is the new method of near infrared spectroscopy (nirs) - near infrared spectroscopy in patients with critical limb ischemia (cli) undergoing invasive treatment (surgical or endovascular).

comparison of two non-invasive methods for measuring tissue oxygenation. one is tcpo2 and the other is the new method of nirs - near infrared spectroscopy in patients with critical limb ischemia (cli) undergoing invasive treatment (surgical or endovascular). the nirs probe has been used to measure tissue oxygenation in the cerebral circulation up to now. while tcpo2 is the established method for measuring tissue oxygenation in patients with cli to evaluate the potential for wound healing.

Eligibility criteria:
inclusion criteria: * 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovascular) exclusion criteria: * pregnancy allergy to iod advanced renal failure cct\<50 active peptic ulcer recent bleeding

Keywords: cli critical limb ischemia pvd peripheral vascular disease nirs near infrared spectroscopy tcpo2 - transcutaneous oxygen pressure
radiation therapy in treating women with invasive breast cancer

Conditions: Breast Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. giving radiation therapy in different ways may kill more tumor cells. purpose: this randomized clinical trial is studying the side effects and best way to give radiation therapy and to see how well it works in treating patients with invasive breast cancer.

objectives: primary * compare the ratio between post- and pre-treatment plasma transforming growth factor-beta 1 (tgf-β) in women with invasive breast cancer undergoing hypofractionated radiotherapy vs standard-fractionated external-beam radiotherapy. secondary * establish longitudinal serum and plasma biorepository for retrospective evaluation of tgf-β and other biomarkers with special relevance to radiation response. * correlate pre-treatment plasma tgf-β levels with clinical fibrosis development. outline: this is a randomized study. patients are randomized to 1 of 2 treatment arms. * arm i (hypofractionated radiotherapy): patients undergo external-beam radiotherapy once daily 5 days a week for up to 3.5 weeks (16 fractions total). * arm ii (standard fractionated radiotherapy): patients undergo radiotherapy as in arm i at a lower dose for up to 5 weeks (25 fractions total). after completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years. projected accrual: a total of 100 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed invasive breast cancer * underwent lumpectomy (breast-preserving surgery) with or without adjuvant chemotherapy within the past 12 weeks * histologically negative surgical margins (i.e., no tumor on ink) * candidates for postoperative breast radiotherapy * determined not to need radiotherapy to regional nodes (e.g., third supraclavicular field) * hormone receptor status not specified patient characteristics: * female * menopausal status not specified * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no history of scleroderma or systemic lupus erythematosis * no other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix prior concurrent therapy: * see disease characteristics * no prior breast radiotherapy

Keywords: invasive ductal breast carcinoma invasive lobular breast carcinoma stage i breast cancer stage ii breast cancer stage iiia breast cancer