Kornimate/medical-research-clean huggingface dataset:
mr inform - mr perfusion imaging to guide management of patients with stable coronary artery disease

Conditions: Coronary Artery Disease; Stable Angina; Myocardial Ischaemia

Summary: the purpose of this study is to determine if mr perfusion imaging is non-inferior to coronary angiography with measurement of fractional flow reserve (ffr) in guiding management of patients with stable chest pain. * all patients will undergo an mr perfusion imaging test. * further management will be guided by the result of the cardiac mri in half of the patients (chosen by random). * the other half will undergo coronary angiography with measurement of ffr. the result of this test alone will guide their further management. the result of the initial mr perfusion test will not be available to the treating doctors of this group. * all patients will receive optimal medical therapy (omt) * all patients will undergo follow-up to find out if they have any relevant heart related events.


Eligibility criteria:
inclusion criteria: * angina pectoris ccs class ii and iii and either * ≥2 cardiovascular risk factors * or positive exercise treadmill test * signed written informed consent * age: at least 18 years exclusion criteria: * contraindication to mr * contraindication to adenosine infusion * ef≤ 30% * inability to lie supine for 60 minutes * previous coronary artery bypass grafts * revascularization within the previous 6 months * cardiac arrhythmias (atrial fibrillation, \>20 ectopic beats/min) * poor renal function (egfr \<30ml/min) * body weight \> 140kg or waist perimeter \> 95cm * known allergy to contrast media

Keywords: adenosine magnetic resonance imaging mr perfusion fractional flow reserve, myocardial ffr pressure wire coronary disease heart diseases cardiovascular diseases arteriosclerosis
to evaluate the efficacy, safety, and tolerability of bbt-877 in patients with ipf

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is a phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of 200 mg twice daily (bid) of bbt-877 in patients with ipf, with or without af approved background therapies (pirfenidone or nintedanib).


Eligibility criteria:
inclusion criteria: * male patients who have completed family planning or female patient, aged 40 years or older * diagnosis of ipf in accordance with american thoracic society/european respiratory society/japanese respiratory society/latin american thoracic association guidelines for diagnosis in effect at the time of screening * chest high-resolution computed tomography (hrct) performed according to ats guidelines within 12 months prior to screening and according to minimum requirements for ipf diagnosis by central review based on hrct and lung biopsy. if no historical acceptable hrct is available prior to screening, an hrct can be performed during screening. in both cases, a central reading of the hrct has to be done as well as a review of lung biopsy slides, if available and potentially supportive for diagnosis. * able to walk at least 150 meters during the 6mwt at screening * resting oxygen saturation of ≥89% using a maximum of 6 l/min of supplemental oxygen at sea level, and up to 8 l/min at altitude during screening * fvc ≥45% predicted of normal * ratio of forced expiratory volume in the first second (fev1) to fvc ≥0.7 * diffusing capacity for the dlco corrected for hemoglobin ≥30% predicted of normal * absence of ipf improvement in the past year, as determined by the investigator * patients receiving either pirfenidone or nintedanib, should be on it for at least 3 months and with a stable dose in the 4 weeks prior to screening, or taking neither pirfenidone exclusion criteria: * unable to perform spirometry as per ats * evidence of ipf exacerbation within 3 months prior to and/or during screening * evidence of emphysema extent greater than the extent of fibrosis * current smoker (tobacco, e-cigarette) * history of lung transplant or lung volume reduction surgery * current immunosuppressive condition * estimated life expectancy of less than 12 months or 30 months in the opinion of the investigator * congestive heart failure class iii or iv according to new-york heart association classification * pulmonary hypertension (ph) requiring ph specific therapy * unstable cardiovascular, pulmonary or other disease within 6 months prior to screening or during the screening period * use of other medications likely to interfere with study assessments * any other current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results
bone mineral density in women with uterine fibroids or endometriosis

Conditions: Uterine Fibroid; Endometriosis

Summary: the purpose of this study is to characterize the longitudinal bone mineral density (bmd) in premenopausal women with uterine fibroids or endometriosis.

this is a prospective observational study to characterize longitudinal bmd of premenopausal women with uterine fibroids or endometriosis over the 52-week observational period. approximately 660 participants will be recruited into two cohorts: (1) premenopausal women with uterine fibroids confirmed by an ultrasound (approximately 260 participants), and (2) premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the screening visit (approximately 400 participants). since age is a strong risk factor for bmd change over time, participants in this observational study will be matched by age category (18 to 24, 25 to 34, 35 to 44, and ≥45 years old), with participants enrolled in the interventional studies of relugolix. during the screening/baseline period, the participant should be assessed for eligibility, and baseline dual-energy x-ray absorptiometry (dxa) scan will be obtained. bone densitometry (lumbar spine \[l1-l4\], total hip, and femoral neck) will be obtained and submitted for central reading at baseline, week 24, and week 52. information related to health care utilization for uterine fibroids or endometriosis and concomitant medications will be collected at every visit and during the phone calls at week 12 and week 36. collection of adverse events in this study will be limited to protocol-specified procedure-related adverse events. reports of pregnancy will also be collected.

Eligibility criteria:
inclusion criteria: 1. is a premenopausal female 18 to 50 years old 2. by the participant's report, had two consecutive regular menstrual cycles immediately prior to enrollment in the study. participants with hormonal intrauterine devices or on other hormonal contraception methods that disrupt cyclic bleeding are not required to have two consecutive regular menstrual cycles. 3. has one of the following conditions: 1. diagnosis of uterine fibroids that is confirmed by an ultrasound within 5 years prior to screening. 2. diagnosis of endometriosis confirmed by surgical or direct visualization and/or histopathologic confirmation. 4. has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment. exclusion criteria: 5. has a weight that exceeds the weight limit of the dual-energy x-ray absorptiometry scanner 6. has a baseline bmd z-score \< -2.0 at spine, total hip, or femoral neck 7. has a history of or currently has osteoporosis, or other metabolic bone disease 8. use within the past 3 months prior to screening or anticipated use of systemic glucocorticoids 9. is currently pregnant or lactating, or intends to become pregnant during the study period

Keywords: uterine leiomyoma uterine fibroids heavy menstrual bleeding menorrhagia endometriosis
autologous stem cell rescue for primary amyloidosis

Conditions: Amyloidosis; Blood and Marrow Transplant (BMT)

Summary: to evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.

to learn about the use of high dose chemotherapy followed by transplantation using peripheral blood stem cells.

Eligibility criteria:
inclusion criteria:1. primary amyloidosis 2. age \< 75 years. 3. patients must have their pathology reviewed and the diagnosis confirmed at stanford university medical center. 4. patients who have undergone bone marrow transplantation previously will not be eligible. 5. patients must have a karnofsky performance status greater than 70%. 6. patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction \>45% on echocardiography, cardiac index \> 1.8 liters/min/m\^2 and pulmonary function tests demonstrating fev1 and dlco \> 60%. 7. patients must be hiv negative. 8. pregnant or lactating women will not be eligible to participate. 9. patients must provide signed informed consent. 10. patients with multiple myeloma and amyloid are eligible. exclusion criteria:1. prior blood or marrow transplant
lymph node 14v dissection in clinical stage t3n+, t4n+ of gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.

the purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection. actually, if the 14v lymph node metastasis is suspected before surgery, it is excluded from the study. in a retrospective study conducted in our hospital, we compared the patients with the 14v lymphadenectomy group and those without the 14v lymphadenectomy group, the survival rate of the 14v lymphadenectomy group was 11% higher than that of the 14v non-lymphadenectomy group.previous studies have suggested that the presence of metastatic lymph nodes in the 14v lymph node is not good and that removal of the 14v lymph node does not affect prognosis. however, if the lymph node is a continuous tissue and the transition to the 14v lymph node is confirmed microscopically, a negative prognosis may be expected because it is likely that the cancer has spread to the distal lymph node. in addition, inadequate resection of the lymphatic or 14v lymph node adjacent to the 14v lymph node in the absence of evidence of metastasis of the 14v lymph node under microscopic examination indicates that cancer may spread even after curative surgery, to prevent cancer metastasis.

Eligibility criteria:
\ * histologically proven primary gastric adenocarcinoma * t3n+, t4n+ by ct scan (ajcc 7th classification) * distal margin of gastric cancer location of distal margin of gastric cancer ; antrum, or angle of the stomach * no evidence of other distant metastasis * age ≥ 20 year old * performance status (ps) of 0 or 1 on eastern cooperative oncology group (ecog) scale * no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection * adequate organ functions defined as indicated below: 1. wbc 3000/mm3 - 12,000/mm3 2. \> serum hemoglobin 8.0 g/dl 3. \> serum platelet 100 000/mm3 4. \< serum ast 100 iu/l 5. \<serum alt 100 iu/l 6. \< total bilirubin 2.0 mg/dl * written signed informed consent \ * active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) * gastric remnant cancer * pregnant or breast-feeding women * mental disorder(diagnosed with mental disorder on medical record) * systemic administration of corticosteroids(include herbal medication) * unstable angina or myocardial infarction within 6 months of the trial * unstable hypertension * severe respiratory disease requiring continuous oxygen therapy * indications total gastrectomy * borrmann type iv in the preoperative examination (including localized) * suspected ln # 14v metastasis during surgery * indications pancreatectomy * suspected a metastasis of ct scans ln # 13, ln # 14 * clinical stage iv group is suspected or confirmed during surgery

Keywords: lymph node 14v d2 lymphadenectomy
the effectiveness of neurodynamic mobilization in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome (CTS); Median Nerve

Summary: this randomized, clinical, single-blinded, controlled study will initially planned to include 86 patients diagnosed with carpal tunnel syndrome who applied to kütahya health sciences university, evliya çelebi training and research hospital, physical medicine and rehabilitation outpatient clinic and kutahya city hospital.patients aged 20-55 years who were diagnosed with mild and moderate carpal tunnel syndrome by electromyography (emg) in the last 6 months were included in the study. the patients were randomized into two groups using the computer-assisted randomization method. median nerve mobilization and ultrasound therapy will be given to the study group, and only ultrasound therapy will be given to the control group. all the patients were evaluated with the visual analog scale (vas), hand and pinching grip test, boston carpal tunnel questionnaire (bctq) and median nerve and abductor pollicis brevis muscle ultrasonography before the intervention and at the third week of intervention.


Eligibility criteria:
inclusion criteria: * diagnosed with mild-to-moderate cts on the dominant hand, based on the electrodiagnostic examination. * aged 20-55 years. * consent to receive the described treatment. * lasting symptoms at least 3 months exclusion criteria: * a systemic inflammatory disease. * any disease that can cause polyneuropathy, for example, diabetes mellitus. * a cognitive disorder. * receiving psychotherapy. * a pacemaker. * any disease that can affect the central nervous system. * carpal tunnel syndrome surgery history

Keywords: carpal tunnel syndrome median nerve mobilization abductor pollicis brevis boston carpal tunnel questionnaire hand grip ultrasonography
novel surrogate markers as predictors of radiation toxicity in breast cancer patients undergoing helical tomotherapy compared to standard radiation therapy

Conditions: Genetic Markers; Cardiac Toxicity; Breast and Skin Motion

Summary: radiotherapy is standard treatment for breast cancer after lumpectomy. although this treatment showed substantial patient benefits and decrease of local recurrence and deaths from breast cancer, it also results in some severe late side-effects, such as skin fibrosis and cardiac failure. it's possible to offer breast irradiation (rt) and minimizing toxicities radiation dose to skin, lung and heart. this will be achieved with highly conformal rt delivery using tomotherapy. we plan to evaluate this approach in clinical study. we plan also to evaluate the value of genomic, cellular and functional imaging endpoints as predictive markers of toxicity in our breast cancer population. this program is expected to prospectively validate that tomotherapy for breast rt can decrease skin, lung and heart toxicities and maintaining excellent cancer control after lumpectomy.

radiotherapy is standard treatment after conservative surgery for early-stage breast cancer. although this approach substantially improves local control and reduces deaths from breast cancer, it also results in some severe late side-effects, including skin fibrosis, deaths from radiation-induced cardiac disease and lung cancer. we will undertake a novel approach to the evaluation of radiation-induced toxicity during and after whole breast irradiation (rt) following breast-conserving surgery, with the long-term strategic goal of minimizing rt toxicity in early breast cancer. theoretically, it is possible to achieve this goal through very highly conformal rt delivery and avoidance of rt in toxicity-prone individuals where possible. we plan to evaluate the utility of genomic analysis, cellular dna repair competence, and functional imaging endpoints as predictive markers of toxicity in our breast cancer population. this program is expected to (a) prospectively validate that ht for breast rt can decrease acute toxicity whilst maintaining excellent cancer control after bcs; (b) demonstrate that novel surrogate markers will aid in the prediction of acute and/or late normal tissue toxicity with a view to identify toxicity-prone (or conversely, robust) individuals from amongst the breast cancer population.

Eligibility criteria:
inclusion criteria: * early breast cancer treated with lumpectomy * must have t1-2 n0-1 invasive carcinoma of the breast * must sign an informed consent * must be at least 18 years of age exclusion criteria: * collagen vascular disease * metastatic disease * pregnant or lactating

Keywords: skin toxicity prediction cardiac toxicity prediction
pulmonary hypertension in hypersensitivity pneumonitis

Conditions: Pulmonary Hypertension

Summary: the investigation serves the identification of pulmonary hypertension (ph) among patients with hypersensitivity pneumonitis (hp). the exact prevalence of ph in hp is unknown. data from south america indicate that the prevalence of pre-capillary ph amongst patients with hp is higher than 20%. there are no reliable data from europe so far. according to the investigators previous analysis, more than 400 hp patients have participated in pulmonary rehabilitation at least once in the past 10 years at klinikum bad gleichenberg (rehabilitation center for agricultural workers in austria). this collective of patients is to be invited to participate in the study. a diagnostic algorithm will be applied in the clinical trial, in the case of clinical suspicion the diagnosis of ph will be confirmed by right heart catheterization. besides the determination of the prevalence of ph in patients with hp the investigators aim to assess the reliability of non-invasive methods (e.g. echocardiography, ecg...) to predict ph.


Eligibility criteria:
inclusion criteria: * patients with confirmed hypersensitivity pneumonitis * written consent * age: 18-90 years exclusion criteria: * severe impairment of the general health condition * pregnancy
multisystem shortness of breath evaluation study

Conditions: Dyspnea

Summary: the muse study is a prospective observational cohort study of patients referred to pulmonary and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. patients will undergo all pertinent testing and will be required to fill out a number of epidemiologic and quality of life related questionnaires. follow up will continue for at least one year.


Eligibility criteria:
inclusion criteria: * patients referred to pulmonary and/or cardiology clinic for the evaluation of unexplained dyspnea. exclusion criteria: * patients with a known cause of dyspnea such as established cardiopulmonary disease
effect of fid 114675a on lens wettability

Conditions: Contact Lens Wettability

Summary: the purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.


Eligibility criteria:
inclusion criteria: * 18 years or age or older with normal eyes, other than correction for refractive error. * at least 5 days successful daily wear (minimum 8 hours per day) of purevision®, acuvue® oasys™, or acuvue® 2 contact lenses prior to visit 1 * vision correctable to 20/30 (snellen) or better in each eye at distance with lenses at visit 1 (day 0 - baseline). * grade 0 or grade 1 wettability in both eyes after at least 15 minutes of lens wear at visit 1 (day 0 - baseline). * other protocol-defined inclusion criteria may apply. exclusion criteria: * any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study. * need to wear contact lenses on an extended wear basis (i.e., overnight) during the study. * use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to visit 1 (day 0 - baseline). * use of over-the-counter (otc) or prescribed topical ocular medications within 7 days prior to visit 1. use of lens rewetting drops is acceptable. * history or current ocular infections or ocular inflammatory events. * ocular surgery within the past year. * participation in any investigational study within the past 30 days. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses contact lens care multi-purpose solution wettability myopia
serum tryptase concentration during general anaesthesia with rocuronium

Conditions: Hypersensitivity Reaction

Summary: rocuronium is a aminosteroid structured, non-depolarizing neuromuscular blocking agents (nmb). epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. determinations of serum tryptase concentrations are interdisciplinary recommended in diagnosis of its adverse reactions. no studies have been performed to explain specific role of rocuronium doses on serum tryptase values. the aim of this study was to investigate the potential effect of rocuronium on serum tryptase concentrations.

the greatest risk of hypersensitivity occurs during anesthesia for female patients and it is connected with the induction phase using skeletal muscle relaxants . epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. due to the multiple advantages reports of triggering allergic or hypersensitivity reactions caused by rocuronium create doubts about the safety of application .

Eligibility criteria:
inclusion criteria: * asa 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia exclusion criteria: * steroid therapy, allergy in medical history, mastocytosis

Keywords: general anaesthesia mast cell rocuronium tryptase
thin-ebus in ex-vivo human lungs

Conditions: Lung Cancer

Summary: this study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (tcp-ebus) in human resected lobes. the primary end point is to clarify the feasibility of using the thin convex probe ebus scope to visualize lung tumors from an intra-bronchial view. the secondary objective is to evaluate the insertion ability, operability, endoscopic image and ultrasound image compared to that of the convex probe ebus.


Eligibility criteria:
inclusion criteria: * any patients scheduled for lobectomy or anatomical segmental resection for malignant lung tumors. * 18 years of age or older exclusion criteria: * any patients with inability to give informed consent.

Keywords: lobectomy