Kornimate/medical-research-clean huggingface dataset:
reduced toxicity fludarabine (flu) + cyclophosphamide (cpm) + rabbit antithymocyte globulin (ratg) conditioning regimen for unrelated donor transplantation in severe aplastic anemia (saa)

Conditions: Aplastic Anemia

Summary: anti-thymocyte globulin (atg) has been used in severe aplastic anemia as a part of the conditioning regimen. among the many kinds of atg preparations, thymoglobulin had been found to be more effective in preventing graft versus host disease (gvhd) and rejection of organ transplants. as the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for transplantation from alternative donors in saa, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce gvhd and to allow good engraftment in unrelated donor transplantation. our previous phase ii study of fludarabine, cyclophosphamide plus thymoglobulin conditioning resulted in good engraftment (100%) and survival rate (74%). but grade iii/iv toxicities occurred in 25% of patients and all events were treatment related mortalities. as cyclophosphamide is more toxic agent than fludarabine, we plan a new phase ii study re; 'reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for unrelated donor transplantation in severe aplastic anemia' by reducing dosage of cyclophosphamide and increasing dosage of fludarabine.


Eligibility criteria:
inclusion criteria: 1. diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria and either marrow criterion. * peripheral blood 1. neutrophils \< 0.5 x 109/l 2. platelets \< 20 x 109/l 3. corrected reticulocytes \< 1% * bone marrow 1. severe hypocellularity (\< 25%) 2. moderate hypocellularity (25-30%) with hematopoietic cells representing \< 30% of residual cells 2. no prior hematopoietic stem cell transplantation. 3. age: no limits. 4. performance status: ecog 0-2. 5. patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases: * heart: a shortening fraction \> 30% and ejection fraction \> 45%. * liver: total bilirubin \< 2 × upper limit of normal; alt \< 3 × upper * kidney: creatinine \ 60 ml/min/1.73m2. 6. patients must lack any active viral infections or active fungal infection. 7. appropriate donor is available: matched in 6/6 of a, b, dr loci. 8. patients (or one of parents if patients age \< 19) should sign informed consent. exclusion criteria: 1. pregnant or nursing women. 2. malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 3. psychiatric disorder that would preclude compliance. 4. congenital aplastic anemia including fanconi anemia. 5. manipulated bone marrow.
vaginal prolapse surgery accompanied by mid urethral sling versus no sling for reduction of postoperative incontinence

Conditions: Stress Urinary Incontinence; Vaginal Hysterectomy; Quality of Life

Summary: prevalence of pelvic organ prolapsed is high in nepal. after prolapse surgery many patients are affected with incontinence. incontinence has physical, social and mental effect to the individual. this study is designed to know the role for mid urethral sling during vaginal prolapse surgery to decrease the rate of incontinence after the surgery.

aim: to de termine the effect of mid urethral sling in reducing postoperative incontinence after vaginal prolapse surgery. general objectives: to compare the risk of de novo postoperative incontinence between prolapsed surgery with mid urethral sling versus no sling. specific objectives: to compare the change in score of bfluts-sf (bristol female lower urinary tract symptoms- sexual function) and udi-6 (urinary distress inventory-6) pre and post surgery between the two groups. research hypothesis: the use of mid urethral sling after vaginal prolapse surgery has role in reduction of postoperative incontinence. materials \& methods: 1. whether study involves humans/animals or both : humans 2. population/ participants: patients with pelvic organ prolapse who are planned for vaginal prolapse surgery in bpkihs (bp koirala institute of health and sciences). 3. type of study design: a randomized controlled trial (e) expected sample size: 54 sample size calculation: previous study done by control groups: patient undergoing vaginal prolapse surgery only without mid urethral sling. there will be small incision in the suprapubic region that mimics the tvt incision. (f) probable duration of study: one and half year (g) setting: bpkihs, department of obstetrics and gynecology (h) parameter/variables to be applied/ measured: age, bmi, popq (pelvic organ prolapse quantification) stage, menopause, esst (empty supine stress test). (i) outcome measures: luts score, udi-6 score, sui (stress urinary incontinence), voiding dysfunction, dyspareunia, satisfaction, complications like bladder injury, hemorrhage. (j) rationale for statistical methods to be employed: attached (k) ethical clearance: study will be started after getting clearance from the irc (institutional review committee) of bpkihs . (l) permission to use copyright questionnaire/proforma: pre designed proforma and questionnaire will be used to collect the data. the internationally valid questionnaire in english will be validated in nepali language first and then it will be used. (m) maintain the confidentiality of subject: the confidentiality of the patients will be maintained throughout the research.

Eligibility criteria:
inclusion criteria: * clinical pop-q stage 3 or more * must have cell phone exclusion criteria: * patient with popq stage less than stage 3 * patient not giving consent * patient with previous pelvic and spine surgery * patient having positive cough stress test on examination
comparison of bio-active-stent to the everolimus-eluting stent in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the purpose of the trial is to compare the safety and effectiveness of bio-active-stent (bas) and everolimus-eluting stent (ees) in patients presenting with acute coronary syndrome.

the base-acs trial is an academic study, which will be conceived and conducted as a multicenter (multi-country) study by experienced interventional cardiologists. this study is independent of commercial interests. the purpose of the trial is to compare the safety and effectiveness of bio-active-stent (titan-2®) and everolimus-eluting stent (xience v®, promus®) in patients presenting with acute coronary syndrome. a total of 850 patients will be included in the randomized study. the primary end point (mace) is the composite of cardiac death, myocardial infarction and target lesion revascularization during 12 months of follow-up. enrollment of patients will start in november 2008 and end in 2009.

Eligibility criteria:
inclusion criteria: * all patients presenting with acute coronary syndrome (unstable angina, non-st-elevation myocardial infarction or st-elevation myocardial infarction)and undergoing percutaneous coronary intervention * written informed consent exclusion criteria: * age \< 18 years * expected survival \< 1 year * allergy to aspirin, clopidogrel or ticlopidine * allergy to heparins, glycoprotein iib/iiia inhibitors or bivalirudin * allergy to everolimus * active bleeding or significant increased risk of bleeding * stent length longer than 28 mm needed * stent diameter \> 4.0 mm needed * thrombolysis therapy * planned surgery within 12 months of pci unless the dual antiplatelet therapy could be maintained throughout the perisurgical period

Keywords: titanium everolimus drug eluting stent stent thrombosis restenosis percutaneous coronary intervention acute coronary syndrome
non-interventional (ni) study to observe efficacy and usage of quetiapine in acute episodes of schizophrenia and as maintenance therapy following standard clinical practice in croatia

Conditions: Schizophrenia

Summary: observational, non-comparative, epidemiological study to collect and analyse real life data on schizophrenic patients receiving quetiapine according to the standard medical practice in croatia. the main objectives are to assess after 6 months of quetiapine therapy severity of illness and global improvement in patients using clinical global impression (cgi) scale.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of schizophrenia * patients who are already treated with quetiapine for at least 12 weeks (outpatients or hospitalised patients) * patients capable of signing icf exclusion criteria: * patients with hypersensitivity to active substance or any of the excipients of this product * patients with contraindication for quetiapine therapy according to the approved smpc
the lung microbiome in sarcoidosis

Conditions: Sarcoidosis

Summary: the objective of this study is to determine the presence of bacterial species, and the immunologic and molecular mechanisms of granuloma formation that might be involved in the pathogenesis of sarcoidosis. the investigators will collect peripheral blood and bronchoalveolar lavage fluid samples to isolate bacterial dna and blood monocytes and lymphocytes. specimens will be obtained from patients with sarcoidosis, with non-sarcoid lung disease, and healthy volunteers to directly compare the bacterial species present and the characteristics of cells thought to be involved in granuloma formation.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of sarcoidosis (30 subjects) or * clinical diagnosis of non-sarcoid interstitial lung disease (10 subjects) or * age-matched controls (30 subjects) * ability to provide informed consent exclusion criteria: * any disease condition (such as anemia, unstable cardiac disease, etc.) that in the opinion of the subject's primary physician would put the patient at risk of harm from having 60 cc of blood drawn or for undergoing bronchoscopy for this study. * patients who are undergoing bronchoscopy for presumed infection. * pregnant women, women who may be pregnant, and women who are breastfeeding. * patients who have undergone lung transplantation. * persons who are unable or unwilling to undergo bronchoscopy, including those unable to be accompanied by a designated driver to the procedure. * persons who have taken antibiotics in the 90 days prior to consent. * known hiv, hcv, alcohol, or other substance abuse history.
effects of myofascial release with and without emmett technique in iliotibial band syndrome

Conditions: Iliotibial Band Syndrome

Summary: the iliotibial (it) tract or band is a lateral thickening of the fascia lata that is composed of the distal fusion of the muscular fascia of the gluteus maximus and tensor fascia lata muscles. the iliotibial tract travels along the lateral side of the thigh and across the knee joint, inserting on the lateral epicondyle of the tibia. a tight it band has been diagnosed in several problems related to the knee including patellofemoral syndrome and iliotibial band syndrome. several authors have suggested that tightness in the it band may contribute to patellofemoral syndrome and knee pain by pulling the patella laterally thereby causing abnormal tracking of the patella in the trochlear groove. stretching of the iliotibial band is frequently recommended in treatment programs for patients with lbp. because the iliotibial band attaches to the ilium, tightness of this muscle is thought to cause anterior innominate rotation and lateral pelvic tilt. the ober test is performed to assess tightness in the iliotibial band. the term myofascial release encompasses various techniques used to release fascial restrictions. many forms of bodywork that includes a soft tissue technique exist with bowen therapy, emmett technique, deep tissue massage, neuromuscular techniques (nmt), muscle energy techniques (met) and foam rolling. this study focusses on effects of myofascial release with emmett technique. this study will be conducted in a clinical set up (saba's physical therapy, rehabilitation and sports injury clinic in gulberg 3) and will take 6 months. study will be conducted on 22 subjects involving 11 subjects in each group. group a will be given myofascial release only and group b will be given myofascial release with emmett technique. total duration of study will be three weeks and assessment will be done before treatment and after every week. numeric pain rating scale, goniometer and vertical jump test are used for assessing pain, flexibility and power respectively.


Eligibility criteria:
inclusion criteria: * positive ober's test * both males and females * age 25 to 45 years exclusion criteria: * tfl (tensor fascia lata) tightness * any pathological and traumatic conditions, fractures and dislocation, * already received few sessions of manual therapy treatment * taking corticosteroids, analgesic or anti-inflammatory drugs. * treatment of lower limb myofascial pain or trigger points at the time of the study • current or previous symptoms of pathology reported in the lower limbs or pelvis
effect of thyroid disorders in liver diseases

Conditions: Fatty Liver Disease

Summary: aims of the research 1. to detect correlation between hyperthyroidism and non alcoholic fatty liver disease (nafld). 2. to detect hepatic risk in subclinical and clinical hypothyroidism . 3. to detect early liver disorders in thyroid disorders using fibroscan .

non alcoholic fatty liver disease (nafld) has been a health problem of growing significance all over the world; its prevalence is increasing in both developed and developing countries ,the overall prevalence of nafld worldwide was estimated to be 32.4%.prevalence increased significantly over time. considering the increasing incidence of nalad/nash, especially in developed and developing countries, it is anticipated that cirrhosis due to these conditions may exceed other causes of cirrhosis in a near future.. thyroid gland is involved in energy homeostasis, lipid and carbohydrate metabolism, regulation of body weight and adipogenesis. in a clinical setting, subclinical hypothyroidism has been associated with metabolic syndrome, cardiovascular mortality and disturbance of lipid metabolism. the prevalence of hypothyroidism was reported to 16.8% among patients with nafld/nash. in recent years, growing body of evidence has led to speculation on the association between nafld/nash and thyroid dysfunction. therefore, understanding the pathophysiology, risk factors and new treatment options of nafld/nash should be among the priorities in the field of hepatology

Eligibility criteria:
inclusion criteria: * the study will include thyroid patients over one year duration ( age above 18 years old exclusion criteria: 1. history of liver failure or patient known to have congenital liver disease. 2. medications associated with weight gain . 3. patients who have diabetes mellitus. 4. patients who already have liver disease eg; chronic viral hepatitis, liver cirrhosis. 5. patients on antistatin.
l test in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of the study was to investigation of the validity and reliability of the l test in children with cerebral palsy. eighty children with cp with mean age of 11.60±3.85 (56 boys, 24 girls) were included in the study. icc ((intraclass correlation coefficient) was used to assess interclass, intraclass and test- retest validity of the l test. two independent examiners made l test, for the inter-rater reliability, twice within 1 day for the test-retest reliability. the minimal clinical important difference at 95% confidence interval intra-class correlation coefficient and standard error of measurements were calculated. the correlations of l test with timed up and go test (tug) and timed up and down stairs test (tuds) were assessed for concurrent validity.

inclusion criteria were: cerebral palsy diagnosis, absence of other diseases that may impact gait performance, ambulatory for at least 20 meters, maximum level 2 according to gross motor function classification system. exclusion criteria were: difficulty in following the instructions, severe lower extremity pain that affects mobility, orthopedic surgery within the last 12 months, bothulium toxin a injection for lower extremity within the last 3 months and walking with a physical assistance from another person. informed consents were obtained from the parents of the participants for the trial. assessments were conducted in a special training and rehabilitation center where children with cerebral palsy received regular treatments.

Eligibility criteria:
inclusion criteria: * cerebral palsy diagnosis, absence of other diseases that may impact gait performance, ambulatory for at least 20 meters, maximum level 2 according to gross motor function classification system exclusion criteria: * difficulty in following the instructions, severe lower extremity pain that affects mobility, orthopedic surgery within the last 12 months, bothulium toxin a injection for lower extremity within the last 3 months and walking with a physical assistance from another person.

Keywords: l test cerebral palsy children validity reliability
first-in-human phase i study to evaluate safety, tolerability and antineoplastic activity of oatd-02 in patients with selected advanced and/or metastatic solid tumours

Conditions: Advanced Ovarian Carcinoma; Advanced Renal Cell Carcinoma; Advanced Pancreatic Carcinoma; Advanced Colorectal Carcinoma; Metastatic Pancreatic Carcinoma; Metastatic Colorectal Carcinoma; Metastatic Renal Cell Carcinoma; Metastatic Ovarian Carcinoma

Summary: the goal of this clinical trial is to learn if the oatd-02 administration (orally) in monotherapy is safe and has the pharmacodynamic potential to restore and enhance tumour responses to immunotherapy through increased arginine levels or intrinsic anti-tumour activity in participants with advanced metastatic colorectal cancer, ovarian cancer, renal cancer or pancreatic cancer.

in this study, subjects suitable for enrollment will be identified by the investigators involved in the study. these subjects will be identified through contact with these investigators and referred for enrollment per protocol. this protocol will include determining enrollment suitability based on inclusion and exclusion criteria. study scheme is based on modified bayesian optimal interval (boin) design. the boin design works by partitioning the probability of toxicity into a set of intervals. this design makes dose-selection decisions determined by the interval in which the probability of toxicity for the current dose is believed to reside. boin seeks a dose with probability of toxicity close to some pre-specified target level. total number of patients will be 30 (plus 10 replacements if dose limiting toxicity (dlt) is not evaluable). study treatment will be up to 6 months.

Eligibility criteria:
inclusion criteria: 1. capable of understanding and complying with protocol requirements. 2. male or female patient aged ≥18 years at screening. 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. histologically or cytologically confirmed advanced and/or metastatic colorectal cancer, renal cell cancer, or pancreatic cancer or recurrent serous ovarian cancer (platinum-resistant/ineligible to receive platinum-based chemotherapy), that either progressed or relapsed after all relevant standard of care cancer therapies (at least 1 line of systemic cancer therapy). 5. written informed consent given by the patient before the initiation of any study procedures. exclusion criteria: 1. unable to take oral medications. 2. clinically active central nervous system metastases and/or carcinomatous meningitis. 3. major surgery within 30 days before the first imp dose. 4. pregnant or breastfeeding women. 5. known allergy to excipients of the imp. 6. severe, uncontrolled systemic disease which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to participate in the study. 7. participation in another clinical study within 4 weeks before the first imp dose.

Keywords: solid tumors renal cancer ovarian cancer pancreatic cancer colorectal cancer
effect of haemodialysis on the efficacy of antiplatelet agents

Conditions: Renal Failure; Coronary Artery Disease; Hemolysis

Summary: the main purpose of our study is to investigate whether haemodialysis itself affects the efficacy of antiplatelet drugs and the effects of two different types of dialysis membranes (polysulfone membranes and polyamide membranes) on antiplatelet efficacy. a total of 60 patients with esrd and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). all included patients will receive haemodialysis by two different types of dialysis membrane.platelet aggregation of venous blood from all patients will be detected by lta and verifynow immediately before and after two times of haemodialysis.


Eligibility criteria:
inclusion criteria: * diagnosis of coronary heart disease including stable angina, unstable angina, acute myocardial infarction * taking dual antiplatelet drugs (clopidogrel 75mg qd + aspirin 100mg qd or ticagrelor 90 mg,bid + aspirin 100 mg,qd) at least 5 days * haemodialysis patients * sign informed consent exclusion criteria: * platelet count\>450 × 10 9 /l or \<100 × 10 9 /l * using iib / iiia inhibitor drugs within 10days * taking nonsteroidal anti-inflammatory drugs other than aspirin * hemorrhagic disease * allergic to aspirin, ticagrelor or clopidogrel * other factors may affect the results of this study
mannitol challenge test in adult asthma patients with fixed dose combinations

Conditions: Asthma

Summary: the primary objective in this pilot study is to explore if asthma patients prescribed fixed dose combinations (budenosid/formoterol (symbicort®), salmeterol/fluticasone (seretide®), beclometasone/formoterol (innovair®) are optimal treated regarding the mannitol challenge test and the following reversibility test. the primary endpoint is to identify asthma patients responding positive or negative to the mannitol challenge test and/or the reversibility test. the hypothesis is that not all patients are well treated.


Eligibility criteria:
inclusion criteria 1. males and females, age 18-65 years. 2. subjects diagnosed with asthma. 3. subjects with a baseline fev1 of ≥70% of the predicted value. 4. outpatients at primary clinic. 5. subjects treated with a fixed dose combination for at least the last three months. 6. subjects who have withheld their asthma- and allergy medication according to individual instructions at the day of the challenge test. 7. subjects who are able to read and comprehend swedish and are willing to sign an informed consent. exclusion criteria 1. subjects with evidence of any other respiratory and/or obstructive disease including recent infection/exacerbation. 2. subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test. 3. any history of hypersensitivity to mannitol challenge test. 4. any contraindications to use of the diagnostic study medication. 5. subjects who are unsuitable for other reason(s) in the opinion of the investigator.

Keywords: asthma mannitol challenge test sweden primary care