Kornimate/medical-research-clean huggingface dataset:
phase 2 study comparing two dose schedules of telintra™ in myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndrome (MDS)

Summary: this is a randomized, open label, multicenter, phase 2 study comparing two dose schedules of telintra in patients with low or intermediate-1 risk mds. patients at least 18 years of age presenting with histologically confirmed low to intermediate-1 risk mds with documented significant cytopenia for at least two months by the iwg criteria are eligible.


Eligibility criteria:
inclusion criteria: * primary or de novo mds * low or intermediate-1 mds * ecog performance status 0 or 1 * documented significant anemia with or without neutropenia and/or thrombocytopenia * adequate kidney and liver function * patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry exclusion criteria: * prior allogenic bone marrow transplant for mds * history of mds ipss score greater than 1.0 * pregnant or lactating women * any severe concurrent disease, infection, or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry * oral steroids e.g. prednisone \>10 mg per day * history of active hepatitis b or c * known history of hiv

Keywords: hematology mds myelodysplastic syndrome low risk mds intermediate-1 risk mds int-1 risk mds telintra ezatiostat hydrochloride ezatiostat tlk199 glutathione glutathione analog glutathione transferase glutathione transferase inhibitor glutathione transferase p1-1 inhibitor gstp1-1 inhibitor apoptosis differentiation enzyme inhibitor
effectiveness of parenting programs on child development and maternal well-being in rural uganda

Conditions: Child Development; Depression

Summary: the purpose of the current study involves the development, implementation and evaluation of a parenting program to target maternal well-being and child health, growth and development in lira, uganda. the current study aims to address maternal care within a parenting program as well as parenting practices emphasizing nutrition, hygiene, and psychosocial stimulation through peer-support, practice and problem-solving. outcomes include child health, growth and development, maternal mental health, mother-child interactions, and maternal-spousal relations. we hypothesize that: 1. children of parents who attend the parenting program will have better health, height and cognitive/language development at post-test, than children whose parents did not have the opportunity to attend parenting sessions. 2. parents who attend the parenting program will have more knowledge about child development and provide more home stimulation, dietary diversity and preventive health practices than parents who do not have the opportunity to attend parenting sessions. 3. mothers who attend the parenting program will have improved well-being compared to mothers who do not have the opportunity to attend parenting sessions.


Eligibility criteria:
inclusion criteria: * mothers of children ages 12-24 months exclusion criteria: * disabled children

Keywords: child nutritional status child development maternal depression
omalizumab in chronic spontaneous urticaria patients non responding to initial standard antihistamine treatment

Conditions: CHRONIC SPONTANEOUS URTICARIA

Summary: evaluate the proportion of patients with an urticaria control test \[uct\] score of greater than or equal to 12 at week 12.


Eligibility criteria:
inclusion criteria: * male or female patients aged between 18 and 75 years. * diagnosis of csu for ≥ 6 months and an inadequate response to nsh1 antihistamines at the time of the request, as defined by the following: * the presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment, despite current use of h1 antihistamine therapy during this time period. * weekly uas7 score (range 0 to 42) 16 and uct score (range 0 to 16) \< 8 prior to enrollment (day 1) * current use of an h1 antihistamine for csu on the day of the initial visit and day * informed consent exclusion criteria: * treatment with an investigational agent within 30 days before enrollment. * routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide. * intravenous (i.v.) immunoglobulin g or plasmapheresis within 30 days prior to day -7 * regular (daily/every other day) doxepin (oral) use within 14 days prior to day -7. * any h2 antihistamine use within 7 days prior to day -7. * any leukotriene receptor antagonist (ltra) (montelukast or zafirlukast) within 7 days prior to day 7. * concomitant use of cyclosporine or any other immunosuppressive agent. * hypersensitivity to omalizumab or any component of the formulation. * history of anaphylactic shock.

Keywords: chronic spontaneous urticaria omalizumab urticaria control test ige025
plantar pressure distribution in patient with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: fifty patients who were referred to receive physiotherapy and 20 healthy volunteers will be participants of the study.participants with multiple sclerosis will evaluate with the following assessment tools: modified ashworth scale will use to evaluation of severity of plantar flexor spasticity. plantar pressure distribution parameters will assess with dynamic pedobarography.

fifty patients who were referred to receive physiotherapy at the neurology department of physiotherapy and rehabilitation of the faculty of health sciences of hacettepe university, ankara with multiple sclerosis and twenty voluntary healthy age matched participants will be the subjects of this study. assessment tools described as following: modified ashworth scale will use to evaluate of severity of plantar flexor spasticity. static and dynamic loading parameters will be evaluate with pedobarography.maximum loading pressure -n/cm2, maximum loading time- ms for; 1st. and 5th metatarsal head, medial and lateral heel and midfoot will be recorded both while the patients standing and walking.

Eligibility criteria:
inclusion criteria: * want to participate individuals with multiple sclerosis who can walk alone for 30 meters healthy participants who diagnosed no disorders or orthopedic problems. exclusion criteria: * want to participate individuals with multiple sclerosis who can walk alone for 50 meters healthy participants who diagnosed no disorders or orthopedic problems.

Keywords: gait loading multiple sclerosis plantar pressure
treatment of her2-positive metastatic breast cancer with herceptin and bevacizumab (antibodies against her2 and vegf)

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (herceptin) and bevacizumab (anti-vegf antibody) in patients with her2-positive metastatic breast cancer.

based on preclinical experiments conducted in our laboratories, we hypothesize that the aggressive behavior of her2-overexpressing breast cancers is due in part to increased angiogenesis resulting from her2-induced increases in vascular endothelial growth factor (vegf) expression. in vivo experiments suggest that combined blockade of the her2 receptor and vegf results in superior anti-tumor efficacy compared with either treatment alone. the current clinical trial, for which the phase i portion has been completed, will examine the efficacy and safety of trastuzumab (herceptin) and bevacizumab (anti-vegf antibody) in the treatment of her2-overexpressing metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * metastatic or relapsed locally advanced breast cancer * her2-positive by fish * no prior chemotherapy for metastatic disease * ecog performance status 0-2 * normal left ventricular ejection fraction * bidimensionally measurable disease * oxygen saturation \> 90% on room air exclusion criteria: * other invasive malignancy within 5 years * more than 3 different metastatic sites * \>50% liver involvement by metastasis * newly diagnosed untreated stage iiib breast cancer * prior chemotherapy for metastatic disease * clinically significant cardiovascular disease * history or evidence of cns disease * major surgery within 28 days prior to day 0 * current or recent use of parenteral anticoagulants * wbc \< 3,000/ul * platelet count \< 75,000/ul * hemoglobin \< 9.0 g/dl * total bilirubin \> 2.0 mg/dl * ast or alt \> 5 time upper limit of normal for subjects with documented liver metastases; \> 2.5 times upper limit of normal for subjects without evidence of liver metastases * proteinuria (\> 1g protein/24 hours at baseline) * prior therapy with herceptin or rhumab vegf (bevacizumab)

Keywords: metastatic breast cancer her2 trastuzumab herceptin vegf bevacizumab avastin
a study evaluating the safety and pharmacokinetics of abbv-744 in participants with relapsed/refractory acute myeloid leukemia (aml) cancer

Conditions: Acute Myeloid Leukemia (AML)

Summary: this is an open-label, phase 1, dose-escalation (segment 1) and expansion (segment 2) study to determine the maximum tolerated dose (mtd) and/or the recommended phase two dose (rptd), and to assess the safety, preliminary efficacy, and pharmacokinetic (pk) profile of abbv-744 in participants with relapsed/refractory acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: * participant must have aml not amenable to curative therapy, refractory to standard of care therapy or for which standard of care therapy does not exist. participants who are candidates for stem cell transplantation must have been offered this therapeutic option. * must consent to provide biomarker analyses as described in the protocol. * must have an eastern cooperative oncology group (ecog) performance status of: * dose escalation (segment 1): 0 - 1 * dose expansion (segment 2): 0 - 2 * dose escalation: must have a serum albumin during screening of \>= 3.0 g/dl. * participant has adequate bone marrow, renal and hepatic function. exclusion criteria: * participant with known active central nervous system (cns) disease. * participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within 14 days prior to abbv-744 dosing. saw palmetto is considered anti-cancer herbal remedy. participant has received anti-cancer therapy within a period of 14 days or 5 half-lives (whichever is longer; except for immunotherapy where a period of 21 days will be acceptable) prior to study day 1. except for hydroxyurea which will be allowed during screening and treatment for controlling leukocytosis. * participant has been previously treated with a bromodomain and extra-terminal (bet) inhibitor * participant has unresolved clinically significant toxicities from most recent prior anti-cancer therapy, defined as any common terminology criteria for adverse events (ctcae v 4.03) grade 2 or higher clinically significant toxicity (excluding alopecia). * participant has received the following within 7 days prior to the first dose of study drug: corticosteroid therapy, cyp3a inhibitors, cyp3a inducers. * participant consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug. * participant had major surgery within 28 days prior to study day 1. * participant is unable to swallow or absorb oral tablets. * participant has known infection with hepatitis b or hepatitis c. * participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis, enteritis, colitis. * participant has symptoms of gross hematuria or gross hemoptysis * has electrocardiogram with a qt interval corrected for heart rate using fridericia's formula (qtcf) \> 470 msec or ecg with second degree type 2 or third degree atrioventricular block.

Keywords: acute myeloid leukemia (aml) relapsed/refractory acute myeloid leukemia dose-limiting toxicity recommended phase two dose pharmacokinetics
impact of education and training of modified rodnan skin scoring on the reliability of test

Conditions: Scleroderma, Systemic

Summary: the aim of the study is evaluating the efficacy of organized education process of the modified rodnan skin score (mrss) in the systemic sclerosis. ten physician in south korea will be voluntarily enrolled and receive the organized training program, which encompass the lecture and demonstration of skin scoring by expert rheumatologist. reliability and accuracy of the skin scoring before and after the education will be compared.

1. participants ten physicians who are voluntarily enrolled in the organized education course 2. organized education course 1. lecture: a expert rheumatologist (master instructor) give a lecture to explain the technique of mrss. 2. demonstration: master instructor demonstrate the patient assessment without revealing his score. 3. practical training: participants assess the mrss of 8 patients with systemic sclerosis. two other expert rheumatologists 3. protocol 1. instructor pre-meeting: three instructors including master instructor assess the mrss of 8 systemic sclerosis patients. modified rodnan score drawn by arrangement among them is defined as standard score of each patient. 2. pre-education scoring: participants assess the mrss of 8 patients before the education course. 3. organized education course 4. post-education scoring: participants assess the mrss of the same 8 patients after i) lecture and ii) demonstration of master instructor 5. written test: participants take written examination regarding the mrss before and after the education. 4. outcomes 1. inter-observer reliability of mrss before and after the education 2. change in difference between score measure by each participant and standard score after the educational course. 3. change in the score of written test after the educational course.

Eligibility criteria:
inclusion criteria: * physician who voluntarily enroll the educational program. exclusion criteria: * non-physician

Keywords: systemic sclerosis education modified rodnan skin score
polarx post approval study (polarx pas)

Conditions: Paroxysmal Atrial Fibrillation

Summary: to collect clinical data on safety, effectiveness and procedural success of boston scientific's cardiac cryoablation system (includes all bsc commercially available polarx/polarx fit catheters) when used to perform pulmonary vein isolation (pvi) in the ablation treatment of de novo atrial fibrillation (af).


Eligibility criteria:
inclusion criteria: * subjects indicated for drug refractory, recurrent symptomatic paf treatment with the cryoablation system, per physician's medical judgement, and as per standard of care * subjects who are willing and capable of providing informed consent; * subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center; exclusion criteria: * any known contraindication to an af ablation or anticoagulation, including those listed in the ifu as legally approved conditions; * any prior la ablation; * known or pre-existing severe pv stenosis; * subjects with severe valvular disease or with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings); * presence of any pulmonary vein stents; * subjects with active systemic infection; * subject is unable or not willing to complete follow-up visits and examination for the duration of the study;- subjects with life expectancy ≤ 1 year per investigator's medical judgement; * women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);

Keywords: cryoablation
phase i study to investigate the drug interaction after oral administration of tamsulosin and sk3530

Conditions: Erectile Dysfunction

Summary: to assess the pharamcodynamic effects of coadministrated sk3530(pde5 inhibitor) and tamsulosin, phase i study in healthy volunteers was designed.

during each of the two periods of a randomized, double-blind, placebo-controlled, crossover study, 16 healthy men received tamsulosin 0.2 mg daily for 7 days and either a single 100 mg of sk3530 or placebo on day7. the blood pressure and heart rate were monitored before and for 24 hours after sk3530 or placebo.

Eligibility criteria:
inclusion criteria: * ages 20 to 50 * body weight of ibm±20% exclusion criteria: * cardiovascular disease * color-blindness or weakness * hypotension, hypertension, orthostatic hypertension * abmormal qtc (\>430 ms)

Keywords: sk3530 tamsulosin hemodynamic interaction safety
effect of n-acetylcysteine (nac) on creatinine in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: n-acetylcysteine is used to reduce the risk of injury to the kidney after the administration of contrast dye. the mechanism and effectiveness of this intervention is not substantiated in the literature. the investigators hypothesize that serum creatinine will be lower in patients who receive nac compared to those who receive the placebo but serum cystatin c will not change in patients who receive nac compared to those who receive the placebo. also urine creatinine will increase after the administration of nac compared to before the administration of nac.


Eligibility criteria:
inclusion criteria: 1. patients with an egfr between 30-60 ml/min calculated using last available creatinine and patient weight. 2. age \> 18 3. no known allergies to or adverse effects from nac 4. no known scheduled radio-contrast procedures 5. no medications known to affect creatinine secretion

Keywords: n-acetylcysteine chronic kidney disease egfr cystatin c proteinuria stage 3 chronic kidney disease
healthy minds program app dosage

Conditions: Depression; Anxiety; Psychological Distress

Summary: the study will evaluate the effectiveness of the healthy minds program (hmp) meditation app on participants experiencing depression and/or anxiety. participants will be assigned to use the hmp app 5- or 15-minutes per day for 4 weeks.

depression and anxiety are highly common, but access to evidence-based treatments is limited. meditation training delivered through mobile health (mhealth) technology may increase access to effective strategies. however, the necessary dosage of meditation practice to produce benefits is unknown. this project will investigate the feasibility, acceptability, and preliminary effectiveness of the hmp app for depression and/or anxiety and the feasibility of randomly assigning participants to practice dosages. further, the project will provide a preliminary evaluation of the linkages between practice dosage and outcomes assessed retrospectively and in-the-moment via ecological momentary assessment (ema).

Eligibility criteria:
inclusion criteria: * age 18 or older * access to a smartphone or device capable of downloading hmp app * self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4 weeks * able to speak, read, and write in english * promis depression or promis anxiety \>55 exclusion criteria: * meditation retreat experience * regular meditation practice (weekly practice for over 1 year or daily practice within the previous 6 months) * previous practice under the instruction of a meditation teacher, other than in the context of an introductory course * promis depression \>70 * audit c score greater than or equal to 4 for men, and greater than or equal to 3 for non-men (any other genders)

Keywords: depression anxiety behavioral symptoms
effectiveness and cost-utility of a complex intervention for fibromyalgia patients

Conditions: Fibromyalgia

Summary: fibromyalgia (fm) is a chronic disease characterized by chronic pain, fatigue and loss of function that leads to a significant deterioration in the quality of life. despite controversies about the most appropriate treatment, studies indicate that a multidisciplinary treatment would be effective. this study aims to analyze the effectiveness and cost-utility of a complex intervention in the quality of life (main variable), the functional impact, the mood and the pain of people with fm treated in the primary care teams (pcts) of the catalan institute of health (cih).

methods and analysis: mixed methodology study following the recommendations of the medical research council, with two phases. phase 1: randomized pragmatic clinical trial with patients diagnosed with fm and assigned to one of the 11 pcts of the cih (territorial management of "terras del ebro"). a total sample of 336 patients is estimated. the usual clinical practice will be carried out in the control group and the usual practice and the complex treatment, in the intervention group. the complex treatment will be based on health education, aerobic physical exercise and cognitive-behavioral therapy, during 12 weeks in sessions of 2 hours/week. statistical analysis: assessment of the standardized mean response and of the size of the standardized effect and multivariate logistic regression analysis will be performed. the economic analysis will be based on useful measures. phase 2: qualitative socio-constructivist study to identify the improvement aspects of the intervention according to the results obtained and the opinions and experiences of the participants (patients and professionals). the sampling will be theoretical with 2 discussion groups composed of participants in the intervention and 2 discussion groups of professionals from different pcts.

Eligibility criteria:
inclusion criteria (all criteria must be met): * have a clinical diagnosis of fibromyalgia * have a fixed or mobile telephone * voluntarily accept participation in the project exclusion criteria: * active psychotic outbreak; * intellectual deficiency; * severe depression and personality disorder; * self and hetero-aggressive behaviors; * individual assessment of active consumption of psychoactive substances; * incompatibility with the group's schedule.

Keywords: quality of life randomized controlled trials costs and cost analysis primary health care
screen-hfi (screening evaluation of the evolution of new heart failure intervention study)

Conditions: Heart Failure

Summary: individuals who were a part of the investigators screen-hf study (nct00400257) whose bnp level are in the top quintile will be offered participation in this study. participants will be randomised to receive either spironolactone or placebo for three years. participants will then be monitored for indications of heart failure. it is anticipated that the medication will reduce the development of heart failure in this group.


Eligibility criteria:
inclusion criteria: 1. was recruited to screen-hf 2. has provided informed consent exclusion criteria: 1. uncorrected hyperkalaemia 2. egfr \< 30 ml/min

Keywords: prevention of heart failure in individuals at high risk