Kornimate/medical-research-clean huggingface dataset:
the safety and effectiveness of r-huepo in patients with aids or advanced aids-related complex (arc) who are anemic

Conditions: HIV Infections; Cytopenias

Summary: to determine the safety and efficacy of erythropoietin administered to patients with aids or advanced aids related complex arc and anemia.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following are excluded: * history of any primary hematologic disease. * clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying hiv disease. * aids-related dementia. * uncontrolled hypertension (diastolic blood pressure \> 100 mmhg). * presence of concomitant iron deficiency. * anemia attributable to factors other than aids or zidovudine (azt) therapy. * acute opportunistic infection. * history of seizures. concurrent medication: excluded: * zidovudine (azt) during the double-blind phase of the study. patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying aids are excluded. prior medication: excluded within 30 days of study entry: * experimental drug or experimental device. * cytotoxic chemotherapy. * excluded within 2 months of study entry: * androgen therapy. * zidovudine (azt) and during double-blind phase of study. clinical diagnosis of aids related anemia. * clinical diagnosis of aids or advanced aids related complex (arc). * clinically stable for 1 month preceding study entry. substance abuse.

Keywords: recombinant proteins erythropoietin acquired immunodeficiency syndrome anemia aids-related complex zidovudine
treatment of impulsive aggression (ia) in adolescent with adhd in conjunction with standard adhd treatment

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study was to evaluate the effect of spn-810 for the treatment of impulsive aggression (ia) in adolescents diagnosed with adhd when taken in conjunction with standard adhd treatment.

this study was an addition to the pediatric studies (chime 1 and chime 2) to assess the efficacy and safety of spn-810 in the improvement of impulsive aggression (ia) behaviors in adolescents with adhd. spn-810 was administered in patients diagnosed with adhd and associated features of ia, who were currently treated with an fda-approved standard adhd treatment and displayed persistent ia behaviors. the frequency of impulsive aggressive behaviors was assessed as a primary outcome. .

Eligibility criteria:
inclusion criteria: * otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at the time of screening) with a primary diagnosis of adhd and currently taking an optimized fda-approved adhd medication. * ia confirmed at screening using r-moas scale and vitiello aggression questionnaire. exclusion criteria: * history or current diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, personality disorder, tourette's syndrome or dissociative disorder, autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or intermittent explosive disorder. * currently meeting dsm-5 criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder or intermittent explosive disorder. * known or suspected intelligence quotient (iq) \<70, active suicidal plan/intent or active suicidal thought, criminal arrest, alcohol or drug use or pregnancy.
long term post marketing specified drug use result survey for evolocumab in japan

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia

Summary: the purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in japan.

the objectives of study are to 1) determine the incidence of adverse events and adverse drug reactions among patients receiving evolocumab for up to 2 years, and 2) identify and describe patient characteristics (e.g. demographics, medical history) associated with the safety and effectiveness of evolocumab therapy for the patients with familial hypercholesterolemia (heterozygous or homozygous) and hypercholesterolemia in japan

Eligibility criteria:
inclusion criteria: * patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved japan prescribing information (i.e., those with familial hypercholesterolemia (heterozygous or homozygous and hypercholesterolemia who have high risk factors for cardiovascular event and do not respond sufficiently to hmgcoa reductase inhibitor (statin) for hypercholesterolemia). exclusion criteria: * no exclusion criteria are applied.
safety and retention rate of the jak and tnf inhibitors in rheumatoid arthritis: a real-life experience

Conditions: Rheumatoid Arthritis; Drug Use

Summary: this study aims to extract data from the hong kong biologics registry for retention rate of the jak inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. these real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. moreover, data will represent our local experience of the jak inhibitors in chinese patients with ra. the retention rate and adverse effects of the jak inhibitors are compared with conventional tnf inhibitors.

this study aims to extract data from the hong kong biologics registry for retention rate of the jak inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. efficacy data and adverse events, in particular major adverse cardiovascular events (maces) and malignancy will be looked at and compared with the tnf inhibitors. retention / withdrawal rates of the drugs will be studied by statistical analyses.

Eligibility criteria:
inclusion criteria: * all ra patients in our biologics registry treated with the jak inhibitors (n=411) * all ra patients in our biologics registry treated with the tnf inhibitors (n=1392) exclusion criteria: - ra patients in our biologics registry treated with other biologic/targeted dmards

Keywords: rheumatoid arthitis biological agents targeted agents
a trial to evaluate the combination of iressa & faslodex® in patients with advanced or metastatic breast cancer

Conditions: Breast Cancer

Summary: the progression free survival and efficacy of 250 mg zd1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, er and/or pr positive breast cancer


Eligibility criteria:
inclusion criteria: * histologically confirmed advanced or metastatic breast cancer * postmenopausal females with amenorrhoea \> 12 months and an intact uterus * fsh levels within postmenopausal range or have undergone a bilateral oophorectomy * er \&/or pr positive * previous adjuvant hormone therapy \> 12 months prior to enrolment * previous adjuvant chemotherapy \> 6 months prior to enrolment * measurable disease according to recist and/or non measurable bone disease * life expectancy of at least 12 weeks * world health organisation (who) performance status (ps) of 0 to 1. exclusion criteria: * male * life-threatening metastatic visceral disease * evidence of clinically active interstitial lung disease * er and pr negative * treatment with lhrh analogues \< 3 months prior to enrolment * patients who have restarted menses or do not have fsh levels within the postmenopausal range * treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months * treatment with hormonotherapy and/or chemotherapy for advanced disease * extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. \>30% of bone marrow, e.g. whole of pelvis or half of spine) * currently receiving oestrogen replacement therapy * treatment with a non-approved or experimental drug within 4 weeks before enrolment * absolute neutrophil count (anc) less than 1.5 x 109/litre (l) or platelets less than 100 x 109/l , serum bilirubin greater than 1.25 times the upper limit of reference range (ulrr, serum creatinine greater than 1.5 mg/dl, alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 2.5 times the ulrr if no demonstrable liver metastases, or greater than 5 times the ulrr in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy * any unresolved chronic toxicity greater than ctc grade 2 from previous anticancer therapy * concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known * severe hypersensitivity to zd1839 or fulvestrant or any of the excipients of this product.

Keywords: advanced breast cancer metastatic breast cancer er positive breast cancer pr positive breast cancer
metyrosine (demser®) for the treatment of psychotic disorders in patients with velocardiofacial syndrome

Conditions: Velo-cardio-facial Syndrome; Psychosis

Summary: this is an exploratory clinical investigation. the objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (demser®) for the treatment of psychosis in patients with velocardiofacial syndrome (vcfs).


Eligibility criteria:
key inclusion criteria: 1. females of childbearing potential cannot be at risk of pregnancy during the study. 2. genetically confirmed diagnosis of vcfs at the time of screening. 3. must have one of the following diagnostic and statistical manual of mental disorders, fourth edition text revision (dsm-iv tr) diagnoses (applicable based upon clinical assessments): schizophrenia, schizoaffective disorder, psychosis not otherwise specified (nos), bipolar disorder, or mood disorder with psychotic features. 4. a total panss composite score \>65. 5. willing to discontinue psychotropic medications. - key exclusion criteria: 1. evidence of acute suicidality. 2. known or observed clinically significant cardiovascular, pulmonary, renal, hepatic, or gastrointestinal disorders; other clinically significant psychiatric/neurological and sleep disorders by dsm-iv-tr criteria; endocrine, or hematological or metabolic diseases. 3. full scale iq of less than 50. 4. pregnancy. 5. not using a reliable means of contraception. 6. systolic blood pressure of ≤110 mm/hg or ≥160 mm/hg, diastolic blood pressure ≤60 mm/hg or ≥90 mm/hg, or has clinically symptomatic orthostatic changes. 7. qtcf \> 450 msec, or pr \> 250 msec, or qrs \> 110 msec on ecg. 8. history of seizure disorder. -

Keywords: patients with velocardiofacial syndrome and psychosis
lumpectomy followed by intraoperative electron radiation therapy (ioert)

Conditions: Invasive Ductal Breast Cancer; Carcinoma Breast Stage I

Summary: the overall objective of this study is to determine the feasibility and tolerability of single dose intraoperative electron radiation treatment ("ioert") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.

evaluate local and distant recurrence rates and cosmetic outcomes. both clinical evaluation of cosmetic outcome by the surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire. local recurrence is evaluated under the same imaging protocol used for whole breast radiation.

Eligibility criteria:
inclusion criteria: * patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer * patient agrees to evaluation of the axilla with sentinel lymph node biopsy * peri or post-menopausal women age \> 50, defined as women who have experienced no menstrual period in the past 6 months or more * brca1 and 2 gene mutation negative, if tested. \[genetic testing is not required based upon personal or family history\] * unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary t-stage of tis or t1 (ajcc criteria) * grade 1, 2, or 3 acceptable * associated lcis is allowed * pure dcis allowed if \ 3 mm (per astro criteria) * estrogen receptor (er) status of positive * patient has clear margins \>2 mm on gross pathologic examination * patient is node-negative, defined as n0 (i-) or n0 (i+) * patient must be deemed functionally and mentally competent to understand and sign the informed consent * neoadjuvant hormonal therapy is allowed if all other astro suitable criteria have been met prior to onset of hormonal therapy exclusion criteria: * prior breast malignancy or other malignancy if metastatic, or with expected survival of \< 5 years * immunocompromised status * pregnancy * women with an active connective tissue disorder (i.e. scleroderma, lupus and others) * breast cancer that involves the skin or chest wall, locally advanced breast cancer * invasive lobular carcinoma * evidence of lymphovascular invasion (lvi) * invasive carcinoma with extensive intraductal component (eic) * neoadjuvant chemotherapy * patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection * someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy

Keywords: stage i breast carcinoma
intervening in diabetes with healthy eating, activity, and linkages to healthcare - the i-d-health study

Conditions: Diabetes Mellitus; Hyperglycemia; Obesity; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms

Summary: the purpose of this study is to compare ways of giving advice and providing support to improve diet and physical activity in adult primary care patients with elevated body mass index and dysglycemia.

this is a randomized comparative effectiveness trial to evaluate the health and economic effects of a community-based intensive lifestyle intervention for adult primary care patients with elevated body mass index and dysglycemia (either type 2 diabetes or pre-diabetes). the study will use qualitative and quantitative methods to assess reach, effectiveness, costs, adoption, implementation, and maintenance of a clinical-community partnership to offer intensive lifestyle intervention resources to eligible adult primary care patients.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older, and 2. body-mass index of ≥ 24 kg/m2, and 3. documented dysglycemia: either by verification of laboratory test (fasting plasma glucose 100-125 mg/dl or 2-hour post-challenge plasma glucose 140-199 mg/dl or a1c 5.7%-10.9%) or confirmation of type 2 diabetes mellitus by self-report with verification exclusion criteria (any of the following): diseases/conditions that could limit lifespan and/or increase risk with a lifestyle intervention: 1. significant cardiovascular disease: * uncontrolled hypertension: systolic blood pressure \>180 mmhg or diastolic blood pressure \>105 mmhg * a1c \> 10.9% * heart attack, stroke, or transient ischemic attack (tia) in the past 6 months * chest pain, dizziness, or fainting with physical exertion 2. lung disease: * chronic obstructive airways disease or asthma requiring home oxygen 3. pregnancy 4. any other known condition that could limit ability to become physically active or limit life span to \<5 years exclusions related to metabolism: 1. use of medications known to produce hyperglycemia 2. known disease leading to abnormal glucose metabolism, other than diabetes mellitus, including cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis exclusion for conditions or behaviors likely to affect the conduct of the study: 1. unable or unwilling to provide informed consent 2. unable to communicate with the pertinent research study staff 3. unable to read written english or spanish

Keywords: prevention & control hyperglycemia obesity diabetes mellitus cost benefit analysis
a study of the long-term safety of crisaborole ointment, 2% in japanese pediatric and adult participants with mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study is a phase 3, multicenter, open-label, long-term safety extension study of studies c3291032 and c3291031 in japanese pediatric and adult participants with mild to moderate atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * male or female participants; * who were patients with mild to moderate ad aged 2 years old or older and met eligibility criteria for study c3291032 at the time when entering study c3291032, and completed treatment period in study c3291032 without safety issues. or * who were patients with mild to moderate ad aged 1 months to \<24 months and met eligibility criteria for study c3291031 at the time when entering study c3291031, and completed treatment period in study c3291031 without safety issues exclusion criteria: * has other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Keywords: eczema crisaborole
sacroiliac joint manipulation effect in chronic piriformis syndrome.

Conditions: Piriformis Syndrome

Summary: the objective of the study was to determine the effects of sacroiliac joint thrust manipulation on pain, pain pressure threshold, piriformis length and straight leg raise, in chronic piriformis syndrome.

in 2017, a systematic review was conducted to measure the effectiveness of physical therapy approach for relieving the sij pain linked with ps. participants were administered with conservative physical therapy, kinesiology taping and sacroiliac joint manipulation in group a, group b and group c respectively. they have concluded that sacroiliac joint manipulation was more effective as compare to the rest of the physiotherapy approach in lowering the sij pain associated with piriformis syndrome. in 2014, an experimental study was conducted to compare the effects of nerve mobilization technique with conventional physical therapy approach. pre and post treatment data was taken from the respective participants. the results of this study concluded that there is a significant differences in the outcome measures of both groups and nerve mobs were proven to be more effective in relieving the sciatic nerve radiating pain associated with inflamed piriformis muscle in ps. a study in july, 2012 was conducted to compare the effects of two possible physical therapy treatments in lowering the low back pain threshold associated with piriformis syndrome. these two techniques were mets and scs. their results concluded that both muscle energy technique and strain counter strain were proved to be equally effective in the management of functional disability and pain in low back associated with chronic ps. an rct was conducted in 2011, to measure the effectiveness of two possible manipulation methods which can be applied in patients with chronic piriformis syndrome. according to this study, manipulating the of sij along with lumber manipulation is more effective as compare to the sij manipulation alone to regain the total piriformis length for patients with chronic ps. another study was conducted by gopal nambi and colleagues in saudi arabia. it was concluded that program comprises of post isometric relaxation is more effective as compare to conservative physical therapy in alleviating the pain, improving hip rom and functional improvement in participants with ps.

Eligibility criteria:
inclusion criteria: * patients having alteast 3 months chronic piriformis syndrome * fair test positive * unilateral or bilateral piriformis syndrome exclusion criteria: * lumber prolapsed intervertebral disc (pivd) * patients having hip osteoarthritis * sacroiliatis (faber test, mennell's test, sacral thrust test, compression test, distraction test, thigh thrust test) * lumbosacral instability * patients having any joint replacement in lumbosacral and hip regions.

Keywords: high velocity low amplitude thrust piriformis syndrome sacroiliac joint manipulation
analysis of coronary reactivity testing with and without intracoronary nitrate testing

Conditions: ANOCA - Angina With Non-obstructive Coronary Arteries; INOCA (Ischemia With Non Obstructive Coronary Artery Disease)

Summary: this single-arm, multi-center, prospective study will assess the coronary flow reserve (cfr), index of microcirculatory resistance (imr), and determinants thereof (transit time, pa, pd) in patients before and after intracoronary nitroglycerine.

this will be a single arm, multi-center, prospective interventional study. we will approach, consent, and enroll patients referred to the cardiac catheterization laboratory for coronary angiography for the indication of angina without obstructive coronary artery disease (cad; lesions \ 0.80, or non-hyperemic pressure index (rfr) \<0.89). patients will undergo invasive assessment with crt first without ic nitrates followed by a dose of 200-500 mcg of intracoronary nitrates and repeat crt. approximately 50 patients undergoing coronary angiography for evaluation of anoca or inoca will be consented for this study. the primary outcome will be comparing the variables assessed by crt with the primary outcome being cfr before and after nitroglycerin administration. the secondary outcomes will be imr, pd, pa, rrr, and transit times before and after nitrates. these variables will be compared to one another using paired t-tests and generalized estimating equations.

Eligibility criteria:
inclusion criteria: 1. aged 18 or older 2. patient being evaluated for anoca or inoca 3. clinical suspicion for angina 4. patient should be able to comply with the protocol. 5. provide written informed consent before study participation. exclusion criteria: 1. existing coronary artery disease 2. previous percutaneous interventions within the coronaries 3. current use (within 48 hours) of long-acting nitrate therapies 4. current use (within 48 hours) of pde-5 inhibitors (sildenafil, tadalafil) 5. any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study. 6. children below 18 years, prisoners, pregnant people and patients who are unable to provide consent are excluded.

Keywords: coronary reactivity testing intracoronary nitroglycerine