Kornimate/medical-research-clean huggingface dataset:
risperidone pharmacokinetics in children with pervasive developmental disorder (pdd)

Conditions: Child Development Disorders, Pervasive

Summary: the purpose of this research is to study the pharmacokinetics of risperidone in a group of pediatric patients with pervasive developmental disorder (pdd). the study will determine how much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following the patient's usual daily dose. the study is designed to look at how fast children absorb, breakdown, and eliminate risperidone.

pervasive developmental disorders is a category of disorders that includes autism and related conditions. while these disorders are rare, they represent a significant public health problem because they are extremely debilitating and lack efficacious therapies. neuroleptic use in pdd is high and the population appears to be at increased risk of serious sequelae including tardive dyskinesia. newer atypical neuroleptics including risperidone are now used in 87% of cases but dosing, safety and efficacy is undetermined in the vulnerable population. this study consists of a total of 3 visits, the initial screening visit where consent, medical history, demographics and vitals will be recorded. two additional visits with blood sampling will occur. the second visit will be no greater than 30 days from the screening visit and the 3rd visit will be one month from visit 2.

Eligibility criteria:
inclusion criteria: * male and female patients between ages of 5 and less than 17 years. * patients meeting dsm-iv criteria for pdd-nos about to initiate clinical treatment or currently clinically treated with risperidone. * patients with autistic disorder or pdd-nos currently on risperidone as a participant in one of the multi-site rupp protocols. exclusion criteria: * children taking psychotropic or other medication that will interact with target cyp 450 isoenzyme activity will not be eligible for the pharmacokinetic study (i.e. cyp2d6 or cyp3a4; to be decided by the pi) * patients with known renal or hepatic dysfunction (e.g. serum creatinine \> 1.5 normal upper limit, transaminases or bilirubin \> 2 times normal upper limit) * failure of the parent/legal guardian to give informed consent.

Keywords: risperidone autism pdd pervasive developmental disorder
study of circulating tumor cells before and after treatment in patients with metastatic melanoma

Conditions: Melanoma

Summary: circulating tumor cells (ctc) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. the detection of ctc by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (cellsearch, veridex llc) was approved by the fda in these indications. however, to date there is no reliable method to detect ctcs in melanoma (cmc). studies based on pcr amplification of mrna by reverse specific melanoma is disappointing. recently, a new detection system of cmc immunomagnetic was presented (cellsearch, veridex llc, united states). this system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. a preclinical study on serial dilutions of melanoma cells has shown encouraging results. the investigators propose a prospective study of the cellsearch system in patients with melanoma. primary objective: to determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma. secondary objectives: * determine the percentage of patients with metastatic melanoma with melanoma cells circulating * seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma * seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma


Eligibility criteria:
inclusion criteria: * patients \> or = 18 years * patients with advanced melanoma stage iiic (unresectable) or stage iv * patient not treated or not responding to chemotherapy with chemotherapy session last\> 1 month * patients who signed informed consent * patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology * patients with a life expectancy greater than 3 months * patients with melanoma measurable by recist version 1.1 * patients with venous good for venipuncture exclusion criteria: * patients with contraindication for treatment with chemotherapy or v600e braf inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma * pregnant women or nursing * people vulnerable detainees, adults under guardianship or curatorship, minors.

Keywords: cancer melanoma circulating tumor cells
therapy of antibody-mediated autoimmune diseases by bortezomib (tavab)

Conditions: Myasthenia Gravis; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Summary: the aim of this pilot study is to investigate the application of proteasome inhibitor bortezomib (velcade®, approved for therapy of multiple myeloma) in patients with therapy-refractory antibody-mediated autoimmune diseases. the investigators hypothesis is that the proteasome inhibition will lead to reduced antibody titers and improved clinical outcome.


Eligibility criteria:
(main) inclusion criteria: * age 18 - 75 years at screening * ability to give written consent, informed written consent * negative pregnancy test at screening * therapy-refractory myasthenia gravis (generalized) or systemic lupus erythematosus or rheumatoid arthritis (main) exclusion criteria: * belimumab therapy within the last 6 months * b-cell-depletion therapy within the last 9 months * heart or kidney insufficiency * known intolerability to bortezomib * participation in another interventional trial within the last 3 months * liver cirrhosis * preexistent sensory or motor polyneuropathy ≥ degree 2 (nci ctc ae criteria), within 14 days before screening * hints on clinically apparent herpes zoster reactivation * active systemic infection, or viral infection (cmv, ebv) within last 6 month before screening * serologically active hepatitis b and /or c, known hiv infection * tumor disease currently or within last 5 years * clinically relevant liver, kidney or bone marrow function disorder * pregnancy or lactation

Keywords: myasthenia gravis systemic lupus erythematosus rheumatoid arthritis proteasome inhibitor bortezomib velcade antibody-mediated autoimmune disease
a long-term study of pa21 in hemodialysis patients with hyperphosphatemia

Conditions: Hemodialysis Patients With Hyperphosphatemia

Summary: the purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.


Eligibility criteria:
inclusion criteria: * receiving stable maintenance hemodialysis 3 times a week. * dialysis patients with hyperphosphatemia exclusion criteria: * patients having history of a pronounced brain / cardiovascular disorder. * patients having severe gastrointestinal disorders. * patients having severe hepatic disorders.

Keywords: hemodialysis hyperphosphatemia
post-marketing surveillance of atrovent® inhalets in chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: study to obtain further information on the tolerability and efficacy of atrovent® inhalets in the treatment of chronic obstructive pulmonary disease under conditions of daily practice


Eligibility criteria:
inclusion criteria: * patients of both genders older than 40 years, who suffer from chronic obstructive pulmonary disease * only patients who have not been treated with atrovent® within the last year are to be considered for inclusion exclusion criteria: * contraindications listed in the instructions for use/summary of product characteristics for atrovent® metered dose inhaler
anti-proteinuric response to acei, arb and diuretics combination.

Conditions: Heavy Proteinuria

Summary: determine the best strategy for proteinuria lowering in patients with proteinuria \> 1 g/day receiving acei and arb combination: either increase of acei and arb dosage or increase of diuretic dosage.


Eligibility criteria:
inclusion criteria: * proteinuria \> 1 g/day with ramipril 5 + valsartan 80 mg/day for 2 months * proteinuria changes \< 50% on 3 separate dosages over 2 months. exclusion criteria: * age \ 80 years systolic bp \ 250 mmole/l * serum creatinine increase on ramipril + valsartan \> 20% * intolerance to acei or arb

Keywords: proteinuria acei arb diuretics blood pressure renal failure
a study to assess change in disease state in adult participants with acute myeloid leukemia (aml) ineligible for intensive chemotherapy receiving oral venetoclax tablets in greece

Conditions: Acute Myeloid Leukemia

Summary: acute myeloid leukemia (aml) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. this study will evaluate how well venetoclax works to treat aml in adult participants who are ineligible for intensive chemotherapy in greece. venetoclax is a drug approved to treat acute myeloid leukemia. all study participants will receive venetoclax as prescribed by their study doctor in accordance with approved local label. adult participants with a new diagnosis of aml who are ineligible for intensive chemotherapy will be enrolled. around 100 participants will be enrolled in the study in approximately 15 sites in greece. participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. the duration of the study is approximately 30 months. there is expected to be no additional burden for participants in this trial. all study visits will occur during routine clinical practice and participants will be followed for 30 months.


Eligibility criteria:
inclusion criteria: * participant diagnosed acute myeloid leukemia (aml) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per greek ministry of health (moh) label. * physician has decided to initiate venetoclax treatment. the decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study. exclusion criteria: - participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Keywords: acute myeloid leukemia venetoclax venclexta venclyxto abt-199 cancer
comprehensive add on study in japan

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.


Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes mellitus 2. male and female patients on diet and exercise regimen who are treated with one antidiabetic drug exclusion criteria: 1. myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism 2. impaired hepatic function 3. glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate \<30 ml/min (severe renal impairment) at visit 1, biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate \<60 ml/min (moderate renal impairment) at visit 1 4. treatment with anti-obesity drugs
cpg 7909 plus herceptin® in patients with metastatic breast cancer

Conditions: Carcinoma, Breast

Summary: to determine the safety and efficacy of cpg 7909 injection given with herceptin to patients with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer with metastases * tumor that has overexpression of her2 as documented by being either fish-positive or her2/neu 3+ confirmed by immunohistochemistry * patients may have had up to three prior chemotherapy regimens for metastatic disease, which may have been given in combination with herceptin® and which may have been discontinued due to toxicities. in addition, patients may have had adjuvant chemotherapy. * phase ii only: must have measurable disease by recist criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques, or as \> 10 mm with spiral ct scan exclusion criteria: * any prior therapy with anthracycline + herceptin® concurrently * significant cardiovascular disease (e.g., nyha class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction \< 50% * pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, sjogren's syndrome, autoimmune thrombocytopenia

Keywords: cpg 7909 subcutaneous injection combination with herceptin® metastatic breast cancer.
quality-of-life study of patients with previously treated ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: quality-of-life assessment of patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment in patients with cancer. purpose: this clinical trial studies the quality of life in patients with previously treated ovarian cancer.

objectives: i. compare quality of life in terms of health status, sexual functioning, psychological/emotional well being, and social functioning in ovarian germ cell cancer survivors vs a matched healthy control group. ii. predict quality of life in these patients through the additive effects of cancer diagnosis and treatment, sociodemographic characteristics, other stressors, and social network variables. outline: patients identify up to 3 healthy acquaintance controls within 3 years of the same age. patients and controls complete a written questionnaire, which takes about 30 minutes, and a telephone interview, which takes about 1 hour, to assess quality of life. projected accrual: a total of 190 patients and 190 healthy controls will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: history of early or advanced ovarian germ cell tumors continuously disease free for at least 2 years prior to study must have been enrolled on gog protocols 45, 78, 90, and 116 or similar protocols of cisplatin-based chemotherapy at m.d. anderson cancer center patient characteristics: age: 18 and over performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: must be able to complete a written questionnaire and telephone interview in english prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics endocrine therapy: not specified radiotherapy: no prior radiotherapy surgery: not specified

Keywords: stage i ovarian germ cell tumor stage ii ovarian germ cell tumor stage iii ovarian germ cell tumor stage iv ovarian germ cell tumor recurrent ovarian germ cell tumor
influence of intensive lipid lowering treatment compared to moderate lipid lowering treatment

Conditions: Myocardial Infarction [C14.907.585.500]

Summary: the aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.


Eligibility criteria:
inclusion criteria: 1. st-segment elevation myocardial infarction 2. no prior treatment with statins and 3. a non significant lesion in one of the two non-culprit coronary arteries exclusion criteria: 1. age below 18 or above 81 years, 2. unconscious patients, 3. serum creatinine \> 176μmol/l, 4. hypothyroidism ((tsh \> 1.5 x uln (upper limit of normal)), 5. current liver disease (alat \> 2 x uln), 6. unexplained creatine kinase \> 3 x uln, 7. alcohol or drug abuse within the last five years, 8. prior myopathy or serious hypersensitivity reaction caused by statins, 9. women with childbearing potential who were not using chemical or mechanical contraception, 10. pregnant or breastfeeding women, 11. history of malignancy unless a disease-free period of more than five years was present, 12. patients with abnormal lung function test (lft), 13. participation in another investigational drug study less than four weeks before enrolment in the present study, 14. treatment with cyclosporine or fibrates

Keywords: index of microcirculatory resistance fractional flow reserve
observational study to assess adverse events when adult female participants are treated with ubrelvy (ubrogepant) or qulipta (atogepant) during pregnancy

Conditions: Migraine

Summary: migraine is a common neurological disorder typically characterized by attacks of throbbing or pulsating headache on one side of the head of moderate to severe pain intensity. the purpose of this study is to evaluate fetal, maternal, and infant outcomes through 12 months of age among women exposed to ubrelvy or qulipta during pregnancy, as well as in 2 comparator groups. ubrelvy (ubrogepant) and qulipta (atogepant) are approved drugs for the acute treatment of migraine in adults. approximately 628 pregnant women with migraine exposed to ubrelvy, 628 pregnant women with migraine exposed to qulipta and 628 pregnant women with migraine in comparator group will be enrolled in this study in the united states. participants enrolled in the ubrelvy-exposed group and qulipta-exposed group will receive ubrelvy and qulipta respectively as prescribed by their physician.


Eligibility criteria:
inclusion criteria: * within the united states or canada. * qualify as a prospective enrollment, defined as currently pregnant. * a diagnosis of migraine by the patient's health care provider (hcp). * provide contact information for the participant and her and her infant(s)', if applicable, hcps. * authorize their hcp(s) to release maternal and infant medical information to the registry, upon request. * provide sufficient information to confirm eligibility for 1 of following: * ubrelvy-exposed women with migraine: documented information indicating that at least 1 dose of ubrelvy was taken during pregnancy, including the estimated number of administrations per trimester. * qulipta-exposed women with migraine: documented information to indicating that at least 1 dose of qulipta was taken during pregnancy, including start and stop date(s) of administration. * internal comparator: ubrelvy/qulipta-unexposed pregnant women with migraine: documented information indicating that they have, a) never taken ubrelvy and/or qulipta, or b) discontinued ubrelvy 2 days prior or qulipta 5 days prior to conception. exclusion criteria: * documentation of exposure to any gepants (acute or preventive) other than ubrelvy and qulipta, or cgrp monoclonal antibodies, from 5 halflives of the respective treatment prior to conception or at any point during pregnancy before enrollment. * women who are no longer pregnant (retrospective cases women for whom the pregnancy has already ended, and the outcome of pregnancy is known at the time of enrollment). * for further clarification of inclusion/exclusion please contact the investigator to the end of this section in case anything is unclear to a potential patient, etc

Keywords: migraine ubrelvy ubrogepant atogepant qulipta med-epi-neu-0649
repaired tetralogy of fallot italian registry

Conditions: Tetralogy of Fallot; Cardiac Death, Sudden; Cardiac Arrhythmia; Cardiac Event

Summary: the cmr/ct wg of the italian pediatric cardiology society set up a multi-center observational clinical database of repaired-tof evaluated. this registry will enroll prospectively patients evaluated by cmr for clinical indication in most of the chd italian centers. data collection will include surgical history, clinical data, imaging data, and also adverse cardiac events for a period of 6 years.

this is an observational prospective registry that will enroll patients presenting with repaired tetralogy of fallot (tof) undergoing a cardiac magnetic resonance (cmr) imaging study in our recruiting cmr-laboratories. cmr imaging studies will include the evaluation of biventricular volumes and function, atrial volumes and function, and the late gadolinium enhancement (lge), along with the evaluation of the anatomy and flow of the main pulmonary arteries and branches. we will also assess the aortic valve for regurgitation and measurement of the aortic size. at follow-up, any interventional or surgical procedures performed and symptoms or any major (death) and cardiac (cardiac-related hospitalization) events will be collected.

Eligibility criteria:
inclusion criteria: * patients with repaired - tof exclusion criteria: * age \< 10 years * other associated complex pathology such as mapcas, atrioventricular canal, ebstein * incomplete cmr exam
a study to compare two dose strengths of cvt-301 (levodopa inhalation powder) with an oral dose of sinemet® (carbidopa-levodopa) tablets

Conditions: Parkinson Disease

Summary: this study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of cvt-301 compared with the reference listed drug (rld), orally administered carbidopa/levodopa, in healthy volunteers.

the primary objective is to determine the relative bioavailability of two cvt-301 (dose levels 1 and 2) capsules compared with the reference listed drug (rld) on a per milligram basis.

Eligibility criteria:
inclusion criteria: * in good general health as determined by medical history, physical examination, electrocardiogram (ecg), vital signs, and clinical laboratory evaluation; * fev1/fvc above the 5th percentile of the predicted normal distribution for age and gender; * body mass index (bmi) between 18 - 30 kg/m2 exclusion criteria: * no flu-like syndrome or other respiratory infections within 2 weeks prior to the screening visit; * negative drug and alcohol testing; * negative pregnancy test for female subjects

Keywords: parkinson's disease episodic motor fluctuations (off periods)
the efficacy and safety of dwp16001 in combination with metformin in t2dm patients inadequately controlled on metformin

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases

Summary: therapeutic confirmatory study to evaluate the efficacy and safety of dwp16001 in combination with metformin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone.

a multi-center, randomized, double-blind, active-controlled, phase 3, therapeutic confirmatory study to evaluate the efficacy and safety of dwp16001 in combination with metformin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone.

Eligibility criteria:
inclusion criteria: 1. subjects with t2dm aged 18 to 80 years 2. subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ hba1c ≤ 10.5% 3. subjects with bmi of 20-45 kg/m2 4. subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study exclusion criteria: 1. subjects with current or history of hypersensitivity to the ip of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or sglt2 inhibitors) 2. diabetic ketoacidosis, diabetic coma or precoma within the past year 3. urinary tract infections or genital infections within 4. uncontrolled hypertension (sbp \> 180 mmhg or dbp \> 110 mmhg) 5. egfr \< 60 ml/min/1.73 m2 6. severe heart failure (nyha class iii/iv)

Keywords: dapagliflozin sodium-glucose transporter 2 inhibitors molecular mechanisms of pharmacological action hypoglycemic agents physiological effects of drugs