Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety and efficacy of two combinations of isocitrate dehydrogenase (idh) mutant targeted therapies plus azacitidine in participants with newly diagnosed acute myeloid leukemia (aml) harboring idh mutations who are not candidates to receive intensive induction chemotherapy

Conditions: Leukemia, Myeloid, Acute

Summary: the purpose of this study are 1. to determine the recommended combination dose of ag-120 and ag-221 separately when administered with azacitidine and, 2. to investigate the safety, tolerability, and efficacy of the combinations of ag-120 with azacitidine and ag-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (aml) with the isocitrate dehydrogenase (idh) enzyme isoforms 1 or 2 mutations, respectively.


Eligibility criteria:
inclusion criteria: * newly diagnosed, primary (ie, de novo) or secondary (progression of myelodysplastic syndrome \[mds\] or myeloproliferative neoplasms \[mpn\], or therapy-related) acute myeloid leukemia (aml) according to the who classification with ≥ 20% leukemic blasts in the bone marrow * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * agree to serial bone marrow aspirate/biopsies exclusion criteria: * suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype * aml secondary to chronic myelogenous leukemia (cml) * received a targeted agent against an isocitrate dehydrogenase 1 (idh1) or isocitrate dehydrogenase 2 (idh2) mutation * has or is suspected of having central nervous system (cns) leukemia. evaluation of cerebrospinal fluid is only required if cns involvement by leukemia is suspected during screening other protocol defined inclusion/exclusion criteria apply

Keywords: acute myeloid leukemia leukemia azacitidine ag-120 ag-221
low-dose iron supplementation in non-anaemic iron-deficient women

Conditions: Iron Deficiency (Without Anemia)

Summary: the goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.

the established therapy for iron-deficiency today is oral iron supplementation. however, this often leads to side effects such as constipation, black stools, nausea, and abdominal pain. there are some studies that have compared the efficacy of low-dose iron with normal-dose iron. these showed that the side effects are dose-dependent. furthermore, some studies have shown that the uptake capacity of high-dose iron is less efficient due to the upregulation of hepcidin. in a pilot study with low-dose iron (6mg per tablet), a significant increase in iron was shown, which can be explained by a lower hepcidin release. therefore, the investigators would like to show the efficacy of the low-dose iron product in a placebo-controlled setting. furthermore, the goal is to examine the reduction of side effects before and after administration of the iron and placebo tablet. additionally, a potential increase of low blood pressure to normal blood pressure will be investigated. there will be two groups of women: one group will be given a low-dose iron supplement of two tablets containing each 6mg for 2 months (60 days), the other one will get two placebo tablet for 2 months, accordingly.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * female gender * premenopausal * age \> 18 years * regular menstrual cycle * bmi in normal range (18-25 kg/m²) * serum-ferritin ≤30µg/l * no anaemia (hemoglobin ≥117g/l) * no intake of dietary supplements containing iron (last 4 weeks) * the participant is linguistically and cognitively able to understand the study procedure exclusion criteria: * current pregnancy * breastfeeding * hypermenorrhea (more than 5 unties/tampons per day) * chronic inflammatory diseases (e.g. colitis) * psychiatric disorders * chronic kidney disease (creatinine \>80 µmol/l) * liver disease (alt \>35 u/l) * increased crp (\>5mg/l) * hypersensitivity to iron-supplements * intake of medicines that interact with oral iron supplementation (e.g. ppi)

Keywords: iron deficiency low dose iron therapy iron therapy
mindfulness-based psychotherapy for drug-resistant epilepsy

Conditions: Epilepsy; Stress

Summary: psychological problems are prevalent among patients with drug-resistant epilepsy. the bi-directional interaction between psychological well-being and seizure have been recognized in recent years. reduction of psychological stress has the potential to improve seizure manifestation. the present study uses an assessor-blinded prospective randomized controlled trial to evaluate the efficacy of a mindfulness-based psychotherapy and an attentional-placebo social support on improving psychological well-being, seizure control and cognitive performance among adult patients with drug-resistant epilepsy.


Eligibility criteria:
inclusion criteria: * a diagnosis of epilepsy * over 18 years of age * resistant to pharmacological treatment according to the ilae guideline * no previous history of neurosurgery * adequate level of reading and understanding ability to fill in questionnaires * capable to communicate with the investigator with considerable expressive capacity * patients who agree to cooperate with the study procedures required by the protocol * patients who understand the nature of the study, agree to participate and sign the informed consent form exclusion criteria: * with primary diagnosis of substance use disorder, mood disorder, bipolar affective disorder, psychosis, or organic mental disorder * with diagnosis of learning disability or mental retardation

Keywords: epilepsy drug-resistant epilepsy seizure mindfulness stress psychotherapy
safety, tolerability,pharmacokinetics(pk)and pharmacodynamics(pd)assessment of lcq908 in patients with severe hypertriglyceridemia

Conditions: Hyperlipoproteinemia

Summary: this study will assess safety, tolerability, and effect of lcq908 on blood lipids in patients with severe hypertriglyceridemia.


Eligibility criteria:
inclusion criteria: * patients with hyperlipoproteinemia type i or type v willing and medically able to discontinue their lipid lowering medication (if prescribed). * non breast feeding women. * women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing. exclusion criteria: patients with: * uncontrolled type 1 or type 2 diabetes mellitus, * active pancreatitis (the month prior to study start), * history of drug or alcohol abuse within the 12 months prior to dosing, * or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study. other protocol-defined inclusion/exclusion criteria may apply

Keywords: familial hyperchylomicronemia lipoprotein lipase deficiency hyperlipoproteinemia triglycerides hypertriglyceridemia lcq908 hyperlipoproteinemia associated with lipoprotein lipase deficiency
role of endothelin-1 modulating insulin-stimulated blood flow and sympathetic nervous system activity in obesity

Conditions: Insulin Resistance; Autonomic Dysfunction; Obesity

Summary: the aim of this project is to determine role for et-1 in individuals with obesity.


Eligibility criteria:
inclusion criteria: * 18-55 years of age * male sex * obese (bmi ≥30 kg/m2) exclusion criteria: * female sex * current smoking/nicotine use * nerve/neurologic disease * cardiovascular, hepatic, renal, respiratory disease * blood pressure ≥140/90 mmhg * diabetes * vigorous exercise \>3 times/week * communication barriers * taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic
autologous regenerative islet transplantation for insulin-dependent diabetes

Conditions: Diabetes

Summary: this is a single-center, phase iit clinical trial to evaluate autologous regenerative islet transplantation for insulin-dependent diabetes mellitus. twenty patients with insulin-dependent diabetes mellitus will be enrolled: poor blood glucose control despite intensive exogenous insulin therapy. the primary endpoint will be defined by the return to normal blood glucose control without insulin at 12 months after transplantation.


Eligibility criteria:
inclusion criteria: * insulin-dependent diabetes mellitus, the specific criteria are (1 of 4-6 is sufficient). 1. age: 18-70 years old; 2. history of diabetes mellitus \>1 year; 3. insulin-dependent and total daily insulin dose \>20 units; 4. poor blood glucose control despite intensive exogenous insulin therapy (or high blood glucose fluctuation, glycation \>8% ); 5. frequent hypoglycemic episodes with unconsciousness; 6) diabetic nephropathy, patients who need to receive kidney transplantation. exclusion criteria: * 1) severe heart disease; 2) severe mental disorders, poor compliance or alcohol abuse; 3) active infection or with malignancy; 4) weight greater than 25% of ideal weight; 5) evidence of endogenous insulin secretion, such as type 2 diabetes; 6) smoking; 7) during gestation or preparation for gestation.
efficacy of tace with endoscopic therapy for unresectable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Esophagogastric Varices

Summary: the study is aimed to explore the efficacy of transarterial chemoembolization (tace) combined with endoscopic therapy for unresectable hepatocellular carcinoma (hcc) complicated with esophagogastric varices (egv) and seek out predictors associated with survival.


Eligibility criteria:
inclusion criteria: * 1. hcc was diagnosed in accordance with the 2017 edition of diagnosis guidelines, all patients were in cnlc stage ib to iiia, and treated with tace; 2. egv was demonstrated through endoscopic examination; 3. child-pugh grade a or b, or grade c patients improved liver function to grade a or b through aggressive treatment; 4. age between 18 and 75 years. exclusion criteria: * 1. hcc with diffuse or distant metastasis, or with other systemic malignancies; 2. severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 3. severe cardiac, cerebrovascular, lung and renal diseases and cannot tolerate endoscopic treatment; 4. severe coagulation dysfunction; 5. severe infection, bleeding with unstable vital signs; 6. history of liver surgery; 7. cannot or refuse to sign the informed consent.
a prospective study of two home based muscle strengthening programs for children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of this randomized, stratified, single-blinded study is to compare two home based strength-training protocols (high intensity interval training and progressive resistance training) and their effects on muscle strength, gait and aerobic and anaerobic capacity in children with cerebral palsy.

cerebral palsy is a common neuro-developmental disorder. among other signs of upper motor neuron syndrome, walking pathologies and muscle weakness are leading signs of disability in children with cerebral palsy. moreover, the gradual decline in muscle strength is part of the aging process and can be particularly devastating for people with motor disabilities. therefore muscle-strengthening programs are indicated for children with cerebral palsy. there is evidence that lower extremity muscle strength can be increased by progressive resistance training (prt) in children with cerebral palsy. however, prt is time consuming and therefore not always feasible for children with neurologic disorders. moreover, it does not influence the anaerobic capacity needed for everyday activities in children. high intensity interval training (hiit) is a time efficient method, which increases both aerobic and anaerobic capacities. the aim of this randomized, stratified, single-blinded study is to compare two home based strength-training protocols (hiit and prt) and their effects on muscle strength, gait and aerobic and anaerobic capacity in children with cerebral palsy.

Eligibility criteria:
inclusion criteria: * ambulatory children with unilateral or bilateral spastic cerebral palsy * age between 8-16 years * ability to accept and follow verbal instruction * gross motor function classification system (gmfcs) at level i-ii * willingness to participate exclusion criteria: * other than spastic form of cerebral palsy (ataxia, athetoid or dystonic) * quadriplegia * history of orthopaedic surgery in the last 12 months * history of botulinum toxin a application in the last 6 months * severe mental retardation

Keywords: cerebral palsy muscle structure strength training
arterial spin labeling (asl) mri for cognitive decline

Conditions: Mild Cognitive Impairment; Alzheimer's Disease

Summary: the purpose of this study is to determine the value of arterial spin labeling (asl) mri, a measure of blood flow to the brain, in mild cognitive impairment (mci) and compare it to existing measures. in particular, the investigators will compare asl mri to positron emission tomography (pet/ct), which measures brain metabolism reflecting how well cells in a patient's brain are functioning. in addition, the investigators will assess the relationship of these measures to specific protein levels associated with alzheimer's disease in the patient's cerebrospinal fluid (the fluid that surrounds the brain and spinal cord) obtained by lumbar puncture. by comparing the information that is available from these procedures to the patient's performance on cognitive tests, the investigators hope to learn which procedures most accurately reflect and assist in determination of the potential causes of cognitive difficulties that arise with mci, and thus, which are most useful in the clinical setting. in particular, pet scans have been found to be very useful in diagnosis of mci and alzheimer's disease, but the investigators want to find out if they can get the same, or better, information from an asl mri scan, which is less expensive and easier to acquire.


Eligibility criteria:
inclusion criteria: * males and females between the ages of 55 and 89. * fluent in english * part of the longitudinal cohort of the pmc/adcc (must already be or agree to become a part of the penn memory center cohort so baseline neuropsychological testing is available before study participation begins) * adequate visual and auditory acuity to allow for neuropsychological testing * women: post-menopausal or surgically sterile * willing and able to complete all required study procedures * completed 6 grades of education * geriatric depression scale less than 6 (assessed within 3 months) patients only: * diagnosis of mci * mmse between 24 and 30 * has a study partner exclusion criteria: * any contraindication to mri (i.e. presence of pacemaker, ferrous metal in the eye, severe claustrophobia that would preclude subject from completing the mri, etc.). * major depression, bipolar disorder, history of schizophrenia * history of substance abuse or dependence within the past 2 years. * any medical or neurological condition that, in the opinion of the investigator, would compromise the subject's safety, successful participation in, or integrity of the study. * pregnancy * recent history of poorly controlled diabetes (e.g. multiple blood glucose reports of ≥ 180 mg/dl.) * currently receiving medical or drug treatment contraindicating protocol participation e.g. anticoagulants such as coumadin/warfarin
preference of tegaserod vs. peg 3350 in patients with constipation

Conditions: Constipation

Summary: to determine whether female patients have a preference for tegaserod of peg 3350 relative to dosage form, convenience, ease of administration and taste


Eligibility criteria:
inclusion criteria: * females aged 18 to 64 years of age * patients with constipation as defined by the rome ii criteria exclusion criteria: * patients who have been previously been treated with tegaserod and/or peg 3350 * evidence of cathartic colon or a history of laxative abuse or laxative dependence * history of fecal impaction which necessitated surgical intervention * patients with clinically significant abnormal tsh levels at screening * women who are pregnant or breast feeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: constipation tegaserod polyethylene glycol 3350 peg
efficacy and safety of odanacatib in postmenopausal women previously treated with alendronate (mk-0822-050)

Conditions: Osteoporosis; Postmenopausal Osteoporosis

Summary: this study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.


Eligibility criteria:
inclusion criteria: * in good general health, and postmenopausal for at least 5 years or more * diagnosed with postmenopausal osteoporosis * currently taking alendronate for at least 3 years or more for the treatment of osteoporosis * one hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission x-ray absorptiometry (dxa) scan (ie, bone mineral density scan) * agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study exclusion criteria: * evidence of metabolic bone disorder * history of malignancy (cancer) for 5 years or less * active thyroid disease that cannot be managed with medication * severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation) * use, misuse, abuse, and/or addiction of illicit drugs and/or recent history (within the last year) of drug or alcohol abuse or dependence * use of estrogen with or without progestin and/or raloxifene (ie, evista®) or tamoxifen (ie, nolvadex®, tamofen®) * use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or strontium-containing products (ie, osteovalin™)
lanreotide (somatuline autogel) in thyroid-associated ophthalmopathy treatment

Conditions: Thyroid-Associated Ophthalmopathy

Summary: the main purpose of this study is to evaluate the efficacy and safety of 3 doses of somatuline autogel 60mg to control the muscle infiltration and edema, eyelid retraction and extraocular muscular contraction in patients with active thyroid-associated ophthalmopathy of moderate intensity.


Eligibility criteria:
inclusion criteria: * patients with autoimmune thyroid disease and whose centre's medical records confirm the presence of euthyroidism for at least two months before being included into the study * thyroid-associated ophthalmopathy diagnosed a minimum of six months before his/her participation in the study, well documented in the centre's medical records and based on the moderate intensity of thyroid-associated ophthalmopathy in the worst eye * patients whose ophthalmopathy activity has been demonstrated by a positive octreoscan exclusion criteria: * the patient presents compressive optical neuropathy signs which require immediate surgical treatment or suffers from serious intensity thyroid ophthalmopathy * the patient has been treated with radio-iodine for his/her thyroid disturbance in the past 6 months * the patient's thyroid-associated ophthalmopathy has been treated previously (except for drops and local measures) or is planned to be treated with radio-iodine or thyroidectomy for his/her autoimmune thyroid disease during the study or suffers from myopia, glaucoma or any other eye disease which could modify the ophthalmological progress * the patient is a smoker of more than 5 cigarettes per day
detection of aspergillus fumigatus and sensitization in copd patients with bronchiectasis vs without bronchiectasis

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a single center case-control study with 100 copd patients will be organized to compare patients with and without bronchiectasis with regard to the presence of aspergillus in sputum samples, aspergillus sensitization and vitamin d. induced sputum samples will be optimized for culture, aspergillus galatomannan analysis and rt-pcr. this study is part of a larger project in which we assume that chronic respiratory infection by aspergillus fumigatus and the accompanying immune response play an important role in the development of bronchiectasis in copd. we suspect that this mechanism is controlled by vitamin d and it fails by suppression of the vitamin d receptor by aspergillus fumigatus. the present study is designed by the laboratory of pneumology and will be conducted in collaboration with the laboratory of clinical bacteriology and mycology of the catholic university of leuven.


Eligibility criteria:
inclusion criteria: * established diagnosis of copd by medical doctor (based on clinical history or pulmonary function test) * smoking history of at least 10 pack-years * ct thorax available for assessment of bronchiectasis * fev1 \>= 30% exclusion criteria: * mechanical or non-invasive ventilation * other main respiratory diagnosis other than copd * active mycobacterial disease * immunosuppression other than steroids * active cancer treatment

Keywords: copd chronic obstructive pulmonary disease aspergillus fumigatus bronchiectasis sensitization vitamin d
ptsd screening in pregnant black women

Conditions: Pregnancy Early; PTSD

Summary: this study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (ptsd) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for black pregnant women.

researchers will examine whether culturally responsive screening, brief intervention, and referral to treatment (sbirt) for obstetrics (ob) is more effective in reducing ptsd symptoms compared to brief screening for ptsd. this study will help participating ob clinics to determine the best option for screening for ptsd in black pregnant persons in their clinic during first-trimester prenatal visits. the study population will include black pregnant women receiving medical care in their first trimester of pregnancy. surveys and chart abstraction will be used in this study to collect data. the approximate study duration for individuals is 4 visits over 12 months.

Eligibility criteria:
inclusion criteria: * 18+ years old, * ability to provide informed consent, * english-speaking, * willingness to participate in the study, * self-identification as black or african american, * pregnant and in the first trimester attending initial prenatal care visit, * endorsement of at least one traumatic event in their lifetime. exclusion criteria: * active suicidality

Keywords: pregnancy black women screening for maternal ptsd obstetric care african-american women