Kornimate/medical-research-clean huggingface dataset:
a study of byl719 in adult patients with advanced solid malignancies

Conditions: Advanced Solid Tumor

Summary: in this study, byl719 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. the trial will investigate the safety and tolerability and determine the mtd of byl719 in japanese patients.


Eligibility criteria:
inclusion criteria: * patients with histologically-confirmed, advanced unresectable solid tumors availability of a representative formalin fixed paraffin embedded tumor tissue sample * at least one measurable or non-measurable lesion age ≥ 18 years * eastern cooperative oncology group(ecog) performance status ≤ 2 good organ (hepatic, kidney, bm) function at screening/baseline visit exclusion criteria: * brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy. * prior treatment with pi3k inhibitor * patient with peripheral neuropathy nci-ctc grade ≥ 2 * patient with diarrhea nci-ctc grade ≥ 2 * patient with acute or chronic pancreatitis * impaired cardiac function or clinically significant cardiac disease incl unstable angina pectoris ≤ 3 months prior to starting study drug and acute myocardial infarction (ami) ≤ 3 months prior to starting study drug * patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus * women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control other protocol-defined inclusion/exclusion criteria may apply

Keywords: pi3k advanced solid tumor
evaluate safety, whole-body distribution and radiation dosimetry in metastatic castration resistant prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: a study to evaluate safety, whole-body distribution and radiation dosimetry of za-001, an alpha-particle-emitting (at211) radiopharmaceutical, in metastatic castration resistant prostate cancer


Eligibility criteria:
inclusion criteria: 1. participants provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. 2. participants must be ≥18 years of age and competent to give informed consent. 3. participants must have progressive mcrpc with histologically or cytologically confirmed adenocarcinoma of the prostate. participants must have documented psa and/or radiographic progression. 4. participants must have gallium 68 psma-11 (ga 68 psma-11) positron emission tomography (pet)/computed tomography (ct) prostate-specific membrane antigen (psma) positive lesions ≤ 30 days prior to beginning study therapy. 5. participant has not received any form of prostate-cancer directed therapy since undergoing screening psma scan. 6. participants must have an eastern cooperative oncology group (ecog) performance status of 0 to 1. 7. participants must have a life expectancy of more than 3 months. 8. effective castration with testosterone level of \<50 ng/dl and plan to continue with chronic medical or surgical castration. 9. participants must have adequate hematological and organ function. exclusion criteria: 1. participants with any medical condition or other circumstances that, in the opinion of the investigator, would preclude participation in this study, compromise obtaining reliable data, achieving study objectives, or completion. 2. pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology not consistent with prostate adenocarcinoma. 3. participants with any psma-negative metastatic lesion these criteria were ineligible. 4. less than 4 weeks since last myelosuppressive therapy (including prior radiotherapy or prior treatment with 223radium, 89strontium or 153samarium containing compounds). 5. with active or uncontrolled infection. 6. have used any other investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment, or have used any investigational medical devices within 4 weeks prior to the start of the study treatment, and plan to receive other investigational drugs or medical devices during the course of this study. 7. previously known to have a history of allergy, hypersensitivity, or intolerance to radioactive drugs; or known to be allergic to ethanol. 8. participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy during and for 90 days after discontinuation of study treatment.

Keywords: psma positive metastatic prostate cancer
treatment of post-traumatic stress disorder with high doses of escitalopram

Conditions: Stress Disorders, Post Traumatic

Summary: the study evaluates the hypothesis that large doses of escitalopram will reduce symptoms of chronic post-traumatic stress disorder (ptsd) in adult civilian survivors of traumatic events. forty survivors of carefully documented traumatic events who had been followed for more than two years and have not improved will receive up to 40 mg of escitalopram (daily) for twelve weeks symptoms of ptsd, depression, anxiety disorders, quality of life and global clinical impression, as well as emergent side effects will be recorded every two weeks (one week for the first four weeks. the primary outcome measure will be symptoms of ptsd as recorded at the end of the study (or the last meeting with the patient - last observation carried forward). the secondary outcome criteria will be treatment continuation, as expressed in the proportion of patients leaving the study for either lack of effect or side effects.

the study evaluates the hypothesis that large doses of escitalopram will reduce symptoms of chronic post-traumatic stress disorder (ptsd) forty adult survivors of carefully documented traumatic events who had been followed for more than two years and have not improved will receive up to 40 mg of escitalopram (daily) for twelve weeks symptoms of ptsd, depression, anxiety disorders, quality of life and global clinical impression, as well as emergent side effects will be recorded every two weeks (one week for the first four weeks. the primary outcome measure will be symptoms of ptsd as recorded at the end of the study (or the last meeting with the patient - last observation carried forward). the secondary outcome criteria will be treatment continuation, as expressed in the proportion of patients leaving the study for either lack of effect or side effects.

Eligibility criteria:
inclusion criteria: * adult survivors of traumatic events with chronic ptsd exclusion criteria: * individuals with past history of psychotic disorder, bipolar disorder, opiate or stimulants abuse. * individuals currently on anti-depressant therapy. * individuals with past history of a failure to respond to escitalopram * pregnant women * medical condition excluding the treatment with escitalopram (e.g., renal or hepatic insufficiency). current, life threatening medical illness. history or severe side effects with escitalopram (e.g., hyponatremia)

Keywords: ptsd pharmacological treatment ssri escitalopram anxiety disorders
early pharmacotherapy aimed at neuroplasticity in autism : safety and efficacy

Conditions: Autism

Summary: the purpose of this study is to determine the efficacy, safety, and population pharmacokinetics and determinants of drug responses to buspirone in children with autism using a randomized, double blind, cross over study in children ages 2 to 6 years.

autism is a neurodevelopmental disorder defined as qualitative impairment in social interaction and communication and restrictive stereotype patterns of behavior, interests and activities. pharmacological agents are being increasingly used off label in very young autistic children, and there is virtually no data regarding the pharmacokinetics, safety or efficacy of these agents in young children. the approach in this study differs from pharmacotherapy studies of autism carried out thus far in several ways: * the rationale underlying our approach is based upon an attempt to alter synaptic plasticity during postnatal development, focusing on very young children * are integrating our drug trial with a pg study evaluating whether buspirone response is related to expression of genes involved in serotoninergic neurotransmission * will assess these variables together with in vivo assessment of serotonin synthesis capacity with pet. this is a prospective, randomized, double blind, crossover study where children will be stratified by age into two groups. treatment will last for 12 weeks with dosing twice a day. parent ratings, cognitive tests and blood sampling will occur throughout the study period.

Eligibility criteria:
inclusion criteria: * meet study definition for the diagnosis of autistic disorder * age 2 to 6 (male or female) * informed consent exclusion criteria: * clinical or lab evidence of renal or hepatic disease * treatment with any medication known to alter the activity of the cyp3a4 enzyme including ketoconazole, itraconazole, grapefruit juice, erythromycin, clarithromycin, cimetidine, verapamil, diltiazem, rifampin, phenytoin, phenobarbital, or carbamazepine within the previous 3 months * use of centrally acting drugs during the 6 weeks prior or during the study * presence or history of neurological disorders, including seizure disorders

Keywords: autism neuroplasticity
innovative ultrasound technology in neuromuscular disease

Conditions: Amyotrophic Lateral Sclerosis; Muscular Dystrophy; Radiculopathy; Myopathy; Polyneuropathy and Mononeuropathies; Trauma Injury; Orthopedic Disorder

Summary: this study is utilizing ultrasound measurement to measure neuromuscular disease status in adult patients. the hypothesis is the by quantifying ultrasound data, it is possible that ultrasound can be utilized as a tool to determine if a disease is responding to therapy or progressing.


Eligibility criteria:
inclusion criteria: * history of a well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy. exclusion criteria: * multiple generalized neuromuscular conditions.
lipolytic effects of gh in human subjects in vivo

Conditions: Metabolic Diseases; Growth Hormone Treatment

Summary: growth hormone (gh) induces fat metabolism. the mechanisms underlying the fat metabolizing effects of gh remain elusive. however, it is known that insulin suppresses fat metabolism, and gh inhibits the expression of certain insulin-dependent signaling proteins. we therefore hypothesize that the fat metabolizing effects of gh depend on abrogation of insulin-dependent signaling pathways. in order to investigate the fat metabolizing effects of gh, we'll analyze consecutive adipose tissue biopsies taken after gh exposure and gh blocking, respectively. knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in long-sight have great importance for the understanding of growth disorders from overweight and type 2 diabetes to malnutrition and eating disorders.


Eligibility criteria:
inclusion criteria: * healthy males * no medication * bmi 28-35 exclusion criteria: * known diseases * regular medication

Keywords: lipolysis atgl
prognostic values of next generation sequencing (ngs) in acute myeloid leukemia patients with allo-hsct

Conditions: Acute Myeloid Leukemia

Summary: acute myeloid leukemia (aml) is a genetically heterogeneous disease and allogeneic hematopoietic stem cell transplantation (allo-hsct) is a curative treatment option for aml except for aml-m3. relapse remains the major cause of treatment failure after allo-hsct. molecular residual disease has been shown to be a strong risk factor for relapse after hsct. in this study, the investigators will detect mutations before/after allo-hsct by using next-generation sequencing (ngs) technique to measure residual disease and evaluate the prognostic impact of molecular residual disease in a cohort of aml participants receiving allo-hsct.


Eligibility criteria:
inclusion criteria: * 18 years or old; * clinical diagnosis of acute myeloid leukemia (aml); * availabe records of micm and ngs results at diagnosis; * be going to receive allo-hsct. exclusion criteria: * active malignancy; * pregnant or breast feeding women.

Keywords: acute myeloid leukemia next generation sequencing hematopoietic stem cell transplantation
randomized trial between weekly and 5 day 3 weekly cisplatin for cervical cancer

Conditions: Locally Advanced Cervical Cancer

Summary: the primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer. the secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.


Eligibility criteria:
inclusion criteria: * stage ib2-iva , histological proven cervical carcinoma * no previous diagnosis of carcinoma * no prior history of chemotherapy or radiotherapy * ecog less than or equal to 2 * above 21 years old * medically fit for radical concurrent cisplatin based chemotherapy and radiotherapy * hemoglobin \>10g/dl * adequate hematological, renal and hepatic function according to all of the following laboratory values: * absolute neutrophil count ≥ 1.5 ×109/l * platelets ≥ 100 ×109/l * serum creatinine ≤ 1.5 times upper limit of laboratory normal * total serum bilirubin ≤ 1.5 times upper limit of laboratory normal * asat(ast) or alat(alt) ≤ 2.5 times upper limit of laboratory normal * alkaline phosphatase of ≤ 2.5 times upper limit of laboratory normal exclusion criteria: * age below 21 * presence of known hiv infection, chronic hepatitis b or hepatitis c infection * psychological, familial, sociological, or geographical condition that would preclude study participation * prior (within the last 3 years) or simultaneous malignancies (other then cutaneous basal cell carcinoma or non-invasive tumors) * patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic. * life expectancy \< 6 months * patients with insulin dependent diabetes * prior tumor-directed surgery * previous systemic chemotherapy or pelvic radiation therapy * as radiation and cytotoxic agents are contraindicated in pregnancy, pregnant women are ineligible and those of childbearing potential should use contraception
js016 (anti-sars-cov-2 monoclonal antibody)with mild and moderate covid-19 or sars-cov-2 asymptomatic infection subects

Conditions: COVID-19

Summary: js016-002-ib/ii is a randomized, double-blinded, placebo-controlled study, to investigate the safety, pk profiles, preliminary efficacy and immunogenicity of intravenous recombinant human anti-sars-cov-2 monoclonal antibody (js016) in participants with mild and moderate covid-19 or of sars-cov-2 asymptomatic infection. three doses of js016 are to be investigated, including 25mg/kg, 50mg/kg and 100mg/kg, given as single dose of intravenous infusion. in total, 90 participants will be enrolled with 30 participants each for 25, 50 and 100mg/kg dose cohort at a ratio of 2:1 to receive investigational product or placebo treatment, respectively.

"each participant will receive js016 or matched placebo intravenous infusion on d1 (randomizing day). non-pharmaceutical supportive background therapy (e.g. oxygen inhalation) for covid-19 is allowed per clinical needs. investigators will be kept blinded to review the preliminary efficacy and safety data on a regular basis. meanwhile, a study evaluation team (set) composed of medical monitors, safety assessors and statisticians will be set up to review the study status, safety and preliminary efficacy of the participants at the pre-specified time points or as necessary.

Eligibility criteria:
inclusion criteria: 1. age of 18-65 years (inclusive) ,women or man 2. sars-cov-2 detected in the diagnostic specimen (nasopharyngeal swab) 3. high homology of viral gene sequencing with the known sars-cov-2." 4. mild/moderateillness covid-19 or sars-cov-2 asymptomatic infection 5. within 7 days from the onset time of symptoms to randomization or within 5 days from the first time of sars-cov-2 positive test to randomization with required viral load 6. no plan of pregnancy and being willing to use effective contraceptive measures 7. signed the informed consent form, sufficiently understanding of the content exclusion criteria: 1. positive igm/igg against sars-cov-2 prior to randomization. 2. severeor critical illness 3. uncontrolled hypertension, cardiovascular/cerebrovascular diseases,lung diseases 4. type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes 5. liver and kidney dysfunction, immune or inflammatory diseases, infections, surgery, tumors, and other major diseases 6. history of sars-cov-2 vaccination or participation in clinical trial with neutralizing antibody against sars-cov-2. 7. use of therapeutic biologics within 3 months prior to screening, or within the elimination period (5 half-lives) of such drugs as the day of dosing 8. has participated in any other interventional clinical study involving anstudy drug within 3 months prior to screening, or within the elimination period (5 half-lives) of the study drug as the day of dosing 9. platelets and hemoglobin test results during screening period are abnormal and have clinical significanc. 10. anaphylaxis, urine drug screening, alcohol dependence, lactation during pregnancy, blood loss, and others
pulmonary vascular changes in early chronic obstructive pulmonary

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the multi-ethnic study of atherosclerosis (mesa) - chronic obstructive pulmonary disease (copd) study aims to characterize the pulmonary vascular changes and their biology in early copd using imaging, gene expression profiling and peripheral cellular measures.

chronic obstructive pulmonary disease (copd) is the third leading cause of death in the us and will soon replace stroke as the third leading cause. translation of promising biological hypotheses of copd pathogenesis to human populations that may lead to new therapies is urgently needed. the vascular hypothesis of copd was articulated almost 50 years ago. bench research on endothelial dysfunction in copd is evolving rapidly and has shown that acrolein in cigarette smoke causes endothelial apoptosis and endothelial apoptosis is directly implicated in copd pathogenesis. clinical studies on endothelial dysfunction and vascular changes in copd are limited. the proposed study is a longitudinal study of smokers nested among the mesa-lung (aaaa7791) and emphysema and cancer action project (emcap) studies (aaaa6484), which together provide a well-defined cohort of 4,617 participants with prior spirometry and ct measures. the multiethnic study of atherosclerosis - chronic obstructive pulmonary disease (mesa copd study) has two main scientific purposes: 1. characterize the pulmonary vascular changes in copd and their biology, and 2. propose novel pathways for new therapies in copd. mesa copd is a longitudinal study of smokers nested within the mesa-lung and emcap cohorts of 360 participants (160 cases with mild, 60 cases with moderate and 40 cases with severe copd and 100 controls) who will be phenotyped with magnetic resonance (mr) pulmonary angiography, pulmonary function testing, full-lung ct scans, serum vascular endothelial growth factor (vegf), cell assays and gene expression profiling. mesa copd study will contribute improving the knowledge of early changes in copd that may lead to novel disease-modifying medical therapies and preventative strategies.

Eligibility criteria:
inclusion criteria: * age 50-79 years at time of enrollment * ever smokers (10 or more pack-years) * participation in mesa or emcap studies exclusion criteria: * clinical cardiovascular disease (left congestive heart failure (chf), valve disease, coronary artery disease (cad), stroke, or congenital heart disease), * asthma, pulmonary embolism or lung disease other than copd, * weight \> 300 lbs, * chronic renal insufficiency (\[estimated glomerular filtration rate (egfr)\] \< 45 ml/min/1.73 m2), * atrial fibrillation, and * contraindications to magnetic resonance imagine (mri), gadolinium, albuterol or spirometry testing.

Keywords: chronic obstructive pulmonary disease (copd) pulmonary vasculature pulmonary hypertension atherosclerosis smokers emphysema
treatment of peripheral neuropathy in patients with diabetes

Conditions: Diabetic Neuropathies; Diabetes Mellitus

Summary: the purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.


Eligibility criteria:
inclusion criteria: * patients must have type i or type ii diabetes mellitus. * have been clinically diagnosed with neuropathy. * have an hba1c less than or equal to 12%. patients with hba1c greater than 9% must be on insulin therapy. * must be 18 years or older. * be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study. exclusion criteria: * history of significant liver problems. * have poor kidney function. * drink an excess of alcohol or abuse drugs. * have recently participated in or are currently participating in a medical study in which you receive an experimental drug. * are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.
omphalitis community based algorithm validation study

Conditions: Omphalitis

Summary: the objective of this study is to develop and test a simple community-based diagnostic algorithm for omphalitis in sub-saharan africa. to date, there has been no validated community-based algorithms developed and tested in the sub-saharan context where the manifestations of omphalitis presentation may vary and diagnosis could be potentially more challenging in infants with darker skin color. given the current attention to cord care at the global and national policy level, validated community-based algorithms will be needed to allow primary health workers to identify cord infections and reduce associated morbidity. after obtaining guardian informed consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits will undergo two independent, parallel evaluations; first, by a community level worker and second, by a zambian medical doctor (gold standard). a third independent assessment of a photo of the cord will be performed remotely by a board-certified pediatrician. using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.


Eligibility criteria:
inclusion criteria: * neonate between day 1-10 of life presenting to livingstone and mazabuka district hospitals and community health centers in southern province, zambia * no prior diagnosis of omphalitis * guardian willing to allow their newborn to participate in the study * guardian aged 15 and above

Keywords: omphalitis neonate zambia neonatal mortality umbilical cord infection
patients with rheumatoid arthritis (ra) treated with rituximab in kuopio university hospital

Conditions: Rheumatoid Arthritis

Summary: one centre follow-up study on safety and efficacy of treatment with rituximab among patients with ra during 4 year period. basic data is collected for the national register of biologicals.

data is collected on regular visits in the outpatient department. in collection national register forms have been used.

Eligibility criteria:
inclusion criteria: * active ra without response to earlier treatment exclusion criteria: * contraindications to rituximab

Keywords: rheumatoid arthritis rituximab therapy