Kornimate/medical-research-clean huggingface dataset:
a 20-week study of a new treatment for men with benign prostatic hyperplasia (bph).

Conditions: Prostatic Hyperplasia

Summary: patients who are currently symptomatic and have been diagnosed with bph by a physician may qualify for this 20-week study. patients must not be diabetic, must not have prostate cancer and must not have had any surgery to repair your prostate or treat your bph. patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications. eligible patients will be scheduled to come in to the clinic to sign an informed consent form. patients will then undergo blood and urine tests, a complete physical examination and history and answer several questionnaires to determine their eligibility. patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this study.qualified patients receive free study medication, free medical care (physical examinations, ekg, laboratory tests) for the duration of the study.

patients must be willing to discontinue their current medications being taken for bph for specified time periods before they become eligible. these include: proscar, saw palmetto, and any "alpha-blocker" drugs. patients with high blood pressure must be on an acceptable medication that controls this condition. medications for other conditions may disqualify a patient from eligibility.patients who are diabetic are not eligible for this study. all patients will, at some time during the study, receive placebo (inactive substance). the study medication is given twice a day in liquid form under the tongue. there is a 33% chance that you would receive placebo for the duration of the study. neither you nor your doctor will know which treatment you are receiving.

Eligibility criteria:
* have an enlarged prostate by dre (digital rectal examination); * have a diagnosis of bph; * have documented symptoms (frequency; urgency; nighttime urination; reduced flow); * have a documented urinary flow rate as required

Keywords: bph benign prostatic hyperplasia benign prostatic hypertrophy enlarged prostate
a study comparing the blood levels of both pegaspargase (s95014) formulations (liquid vs lyophilized) in the treatment of paediatric patients with acute lymphoblastic leukemia (all)

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to compare the pharmacokinetics (pk) of both lyophilized and liquid s95014 formulations during the induction phase after a single iv dose in newly diagnosed paediatric patients with all


Eligibility criteria:
inclusion criteria: * patients aged 1 to \< 18 years * patients with cytologically confirmed and documented newly diagnosed all according to national comprehensive cancer network guidelines 2020 (see appendix 2), excluding b-cell burkitt all * eastern cooperative oncology group performance status (ecog ps) 0-2 (see appendix 3) * highly effective contraception method * signed informed consent and assent, when appropriate non-inclusion criteria: * unlikely to cooperate in the study * pregnant and lactating women * participation in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed * participant already enrolled in the study (informed consent signed) * women of childbearing potential tested positive in a serum pregnancy test within 7 days prior to the treatment period * inadequate hepatic function (bilirubin \> 1.5 times upper limit of normal (uln), transaminases \> 5x uln) * inadequate renal function defined as serum creatinine \> 1.5 x uln * prior treatment with chemotherapy or radiotherapy (except steroids and intrathecal therapy) * prior surgery or bone marrow transplant related to the studied disease * down syndrome * psychiatric illness/social situation that would limit compliance with study requirements * known history of pancreatitis * known history of significant liver disease * known carriers of hiv antibodies * significant laboratory abnormality likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion * pre-existing known coagulopathy (e.g. haemophilia and known protein s deficiency) * history of previous or concurrent malignancy * history of sensitivity to polyethylene glycol (peg) or peg-based drugs * severe or uncontrolled active acute or chronic infection * uncontrolled intercurrent illness including life-threatening acute tumor lysis syndrome (e.g. with renal failure), symptomatic congestive heart failure, cardiac arrhythmia

Keywords: oncology / haematology phase ii acute lymphoblastic leukemia parallel group pegaspargase pharmacokinetics comparability lyophilized pegaspargase liquid pegaspargase pegaspargase formulation randomized, open-label
a study to examine the efficacy of the arthritis self management program

Conditions: Osteoarthritis

Summary: this study will examine the efficacy of the arthritis self managemnet program (asmp)and determine changes in health resource utilization after completeing the asmp program.

this study will provide an analysis of the efficacy of the arthritis self management program (asmp) using both patient administered questionnaires as well as the health utilization data maintained within the administrative databases at alberta health and wellness. this study will also provide other information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information that has not yet been evaluated in other arthritis self management studies including co-morbidity data and other specific health related utilization information as it is recorded in administrative databases, will include a control group and will adjust for potential confounding variables such as sex, age, body mass index (bmi) and stage of disease.

Eligibility criteria:
inclusion criteria: * oa of the hip and/or knee * patient is 18 years of age and over exclusion criteria: * a concurrent systemic inflammatory disease * patient has previously participated in an arthritis self management educational program * patient is awaiting total hip or total knee replacement surgery patient has a medical co-morbidity that would render the patient to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with anticipated life expectancy of equal to or less than 2 years * patient has been diagnosed with senile dementia or alzheimer's disease

Keywords: osteoarthritis, knee osteoarthritis, hip osteoarthritis, ankle arthritis self-management
coupons for safe water project

Conditions: Death; Death, Infant; Diarrhea; Diarrhea, Infantile; Water-Borne Infectious Disease; Water-Related Diseases

Summary: guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. coupons for free dilute chlorine solution are a cost-effective and effective way of ameliorating child health and reducing diarrhea incidence. it is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. in this study, investigators conduct a randomized controlled trial (rct) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. investigators further investigate the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics.

guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. coupons for free dilute chlorine solution are (i) a cost-effective solution to targeting water treatment for households that need it and will use it and (ii) an effective way of ameliorating child health and reducing diarrhea incidence. it is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. in this study, investigators conduct a randomized controlled trial (rct) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. investigators further study the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics. investigators monitor the program's impact at health and demographic surveillance systems (hdss) sites in collaboration with the kenya medical research institute (kemri). data collection includes child mortality, as well as verbal autopsies for deceased children. data on mortality will be useful for future meta-analyses that pool data from multiple studies in order to estimate the mortality impact of free chlorine distribution schemes.

Eligibility criteria:
inclusion criteria: * currently pregnant women * women living inside health and demographic surveillance systems (hdss) catchment areas. exclusion criteria: - women who do not consent.

Keywords: child health child mortality chlorine safe water targeting coupons rct east africa kenya
gut microbiota in itp

Conditions: ITP

Summary: prospective, observational study to explore the significance of gut microbiome in the diagnosis of itp, and to identify the predictive value of baseline gut microbiome for gc resistance/relapse.

a prospective, observational study to (1) collect fecal samples from itp patients at initial diagnosis (baseline) and after first-line gc treatment, (2) detect the composition of gut microbiome and related metabolites using metagenomic sequencing combined with metabolomics, (3) observe the impact of first-line treatment on gut microbiome, (4) explore the significance of gut microbiome in the diagnosis of itp, and (5) identify the predictive value of baseline gut microbiome for gc resistance/relapse, thus to provide new ideas for clinical diagnosis and treatment of itp.

Eligibility criteria:
inclusion criteria: * 18 years or older; * isolated thrombocytopenia (platelet count of less than 100×10\^9/l); * normal leukocyte and erythrocyte counts according to routine blood tests; * did not receive any medication for thrombocytopenia for 6 months. exclusion criteria: * secondary itp such as drug-associated thrombocytopenia; * thrombocytopenia caused by viral infection (hiv, hepatitis b virus or hepatitis c virus); * nursing or pregnant women; * severe dysfunction of the heart, kidney, lung or liver; * active or previous malignancy; * patients with other diseases were undergoing treatment with immunosuppressants; * myelodysplastic disorder or myelofibrosis; * patients who were undergoing first - or second-line therapy for thrombocytopenia within 6 months.
micronized and ultramicronized palmitoylethanolamide in fibromyalgia patients

Conditions: Fibromyalgia

Summary: the onset of chronic fibromyalgia symptomatology is due to central alterations, together with peripheral neuroimmune modifications. using positron emission tomography (pet), it has been observed for the first time that fibromyalgia patients have a high activation of microglial cells compared to normal subjects. experimental evidence in neuroinflammation models in vitro and in vivo have demonstrated the anti-inflammatory and neuroprotective effect of palmitoylethanolamide (pea), effects confirmed by observational clinical investigations conducted in patients with fibromyalgia in which micronized and ultra-micronized palmitoylethanolamide (mpea and umpea) reduced the intensity of pain improving the quality of life. the aim of this study is to investigate the efficacy and tolerability of pea-m + pea-um administered as an add-on therapy with a double-blind, randomized, placebo-controlled clinical investigation.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia according to the criteria of the american college of rheumatology 2016 (symptoms for at least 3 months, widespread pain index (wpi) ≥ 7 and symptom severity (ss) ≥ 5 or wpi 4-6 and ss ≥ 9) * pain intensity assessed on the visual analogue scale (vas) ≥ 40 * pea-naive patients * patients who agree to sign informed consent exclusion criteria: * values of wpi \<7 and ss \<5 * pain intensity assessed on the visual analogue scale (vas) \<40 * patients who have already taken pea in the past * allergic or hypersensitive subjects to the product and / or one or more of its excipients * patients who refuse to sign informed consent
multidimensional impact of telemonitoring in heart failure (impact-hf)

Conditions: Heart Failure

Summary: the goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. the main questions it aims to answer are: * does telematic follow-up reduce de use of healthcare resource utilization of patients with heart failure? * is telematic follow-up cost-efficient in terms of reducing direct healthcare costs in heart failure patients? * is telematic follow-up cost-efficient in terms of reducing non-healthcare costs in heart failure patients? participants will be randomized to usual care (control group) or telematic care (interventional group). patients randomized to the interventional group will be included in a protocol of daily automatic telemonitoring of arterial pressure, peripheral oximetry, heart rate and weight, and telematic consultations lead by a heart failure clinical specialized team. researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group.


Eligibility criteria:
inclusion criteria: * diagnosis of hf according to the 2021 guidelines of the european society of cardiology criteria for ≥3 months. * admitted for decompensation of chronic hf. * admitted for hf decompensation ≥30 days and ≤6 months. * hf decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or \>50% increase in loop diuretic dose. * with previous optimized prognostic medical treatment. * under treatment with loop diuretic drugs. * new york heart association functional class ii, iii or iv. exclusion criteria: * inclusion in other intervention studies. * hemodynamic instability. * acute myocardial infarction, acute pulmonary thromboembolism or stroke in the previous 40 days. * uncontrolled arrhythmias * on waiting list for transplantation (any organ) or other cardiac surgery. * advanced mechanical circulatory support. * chronic renal disease on hemodialysis. * life expectancy less than 1 year. * moderate-severe cognitive impairment. * manifest inability to use a technological system. * institutionalized. * limiting psychiatric pathology.
study of tigecycline pharmacokinetics in patients undergoing continuous renal replacement therapy(crrt)

Conditions: Bacterial Infection; Critically Ill

Summary: the aim of this study is to determine the pharmacokinetics/pharmacodynamics(pk/pd) of tigecycline in critical ill patients undergoing continuous renal replacement therapy（crrt）and examine whether the dosage needs adjustment. the study will observe two groups of patients respectively and compare the difference between them. patients who need to receive crrt when treat with high-dose tigecycline will be collected in group crrt. patients who treat with high-dose tigecycline only will be collected in group non-crrt.


Eligibility criteria:
inclusion criteria: * aged 18-75 years,hospitalized icu patients, male or female; * having definitive diagnosis to treat with tigecycline for bacterial infection; * receiving crrt with renal insufficiency or not receiving crrt with normal renal function. exclusion criteria: * patients with child-pugh c cirrhosis; * allergic to tetracycline or tigecycline; * patients received crrt for \< 3 days or treated with tigecycline \< 3 days; * patients who are pregnant.

Keywords: tigecycline continuous renal replacement therapy pharmacokinetics
safety and efficacy comparator trial of a new drug against genital herpes

Conditions: Genital Herpes

Summary: the aim of the study is to evaluate the safety and efficacy of "aic316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of hsv-2 genital shedding.

enrolled patients with mucocutaneous genital hsv, will be randomized to receive either aic326 or valacyclovir first and then will be crossed over to receive the opposite intervention. the study will consist of two treatment periods of 28 days separated by a washout period of 28 days.

Eligibility criteria:
inclusion criteria: * adult, immunocompetent men and women in good health of any ethnic group * seropositive for herpes simplex virus type 2 (hsv-2) * history of recurrent episodes (\>=4 to \<=9) of genital herpes for at least 12 months and willingness to obtain 4 swabs per day. exclusion criteria: * present episode of genital herpes at time of randomization * clinically relevant acute or chronic infections (excluding hsv-2) * known intolerance to valacyclovir, acyclovir, or any component of the formulation * documented hsv resistance to acyclovir, valacyclovir, famciclovir or penciclovir

Keywords: aic316 viral shedding
safety and efficacy of allo-501 anti-cd19 allogeneic car t cells in adults with relapsed/refractory large b cell or follicular lymphoma

Conditions: Relapsed/Refractory Large B Cell Lymphoma; Relapsed/Refractory Follicular Lymphoma

Summary: the purpose of the alpha study is to assess the safety, efficacy, cell kinetics and immunogenicity of allo-501 in adults with relapsed or refractory large b-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and allo-647.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of large b-cell lymphoma (lbcl) or follicular lymphoma. * relapse or refractory disease after at least 2 lines of chemotherapy * at least 1 measurable lesion at time of screening. * eastern cooperative oncology group performance status of 0 or 1. * adequate hematological, renal, liver, pulmonary, and cardiac functions. exclusion criteria: * current or history of central nervous system (cns) lymphoma. * clinically significant cns dysfunction. * asct within last 6 weeks or allogeneic hsct within last 3 months prior to allo-647. * prior treatment with anti-cd19 therapy, any gene therapy, any genetically modified cell therapy or adoptive t cell therapy * systemic anticancer therapy within 2 weeks prior to study entry. * on-going treatment with immunosuppressive agents. * active acute or chronic graft versus host disease (gvhd), or gvhd requiring immunosuppressive treatment within 4 weeks of enrollment. * any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease). * current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy. * patients unwilling to participate in an extended safety monitoring period

Keywords: car t cell therapy allogeneic cell therapy cellular immuno-therapy allocar t allo-501 allo-647 lbcl lymphoma follicular lymphoma large b-cell lymphoma
a study of jab-21822 in advanced or metastatic nsclc with kras p.g12c and stk11 co-mutation and wild-type keap1

Conditions: Non-small Cell Lung Cancer

Summary: evaluate the safety and tolerability, drug levels, and clinical activity of jab-21822 in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) whose tumors with kras p.g12c mutation and a serine/threonine kinase 11 (stk11) co-mutation.

the primary objective of this study is to evaluate the safety and tolerability of jab-21822 during dose escalation phase and preliminary antitumor activity in patients with nsclc with concurrent kras g12c mutant and stk11 mutant and keap wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..

Eligibility criteria:
inclusion criteria: 1. pathologically documented, locally-advanced or metastatic nsclc with kras p.g12c mutation identified through molecular testing. 2. stk11 co-mutation and keap1 wild-type (local confirmation) 3. treatment naïve or have received at least 1 prior standard therapy for advanced nsclc 4. ecog 0-1 exclusion criteria: 1. has cns metastases or carcinomatous meningitis, except treated cns metastases with no evidence of radiographic progression or hemorrhage for at least 28 days 2. any severe and/or uncontrolled medical conditions 3. active infection requiring systemic treatment within 7 days 4. therapeutic radiation therapy within 3 weeks of study day 1
collection of blood and urine from patients undergoing radiation therapy

Conditions: Carcinoma; Cancer; Tumor

Summary: background: -research in nci's radiation oncology branch depends on the availability of blood and urine samples from patients receiving radiation therapy. objectives: -to explore the effects of radiation therapy on gene expression in white blood cells, to measure radiation damage in red blood cells and to examine changes in hormone levels in the blood and urine after radiation therapy. eligibility: -patients 18 years of age and older who are receiving radiation therapy. design: * blood and urine samples are collected when participants enter the study. * additional samples may be collected at different times during and after treatment. ideally, samples are obtained before, at the completion of, and 1 month following radiation therapy. blood samples usually will be collected during routine patient monitoring procedures and will not require an additional needle stick. * a total of 300 patients will be studied at the nci in bethesda, md, johns hopkins university in baltimore and the university of pennsylvania in philadelphia.

background: evolving research initiatives in the radiation oncology branch (rob) nci, depend upon the availability of blood and urine samples from patients receiving radiotherapy. examples of planned studies include an exploration of the effects of radiotherapy on peripheral leukocyte phenotype, peripheral blood protein and metabolism changes as well as measurements of matrix metalloproteinases (mmp) in urine. objectives: this protocol provides a means of acquiring blood and urine samples in patients receiving radiation therapy for a variety of conditions. eligibility: patients seen in the radiation oncology clinic will be asked to donate blood and/or urine before, during and after their treatment. design: this is a pilot, exploratory study to evaluate the effects of ionizing radiation in blood and/ or urine. on most occasions, the blood samples will be obtained as a component of routine patient monitoring and will not necessitate an additional venipuncture. blood and urine samples will be processed and stored in the radiation oncology branch and basic research laboratory, ccr, nci, for use in the research efforts of the branch.

Eligibility criteria:
* inclusion criteria: 1. patients must be co-enrolled in a nih cc protocol in which radiation will be administered. 2. patients must a candidate for, or currently receiving radiotherapy. 3. age greater than or equal to 18 years. 4. ability of subject or legally authorized representative (lar) to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. patients who have unobtainable data regarding previous radiation therapy.

Keywords: blood samples radiation urine cancer natural history