Kornimate/medical-research-clean huggingface dataset:
effect of whey protein supplementation and resistance exercise on muscle parameters in older adults

Conditions: Mobility Limitation

Summary: this research study is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise.


Eligibility criteria:
inclusion criteria: * male and females 70-85 yrs * community dwelling * short physical performance battery score \< 10 * bmi = 21-32.5 exclusion criteria: * acute or terminal illness * mini mental state exam \< 23 * myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure * upper or lower extremity fracture in previous 6 months * uncontrolled hypertension (\>150/90 mm hg). * neuromuscular diseases and drugs which affect neuromuscular function. * hormone replacement therapy * egfr \<30 ml/min/1.73m2 * types i and ii diabetes mellitus * dietary protein intake \< 0.8 g.kg-1.day-1 * disorders of nutrient absorption * milk, or whey allergy * sulfa drugs and allergy to paba-containing sunscreens

Keywords: whey protein resistance exercise physical activity mobility disability physical function muscle mass muscle strength older adults mobility-limited
efficacy and safety of lucerastat oral monotherapy in adult subjects with fabry disease

Conditions: Fabry Disease

Summary: this study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with fabry disease.

the primary objective of this prospective, multicenter, double-blind, randomized, placebo-controlled, parallel group, phase 3 study is to determine the effect of oral lucerastat monotherapy on neuropathic pain in subjects with fabry disease (fd) through daily collection of patient-reported outcomes with an electronic diary.

Eligibility criteria:
inclusion criteria: 1. signed and dated icf prior to any study-mandated procedure; 2. male or female adult subjects; 3. fd diagnosis confirmed with local genetic test results; 4. fabry-associated neuropathic pain, as defined by the subject, in the last 3 months prior to screening; 5. enzyme replacement therapy (ert) status: 1. subject never treated with ert; or 2. subject has not received ert for at least 6 months prior to screening; or 3. subject treated with ert since at least 12 months at the time of the screening visit, and agreeing to stop ert for approximately 8 months. 6. a woman of childbearing potential is eligible only under certain conditions, e.g. taking contraceptive measures. 7. subjects with moderate or severe neuropathic pain during the screening period. exclusion criteria: 1. pregnant, planning to be become pregnant, or lactating subject. 2. severe renal insufficiency (egfr \< 30 ml/min/1.73 m2) at screening. 3. subject on regular dialysis for the treatment of chronic kidney disease. 4. known and documented transient ischemic attack, stroke, unstable angina, or myocardial infarction within 6 months prior to screening. 5. clinically significant unstable cardiac disease (e.g. uncontrolled symptomatic arrhythmia, congestive heart failure nyha class iii or iv). 6. any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
interventional structural registry - luebeck

Conditions: Structural Heart Disease

Summary: the aim of the registry is to investigate the effect of catheter-assisted procedures in the context of structural heart disease on clinical morbidity and mortality. furthermore, the long-term prognosis of patients after a catheter-based procedure is to be evaluated. in particular, the following parameters will be documented and the following questions discussed: * underlying and concomitant diseases of these patients * evaluation of the methods in relation to the respective disease * safety - acute and long-term * effectiveness - periprocedural, hospital and long-term course * concomitant therapies


Eligibility criteria:
inclusion criteria: * structural heart disease exclusion criteria: * patients without consent/information * age ≤ 18 years
nurse-family partnership impact evaluation in south carolina

Conditions: Preterm Birth; Injuries; Maternal Behavior

Summary: this study evaluates the effects of the nurse family partnership (nfp), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. the study will be based in south carolina, where a medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on medicaid. the study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. the study will evaluate the program's impacts on outcomes using administrative records. this study aims to yield new evidence on the effect of nfp in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.

this study is an individual-level randomized controlled trial, with randomization post-consent. the study will enroll pregnant women who are income-eligible for medicaid, less than 28 weeks pregnant, and have not had a previous live birth. all eligible applicants who provide written consent will be randomly assigned either to a treatment group that is offered access to nfp or to a control group that is not. two-thirds of those recruited will be randomized to the treatment group and one-third to the control group. control group members will have access to the standard of care and whatever other programs and services are available in the community. the investigators will assess the effect of nfp on a range of short- and long-run maternal and child outcomes using administrative data that will be available for all members of both treatment and control groups. several of the outcomes the investigators will evaluate are required as part of the medicaid waiver and pay-for-success financing model.

Eligibility criteria:
inclusion criteria: * female * no previous live births * currently pregnant * gestation period less than 28 weeks (i.e. less than or equal to 27 weeks, 6 days) at time of recruitment * ages 15-55 * income level meets medicaid eligibility criteria * live within an area serviced by a nfp implementing agency * not currently enrolled in the study * not incarcerated or living in lock down facilities exclusion criteria: * men * women who have had a previous live birth * women who are not currently pregnant * women who are past their 28th week of gestation (i.e. greater than or equal to 28 weeks, 0 days) at time of recruitment * women who are younger than 15 or older than 55 years of age * women whose income level does not meet medicaid eligibility criteria * women who live outside of an area serviced by a nfp implementing agency * women who are currently enrolled in the study * women who are currently incarcerated or living in a lock down facility
real-time assessment of frameless intrafraction motion

Conditions: Brain Tumor

Summary: the purpose of this study is to assess the ability of a modified thermoplastic mask system in keeping an individual head stationary for a predefined amount of time. the investigators hope to know if the modified mask is study enough, and also if the modification on the mask will allow the investigator see and track the individual's movement underneath the mask by means of a camera that can detect light reflected from the individual. participants will lay down on their backs and their heads will be held in place with the mask system for approximately 1 hour.


Eligibility criteria:
inclusion criteria: * healthy individual * age \> 18 years. * males and females of all races and ethnic groups exclusion criteria: * severe claustrophobia
treatment effects of narrative exposure therapy

Conditions: Posttraumatic Stress Disorder

Summary: this study compares narrative exposure therapy with a waiting list control group, both consists of traumatized patients with diagnosed posttraumatic stress disorder. the main aim is to investigate if the patients psychiatric symptoms and levels of the stress hormone cortisol will improve more after narrative exposure therapy than the waiting list (i.e. no intervention).

in this study we want to compare narrative exposure therapy (net) to waiting list controls. adult patients with diagnosed posttraumatic stress disorder following different types of trauma, will be included. clinicians in psychiatric outpatient clinics will treat patients with net, either immediately after assessment, or after a second assessment 3 months later. all patients will also be assessed 1 and 6 months after treatment completion. all patients will be assessed for psychiatric symptoms by the mini international neuropsychiatric interview (version 5.0.0) and the clinician-administered ptsd scale. patients will also answer several questionnaires (ies-r, scl-90, bdi-ii, des and ucl). baseline level of the stress hormone cortisol will be collected in saliva for measuring the diurnal cycle. we will investigate if patients with posttraumatic stress disorder will show more symptom improvement with net than those on the waiting list (i.e. no intervention) in addition to measuring potential differences in cortisol between the groups.

Eligibility criteria:
inclusion criteria: * posttraumatic stress disorder (ptsd) * age above 18 years * understands, speaks and writes norwegian * informed, written consent exclusion criteria: * active psychosis * active suicidality * serious self mutilation * active alcohol or drug abuse * serious dissociative symptoms * disease in nervous system or head injury * hormonal disease * pregnancy

Keywords: ptsd
taxotere prostate cancer new indication registration trial in china

Conditions: Prostatic Neoplasms

Summary: to compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven prostate adenocarcinoma * androgen independent prostate cancer s/p orchiectomy and/or lhrh agonist testosterone \< 50 ng/dl (ie 1.735 nmol/l) * documented progressive disease * patients should have achieved stable analgesia for 7 days * karnofsky performance status ≥ 70 * no prior treatment with cytotoxic agent (except estramustine) * normal cardiac function must be confirmed by left ventricular ejection fraction * adequate organ function: 1. hematology: * neutrophils \> 1.5 x 10\^9/l * hemoglobin \> 10 g/dl. erythropoietin use is allowed, but red blood cell transfusion to upgrade the hemoglobin level is not allowed * platelets \> 100 x 10\^9/l 2. hepatic function: * total bilirubin \< the upper-normal limit of the institution. * alanine aminotransferase and aspartate transaminase \< 1.5 times the upper-normal limit of the institution. 3. renal function: * creatinine \< 1.5 times the upper normal limit (ie national cancer institution grade \< 1) * no brain or leptomeningeal metastases exclusion criteria: * prior radiotherapy to \>25% of bone marrow (whole pelvic irradiation is not allowed) * prior cytotoxic chemotherapy, except monotherapy with estramustine * prior isotope therapy * history of another cancer within the preceding five year * symptomatic peripheral neuropathy grade ≥ 2 * other serious illness or medical condition: 1. congestive heart failure even if controlled. previous history of myocardial infarction or angina pectoris within 1 year from study entry, uncontrolled hypertension or uncontrolled arrhythmias. 2. active uncontrolled infection 3. peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids. 4. auto-immune disease (lupus, sclerodermia, rheumatoid polyarthritis) * treatment with any other anti-cancer therapy * treatment with bisphosphonates the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
cytidine- and creatine-containing drug in treating bipolar depression

Conditions: Bipolar Depression

Summary: this proposed research is aimed to investigate the efficacy and safety of combined cytidine- and creatine-containing drug and dietary supplement in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using magnetic resonance spectroscopy.


Eligibility criteria:
inclusion criteria: * 19-65 year-old male or female * bipolar depression diagnosed by structured clinical interview for dsm-iv (scid-iv) * written informed consent exclusion criteria: * present use of drugs for bipolar depression or any psychotropic medication * use of psychoactive medication that may affect brain imaging findings * diagnosis of any other axis i psychiatric disorder * presence of borderline personality disorder or antisocial personality disorder * presence of any major physical or neurological illness (e.g., epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc.) * hypersensitivity to divalproate, valpromide or diagnosis of porphyria * past or current liver disease, current severe liver or pancreas dysfunction * currently taking mefloquine * presence of alcohol or drug dependence, drug abuse * intelligence quotient below 80 * contraindications to magnetic resonance imaging * women who are pregnant, breastfeeding, or planning pregnancy * allergy or intolerance to the study drugs

Keywords: bipolar depression magnetic resonance spectroscopy cytidine- creatine-
plastic stent within a lumen-apposing stent for malignant biliary obstruction

Conditions: Pancreatic Cancer; Endoscopy; Oncologic Disorders; Therapy Related Neoplasms

Summary: there are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (dps) within the lumen-apposing metal stents (lams) in the eus-guided transmural biliary drainage (bd). the aims was to evaluate the safety of lams with and without a coaxial dps in eus-bd for the palliative management in malignant biliary obstruction.


Eligibility criteria:
inclusion criteria: * consecutive unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent eus-bd after failed ercp cannulation or inaccessible papilla exclusion criteria: * borderline cancer cases * others type of biliary stents * severe coagulopathy or thrombocytopenia.

Keywords: malignant biliary obstrucction therapeutic endoscopy biliary drainage lumen apposing stent endoscopic ultrasound pancreatic neoplasm
brain imaging study of acupuncture in chronic low back pain

Conditions: Low Back Pain; Back Pain Lower Back Chronic; Low Back Pain, Recurrent

Summary: we are doing this research study to learn about how acupuncture treatment works. this study is being done to look at changes in the brain, not to treat pain. we want to learn about brain activity during acupuncture. we will look at brain activity when a heating device touches the skin of a subject before and after the subject has acupuncture, to see what changes.


Eligibility criteria:
inclusion criteria: * meet the classification criteria of chronic lbp (having low back pain for more than 6 months), as determined by the referring physician * at least 4/10 clinical pain on the 10-point lbp intensity scale on average during the past two weeks prior to enrollment * at least a 10th grade english-reading level; english can be a second language provided that the patients feel they understand all the questions used in the assessment measures * must have had a prior evaluation of their low back pain by a health care provider, which may include radiographic studies. documentation of this evaluation will be obtained from the subject's medical record exclusion criteria: * specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections) * radicular pain extending below the knee * complicated back problems (e.g., prior back surgery, medicolegal issues) * possible contraindications for acupuncture (e.g., coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis) * conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator and/or a t score \> 60 on the psychological measures assessed during session 1) * prior acupuncture treatment for back pain; 1 year minimum wait for any condition other condition. * active substance abuse disorder in the past two years, as determined by subject self-report. * the intent to undergo surgery during the time of involvement in the study. * history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. for example: asthma or claustrophobia. * presence of any contraindications to mri scanning. for example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy. * unresolved legal/disability/workers compensation claims in connection with low back. * instability of pain ratings in session 2 or session 3. * use of more than 60 mg prescription opioids or steroids for pain.

Keywords: acupuncture fmri clbp pain low back pain back pain
nafamostat mesilate in the treatment of severe infection-associated coagulopathy

Conditions: Sepsis; Sepsis-induced Coagulopathy; Nafamostat Mesilate

Summary: the objective of this study was to evaluate the therapeutic effect of nafamostat mesilate on patients with severe infection-related coagulation。


Eligibility criteria:
inclusion criteria: * meets the criteria for sepsis 3.0". * targeted population for sic anticoagulant therapy（http://research-kudo-prediction.s3-website-ap-northeast-1.amazonaws.com/） exclusion criteria: * age less than 18, pregnant women, and lactating women * patients with a history of hypersensitivity to nafamostat mesilate (previous use of nafamostat mesilate resulted in significant bleeding complications) * fibrinogen \< 1.5g/l * patients with bleeding or high bleeding risk patients in the acute phase of trauma or with active bleeding (such as flail chest, significant contusions of the lungs, liver, kidneys, spleen, retroperitoneal bleeding, pelvic fractures, etc.) history of severe traumatic brain injury, intracranial surgery, stroke, cerebral aneurysm, or arteriovenous malformation within the past month prior to enrollment patients with a history of congenital bleeding disorders (such as hemophilia) patients with underlying fulminant hepatitis, decompensated cirrhosis, or other severe liver diseases * patients receiving the following medications patients who have received heparin and heparin analogs (including low molecular weight heparin, dalteparin, etc.) within the past 12 hours prior to treatment patients who have received warfarin within the past 7 days prior to the study and have an inr level above normal patients who have undergone thrombolytic therapy within the past 3 days prior to the study patients who have received platelet inhibitors (such as aspirin, clopidogrel, ticlopidine, dipyridamole, etc.) within the past 7 days prior to the study patients currently receiving other novel anticoagulant medications (such as xa factor inhibitors like apixaban, rivaroxaban, edoxaban, etc., direct thrombin inhibitors like dabigatran * icu treatment time is expected to be no more than 24h * patients who have undergone cardiopulmonary resuscitation within the past 7 days prior to the study * patients who have participated in other studies within the 30 days prior to enrollment * due to irreversible disease states, such as advanced malignant tumors or other end-stage diseases; or patients in a terminal state deemed by the physician to be approaching death
a study to investigate the safety and efficacy of iov-3001 in adults with advanced melanoma who will receive lifileucel

Conditions: Unresectable Melanoma; Metastatic Melanoma; Ocular Melanoma

Summary: a phase 1/2, open-label study of a modified interleukin-2 fusion protein (iov 3001) in participants with previously treated, unresectable or metastatic melanoma who will receive lifileucel.

this study is the first-in-human (fih) study of iov-3001. iov-3001 is an antibody interleukin-2 (il-2) fusion protein in which a modified form of aldesleukin is incorporated into the antibody palivizumab. the phase 1 portion will include 2 parts. participants will receive iov-3001 either before the lifileucel regimen (part 1) or after lifileucel instead of aldesleukin (part 2).

Eligibility criteria:
inclusion criteria: 1. participant must be ≥ 18 years of age at the time of signing the informed consent. 2. participant has unresectable or metastatic melanoma. 3. participant has melanoma not of uveal/ocular origin and experienced documented radiographic disease progression during systemic therapy with a pd-1/pd-l1 blocking antibody or within 12 weeks after the last dose of the pd-1/pd-l1 blocking antibody. if the tumor is braf v600 mutation positive, the participant also received or refused a braf inhibitor with or without a mek inhibitor. or phase 1, part 1 only: for participants with uveal melanoma, tebentafusp must have been received if available as standard of care (human leukocyte antigen \[hla\]-a\*02:01 positive participant and approved by local authorities for uveal melanoma) or refused. 4. participant has an ecog performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of \> 6 months. 5. phase 1, part 2 only: following tumor resection for lifileucel generation, the participant will have at least one remaining measurable lesion, as defined by recist v1.1. 6. participant has recovered from all prior anticancer treatment-related aes exclusion criteria: 1. participant has symptomatic untreated brain metastases. 2. participant is at an increased risk for systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems. 3. participant has active uveitis that requires active treatment. 4. participant has any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease \[scid\] or aids). 5. participant has a history of hypersensitivity to any component of the study intervention. 6. participant had another primary malignancy within the previous 3 years. 7. participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose. 8. participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.

Keywords: tumor infiltrating lymphocytes til unresectable melanoma metastatic melanoma cell therapy autologous adoptive cell therapy cellular immuno-therapy il-2 autologous adoptive cell transfer melanoma lifileucel stage iv melanoma malignant melanoma uveal melanoma