Kornimate/medical-research-clean huggingface dataset:
alternate day prednisone or daily fish oil supplements in patients with immunoglobulin a nephropathy

Conditions: IgA Glomerulonephritis

Summary: objectives: evaluate the efficacy of alternate day prednisone versus daily fish oil supplements in slowing or preventing the decline in renal function in children, adolescents, and young adults with moderate to severe immunoglobulin a nephropathy.

protocol outline: this is randomized, double blind, placebo controlled, multicenter study. patients are randomized into one of three treatment arms: placebo, prednisone, or fish oil. the placebo arm is further randomized to receive either fish oil placebo capsules or prednisone placebo tablets. arm i: patients receive placebo tablets or capsules for 2 years. arm ii: patients receive a tapering regimen of prednisone tablets administered every other day for 2 years in the absence of unacceptable toxicity. arm iii: patients receive fish oil capsules daily for 2 years. patients may also receive enalapril for hypertension. patients are followed every 3 months for 3 years after treatment.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- histologically confirmed immunoglobulin a nephropathy (igan) patients must have either: - persistent severe proteinuria alone (urine pr/cr ratio at least 1.0) or - moderate proteinuria plus renal biopsy changes indicating risk of progression (glomerulosclerosis or proliferation) --prior/concurrent therapy-- endocrine therapy: at least 1 month since any prior prednisone no more than 3 months of prior prednisone therapy since renal biopsy other: at least 1 month since any prior immunosuppressive therapy or fish oils no more than 3 months of prior immunosuppressive therapy or fish oil administration since renal biopsy --patient characteristics-- hepatic: bilirubin less than 2 times upper limit of normal (uln) ast less than 2 times uln no known chronic liver disease renal: protein excretion greater than 0.5 g/1.73 m2/24 hours or urine protein/creatinine ratio greater than 0.5 on 2 occasions at least 4 weeks apart in the 6 months prior to study creatinine clearance at least 50 ml/min other: no systemic lupus erythematosus no henoch-schonlein purpura no diabetes mellitus, cataracts, aseptic necrosis of any bone, or other conditions potentially exacerbated by prednisone therapy not pregnant adequate contraception required of all fertile patients

Keywords: iga glomerulonephritis rare disease renal and genitourinary disorders
an extension study of venetoclax for subjects who have completed a prior venetoclax clinical trial

Conditions: Chronic Lymphocytic Leukemia; Acute Myeloid Leukemia; Multiple Myeloma; Non-Hodgkin's Lymphoma; Acute Lymphoblastic Leukemia; Cancer

Summary: the purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.


Eligibility criteria:
inclusion criteria: * subject has been enrolled and dosed in an ongoing venetoclax study and continues to tolerate and derive benefit from the study drug. * male subject agrees to refrain from sperm donation. * female subjects must not be pregnant or breastfeeding. exclusion criteria: - none.

Keywords: chronic lymphocytic leukemia (cll) acute myeloid leukemia (aml) multiple myeloma (mm) non-hodgkin's lymphoma (nhl) acute lymphoblastic leukemia (all) cancer venetoclax
impact of anti-tumor necrosis factor (tnf) antibodies on the t-lymphocyte and macrophage cooperation in crohn disease

Conditions: Crohn Disease

Summary: the aim of this research is to study crohn disease patients before and after anti-tnf, the cooperation between lamina propria t-lymphocytes and macrophages, through the expression of co-signalisation molecules and their ligands, the production of cytokines participating in this cooperation, and the potential role of regulatory t lymphocytes.

crohn disease is an inflammatory disease and its frequency has been increasing over the last 25 years. the physiopathology involves a failure in the negative regulatory mechanisms of the inflammatory responses in the intestines, along with an excessive production of tnf-α by t-lymphocytes and macrophages of the lamina propria. anti-tnf-α antibodies usually give good therapeutic results, in particular in patients who are resistent or dependant on steroids. nevertheless, in crohn disease, the destructive t-lymphocytes - macrophage interactions, their inhibition by anti-tnfα, and the impact of these antibodies on cellular signaling remain largely unknown. two groups of 10 patients with active crohn disease, with or without azathioprine, and requiring the start of anti-tnf treatment are included in this study. rectosigmoïdal biopsies and blood tests will be done before starting the treatment and after 10 weeks of treatment. surface antigens, cytokines and cellular molecules and the number of apoptotic cells will be analyzed by facs, and the quantification of rna will be analyzed by rt-pcr. this will therefore enable us to study, before and after anti-tnf-α, in patients treated or not with azathioprine, on intestinal and blood lymphocytes, the production of cytokines involved in the lymphocyte-macrophage interaction, and the potential role of regulatory t cells.

Eligibility criteria:
inclusion criteria: * patient older than 18 * social security * active crohn disease defined by a cdai \> 250 * sigmoïdal and/or rectal lesions * requiring treatment by infliximab * having never received any anti-tnf treatment * a negative pregnancy test for women * prescription of efficient contraception for women, having started at least a month before beginning the study, and throughout the duration of the study * acceptance to participate in this research and having signed the consent form * not participating in any other study exclusion criteria: * consent withdrawal * the halt of infliximab treatment
reframe-o1: a study to investigate the efficacy and safety of luveltamab tazevibulin versus investigator's choice (ic) chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing folr1

Conditions: Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Platinum-resistant Ovarian Cancer

Summary: a phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus ic chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing folr1.

this is a randomized, multicenter, international, open-label, 2-part, phase 2/3 study designed to assess the efficacy and safety of luveltamab tazevibulin versus ic chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing folr1. part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (cohort a and cohort b), with subjects randomized 1:1. part 1 will be used to select the optimized dosing regimen. part 2 will further evaluate the efficacy and safety of the selected dosing regimen versus ic chemotherapy. luveltamab tazevibulin will be administered intravenously (iv) over a 1-hour infusion time every 3 weeks.

Eligibility criteria:
inclusion criteria: 1. high grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer 2. age ≥ 18 years 3. ecog performance status 0 to 1 4. positive folr1 expression per central laboratory testing 5. relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens 6. prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication 7. at least 1 measurable target lesion per recist v1.1 8. adequate organ function exclusion criteria: 1. low grade (grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas 2. prior treatment with a folr1- targeting adcs or with adcs that contain a tubulin inhibitor 3. primary platinum-refractory disease 4. history of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment 5. pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition 6. previous solid organ transplantation 7. history or clinical signs of meningeal or active central nervous system involvement 8. concurrent participation in another therapeutic treatment trial

Keywords: folr1 folrα frα folate receptor alpha antibody drug conjugate luveltamab tazevibulin stro-002 luvelta
study of the contribution of osteopathic treatment to classic medical management in patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the management of chronic low back pain is now part of a multi-disciplinary set of proposals with the aim of adapting for each patient orientations of both medicated and non-medicated care. very classically, analgesic treatment of stage i or ii is of use, reinforced by the occasional use of nsaids in the absence of contraindication. in this medical attempt of the control of the pain associates a physical care (supervised exercises, physiotherapy care), cognitive and behavioral therapy, multidisciplinary care. osteopathic treatment is a specific manual diagnostic and therapeutic procedure. this study aims to evaluate the relevance of providing osteopathic treatment in combination with classical medical treatment in the management of patients with chronic non-specific low back pain.

the primary objective is to show that the addition of osteopathic treatment to classical medical treatment decreases pain for patients with chronic nonspecific low back pain. this goal will be evaluated at 3 months by comparing * the 3-month change in the level of pain observed in arm 3 (classical medical treatment + osteopathic treatment) versus that observed in arm 1 (classical medical treatment), and * the 3-month change in the level of pain observed in arm 3 (classical medical treatment + osteopathic treatment) versus that observed in arm 2 (classical medical treatment+ sham osteopathic treatment ).

Eligibility criteria:
inclusion criteria: * patient with chronic non-specific low back pain: degenerative lumbalgia and low back pain unrelated to anatomical lesions that have been evolving for more than 3 months. * patient affiliated with a social security scheme or equivalent * patient having signed the study informed consent form. exclusion criteria: * patient with specific low back pain: patient with one of the following pathologies: degenerative neurological pathology; infectious pathology; fracture vertebral lesion less than 1 year; vertebral osteosynthesis material or canal narrowing. * patient following a treatment of the morphinic or neuroleptic type. * pregnant, breastfeeding or parturient woman * patient participating in another clinical study * protected patient: major under some form of guardianship ; hospitalized without consent

Keywords: osteopathic treatment sham osteopathic treatment low back pain
the effect of "eye drop guide" on the success rate of eye drops self-instillation in glaucoma patients

Conditions: Eye Drops Self-instillation

Summary: to investigate if the eye drop guide more effective than carefully instructed routine technique for chronic glaucoma patients to self-instill eye drops. and what factors are associated with the failure of self-instillation eye drops with the eye drop guide?

the participants are randomized into 2 groups. for group i; the participants will be instructed to use the eye drop guide first while for group ii; the participants will be instructed to use the routine self-instillation technique first. the instruction will be given to all participants by the same investigator. the participants are allowed to practice until confidence in the techniques to which they are assigned. the participants then are instructed to use only that technique to instill eye drops in both eyes every day and keep the diary to document the date, time of practice, and number of bottles use in each eye for practice at home. the investigators make a telephone visit at 1 week to remind the practice routine and the follow up schedule. the 2 week follow up will be scheduled to evaluate the self-instillation performance using the techniques to which they are assigned by the vdo recordings under the same setting as day 1. after vdo recordings the participants will be switched to receive the other technique with the same instruction as the other group. allow the same period of practice in the hospital and at home. the investigators again will make a 1-week telephone visit and 2-week follow up after self-practice at home. at week 4 the vdo recordings of self-instillation performance will be taken again under the same setting as previous records.

Eligibility criteria:
inclusion criteria: * have been diagnosed of chronic glaucoma for 3 months or longer * age of 18 years or over * self-administer eye drops regularly exclusion criteria: * perioperative patients * patients who were blind from other diseases * patients with ophthalmic conditions that affect the eye drop instillation e.g. nystagmus, ptosis, exophthalmos, enophthalmos, microphthalmos, symblepharon, restrictive ophthalmoplegia * patients whose underlying conditions would affect the patient's adherence to the protocol e.g. dementia, psychosis, mental retardation, neurological conditions resulting in tremor or paralysis, rheumatoid arthritis, hand deformities * patients who are allergic to artificial tears eye drop * patients who are not able to return for the follow-up schedule

Keywords: eye drops self-instillation
immersive care - virtual mirror therapy

Conditions: Stroke

Summary: the purpose of this implementation study is - primarily - to investigate the feasibility, acceptability, tolerability of a new virtual reality application in stroke patients, and -secondarily - to gain initial insights in the preliminary clinical effects of this application.

although immersive technologies have great potential in healthcare, they are still relatively unknown and underutilized in this field. in this study a new virtual reality (vr) application will be implemented and tested in two groups of stroke patients (10 acute phase/10 chronic phase). in an attempt to reactivate the affected upper limb in stroke patients, therapists often use mirror therapy. using a mirror, the movement of a paralyzed limb is feigned in order to reprogram the brain. a patient performs exercises with the healthy limb, but through the mirror the patient seems to use the affected limb. a high number of repetitions is essential to stimulate the so-called neuroplasticity of the brain, but this makes mirror therapy monotonous. in addition, the therapy also has its limitations. activities are limited by the physical boundaries of the modality, with exercises largely limited to distal movements and simple functional activities. larger, free-standing mirrors provide a wider range of motion for therapeutic activities, but offer less protection against environmental distraction. with vr, these obstacles can be overcome. by focusing on virtual mirror therapy using a vr headset, therapists hope to create a more pleasant and realistic experience for the patients.

Eligibility criteria:
inclusion criteria: * stroke patients in the subacute or chronic phase, aged between 18 and 85 years old with a normal functioning upper limb on the unaffected side and a reduced use and / or weakness and / or paralysis of the upper limb on the affected side * ability to sit on a chair or in a wheelchair with adequate trunk stability so that the unaffected upper limb can move freely * ability to follow verbal instructions * ability to communicate verbally with the researchers exclusion criteria: * stroke patients in acute phase * severe medical conditions that interfere with the proper execution of the research * patients who are medically unstable * cognitive disorders which may complicate the research or make it impossible * speaking disorders (aphasia, dysarthria) which may complicate the proper execution of the research and the communication of important verbal information * visual disorders which complicate carrying out adl activities or make it impossible * known allergies to any of the materials of the vr headset * epilepsy * extreme sensitivity to motion sickness * specific anxiety disorders that hinder the use of the vr headset such as claustrophobia * skin diseases or lesions in the contact area of the vr headset

Keywords: upper extremity rehabilitation virtual reality immersive technology mirror therapy
post-marketing surveillance study of ex-intravenous drug abusers with chronic hepatitis c treated with pegintron plus rebetol (p04408/mk-4031-261)

Conditions: Hepatitis C, Chronic; Substance Abuse, Intravenous

Summary: previous intravenous drug abusers with chronic hepatitis c who are under substitution therapy (buprenorphine, methadone) will be treated with pegintron and rebetol according to the approved european labeling. the study will assess the tolerability, safety and efficacy of the treatment with pegintron plus rebetol in this study population. the objective of the study is to collect data on the prevalence of the hepatitis c infections in drug-substituted patients. the study will also compare the feasibility of hcv (hepatitis c virus) treatment in patients receiving subutex® vs other drug substitution pharmacotherapies.


Eligibility criteria:
inclusion criteria: * treatment-naïve participants or relapsers to interferon monotherapy * participants with chronic hepatitis c infection * at least 18 years of age * must meet the following laboratory criteria: * platelets \>=100,000/mm\^3 * neutrophil count \>=1,500/mm\^3 * tsh (thyroid stimulating hormone) within normal limits * hemoglobin \>=12 g/dl (females); \>=13 g/dl (males) * ex-intravenous drug abusers who are under stable substitution therapy * women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment. * sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment exclusion criteria: * any contraindications specified in the spc (summary of product characteristics) and approved european labeling * hypersensitivity to the active substance or to any interferons or to any of the excipients * pregnant women * women who are breast-feeding * existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt * a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months * severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \<50 ml/min * coinfection with hiv (human immunodeficiency virus) * autoimmune hepatitis or history of autoimmune disease * severe hepatic dysfunction or decompensated cirrhosis of the liver * pre-existing thyroid disease unless it can be controlled with conventional therapy * epilepsy and/or compromised central nervous system function
the drug-drug interaction of sp2086 and valsartan

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to investigate the potential interaction between sp2086 and valsartan after multiple oral doses treatment in healthy adult volunteers.

this is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of sp2086 and valsartan in healthy adult volunteers. all subject were randomized into two groups, and the drugs will be administered according to the ab and ba sequences, all subjects must completed the two stages(a and b). the a sequence was that valsartan was taken at 160mg qd on days1-day12; sp2086 will be administered orally (by mouth) as 200mg on days 8-day12.the b sequence was that sp2086 was taken at 200mg qd dose on days 8-day12.there were 6 days washout period between the two stages. the whole study needs 31 days.

Eligibility criteria:
inclusion criteria: * healthy volunteers with a body mass index(bmi) between 19 and 24 kg/m2 * had signed the informed consent himself or herself. exclusion criteria: * have the abnormal lab or other examination results and the change have clinical significance. * history of or current clinically significant medical illness as determined by the investigator. * have a family history of thyroid cancer, submandibular gland cancer or long qt syndrome * known allergy to sp2086 or glyburide or any of the excipients of the formulation of sp2086 or glyburide. * history of using the sulfa or sulfonylureas or dpp-ivor glp-1 drugs or other similar structure drugs. * history of severe unconsciousness hypoglycemia * history of any surgery prior to screening in 6 months. * history of blood donation≥400 ml prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month. * history of participate any drug or medical device prior to screening in 3 months. * within a month before the screening using any prescription drugs, over-the-counter drugs, chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins). * 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion. * the hepatitis b surface antigen, hepatitis c antibody, hiv antibody and syphilis antibody was positive. * pregnancy or lactation women, or a fertility male or female is not willing to contraception during test. * researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Keywords: sp2086 valsartan drug-drug interaction