Kornimate/medical-research-clean huggingface dataset:
a study of venetoclax plus lenalidomide and dexamethasone for the treatment of newly diagnosed t(11;14)-positive multiple myeloma in subjects who are ineligible for high-dose therapy

Conditions: Multiple Myeloma

Summary: this study will evaluate the safety and preliminary efficacy of venetoclax when combined with lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14) positive multiple myeloma (mm). this study will consist of 2 parts: part 1 dose escalation and part 2 dose expansion.


Eligibility criteria:
inclusion criteria: * must have documented, confirmed active multiple myeloma (mm) with greater than or equal to 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary plasmacytoma and any one or more of the following myeloma-defining events: * evidence of end organ damage attributed to the underlying plasma cell proliferative disorder and satisfying at least one of the protocol specified laboratory criteria for calcium elevation, renal failure, anemia, or lytic bone lesions; or * one or more of the biomarkers of malignancy as described in the protocol. * must have mm positive for the t(11;14) translocation, as determined by methods described in the protocol. * must have measurable disease defined by at least one of the following criteria: * serum m-protein ≥ 1.0 g/dl (immunoglobulin \[ig\]g myeloma) or greater than or equal to 0.5 g/dl (iga, igm, igd, or ige myeloma); * urine m-protein greater than or equal to 200 mg/24 hours; * serum free light chain (flc) greater than or equal to 10 mg/dl (100 mg/l) provided serum flc ratio is abnormal. * newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic stem cell transplantation (hsct) * must have eastern cooperative oncology group performance status less than or equal to 2. exclusion criteria: * has a co-existing condition as specified in the protocol. * has history of other active malignancies, including myelodysplastic syndromes (mds) within the past 3 years with specific exceptions detailed in the protocol. * has been treated with or received any of the following: * prior or current systemic therapy or hematopoietic stem cell transplantation (hsct) for mm (a short course of treatment with corticosteroids equivalent to dexamethasone 40 mg/day for a maximum of 4 days is allowed before treatment); use of systemic strong or moderate inhibitor or inducer of cytochrome p450(cyp)3a within 7 days before the first dose of study drug. * radiation therapy within 2 weeks of dosing * plasmapheresis within 4 weeks of dosing * immunization with live vaccine within 8 weeks of dosing * has a contraindication or inability to comply with antithrombotic prophylaxis.

Keywords: multiple myeloma cancer t(11;14)-positive multiple myeloma venetoclax lenalidomide
ultrasound-guided percutaneous neuromodulation in spasticity

Conditions: Multiple Sclerosis

Summary: the multiple sclerosis (ms) is a chronic, inflammatory, autoimmune disease characterised by the appearance of lesions, characterised by heterogeneity in their anatomopathological, clinical and radiological presentation. its aetiology is complex and multifactorial, with genetic and environmental interactions with a predominance in women (3:1) and is the second leading cause of disability in young adults (25-30 years). it has a socio-economic impact, affecting interpersonal relationships and causing a significant reduction in quality of life. main objective to assess the effect on spasticity of the percutaneous ultrasound-guided neuromodulation (pmn) technique in patients diagnosed with ms with upper limb spasticity. secondary objectives * to assess changes in the strength parameter of the wrist flexor musculature wrist before and after the application of a pmn programme. * to assess changes in the functionality scales (modified asworth, established for spasticity * to assess changes in the range of motion (rom) of the joints under study. * assess changes in the quality of life scale (msqol54). * to assess the adverse effects of the technique. all patients will receive a percutaneous echoguided neuromodulation (pnm) in the median nerve at the elbow, medial to the brachial artery, running between the humeral and ulnar heads of the pronator teres muscle. once the nerve is located, a needle shall be inserted in the vicinity of the nerve and is stimulated using an electrical current with a frequency of 10 hz, with a pulse width of 250 µs and a tolerable intensity causing a visible muscle cont raction for 1.5 minutes. after assessing the correct application of ethics in the study, it was decided to use the individual's own baseline data as a control group, as simulating the technique is complex.


Eligibility criteria:
inclusion criteria: * sign the consent form to participate in the study * be a patient diagnosed with multiple sclerosis. * be over 18 years of age and less than or equal to 55 years of age. * have spasticity (asworth 2) in the upper limb. * be able to travel to the place of the session exclusion criteria: * failure to comply with the above * withdrawal of informed consent * having a disease associated with ms that is incompatible with the technique. use of anticoagulation * cognitive impairment * belenophobia
patients' experiences of information after total knee arthroplasty - a qualitative interview study

Conditions: Knee Osteoarthrosis; Total Knee Arthroplasty

Summary: the aim of this qualitative interview study is to gain new and in-depth knowledge about patients' experiences of information following total knee arthroplasty. participants will be interviewed in the recovery phase after surgery. researchers will use a semi-structured interview guide. the interviews will be analysed with qualitative content analysis.

a qualitative interview study will be conducted. interviews will be conducted 24-28 weeks after total knee arthroplasty. a semi-structured interview guide will be used to answer the following research questions: * what are the patients' positive and negative experiences of the information provided before and after total knee arthroplasty (tka)? * what are the patients' experiences and perceptions regarding the content and scope of the information, as well as how and when it is communicated? * what are the patients' experiences and perceptions of their access to information? * what are the patients' experiences and perceptions of the significance of the information for postoperative care and their expectations of the surgical outcome? * how do patients perceive the information provided before and after surgery in relation to their expectations of the information? * how do patients think the information provided before and after tka could be improved?

Eligibility criteria:
inclusion criteria: * men and women of all ages who have undergone total knee arthroplasty due to osteoarthritis and are undergoing rehabilitation in primary care. exclusion criteria: * previous joint replacement in the hip or knee.

Keywords: total knee arthroplasty qualitative research knee osteoarthrosis primary care physical therapy specialty
phrenic nerve conduction study to diagnose unilateral diaphragmatic paralysis

Conditions: Unilateral Diaphragmatic Paralysis

Summary: the study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (pdi) measurement versus phrenic nerve conduction (npc) study. the secondary objective of the study is the strengths and weaknesses of different tests. diagnostic threshold values.

inpatient patients in raymond poincaré hospital are informed of the utilization of their data retrospectively by the hospital's welcome booklet and reports of patients' hospitalization. period of date collected: november 2015 to june 2018. the reference standard was the diagnosis established during a multidisciplinary meeting held during patient management involving a neurologist, an electrophysiologist, a pulmonologist, and a respiratory physiologist. the medical history, physical findings, and all available investigations including imaging studies, enmg, lung function tests, and pdi measurement were considered during the meeting.

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years; * available data of pdi and pnc; * suspected unilateral diaphragmatic paralysis. exclusion criteria: * abnormalities in thoracic wall which susceptible to modify the investigation's results; * scoliosis; * pleural effusion.

Keywords: unilateral diaphragmatic paralysis diagnose phrenic nerve
randomized clinical trial to improve mobility after hospitalization

Conditions: Hypertension; Diabetes; Heart Failure; Ambulatory Difficulty; Mobility Limitation

Summary: the objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) to increase physical activity after hospital discharge to reduce incident mobility disability among older adults.

move on is a 2-arm, randomized trial enrolling older adults 50 years or older with a recent hospitalization for hypertension, diabetes, and mild-moderate heart failure. the 52 week trial compares a control group wearing a wearable activity tracker to the intervention group that uses the same device and receives a supportive social incentive-based gamification intervention. the primary goal is to increase physical activity after discharge from the hospital to reduce incident mobility disability associated with acute illness and to reduce acute and post-acute care utilization.

Eligibility criteria:
inclusion criteria: * age 50 years or older * admitted to the university of pennsylvania health system acute care hospital (hospital of the university of pennsylvania, penn presbyterian medical center, pennsylvania hospital, lancaster general health, chester county hospital, or penn medicine princeton medical center) and discharged to home * able to ambulate independently exclusion criteria: * inability to provide informed consent * does not have daily access to a smartphone compatible with the wearable device and is not willing to use a device that the investigators can provide participants' with * already enrolled in another physical activity study * low mobility score indicating that the patient is not able to walk distances greater than 1000 steps/day independently * any other medical conditions that would prohibit participation in a 6-month physical activity program * unable to complete the baseline period (must have at least 4 out of 7 days of step data with minimum step count of 1000 steps/day) * not willing to use the wearable device for the full duration of the study * enrolled in hospice

Keywords: gamification physical activity behavioral economics social support mobility
type 2 diabetes in fayoum

Conditions: Diabetes Mellitus

Summary: study the prevalence of type ii diabetes mellitus, prevalence of newly diagnosed type ii diabetic patients

study the prevalence of type ii diabetes mellitus, prevalence of newly diagnosed type ii diabetic patients, status of glycemic control and associated risk factors and complications of diabetes among population of fayoum governorate

Eligibility criteria:
inclusion criteria: * community sample as obese persons,family history of diabetes,diabetics,hypertensives,dyslipidemics exclusion criteria: * subjects known to have:chronic liver disease,ckd,cushing
metagenome analysis of gut microbiota in cc patients

Conditions: Constipation

Summary: constipation is a heterogeneous and multifactorial disease, influenced by a number of different genetic and environmental factors. by applying the standard two-stage gwas strategy to design and carry out a metagenome-wide association study (mgwas) to find the relationship between gut microbiota and constipation, to identify disease-associated metagenomic markers.

this study is a two-stage case-control metagenome-wide association study (mgwas) based on deep next-generation shotgun sequencing of dna extracted from the stool samples from a total of 50 chinese constipation patients and healthy controls.

Eligibility criteria:
inclusion criteria: 1. chronic constipation according to rome iii criteria; 2. age ≥ 18 years; 3. bmi: 18.5-25kg/m2; exclusion criteria: 1. bowel constipation due to innate factor (e.g. megacolon) or secondary interventions (e.g. drugs, endocrine, metabolic, neurologic or psychologic disorders); 2. history or evidence of gastrointestinal diseases (e.g. cancer, inflammatory bowel diseases); 3. previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section; 4. previous proctological or perianal surgery; 5. rectal prolapse and/or grade 3-4 internal hemorrhoids according to aga classification; 6. a constipation condition meeting the rome iii criteria for ibs or functional abdominal pain syndrome; 7. pregnant or breast-feeding women; 8. infection with enteric pathogen; 9. usage of probiotics, prebiotics, antibiotics or ppis within the last month; 10. smoking or alcohol addiction within the last 3 months; 11. uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease; 12. disease or therapy with drugs (e.g. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.
itopride hydrochloride in diabetes: effects on gastric emptying and glycemia

Conditions: Gastroparesis

Summary: itopride is a new compound that is already marketed in japan and in some countries of eastern europe under the name of ganaton. it is used to treat symptoms associated with gastroparesis. due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. the goal of this study is to evaluate the effects of itopride on gastric motor function and glycemia in patients with diabetes.

this is a mechanistic study evaluating in a cross-over design the effects of itopride hydrochloride. the primary objective of this study is to evaluate the acute effects of itopride hydrochloride (200 mg three times daily) on gastric emptying of solid and liquid meal components in patients with type 1 and type 2 diabetes mellitus. secondary objectives are to evaluate the effects of itopride hydrochloride on the glycaemic response to a meal, "meal-related" upper gastrointestinal symptoms and intragastric meal distribution.

Eligibility criteria:
inclusion criteria: * type-1 and type-2 diabetic patients * 18 to 65 years old * glycated haemoglobin level (hba1c) below 9% * body mass index (bmi) between 18 and 35 kg/m2 exclusion criteria: * use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g. prokinetic drugs, macrolide antibiotics) * exposure to radiation for research purposes during the previous 12 months
rituximab and involved field radiotherapy in early stage follicular lymphoma

Conditions: Lymphoma, Malignant

Summary: combination of involved field radiotherapy for the control of macroscopic disease and cd20 antibody rituximab for the control of microscopic remainders in other regions in patients with early stage nodal follicular lymphoma /grade i or ii). evaluation of dfsl and toxicity.

the mir (mabthera(r) and involved field radiation) study is a prospective multicenter trial combining systemic treatment with the anti cd20 antibody rituximab (mabthera(r)) in combination with involved field radiotherapy (30 - 40 gy). this trial aims at testing the combination's efficacy and safety with an accrual of 85 patients.primary endpoint of the study is progression free survival. secondary endpoints are response rate to rituximab, complete remission rate at week 18, relapse rate, relapse pattern, relapse free survival, overall survival, toxicity and quality of life. more details: witzens-harig m, hensel m, unterhalt m, herfarth k. treatment of limited stage follicular lymphoma with rituximab immunotherapy and involved field radiotherapy in a prospective multicenter phase ii trial-mir trial. bmc cancer. 2011; 11: 87.

Eligibility criteria:
inclusion criteria: * verified follicular lymphoma grade 1 or 2 * only nodal involvement (incl. waldeyer) clinical stage i or ii * largest tumor ≤ 7 cm * adequate bone marrow reserves exclusion criteria: * ecog \>2 * follicular lymphoma grade 3 * buky disease (\>7 cm) * involvement of the spleen * neoplasia in pmh (except: basalioma, spinalioma) * immunodeficiency syndromes, viral hepatitis, connective tissue disease * severe psychiatric disease * pregnancy or breast feeding * known allergies against foreign proteins

Keywords: untreated
a prospective, randomized, subject and vision-assessor masked, multicenter study comparing bilateral clareon panoptix, bilateral clareon panoptix pro, and mixed clareon panoptix pro/vivity intraocular lens implantation in cataract subjects

Conditions: Cataract

Summary: prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with stage 1 as a three-arm initial enrollment period, followed by stage 2 as a head-to-head study refined based on the stage 1 data.


Eligibility criteria:
inclusion criteria: * adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes. * ability to understand and sign an ethics committee-approved informed consent form. * willingness and ability to attend all scheduled study visits as required by the protocol. * postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator. * preoperative corneal astigmatism that can be corrected with a t3 or t4 toric iol, or with a spherical iol and lris or aks resulting in a predicted postoperative astigmatism of less than 0.5 diopters (d). * ability to understand and complete questionnaires. exclusion criteria: * women who are pregnant, planning to become pregnant during the study, or breastfeeding. * ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy. * any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma). * participation in another clinical study that could interfere with the results. * systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders). * subjects with nystagmus, strabismus, zonular laxity or dehiscence, and pseudoexfoliation. * prior ocular surgery (except for uncomplicated cataract surgery in the fellow eye). * participants desiring monovision. * any active ocular infection or inflammation (except for routine post-operative inflammation in the fellow eye) * psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide accurate self-assessments. * rms total higher-order aberrations (hoas) \>0.70 µm or coma \>0.40 µm as measured by tomography or topography with a 4 mm pupil setting.
liver transplantation results in hepatocellular carcinoma patients with immunosuppression without steroids

Conditions: Immunosuppression; Hepatocellular Carcinoma; Liver Transplantation; Post-operative Complications

Summary: the purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in hepatocellular carcinoma (hcc) patients.


Eligibility criteria:
inclusion criteria: * all liver transplantation patients with hepatocellular carcinoma in our center between jan 2005 and dec 2009 were potentially eligible for enrollment exclusion criteria: * the recipient pass away within 3 month following up liver transplantation * inability to provide written informed consent prior to study entry * acute rejection are treated only with steroids
an observational ltfu study for patients previously treated with autologous ex vivo gene therapy for ada-scid

Conditions: Adenosine Deaminase Deficiency; Severe Combined Immunodeficiency (SCID)

Summary: this observational long-term follow-up study is designed to collect safety and efficacy data from ada-scid patients previously treated with autologous ex vivo gene therapy products based on the efs-ada lv encoding for human adenosine deaminase (ada) gene (efs-ada lv), as part of the otl-101 clinical development program. no investigational medicinal product will be administered to these patients as part of the otl-101-6 study.


Eligibility criteria:
inclusion criteria: a patient is eligible for enrollment in the study if all of the following criteria are met: 1. the patient has been treated with an autologous ex vivo gene therapy product based on the efs-ada lv, as part of the otl-101 clinical development program; 2. the patient displays persistent detectable gene marking, as determined by the investigator; 3. the patient or, if applicable, the patient's parent(s)/legal guardian(s), are able and willing to provide informed consent. exclusion criteria: * there are no exclusion criteria for participation in this observational ltfu study.

Keywords: otl-101
a study of trastuzumab emtansine (t-dm1) plus pertuzumab/pertuzumab placebo versus trastuzumab [herceptin] plus a taxane in participants with metastatic breast cancer (marianne)

Conditions: Breast Cancer

Summary: this randomized, 3-arm, multicenter, phase iii study will evaluate the efficacy and safety of trastuzumab emtansine (t-dm1) with pertuzumab or trastuzumab emtansine (t-dm1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (herceptin) plus taxane (docetaxel or paclitaxel) in participants with her2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. participants will be randomized to 1 of 3 treatment arms (arms a, b or c). arm a will be open-label, whereas arms b and c will be blinded.


Eligibility criteria:
inclusion criteria: * adult participants \>/=18 years of age * her2-positive breast cancer * histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent. * participants must have measurable and/or non-measurable disease which must be evaluable per response evaluation criteria in solid tumors (recist) 1.1 * eastern cooperative oncology group (ecog) performance status 0 or 1 * adequate organ function as determined by laboratory results exclusion criteria: * history of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease * an interval of \<6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis * hormone therapy \<7 days prior to randomization * trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) \<21 days prior to randomization * prior trastuzumab emtansine or pertuzumab therapy