Kornimate/medical-research-clean huggingface dataset:
a study comparing a plant-based diet with supplements and placebo in people with monoclonal gammopathy of undetermined significance (mgus) or smoldering multiple myeloma (smm)

Conditions: Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance

Summary: the researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. all participants will have monoclonal gammopathy of undetermined significance (mgus) or smoldering multiple myeloma (smm). we will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of mgus or smm * if non light chain mgus/smm then m spike must be either ≥ 0.2 g/dl or bm pc ≥10% (both not required) * if light chain mgus/smm then involved must be ≥10 mg/dl or bm pc ≥10% (both not required) * if iga mgus/smm then an iga level \>350 mg/dl and an abnormal immunofixation is required (m spike criteria not required). * if igd mgus/smm then an igd level \>50 mg/dl and an abnormal immunofixation is required (m spike criteria not required). * age ≥18 years * willingness to comply with all study-related procedures * ecog performance status of 0-3 * interested in learning to cook plant based recipes exclusion criteria: * patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded) * legume allergy * severe allergies such as anaphylactic shock to nuts (specifically cashews). peanuts are not included in the meals. * concurrent participation in weight loss/dietary/exercise programs * mental impairment leading to inability to cooperate * enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date * concurrent pregnancy * positive hbv, hcv or hiv pcr test will need to be treated first and once undetectable viral load patients may enroll * ≥ grade 2 electrolyte abnormalities as defined by ctcaev5.0 (need to be resolved before enrolling on study) * if in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications * heavy drinker (defined as \>2 drinks per day or \>14 drinks per week) * current self-reported illicit drug use (eg heroin, cocaine not marijuana)

Keywords: plant-based diet supplements 22-175
cartomerge versus navx fusion in catheter ablation of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: comparison of two strategies for catheter ablation of atrial fibrillation - a comparison of ablation guided by cartomerge and navx fusion. 3d mapping systems are widely used in catheter ablation of af. integration of a previously acquired image of the left atrium into the electroanatomical (ea) map offers several potential advantages, including visualisation of the complex anatomy of the left atrium, reduction of fluoroscopy time and improved results . the two most widely used systems are cartomerge (biosense webster, etc) and navx fusion (sjm, etc). although both systems have been independently validated, their clinical utility has not previously been directly compared in a randomised trial

patients are randomised to either navx fusion or cartomerge. they undergo a standard catheter ablation procedure and data is collected. both systems are routinely used in our clinical practise. this is a comparison trial of 2 mapping technologies.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age * be undergoing their first planned procedure for electrophysiology mapping and ablation in the left atrium of af * be willing and able to sign the study specific informed consent * have a negative pregnancy test for female subjects of child bearing potential exclusion criteria: * have a left ventricular ejection fraction (lvef) of \<40% as evaluated by pre-procedure tte * have any contraindication or allergy to routine procedural medications or catheter materials * have any condition for which the investigator feels it is unsafe for the subject to undergo an invasive electrophysiology procedure (ep) catheterisation * be currently participating in another clinical research study * have any condition for which the subject's life expectancy is less than twelve months

Keywords: 3d mapping image integration atrial fibrillation catheter ablation
early detection of gestational diabetes mellitus in pregnancy

Conditions: Gestational Diabetes Mellitus in Pregnancy; Pregnancy, High Risk

Summary: the purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (gdm).

gestational diabetes mellitus (gdm) is an important contributor to both maternal and neonatal morbidity and mortality in pregnancy. gdm has lifelong complications including an increased risk of developing type 2 diabetes mellitus and cardiovascular disease for women, and their offspring are at higher risk of being obese and also having diabetes in childhood and adolescence. approximately 1 in 8 pregnancies is impacted by gestational diabetes mellitus worldwide. first trimester gdm screening is varied due to conflicting national guidelines, and the best strategy is unknown. the goal of the proposed research is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gdm. the investigators will utilize a pilot randomized controlled trial to recruit 80 high-risk pregnant women in the first trimester, of whom half will receive protocolized early gdm screening with serum biomarkers before 12 weeks and the remaining half will receive the current standard of care with screening between 24 and 28 weeks of gestation with possible early screening based on provider discretion.

Eligibility criteria:
inclusion criteria: * 1) age greater than or equal to 18 years old, * 2) singleton gestation less than or equal to 12 weeks at initial obstetric visit, * 3) receiving prenatal care at ummhc and plans to deliver at ummhc, * 4) able and willing to provide informed consent, * 5) english or spanish speaking, and * 6) are at high risk for developing gdm by acog clinical risk factor guidelines. exclusion criteria: * 1) known diagnosis of pre-existing pregestational diabetes, * 2) plan to receive prenatal care or deliver outside of ummhc, * 3) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or * 4) systemic steroid use.

Keywords: pregnancy gestational diabetes screening maternal outcomes neonatal outcomes
protocols for improved in vitro fertilization (ivf) outcomes

Conditions: Infertility

Summary: many infertile patients have a decreased chance of becoming pregnant when using in vitro fertilization (ivf). for these patients, many different treatments are available, but none of them have been shown to be better than the others. we are testing which of three different treatments are better than the others. patients who are expected to have a decreased response to ovarian stimulation will be randomized to either a microflare protocol, an antagonist protocol, or a demi-halt protocol.

infertile patients with an anticipated poor response to ovarian stimulation will be randomized to one of three different protocols in their upcoming ivf cycle. each of the protocols will be performed as is the standard of care with the addition of serum evaluation during the course of the stimulation as well as follicular fluid analysis which is obtained as a byproduct of the oocyte retrieval. chart review will be performed to collect background characteristics (including age, ethnicity, previous fertility treatment), treatment response (such as oocyte number, embryo grade, embryo quality), and pregnancy outcome (such as miscarriage, singleton pregnancy, or higher-order multiple pregnancy). statistical analysis will be performed to determine if one protocol leads to higher pregnancy rates and multivariate analysis will be performed to determine potential etiologic variables.

Eligibility criteria:
inclusion criteria: * infertile patients * undergoing ivf * antral follicle count less than 10 * prior history of less than 5 oocytes generated during an ivf cycle

Keywords: in vitro fertilization infertile infertility pregnancy pregnancy rates microflare protocol antagonist protocol demi-halt protocol poor responders low antral follicle count infertile patients undergoing in vitro fertilization (ivf) patients with a previous poor response to ovarian stimulation patients with an antral follicle count of less than 10
comparative study of chemoradiation and sequential chemoradiation about lung adenocarcinoma patients with postoperative in pn2

Conditions: Lung Adenocarcinoma Patients With Postoperative in pN2

Summary: the purpose of this study compares chemoradiation and sequential chemoradiation about lung adenocarcinoma patients with postoperative in pn2 and then determines which therapeutic method is better for the patients.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of lung adenocarcinoma * postoperative staging pn2 period * voluntary participation and informed consent * age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy * performance status( ps) score 0-2. * hemoglobin ≥ 80 g / l, white blood cell ≥ 4 × 109 / l, platelets ≥ 100 × 109 / l. * liver function: alanine aminotransferase (alat), aspartate transaminase (asat) \<upper limit of normal (uln) of 1.5 times, bilirubin \<1.5 × uln. * renal function: serum creatinine \<1.5 × uln. * compliance, and can be regular follow-up, voluntary compliance with study requirements exclusion criteria: * do not meet the inclusion criteria * there is evidence of distant metastases * suffered from other malignancies in five years * within the past january subjects received other drug trials * having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin b12 patients * severe lung or heart disease, a history * refuses or is unable to sign informed consent to participate in trials * the abuse of drugs or alcohol addicts. * patients with difficult to control bacterial, viral, fungal infections * having a personality or mental disorders, without civil capacity or restricted civil capacity. * being pregnant or lactating women.

Keywords: lung adenocarcinoma concurrent chemoradiotherapy sequential chemoradiotherapy progression-free survival
efficacy, safety and tolerability of ath3g10 in patients with st-elevation myocardial infarction

Conditions: ST Elevation Myocardial Infarction

Summary: patients with st-segment elevation myocardial infarction (stemi) that have suffered a major anterior wall infarction or where coronary blood flow is less than normal in spite of successful percutaneous coronary intervention (pci) have a poor prognosis. there are today no medical treatments that specifically reduce risk in these patients. the acute inflammatory reaction in conjunction with a stemi and reperfusion by pci determines the final size of the infarction and the signals leading to left ventricular remodelling. this study is designed to assess the efficacy and safety of single intravenous injection with ath3g10, a fully human igg1 antibody against phosphorylcholine, in high-risk subjects with stemi. ath3g10 aims to reduce inflammation and thereby infarction size and remodeling.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction with st elevation at the j-point in two contiguous leads * start of pci less than 4 hours after symptom onset. exclusion criteria: * cardiogenic chock, non-compensated acute heart failure and/or pulmonary edema. * previous major vascular intervention within the last 4 weeks. * history of an infarct in the same artery that is currently affected. * conditions contraindicating mri
prevention of renal failure in children with urinary tract infections

Conditions: Urinary Tract Infections

Summary: the aim of the study is to describe the current clinical management of young children with urinary tract infections in dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure.

the aim of the study is to describe the current clinical management of young children with urinary tract infections in dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure. the 4 phases of the study contain the following questions: * phase 1: what is the current clinical management of urinary tract infections in young children in primary care? * phase 2: what are the possibilities for improving the clinical management of urinary tract infections and are these improvements practically achievable? * phase 3: what is the cost-efficiency of the several interventions for improving clinical management of urinary tract infections * phase 4: what is the influence of the intervention on clinical management?

Eligibility criteria:
inclusion criteria: * children between 0-12 years of age with a proven urinary tract infection in general practice exclusion criteria: -

Keywords: urinary tract infections renal failure renal scarring prevention primary care general practice intervention studies children
platelet-rich plasma in calcific tendinitis

Conditions: Calcific Tendinitis

Summary: needle aspiration of calcific deposits (nacd ) is the treatment of choice for calcific tendinitis which does not respond to conservative treatment. nacd is effective in approximately 70% of the patients.when nacd is not effective, surgery is often the only treatment that remains.surgery, however, is discouraged by th e dutch guidelines for diagnosing and treating patients with subacromial pain syndrome.therefore,both patients and the doctors treating those patients will benefit from a more effective minimal invasive treatment for calcific tendinitis.injection of platelet-rich plasma (prp) might, considering its positive effect on tissue repair, be a possible solution here.previous research investigating the effects of prp on other tendinopathies did, however, show controversial results. the aim of this double-blind randomized controlled trial is to investigate the effect of the adjuvant application of prp after nacd on pain reduction ,recovery of shoulder function, tendon recovery,resorption of calcific deposits, the percentage of patients with persistent complaints and quality of life.


Eligibility criteria:
inclusion criteria: * age \> 18 yrs * clinical manifestions of tendinitis calcarea (pain, stifness, lock sensations, muscle atrophy) * persistent pain sympoms \>6 months * standardized ap x-ray shows calcific deposit of \> 5mm \& morphologic type i \& ii deposits (classification of gärtner en simons) * ineffective intervention \> 2 types of conservative treatment (among which are non-steroidal anti-inflammatory drugs, physiotherapy, local anesthesia injection and/or corticosteroids, extracorporele shock wave therapy) * indication and referral for barbotage by orthopeadic surgeon exclusion criteria: * age \> 55 years * morphological type iii deposits according to classification of gärtner and simons) (as indicated by standardized x-ray ap) * bigliani type iii acromion, and acromial spur of acromioclavicular osteovyt * previous (ineffective) barbotage * the existence of other shoulder related injuries next to calcific tendinitis (full-thickness rupture of the rotator cuff, adhesive capsulitis (frozen shoulder), arthrosis of the glenohumeral- or acromioclavicalar joint * shoulder joint instability * shoulder injury due to trauma or previous shoulder surgeries * other types of disorders that could negatively influence the outcomes (rheumatic arthritis. cervical spine disorders, neurological upper extremity disorders, diabetes mellitus, infections, blood disorders, malignity, pregnancy) * known allergic responses to one of the medications applied in the current study (lidocaine, bupivacaine, kenacort) * usage of anti-coagulants other than ascal of plavix

Keywords: plasma, calcific tendinitis, rotator cuff, prp
the safety and effectiveness of mk-639 and zidovudine, used alone and together, in hiv-infected patients who have never taken anti-hiv drugs

Conditions: HIV Infections

Summary: to compare the effects on cd4 counts and safety of mk-639 (indinavir, idv) and azt administered concomitantly to mk-639 alone and azt alone in hiv-1 seropositive patients.

patients are randomized to 1 of 3 groups for 12 months of treatment. group 1 receives mk-639 plus azt. group 2 receives mk-639 alone. group 3 receives azt alone. safety and tolerability are assessed by the incidence of clinical and laboratory adverse experiences. blood and urine samples are collected for safety assessment and to determine cd4 cell counts and serum viral rna levels. if therapy with mk-639 alone or with azt is found to be generally safe and clinically efficacious, patients who have completed the study will have the opportunity to continue in an extension study protocol on a treatment regimen including mk-639.

Eligibility criteria:
inclusion criteria patients must have: * hiv seropositivity. * average cd4 count between 50 and 500 cells/mm3 based on 2 separate pre-study determinations at least 1 week apart. note: * patients with known hemophilia may be enrolled at the discretion of the investigator. prior medication: excluded: * any protease inhibitor. * significant prior use (greater than 2 weeks) of nucleoside analogues. * chronic therapy for an active opportunistic infection. (allowed: * prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, dapsone, topical antifungals, and isoniazid). * investigational agents or immunomodulators within 30 days prior to study entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * acute hepatitis. * lymphoma. * visceral kaposi's sarcoma. * invasive cervical cancer. * active infection. concurrent medication: excluded: anticipated immunosuppressive therapy.
fluid balance during closure of atrial septal defect

Conditions: Heart Defects,Congenital; Heart Septal Defects, Atrial

Summary: this project will evaluate fluid balance and oedema formation in children with the same congenital heart disease (atrial septal defect) who will either go through heart surgery with the use of cardio pulmonary bypass and hypothermia or through interventional catheterization. the investigators will measure interstitial colloid osmotic pressure, distribution of proteins and cytokines. the study hypothesis is that "oedema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane".


Eligibility criteria:
inclusion criteria: * the diagnosis of atrial septal defect scheduled for closure * informed consent exclusion criteria: * renal failure, * liver failure, * coexisting cardiac malformations

Keywords: heart septal defects, atrial oedema formation
assessment of the effect of spa therapy on the quality of life of patients with chronic venous insufficiency (neyrac)

Conditions: Chronic Venous Insufficiency

Summary: evaluation of the effectiveness of a phlebology-oriented spa therapy at 6 months on the quality of life of patients suffering from chronic venous insufficiency of the lower limbs

neyrac is a: * prospective, before/after, cohort follow-up study with repeated measurements * monocentric study with the dispensation of a 3-week phlebology-oriented spa therapy in neyrac-les-bains

Eligibility criteria:
inclusion criteria: * age greater than 18 years * patient with chronic venous insufficiency of the lower limbs (ceap category c4a, c4b and c4c) * patient presenting an indication for a phlebology-oriented spa treatment as the primary orientation. patients with a dermatological or rheumatological pathology can benefit from a dual orientation spa treatment with a main phlebology orientation * patient affiliated to the social security system or such a system * available for an 18-day spa treatment and a 6-month follow-up * for women of childbearing age: effective contraception * patient close to a study investigator (excluding teleconsultation) if not patient with access to the necessary equipment to perform a teleconsultation (smartphone, tablet or computer with an internet connection + taking and sending photos of the lower limbs) non inclusion criteria: * venous surgery or venous interventional therapy within 3 months prior to inclusion or scheduled within the next 3 months * history of venous ulcer * contraindication to spa therapy (immune deficiency, evolving cardiopathy neoplasia, infection, pulmonary tuberculosis, severe renal insufficiency, alcoholic cirrhosis, advanced senility and severe mental disorders) * predictable intolerance to thermal treatments (intolerance to heat, baths, etc.) * persons suffering from venous insufficiency of the varicose vein type (category ceap c2) or edema alone (category ceap c3) or open or healed ulcers (ceap category c5 and c6) * patient who has already undergone a phlebology-oriented spa treatment within the current thermal season * subject already included in an interventional clinical research protocol * persons referred to in articles l1121-5 to l1121-8 of the "code de la santé publique" (pregnant women, women in labour and parturient and nursing mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure or not being able to verbally communicate their agreement, minor)

Keywords: spa therapy phlebology chronic venous insufficiency