Kornimate/medical-research-clean huggingface dataset:
pulmonary artery denervation for treatment of pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. however this single non-randomized study requires confirmation. the investigators propose a prospective multi-center, randomized, single-blinded trial. its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mpap) at six months, compared to continued medical treatment following a simulated (sham) procedure. the principal evaluation criteria will be the mpap change (in mm hg) as measured by right heart catheterization. the study will run for 18 months and it will be necessary to recruit 50 patients. all adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria. the investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers in both groups.


Eligibility criteria:
inclusion criteria: * patients with pulmonary artery hypertension (group 1 of the nice classification of pulmonary hypertension) * aged over 18 years old * nyha class iii or iv * not controlled by optimal medical management as defined by: * dual therapy including a prostacyclin. * or dual therapy including an endothelin receptor antagonist and a * 5-phosphodiesterase inhibitors, in patients with contra-indication of prostacyclin, poor tolerance to this treatment, prostacyclin derivative treatment failure or patient refusal. * valid status in the social security system * signed informed consent exclusion criteria: * patient eligible for pulmonary transplantation * pregnancy or breastfeeding * adults of the age of majority subject to guardianship court order or deprived of liberty * patient with history of radio frequency procedure * known heparin allergy
rebeat resynchronisation and beta-blocker european trial

Conditions: Heart Failure

Summary: this protocol will evaluate the effect of cardiac resynchronization therapy (crt) combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up titrated to optimal doses before crt. cardiac resynchronization therapy will be combined with automatic implantable cardioverter defibrillator (aicd, crt-d) as it has been shown to be associated with an improvement in prognosis in the patients with left ventricular systolic dysfunction and heart failure.

the purpose of this investigation is to evaluate the effect of crt combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up-titrated to optimal doses before crt.

Eligibility criteria:
inclusion criteria: * symptomatic heart failure and indication for cardiac resynchronization therapy (crt), hemodynamic stability with documented intolerance to beta-blocker therapy or treatment with beta-blocking agents at sub-optimal dosages (\<25% of optimal dosage). exclusion criteria: * chronic atrial fibrillation; indications for permanent antibradycardia pacing; mechanical tricuspid valve; severe aortic stenosis or other primary valve disease causing cardiomyopathy
a research study looking at long-term treatment with etavopivat in people with sickle cell disease or thalassaemia

Conditions: Sickle Cell Disease, Thalassemia

Summary: etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. haemoglobin is the protein that carries oxygen through the body. this study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. the study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.


Eligibility criteria:
inclusion criteria: * participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (scd) or thalassaemia and have completed at least a treatment period of the parent study. * participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator. * any participant with dose reduction or temporary discontinuation will need to be rechallenged before transferring. * participants on hydroxyurea (hu), crizanlizumab or l-glutamine oral powder (endari®) treatment at the time of consent may be eligible if they: * have been on a stable dose during participation in the parent study (i.e., no changes to the dose except for changes to weight or age reasons). * have been compliant with the treatment regimen at the discretion of the investigator during participation of the parent study. exclusion criteria: * any disorder, except for conditions associated with scd or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study. * participants on permanent dose reduction or temporary treatment discontinuation. * use of any of the following within the timeframes prior to the transfer visit as stated: * use of voxelotor within participation of the parent study or anticipated need for this agent during this study. * use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study. * use of erythropoietin or other haematopoietic growth factor treatment within the parent study or anticipated need for such agents during this study. * receiving or use of concomitant medications that are strong inducers of cytochrome p450 (cyp) 3a4 within 2 weeks of the transfer visit or anticipated need for such agents during the study. * current participation in a study that is not a designated parent study, or planned participation in any other clinical trial, for the duration of floral.
dupilumab de-escalation in pediatric atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (ad) control on dupilumab.

participants will be randomly assigned to one of three groups: discontinuation of dupilumab; reduction of dupilumab dose; or continuation of standard dupilumab dose. during the active study treatment period, participants will be asked to complete 5 study visits. at these visits, a physician will conduct a skin examination to assess atopic dermatitis (ad) severity and participants will complete questionnaires about their ad symptoms and severity. during the observational period, participants will be asked to complete questionnaires about their ad symptoms and medication use every twelve weeks, for a total of 3 follow-up contacts. the purpose of this study is to evaluate the feasibility and sustainability of reducing or discontinuing dupilumab in children with well-controlled ad.

Eligibility criteria:
inclusion criteria: * aged 1 to \<18 years old, either sex, any race or ethnicity * provide signed informed consent by parent or legal guardian and informed assent if applicable * has a physician confirmed diagnosis of atopic dermatitis * has received dupilumab for at least 12 months for the treatment of atopic dermatitis * has had well-controlled atopic dermatitis on dupilumab within last 6 months (defined as poem\<=7, easi\<=7, or iga\<=2) * able to speak english * able and willing to adhere to all study procedures exclusion criteria: * taking concurrent systemic medication for atopic dermatitis (e.g., methotrexate, cyclosporine, tralokinumab, abrocitinib, upadacitinib, systemic corticosteroids) * using concurrent phototherapy for atopic dermatitis * taking dupilumab for a clinical indication other than atopic dermatitis (such as asthma or eosinophilic esophagitis) * poor control of atopic dermatitis * poor control of asthma or eosinophilic esophagitis * has used an investigational drug within 90 days or plan to use an investigational drug during the study period * does not have health insurance or will lose health insurance during the study period
phase ii study of tki258 in advanced urothelial carcinoma

Conditions: Urothelial Cancer

Summary: this study will evaluate the efficacy of tki258 in patients with advanced urothelial cancer


Eligibility criteria:
inclusion criteria: * patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis * patients who have archival tumor tissue available for fgfr3 mutational status screening * patients with progressive disease * patients with measurable disease by recist * patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting * age ≥ 18 years * who performance status ≤ 2 * patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests * patients with signed and witnessed informed consent form * patients with adequate organ function exclusion criteria: * patients with brain cancer * patients with other cancers except for certain skin, cervical \& prostate cancers * patients who have not recovered from previous cancer treatment * patients who have severe and/or uncontrolled medical conditions which could affect participation in the study other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced urothelial cancer
treatment and suppression of hairy leukoplakia in arc patients with oral acyclovir (acv)

Conditions: Leukoplakia, Hairy; HIV Infections

Summary: to evaluate the efficacy of oral acyclovir for the treatment and suppression of epstein-barr virus (ebv) related hairy leukoplakia (hl). to determine the long-term safety of acyclovir in the aids-related complex (arc) patient with hl. to monitor the progression of hiv disease in the hl patient and compare to existing historical control data.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * topical antifungal therapy. patient must have: * newly diagnosed clinical and histological hairy leukoplakia. * positive hiv antibody by licensed elisa or western blot. exclusion criteria co-existing condition: patients with aids or a history of intolerance or allergy to acyclovir are excluded. concurrent medication: excluded within 2 weeks of study entry: * systemic antifungal treatment. * excluded within 6 weeks of study entry: * immunomodulators. * systemic antiviral treatment. patients with aids or a history of intolerance or allergy to acyclovir are excluded. prior medication: excluded within 2 weeks of study entry: * systemic antifungal. * excluded within 6 weeks of study entry: * immunomodulators. * systemic antiviral treatment. * excluded within 8 weeks of study entry: * zidovudine (azt) or other antiretroviral therapy.

Keywords: aids-related opportunistic infections leukoplakia, oral herpesvirus 4, human acyclovir aids-related complex
bone mineral density (bmd) in cemented versus cementless hip resurfacing

Conditions: Osteoarthritis

Summary: the purpose of this study is to compare the bone mineral density of patients who have undergone either cemented or cementless hip resurfacing.

recent research is inconclusive regarding the degree to which the density or strength of the bone around the hip implant is preserved following a hip resurfacing system. certainly, there are many factors which contribute to the preservation of bone mineral density - we are studying the role of cement. more specifically, we are trying to compare outcomes between patients who receive the cementless cormet hip resurfacing system to those who receive the cemented conserve® plus total resurfacing hip system. therefore, the primary purpose of the current study is to compare the bone mineral density between the cementless and cemented hip resurfacing systems. we are also comparing patients who receive these two different hip systems in terms of their x-rays and how they are managing with their hip.

Eligibility criteria:
inclusion criteria: * must be undergoing primary hip surgery for noninflammatory degenerative joint disease * must be skeletally mature, as determined by risser sign or reaching 18 years of age * is reasonable expectation that patient will remain available for all fu's scheduled over course of 5 years exclusion criteria: * previous fusions, acute femoral neck fractures, and above knee amputations * evidence of active local infection * neurologic or musculoskeletal disease that may adversely affect gait or weight bearing * having previously undergone ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device * bmi \>35 * neuropathic joints * severe documented psychiatric disease * patients requiring structural bone grafts * documented allergy to cobalt chromium molybdenum * ipsilateral girdlestone * sickle cell disease * significant femoral head or neck deformity, or significant acetabular wall deficiency * patients with renal failure, defined as serum creatinine greater that 180 µmol/l

Keywords: non-inflammatory degenerative joint disease hip resurfacing bone mineral density cemented cementless
lepu renal denervation system for resistant hypertension

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Summary: the purpose was to evaluate 6-month outcomes of renal denervation(rdn) for the treatment of resistant hypertension in chinese patients in a prospective cohort study.

currently, considerable data on rdn have been obtained from western populations, while the clinical outcomes of rdn in east asian populations are seldom reported. therefore, the purpose was to evaluate 6-month outcomes of rdn for the treatment of resistant hypertension in chinese patients.in a prospective single-center cohort study, 50 chinese patients with resistant hypertension would be recruited to undergo rdn by lepu renal denervation system, which was similar to symplicity the symplicity renal-denervation system (medtronic). the primary effectiveness endpoint was change in systolic and diastolic blood pressure at six months as measured by office-based blood pressure assessment and 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline. the primary safety endpoint was the incidence of major adverse event (mae) through 6 months , including severe renal artery dissection/stenosis(\>60%) that required stenting or surgery, cerebrovascular accident, myocardial infarction, death.

Eligibility criteria:
inclusion criteria: * age 18-65 years * stable medication regimen including ≥3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to rdn) * 1) office sbp and/or dbp ≥160/100 mm hg ( ≥ 150/95 mmhg for type ii diabetic patients) , 2) abpm 24 hour mean sbp and/or dbp ≥140 and/or 90 mmhg * main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation) * egfr ≥45 ml/min/1.73 m2 * written informed consent exclusion criteria: 1. clinical exclusion criteria: * known secondary hypertension * type 1 diabetes mellitus * has an implantable cardioverter defibrillator (icd) or pacemaker * myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period * widespread atherosclerosis with documented intravascular thrombosis or unstable plaques * has hemodynamically significant valvular heart disease * pregnant, nursing, or planning to be pregnant * any serious medical condition that may adversely affect the safety of the participant or the study * currently enrolled in another investigational drug or device trial 2. anatomic exclusion criteria * renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery * history of prior renal artery intervention including balloon angioplasty or stenting * multiple renal arteries where the main renal artery is estimated to supply \<75% of the kidney * main renal arteries with \<4 mm diameter or with \<20 mm treatable length (by visual estimation) * renal artery abnormalities
rogycare: the impact of a cancer survivorship care plan on patient reported outcomes and health care providers

Conditions: Ovarian Cancer; Endometrium Cancer

Summary: earlier diagnoses and improved treatments have contributed to the growing cohort of cancer survivors. nevertheless, these patients remain at risk for adverse long-term or late physical or psychosocial effects of cancer and its treatment. there is increasing recognition to improve information disclosure and cancer survivorship care. the american institute of medicine (iom) and health council of the netherlands both recommend that cancer survivors receive a summary of their course of treatment as a formal document, that also includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion, the survivorship care plan (scp). however, no evidence exists concerning the positive and negative effects of the implementation of the scp in daily clinical practice. the purpose of this study is to assess the impact of scp care in routine clinical practice on cancer survivors' satisfaction with information disclosure and care, quality of life, illness perception, and health care use.


Eligibility criteria:
inclusion criteria: * women who are newly diagnosed with endometrial or ovarian cancer in one of the 12 participating hospitals. * the patients have to be able to complete a dutch questionnaire. exclusion criteria: * patients who are not able to read or write dutch will be excluded, as they are not able to complete a dutch questionnaire.

Keywords: patients
the use of music as pain therapy in patients undergoing laparoscopic cholecystectomy in a day care unit

Conditions: Pain; Ponv; Fatigue

Summary: the study is undertaken to investigate whether relaxing music therapy before, during and after laparoscopic cholecystectomy has any effect on pain, ponv or fatigue and level of stress as measured by cortisol and c reactive protein. patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1 and 7 post-op.


Eligibility criteria:
inclusion criteria: * all patients going for laparoscopic cholecystectomy exclusion criteria: * age below 18, * use of nsaid, morphine, steroids * disability * previous surgery in the past month * pregnancy

Keywords: laparoscopic cholecystectomy pain ponv music therapy fatigue after elective laparoscopic cholecystectomy
effects of intravenous metabolic recovery agent in elderly septic patients on prognosis and microcirculation.

Conditions: Septic Shock

Summary: this study intends to observe the effect of intravenous hydrocortisone combined with vitamin c and vitamin b1 infusion on the prognosis and sublingual microcirculation in patients with sepsis or septic shock through a prospective randomized controlled study method.

shock is a common pathophysiological state in critical care medicine and occupies an important position. in recent years, some studies have had uesd metabolic resuscitation agent -- namely hydrocortisone + vitamin c + vitamin b1 cocktail therapy in the treatment of sepsis patients, studies found that this method may reduce the lactate level, improve renal failure and circulatory failure, and then improve the prognosis of such patients. there are also study groups that do not significantly prolong the survival of septic shock, suggesting that we need to screen out the use of metabolic resuscitation agents. given the important role of vitamins in shock, uncontrolled inflammatory response, capillary leakage, and microcirculation dysfunction, whether the improved prognosis may be related to the patients' own vitamin levels. vitamin deficiency is often present in the elderly. this study aims to observe the effect of precision treatment of metabolic resuscitation agent on mortality and sublingual microcirculation in the follow-up prognosis of elderly septic patients on the basis of monitoring vitamin b1 and c levels in elderly septic patients.

Eligibility criteria:
inclusion criteria: * age ≥60 and ≤85 years old; * diagnosis of sepsis or septic shock; * clinical judgment for hydrocortisone treatment; * signing informed consent. exclusion criteria: * patients in palliative care; * uncontrolled malignancy with multiple metastases; * ineffective surgical intervention for the infectious agent; * estimated death within 24 hours; * glucocorticoids used in the last 7 days; * allergy to hydrocortisone, vitamin c or vitamin b1; * inability to measure sublingual microcirculation.

Keywords: hydrocortisone vitamin c vitamin b1 sepsis septic shock mortality microcirculation
efficacy study of amazing me program

Conditions: Self Esteem; Body Distorted Images

Summary: the objective of the efficacy study of amazing me program is to deliver the amazing me intervention and assess its efficacy. the amazing me intervention aims to help children between the ages of 9 and 11 build self-esteem, body confidence, and eliminate weight-based bullying and teasing. the amazing me intervention teaches students to be kind to themselves, their bodies, and to others.

body dissatisfaction is one of the most robust risk factors for developing unhealthy behaviors, low self-esteem, and contributes to anxiety and depression in adolescence. despite evidence that body dissatisfaction can emerge during the elementary school years, the majority of body confidence programs are for girls over the age of 15. there is very little to no research on interventions for elementary school children. the body project is an empirically supported body confidence prevention program for high school girls with over 100 articles to support its efficacy, effectiveness and theoretical model; it is the only body confidence program for youth to acquire the blueprints certification. together with two 4th and 5th grade teachers, the investigators have adapted the body project curriculum for youth between the ages of 9 to 11 years old (i.e., 4th and 5th graders). the curriculum is called amazing me and will be implemented in classrooms by teachers. the curriculum was developed meeting several competencies for national health and wellness standards for elementary students. the aim of the current study is to conduct a national randomized control trial of the curriculum 100 classrooms with 4th and 5th graders. the primary aim of the current study is to deliver the amazing me intervention and assess its efficacy. it is hypothesized that compared to controls, children that undergo the body confidence curriculum will report higher body satisfaction and body esteem scores, overall greater self-esteem, and will report less engagement in appearance comparisons.

Eligibility criteria:
inclusion criteria: * educators teaching 4th and 5th graders. thus students will be on average between 9 and 11 years old. exclusion criteria: * none.

Keywords: body satisfaction self esteem weight-based bullying and teasing