Kornimate/medical-research-clean huggingface dataset:
efficacy of rapamycin (sirolimus) in the treatment of peutz-jeghers syndrome

Conditions: Peutz-Jeghers Syndrome

Summary: a prospective non-randomized open label single arm clinical trial to examine the efficacy and safety of sirolimus in patients with peutz-jeghers syndrome.

pjs (peutz-jeghers syndrome) is mostly caused by mutations in lkb1 gene, which leads to an increased activity of mtor pathway, thus making mtor inhibitor (sirolimus) a promising candidate in treatment and prevention of pjs. the efficacy of sirolimus (rapamycin) on pjs has been demonstrated in mouse model, but no clinical trials have been reported. our study was designed as a prospective non-randomized open label single arm clinical trial to examine its efficacy and safety.

Eligibility criteria:
inclusion criteria: * patients are diagnosed with pjs. * patients have gastrointestinal polyps related syndromes, including abdominal pain, abdominal distension, gastrointestinal bleeding, etc, with imageological examination suggesting intestinal obstruction or intussusception; or whose symptoms recur after previous digestive endoscopic treatment and surgery; or who are inappropriate or unwilling to accept the above treatment again and wish to receive pharmacotherapy. * conventional treatment didn't work well in patients combined with pjs-related tumors. * physical condition (ecgo): 0\~3 * organ function is good and biochemical indices meet the following conditions: * ast≤2.5×upper limit of normal value (uln), * alt≤2.5×upper limit of normal value (uln), * serum total bilirubin (tsb)≤1.5×upper limit of normal value (uln), * creatinine≤1.5×upper limit of normal value (uln). * no other medications have been received for intestinal polyps within 3 months prior to the clinical trial. * patients participate in the trial voluntarily and have signed the informed consent by the participant or his/her legal guardian. exclusion criteria: * patients underwent a surgery within 2 weeks. * patients may need emergency surgery in the near future. * patients are allergic to any ingredient of rapamycin. * patients suffer from a disease requiring immediate blood transfusion. * patients suffer from any disease or condition that may impact implementation of the study or interpretation of the results. this type of diseases includes: * known severe blood coagulation disorders * known anemia that is not caused by intestinal polyps * known hemoglobinopathy * other gastrointestinal infectious diseases * serious heart, liver, kidney and other concomitant diseases that may endanger lives * patients are in pregnancy and lactation. * alcohol or drug (such as aperient) abuse * patients took part in another clinical trial that may influence this study. * the researchers believe that there are other unfavorable reasons for the patient to become a subject.

Keywords: peutz-jeghers syndrome (pjs) rapamycin (sirolimus) mammalian target of rapamycin (mtor) inhibitor treatment
study of exercise to manage distress during breast screening

Conditions: Breast Cancer; Anxiety; Depression

Summary: the breast cancer screening and diagnostic period is associated with heightened symptoms of anxiety and depression. physical exercise has been found to effectively decrease these symptoms in healthy and diseased populations. this study aims to determine if a pre treatment exercise intervention can minimize symptoms of anxiety and depression in women undergoing screening for breast cancer.

the breast cancer diagnostic process is associated with anxiety and depression. physical exercise has emerged as an attractive non-pharmacologic approach to mitigating the psychological and physical sequelae of breast cancer and its treatments, however pre treatment interventions are not integrated into current practice. this study aims to determine the effectiveness and feasibility of a pre treatment exercise intervention in attenuating levels of anxiety and depression following breast biopsy and throughout the diagnostic period.

Eligibility criteria:
inclusion criteria: * undergoing breast biopsy at st. joseph's health care, london ontario * minimum bi-rads 4a * physically inactive exclusion criteria: * meeting health canada guidelines for physical activity for past 6 months * medical contraindications to exercise * unable to participate in moderate intensity exercise program

Keywords: anxiety depression exercise breast cancer biopsy screening diagnosis
long-term effect of the physical activity promotion on the clinical characteristics and vascular risk in patients with mild-moderate obstructive sleep apnea

Conditions: Sleep Apnea

Summary: main objective: to assess the effect of the daily physical activity promotion with a pedometer during 12 months on the apnea-hypopnea index (ahi) in patients with mild to moderate obstructive sleep apnea (osa). study patients. subjects 30-80 years old with diagnosis of mild-moderate osa (ahi: 5-30 and predominance of obstructive events \[\>80%)\]. design. randomized, parallel and open-label clinical trial, controlled with conventional treatment. intervention: patients will be randomized (1:1) to control group \[treatment and follow-up according to conventional clinical practice\] or intervention group \[in addition to conventional treatment and follow-up, the patients will receive a pedometer to measure the number of steps walked daily. based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol (\ 10000 steps/day: maintain or increase steps). measurements. at , 12, 24 and 52 weeks of randomization, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms, comorbidities, current medication); questionnaires (ess, fosq, sf-12, euroqol and ipaz); heart rate and blood pressure; analytical determinations (hba1c, homa index, cholesterol, ldl-cholesterol, hdl-cholesterol, triglycerides, homocysteine, nt-probnp and hscrp); plasmatic biomarkers (8-isoprostane, il1beta, il6, il8 and tnfalpha); and evaluation of daily physical activity using an accelerometer.


Eligibility criteria:
inclusion criteria: * age from 30 to 80 years * diagnosis of mild-moderate obstructive sleep apnea \[apnea-hypopnea index 5-30 h-1\] by polysomnography or respiratory polygraphy * predominance of obstructive events (\> 80%) * signature of informed consent exclusion criteria: * previous diagnosis of chronic obstructive pulmonary disease, asthma, diffuse interstitial lung disease or chest wall disease. * evidence of central apneas, hypoventilation syndrome or respiratory failure * previous diagnosis of refractory arterial hypertension, congestive heart failure, ischemic heart disease or cerebro-vascular disease. * neurological or osteoarticular limitation that prevents ambulation. * professional drivers or occupational risk or respiratory * previous treatment with cpap * participation in another clinical trial in the 30 days prior to randomization.
effects of pioglitazone treatment on sympathetic nervous system function in metabolic syndrome obesity

Conditions: Metabolic Syndrome

Summary: an abdominal distribution of fat is associated with the greatest heart disease risk, because commonly, several risk factors of metabolic origin cluster in these individuals. when this occurs the condition is called the 'metabolic syndrome'. increased activity of the sympathetic nervous system resulting in enhanced release of the stress hormone 'noradrenaline', may be one mechanism by which adverse cardiovascular and metabolic sequela of the metabolic syndrome might be mediated. impaired insulin action may be one factor contributing to increased noradrenaline release. the aim of this study is to determine whether treatment with a drug called pioglitazone which is known to improve insulin action, results in reduced sympathetic nervous system activity and stress hormone release when compared to treatment with a dummy drug (placebo).

the rapidly growing burden of obesity together with a population that is becoming older raises the importance of effective strategies for the primary prevention and treatment of the metabolic syndrome in order to combat the epidemic of type 2 diabetes and to reduce the increased risk of cardiovascular mortality. increased sympathetic nervous system activity may participate in the pathogenesis and complications of the metabolic syndrome. this study will use a randomised controlled design to evaluate the effects of pioglitazone treatment on sympathetic activity in middle-aged subjects with the metabolic syndrome.the results will generate new information on the neuroadrenergic effects of thiazolidinediones in this clinical setting. this is relevant to the understanding of the pathophysiology of the metabolic syndrome and to its clinical management.

Eligibility criteria:
inclusion criteria: * males and females aged 45-65 years, * non-smokers, * homa index \> 2.5 and * who meet atp iii criteria for the metabolic syndrome exclusion criteria: * history of diabetes, * previous mi, stroke, heart failure, impaired hepatic or renal function. * inability to cease medications which may affect study parameters.

Keywords: sympathetic nervous system, pioglitazone, metabolic syndrome
multi-center mrd registry for inflammatory breast cancer

Conditions: Breast Cancer

Summary: to collect data from participants with ibc who may have had mrd testing and may have surgery in the future.

primary objectives -to determine the incidence of protocol specified pre-surgery mrd-positivity in ibc (assessment between completion of planned systemic therapy and surgery). secondary objectives * to establish the feasibility of multi-institutional mrd data collection using standard of care signatera analysis in ibc participants. * to evaluate the association of pre-surgery mrd to pathologic response. * to evaluate participant reported qol for worry about recurrence based in participants receiving mrd results * to establish protocol-optional baseline and longitudinal mrd data collection in ibc participants and report the frequency of mrd longitudinally * to determine the median lead time between the first mrd-positive result and clinical recurrence. * to determine whether adjuvant therapies decrease the amount of mrd in participants, and the association with relapse.

Eligibility criteria:
inclusion criteria: * female or males ≥18 years of age with the ability to understand and sign a written * participants who have a clinical diagnosis of stage iii or iv inflammatory breast cancer (ibc). * participants who are planning to have or already completed a minimum of one blood draw for signatera testing, for which the result and clinical data can be deposited into the study database. * participants must be within eight months of diagnosis and have not undergone breast surgery for this diagnosis of breast cancer. * participants must be english-speaking. exclusion criteria: -
study to evaluate biological & clinical effects of significantly corrected cftr function in infants & young children

Conditions: Cystic Fibrosis

Summary: this is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (cftr) modulators and their impact on children with cystic fibrosis (cf).

this is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (cftr) modulators and their impact in children with cystic fibrosis (cf) on endocrine growth factors and height, gastrointestinal function and gut microbiome, lung function and respiratory microbiome, liver and pancreatic function, sweat chloride, inflammatory markers, and bone health. total duration of the study is expected to be 10 years. part a will be a prospective cross-sequential study to describe the natural history of hormonal growth factors in early childhood and assess the feasibility of additional measurements. in part a, subjects will have up to 8 visits over a period of up to 5 years. part b will be a prospective longitudinal study to observe the effects of administration of either ivacaftor or elexacaftor/tezacaftor/ivacaftor (elex/tez/iva) on growth. in part b, subjects will have 1 "before ivacaftor or elex/tez/iva" visit within 30 days before initiation of the therapy and 8 "after ivacaftor or elex/tez/iva" visits over a 60-month follow-up period.

Eligibility criteria:
inclusion criteria: * part a: * less than 10 years of age at the first study visit. * documentation of a cf diagnosis. part b: * participated in part a or less than 7 years of age at the first study visit. * documentation of a cf diagnosis. * cftr mutations consistent with fda labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor). * physician intent to prescribe ivacaftor or elexacaftor/tezacaftor/ivacaftor. exclusion criteria: * part a and part b: * use of an investigational drug within 28 days prior to and including the first study visit. * use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 28 days prior to and including the first study visit. * use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.

Keywords: cystic fibrosis cf cftr modulator triple combination therapy elexacaftor tezacaftor ivacaftor
retrospective prospective multicentric clinical follow up of patients after being treated with tricvalve®

Conditions: Tricuspid Regurgitation; Tricuspid Valve Insufficiency; Tricuspid Insufficiency; Heart Failure; Heart Diseases; Heart Valve Diseases

Summary: retrospective prospective multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the tricvalve® transcatheter bicaval valves system.

the study shall enrol subjects who were treated with the tricvalve® transcatheter bicaval valves system® in the inferior vena cava and superior vena cava. on compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study. the study duration for the individual subject will be up to 5 year follow up. the follow-up should be made through pre-established periodic clinical consultations at discharge, 1 month, 6 months, 1 year follow up to 5 years after the procedure. in the consultations, routine exams such as hemogram, renal function, electrocardiogram and echocardiography in order to ascertain the bioprosthesis functioning and its hemodynamic profile are documented as per clinical routine practise.

Eligibility criteria:
inclusion criteria: * successful treatment with tricvalve transcatheter bicaval valves system * patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent exclusion criteria: * no exclusion criterion

Keywords: cardiovascular disease
a cohort of patients with possible or confirmed sars-cov-2 (covid-19)

Conditions: SARS-CoV-2; COVID-19

Summary: sarv-cov-2 infection was considered pandemic on march 11, 2020. the sarv-cov-2 epidemic affected france from the beginning of march, spreading in particular from a 4-day large evangelical meeting of 2500 people on february 17 in the city of mulhouse (north east of france). the montpellier university hospital has set up a clinical pathway for people suspected of being infected with sarv-cov-2 because of signs compatible with pneumonia (screening criteria in france during the study period). this includes an emergency department, an infectious disease department dedicated to the surveillance of infected people requiring hospital treatment, and an intensive care unit for the most severe cases. the diagnosis of infection with sarv-cov-2 was confirmed in approximately 20% of people initially referred in this special care system. the main objective of this cohorte is the collection of clinical data and biological samples from care for non-interventional research on the patients with a possible or confirmed sars-cov -2 infection, from diagnosis to long-term follow-up.


Eligibility criteria:
inclusion criteria: - patients care at the montpellier university hospital suspected of a covid-19 infection exclusion criteria: * patient opposed to the use of his data for research purposes * patient deprived of liberty by judicial decision * patient not affiliated to a social security scheme

Keywords: presence of covid-19 symptoms covid-19 infection
an rct of nbi vs. white light guided endobronchial biopsy in suspected sarcoidosis

Conditions: Sarcoidosis, Pulmonary

Summary: in the diagnosis of patients with sarcoidosis, there is paucity of literature on the diagnostic yield of the endobronchial biopsies obtained with narrow band imaging (nbi) bronchoscopy. the present study aims to compare the diagnostic yield of endobronchial biopsyperformed under direct narrow band imaging or white light bronchoscopy guidance in suspected sarcoidosis.we hypothesize that the use of nbi will improve the yield of endobronchial biopsy in patients with sarcoidosis.

the present study will be a randomized controlled trial. it will be performed in the bronchoscopy suite of the department of pulmonary medicine, pgimer. subjects meeting the selection criteria will be randomized 1:1 to undergo ebb under real-time visualization with nbi or white light bronchoscopy. the randomization sequence will be computer generated and the study group allocations will be placed in opaque sealed envelopes. they will be opened just before the performance of the bronchoscopic procedures. primary outcome:the diagnostic yield of ebb (demonstration of granulomatous inflammation in ebb specimen, in subjects with a final diagnosis of sarcoidosis) secondary outcomes: 1. complications related to the procedure (bleeding) 2. duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)

Eligibility criteria:
inclusion criteria: 1. age more than 18 years. 2. clinical presentation and radiological findings (enlarged hilar and or mediastinal lymph nodes \>10 mm \[short axis\], and/or perilymphatic nodules or peribronchovascular thickening on computed tomography \[ct\] chest) suggesting sarcoidosis. 3. willing to give informed consent. exclusion criteria: 1. hemodynamic instability (systolic bp \<100 mm hg). 2. pregnancy. 3. treatment with systemic glucocorticoids for more than three weeks in the preceding three months. 4. diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy.
a study of axl inhibitor fc084csa in patients with advanced malignant solid tumors

Conditions: Advanced Malignant Solid Tumors

Summary: this is a phase i clinical study to evaluate safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of axl inhibitor fc084csa in patients with advanced malignant solid tumors who have failed standard anti-cancer treatment.

fc084csa accelerated doses at 100mg qd, and then started the conventional "3+3" design from 200mg qd.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 75 years old male and female. 2. patients with advanced malignant solid tumors who have failed standard treatments. 3. according to recist 1.1, there is at least one measurable lesion. 4. ecog performance status 0-1. 5. laboratory examination should meet: ① blood routine: hemoglobin (hgb) ≥85 g/l, neutrophil count (anc) ≥1.5×10\^9/l, platelet count ( plt) ≥75×10\^9/l; ②blood biochemistry: total bilirubin (tbil) ≤1.5×upper limit of normal (uln), alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤3.0×uln, serum creatinine ( cr)≤1.5×uln or calculate the creatinine clearance ≥50 ml/min according to the cockcroft-gault formula method. exclusion criteria: 1. not recovered from the adverse reactions caused by previous anti-tumor treatments (≥ctcae grade 1). 2. received anti-tumor therapy within 4 weeks before enrollment. 3. participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period. 4. have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started. 5. patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods. 6. central nervous system metastases with clinical symptoms. 7. with any situations that the researcher considers inappropriate to participate in this research.
effect of music in intraoperative period

Conditions: Music Therapy; Perioperative Care; Postoperative Pain; Anxiety; Total Knee Arthroplasty; Vital Signs; Spinal Anesthesia

Summary: background and aims: music therapy has a wide range of uses in health care practice. the aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status. methods: the study was performed in an operating room with a total of 90 patients, of whom 30 were in the music group, 30 were in the control group and 30 were in the sedated group. the ethics committee's approval, institutional permission, and the study participants' written informed consent were obtained. data were collected using patient information and intraoperative observation form for vital signs as well as through the visual analog scale and state anxiety scale. preoperative and postoperative anxiety, the intraoperative and postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.


Eligibility criteria:
inclusion criteria: * the patients that had an orthopedic operation * the patients who took spinal anesthesia * able to understand, read and speak turkish, so they may complete the informed consent and questionaires * aged 18 or older * have a body mass index (bmi) \<40 * asa (american society of anaesthesiologists) i-ii-iii statuses. exclusion criteria: * patients with vision and hearing problems and inability to complete questionnaires, * the patients not have psychiatric disease history and psychiatric drug use, * the patients not have diseases that could be evaluated as severe (such as heart, kidney, liver failure) * the patients not underwent emergency surgeries

Keywords: music therapy perioperative care postoperative pain anxiety total knee arthroplasty vital signs spinal aesthesia
impact of mirabegron on erectile function in bph patients

Conditions: Males With Benign Prostatic Hyperplasia Symptoms

Summary: evaluation of impact of mirabegron on erectile function for patients treated for bph

50 patients (group a) will receive mirabegron \& alpha blocker 50 patients (group b) will receive alpha blocker only evaluation using iief 5 scoring system

Eligibility criteria:
inclusion criteria: * all males above age 50 with luts due to bph not candidate for prostatectomy exclusion criteria: * males below age 50 * neurologic abnormality * any indication for prostatectomy * abnormal bladder contractility i.e diabetics
the clinical effect of hip protection orthosis for the hip protection of hip dislocation in patients with severe neuromuscular disease, pilot study

Conditions: Cerebral Palsy

Summary: the clinical effect of hip protection orthosis for the hip protection of hip dislocation in patients with severe neuromuscular disease


Eligibility criteria:
inclusion criteria: * age from 1 to 15 * patients with severe neuromuscular disease * patients who agreed to participate in the study * hip dislocation more than 10% (migration index) exclusion criteria: * if do not agree with the study * those who are determined to be difficult to participate under the judgment of the research director * history of hip joint surgery