Kornimate/medical-research-clean huggingface dataset:
aggressive thoracic radiotherapy for stage ⅳ non small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung; Stage IV; Thoracic Radiotherapy

Summary: this phase ii trial studies the safety and efficacy of aggressive thoracic radiotherapy in treating patients with non-small cell lung cancer that has not progressed after the first line systemic therapy. in this trial, patients with stage ⅳ non small cell lung cancer who did not progress after first line systemic therapy will receive the aggressive thoracic radiotherapy, and the safety and efficacy of aggressive thoracic radiotherapy will be evaluated. the primary end points of the study are overall survival (os), the secondary end points are local control rate, local progression free survival(lpfs), pfs, and toxicity and quality of life(qol).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed nsclc * stage iv disease * no progression after first line systemic therapy * 18 to 80 years of age * karnofsky performance status(kps) score ≥70% * no contraindications to radiation therapy * presumed ability to tolerate thoracic radiation therapy to a bed≥53gy exclusion criteria: * a history of thoracic surgery, radiation therapy, or more than first line chemotherapy * pregnancy or lactation at the time of enrollment * previous malignancy or other concomitant malignant disease
risk stratification and new early prevention and treatment strategies for patients with cardiomyopathy (strength）

Conditions: Cardiomyopathies

Summary: this study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. by collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment.

this study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. by collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * age \>18 years old. * the diagnosis of cardiomyopathy was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing. * patients or their families agreed to participate in the study and authorized informed consent. exclusion criteria: * incomplete clinical data. * do not agree to the inclusion or refuse to authorize the informed consent.

Keywords: cardiomyopathies prognostic factors
calculating of correlations between adr, pdr, map

Conditions: Colon Neoplasm

Summary: the aim of our study is to compare map (mean adenoma per colonoscopy) with adr (adenoma detection rate) and pdr (polyp detection rate) of all colonoscopists in our department

adr (adenoma detection rate) is generally accepted quality indicator. for possible gaming with adr other indicators are needed. map (mean adenoma per colonoscopy) reflects the quality of examination of entire colon and is considered to be the most objective quality indicator. the aim of our study is to compare map with adr and pdr (polyp detection rate) of all colonoscopists in our department. we want to retrospectively assess the quality indicators of all colonoscopies from january 2013 to december 2017. we want to calculate adr, pdr and map of all our endoscopists for all colonoscopies in patients over 50 years of age excluding therapeutic, ibd, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. correlations between map/adr and map/pdr will be performed using pearson´s correlation coefficient.

Eligibility criteria:
inclusion criteria: * people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic) exclusion criteria: * age under 50 years * indication for colonoscopy: therapeutic, ibd, management of complications and sigmoidoscopies
ecopipam tablets to study tourette's disorder in children, adolescents and adults

Conditions: Tourette Disorder

Summary: this phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of tourette's disorder (td). the study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.

following a 28-day screening period and baseline visit, eligible subjects will be enrolled into the open-label stabilization period comprised of a 4-week titration phase to achieve a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam hcl) followed by an 8-week open-label maintenance phase. responders to ecopipam will be randomized to ecopipam 1.8 mg/kg/day (2 mg/kg/day ecopipam hcl) or placebo in a 1:1 fashion and enter the double-blind randomized-withdrawal (r/wd) period at week 12. during the 12-week r/wd period, any subject meeting relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

Eligibility criteria:
inclusion criteria: * ≥ 6 years of age * ≥ 18 kg (\~ 40 lbs.) * td diagnosis and both motor and vocal tics that cause impairment with normal routines * minimum score of 20 on the ygtss-r total tic score * may not be taking any medications used to treat motor or vocal tics for at least 14 days prior to baseline. * effective contraception during the study and 30 days after last study dose for sexually active subjects exclusion criteria: * previous exposure to ecopipam * certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder) * unstable unstable medical illness or clinically significant lab abnormalities * risk of suicide * pregnant or lactating women * moderate to severe renal insufficiency * hepatic insufficiency * positive urine drug screen * unstable doses for drugs to treat anxiety, depression, attention deficit hyperactivity disorder * certain medications that would lead to drug interactions * recent behavioral therapy
atgam general investigation

Conditions: Aplastic Anemia

Summary: the objective of this study is to confirm the safety of atgam in patients with moderate to severe aplastic anemia under the actual use in japan. the registration criteria is patients with moderate to severe aplastic anemia who receive atgam. the observation period is 24 weeks (6 months) from the start of administration (day 1). however, in cases where treatment has been completed or discontinued less than 24 weeks after the start of administration, observation is continued until completion (discontinuation) of treatment.


Eligibility criteria:
inclusion criteria: * patients with moderate to severe aplastic anemia who receive atgam exclusion criteria: * no exclusion criteria is set out in this study.

Keywords: atgam; anti-human thymocyte immunoglobulin, equine; aplastic anemia;
agonist versus classical hcg trigger (poor responders, normoresponders and high responders)

Conditions: Ovulation Induction; In Vitro Fertilization (IVF); Infertility, Female; Oocytes

Summary: agonist triggering in controlled ovarian stimulation protocols is being used during last years (among high responder patients to avoid ohss). indeed, agonist triggering is more physiologic than hcg triggering. investigators propose to compare the effectiveness of both types of trigger among three different subsets of patients: 1. poor responders. 2. normo-responders 3. high responders comparing both the number and the quality of achieved oocytes.

during the last years, ovulation triggering in controlled ovarian stimulation protocols has been used specially to avoid hyperstimulation syndromes (ohss). indeed, the substitution of the classical hcg triggering by the agonist one, reduces almost to zero the risk of ohss. on the other hand poor responder patients to ovarian stimulation represent a challenge in assisted reproduction. defining poor responders is not easy, but we can define them as those patients with less than 4 eggs obtained after oocyte retrieval. different strategies have been proposed to overcome this problem. in other words, to obtain more oocytes. these include an increase in fsh doses, an increase in fsh action by adding sensitizers agents. among the possible strategies, investigators propose the agonist triggering. hcg (classical) triggering represents the use of a lh-like product (with a prolonged action). the administration of a gnrh agonist provoke the production and liberation of both fsh and lh. thus, the pro-ovulatory action is more physiologic , and possibly, more effective. so, the use of a triggering protocol that nowadays is being used among high responders (thus reducing the ohss risk) is proposed for both poor responder and normo-responder patients trying to achieve more oocytes, and specifically more mature oocytes.

Eligibility criteria:
inclusion criteria: * women scheduled for ivf treatment. * first ovarian stimulation * two ovaries present * no previous ovarian surgery * no contraindication for any of the assigned treatments exclusion criteria: * previous ovarian surgery. * previous ivf treatments. * absence of one ovary * presence of an endometrioma

Keywords: agonist trigger ovulation induction controlled ovarian stimulation (cos) poor responder
intra-articular injection: a innovational approach for joint disorder

Conditions: Temporomandibular Joint Dysfunction

Summary: the goal of this clinical trial is to study about the clinical effect of intra-articular injection on temporomandibular joint dysfunction the main question it aims to answer is: • can intra-articular injection help improve the temporomandibular joint dysfunction participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. the experimental group will be given intra-articular injection additionally, the study lasts 15 days for each patient. researchers will compare the assessments between the two groups to see if intra-articular injection can help improve the temporomandibular joint dysfunction

the background of temporomandibular joint dysfunction is that it is one of the common diseases in the oral and maxillofacial region, and it is the most common among temporomandibular joint diseases. it is more prevalent in young adults, with the highest prevalence rate at 20-30 years old. the goal of this clinical trial is to study about the clinical effect of intra-articular injection on temporomandibular joint dysfunction the main question it aims to answer is: • can intra-articular injection help improve the temporomandibular joint dysfunction participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. the experimental group will be given intra-articular injection additionally, the study lasts 15 days for each patient. researchers will compare the assessments between the two groups to see if intra-articular injection can help improve the temporomandibular joint dysfunction

Eligibility criteria:
inclusion criteria: * presence of significant temporomandibular disorder clinical symptoms. * meeting the diagnostic criteria for temporomandibular joint dysfunction and confirmed by x-ray examination. * patients voluntarily participate in this study and provide signed informed consent. * normal cognitive function exclusion criteria: * rheumatic, rheumatoid, or other severe systemic diseases. * infectious temporomandibular joint arthritis or joint tumors. * individuals who have recently received joint injection treatment or photodynamic therapy.
treatment for specific phobias in children

Conditions: Phobic Disorders; Anxiety Disorders

Summary: this study will compare the effectiveness of three treatments in reducing symptoms of phobia in children and adolescents.

children with specific phobias may experience academic, social, and personal distress, as well as interference in day-to-day activities. one-session treatment has been found a rapid and effective treatment for adults with phobic disorders. however, its utility in the treatment of childhood phobia has not been examined. participants are randomly assigned to 1 of 3 groups: a one-session treatment group, an education/support group, and a waitlist control group. the one-session treatment group is directly exposed to a phobia object or situation during a 3-hour treatment session. in the education/support group, children are given information about fear and phobias and are taught how to deal with them through workbook activities. children who participate in the one-session treatment group or the education/support group are assessed 1 week post-treatment and again after 6 months. participants with improved symptoms have a 1-year follow-up. participants with phobias that persist at 6 months are encouraged to participate in alternative treatment. waitlist control participants are assessed pre-treatment and 1 month post-treatment. those who continue to have phobias at the 1-month assessment are randomly assigned to 1 of the 2 active treatments.

Eligibility criteria:
inclusion criteria: * primary diagnosis of specific phobia disorder exclusion criteria: * mental retardation * developmental disabilities * suicide threat
a study to evaluate the effects of rad1901 in the treatment of vasomotor symptoms in postmenopausal women

Conditions: Hot Flashes

Summary: the purpose of this study is to determine whether rad1901 is effective in decreasing hot flashes in postmenopausal women.


Eligibility criteria:
inclusion criteria: 1. have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week. 2. be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities. 3. have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound. 4. have a normal mammogram at the time of study screening. exclusion criteria: 1. a history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. a history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders. 2. a history of active presence of stroke, transient ischemic attack (tia), heart attack or ischemic heart disease. 3. unexplained vaginal bleeding within the 3 months prior to study entry.

Keywords: hot flashes hot flushes vasomotor symptoms postmenopausal
high intensity interval training in chronic heart failure

Conditions: Chronic Heart Failure; Cardiac Rehabilitation

Summary: the aim of this study is to investigate the effect of high-intensity interval training and moderate intensity continuous training on cardiopulmonary functions in chronic heart failure.

enroll chronic heart failure patients into 3 randomized controlled group * high intensity interval training * moderate intensity continous training * control perform cardica rehab for 12 weeks, compare primary and secondary endpoints between baseline and 12 weeks results

Eligibility criteria:
inclusion criteria: * medically stable chronic heart failure * nyha ii-iii * can perform cardiopulmonary exercise test * after 3months with proper medication * age 30 to 70 * ejection fraction\< 40% exclusion criteria: * contraindication to cardiopulmonary exercise test * musculoskeletal problem who cannot perform cardiopulmonary exercise test * cognition deficit who cannot understand directions * severe medial illness
cocktail injection improves outcomes of ffr guided pci

Conditions: Acute Coronary Syndromes

Summary: this is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (ffr) measurement when guiding percutaneous coronary intervention (pci) in patients with acute coronary syndrome (acs).

this is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (ffr) measurement when guiding percutaneous coronary intervention (pci) in patients with acute coronary syndrome (acs). patients with acs will be randomized into the cocktail plus ffr guided group or the qca guided group. the primary outcome of the cocktail ii study is the composite of death, myocardial infarction, class iv heart failure and target vessel revascularization within 1 year. the secondary outcome of the cocktail ii study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of recent acs within 5 days exclusion criteria: * haemodynamic instability * intolerance to anti-platelet drugs * ineligible for coronary revascularization * a treatment plan for non-coronary heart surgery (e.g. valve surgery) * a history of prior pci or cabg * angiographic evidence of severe (e.g. diffuse calcification) or mild (\<30% severity) coronary disease * a life expectancy less than 1 year * adenosine allergy

Keywords: acute coronary syndromes fractional flow reserve percutaneous coronary intervention
endoscopy and endomicroscopy for assessment of mucosal healing in inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Summary: inflammatory bowel disease (ibd) encompasses two major forms of chronic intestinal disorders, crohn's disease and ulcerative colitis (uc). diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. confocal laser endomicroscopy (cle) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure. the main objective of this study is to determine endoscopic and endomicroscopic features of mucosal healing in patients with ibd.


Eligibility criteria:
inclusion criteria: * written informed consent * age 18-85 years * ability of subjects to understand character and individual consequences of clinical trial * subjects undergoing colonoscopy exclusion criteria: * inability to provide written informed consent * severe coagulopathy (prothrombin time \ 50 s) * pregnancy or breast feeding * active gastrointestinal bleeding * residing in institutions (e.g. prison) * known allergy against fluorescein

Keywords: mucosal healing
ak112 combined with chemotherapy versus durvalumab combined with chemotherapy in advanced biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: this is a phase 3 study. all subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (btc), eastern cooperative oncology group (ecog) performance status 0-1. the purpose of this study is to evaluate the efficacy and safety of ak112 in combination with chemotherapy versus durvalumab in combination with chemotherapy in patients with unresectable locally advanced or metastatic btc.


Eligibility criteria:
inclusion criteria: * be able and willing to provide written informed consent. * has an eastern cooperative oncology group (ecog) performance status of 0 or 1. * has a life expectancy of at least 3 months. * has a histologically or cytologically confirmed diagnosis of biliary tract cancer (btc). * has no prior systemic anti-tumor therapy for unresectable locally advanced or metastatic btc. * has measurable disease based on response evaluation criteria in solid tumors (recist) v1.1. * has adequate organ function. exclusion criteria: * has other malignancies within 5 years prior to enrollment. * is currently participating in a study of an investigational agent or using an investigational device. * has known active central nervous system (cns) metastases. * has an active autoimmune disease that has required systemic treatment in the past 2 years. * has an active infection requiring systemic therapy. * has known active hepatitis b or hepatitis c. * history of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to enrollment. * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * has received a live virus vaccine within 30 days of the planned first dose of study therapy. * has any concurrent medical condition that, in the opinion of the investigator, would complicate or compromise compliance with the study or the well-being of the subject.
a study on the effect of mepolizumab therapy on daily physical activity of patients with severe eosinophilic asthma

Conditions: Severe Eosinophilic Asthma

Summary: daily physical activity in adult patients with asthma remains overlooked. limited evidence demonstrates reduced levels of daily physical activity in asthma populations but studies examining the potential effect of available therapies are missing. this study aims to investigate the overall levels of daily physical activity in patients with severe eosinophilic asthma and whether anti-interleukin-5 therapy with mepolizumab, on top of existing, maximal, and optimised asthma treatment, may improve patient's daily physical activity.

a multi-centre, prospective, observational study of continuous patients who fulfil the definition of severe asthma and the criteria for mepolizumab (nucala; gsk) therapy. patients have their daily physical activity recorded using triaxial accelerometry (dynaport movemonitor; mcroberts) prior to treatment, and at 6 and 12 months of mepolizumab therapy (100 mg subcutaneously once every 4 weeks).

Eligibility criteria:
inclusion criteria: 1. severe asthma 2. criteria for mepolizumab therapy: blood eosinophils ≥150 cells/μl at screening or ≥300 cells/μl in the past 12 months. exclusion criteria: comorbidities limiting physical activity

Keywords: severe asthma biologic therapy physical activity monitoring
mic cell therapy for individualized immunosuppression in living donor kidney transplant recipients

Conditions: Kidney Failure, Chronic

Summary: a phase- i clinical trial to determine safety and feasibilty of intravenous administration of mitomycin c-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage kdigo 4 or 5 (i.e. gfr 15-30 ml/min or \< 15 ml/min) who receive a kidney transplant from a living donor.


Eligibility criteria:
inclusion criteria: * chronic kidney disease stage kdigo 4 or 5 * first kidney transplant from a living donor * age ≥ 18 years * abo compatible * cdc-pra \< 20% * no donor-specific antibodies * negative cdc and elisa crossmatch * immunosuppression with cyclosporin a, ec-mps and methylprednisolone * informed consent * adequate contraception (women with child bearing potential) exclusion criteria: * psychiatric disorder * heart failure (nyha iii or iv) * severe liver disease * active hepatitis b or c or hiv infection * active bacterial, fungal or viral disease * malignancy or malignancy in the last 5 years before screening * preexisting immunosuppression * vaccination with a live vaccine in the last 3 months before screening * s/p splenectomy * substance abuse * pregnancy or lactation * women: child/pregnancy with the intended donor * allergy against the investigational drug or part of it * other diseases that prohibit participation in the study (in the opinion of the investigator) * participation in an other interventional study