Kornimate/medical-research-clean huggingface dataset:
cik in treating patients with esophageal cancer

Conditions: Esophageal Squamous Cell Carcinoma

Summary: chemotherapy is the main treatment method for patients with esophageal cancer. however, relapse remains the major cause of treatment failure.biological therapies such as cik stimulate the immune system and stop tumor cells from growing. a series of studies reported that cytokine-induced killer cells (cik) have a broad anti-tumor spectrum. the investigators suppose that cik will improve the prognosis. combining chemotherapy with biological therapy may kill more tumor cells. in this study, the patients will be treated with cik cells after chemotherapy. the purpose of this study is to evaluate the efficacy of cik for esophageal cancer.

about 2000 patients with staging i-iii of esophageal cancer, after accepting chemotherapy, will be randomly divided into group a (receive cik treatment) or group b (just regularly follow up), and the randomize ratio will be 1:1. patients in group a will receive 3 cycles of cik cells treatment (every 12 weeks). patients in group b will have no anti-tumor therapy.

Eligibility criteria:
inclusion criteria: * patients histologically confirmed esophageal carcinoma; * patients with staging i-iii of esophageal carcinoma; * patients who had completed chemotherapy; * patients who have a life expectancy of at least 12 weeks; * eastern cooperative oncology group (ecog) performance status was 0-1; * the bone marrow functioned normally (wbc\>4.0×10\^9/l, hb\>120 g/l, platelet(plt)\>100×10\^9/l); * the ecg results were normal, and the liver and kidney were functional. exclusion criteria: * patients who had distant metastases by imaging studies; * patients with uncontrolled infection; underlying disease that was severe or life-threatening; * patients who were lactating; * ecog perform status ≥ 2; * patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment; * patients who are pregnant or nursing; * patients with active tuberculosis (highly positive skin tests allowed if no active disease); * patients with disease that would preclude general anesthesia; * patients with active intractable or uncontrollable infection.
the rhytmia system to determine the precise location and potential mechanism of premature contractions

Conditions: Cardiac Arrhythmia; Cardiomyopathy, Dilated

Summary: this is a purely observational project and the objectives are to record and analyze the local potentials at the site of premature ventricular contraction (vpc) focus through the rhythmia system, ti determine the short and long-term success of the procedure and compare it to the existing literature about standard procedures, to highlight the advantages of the system compared to conventional mapping and to characterize optimal pace map or activation map as achieved by the rhythmia system.

this is a purely observational study. no special methodology choice, no comparison. the study want to find the determination of precise location of the focus and mechanisms involved constitutes a challenge for conventional electrophysiology, even with tridimensional systems, because of the time needed for accurate delineation of the location (due to the sometimes unfrequent ventricular premature beats (vpb)) and to the insufficient mapping density or inadequate signal characteristics. the rhythmia system could allow better determination of the focus location in relation to the anatomical structures, especially with unfrequent vpb, because of the available high density mapping due to the number of closed high-resolution electrodes located on the orion catheter. better delineation of the true focus origin and of the mechanisms involved (automaticity vs re-entry) may be of useful help for better understanding and efficient therapy.

Eligibility criteria:
inclusion criteria: * patients with symptomatic monomorphic pvc with or without heart disease refractory to anti arrhythmic drugs * patients with dilated cardiomyopathy and altered left ventricular ejection fraction (lvef) suspected to be causes by frequent monomorphic vpc * patients with malignant ventricular arrhythmias reproducibly induced by monomorphic pvc exclusion criteria: * patients with non-symptomatic vpc and without cardiomyopathy * patients under 18 yo * pregnant women * patients with polymorphic pvc arising from clearly different areas * patient protected by the french law: guardianship and trusteeship

Keywords: rythmia system
a study to assess the efficacy and safety of risankizumab in participants with ulcerative colitis

Conditions: Ulcerative Colitis (UC)

Summary: the purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (uc) in participants who responded to induction treatment with risankizumab in a prior abbvie study of risankizumab in uc. this study consists of three sub-studies and a continuous treatment extension (cte): substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; substudy 2 is 52-week, randomized, exploratory maintenance study; and substudy 3 is an open-label long-term extension study for participants who completed substudy 1 or 2, or participants who responded to induction treatment in study m16-067 with no final endoscopy due to the covid-19 pandemic or due to the geopolitical conflict in ukraine and surrounding impacted regions. the cte is an open-label extension for substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.


Eligibility criteria:
inclusion criteria: - participants who have completed study m16-067 and have achieved clinical response as defined in the protocol. exclusion criteria: * participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (cho) or had an adverse event (ae) during studies m16-067 that in the investigator's judgment makes the participant unsuitable for this study. * participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study. * participant is not in compliance with prior and concomitant medication requirements throughout studies m16-067.

Keywords: abbv-066 bi 655066
portuguese registry with meril myval thv series - myportuval registry

Conditions: Aortic Valve Stenosis; TAVI(Transcatheter Aortic Valve Implantation)

Summary: a prospective, single-arm, multi-centre registry to evaluate the safety and performance of myval thv series using transcatheter aortic valve implantation (tavi) procedure in patients with symptomatic severe native aortic valve stenosis.


Eligibility criteria:
inclusion criteria: 1. patient over the age of 18 years with symptomatic aortic stenosis (severe as) who underwent tavi using myval thv series as assessed by heart team and investigator. 2. patient has provided written informed consent as approved by the ethics committee (ec) 3. patient is willing to undergo all registry procedures and follow-up requirements exclusion criteria: 1. patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media. 2. ongoing infective endocarditis or any similar infection. 3. pregnant or lactating females. 4. liver failure (child-pugh class b or c) 5. patient is currently participating in another clinical investigation where the primary endpoint has not been achieved. 6. any condition, which in the investigator opinion, would preclude safe participation of the patient in the registry.

Keywords: myportuval tavi portuguese tavi registry
long term effects and of a pulmonary rehabilitation maintenance program

Conditions: Chronic Respiratory Disease

Summary: chronic respiratory diseases are characterized by a progressive and long term deline. pulmonary rehabilitation (exercise training and therapeutic education) can improve several disease outcomes like dyspnea, exercise tolerance and health-related quality of life. after an inpatient pr program, maintenance program can stabilize the disease outcomes. however, maintenance program are heterogeneous and long term benefits (\>36 month) have been observed in only one study, which is not feasible in france. a realistic maintenance program as proposed by the french air+r network (http://airplusr.com/wordpress/) has only demonstrated benefits after 12 month. in addition, the time course of patients may be heterogeneous, with differens clusters that could be influenced by the clinical, functional and systemic determinants. in particular, the cellular muscle microenvironment could be deleterious for the muscle function in patients, caused by a "spill-over" of inflammatory pulmonary molecules in the systemic milieu.


Eligibility criteria:
inclusion criteria: patients with a chronic respiratory disease (copd, asthma, bronchiectasis , fibrosis, sleep apnea, ...) undergoing pulmonary rehabilitation (maintenance or inpatient) exclusion criteria: contraindication to exercise training

Keywords: pulmonary rehabilitation maintenance program cohort microenvironment long-term benefits
reliability and validity of the elderly mobility scale, french version

Conditions: Locomotor Activity; Functionally-Impaired Elderly; Frail Elderly

Summary: this study evaluates the reliability of the french version of the "elderly mobility scale" and its correlation with the "frailty elderly scale "

the research question: how to effectively measure the physical independence of the elderly at home and how, from this measure, the investigators can determine the fragility threshold of the elderly. the elderly mobility scale measures the critical points of the patient's physical autonomy. this scale was developed in great britain. the purpose of this study is to establish the reliability of this french version scale and to study the correlation with the elderly scale fragility. people are recruited by a medical consultant. after consent, their frailty is measured and a prescription is done to see a physical therapist. the physical therapist will evaluate the physical points measured/ mentioned in the elderly mobility scale, twice in a week, with two different assessors.

Eligibility criteria:
inclusion criteria: * living at home, more than 70 years old exclusion criteria: * current recovery for orthopaedic problems * cognition impairment * all acute problems with an impairment of mobility
a study of sc administration of trastuzumab (herceptin) by sid at home in her2-positive ebc participants

Conditions: Breast Cancer

Summary: this single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (sc) by a single-use injection device (sid) in participants with human epidermal growth factor receptor 2 (her2)-positive early breast cancer (ebc), following surgery and chemotherapy (neo-adjuvant or adjuvant).


Eligibility criteria:
inclusion criteria: * histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast * her2-positive disease * eastern cooperative oncology group (ecog) performance status 0-1 * hormonal therapy will be allowed as per institutional guidelines * prior use of anti-her2 therapy will be allowed * left ventricular ejection fraction (lvef) greater than or equal to (\>/=) 50 percent (%) * no evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant) * use of concurrent radiotherapy will be permitted * completion of surgery and chemotherapy (if applicable) exclusion criteria: * history of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for the last 5 years * participants with severe dyspnea at rest or requiring supplementary oxygen therapy * participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness * serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ecg), poorly controlled hypertension * pregnant or lactating women * women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment * concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment * known hypersensitivity to trastuzumab, murine proteins, to any excipients of herceptin, including hyaluronidase, or the adhesive of the sc device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma * inadequate hepatic or renal function
using fmri to evaluate instructional programs for children with developmental dyslexia

Conditions: Developmental Dyslexia

Summary: dyslexia is a common reading disorder. specialized instructional programs can improve reading ability in children with dyslexia. this study will use functional magnetic resonance imaging (fmri) to examine changes in the brains of children who have taken part in these programs.

reading is a uniquely human endeavor and failure to develop this skill can lead to serious educational and emotional consequences. reading more slowly or less accurately, as is the case in developmental dyslexia, occurs in between 5% and 15% of individuals in the united states. developmental dyslexia significantly interferes with academic achievement and with activities of daily living that require reading skills. although dyslexia is considered a reading disorder, dyslexia's clinical signs are varied and include deficits in the sensory domain, abnormal phonological awareness, and problems in related linguistic skills. phonological awareness training and visual perceptual training can improve reading ability in children with dyslexia. recent functional imaging studies on sensory and language processing in dyslexia have demonstrated involvement of the posterior temporal and inferior parietal cortical systems of the brain. however, how these brain areas are changed as a result of dyslexia treatment has not been determined. this study will investigate the neurophysiologic changes before and after treatment in 11- to 14-year-old children immersed in lindamood-bell training utilizing either phonological (lips) or visual (seeing stars) strategies. these training programs have successful behavioral outcomes, but neurophysiologic changes have not been evaluated. the study will determine whether behavioral changes in reading skills result in physiological differences in the brain identifiable with functional brain imaging and whether initial physiological observations are indicative of the degree of success of the intervention. participant will be randomized to receive either lindamood-bell training, a math intervention (active control), or no intervention (passive control). the intervention will last 6 weeks; children will have both pre- and post-intervention behavioral testing and fmri scans.

Eligibility criteria:
inclusion criteria * developmental dyslexia diagnosis * english speaking * right-handed * general good health exclusion criteria * metal implant, braces, or other device that prevents child from undergoing fmri

Keywords: reading brain imaging
evaluation of the safety, tolerability and efficacy of ezetimibe on a select population of filipinos with hypercholesterolemia (study p04748)(completed)

Conditions: Primary Hypercholesterolemia; Homozygous Familial Hypercholesterolemia

Summary: the purpose of this study is to evaluate the overall safety, tolerability, and efficacy of ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia


Eligibility criteria:
inclusion criteria: * outpatient men or women, age 18 years and above. * patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia. exclusion criteria: * known hypersensitivity to ezetimibe. * moderate to severe hepatic insufficiency. * persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal. * pregnancy or lactation. * concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
obese patients with untreated dyslipidemias

Conditions: Obesity; Dyslipidemia

Summary: to assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia


Eligibility criteria:
* bmi must be greater than 27 and less than 40 * patients with untreated dyslipidemia * stable weight (variation of less than 5 kg within 3 months prior to screening visit)

Keywords: obesity
sex and obesity: effects on heart failure study

Conditions: Obesity; Heart Failure

Summary: sex has a major impact on myocardial metabolism and blood flow. in those without heart failure men's hearts tend to use proportionally more glucose and women's hearts use more fat and have higher blood flow. obesity is a major risk factor for heart failure. in those without heart failure, increasing body mass index is predictive of increased blood flow and fatty acid metabolism in women, but not men. to measure blood flow and metabolism we used radioactive materials and a pet (positron emission tomography) scan to study the blood flow and substrate metabolism of the heart. hypotheses: 1) women with heart failure with reduced ejection fraction (hfref) will have higher levels of heart blood flow and fatty acid metabolism and lower glucose metabolism rates than men with hfref. a secondary aim was to test the hypothesis that body mass index (bmi), a measure of obesity, correlated with myocardial blood flow and myocardial metabolism measures in patients with hfref.


Eligibility criteria:
inclusion criteria * heart failure (hf) and a systolic ejection fraction \<45% per a recent echocardiogram report) * nonischemic hf new york heart association class ii-iii * ambulatory * able to give informed consent * on a stable medical regimen including the standard-of-care hf medications (i.e., a beta-blocker, ace-inhibitor or angiotensin receptor blocker \[arb\]) exclusion criteria * participants who were pregnant or lactating * actively losing weight * nonsedentary (performing aerobic exercise \> 30 minutes x 3 times/week) * those who have more than class i hypertension * those who require alterations in beta-blocker or ace or arb-inhibition medication * those with hypertrophic, constrictive, or restrictive cardiomyopathies * those unable to lie flat in the pet scanner * severe major organ system dysfunction (other than heart failure) * significant coronary artery disease by catheterization * those unable to give informed consent

Keywords: obesity heart failure pet (positron emission tomography) radiation metabolism
mentalization based treatment - introductory (mbt-i) group for male prisoners with borderline and/or antisocial personality disorder

Conditions: Borderline Personality Disorder (BPD); Antisocial Personality Disorder (ASPD)

Summary: established evidence base with mbt for treatment of borderline personality disorder (bpd) and/or antisocial personality disorder (aspd). demographic information of united kingdom prison population highlights large proportion of offenders with pd. there is no agreed universal approach to treatment of pd within scottish prisons with large variance across the prison estate. mbt pilots in hmp edinburgh and hmp cornton vale have demonstrated positive findings in female offenders which could be replicated in male populations.


Eligibility criteria:
inclusion criteria: * primary diagnosis of bpd and/or aspd * co-morbidity with other personality disorder is accepted * sentenced prisoners with estimated date of liberation \> six months exclusion criteria: * co-morbid severe and enduring mental illness (schizophrenia, delusional disorder, bipolar affective disorder, major depressive disorder) * co-morbid organic brain disorder (acquired brain injury, alcohol related brain damage) * remand prisoners * uncontrolled substance dependence * index offence of sexual offending * repeatedly chaotic, antisocial or violent behaviour in prison * care in segregation and reintegration unit in past 3 months * current individual specialist psychological therapy in prison * english as not first language
bi655130 (spesolimab) induction treatment in patients with moderate-to-severe ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: this trial has two sequentially enrolling parts with different objectives. the primary objectives of this trial are * to prove the concept of clinical activity of bi655130 (spesolimab) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in part 1 (phase ii) * to confirm efficacy and safety of bi655130 (spesolimab) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in part 2 (phase iii) * to provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.


Eligibility criteria:
inclusion criteria: * 18 - 75 years, at date of signing informed consent, males or females * diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report * moderate to severe activity (total mcs 6 to 12 with a rbs ≥ 1 and an sfs ≥ 1 and mess ≥ 2 within 7-28 days prior to first dose) * endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge) * well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of tnfɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both tnfɑ antagonists-and-vedolizumab failure patients will be capped once 48 randomized patients in part 1 and 117 randomized patients in part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study) * further inclusion criteria apply exclusion criteria: * evidence of abdominal abscess at screening * evidence of fulminant colitis or toxic megacolon at screening * ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine * further exclusion criteria apply