Kornimate/medical-research-clean huggingface dataset:
colchicine and thiamine in heart failure due to ischemic heart disease

Conditions: Heart Failure

Summary: the goal of this 2x2 factorial clinical trial is to test the efficacy of i) colchicine, and ii) thiamine in heart failure (hf) secondary to ischemic heart disease. the main questions it aims to answer are: * does colchicine reduce the risk of cardiovascular (cv) death, a hf event, or an ischemic cv event * does thiamine reduce the risk of cardiovascular (cv) death, or a hf event participants will undergo the following procedures: * run-in: all participants will receive colchicine 0.5 mg daily to assess drug tolerance over a 3-4 week period. * randomization: if colchicine is tolerated during run-in, eligible participants will be randomized in a 2x2 factorial design to receive i) colchicine 0.5mg daily or placebo, and ii) thiamine 300mg daily or no thiamine. * follow-up: clinical outcomes, side effects, adverse events, and drug adherence will be captured during follow-up


Eligibility criteria:
inclusion criteria: 1. age \>/= 45 years 2. documented ischemic hf as the etiology of hf, which includes: 1. a prior history of cad (defined as a history of myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, or non-invasive or invasive cardiac testing consistent with a diagnosis of cad), and 2. determination of cad to be the cause primary cause of hf based on local investigator assessment 3. new york heart association (nyha) class ii-iv symptoms 4. documented lvef \</= 45% within 1 year prior to enrollment 5. optimization of hf treatment based on local practice. 6. ambulatory hf patients or stable hospitalized patients with hf will both be eligible for enrollment in the trial. for hospitalized patients, enrollment will require i) evidence of clinical stability from hf defined as no use of an inotropic agent or intravenous diuretic agent in the prior 24, and ii) expected discharge from hospital in the next 72 hours. exclusion criteria: 1. female who is pregnant, breast-feeding, or of childbearing potential and not using an effective form of birth control\* 2. regular or required use colchicine or thiamine for other clinical indications.\*\* 3. history of allergic reaction to colchicine or to thiamine; or current or planned use of cyclosporine, verapamil, diltiazem, azole antifungal, macrolide antibiotic (except azithromycin), or hiv protease inhibitor 4. use of a ventricular assist device or prior heart transplant 5. coronary revascularization (coronary artery bypass graft surgery or percutaneous coronary intervention) within the 4 weeks prior to enrollment, or planned within the next 4 weeks. 6. severe valvular disease 7. chronic and severe renal dysfunction defined as egfr \< 15 ml/min/1.73m2 based on local laboratory measurement done within 6 months prior to run-in\*\*\* 8. history of liver cirrhosis 9. active malignancy (excluding basal cell or treated squamous cell carcinoma of the skin) requiring treatment and with a life-expectancy of \< 2 years. 10. concurrent use of other experimental pharmacologic agents -
warm contrast media for pain reduction during hystersalpingography

Conditions: Infertility

Summary: the aim of this study is to compare between body-temperature to room-temperature contrast media used during hysterosalpingography. we hypothesize that warmed medium will reduce pain associated with the procedure.

infertility occurs in about 15% of all couples. one of the common methods for evaluation of mechanical infertility is hysterosalpingography (hsg). several reports have shown that this common procedure is associated with moderate pain, i.e. around 5 on a visual analog scale (vas)of 1-10. it is therefore important to find modes for pain reduction for hsg. according to a report on sonohydrosonograpy, a similar technique using sonography, insertion of media warmed to body temperature into the uterus significantly reduced the pain during the procedure compared with media at room-temprature. the use of room-temperature media is the routine in our institution, as well as in many others. a comparison between the media at different temperatures has not been reported so far. we plan to perform a prospective trial in which patients referred for hsg will be randomized to the procedure using either warmed or room-temperature media. we will asses pain levels using vas during the procedure.

Eligibility criteria:
inclusion criteria: * diagnosis: infertility * sex: female * age: 18-45 exclusion criteria: * active pelvic inflammotory disease * known sensitivity to contrast medium

Keywords: mechanical infertility hysterosalpingogram hysterosalpingography
pimecrolimus cream 1% plus topical corticosteroid in patients (2-17 years of age) with severe atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). the active ingredient of pimecrolimus inhibits the t-cell activation. these cells are involved in the inflammatory component of the disease. this study will test the safety of pimecrolimus cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * severe atopic dermatitis * 5% of total body surface area (tbsa) affected exclusion criteria: * concurrent skin diseases (infections) * immunocompromised * recently received phototherapy or systemic therapy

Keywords: atopic dermatitis t-cell pimecrolimus children topical corticosteroids
clozapine versus olanzapine as treatment for comorbid psychotic disorder and substance use disorder

Conditions: Psychosis; Substance Use Disorders

Summary: the purpose of this trial is to determine if patients with comorbid psychotic disorder and substance use disorder will continue in treatment longer if treated with clozapine than with olanzapine, and will have greater reductions in psychosis and in substance use if treated with clozapine than treated with olanzapine. the specific aims and hypotheses of this trial are: 1. to compare the enduring effectiveness and tolerability of clozapine and olanzapine, as measured by time to all-cause treatment discontinuation, over 12 weeks of follow-up; the investigators hypothesize that patients assigned to clozapine treatment will have significantly longer times to all cause treatment discontinuation, 2. to compare the total psychosis items scores between patients treated with clozapine and patients treated with olanzapine over 12 weeks of follow-up; the investigators hypothesize that patients treated with clozapine will have significantly lower total psychosis items scores than patients treated with olanzapine, and 3. to compare the frequencies of positive urine drug screens and blood alcohol levels (obtained weekly throughout 12 weeks of follow-up) between patients treated with clozapine and patients treated with olanzapine; the investigators hypothesize that patients treated with clozapine will have significantly fewer positive urine drug screens and blood alcohol levels than patients treated with olanzapine.


Eligibility criteria:
inclusion criteria: * 18-60 years of age, male or female (post-menopausal, surgically sterilized, or receiving either one of the listed contraception - depot contraceptive, intrauterine device, or implanted hormonal contraceptive), * who meet dsm-v criteria for schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, depression with psychotic features, or delusional disorder, and have ratings of moderate or greater on at least one of the brief psychiatric rating scale psychosis items, * who meet dsm-v criteria for at least one of alcohol, marijuana, cocaine, stimulant, or opioid use disorder, and have an admission urine drug screen positive for at least one of these substances, * who have a stable living situation (family or supervised living, e.g. personal care home) to return to after release into the community, * and who provide signed informed consent to participate (after testing for comprehension). exclusion criteria: * prior failure to respond or tolerate clozapine or olanzapine * logistics that prevent outpatient follow-up at serenity behavioral health adult outpatient services

Keywords: schizophrenia schizoaffective disorder bipolar disorder major depressive disorder psychosis substance abuse clozapine olanzapine
prediction of anastomotic complications and recurrent laryngeal nerve injury based on postoperative early endoscopic evaluation

Conditions: Esophageal Neoplasm; Anastomotic Leak; Recurrent Laryngeal Nerve Injuries; Anastomotic Stenosis; Endoscopic Evaluation

Summary: analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury.


Eligibility criteria:
inclusion criteria: 1. diagnosed with esophageal squamous cell carcinoma; 2. 18 - 80 years old; 3. ecog ps 0-1; 4. thoracic esophageal cancer (20-40cm from the incisors); 5. received radical resection of esophageal cancer in our hospital from april 2024 to july 2024; 6. received the mckeown procedure in our hospital's single treatment group; 7. received gastric reconstruction and cervical anastomosis with a side-to-side anastomotic device; 8. complete clinical materials. exclusion criteria: 1. history of other malignant tumors; 2. incomplete or missing clinical materials; 3. received combined surgery (total laryngectomy + esophagectomy, esophagectomy + lung resection, esophagectomy + aorta, etc.); 4. gastric reconstruction or cervical anastomosis with a side-to-side anastomotic device was not performed; 5. patients who underwent 3-field lymph node dissection; 6. patients with clear intraoperative recurrent laryngeal nerve section; 7. highly suspected anastomotic fistula before the first endoscopic evaluation (abnormal secretion at the cervical anastomotic site, abnormal drainage fluid in the chest tube, and high fever that other reasons cannot explain); 8. lost to follow-up.
influence of rtms on symptoms and cognitive function in patients with psychiatric disorders

Conditions: Schizophrenia; Major Depressive Disorder

Summary: the investigators investigated the effects of high frequency (10hz) repetitive transcranial magnetic stimulation (rtms) on the symptoms and cognitive functioning in patients with psychiatric disorders

objective: this study aimed to evaluate the efficacy of high-frequency rtms over left dorsolateral prefrontal cortex in the treatment of symptoms and cognitive functioning in 200 chronic patients with schizophrenia and 200 patients with major depressive disorders methods: 1. clinical trial：the study consists of 4 weeks of treatment. 2. assess procedures: 2.1 primary outcome variable-psychopathology: the psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the positive and negative syndrome scale (panss) or dsm-iv for depression, and repeatable battery for the assessment of neuropsychological status(rbans).patients are interviewed at screening, at at baseline, 4 weeks, 16 weeks. 2.2 side effects: the side effect rating scale (uku) was used to assess the side effect at baseline, 4 weeks, and 16 weeks. 2.3 weight gain measurement: weight gain every week

Eligibility criteria:
inclusion criteria: for schizophrenia patients: * diagnosis of schizophrenia by two senior psychiatrists * between 18 and 60 years and han chinese * duration of symptoms at least 12 months * with unresolved negative symptoms (negative scale of panss ≥20 and positive scale of panss \< 24) * smoking for major depressive disorder patients: * diagnosis of major depressive disorder by two senior psychiatrists * between 18 and 60 years and han chinese * duration of symptoms at least 12 months * smoking exclusion criteria: * documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, huntington's disease, multiple sclerosis * acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension) * severe headache for unknown reasons and cardiovascular diseases, intracranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months * past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures * education level less than 5 years by subject report * receiving or planning to start the psychotherapy during the rtms treatment or past received psychotherapy 6 months before the current study * subjects who suffered from alcohol or illegal drug abuse/dependence

Keywords: schizophrenia smoking rtms major depressive disorder
bilateral treatment of medication refractory essential tremor

Conditions: Essential Tremor

Summary: the purpose of this study is to see if the mr-guided focused ultrasound (mrgfus) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.


Eligibility criteria:
inclusion criteria: 1. men and women age 22 years or older 2. diagnosis of medication-refractory essential tremor 3. has previously underwent an exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial 4. able to communicate sensations during the exablate thalamotomy procedure exclusion criteria: 1. has experienced any non-transient neurological event or worsening following the exablate index procedure 2. presence of unknown or mr unsafe devices anywhere in the body 3. non-transient hemiparesis as determined by physical examination 4. clinically significant abnormal speech function as determined by a speech pathologist 5. pregnant or breastfeeding 6. unstable cardiac status 7. behavior(s) consistent with ethanol or substance abuse 8. history of bleeding disorder 9. has received anticoagulants within one month of exablate procedure 10. cerebrovascular disease 11. intracranial tumor 12. active or suspected acute or chronic uncontrolled infection 13. has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus 14. implanted objects in the skull or the brain 15. currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research 16. unable to communicate with the investigator and staff
ten-year practice of labor pain control in china

Conditions: Labor Pain

Summary: since 1999, labor pain control has being performed in china, and the initial time of analgesia is at the cervix \>= 2 cm. meanwhile, american society of obstetrics \& gynecology recommended that the labor analgesia with neuraxial block should be performed at the cervix \>= 4 cm in 2002. after that, the threshold has been revised to at least \>= 2 cm in 2006 by the society. however, in china, the practice of labor analgesia with neuraxial block has being performed for over seven years. up until now, the practice has being experienced during this ten-year period at the cervix around 1 cm. the investigators hypothesized that labor pain control in different stages had different characteristics and had different influence on patients short- and long-lasting outcomes. this study is mainly investigating different labor analgesia procedures in different stages since the initiation of the practice in 1999, and assessing their influence on the outcomes to display the trajectory of development of labor analgesia in china of which might fit to the the whole process of the study of labor analgesia throughout the world. all these were done by analyzing the data records since from january 1999 to december 2008.


Eligibility criteria:
inclusion criteria: * parturients used labor analgesia exclusion criteria: * following criteria were based on the records of information received from the ten-year practice screened by investigators: 1. chronic pain and psychiatric diseases records 2. participants younger than 18 years or older than 45 years 3. alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics 4. subjects with a nonvertex presentation or scheduled induction of labor 5. diagnosed diabetes mellitus and pregnancy-induced hypertension 6. twin gestation and breech presentation

Keywords: combined spinal-epidural analgesia patient-controlled analgesia epidural analgesia
everolimus roll-over protocol for patients who have completed a previous novartis-sponsored everolimus study.

Conditions: Neoplasms

Summary: study to allow access to everolimus for patients who are on everolimus treatment in a novartis-sponsored study and are benefiting from the treatment as judged by the investigator

this multi-center, open-label roll-over study aimed to better characterize the long-term safety of everolimus in subjects currently being treated in a novartis-sponsored studies and who were receiving clinical benefit on the current study treatment as judged by the investigator. the study was designed to provide continued treatment with everolimus monotherapy to the subjects. subjects were allowed to continue combination therapy with sandostatin lar® depot if they were receiving this combination therapy on the parent protocol. subjects were allowed to continue in this roll-over study until they no longer benefitted from the everolimus treatment as judged by the investigator, discontinued due to toxicities, subject withdrew consent or lost to follow-up, disease progression, protocol non-compliance, or subject death, whichever occurred first. a subject was considered to have reached end of study when everolimus treatment was permanently discontinued. as per the original protocol, it was designed to collect only serious adverse events (saes) and protocol defined adverse events of special interest (aesis). however, due to the feedback received from health authorities, the protocol was amended in 2016 (3 years after study was initiated) to collect all aes (non-serious and serious aes, and aesis). the protocol was also amended to include an investigator assessment of clinical benefit at every visit for remaining subjects.

Eligibility criteria:
inclusion criteria: * subject enrolled in a novartis-sponsored, cd\&ma study receiving everolimus or everolimus plus sandostatin lar depot and fulfilled all their requirements in the parent study * subject benefiting from treatment with everolimus, as determined by the guidelines of the parent protocol. exclusion criteria: * subject was permanently discontinued from everolimus study treatment in the parent study. * subject was receiving everolimus in combination with an unapproved or experimental treatment other protocol-defined inclusion/exclusion criteria might apply

Keywords: neoplasms carcinoid tumor neuroendocrine tumor
effect of detrol la on overactive bladder symptoms, sexual quality of life and sexual function in women

Conditions: Urinary Incontinence

Summary: the purpose of the study is to assess the impact of treatment with tolterodine er versus placebo on urgency urinary incontinence in sexually active women with oab symptoms.


Eligibility criteria:
inclusion criteria: * female outpatients 18 years or older. * overactive bladder symptoms (subject-reported) for greater than or equal to 3 months. * currently sexually active with a male partner. exclusion criteria: * diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction. * symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator. * treated with antimuscarinic/ anticholinergic medication, for any reason including oab, within the last 3 months or are expected to start therapy during the study treatment period. * any drug for urgency urinary incontinence (uui) initiated within the past 3 months prior to visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to visit 1 (screening)
beta-cell - liver interactions in situations of modified beta-cell function

Conditions: Obesity, Childhood; Type 2 Diabetes Mellitus in Obese

Summary: the investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism. the values will be compared to those obtained in healthy volunteers. the aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in children with obesity with or without type 2 diabetes.

one-center prospective study performed in collaboration between the pediatric endocrine and diabetology unit of the university hospitals of geneva (hug) and prof. pierre maechler, diabetes center of the faculty of medicine, university of geneva switzerland. 1,5-anhydroglucitol (1,5-ag), a deoxyhexose present in almost all foods and forming a stable pool in human subjects, has recently been found to be correlated with functional beta-cell mass in two different mouse models of beta-cell dysfunction leading to diabetes. the decline of this biomarker precedes the development of hyperglycemia in lean b-phb2 -/- and obese db/db diabetic mice, where beta-cell loss occurs through two different mechanisms. additional studies have shown a correlation of 1,5-ag levels with risk of progression of type 1 diabetes (t1dm) in auto-antibody positive children, as well as with glycaemic control in patients with type 2 diabetes (t2dm). the present project will analyse the correlation between functional beta-cell mass and the circulating levels of 1,5-ag in children with obesity with or without t2dm. this should contribute to the evaluation of a novel biomarker of beta-cell mass and function in t2dm.

Eligibility criteria:
inclusion criteria: * children aged 12 to 16 years * obesity. defined as a body-mass index above the 97th percentile. * ability to give informed consent as documented by signature exclusion criteria: * patients with diabetes mellitus and positive autoantibodies against islets, insulin, islet antigen 2, glutamic acid decarboxylase or zinc transporter 8. * patients with known liver disease (other than nafld) * patients treated with an oral antidiabetic drug, glucagon-like peptide-1 analogues or insulin at the time of or less than 2 weeks prior to inclusion. * patients treated with a drug known to affect liver function