Kornimate/medical-research-clean huggingface dataset:
observational familial adenomatous polyposis registry study in patients receiving celecoxib compared to control patients

Conditions: Familial Adenomatous Polyposis (FAP)

Summary: this is a registry-based observational study assessing clinical outcomes in fap patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib. both retrospective and prospective data will be utilized. no sampling methods apply.

the study prematurely discontinued on april 11, 2008 due to slow enrollment. it should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility criteria:
inclusion criteria: celecoxib treated patients: * diagnosis of fap based on the expression of the fap phenotype. * celecoxib treatment prescribed outside of a clinical trial setting with expected duration of celecoxib treatment of at least six months. historical/concurrent control patients: * diagnosis of fap based on the expression of the fap phenotype. * be greater than or equal to 12 years old at the time of study enrollment. * have an endoscopically assessable colonic, rectal, ileal pouch and/or gastroduodenal segment. * for the group of post-surgical patients, ira or ipaa performed from 1985 onward (in order to assure standardized surgical techniques and post-surgical management). patients whose primary colorectal surgery was performed prior to 1985 will not be eligible to serve as historical controls. exclusion criteria: celecoxib treated patients: * have received a pharmacological treatment (other than celecoxib) within the last 3 months for their fap disease including treatment of any extracolonic manifestation of fap. * have received a non-steroidal anti-inflammatory drug (nsaid) within the last 3 months, other than celecoxib, for any reason. historical/concurrent control patients: * have pharmacological treatment recorded for their fap disease at the defined index date. * have received a non-steroidal anti-inflammatory drug (nsaid) within the last 3 months for any reason.

Keywords: familial adenomatous polyposis celecoxib ira ipaa
a phase 2 extension study to enroll subjects who were enrolled in b5301001 study

Conditions: Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery

Summary: study is a multicenter, two-part, open-label phase ii study in adults, evaluating the safety and long-term efficacy of pf-06473871 one year after surgical revision and treatment with pf-06473871.


Eligibility criteria:
inclusion criteria: * subjects previously randomized to pfizer clinical study b5301001. * subjects must be able to tolerate up to a 3 hour scar revision surgery under sedation and local anesthesia. exclusion criteria: * pregnant female subject; breastfeeding female subjects; male subjects with partners currently pregnant. * any previous history of intolerable adverse reactions to pf-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to ae in prerequisite study b5301001.

Keywords: phase 2 open-label safety hypertrophic scar revision surgery
a phase i study of tq-b3101 on tolerance and pharmacokinetics

Conditions: Advanced Cancer

Summary: to study the pharmacokinetic characteristics of tq-b3101 in the human body, recommend a reasonable regimen for subsequent research.

single arm, single or repeat dosing of tq-b3101 on patients with solid tumors.

Eligibility criteria:
inclusion criteria: * histological documentation of advanced solid tumors * lack of the standard treatment or treatment failure * 18-70years,ecog ps:0-1,life expectancy of more than 3 months * main organs function is normal * women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped * patients should participate in the study voluntarily and sign informed consent exclusion criteria: * patients with treatment failure by alk/ros1 inhibitor * patients with anti-teratment,radiotherapy or surgery within 4 weeks * patients participated in other anticancer drug clinical trials within 4 weeks or alk/ros1 inhibitor within 1 week * blood pressure unable to be controlled(systolic pressure\>140 mmhg，diastolic pressure\>90 mmhg). patients with grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including qt≥470ms) * patients with non-healing wounds or fractures * patients with drug abuse history and unable to get rid of or patients with mental disorders * history of immunodeficiency * patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
circulating sirt6 expression, effect on aging quality

Conditions: Aging

Summary: this study follows the results of the compaliclamp study (nct00951392) where the investigators showed a differential expression of sirtuins protein isoforms, sirt6, in muscle depending on the quality of aging. the investigators seek to confirm this difference in expression level of circulating leukocytes on a larger sample.


Eligibility criteria:
inclusion criteria: * volunteers from the suvimax 2 aging cohort * men and women * older than 60 * subject with a global aging quality score of 1 or 3 in the su.vi.max. 2 study * covered by health insurance system exclusion criteria: * subject not in compliance with the recommendation of french national law

Keywords: sirtuins aging metabolic disease
comparison of two pharmacological treatments of pedophilia

Conditions: Pedophilia

Summary: sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims. objective: to compare the therapeutic efficacy of cyproterone acetate (cpa) and leuprolide, with the hypothesis that leuprolide will be more effective.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pedophilia * high frequency of sexual urges and deviant behavior as demonstrated by a score equal to 8 on the scale of rösler \& witztum (rösler \& witztum, 1998) ; * age: 18-60 years * informed consent exclusion criteria: * iq\<70 * schizophrenia, schizoaffective disorder, or delusional disorder * already receiving one of the tested drugs * contraindication for one of the tested drugs * no current or planned incarceration

Keywords: pedophilia antiandrogens gonadotropin releasing hormone agonists
management of patients with hf by using educational or educational & telephone or telephone interventions and support in cyprus

Conditions: Heart Failure

Summary: the current trial aims to examine the effectiveness of three different types of nursing interventions, on heart failure (hf) patients' quality of life and on hf outcomes, compared to the usual care. the interventions include promotion of self-care practices through education and support; they are either provided before discharge, post-discharge through telephone, or both.

the current trial aims to examine the effectiveness of three different types of nursing interventions, on heart failure (hf) patients' quality of life and on hf outcomes, compared to the usual care. the interventions include promotion of self-care practices through education and support. hf patients admitted in the public hospitals of the cyprus republic are screened for eligibility. consented patients who meet the inclusion criteria are recruited before their discharge, and are randomly allocated to one of the four groups of the trial. patients of the three intervention groups receive educational intervention and support, before discharge or post-discharge through telephone, or both. patients of the fourth group receive the usual care (control group). the patients' follow up period is 3 months. the main purpose of the study is to determine whether the combination of predischarge education/support and tele-management is more efficient in improving hf outcomes, rather than the in-person and telephonic components alone. outcome measures include quality of life and hf events (re-admissions and death) and time to hf event.

Eligibility criteria:
inclusion criteria: * hospitalized adult patients with evidenced hf * planned for discharge * nyha class i-iv * greek speaking * able and willing to give informed consent exclusion criteria: * severe mental illness or severly impaired cognitive function * patients that are to be transferred to nursing or rehabilitation homes * patients unable to be contacted via telephone * patients with active cancer * patients on dialysis * patients scheduled for surgery * patients recently undergone surgery (up to 3 months) * patients with less than 3 months life expectancy (end-stage) * patients with chronic degenerative diseases

Keywords: heart failure randomized control trial disease management self-care nursing patient education as topic
functional outcomes of surgical management of deep endometriosis infiltrating the rectum

Conditions: Endometriosis, Rectum

Summary: the purpose of this study is to determine whether performing colorectal resection in deep endometriosis infiltrating the rectum is responsible for a higher rate of postoperative digestive and urinary dysfunction when compared to rectal nodules excision (conservation of the rectum).

the study compare digestive and urinary functional outcomes following surgical management of rectal endometriosis by either colorectal resection or conservative surgery (shaving or full thickness excision of rectal nodules). patients managed for rectal endometriosis are randomized in two arms, and followed up for 24 months. the assessment of digestive and urinary functions is performed at 6, 12, 18 and 24 months using standardized questionnaires. postoperative complications and improvement of endometriosis related pain are also recorded.

Eligibility criteria:
inclusion criteria: * female * age \>18 and \<45 * at least one digestive symptom related to deep endometriosis (pain defecation, either cyclic diarrhea or cyclic constipation, cyclic rectorrhagia) * preoperative work up revealing a deep endometriosis nodule infiltrating the rectum (either muscular or submucosal layer, on less than 50% of rectal circumference) and measuring at least 20 mm * affiliation to the national social security system exclusion criteria: * pregnant women or likely to be at the moment of the surgery * no preoperative hypothesis of rectal involvement * no intraoperative confirmation of the rectal involvement * advanced rectal endometriosis involving rectal mucosa or more than 50% of the rectal circumference (preoperative assessment using rectal endoscopy or ultrasonography) * women unable to give an informed consent (guardianship or trusteeship)

Keywords: deep infiltrating endometriosis rectal endometriosis colorectal resection nodule excision rectal shaving functional outcomes constipation
real-world use of nivolumab for the treatment of patients with metastatic upper gastrointestinal cancer in canada

Conditions: Upper Gastrointestinal Cancer

Summary: the purpose of this observational study is to describe the demographics, and disease characteristics of participants with metastatic upper gastrointestinal cancer, along with the treatment characteristics of these patients when treated with nivolumab.


Eligibility criteria:
inclusion criteria: * enrolled in the bristol-myers squibb gastroesophageal opdivo in non-resectable, advanced or metastatic adenocarcinoma patient support program (georgia psp) in canada * have consented to the use of their de-identified data generated from information collected during the course of the georgia psp exclusion criteria: * aged \<18 years * her2 positive status * untreated brain metastases
immune profile of acute vkh patients pbmc

Conditions: VKH Syndrome

Summary: the investigators will collect blood samples of different courses of vkh patients for investigating immune profile, observe major immune cells number ,functional and membrane molecular changes in the course of treatment, to investigate pathogenesis of vkh. meanwhile, the investigators will collect clinical data of vkh patients to observe choroid and retina change in different courses.


Eligibility criteria:
inclusion criteria: 1. acute vkh patients, meet a criterion of vkh, no recurrence. 2. age range from 18 to 50 years old. exclusion criteria: 1. patients with severe cardiovascular and cerebrovascular diseases 2. patients allergic to steroid or contrast agents; 3. a history of ocular trauma or intraocular surgery within 3 months; vaccinated; history of infectious diseases 4. having a history of heredity, immune system correlation, neuroendocrine and digestive system diseases 5. patients who take health care products for a long time and have heavy alcohol and tobacco addiction.

Keywords: vkh; immune profile;
dual integrated attention program (daip) in people with severe dual diagnosis

Conditions: Diagnosis, Dual (Psychiatry)

Summary: aim: validate a dual integrated attention program (d-aip) for mental health nursing in people with severe dual diagnosis admitted to a psychiatric hospitalization unit design: randomized controlled trial. population: inpatients with dual diagnosis.

the main objective of the project is to validate a dual integrated attention program (d-aip) for mental health nursing in people with severe dual diagnosis admitted to a psychiatric hospitalization unit, assessing change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety, which this context generates. for this purpose, a randomized, prospective, one-year-longitudinal clinical trial will be conducted. this study will be applied on patients with diagnosis of schizophrenia, schizoaffective disorder and bipolar disorder types i and ii who, after accepting to participate in the study and signing the informed consent, answer the prism questionnaire of admission in the hospitalization unit and fulfill the dual pathology criteria. after, they will be randomized in control group and intervention group (only the later will complete the d-aip). the d-aip will consist on 6 individualized sessions with the psychiatric inpatients, and during follow-up up to one year after discharge in which 4 individual sessions and 3 telephone contacts will be made. in both groups, a different person from the one who performs the intervention and without knowledge of the group belonging will assess them with questionnaires in 9 moments during the whole follow-up year (socrates 8d, scale of unawareness of mental disorder "sumd", morisky medication adherence scale "mmas-8", working alliance inventory "wai", hamilton anxiety rating scale "hars" y hopelessness scale "hs") and will collect a urine sample in each evaluation. the sample size will be 86 subjects, for α=0.05 and power=0.80.

Eligibility criteria:
inclusion criteria: 1. inpatients diagnosed with some serious mental illness of the following: * inpatients with diagnosis of schizophrenia * inpatients with diagnosis schizoaffective disorder * inpatients with diagnosis bipolar disorder types i * inpatients with diagnosis bipolar disorder types ii 2. consumption of addictive substances exclusion criteria: * intellectually disabled

Keywords: psychiatric dual diagnosis integrated attention program
study of pf-04691502 (pi3k/mtor inhibitor) in combination with exemestane compared with exemestane alone in patients with advanced breast cancer

Conditions: Breast Neoplasms

Summary: pf-04691502 is an inhibitor of pi3k and mtor kinase. exemestane is an aromatase inhibitor for the treatment of advanced breast cancer in women whose disease has progressed following tamoxifen therapy. the combination of pf-04691502 and exemestane might mitigate resistance to hormonal therapy and result in greater clinical benefit than exemestane alone in women with estrogen receptor positive advanced breast cancer.


Eligibility criteria:
inclusion criteria: * inoperable estrogen receptor positive, her-2 negative advanced breast cancer * previously treated with an aromatase inhibitor * primary or secondary hormone resistance * acceptable glucose control, bone marrow, liver and kidney function exclusion criteria: * inflammatory breast carcinoma * prior therapy with an agent active on pi3k, akt, and/or mtor * known hypersensitivity to exemestane * significant gastrointestinal abnormalities which may impair intake, transit, or absorption of the study drugs * current or anticipated need for food or drugs that are known inhibitors or inducers of cyp3a4

Keywords: estrogen receptor positive her-2 negative advanced breast cancer breast cancer
sr-wbv training for frail elderly in the skilling up stage

Conditions: Poor Performance Status; Muscle Weakness

Summary: this randomized controlled study aims to examine long term effects in the skilling up phase over 4 weeks on physical functional performance and strength of mechanical sr-wbv and dance therapy intervention in a frail elderly population.

this study is based on the guideline of falls management exercise programs (fame; from skelton and dinan). the goals: skilling up: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity. training gain: improvement of functional abilities. maintaining the gains: muscle growth, improvement of bone density and multi-sensory exercises. first, a pilot study was conducted with untrained elderly ("effects of stochastic resonance therapy on postural control in the elderly population" (kek bern: no.228/09, clinical trial registry: nct01045746). following, a second pilot study was conducted with frail elderly (application of whole-body vibration with stochastic resonance in frail elderly: the effects on postural control clinical trial registry:nct01543243). it was found that the selected chosen form of recruitment (presentation and advertisement) and the measurements methods are suitable for untrained elderly. but for frail elderly the chosen form of recruitment and the measurement methods are not sufficient. for this study, measurement parameters for functional performance and strength will be used. goals of the study in the skilling up phase: 1. feasibility 2. study the effect on physical functional performance 3. study the effects on muscle strength. the participants will be recruited in canton bern - swizerland and will be randomly allocated to an intervention group or sham group.

Eligibility criteria:
inclusion criteria: * rai (resident assessment instrument) \>0 * live in canton bern * in terms of training load be resistant. exclusion criteria: * acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute -- surgical scars * seniors with prosthesis. * alcoholic * acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb * acute inflammation or infection tumors * fresh surgical wounds * severe migraine * epilepsy * acute severe pain
sarcosine (n-methylglycine) monotherapy for schizophrenia

Conditions: Schizophrenias; Psychoses; Psychotic Disorders; Schizophrenic Disorders

Summary: the etiology of schizophrenia remains unclear. schizophrenia patients reveal positive symptoms, negative symptoms, and cognitive impairments. in addition to dopamine system hyperactivity, hypofunction of n-methyl-d-aspartate (nmda) receptor plays a role in the pathophysiology of schizophrenia. consequently, enhancing nmda receptor neurotransmission has been considered as a novel treatment approach. to date, there have been several trials on nmda enhancers reported. for example, sarcosine (n-methylglycine, a glycine transporter i inhibitor) showed therapeutic effects not only in chronically stable patients but also in acutely exacerbated ones when added-on to antipsychotics. in addition, sarcosine yields excellent safety profiles, in comparison to current antipsychotics. it remains unclear whether nmda enhancers, such as sarcosine, can serve as monotherapy for schizophrenia. the aims of this project are to examine the efficacy and safety of sarcosine monotherapy for acutely-ill schizophrenic patients, and to compare the effects of 2 grams/day, effective dose, with 1 gram/day, ineffective lower dose.

in the study, 20 schizophrenic patients are recruited into the 6-week trial and randomly assigned into the two groups (1 g/d and 2 g/d) with a double-blind manner. clinical manifestation (positive and negative syndrome scale; scale for the assessment of negative symptoms), side effects and quality of life are evaluated every two weeks during the trial. the efficacies of two groups are compared, and the characteristics of better responders are analyzed.

Eligibility criteria:
inclusion criteria: * fulfill the criteria of schizophrenia according to the diagnostic and statistic manual, fourth edition (dsm-iv). * free from antipsychotics for at least 7 days before enrollment. * agree to participate in the study and provide informed consent exclusion criteria: * meet dsm-iv criteria of major mood disorder, current substance dependence or mental retardation * history of epilepsy, head trauma or cns diseases * major, untreated medical diseases * pregnancy or lactation * receiving psychotropic agents or depot within three months prior to study entry
yoga in an urban school for children with emotional behavioral disorders

Conditions: Emotional Behavioral Disorders

Summary: yoga is becoming a part of therapies for children with emotional behavioral disorders. the goal is to examine the feasibility and efficacy of yoga sessions for children with emotional behavioral disorders at an urban elementary school.

participants: children in 4th and 5th grade at an urban elementary school, identified by the special education director and the teaching staff, as having emotional behavioral disorders including anxiety, depression, aggression, conduct disorder, hyperactivity and attention difficulties. these grades have a combined student population of 160 students. enrolled over two years. inclusion/exclusion criteria: eligible if identified by the teaching staff or special education director as having an emotional behavioral disorder. exclusion criteria: inability to comprehend english sufficiently to complete written assessments and follow the yoga intervention. pre- and post-intervention assessments (teachers) 1. behavior assessment scale for children (basc). 2. the swanson, kotkin, agler, m-flynn \& pelham rating scale (skamp)

Eligibility criteria:
inclusion criteria: * identified by the teaching staff or special education director as having an emotional -behavioral disorder exclusion criteria: * inability to comprehendread in english sufficiently to complete written assessments and follow the yoga interventionintervention protocols

Keywords: yoga emotional behavioral disorder intervention school meditation focus: yoga intervention in students with emotional behavioral disorders in an urban school