Kornimate/medical-research-clean huggingface dataset:
assessment of quality of life and independence, as well as received social support for spinal cancer.

Conditions: Spinal Canal Tumors

Summary: * evaluation of the quality of life of patients before and after surgery for benign and malignant spinal cancers, assessing whether it depends on the size of the tumor, type of cancer, malignancy and its location * evaluation of patients' independence before and after surgery for benign and malignant spinal tumors, evaluation of what factors influenced patients' different independence * multidimensional assessment of perceived social support of patients before and after surgery for benign and malignant spinal cancers, taking into account three sources of support: significant person, family and friends

research project description, research methodology: research objectives: * to evaluate the quality of life of patients before and after surgery for benign and malignant spinal cancers, to assess whether it depends on the size of the tumor, type of cancer, malignancy and its location * evaluation of patients' independence before and after surgery for benign and malignant spinal tumors, assessment of what factors influenced patients' different independence * multidimensional evaluation of perceived social support of patients before and after surgery for benign and malignant spinal cancers, taking into account three sources of support: significant person, family and friends scientific (research) problems: * what is the quality of life of patients before and after surgery for benign and malignant spinal cancers ? is the quality of life in patients with spinal cancer dependent on tumor size, malignancy, location or type of cancer ? * how do patients rate their independence both before and after surgery for spinal cancers at different stages of the disease? * how do patients with spinal cancer at different stages of the disease rate the social support they received both before and after surgery?

Eligibility criteria:
inclusion criteria for the study: -clinical diagnosis of spinal cancer study exclusion criteria: -inflammatory and disc disease of the spinal column
the effect of tegaserod on patterns of flow in the small bowel of patients with irritable bowel syndrome (ibs)

Conditions: Constipation Predominant; Irritable Bowel Syndrome (IBS-C)

Summary: evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female ibs-c patients.


Eligibility criteria:
inclusion criteria: * female 18 and older * ibs-c patients diagnosed on the basis of rome ii criteria * ability to comply with the requirements of the entire study exclusion criteria: * evidence of structural abnormality of the gastrointestinal tract or disease/conditions. * patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy. * evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study other protocol-defined inclusion/exclusion criteria may apply.

Keywords: ibs-c female
olanzapine versus clozapine in treatment refractory schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the study involves a six-month, double-blind protocol during which eighty patients, across three sites around the country, will be randomly assigned to receive clozapine or olanzapine. the specific aims of the study are to evaluate the relative effects of olanzapine and clozapine on clinical outcomes and cognition in patients diagnosed with schizophrenia or schizoaffective disorder who have demonstrated resistance to treatment in the past.


Eligibility criteria:
inclusion criteria: 1. patients will be males and females, ages 18-60, with a definite diagnosis by dsm-iv criteria of schizophrenia (any subtype) or schizoaffective disorder. 2. 2) all participants will be refractory according to the kane et al (1988) criteria, with modification on the number of drug trials to at least two neuroleptic drugs at adequate doses for periods \> 3 months. the criteria of kane et al. for treatment resistance are as follows: three or more trials with antipsychotic drugs of adequate dose and duration (this is usually 4-6 weeks). the original criteria involved three types of typical neuroleptic drugs. now, it can include any antipsychotic drug other than clozapine. olanzapine may have been tried but the dose must not have exceeded 30 mg/day. 3. subjects must have a panns-derived bprs total score \> 24 (0-6 scale) or bprs positive subscale item score \> 3 on at least two of the four items. 4. participants will be in generally good and stable physical health. 5. written informed consent will be obtained from all participants after a full explanation of the study and procedures. for those patients with a legal guardian, written informed consent will be obtained from the guardian, with verbal assent by the research subject. 6. since both clozapine and olanzapine are approved agents, no specific birth control will be required for females, but advice about birth control will be provided exclusion criteria: 1. uncontrolled diabetes or hypertension. 2. cardiac conduction abnormality or uncontrolled arrhythmia. 3. history of any blood dyscrasia, including leukemia. 4. significant active hepatic or renal disease, including chronic hepatitis. 5. clinically significant neurological disorder, including (but not limited to) parkinson's disease, multiple sclerosis, seizure disorder, intracranial mass lesion (note that the presence of tardive dyskinesia is not an exclusion for participants). 6. active cancer with or without chemotherapy within the last five years (not to include a completely excised basal cell carcinoma). 7. active endocrinological disorder (which does not include adequately treated hypothyroidism). 8. pregnancy or lactation. 9. an active substance use disorder within the last six months. 10. history of lack of response to an adequate trial of monotherapy with either clozapine or olanzapine in which the dose of clozapine must be \> 600 mg/day or the dose of olanzapine must be \> 20 mg/day; and the duration of treatment with either must be \> 6 weeks. 11. history of intolerance of clozapine or olanzapine, including blood dyscrasia
fecal microbiota transplantation for ulcerative colitis

Conditions: Ulcerative Colitis; Fecal Microbiota Transplantation

Summary: fecal microbiota transplantation (fmt) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(uc) by fecal microbiota transplantation needs to be further explored.the investigators propose to determine the efficiency and safety of fmt in patients with ulcerative colitis(uc).

the present clinical trial aims to re-establish a gut functionality state of intestinal flora through fmt as a therapy for ulcerative colitis(uc). we established a standard microbiota isolation from donated fresh stool in lab. then the microbiota is transplanted to the intestine. patients from guangzhou first people's hospital in this study will be assigned to receive fmt at least two times according to associated guidelines and follow-up for at least three months.

Eligibility criteria:
inclusion criteria: * active, moderate to severe severity (mayo score more than 6) * safety using history of 5-asa * able to undergo endoscopy examination exclusion criteria: * antibiotic using in 7 days * high risk of toxic megacolon * colon cancer or neoplasia in pathophysiology * other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)
effect of implant position on magnetic resonance image distortion

Conditions: Neurofibromatosis Type 2

Summary: patients with neurofibromatosis type 2 (nf2) almost always develop acoustic neuromas in both ears. as a result of the tumours themselves or the treatment of the tumours, many patients become profoundly deaf in both ears. it is possible to restore a degree of hearing by placing a hearing implant in the brainstem adjacent to the hearing pathways within the brain. this is termed an auditory brainstem implant (abi). the aim of this study is to find the optimum head position in relation to the mri magnet field, which would produce least area of image distortion in patients with abis. this will be of benefit in optimising the mr imaging in future patients with implants.

auditory brainstem implants (abi) are placed against the auditory centres in the brainstem if it is not possible to implant the cochlea or if the cochlear nerve, which conveys neural signals from the cochlea to the brainstem, is damaged or absent. the latter device is usually used in patients with neurofibromatosis type 2 (nf2) who develop bilateral benign inner ear tumours called vestibular schwannomas as well as other neurological tumours1. these patients often become bilaterally profoundly deaf either as a result of the disease or because of surgery to remove the tumours and require an abi. patients with nf2 require monitoring of their tumours. in the absence of an auditory implant it is possible to use magnetic resonance imaging. this is the gold standard imaging technique as it gives excellent views of the soft tissues of head. however, there has been concern regarding the use of mri in patients with auditory implants until recently because of potential problems such as demagnetisation of the magnet within the implant, implant magnet displacement and risk to the integrity of the implant electronics. in addition, the magnet field of the implant magnet results in imaging artefact (manifesting as a signal void) around the implant site that limits the information that can be obtained.

Eligibility criteria:
inclusion criteria: - any patient over the age of 18 with nf2 who has an auditory implant (cochlear or auditory brainstem implant) in situ and requires mri scanning. exclusion criteria: children under the age of 18 years claustrophobia bilateral implants contraindications and relative contraindications for mri (as per the radiology department mri protocol) including: pacemaker certain metallic heart valves ferromagnetic implanted materials and foreign bodies
the potential for clinical dependence and withdrawal symptoms associated with valbenazine

Conditions: Tardive Dyskinesia (TD)

Summary: this is a phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.


Eligibility criteria:
inclusion criteria: 1. subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study. 2. have one of the following clinical diagnoses for at least 3 months before screening: schizophrenia, schizoaffective disorder, or mood disorder 3. have a clinical diagnosis of neuroleptic-induced td for at least 3 months before screening. 4. be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. subjects with bipolar disorder must be on stable doses of a mood stabilizer. 5. be in general good health. 6. have adequate hearing, vision, and language skills to perform the procedures specified in the protocol. exclusion criteria: 1. have an active, clinically significant unstable medical condition within 1 month before screening. 2. have a known history of substance (drug) dependence, or substance or alcohol abuse. 3. have a significant risk of suicidal or violent behavior. 4. have a known history of neuroleptic malignant syndrome. 5. have a known history of long qt syndrome or cardiac arrhythmia. 6. have a cancer diagnosis within 3 years prior to screening (some exceptions allowed). 7. have ever taken valbenazine (ingrezza or nbi-98854) or participated in a valbenazine clinical study. 8. have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than nbi-98854) during the study. 9. have a blood loss ≥550 ml or donated blood within 30 days prior to baseline. 10. have an allergy, hypersensitivity, or intolerance to vmat2 inhibitors (eg, tetrabenazine, deutetrabenazine). 11. are currently pregnant or breastfeeding. 12. have hiv or hepatitis b.
a study to evaluate the safety and efficacy of gs-6624 (formerly ab0024) in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the study consists of 2 parts: part a is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate gs-6624 in subjects with idiopathic pulmonary fibrosis (ipf) and was completed in october 2011. part b is a randomized, two-dose, open-label dose expansion study to evaluate gs-6624 in subjects with ipf and is currently enrolling.

the primary objective of this study is to characterize the safety, tolerability, and pk of gs-6624 after multiple iv administrations in patients with ipf. the secondary objectives are to evaluate the formation of anti-gs-6624 antibodies and to measure the effects of gs-6624 on fvc, dlco, and sgrq score. a total of 48 patients will be enrolled. in the double-blind phase (part a), a total of 18 patients were enrolled at 3 dose levels. part a was completed in october 2011. in part b, 30 patients will be enrolled at 2 dose levels. part b is open-label and is currently enrolling.

Eligibility criteria:
inclusion criteria: 1. acceptable results on pulmonary function tests 2. at rest oxygen saturation ≥90% on room air 3. adequate organ function exclusion criteria: 1. high resolution computer tomography pattern showing emphysema that is greater than fibrosis 2. acceptable results on whole body plethysmography 3. history of clinically significant hepatic or renal disease 4. poorly controlled or severe diabetes mellitus 5. use of systemic immunosuppressants within 28 days of gs-6624 infusion

Keywords: fibrosis pulmonary fibrosis lung diseases interstitial
reveal-ckd: prevalence and consequences of undiagnosed chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: this is a retrospective, multinational, non-interventional, observational study. a series of cohort studies will be conducted to assess the prevalence of undiagnosed stage 3 ckd in each region. the study will also assess the current state of ckd management in patients with undiagnosed ckd

this study is a retrospective, multinational, non-interventional observational study. the study does not attempt to test any specific a priori hypothesis; it is descriptive only and will collect data under conditions of routine medical care. relevant secondary databases will be identified, and a series of cohort studies will be conducted to assess the prevalence of undiagnosed ckd. the study will also assess the current state of ckd management in patients with undiagnosed ckd. primary objectives 1. estimate the point prevalence of undiagnosed stage 3 ckd (proportion of patients with egfr measurements indicating stage 3 ckd with no corresponding ckd diagnostic code either before or up to six months after the second abnormal egfr value) 2. describe time to ckd diagnosis in patients with no prior ckd diagnosis code at index date (time of second qualifying egfr), overall and by patient characteristics secondary objectives 1. assess trends in the prevalence (point prevalence) of undiagnosed ckd by calendar year 2. describe baseline characteristics among those with undiagnosed versus diagnosed ckd 3. assess ckd management and monitoring practices (post index date) in patients with diagnosed versus undiagnosed ckd exploratory objectives (pending feasibility) 1. describe the risk of selected adverse clinical outcomes longitudinally among those with undiagnosed versus diagnosed ckd 2. describe hcru associated with undiagnosed versus diagnosed ckd 3. assess association between the timing of the ckd diagnosis and the risk of selected adverse clinical outcomes and hcru in patients with no ckd diagnosis code prior to the index date 4. describe health care costs associated with undiagnosed versus diagnosed ckd 5. for ckd patients with egfr 25-75 ml/min/1.73m2 and urine albumin creatinine ratio (uacr) 200 - 5000 mg/g (dapa-ckd trial-like population): 1. estimate the point prevalence of undiagnosed ckd 2. describe the risk of selected adverse clinical outcomes longitudinally among those with undiagnosed ckd 3. describe hcru and costs associated with undiagnosed ckd

Eligibility criteria:
inclusion criteria: * at least two consecutive egfr laboratory tests with values ≥30 and \ 90 and ≤730 days apart. the index date is the date of the second egfr measure meeting the criteria for stage 3 ckd * at least 12 months of continuous presence in the database or registration in the data prior to the first qualifying egfr (for data sources with information on enrolment) * age ≥18 years at index date exclusion criteria: * solid organ transplant before the study index date * any evidence of advanced ckd (stage 4, 5) based on ckd diagnostic codes, or renal replacement therapy before the index date
selection of embryos by time-lapse

Conditions: Infertility

Summary: in order to improve success rate by assisted reproductive techniques new techniques are being developed for selection of the embryo with best chance of implantation, establishement of pregnancy and subsequent delivery.the present study is based upon the hypothesis that time-lapse (frequent imaging) may give information about important steps in embryonic development, which could help to optimize selection of embryo(s) for treatment in ivf. the present study evaluates the outcome of conventional embryo culture with culture in a specially developed incubator equipped with a time-lapse system (embryoscope). embryos from 50 ivf cycles (400 embryos) will be randomised to either conventional incubation or to culture in the embryoscope. embryos will be cultured for five days to the blastocyst stage. the primary endpoint is fraction of embryos developed to the four cell stage.

in vitro fertilization for infertility has a success rate on average in europe of 25% in terms of baby take-home rate per cycle. one way to improve this rather low succes rate is to develop new measures for selection of the best embryo among peers as presently evaluated by embryo morphology. one of these promising methods is contineous imaging of embryo development by time-lapse. a new and unique equipment for this purpose - an embryoscope - har been developed by unisense fertilitech. the present study evaluates embryo 4-cell rate during cultivation to blastocyst stage in a conventional incubator with 4-cell rate in the embryoscope to ensure non-inferiority of the latter.

Eligibility criteria:
inclusion criteria: * patients undergoing 2.nd or 3.rd ivf cycle with expected retrieval of 8 oocytes or more. age \< 38 years exclusion criteria: * endometriosis

Keywords: ivf, infertility, embryo selection, embryoscope, time-lapse
mindful movement in women receiving adjuvant or neoadjuvant therapy for breast cancer

Conditions: Breast Cancer; Cancer of Breast

Summary: the investigators hypothesize that a personalized yoga program with mindful movement implemented during breast cancer therapy will benefit women in multiple ways. the investigators predict that women participating in the program will experience less weight gain and fatigue and will have an improved quality of life compared to women not participating in the program. the investigators predict that this will be associated with decreased markers of inflammation. the investigators will also evaluate whether there is improved pathologic response rate compared to historical controls. this study will provide pilot data for a larger randomized controlled trial assessing whether program can provide long-term improvement in quality of life, weight maintenance, and the serum and tumor changes correlating with a reduced risk of recurrence and mortality.


Eligibility criteria:
eligibility critera: * age ≥ 18. * female. * newly diagnosed with stage i-iii breast cancer. * scheduled to undergo neoadjuvant or adjuvant chemotherapy or neoadjuvant endocrine therapy. * not currently regularly practicing yoga (defined as at least once a month). * able to read and understand english * able to understand and willing to sign an irb-approved written informed consent document
evaluation of the id-systemtm, one-handed disposable internal defibrillation system.

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Summary: the main aim is to evaluate the safety and efficacy of the id-system™, one-handed disposable internal defibrillation system the device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock from a defibrillation device to the patient's heart, in combination with the id-electrode. the device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery.

the main aim is to evaluate the safety and efficacy of the id-system™, one-handed disposable internal defibrillation system the device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock from a defibrillation device to the patient's heart, in combination with the id-electrode. the device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery. in case ventricular fibrillation occurs and the id-system is not effective to restore the sinus trythm, the conventional approach with use of the two paddels spoons will be performed immediately. the following will be assessed: * ease of use of the device * safety of the device * efficacy of the device

Eligibility criteria:
inclusion criteria: * all races and ethnicity (\>18 years) * written informed consent form (icf) has to be obtained from the patient. * elective surgery: cardiac surgery on pump (cpb) * coronary artery bypass surgery * heart valve repair and/or replacement * mini sternotomy * median sternotomy * redo surgery exclusion criteria: * patients without cardiopulmonary bypass (referred to as heart-lung machine or pump) * emergency surgery without a sufficient amount of time to explain and ask for icf
impact of art therapy on anxiety identified during hospitalizations among children with cystic fibrosis aged 8 to 13

Conditions: Cystic Fibrosis

Summary: currently the management of cystic fibrosis (cf) patients is mainly based on symptomatic treatments. the arrival of children in day hospital, every 2 to 3 months, is for many of them and those around them, stressful, rarely expressed, but noticeable by the care team. in line with the recommendations of the high authority of health, the multidisciplinary team of resources and skills centre for cystic fibrosis (crcm) pediatric of nantes university hospital offers a therapeutic education program tailored to the needs of children with cystic fibrosis and their families . the aim is to support children and parents in the acquisition of self-care skills (knowledge and skills) and coping skills, such as managing stress and emotions . our goal is to demonstrate that art therapy, mobilizing coping skills of the child, facilitates its expressive capabilities and reduces anxiety.


Eligibility criteria:
inclusion criteria: * children with cf aged 8 to 13 years as part of their monitoring at crcm children of nantes university hospital * parents and children willing to participate in research non inclusion criteria: * emergency consultation * planned move