Kornimate/medical-research-clean huggingface dataset:
efficacy & safety in moderately active refractory ulcerative colitis patients

Conditions: Ulcerative Colitis

Summary: this study is designed as a proof of concept of krp203 for induction of remission in ulcerative colitis (uc). the purpose of this study is to evaluate clinical benefit of krp203 in subjects with moderately active refractory ulcerative colitis. the study will provide safety and tolerability data in this subject population up to eight weeks of treatment with krp203. additionally, this study will evaluate the duration of a clinical response to krp203 by following up responding subjects for an additional 12 weeks.

this is a multi-centre, double-blind, placebo controlled, parallel group, proof of concept study to evaluate the efficacy, safety and tolerability of krp203 in subjects with moderately active refractory ulcerative colitis subjects. in total, approximately 72 subjects will be randomized into the study. after 30 patients have completed the 8 week treatment period with krp203 or placebo, there will be an interim analysis to determine preliminary efficacy. the study will consist of up to 28 day screening period (day -35 to -8), baseline period (day -7 to day -1), treatment period (day 1 to day 56), follow-up period and study completion.

Eligibility criteria:
inclusion criteria: * active disease defined by partial mayo score and modified baron score with disease extending at least 25 cm from the anal verge * subjects must have inadequately responded or intolerance to 5-asa therapy exclusion criteria: * subjects receiving treatment for uc (other than 5-asas and steroids) within the time frame mentioned in protocol * past or recent history of significant medical illness and/or clinically significant lab abnormalities including but not limited to hematology, clinical chemistry, urine analysis, ecg abnormalities, hiv, hepatitis b/c * presence or history of underlying metabolic, endocrine, hematologic, pulmonary, ophthalmic, cardiac, blood, renal, hepatic, infectious, psychiatric or any medically unstable condition, as assessed by the primary treating physician which, in the opinion of the investigator, would immunocompromise the subject and/or place the subject at unacceptable risk for participation in a study of an immunomodulatory therapy other protocol-defined inclusion/exclusion criteria apply

Keywords: inflammatory bowel disease ulcerative colitis
pelvic floor activity and breathing in women

Conditions: Pelvic Floor; Respiration

Summary: the pelvic floor and diaphragm work together in many different functions. two important functions are breathing and continence. the pelvic floor muscles have to lift and squeeze to maintain continence. breathing, specifically breathing out, makes the pelvic floor lift. the investigators don't know how much the pelvic floor lifts and squeezes during different types of breathing out. the purpose of this study is to measure pelvic floor lift and squeeze during different types of breathing out.

the pelvic floor (pf) activates automatically, both squeezing and lifting, during times of increased intra-abdominal pressure for postural stability and continence. expiration additionally produces automatic activation of the pf. no study to date has investigated the effects of forced expiration on pf displacement and squeeze pressure. the purpose of this study was to investigate the effects of variations in forced expiration effort on pf muscles' automatic activation.

Eligibility criteria:
inclusion criteria: * women * young (age 18-35) * nulliparous * pre-menopausal exclusion criteria: * pregnancy * history of lower back or pelvic pain * history of lower back or pelvic surgeries * incontinence * history of pelvic floor dysfunction * diabetes * endometriosis * neuromuscular disease * connective tissue disease

Keywords: pelvic floor rehabilitation respiration urinary incontinence
neuromodulation with spinal stimulation methods

Conditions: Spinal Cord Injuries; Spinal Cord Injury at C5-C7 Level; Paraplegia, Spinal; Paraplegia, Incomplete

Summary: this is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (sci). up to 24 participants will be enrolled. a variety of stimulation parameters and outcome measures will be assessed.

purpose of this project spinal cord stimulation has the potential to improve motor function recovery after spinal cord injury. commonly used approaches include low-intensity, direct current (dc) stimulation applied across multiple segments, electrical transcutaneous (etc) stimulation, and magnetic transcutaneous stimulation (mtc). objective: to evaluate and compare the voluntary and reflexive motor performance in the same subjects, including people with and without spinal cord injury, after non-invasive spinal cord stimulation interventions. comparing two different interventions applied in different experimental sessions and the respective sham stimulation is the goal of this study. corticospinal and spinal motor pathways in paraplegics and in non-injured humans will be tested.

Eligibility criteria:
inclusion criteria: * spinal cord injury c4 to l4 * ability to understand and follow directions exclusion criteria: * history of seizures, head injury, concussion, unexplained loss of consciousness or if they lived with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device or live with metal implants in their body or if they are pregnant.
a study to assess change in patient experience in adult participants with chronic lymphocytic leukemia (cll) receiving oral venetoclax tablets + intravenous rituximab or bruton's tyrosine kinase inhibitors tablets in the united kingdom

Conditions: Chronic Lymphocytic Leukemia

Summary: chronic lymphocytic leukemia (cll), a form of non-hodgkin's lymphoma, is the most common type of leukemia in adults, affecting approximately 3,800 people in the uk each year. this study will evaluate the patient experience of cll in adult participants who are prescribed venetoclax+rituximab or bruton's tyrosine kinase inhibitors in the united kingdom (uk). venetoclax+rituximab is a drug approved to treat cll. study participants will receive venetoclax+rituximab as prescribed by their study doctor in accordance with approved local label. adult participants prescribed venetoclax+rituximab or bruton's tyrosine kinase inhibitors will be enrolled. around 140 participants will be enrolled in the study in approximately 10 sites in the uk. participants will receive venetoclax tablets to be taken by mouth and rituximab intravenous (iv) injection according to the approved local label. there is expected to be no additional burden for participants in this trial. all study visits will occur during routine clinical practice.


Eligibility criteria:
inclusion criteria: * has a confirmed diagnosis of chronic lymphocytic leukemia (cll) (as defined by 2008 modified international workshop for chronic lymphocytic leukemia national cancer institute working group (iwcll nci-wg) guidelines). * has relapsed/refractory (r/r) disease having received only 1 prior line of treatment, which must have been a chemotherapy or chemoimmunotherapy treatment. * has treatment experience with venetoclax+rituximab (ven+r) or bruton's tyrosine kinase inhibitor (btki)s that meets the criteria for inclusion described in the protocol, for which recruitment targets have not yet been met. exclusion criteria: * previously treated with a btki, a bcl-2 inhibitor or other investigational agents. * has any other medical condition or disorder that, in the opinion of the site investigator or study director, could compromise participant's ability to give written informed consent and/or prevent or interfere with his or her ability to comply with study procedures and provide meaningful information about his or her cll experience.

Keywords: chronic lymphocytic leukemia rituximab bruton's tyrosine kinase inhibitor venetoclax venclexta venclyxto abt-199 cancer
exercise training intervention in children with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: type 1 diabetes mellitus (t1dm) is associated with multiple co-morbidities, such as hypertension, dyslipidemia, coronary heart disease and osteoporosis. the foundation of these conditions lays in childhood. exercise is known to have a positive influence on bone mineral density (bmd) and some impact on cardiovascular disease risk factors in healthy children, but little is known about these associations in children with t1dm. the main purpose of this study is to assess the effects of a 9-month weight-bearing exercise training program on skeletal development in children with t1dm, compared to healthy subjects. the second aim is to evaluate whether the program influences also cardiovascular diseases risk factors. this is a randomized controlled study incorporating 30 children with t1dm and 30 healthy children. both groups are randomly divided (1:1) in an exercise or a control group: 1) exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy. exercise groups participate to an identical weight-bearing exercise training program 2 x 90 minutes per week and controls are relatively inactive. main measures include: total body, lumbar spine and hip bmd by dxa, body fat and fat-free mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood lipids.


Eligibility criteria:
list of inclusion criteria for type 1 diabetes patients: 1) disease for at least 1 year. list of inclusion criteria for healthy subjects: 1) good general health and normal growth. list of exclusion criteria for all subjects: 1. presence of other chronic disease, including thyroid disease; 2. medications, hormones other than insulin, or calcium preparations taken in the preceding 6 months; 3. presence of nephropathy; 4. systemic disease or hospitalization for more than 2 weeks in the preceding year; 5. less than 6 menstrual cycles in the past year for post-menarche girls; 6. participation in competitive sport.

Keywords: type 1 diabetes, bone mineral density, growth cardiovascular diseases, exercise, training, child, adolescent
evaluate the glycemic control of ckd-501 in type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the safety and effectiveness of three doses of ckd-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.


Eligibility criteria:
inclusion criteria: * type ⅱ diabetes mellitus * fasting plasma glucose(fpg)≥ 126 and ≤ 270 * hba1c between 7 and 11% * body mass index (bmi) in the range 21-40 * the patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month * agreement with written informed consent exclusion criteria: * type i diabetes, gestational diabetes or secondary diabetes * treatment with insulin(over 1month) within 3 months * fasting plasma glucose level is over 270 mg/dl * triglyceride level is 500 mg/dl and over * uncontrollable hypertension * history of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months * severe hepatic dysfunction: ast, alt, total bilirubin, alp level over or equal to 3 times as high as upper normal limit(unl) * severe renal dysfunction: renal failure or serum creatinine greater than 30% normal limit * needs treatment for acute disease, uncontrolled other diseae or diabetic complications * in treatment concomitant drug having severe risk drug interaction with investigational drug * history of cancer within 5 years * history of drug abuse or alcoholism * hepatitis b antigen(hbsag) test is positive * treatment systemic or inhalant corticosteroids within 1 month prior to screening * patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones * fertile women who not practice contraception with appropriate methods pregnant women or nursing mothers * has a contraindication to treatment investigational drug from the medical and psychogenic side * participated in other trial within 4 weeks participating in other trial at present * an impossible one who participates in clinical trial by legal or investigator's decision

Keywords: diabetes mellitus, type 2 glitazone
clinical effectiveness and safety of a novel oral rehydration solution

Conditions: Gastroenteritis Acute

Summary: this is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ors compared with a commercial ors in children 1 to 5 years of age attending emergency departments with gastroenteritis.


Eligibility criteria:
inclusion criteria: * 1 to 5 years of age, inclusive at randomization * hospitalized with mild to moderate dehydration due to ongoing diarrhea * signed informed consent obtained for child's participation in the study exclusion criteria: * severe dehydration and/or use of iv fluids for current hospitalization * experiencing bloody diarrhea or diarrhea due to cholera, dysentery, persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated with recent antibiotic use * in the opinion of the investigator, not suitable for treatment with ors * have any underlying disease or disorder that may, in the opinion of the investigator, affect the results of the study if they were enrolled (includes, but is not limited to, gastrointestinal disorders such as crohn's disease or other inflammatory bowel disease or congenital malabsorption disorders) * cause of the dehydration is something other than diarrhea * known to be allergic to any of the components of the investigational ors
comparison of two strategies for endotracheal tube cuff underinflation prevention during invasive mechanical ventilation

Conditions: Acute Brain Injury; Brain Injuries

Summary: during invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (pcuff) around 25 cmh2o is recommended for sealing the upper airways. the continuous control of pcuff with a simple mechanical device, the tracoe smart cuffmanagertm, has never been assessed. the investigators hypothesize that the tracoe smart cuffmanagertm would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of pcuff control.

during invasive mechanical ventilation, maintaining a tracheal cuff pressure (pcuff) around 25 cmh2o is recommended to prevent cuff over- (\> 30 cmh2o) and underinflation (\< 20 cmh2o), identified as risk factors for tracheal ischemic damage and for oropharyngeal microaspirations, respectively. intermittent measurements with intermittent adjustments of pcuff is the widely used strategy but, between measurements, over- and underinflation episodes could occur. devices allowing a continuous control of pcuff are therefore appealing. as microaspiration is the most relevant mechanism for ventilator-associated pneumonia (vap), the use of such devices may decrease the incidence of vap for instance. to the knowledge of the investigators, the continuous control of pcuff with a simple mechanical device, the tracoe smart cuffmanagertm, has never been assessed. the investigators hypothesize that the tracoe smart cuffmanagertm would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of pcuff control. as secondary objectives, the investigators aim to assess the impact of the use of the tracoe smart cuffmanagertm on the incidence of overinflation episodes and on the incidence of early ventilator-associated pneumonia. a homogenous population will be studied for this purpose: patients admitted with severe acute brain damage.

Eligibility criteria:
inclusion criteria: * with severe acute brain damage * admitted in the icu for less than 48 hours * and expected to receive invasive mechanical ventilation (through orotracheal tube with a low pressure-high volume cuff) for at least 48 hours after inclusion. exclusion criteria: * change in the upper airway management within the 48 hours following the inclusion (extubation or change in the tracheal tube or tracheostomy) * pregnancy, moribund status.

Keywords: endotracheal tube ventilator's associated pneumonia intensive care unit orotracheal intubation
diagnostic accuracy of pleural effusion aspergillosis biomarker testing

Conditions: Invasive Aspergillosis; Pleural Effusion; Immunosuppression

Summary: diagnostic accuracy of biomarker testing (galactomannan (gm), (1

a multicentre, open, prospective diagnostic study on the diagnostic accuracy of biomarker testing (galactomannan (gm), (1

Eligibility criteria:
inclusion criteria: * prolonged neutropenia \> 10 d, patients * after allogeneic stem cell transplantation or solid organ transplantation, * patients wth acute leukemia in induction treatment, * patients witrh graft-versus-host-disease, * patients under chronic immunusuppressive therapy such as ciclosporin, * patients with hiv, * patients with chronic steroid treatment exclusion criteria: * age \< 18 years * missing informed consent * contraindication for pleural centesis
risk factors of venous thromboembolism after colorectal cancer surgery

Conditions: Colorectal Cancer; Venous Thromboembolism

Summary: aim of our study is to find frequency and identify risk factors for venous thromboembolism development in patients who underwent surgery for colorectal cancer. there were 137 patients enrolled in our retrospective observational cohort study. included patients were operated for incisional hernia in saveljev university surgery clinic from january 2016 to december 2017. compression duplex ultrasound of lower legs veins was performed in 2-14 days after surgery for all participants. the primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism.


Eligibility criteria:
inclusion criteria: operated for incisional hernia in saveljev university surgery clinic. no exclusion criteria

Keywords: colorectal cancer surgery thromboprophylaxis
influenza immunization of children in india

Conditions: Influenza

Summary: influenza viruses are significant causes of human illness and death in developed and developing countries. this study will measure the ability of influenza vaccine given to children in india to protect both the children and unimmunized persons around them from influenza. it will also determine whether the best time to immunize in a country like india that has both summer and winter outbreaks of influenza is in the fall, as is done now, or whether immunization should be in the spring to protect against influenza infections in the summer.

although influenza vaccines are used routinely in the united states, including in young children, influenza vaccines have not seen widespread use in india. this is likely contributed to by the lack of information from india about disease burden due to influenza and because influenza vaccines have not been tested for efficacy in india. in addition, because young children are thought to be important in the spread of influenza in families, it is possible immunization of children against influenza will reduce influenza infections among older children and adults in the home. the study described here is an extension of an earlier study (clinicaltrials.gov nct00934245) that tested the use of immunization against influenza in the fall. the current study will administer influenza vaccine in the spring prior to the summer monsoon rains that are associated with peaks of influenza activity in parts of india. reduction of influenza infections among the influenza immunized children and their household members will be compared to the children and household members in the control vaccine group.

Eligibility criteria:
inclusion criteria: inclusion in either vaccine group (tiv or ipv) will require ages 6 months through 10 years of age. all individuals in enrolled households will be eligible for enrollment into surveillance arm. exclusion criteria: exclusion criteria from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of the vaccines.

Keywords: influenza india children trivalent influenza vaccine (tiv) inactivated poliovirus vaccine (ipv) direct influenza vaccine effectiveness total influenza vaccine effectiveness indirect influenza vaccine effectiveness
physical impairments in children with cystic fibrosis

Conditions: Cystic Fibrosis (CF); Cystic Fibrosis in Children

Summary: it is aimed to reveal impairments regarding urinary incontinence, dyspnea, muscle strength, functional capacity or quality of life in children and adolescents with cystic fibrosis compared to healthy children and adolescents.

this study aims to compare dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life between children and adolescents with cystic fibrosis and healthy children and adolescents. participants will be assessed for these parameters through clinical evaluations, exercise tests, questionnaires and measurements. the study aims to understand the health implications of cystic fibrosis and provide the basis for improvements in the health management of these individuals.

Eligibility criteria:
inclusion criteria for children and adolescents with cystic fibrosis: * to be between the ages of 6-18 * to have been diagnosed with cystic fibrosis * to be clinically stable for at least 3 weeks * to have the necessary cooperation for the measurements * to volunteer to participate in the study inclusion criteria for healthy children and adolescents: * to be between the ages of 6-18 * to be in a similar average and ratio with the group of children and adolescents with cystic fibrosis in terms of age and gender * to have the necessary cooperation for the measurements * to volunteer to participate in the study exclusion criteria for children and adolescents with cystic fibrosis: * having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months * smoking or quitting smoking exclusion criteria for healthy children and adolescents: * having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months * having any chronic disease * smoking or quitting smoking

Keywords: cystic fibrosis urinary incontinence dyspnea muscle strength quality of life exercise test
optimization and refinement of technique in in-office sinus dilation 2

Conditions: Sinusitis

Summary: a prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (crs). all products intended for use in this study have been fda cleared for sale in the u.s.a.


Eligibility criteria:
inclusion criteria: * male/female, 18 year or older * diagnosis of chronic rhinosinusitis * planned endoscopic sinus surgery exclusion criteria: * cystic fibrosis * severe polyposis * sinonasal tumors * history of facial trauma precluding access to sinus ostium * ciliary disfunction * planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.) * pregnant or lactating female * inability to tolerate an awake procedure * participation in another investigational clinical study involving treatment for chronic rhinosinusitis