Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of open-label flexible-dose brexpiprazole as maintenance treatment in adolescents with schizophrenia

Conditions: Schizophrenia

Summary: to further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

this is a long-term, multicenter, open-label trial designed to examine the long-term safety and tolerability of brexpiprazole in adolescent subjects (ages 13-17) with a dsm-5 diagnosis of schizophrenia.

Eligibility criteria:
inclusion criteria: * male \& female subjects 13-17 years of age, inclusive. * subjects who turn 18 during trial 331-10-234 are permitted in this trial. * subjects with a current primary diagnosis of schizophrenia, as defined by diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria and confirmed by the k-sads-pl completed at time of entry into trial 331-10-234. for de novo subjects who did not participate in trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the k-sads-pl at screening. * subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s). exclusion criteria: * subjects with a dsm-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening * subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use). * history of failure of clozapine treatment or response to clozapine treatment only. * history of neuroleptic malignant syndrome

Keywords: brexpiprazole schizophrenia
safety and efficacy of a device for the relief of pain due to carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: interventional study to evaluate efficacy and safety of an active splint.


Eligibility criteria:
inclusion criteria: * male or female patients, above 40 years of age. * able to understand and sign informed consent * pain associated with mild to moderate carpal tunnel syndrome in a single wrist * numbness and tingling in the median nerve distribution * nocturnal numbness * weakness and/or atrophy of the thenar musculature * demonstrate positive phalen's test of the affected extremity * demonstrate positive tinel's test of the affected extremity * sensory impairment defined as a loss of 2-point discrimination * have recent (within 3 months) electro-diagnostic evidence of carpal tunnel syndrome exclusion criteria:• currently receiving treatment for carpal tunnel syndrome * history of surgical carpal tunnel release * pregnancy * diabetes not controlled by medication * radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy * thoracic outlet syndrome * compromised skin integrity * past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand
nintendo wii virtual reality application in dementia

Conditions: Age-Related Memory Disorders

Summary: •this study was planned to investigate the effects of the nintendo wii virtual reality application on muscle strength and fall risk in individuals with ad. the aim of the present study is to investigate the effect of the virtual reality application on muscle strength and fall in individuals with alzheimer' dementia (ad).

purpose: this study was planned to investigate the effects of the nintendo wii virtual reality application on muscle strength and fall risk in individuals with ad. method: the study included a total of 32 volunteers between the ages of 65-80, with mild or moderate ad diagnosed. these individuals were divided into 2 groups as a training group and control group. the training group was trained with games from different categories such as balance and aerobic exercises with a nintendo wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes. mini-mental state test, knee extension muscle strength, timed up and go test, tinetti falls efficacy scale results of individuals were recorded in the evaluation.

Eligibility criteria:
inclusion criteria: * included volunteers between the ages of 65-80 with mild or moderate ad diagnosis, * who did not have any difficulty or problems in communicating, * who did not have any neurological diseases that disrupt balance and coordination such as a cerebrovascular event, parkinson's disease, multiple sclerosis, and neurological disorder, * who obtained a score of 18 - 24 points in the mini-mental state test (mmst) exclusion criteria: * patients diagnosed with rapidly progressing dementia (infection, vascular, hematologic diseases), * those who could not be contacted during the follow-up period or who did not participate in the training session, those who experienced cardiac and cerebrovascular events, endocrine disorders, fluid-electrolyte imbalance and infection, * those with malignancy and those who received chemotherapy and radiotherapy that causes malignancy, delirium or depression and malignant sensory loss (those with the semmes-weinstein monofilament thickness of 4.56 and above), * those with a lower or upper extremity amputation at any level

Keywords: alzheimer's dementia muscle strength fall virtual reality
concurrent use lymphoseek & indocyanine green in sentinel lymph node detection in endometrial cancer

Conditions: Endometrial Cancer

Summary: the goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.

primary objective: to determine the detection rate of bilateral sentinel lymph nodes with the concurrent use of lymphoseek and indocyanine green. secondary objective: (1) to determine the overall detection rate of sentinel lymph nodes with concurrent use of lymphoseek and indocyanine green (2) to determine location and number of lymphoseek-positive sentinel lymph nodes preoperatively by single-photon emission computed tomography (spect/ct imaging) and intraoperatively by a laparoscopic handheld gamma detection device and near- infrared fluorescent imaging (3) to determine the concordance of lymphoseek-positive sentinel lymph nodes with intraoperatively detected indocyanine green-positive sentinel lymph nodes.

Eligibility criteria:
inclusion criteria: * the patient has histological diagnosis of cancer of the endometrium of any histology or grade. * the patient should have received no prior treatment for her endometrial cancer. * the patient has clinically uterine confined disease. * the patient is a candidate for minimal invasive surgery, with sentinel lymph node assessment with ic-green planned as part of standard of care. * the patient has an eastern cooperative group (ecog) performance status of 0-2. * if age less than or equal to 55 years, the patient has a negative pregnancy test within 72 hours before administration of lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year. * the patient has provided written informed consent. * the patient is at least 18 years of age at the time of consent exclusion criteria: * the patient has clinical or radiological evidence of metastatic disease. * the patient has a history of a prior loop electrosurgical excision procedure (leep) or cone procedure performed on her cervix. * the patient has participated in another investigational drug study within 30 days of scheduled surgery. * the patient has an iodine allergy. * the patient is pregnant or lactating.
sequential versus quadruple therapy in the second-line treatment

Conditions: Helicobacter Pylori Infection

Summary: objectives: a recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. however, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. therefore, the investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the second line treatment.

this will be a multi-center, open labeled, randomized comparative trial patients: 240 patients with h. pylori infection who failed after first-line therapy will be eligible interventions: eligible patients will be randomized into one of the two groups group (a): sequential therapy for 14 days (s14) d1-d7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days d8-d14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days group (b): bismuth quadruple therapy for 10 days (q10) d1-d10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days primary end point: eradication rate in the second line treatment according to intention to treat (itt) analysis in the two treatment groups

Eligibility criteria:
inclusion criteria: * h. pylori infected patients who fail from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor will be eligible in this study. exclusion criteria: patients will be excluded from the study if any one of the following criteria was present: * children and teenagers aged less than 20 years, * history of gastrectomy, * gastric malignancy, including adenocarcinoma and lymphoma, * previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and ppi (esomeprazole), * contraindication to treatment drugs, * pregnant or lactating women, * severe concurrent disease, or * unwilling to accept random assignment of subjects.

Keywords: efficacy, self
efficacy, safety, and tolerability of nva237 compared to tiotropium in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study compared the efficacy and safety of nva237 with tiotropium in patients with moderate to severe copd. tiotropium belongs to the same drug class as nva237.

this was a randomized, blinded, double-dummy, parallel-group 12-week study to assess the efficacy, safety, and tolerability of nva237 (50 μg o.d.) compared to tiotropium (18 μg o.d.) in patients with chronic obstructive pulmonary disease (copd).

Eligibility criteria:
inclusion criteria: * patients with moderate to severe stable copd (stage ii or stage iii) according to the current gold guidelines (gold 2010). * patients with a post-bronchodilator forced expiratory volume in 1 second (fev1) ≥ 30% and \< 80% of the predicted normal, and a post-bronchodilator fev1/ forced vital capacity (fvc) \< 0.70 at screening * current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack/day x 10 yrs, or ½ pack/day x 20 yrs). * symptomatic patients, according to daily electronic diary data between visit 2 (day -14) and visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3. exclusion criteria: * pregnant or nursing (lactating) women * patients who, in the judgment of the investigator, or the responsible novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition before visit 1. * patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (bph patients who are stable on treatment can be considered). * patients receiving medications in the classes listed in the protocol as prohibited. other protocol-defined inclusion/exclusion criteria apply and can be found in the study protocol

Keywords: copd
bike skills training for children with cerebral palsy

Conditions: Cerebral Palsy

Summary: an assessor blinded multi-centre randomized controlled trial will be conducted in which 60 participants will be randomized to either a novel task-specific approach to training bike skills or a parent-led home program comparison group. baseline assessment will take place within 6 weeks prior to starting the intervention (t0) and outcomes will be assessed within a week following (t1); and at 12 - 14 weeks following (t2) the week long intervention. the primary outcome is attainment of individualised two-wheel bike specific goals at t1. all statistical analysis will be conducted on an intention-to-treat basis. logistic regression will be used to assess the effect of providing the novel intervention compared to the parent-led home program on bike-specific goal attainment.


Eligibility criteria:
inclusion criteria: * live in victoria, australia * diagnosis of cerebral palsy * aged 6 - 15 years * independently ambulant without mobility aids * have goals specific to two-wheel bike skills * have medical clearance to participate * have access to an appropriate bike and helmet * have a primary care giver who understands written and spoken english available to participate for each participant. exclusion criteria: * has a moderate to severe intellectual impairment * has a dual diagnosis with another developmental disability or medical condition that may impact on their ability or safety to train two-wheel bike skills. this includes; autism spectrum disorder, trisomy 21, spina bifida, uncontrolled epilepsy, significant visual or hearing impairment as determined by medical clearance from the child's general practitioner or paediatrician * had musculoskeletal surgery, or other major surgery including insertion of a baclofen pump that may affect their physical ability, in the 6 months prior to randomisation or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis) * has botulinum toxin-a (bont-a) injections to the lower limbs and/or upper limbs in the 6 months prior to randomisation, or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)

Keywords: motor learning participation
i vaccinate: testing multi-level interventions to improve hpv vaccination

Conditions: Cervical Carcinoma; Human Papillomavirus-Related Malignant Neoplasm

Summary: this trial studies how well a multi-level health system-based intervention works in improving human papillomavirus (hpv) vaccine initiation and completion among children in health systems in four appalachian states. utilizing educational and promotional materials and electronic health record reminders, may improve the uptake of the hpv vaccine in children and young adults, ultimately preventing the development of cervical cancer.

primary objective: i. test the effectiveness of a multi-level intervention (mli) directed at clinics, providers, and patients (parents of children aged 11-12) to improve hpv vaccine initiation and completion in health systems in four appalachian states (kentucky \[ky\], ohio \[oh\], west virginia \[wv,\] and virginia \[va\]) among children aged 11-12 and assess the effectiveness of the intervention program among subgroups, e.g., females versus (vs) males. secondary objectives: i. assess sustainability of the intervention. ii. assess cost impacts of the intervention iii. assess changes in clinic practices that occur as a result of the intervention in terms of staff responsibilities for the vaccination process and reducing missed opportunities for vaccination. iv. assess whether interventions focused on 13-26 year olds increases catch-up vaccination. v. examine changes in knowledge and attitudes of providers via educational session pre-post surveys. vi. satisfaction with the intervention at the multiple levels. outline: health systems are randomized to 1 of 2 arms. arm i (early intervention): health systems receive educational materials consisting of posters, brochures and table tents. providers complete survey about hpv knowledge, participate in educational session over 1 hour and receive educational handouts on the hpv vaccine. patients receive educational materials about hpv vaccine and reminder letters for hpv vaccination. arm ii (delayed intervention): health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in arm i.

Eligibility criteria:
inclusion criteria: clinic * located in one of the counties that are part of this program * provides care to patients aged 11-26 * provides immunizations health care providers (physicians, nurses) and office staff * practicing in a clinic in one of the participating health systems * personnel involved in the vaccine process (determined by individual clinics) * able to speak, read, and write english
multicenter cohort prospective study on multidisciplinary treatment of rectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to describe the diagnostic and treatment procedures employed for patients with rectal cancer in each participating center. outcomes to treatment, costs of treatment will be described. exploratory analyses will be done to identify factor that influence patient prognosis, as well as factors that predict patient response to treatment.


Eligibility criteria:
inclusion criteria: * histologic diagnosis rectal carcinoma * signed informed consent exclusion criteria: * refusal or incapability of providing informed consent
laparoscopic intersphincteric resection in elderly patients

Conditions: Rectal Cancer

Summary: the aim of the present study is to assess if it is possible to offer intersphincteric rectal resection (irr) to selected patients older than 70 years affected by ultra-low rectal cancer. the study, involving patients with rectal cancer at less than 5 cm from the anal verge, will compare elderly patients refusing standard sphincteric demolition and undergoing irr, with some control groups (younger patients undergoing irr, \>70 years old patients undergoing abdominoperineal resection + colostomy in left iliac fossa, \>70 years old patients undergoing abdominoperineal resection + perineal colostomy). the groups will be compared in terms of quality of life, quality of life associated to incontinence, overall survival, disease free survival and post-operative complications. this will be helpful to identify conditions for extending irr to elderly patients. the study is run by colo-rectal surgery unit at policlinico san matteo in pavia (italy) from 2009 to 2016, directly led by dr. sandro zonta (principal investigator) and funded by the hospital itself.


Eligibility criteria:
inclusion criteria: * patients over 70 years old who were affected by rectal cancer sited lower than 5 cm from anal verge and refused abdomen-perineal treatment. exclusion criteria: * cancer extension over internal sphincteric muscle (t4) evaluated through mri during staging work out; * diabetic neuropathy conditioning previous partial/total incontinence; * other pre-existing pathological condition affecting faecal incontinence.

Keywords: intersphincteric resection elderly rectal cancer
harmony tpv emea pms

Conditions: Severe Pulmonary Valve Regurgitation

Summary: the harmony transcatheter pulmonary valve (tpv) system is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.

prospective, non-randomized, multi-center, post-market interventional clinical study

Eligibility criteria:
inclusion criteria: 1. subject eligible to receive harmony tpv system in conformity with instructions for use (ifu) and local regulations at time of study enrollment. 2. subject or subject's parent(s)/legal guardian(s) must be willing and able to consent to participate in the study and will commit to completion of all follow-up requirements exclusion criteria: 1. obstruction of the central veins. 2. planned concomitant branch pulmonary artery stenting at time of implant. 3. subjects previously treated with an rv-pa conduit or previously implanted bioprosthesis. 4. a major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year. 5. planned implantation of the harmony tpv in the left heart. 6. echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 7. pre-existing prosthetic heart valve or prosthetic ring in any position 8. subject is pregnant as confirmed by a positive pregnancy test before implant procedure for female subjects of childbearing potential. 9. subjects that are vulnerable as defined in the section 10.5 subject consent subject consent section excerpt: * vulnerable adults, defined as subjects incapable of giving consent, as assessed per investigator's opinion and in consideration of vulnerable adult definition per iso 14155, will not be included in this study. * any subject with mental incompetence (e.g. alzheimer's, dementia, psychiatric disorders, developmental disorders, chromosomal abnormalities with associated cognitive impairment) should be assessed by the investigator for vulnerable status. if pediatric or adult subject is deemed by the investigator mentally incompetent as described above, the subject will not be included in this study.

Keywords: harmony tpv severe pulmonary regurgitation pulmonary valve replacement
microrna as markers in testicular cancer

Conditions: Testicular Germ Cell Cancer; Seminoma; Non-Seminoma Testicular Cancer; Stage I Testicular Cancer; Stage II Testicular Cancer; Stage III Testicular Cancer; Stage IV Testicular Cancer; Relapse Testicular Cancer

Summary: the main objective of this study is establish the performance of mir371 in management of testicular cancer

the main objective of the study is to asses the sensitivity and specificity of microrna-371a-5p (mir371) in detection of viable testicular germ tumour cells. to assess the utility of mir371 at orchiectomy, during treatment and surveillance and in early detection of recurrence.

Eligibility criteria:
inclusion criteria: * patients with suspected testicular cancer, referred to orchiectomy. * patients diagnosed with testicular germ cell cancer. * age 18-70 years of age. * must be able receive information and to consent. exclusion criteria: * other prior or concomitant malignancy (other than testicular cancer). * other diseases or conditions that hinder the ability to receive information and to participate in follow-up procedures.