Kornimate/medical-research-clean huggingface dataset:
cohorts and collections: clinical and genetic study of parkinson's disease and epilepsies

Conditions: Parkinson's Disease; Epilepsy

Summary: the dna and cell bank of instituts federatifs de recherche (ifr) of neurosciences has been running for the last 15 years at the institut national de la santé et de la recherche médicale (inserm) unit 679 (former unit 289). since its creation, this structure has been the support of research projects in genetics for neurological and psychiatric disorders. the cohorts established have led to discoveries in monogenic disorders, such as cerebellar ataxias, spastic paraplegias, frontotemporal dementias, epilepsies, parkinson's and alzheimer's disease, charcot-marie-tooth disease and related entities. the research projects based on the study of the genetic bases in parkinson's disease and epilepsies are especially developed for this grant. concerning parkinson's disease, the project is based on the extension of the existing cohort throughout the french parkinson's disease study group network. concerning epilepsies, this project is the occasion to build this network with the constitution of a new cohort. the specific aims of the scientific projects are the following for parkinson's disease: * to evaluate the frequency, the nature and the phenotype associated with parkin mutations in familial or sporadic forms of the disease, according to the age at onset, and * to identify the genetic susceptibility factors in parkinson's disease with the study of affected sibpairs and with case/controls association studies. for epilepsies, the aims are: * to evaluate the frequency, the nature and the phenotype associated with scn1a, scnab and gabr2 gene mutations in familial or sporadic forms of the affection associated with febrile seizures, and * to search for an intervention scn1a, scn1b and gabrg2 as susceptible genes in these forms of epilepsies.


Eligibility criteria:
inclusion criteria: * patients presenting with parkinson's disease, with a family history or not, * minors presenting clinical signs of the disease, * controls (without signs of the disease), matched by sex and age with the patients, * relatives for the familial cases, * patients presenting with an epilepsy episode (myoclonic epilepsy of the newborn, with febrile seizures, of the frontal lobe) exclusion criteria: * lack of signed informed consent

Keywords: parkinson's disease parkin epilepsy phenotype-genotype correlations ionic channels
a single-blind, dose-tapering study of kwa-0711 in patients with chronic constipation

Conditions: Chronic Constipation

Summary: the purpose of this study is to evaluate the efficacy and safety of tapered kwa-0711 dose in chronic constipation patients.


Eligibility criteria:
inclusion criteria: * the patients who experienced fewer than three spontaneous bowel movements per week for more than 6 months prior to the enrollment. * the patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation exclusion criteria: * patients who have secondary constipation caused by systemic disorder. * patients who have organic constipation. * patients who received intestinal resection.

Keywords: chronic constipation constipation functional gastrointestinal disorders
design, implementation, and evaluation of virtual reality in the nursing curriculum

Conditions: Pressure Ulcer

Summary: the aim of the study is to determine the effectiveness of an immersive virtual reality learning programme for nursing students, based on virtual glasses, in acquiring the competence (knowledge, skills and attitudes) to care for patients with pressure ulcers, and to compare it with the traditional teaching method. the design was an exploratory randomised controlled trial. the variables used to measure effectiveness were competence and its attributes: knowledge assessment by a multiple-choice test (pressure ulcer knowledge assessment tool, pukat 2.0 instrument), skill performance by direct observation of procedural skills (simulated cases with standardised patients) and satisfaction and usability assessment (usefulness, satisfaction and ease of use questionnaire).

the study was a prospective, randomized, double-blind controlled trial conducted from march to may 2022 at a nursing faculty. the participants were second-year nursing bachelor degree students from a university in the north of spain. a convenience sample of students in the second year of the nursing program participated in the study. according to the sample size calculation for a two-tailed independent t-test, conducted using the g\*power 3.1.9 program, with a type i error rate of 0.05, power of 0.80, and an effect size of 0.71, the estimated minimum required sample size was 33. the recommended sample size was 40 participants per group, accounting for a 10% allowance for withdrawals, missing data, and lost follow-up. after registering to enrol in the study, 127 students were screened by the researchers for eligibility. of these, 99 volunteers met the inclusion criteria and were contacted to schedule the pre-test phase. following the pre-test assessment, participants were randomly assigned to either the intervention group (50 students) or the control group (49 students) at a 1:1 allocation ratio using a computer-generated assignment. during the study, three participants in the intervention group and two in the control group were excluded due to missing follow-up (refusal to continue in the research), and one student in the control group was removed by statistical analysis. in total, 93 participants were included in the data analysis. data was collected from february to may, a period during which the students did not have exams. the demographic information form included fields for age, gender, specific learning related to pressure ulcer care at degree level, and previous experience with virtual reality devices and environments.

Eligibility criteria:
inclusion criteria: * students enrolled in the 2rd year of nursing at the faculty of nursing of the university of navarra and who voluntarily agree to participate in the study. exclusion criteria: * students who had acquired the skill of caring pressure ulcers in advance.

Keywords: virtual reality,
vagal nerve stimulation in enhanced stroke recovery: the valor registry

Conditions: Chronic Ischemic Stroke

Summary: vagal nerve stimulation is a novel proven therapy for patients with chronic ischemic stroke. the primary objective of this registry is to assess the safety of vagal nerve stimulation for stroke recovery through monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. this registry will monitor patients undergoing vns for stroke recovery in the mount sinai health system and collect clinical and procedural details, objective outcomes, and patient-reported outcomes associated with vagal nerve stimulation for stroke recovery.

the vagal nerve stimulation device implantation is a common, standardized neurosurgical procedure that has been performed for over two decades for the treatment of epilepsy and depression and has recently been approved for chronic ischemic stroke. the intended purpose of this registry is to monitor the safety, feasibility, and efficacy of vagal nerve stimulation for stroke recovery. this will be accomplished by monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. the secondary objectives of this study focus on the feasibility and efficacy of employing vagal nerve stimulation for ischemic stroke recovery, as well as obtaining qualitative data on the experience associated with stroke rehabilitation paired with vns. additional research questions regarding vagal nerve stimulation for stroke recovery may be addressed as well.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all procedures in the vns-enhanced stroke recovery program * aged 18 or older * history of ischemic stroke * upper extremity weakness * planned to undergo vns implantation exclusion criteria: * unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, prior injury to the vagus nerve etc.). * medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline.
an efficacy and safety study with licroca depot, a controlled release product, injected into the prostate

Conditions: Prostate Cancer

Summary: the primary objective was to evaluate efficacy of a single dose of liproca depot in patients with localized prostate cancer. primary efficacy variable was the proportion of patients showing psa nadir. 24 caucasian men, with a mean age at inclusion of 68.4 years, with localized prostate cancer were injected once with a ready made paste including 600 mg 2-hydroxyflutamide (liproca depot) into the site of the prostate where the tumour was localized. the patient was monitored for prostate-specific antigen (psa) for maximum 6 months or to progression within this time period. the primary endpoint showed interesting results with high success rate (83%), i.e. proportion of patients (responders) that reached plasma psa nadir.

patients with localized prostate cancer were followed to progression or maximum 24 weeks after a single injection in one lobe of 2-8 ml ready-made paste (corresponding to 400-1600 mg 2-hydroxyflutamid). progression was defined as an increase in psa by \> 25% over baseline or on-treatment nadir.among the 24 patients the primary endpoint, plasma psa nadir, was reached by 20 patients (responders). efficacy was measured primarily as psa nadir, and secondly as time to psa nadir and prostate volume change. safety was monitored throughout the whole study period.

Eligibility criteria:
inclusion criteria: 1. age ≥ 45years 2. histologically confirmed localized prostate cancer (t1-t2), predominantly in one side of the peripheral zone, verified by biopsy. 3. psa value \< 20 ng/ml within 6 weeks before enrolment. 4. gleason score ≤ 3+4 at diagnostic biopsy 5. adequate renal function: creatinine \< 1.5 times upper limit of normal. 6. adequate hepatic function: asat, alat and alp \< 1.5 times upper limit of normal. 7. negative dipstick for bacturia. 8. patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit. exclusion criteria: 1. previous or ongoing hormone therapy for prostate cancer. 2. ongoing or previous therapy (within3 month) of finasteride or dutasteride. 3. ongoing or previous invasive therapy for benign prostate hyperplasia (turp, tumt). 4. symptoms or signs of acute prostatitis. 5. symptoms or signs of ulceric proctitis 6. severe micturation symptoms (i-pss \>17) 7. concomitant systemic treatment with corticosteroids, or immunomodulating agents. 8. known immunosuppressive disease (e.g. hiv, insulin dependent diabetes). 9. simultaneous participation in any other study involving not market authorized drugs or having participated in a study within the last 12 months prior to start of study treatment.

Keywords: prostate cancer
a single and multiple ascending dose study with azd9164 given for 13 days in healthy male and female japanese subjects

Conditions: Healthy

Summary: this is a single centre, double blinded, randomised, placebo-controlled, parallel group study to access the safety, tolerability, and pharmacokinetics of inhaled azd9164 after administration of single and multiple ascending doses in japanese subjects.


Eligibility criteria:
inclusion criteria: * healthy japanese subjects with suitable veins for cannulation or repeated venipuncture * have a body mass index (bmi) between 18 and 27 kg/m2 and a body weight between 50 and 85 kg * male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

Keywords: phase i japanese healthy volunteer azd9164
a study of pf-05190457 in healthy volunteers and type-2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to evaluate the safety and tolerability of pf-05190457 after administration of multiple doses to healthy volunteers and type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.


Eligibility criteria:
inclusion criteria: * healthy males and females of non-childbearing potential between ages of 18 and 55 years, bmi of 18.5 to 30.5 kg/m\^2, and weight between 50 and 100 kg, inclusive. * type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, bmi of 18.5 to 40.0 kg/m\^2, weight between 50 and 150 kg, and hba1c of 7.0-10.0%, inclusive. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.

Keywords: phase 1 multiple ascending doses safety pharmacokinetics healthy volunteers type 2 diabetic patients
the rilpivirine cerebrospinal-fluid (csf) study

Conditions: HIV

Summary: this is a phase i pharmacokinetic study of hiv positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. on day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. the participants will then restart their original regime with nevirapine.

to investigate the following parameters in hiv-infected patients switching antiretroviral therapy from tdf/ftc/nevirapine to tdf/ftc/rilpivirine for 60 days: * csf exposure and csf : plasma ratio of rilpivirine * safety and tolerability of switching antiretroviral therapy from tdf/ftc/nevirapine to tdf/ftc/rilpivirine * changes in cerebral metabolites measured via 1-h mrs after switching antiretroviral therapy to tdf/ftc/rilpivirine * seminal fluid exposure of rilpivirine

Eligibility criteria:
inclusion criteria: * hiv-1 infected males subjects * signed informed consent * willing to switch therapy as per study protocol * no previous exposure to rilpivirine * plasma hiv rna \< 50 copies/ml at screening and on at least one other occasion over the last 3 months * currently receiving a stable antiretroviral regimen comprising of tdf/ftc with nevirapine with nevirapine dosed either 200 mg twice daily or 400 mg once daily with no antiretroviral drug switches for at least 3 months * no clinically-significant resistance documented on any prior hiv-1 genotypic resistance testing * subjects in good health upon medical history, physical exam, and laboratory testing * bmi above or equal to 18 and below 32 * male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom and diaphragm) during heterosexual intercourse, from screening through completion of the study. * have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance * no contraindications to having a lumbar puncture examination found on mri of the brain exclusion criteria: * current alcohol abuse or drug dependence * positive urine drug of abuse screening * active opportunistic infection or significant co-morbidities * current disallowed concomitant medication (as listed in section 4.1.3) * contraindication to mr examination or lumbar puncture examination * recent head injury (in last 30 days) or chronic ongoing neurological diseases

Keywords: rilpivirine csf pharmacokinetics
clinical study evaluating safety of pentoxifylline and celecoxib in patients with grand-mal epilepsy treated by phenytoin monotherapy

Conditions: Epilepsy

Summary: epilepsy is a chronic neurological disorder affecting millions of people all over the world. epileptic seizures are caused by abnormal synchronized electrical neuronal discharges that could be either focal or widespread. pathogenesis of epilepsy involves multiple processes including genetics, oxidative stress, ion channels, neuroinflammation, and cellular damage through autophagy and apoptosis. neuroinflammation is considered one of the most important factors contributing critically to epileptogenesis.


Eligibility criteria:
inclusion criteria: - patients aged ≥ 18 years old. patients with grand mal epilepsy on phenytoin monotherapy. women with a negative pregnancy test and women on effective contraception exclusion criteria: - patients with significant liver and kidney function abnormalities. alcohol and/or drug abusers. patients with known allergies to the study medications patients with known allergy to sulfonamides (cross hypersensitivity with celecoxib). pregnant women and women with a planned pregnancy. subjects on medication are known to have possible positive effects on epilepsy. patients who are currently using other antiepileptic drugs. patients with cvd and a history of coronary artery bypass graft (cabg) surgery. patients on aspirin or fluconazole therapy patients with a recent retinal or cerebral hemorrhage
a phase 1 study of the safety and pharmacokinetics of ags-16m18 in subjects with advanced renal cell cancer

Conditions: Carcinoma, Renal Cell; Kidney Neoplasms; Kidney Diseases

Summary: this is a first in human study of ags-16m18 given every week to subjects with advanced renal cell cancer. ags-16m18 will be administered as a 60 minute iv infusion on consecutive days until the disease worsens.

subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard, dose escalation study design. a disease assessment will be performed at study week 5 (+/- 3 days) by the investigator. the assessment will be based both on changes in clinical symptoms, and radiographic images. subjects without evidence of disease progression may receive ags-16m18 extended therapy at the dose and schedule of their assigned cohort until disease progression or intolerability of ags-16m18. disease assessments will be performed every 8 weeks during the extended period. a safety follow-up visit will occur 4 weeks after the last infusion of ags-16m18.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amendable to cure by surgery or other means, and must have failed at least one prior systemic therapy, including but not limited to treatment with sunitinib, temsirolimus or sorafenib * evaluable/measureable disease according to response criteria for solid tumors * eastern cooperative group performance status of 0-1 * therapeutic anti-coagulation (pt, and/or inr, ptt) permitted, if clinically stable and \>/= 3 months from initiation exclusion criteria: * past or present documented central nervous system (cns) tumor or cns metastasis * use of investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer) * history of thromboembolic events and bleeding disorders \</= 3 months (e.g., dvt or pe) * major surgery (that requires general anesthesia) within 4 weeks of study enrollment

Keywords: clinical trial, phase 1 carcinoma, advanced renal cell kidney pharmacokinetics safety ags-16m18
correlation between motor control dysfunction and radiographic parameter in non specific chronic low back pain

Conditions: Chronic Non Specific Low Back Pain

Summary: this study aims to investigate the relationship between motor control dysfunction (mcd) and radiographic parameters in non-specific chronic low back pain (nsclbp). participants will undergo specific clinical motor control tests and lumbar spine x-rays to evaluate the alignment and coordination of spinal and pelvic structures. understanding this relationship may help improve rehabilitation strategies and reduce pain in affected individuals.

non-specific chronic low back pain (nsclbp) is a common musculoskeletal condition associated with impaired neuromuscular coordination and motor control dysfunction (mcd). this study seeks to determine the correlation between mcd and radiographic parameters including pelvic incidence (pi), pelvic tilt (pt), sacral slope (ss), and lumbar lordotic angle (lla). a total of 64 participants aged 20-40 with nsclbp will be evaluated at the faculty of physical therapy, cairo university. motor control will be assessed using a pressure biofeedback unit in two positions (crock lying and prone) via the abdominal draw-in maneuver (adim). radiographic measurements will be taken using lateral lumbar spine x-rays in standing posture. the aim is to identify whether poor activation of deep stabilizing muscles (transverse abdominus and multifidus) correlates with abnormal pelvic alignment and altered spinal curvature. outcomes may support more effective personalized rehabilitation protocols targeting neuromuscular control to improve spine-pelvis function in nsclbp patients. statistical analysis will include pearson correlation to test for associations between motor control test performance and radiographic angle values.

Eligibility criteria:
inclusion criteria: * . patients diagnosed with non-specific chronic low back pain (nsclbp) for more than 3 months * age between 20 and 40 years * both males and females * body mass index (bmi) between 18.5 and 29.9 * no physical therapy or medical treatment during the last 3 months * able and willing to provide informed consent exclusion criteria: * • patients with specific causes of low back pain (e.g., disc herniation, fractures, tumors, infections) * history of spinal or lower limb surgery or injury * radiculopathy or neurological disorders affecting motor control * diagnosed spinal deformities (e.g., scoliosis, spondyloarthropathy, ankylosing spondylitis) * contraindications to x-ray (e.g., pregnancy) * patients currently undergoing physical therapy or medical intervention

Keywords: lumbar motor control dysfunction lumbopelvic parameters radiographic alignment transverse abdominis multifidus