Kornimate/medical-research-clean huggingface dataset:
a study to investigate the safety, efficacy and pk of multiple doses of ql-007 in chronic hepatitis b patients in china

Conditions: Chronic Hepatitis b

Summary: this is a randomized, open-label, positive-control, dose-escalation phase 1b trial in 60 patients with chronic hbv infection to determine the safety, preliminary efficacy, and pharmacokinetics (pk) of ql-007 after administration over 28 days of multiple oral doses in a fasted state at the following planned dose levels: 200, 400, and then 600 mg.

this is a randomized, open-label, positive-control, dose-escalation phase 1b trial in 60 patients with chronic hbv infection to determine the safety, preliminary efficacy, and pharmacokinetics (pk) of ql-007 after administration over 28 days of multiple oral doses in a fasted state at the following planned dose levels: 200, 400, and then 600 mg.

Eligibility criteria:
inclusion criteria: * chronic hepatitis b infection, defined as positive test for hepatitis b surface antigen (hbsag) for more than 6 months prior to randomization * hbv dna at screening greater than or equal to (\>/=) 2 × 10\^4 international units per milliliter (iu/ml) for hepatitis b e antigen (hbeag) positive participants, or \>/=2 × 10\^3 iu/ml for hbeag-negative participants * alt\> 1 x upper limit of normal (uln) and \< 10 x upper limit of normal (uln) * anti-hbv treatment-naive adults; adults who have taken oral anti-hbv nucleoside therapy with the last dose ≥4 weeks prior to screening are also eligible. * signed informed consent. exclusion criteria: * known co-infection with hiv, hepatitis c virus (hcv) or hepatitis d virus (hdv) * presence of autoimmune disorders * history of liver disease other than hepatitis b * history of gilbert's disease * any sign of decompensated liver disease * known or suspected cirrhosis * evidence of hepatocellular carcinoma * patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months) * pregnant or lactating females * diabetes * alcohol or substance abuse * history of bleeding diathesis * patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator. * history of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric or neurological disease.
visual (path)ways in multiple sclerosis - part ii

Conditions: Multiple Sclerosis, Optic Neuritis, Demyelinating Disease

Summary: multiple sclerosis (ms) is an inflammatory demyelinating and degenerative disease of the central nervous system. the mechanisms of neuro-axonal loss remain incompletely elucidated. an acute demyelinating lesion will produce both immediate and delayed axonal loss. immediate axonal loss is linked to the occurrence of axonal transection. delayed axonal loss is the cause of axonal degeneration in progressive ms. visual impairment is common in the disease (vision, oculomotricity, cognition). through a longitudinal multimodal analysis of visual pathways, we would like to investigate physiopathological mechanisms leading to neurodegenerative process and visual impairment.


Eligibility criteria:
patients with relapsing-remitting multiple sclerosis receiving high-efficacy or non-high-efficacy treatment and follow-up at the crcsep of the lille university hospital through past participation in the vwims study. inclusion criteria: * male and/or female participants in the vwims research project * at least 18 years of age at the time of inclusion in vwims - ii * patient having given written consent to participate in the study * socially insured patient * patient willing to comply with all study procedures and duration exclusion criteria: * age \< 18 years * other neurological pathologies that may interfere with mri and/or oct data (diabetes, retinopathy \[any cause\], glaucoma, retinal detachment, ametropia \> 6 diopters) * contraindications to mri (claustrophobia, incompatible metal foreign bodies such as certain pacemakers and mechanical valves, cochlear implants, intra-orbital metal splinters, pregnancy, certain brands of iud because of the 3 tesla magnetic field). * contraindication to injection: severe renal failure with creatine clearance \<30, allergy to contrast media, pregnancy, breast-feeding. * pregnant women * nursing women * persons incapable of giving consent on their own, with or without legal protection (guardianship/curatorship) * person under legal protection * persons deprived of their liberty * administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent form

Keywords: multiple sclerosis, cognition, oct, mri, visual impairment
effect of pelvic control exercises in stroke

Conditions: Stroke

Summary: the purpose of the study is to investigate the combined effect of pelvic and trunk control exercises on muscle performance of affected upper extremity in stroke patients.

the study conducted on forty stroke patients. they assessed by biodex system 3 pro isokinetic, modified ashworth scale(mas), fugel meyer assessment scale (fmas), box and block test and hand grip dynamometer. patients divided into control group and study group. the control group treated by a traditional physical therapy program.the study group treated by the traditional physical therap program in addition to pelvic and trunk control exercises for 40 min.

Eligibility criteria:
inclusion criteria: * patient's age will range from 45 - 60 years. * muscle tone grade will range from 1 to 1+ according to modified ashworth scale. * duration of illness will range from 6 to 18 months after stroke onset. * ability of the patient to stand without assistive devices. exclusion criteria: * • other neurological or musculoskeletal disorders that might affect pelvic alignment such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures, contractures of fixed deformity or leg length discrepancy. * severe chronic back and/or knee pain that might affected standing posture. * recurrent stroke * shoulder or upper limb injury that might affect the recovery. * perceptual or cognitive dysfunctions. * bmi \> 30
a study on safety, tolerability and pharmacokinetics of ro5303253 in healthy volunteers and patients with chronic hepatitis c genotype 1

Conditions: Hepatitis C, Chronic, Healthy Volunteer

Summary: this randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of ro5303253 in healthy volunteers and patients with chronic hepatitis c genotype 1. in part a, cohorts of healthy volunteers will be randomized to receive single ascending doses of ro5303253 or placebo. in part 2, healthy volunteers will receive a single dose of ro5303253 or placebo in a cross-over design (with a washout period of at least 7 days) to assess food effects on pharmacokinetics. in part 3, patients with chronic hepatitis c will be randomized ro receive either ro5303253 or placebo for 5 days.


Eligibility criteria:
inclusion criteria: * healthy volunteers or patients with chronic hepatitis c genotype 1, 18 to 60 years of age * patients must be treatment-naïve for antiviral therapy for chronic hepatitis c with interferon based therapy * body mass index (bmi) 18 - 32 kg/m2 inclusive, minimum weight 45 kg * females must be surgically sterile or menopausal * male subjects and their partners of childbearing potential must use 2 methods of contraception throughout the study and for 70 days after the last dose exclusion criteria: * pregnant or lactating women and male partners of women who are pregnant or lactating * women with reproductive potential * positive for hepatitis b or hiv (or hepatitis c for healthy volunteers) at screening * for hepatitis c patients: decompensated liver disease or impaired liver function, evidence of cirrhosis documented at any time, presence or history of non-hepatitis c chronic liver disease
effects of dance on the turning characteristics of patients with parkinson's disease

Conditions: Parkinson Disease(PD)

Summary: the proposed control intervention trial, aims to analyse the effects of dance in the turning characteristics in patients with parkinson disease (pd) using three- dimensional (3d) analysis during the timed up and go (tug) test.

experimental design: control intervention non-randomized trial. search location: university of wolverhaptom, walsall campus, united kingdom; federal university of rio grande do sul, brazil. participants: 15 adults aged between 50 and 80 years, with a clinical diagnosis of idiopathic pd, staging between 1 and 4 of the hoehn \& yahr scale, recruited from dance for parkinson's projects, west-midlands county, united kingdom, and from parkinson's uk (united kingdom). interventions: dance intervention for 3 months, 2 times/week (1 instructor lecture session and 1 home session following a prepared video), 2 hours per week. controls, not alter their personal lifestyle, but undergo the same testing as the exercise intervention group. outcomes: clinical-functional parameters (number of steps and total time of the 180 turning phase of the timed up and go test - tug - and biomechanics parameter - girdle dissociation) data analysis: data will be described by average values and standard deviation values. all statistical analyses will be carried out using spss version 23, and microsoft excel program version 16.44. the significance level is set at p\<0.05. the cohen's d is going to be used to predict effect interpreted as small d= 0.2, medium d=0.5, and large d=0.8, and 95% confidence intervals were presented.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pd according to the london brain bank criteria; * able to understand the verbal instructions for the tests and to walk; * or attempt to walk independently with no walking aid. exclusion criteria: * recent surgeries, * deep brain stimulation (dbs); * severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year; * fitted with a pacemaker; * prostheses in the lower limbs; * stroke or other associated neurological diseases.

Keywords: dance functional mobility turning
comparing optical coherence tomography (oct) and visual acuity outcomes in subjects undergoing cataract surgery, who receive xibrom ophthalmic solution and standard presurgical care vs. xibrom ophthalmic solution plus prednisolone acetate 1% and standard presurgical care

Conditions: Cataracts

Summary: to compare the efficacy of twice-daily topical bromfenac (xibrom) ophthalmic solution alone versus twice-daily topical xibrom with prednisolone acetate 1% three-times daily on visual acuity and oct measurements.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age. * expectation of 20/25 best corrected visual acuity (bcva) post-operatively. * patients should be in good general health and devoid of recognized risk factors for cme. * patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy) * patients must be likely to provide informed consent, take study medications as directed, and complete all study visits * only one eye of each treated patient may be included in the study exclusion criteria: * any known contraindications to any study medication or their component * presence of uncontrolled systemic disease * required use of other ocular medications during the study o artificial tears may be used * diabetics with any clinically evident or history of retinopathy * individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation * abnormal pre-operative oct (if obtainable)
a phase 3 clinical study of khk4827

Conditions: Psoriasis

Summary: this study is designed to evaluate safety and efficacy of long-term exposure of khk4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding study 4827-002.


Eligibility criteria:
inclusion criteria: * subject has voluntarily signed the written informed consent form to participate in this study * subject has completed the week 12 evaluation of study 4827-002 exclusion criteria: * subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration) * subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators
multicentre evaluation of bucco-dental health in patients with schizophrenia in côte d'or

Conditions: Schizophrenia

Summary: the aim of this study is to know the bucco-dental status of patients with schizophrenia in côte d'or. participation in this study will last only as long as it takes to: * carry out a bucco-dental examination: evaluation of dental plaque and calculus * take a blood sample to assess needs in vitamin c (only for patients included at dijon chu and chs chartreuse) * complete a 30-minute questionnaire: clinical data and answers to questions concerning dental hygiene and eating habits.


Eligibility criteria:
inclusion criteria: * patients who have provided consent * patients over 18 years of age * persons with schizophrenia according to the icd 10 criteria and followed in hospital (complete or day hospital) in one of the hospitals taking part in the study exclusion criteria: * adult under guardianship * patient not covered by national health insurance * pregnant or breast-feeding women * patients not stabilized from a psychiatric viewpoint * patients experiencing an acute psychiatric episode * impossibility to understand and /or poor understanding of french
a study to compare early and partial weight-bearing after hallux valgus surgery

Conditions: Hallux Valgus; Orthopedic Disorder

Summary: this is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified lapidus arthrodesis with/without an akin or a weil/hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks as a novel approach for rehabilitation after a foot surgery.

the surgical operation will be carried out according to the standard clinical practice, namely following the modified lapidus general and specific rules concerning the surgical treatment of hallux valgus with/without an akin or a weil/hohmann surgery fusion. post-operatively, patients who meet the eligibility criteria will be randomized into one of the two groups (partial weight-bearing limited at 15kg vs full weight-bearing) patient in both groups will be wearing a vacopaso shoe for 6 weeks. standard x-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at weeks 6, 12, 24. change in pain severity from the day of surgery to 6, 12 and 24 weeks postoperatively will be measured using the pain visual analogue scale (vas). quality of life will be assessed through the american orthopedic foot and ankle score (aofas). subjective functional recovery through the olerud and molander ankle score (omas).

Eligibility criteria:
inclusion criteria: * patient who undergo modified lapidus arthrodesis operation and associated with: * additional surgical gestures such as e.g. interventions on the proximal phalanx of the first finger (akin) or interventions on the 2nd and / or 3rd ray (weil / hohmann) \[23,24\]. * willingness and ability to participate in the trial * signed informed consent exclusion criteria: * diabetes mellitus * rheumatoid arthritis * previous foot surgery * classic lapidus surgery * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc. * inability or contraindications to undergo the investigated intervention * pregnant women

Keywords: quality of life bone consolidation foot surgery lapidus surgery weil surgery hohmann surgery akin surgery
transcranial magnetic stimulation (tms) for primary progressive apraxia of speech (ppaos)

Conditions: Apraxia Speech

Summary: the purpose of this study is to assess the influence of transcranial magnetic stimulation (tms) on speech performance in individuals with primary progressive apraxia of speech.

apraxia of speech (aos) is a motor speech disorder affecting the programming of motor speech production. it is characterized by the impaired ability to coordinate the sequential, articulatory movements necessary to produce speech sound. it can result from insult to the brain, such as in stroke, or as the presenting sign/symptom of another neurodegenerative disease. tms is a neurostimulation technique which has been shown to modulate cortical excitability in a non-invasive manner, and has been associated with positive outcomes in a variety of neurological and psychological disorders.there is evidence to support the role of tms in individuals with primary progressive aphasias. in addition, there is a a case report suggesting an improvement in speech following tms in an individual with primary progressive aos. this study is being undertaken to further examine the role of tms in primary progressive aos.

Eligibility criteria:
inclusion criteria: * adults ages 18 and above who are able to consent * diagnosis of primary progressive apraxia of speech based on neurological evaluation exclusion criteria: * any uncontrolled medical condition expected to limit life expectancy or interfere with participation in the trial (i.e. unstable cancer, severe depression or anxiety by dsm-iv criteria) * abnormal stress test, as determined by the treating physician (unless cardiology clearance provided) * active substance abuse or alcohol dependence * uncorrected vision or hearing deficits that would preclude administration of the cognitive measures * unwilling or unable to provide written informed consent * history of fainting spells of unknown or undetermined etiology that might constitute seizures * history of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) eeg or family history of treatment resistant epilepsy * no medication is an absolute exclusion from tms. medications will be reviewed by the responsible md and a decision about inclusion will be made based on the following: * the subject's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other cns active drugs. * the published tms guidelines review medications to be considered with tms * any metal in the brain, skull or elsewhere unless approved by the responsible md * any medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible md * substance abuse or dependence within the past six months * absence of corticospinal functional integrity
head-mounted vibrotactile prosthesis for patients with chronic postural instability

Conditions: Dizziness

Summary: the goal of this project is to provide individuals that have a balance deficit with a device that will give them signals that they can feel (vibrations) in order to help them maintain a correct sense of balance and perception of place in the environment.

this proposal addresses a national institute on deafness and other communication disorders (nidcd) research topic that emphasizes the "development of assistive devices for balance disorders". the proposed work will evaluate the assistive efficacy of such a balance prosthesis in a population of chronic imbalance patients spanning a wide range of disease etiologies.

Eligibility criteria:
inclusion criteria: * ambulatory patients who have had chronic imbalance for at least one year, and have reached a functional performance plateau with respect to their balance adaptation. exclusion criteria: * neurological disorders other than chronic balance disorders, as determined by medical history and neurological screening procedure. * any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests. * peripheral neuropathies of the lower extremities. * subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.

Keywords: chronic imbalance vestibular disorders balance prosthesis
sensitivity of organoids to predict treatment outcome in breast cancer metastases

Conditions: Breast Neoplasms

Summary: the aim of the study is to generate patient-derived organoids (pdos) from brain resection or biopsied extra-cranial metastases. the preliminary data collected will be used to assess the ability of pdos to predict patients' treatment response and their radio-sensitivity and chemo-sensitivity can be correlated with their survival outcome.

the soto-bc trail is an observation study and the patients will continue their clinical visits and follow-up as per normal standard of care. patient cohorts: 1. breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy (srs or whole brain radiotherapy) 2. breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy primary objective: to assess the percentage of successful generated organoids from resected brain or resected/biopsied extra-cranial metastases of breast cancer patients secondary objectives: 1. to assess the sensitivity of radiotherapy in pdos 2. to assess the sensitivity of the same systemic treatments that the patients previously had and will have in pdos 3. to correlate the treatment sensitivities of pdos above with the treatment outcome of patients 4. to correlate ic50 doses/dose response curves above with the objective response rates of patients undergoing same systemic treatment study procedures: breast cancer patients with resectable brain or extra-cranial metastases or who will undergo a biopsy of the extra-cranial metastases will be asked to consent for this study and for their resected/biopsied samples to be used to generate pdos. the investigators aim to recruit 20 patients in the pilot phase of the study. when the pdos contain sufficient cells, these cells will be treated with increasing doses of radiotherapy and/or relevant systemic treatments in order to determine the ic50 and to obtain dose-response curves of these pdos to the treatments. the investigators will treat the pdos with the same treatments that the patients had or will receive in order to correlate the responses to radiotherapy and/or systemic treatments including immunotherapy (co-cultured with immune cells). the response of these pdos will be compared to the treatment outcome and survivals in these patients.

Eligibility criteria:
inclusion criteria: * breast cancer patients with brain metastases who are suitable for surgical resection or breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy * age \> 18 years old exclusion criteria: * patients unable to give informed consent e.g., mental disability or vulnerable adults