Kornimate/medical-research-clean huggingface dataset:
a study to confirm the long-term safety and effectiveness of kalydeco in patients with cystic fibrosis who have an r117h-cftr mutation, including pediatric patients

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to confirm the long-term safety and effectiveness of kalydeco® (ivacaftor) in us cf patients with the r117h-cftr mutation \<18 years of age and to describe the long-term safety and effectiveness of kalydeco in cf patients with the r117h-cftr mutation overall and in patients ≥18 years. the long-term safety and effectiveness of kalydeco will be examined in totality through the evaluation of the primary outcome measures.

patient follow-up (i.e., collection of outcomes data after treatment initiation) in the non-interventional cohort will be at least 36 months. the study also includes retrieval of retrospective data entered into the registry for 36 months before the initiation of kalydeco treatment, from patients matched for non-interventional cohorts. this will permit a within-group comparison of outcomes before and after kalydeco treatment for effectiveness and safety. the interventional cohort will not be utilized.

Eligibility criteria:
inclusion criteria: non interventional cohort * male or female with confirmed diagnosis of cf * must have at least 1 allele of the r117h-cftr mutation * enrolled in the us cff patient registry * with a record of kalydeco treatment initiation from 01 january 2015 through 31 december 2016 historical cohort * patients with cf in the cff patient registry as of 01 january 2009 * must have at least 1 allele of the r117h-cftr mutation * patients with no evidence of any prior kalydeco exposure
a study to evaluate the effects of ym872 on brain function and disability when administered in combination with alteplase (tissue plasminogen activator)

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to determine if ym872 in combination with t-pa can reduce disability and brain damage from stroke. ym872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. it is important that the study medication, ym872 or placebo, is administered prior to the completion of the t-pa administration. the clinical effects of ym872 in addition to t-pa will be determined by assessing neurological function and disability scores at follow up visits through day 90 of the study.


Eligibility criteria:
inclusion criteria: * patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night). * patients who are able to provide written informed consent or have consent provided by a legally authorized representative. * patients who are at least 18 years of age. * patients who have a national institutes of health stroke scale (nihss) score of at least 7 but not more than 23 and who are conscious. * other criteria as specified in the study protocol exclusion criteria: * patients who are not eligible to receive treatment with alteplase (t-pa) due to brain hemorrhage, risk for hemorrhage, or other criteria. * patients who have stroke of the brainstem or cerebellum. * patients who have renal (kidney) disease or insufficiency. * patients who have active epilepsy or convulsions during the current stroke episode. * patients who are iv drug users or are inebriated. * patients who have a history of drug-related anaphylaxis. * patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment. * patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment. * patients who have a known vitamin hypersensitivity. * other exclusion criteria as specified by the study protocol

Keywords: artist
fat reduction and muscle toning of thighs

Conditions: Fat Burn

Summary: this study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.


Eligibility criteria:
inclusion criteria: * age \> 21 years * voluntarily signed an informed consent form * bmi ≤ 35 kg/m2 * women of child-bearing potential are required to use birth control measures during the whole duration of the study * subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation * subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation exclusion criteria: * electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators) * metal implants * drug pumps * malignant tumor * pulmonary insufficiency * injured or otherwise impaired muscles * cardiovascular diseases * disturbance of temperature or pain perception * hemorrhagic conditions * septic conditions and empyema * acute inflammations * systemic or local infection such as osteomyelitis and tuberculosis * contagious skin disease * elevated body temperature * pregnancy, postpartum period, nursing, and menstruation * intrauterine device (iud) * swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area * basedow's disease

Keywords: muscle strengthening muscle tone fat reduction
safety study of cetuximab, radiotherapy and temozolomide in primary glioblastoma multiforme(gert)

Conditions: Glioblastoma Multiforme

Summary: gert is a one-armed single-center phase i/ii trial. in a first step, dose-escalation of tmz from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. should safety be proven, the phase ii trial will be initiated with the standard dose of 75mg/m2 of tmz. cetuximab will be applied in the standard application dose of 400mg/m2 in week 1, thereafter at a dose of 250mg/m2 weekly. a total of 46 patients will be included into this phase i/ii trial. primary endpoints are feasibility and toxicity, secondary endpoints are overall and progression-free survival. an interim analysis will be performed after inclusion of 15 patients into the main study. patients' enrolment will be performed over a period of 2 years. the observation time will end 2 years after inclusion of the last patient.


Eligibility criteria:
inclusion criteria: * \>= 18 and \< 70 years of age * karnofsky performance score \>= 60 * histologically confirmed supratentorial gbm * interval between primary diagnosis and registration for the study \< 4 weeks * patients will be included according to the incidental gender distribution for patients with gbm of ♀/♂ 2:3 * adequate blood values (not older than 14 days prior to initiation of rcht) * neutrophil count (anc) ≥1500/mm3 or white blood cells (wbc) ≥2000/mm3 * platelets ≥100.000/mm3 * hemoglobin ≥10g/dl * bun \<1.5 times the upper range * total and direct bilirubin \<1.5times the upper laboratory limit * adequate liver enzymes \<3 times the upper laboratory limit * life expectancy \>12 weeks * written informed consent exclusion criteria: * refusal of the patients to take part in the study * previous radiotherapy of the brain or chemotherapy with dtic or tmz * known allergy against extrinsical proteins * previous chemotherapy or therapy with an egfr-inhibitor * previous antibody therapy * patients who have not yet recovered from acute toxicities of prior therapies * acute infections requiring systemic application of antibiotics * frequent vomiting or a medical condition preventing the oral application of tmz * clinically active kidney- liver or cardiac disease * known carcinoma \< 5 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) * hiv * pregnant or lactating women * participation in another clinical study

Keywords: cetuximab
gbr with ptfe with bovine bone with and without autogenous

Conditions: Atrophied Anterior Maxillary Ridges

Summary: ridge augmentation in atrophic anterior maxillary ridges with a titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone-derived mineral in intervention group and anorganic bovine bone-derived mineralwith particulated autogenous bone chips in control group. cbct will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm. bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio * 1ry outcome: amount of bone gain will be measured using linear measurements from cbct immediate after surgery and after 6 month. * 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.


Eligibility criteria:
inclusion criteria: * • patients with atrophied anterior maxillary ridge area. * age: 18 years and older. * both sexes. * no intraoral soft and hard tissue pathology. * no systemic condition that contraindicate bone augmentation exclusion criteria: * • heavy smokers more than 20 cigarettes per day.(32) * patients with systemic disease that may affect normal healing. * psychiatric problems. * disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia. * pregnant or nursing women. * patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis. * patient with previous history of radiotherapy.
monocular action video game treatment of amblyopia

Conditions: Amblyopia; Amblyopia Occlusion; Unilateral Amblyopia; Anisometropic Amblyopia; Strabismic Amblyopia

Summary: this study evaluates the effectiveness of the monocular treatment with action video-games in comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with the different evaluated treatments.

amblyopia is the condition in which there is a decrease in monocular visual acuity or, less frequently, binocular, in absence of structural anomalies or ocular pathology. it is a reversible condition that affects up to 5% of the population, and that is the result of an abnormal visual experience during the most sensitive period of visual development. the aim of this study is reviewing, analyzing and, if applicable, updating the current treatment model for amblyopia. a randomized clinical trial will be performed to evaluate the effectiveness of the monocular treatment with action video-games in comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with the different evaluated treatments. the participants will be distributed in two groups. the first group will include those participants who will follow a daily occlusive treatment and the second group will include patients who will be treated with monocular therapy with video-games.the sample will include subjects between 4 to 10 years old with a diagnosis of refractive and / or strabismic amblyopia.

Eligibility criteria:
inclusion criteria: * age 4-10 years old * anisometropic amblyopia * strabismic amblyopia or mixed * interocular visual acuity (va) difference of at least 0.2 logmar * no history of eye surgery exclusion criteria: * non-comitant and/or large constant strabismus (\>30 prism diopters) * any ocular pathological condition or nystagmus

Keywords: action video games amblyopia treatment
long term follow up study to comp 001 and comp 003 trials (p-trd ltfu)

Conditions: Treatment Resistant Depression

Summary: the primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the montgomery and asberg depression rating scale (madrs) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from comp 001).

in this present study (comp 004), the aim is to follow up participants from comp 001 and comp 003 in a long-term follow up study, with both remote and digital assessments, to explore the long term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with trd as a monotherapy in comp 001 and 25 mg psilocybin administered as an adjunct to an ssri in comp 003. patients previously treated in comp001 will be followed for approximately 40 weeks and patients previosuly treated in comp003 will be followed for approximately 49 weeks giving a total follow up period of 52 weeks from psilocybin dosing.

Eligibility criteria:
inclusion criteria: signed icf each participant having completed the final study visit of either comp 001 or comp 003 ability to complete all protocol required assessment tools (including having access to the internet in order to complete the digital assessments) without any assistance or alteration to the copyrighted assessments, and to comply with all study visits exclusion criteria: subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject eg participation could compromise the wellbeing of the participant or prevent, limit, or confound the protocol-specified assessments
efficacy and safety study of mizoribine in active rheumatoid (amoled)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to access the efficacy and safety of mizoribine 150mg qid and 50mg tid in active rheumatoid arthritis patients unsuccessfully treated with disease-modifying antirheumatic drug.

1. eular response after 24weeks of treatment 2. eular response after 12weeks of treatment 3. das28 value change 4. khaq-20 value change

Eligibility criteria:
inclusion criteria: * male or female aged from 20 to 80 years old * signed and dated informed consent document indicating that the patient * patients must have a diagnosis of rheumatoid arthritis(ra) of at least 3months duration as defined by the 2010 american college of rheumatology(acr) classification criteria. * patients should have a disease activity score 28 greater than or equal to 3.2 (das28 ≥ 3.2) and have received treatment with more than 1 kind of disease-modifying antirheumatic drug(including mtx). * esr≥28mm/h or crp≥1.0mg/dl at screening. exclusion criteria * at screening, patients have laboratory result as defined by : white blood cell ≤ 3,000/mm3 , hemoglobin \ 2.0 mg/dl, aspartic acid transaminase/alanine transaminase ≥ 2\*upper limit of normal , uric acid ≥ 1.5\*upper limit of normal * patient must not have bleeding disorder or taking anticoagulant. (but, lt is allowed to take 100mg/day of asprin) * patients with a history of operation on index knee joint which could have influence on the result and need to have surgery as determined by investigator. * patients have severe infection, including moderate respiratory disease and have received treatment with systemic antibiotics within 2 weeks. * patients have cardiovascular disease or associated disease which is not controlled. * patients have a history of malignancy within 5years. (but, basal cell or squamous cell carcinoma or carcinoma in situ of the uterine cervix have been treated is allowed) * patients have hypersensitivity reaction on this drug. * patients on any other clinical trial or experimental treatment in the past 3months. * female patients who are breast feeding, pregnant or plan to become pregnant during the trial or for two months following study termination. * not allowable medication recorded below ; intra-articular injections within weeks at baseline visit, patients taking oral steroid over 10mg /day or using new treatment or changing dosage within 4weeks at baseline visit, using new nonsteroidal antiinflammatory drug within 4 weeks or changing nonsteroidal antiinflammatory drug dosage within 2 weeks at baseline visit. * having experience of use biologic agent, immunosuppressant, cytostatic preparations within 8weeks at baseline visit. (but, rituximab is not allowed within 6months) * start to treatment new disease-modifying antirheumatic drug or need to change dosage of disease-modifying antirheumatic drug which is taking on the trial. (leflunomide(arava®) is not allowed within 12weeks, but, cholestyramine is allowed after 48 hours later stopping. if it use three times a day, 8g, for 11days)

Keywords: rheumatoid arthritis ra mizoribine das28 european league against rheumatism
halitosis and mouth breathing in children

Conditions: Mouth Breathing; Halitosis

Summary: objective: determine whether there is a correlation between halitosis and mouth breathing in children. study design: fifty-five children between three and 14 years of age were divided into two groups (nasal and mouth breathing) for the assessment of halitosis. descriptive analysis was carried out regarding the degree of halitosis in each group. the chi-square test was used for the comparison between groups, with 5% level of significance.


Eligibility criteria:
inclusion criteria: all children registered at the clinic of the specialization course in pediatric dentistry of the abcd/sp in 2008 were included in the study. exclusion criteria: -

Keywords: halitosis pediatric dentistry mouth breathing
effectiveness of telerehabilitation on the performance of post-stroke patients' daily living activities and evaluation of satisfaction in post-stroke patients in vietnam

Conditions: Stroke; Telerehabilitation; Acute Stroke

Summary: this study aims to evaluate the efficacy of telerehabilitation on stroke patients' capability to perform adls after three months of telerehabilitation intervention. additionally, the investigators also conducted a survey on the satisfaction of patients after telerehabilitation

the performance of stroke patients' daily living activities (adls) is severely affected because of hemiplegia. the consequences of stroke on patients can lead to a financial and welfare burden on society. thus, it is vital to provide a rehabilitation program to enhance patients' performance in adls and help them become more independent. this study aims to evaluate the efficacy of telerehabilitation on stroke patients' capability to perform adls after three months of telerehabilitation intervention. additionally, the investigators also conduct a survey on the satisfaction of patients after telerehabilitation. the investigators will recruit 32 stroke patients from five hospitals in vietnam. all subjects will be provided the three-month treatment that includes video-based rehabilitation and the online meeting section. the investigators will use the barthel index (bi) to evaluate the intervention and use the paired t-test to review the results. evaluation of the satisfaction of stroke patients with telerehabilitation is conducted by telemedicine satisfaction and usefulness questionnaire (tsuq).

Eligibility criteria:
inclusion criteria: * age: over 18 years old * diagnosis: first stroke * stroke severity: national institutes of health stroke scale (nihss) score between 5 and 15 (moderate impairment) * support system: has a caregiver available during the research process * technology access: possesses a smartphone or computer with internet connection and online meeting application capabilities exclusion criteria: - existing conditions: severe cognitive impairment, sensory impairment, language disorder, or musculoskeletal diseases limiting motor function

Keywords: stroke telerehabilitation
effect of probiotics on oral homeostasis during oral hygiene discontinuation

Conditions: Gingivitis

Summary: the present study is a double-blinded randomized clinical trial with a duration of 28 days.

the present study is a double-blinded randomized clinical trial with a duration of 28 days. 80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline. the intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care. clinical measurements and sampling will be performed at baseline, day 14 and day 28 primary endpoint: changes in microbial composition. secondary endpoints: changes in clinical and immunological parameters

Eligibility criteria:
inclusion criteria: - age \> 18 yrs. exclusion criteria: * presence of oral diseases i.e. gingivitis, periodontitis and dental caries * current smokers * any systemic diseases and current use of any medication with known effect on oral health * use of systemic antibiotics within the latest three months * age \ 30 yrs.
bdnf promoter methylation: effects on cognition, stress and anxiety and depression symptom in healthy women.

Conditions: BDNF; Memory Impairment; Stress; Well-being; Methylation

Summary: the purpose of this study is to explore the association between bdnf methylation and neurocognitive performance, perceived stress, and well-being in healthy women.


Eligibility criteria:
inclusion criteria: (1)brazilian female aged between 23 and 65 years and (2) currently working in the classroom exclusion criteria: 1. diagnosis of depression 2. diagnosis of anxiety disorder 3. diagnosis of squizofrenia 4. report of an infectious condition in the last 15 days before collecting a blood sample;

Keywords: bdnf methylation memory women stress
the study to test the effect of standardization of fluid intake in female patients with overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this study is to determine if standardizing fluid intake in a clinic setting will reduce variability of individual voiding parameters and potentially serve as a way to limit patient exposure in the initial assessment of efficacy of compounds being developed for overactive bladder.


Eligibility criteria:
inclusion criteria: * eligible participants will be females who are 18 years of age or older, with overactive bladder as evidenced by daily episodes of urgency without incontinence, which may be associated with frequency or nocturia but without bladder pain. at screening, eligible patients must report frequency, defined as at least 8 micturitions per 24 hour period. * eligible patients must have signed the informed consent and must meet all inclusion and exclusion criteria as determined during the screening visit. exclusion criteria: * any abnormality identified on the screening examination or any other medical condition or circumstance making the patient unsuitable for participation in the study based on the investigator's and medical monitor's assessment * any contraindication to detrol la or other anti-muscarinic medications * inability to consume 10 cc/kg of fluid within 30 minutes * regular alcohol consumption averaging ³7 drinks/week for women (1 drink = 100ml of wine or 285ml of beer or 30ml of hard liquor) * positive urine drug or alcohol at screening at screening * average blood pressure measurements systolic ≥140 or diastolic ≥90 at screening at screening * qtcb value ≥ 450 msec at screening * poorly-controlled diabetes mellitus or hypertension, as evidenced by a change in medication within the 2 months prior to initiation of the study * history of urinary retention or gastric retention * known history of narrow-angle glaucoma * history of qt prolongation * known reduction in hepatic or renal function * concomitant use of loop diuretics (eg. furosemide) * concomitant use of a medication that is a potent inhibitor of cyp3a4 * class ia or class iii antiarrhythmic medications * patient is unable and/or unwilling to adhere to lifestyle guidelines * for women of child bearing potential, a positive serum β-hcg at screening or pre-dose, or an unwillingness to agree to adequate contraception from the time of screening until the completion of the study: * positive for hepatitis c antibody, hepatitis b surface antigen or hiv at screening. * presence of urinary tract infection within 4 weeks of screening. * post-void residual of \>150 ml (bladder ultrasound).

Keywords: experimental medicine