Kornimate/medical-research-clean huggingface dataset:
a study of sepiapterin in participants with phenylketonuria (pku)

Conditions: Phenylketonuria

Summary: the main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with pku when treatment is initiated in early childhood.

the study includes 2 parts: part 1 and 2. part 1 is an open-label sepiapterin-responsiveness test, and part 2 is an open-label treatment period.

Eligibility criteria:
key inclusion criteria: for all participants: * women of childbearing potential must have a negative pregnancy test at screening and agree to abstinence or the use of at least one highly effective form of contraception for the duration of the study, and for up to 90 days after the last dose of the study drug. * willing to maintain prescribed daily protein/phe during screening and part 1. * established diagnosis of pku with hyperphenylalaninemia (hpa) evidenced by at least 1 blood phe measurement ≥600 micromoles (μmol)/liter (l) as documented in the medical history. * for participants ≥1 month of age at screening: a minimum of 1 documented blood phe measurement \<480 μmol/l within 1 month prior to screening. * for participants ≥1 month of age at screening: two screening blood phe concentration values must be in the range ≥120 to ≤480 μmol/l. for participants \<1 month of age at the time of informed consent/assent only: * blood phe at newborn screening ≥600 μmol/l. for participants ≥30 months to \<12 years of age: * baseline fsiq score ≥80. key exclusion criteria: * history of allergies or adverse reactions to any of the ingredients or excipients of synthetic tetrahydrobiopterin (bh4) or sepiapterin. * serious neuropsychiatric illness (for example, major depression) not currently under medical control or other concurrent disease or condition that, in the opinion of the investigator or sponsor, would interfere with the participant's ability to participate in the study or increase the risk of participation for that participant. * treatment with bh4 supplementation (sapropterin, kuvan) within 3 months prior to screening. * current participation in another investigational drug study or use of any investigational agent within 30 days prior to screening. * confirmed diagnosis of a primary bh4 deficiency as evidenced by biallelic pathogenic mutations in 6-pyruvoyltetrahydropterin synthase, recessive guanosine-5'-triphosphate (gtp) cyclohydrolase i, sepiapterin reductase, quinoid dihydropteridine reductase, or pterin 4-alphacarbinolamine dehydratase genes. * any clinically significant laboratory abnormality as determined by the investigator. * any past medical history of an abnormal physical examination and/or laboratory findings indicative of signs or symptoms of renal disease, including calculated (bedside schwartz equation) glomerular filtration rate (gfr) \<60 milliliters (ml)/minute (min)/1.73 square meter (m\^2). * major surgery within 90 days prior to screening visit. note: other protocol-defined inclusion and exclusion criteria may apply.
internet gaming disorder and psychiatric disorder

Conditions: Psychiatric Disorder

Summary: the fifth edition of the diagnostic and statistical manual of mental disorders (dsm-5) recently identified internet gaming disorder as a new potential psychiatric disorder which need further research. several studies showed the important prevalence of psychiatric disorders among patients suffering from internet gaming disorder. investigators hypothesize that on an other side the prevalence of internet gaming disorder among patients suffering from psychiatric disorders shall be high but it has never been studied yet. the main goal of this trial is to examine the prevalence of internet gaming disorder using the internet gaming disorder test-10 (igdt-10) among inpatient aged from 12 to 17 of 4 psychiatric units of french region auvergne-rhône-alpes. secondary goals will be to assess a parental version of the igdt-10 (igdt-10-p) and to compare the two versions. igdt-10 will be passed during 6 months to every inpatient and igdt-10-p to their parents within the 21 first days of the hospitalisation.


Eligibility criteria:
inclusion criteria: * patient aged from 12 to 17 * parents of the patient, older than 18 years old * patients hospitalized in 4 psychiatric units of french region auvergne-rhône-alpes exclusion criteria: * patient and/or theirs parents are not fluent in french * intellectual deficit (known intelligence quotient below 70) * behaviour disorder making impossible to pass the questionnaire
exercise influence on covid-19

Conditions: Infection Viral; Exercise; Coronavirus; Habits

Summary: an observational study is carried out in the university population of the university of salamanca to know the impact of the covid-19 pandemic and the influence of physical exercise on the severity of symptoms.

* investigate the relationship between the regular practice of moderate physical exercise and the severity of the covid-19 disease in the university community of the university of salamanca. * prepare an epidemiological study of the impact of the pandemic at the university of salamanca. * analyze the influence of the pandemic on the sports habits of the university community. * the study population will be the entire university community (teaching and research staff, administration and services staff, and students) who will be contacted via email.

Eligibility criteria:
inclusion criteria: * university of salamanca population * complete the survey exclusion criteria: * survey not filled out completely

Keywords: exercise universities coronavirus habits
a study of canakinumab in patients with systemic juvenile idiopathic arthritis or hereditary periodic fevers who participated in the cacz885g2301e1, cacz885g2306 or cacz885n2301 studies

Conditions: Systemic Juvenile Idiopathic Arthritis; Hereditary Periodic Fevers

Summary: the objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in france who completed study cacz885g2301e1(nct00891046), cacz885g2306 (nct02296424) or cacz885n2301 (nct02059291) until a decision regarding reimbursement in france is effective for canakinumab (ilaris®) in these indications.


Eligibility criteria:
inclusion criteria criteria applicable for patients with systemic juvenil idiopathic arthritis sjia): patients who have completed the international studies cacz885g2301e1 or cacz885g2306 without any significant safety issue according to investigator's opinion. patients who have completed the international cacz885g2306 study and who successfully withdrew canakinumab treatment per protocol but with a disease relapse after the end of study visit will be allowed to participate in cacz885gfr01 study (whatever the time of relapse from the end of study visit), if the investigator states that there is an indication to resume canakinumab. patients who have participated in the international cacz885g2306 study but could not be randomized and then have continued canakinumab in part i until the end of the study at a dose of 4 mg/kg every 4 weeks may be switched to cacz885gfr01 study if the investigator thinks that, in the interest of the patient, there is an indication to taper off canakinumab dose after a prolonged remission. criteria applicable for patients with hpf (traps, hids, crfmf): patients who have completed the international cacz885n2301 study without any significant safety issue according to investigator's opinion. criteria applicable for all patients: parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's written informed consent for patients ≥ 18 years of age must be obtained before any study related activity or assessment is performed. exclusion criteria: * history of recurring infections * hypersensitivity to the active substance or to any of the excipients other protocol-defined inclusion/exclusion criteria may apply

Keywords: juvenile rheumatoid arthritis (jra) chronic systemic inflammatory disorder painful joints inflammation of the synovial membrane auto-immune rheumatoid disease reactive rheumatoid arthritis systemic juvenile rheumatoid arthritis (sjra) hereditary periodic fevers hereditary periodic fever syndrome(hpfs) familial mediterranean fever syndrome(fmfs) hyperimmunoglobulinemia d tumor necrosis factor (tnf) receptor-associated periodic syndrome (traps) muckle-wells syndrome (mws) familial cold auto inflammatory syndrome
rct of the effectiveness of the wfwi intervention in afghanistan

Conditions: Domestic Violence; Depressive Symptoms; Livelihoods

Summary: this is an individually randomised control trial to assess the effectiveness of a livelihoods and social empowerment intervention, delivered by women for women international, on married women's experiences of intimate partner violence in afghanistan. it has a 22 month follow up.


Eligibility criteria:
inclusion criteria: * women should be in the lowest economic level (earning less than us$1.25/day) * unemployed * no in education/school * not involved in a similar programme * able to provide informed consent exclusion criteria: * not mentally incapacitated, so as unable to provide informed consent * already been part of the wfwi intervention previously
abnormal post-partum glucose metabolism after gestational diabetes diagnosed before or after 24 weeks of gestation

Conditions: Gestational Diabetes; Type 2 Diabetes; Glucose Intolerance

Summary: the main objective of the study is to estimate and compare the percentage of patients with abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed with gestational diabetes before or after 24 weeks of pregnancy. abnormal glucose metabolism is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.

the secondary objectives of this study are to compare between the two groups: a. the rate of type 2 diabetes only, glucose intolerance only, impaired fasting glucose only, and patients requiring insulin at 4-12 weeks postpartum b. rates of maternal and obstetric complications c. risk factors (age, body mass index, personal history of gestational diabetes or macrosomia, first degree family history of diabetes). d. for fasting glucose done before 24sa, we will calculate the optimal threshold for predicting abnormal glucose metabolism in the immediate postpartum period among women with gestational diabetes.

Eligibility criteria:
inclusion criteria: * the patient must have given her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 10 months of follow-up * the patient is pregnant and consulting before 24 weeks of amenorrhea and has at least one of the following risk factors: age \> 35 years; body mass index \> 25; family history of type 2 diabetes; history of gestational diabetes; history of macrosomia. * the patient has a fasting blood glucose level \>= 0.92 g/l before 24 weeks of amenorrhea or a fasting blood glucose level \< 0.92 g/l before 24 weeks of amenorrhea and an abnormal oral glucose tolerance test (75 g of glucose) between 24 and 28 weeks of amenorrhea (normal values are set at t0 \< 0.92 g/l; t60 \< 1.80 g/l; t120 \< 1.53 g/l). exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study, with the exception of the following studies: papillo pma (rcb 2013-a00538-37), lxrs (rcb 2009-a00968-49), grosspath (rcb 2014-a01120-47), bakri (rcb 2013-a00914-41), oasis ii (rcb 2013-a00773-42), elastomap (rcb 2013-a01148-37), elastodéclench (rcb 2014-a00828-39) and upsidedown (rcb 2014-a01921-46). * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient cannot read french * the patient has a known history of type 2 diabetes * the patient is diagnosed with type 2 diabetes during pregnancy (fasting blood glucose level \> 1.26 g/l) * the patient has a contra-indication for a treatment necessary for this study * the patient is taking chronic or intermittent oral or inhaled corticosteroids, or a β2 agonist treatment for a previous disease or a disease discovered during pregnancy within one week preceding the fasting glucose or oral glucose tolerance test.

Keywords: post partum diabetes impaired fasting glucose
safety, tolerability, and immunogenicity of v114 in healthy infants (v114-029)

Conditions: Pneumococcal Infections; Pneumococcal Vaccines

Summary: the purpose of this study is to evaluate the safety, tolerability, and immunogenicity of v114 in healthy infants. the primary hypotheses are that: 1) v114 is non-inferior to prevnar 13™ for the 13 shared serotypes between v114 and prevnar 13™ based on response rates at 30 days following dose 3; 2) v114 is non-inferior to prevnar 13™ for the 2 unique v114 serotypes based on the response rate of the 2 unique v114 serotypes compared with the lowest response rate of any of the shared serotypes in prevnar 13™, excluding serotype 3, at 30 days following dose 3; 3) v114 is non-inferior to prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (pnps) serotype-specific immunoglobulin g (igg) geometric mean concentrations (gmcs) at 30 days following dose 3; 4) v114 is non-inferior to prevnar 13™ for the 2 unique v114 serotypes based on the anti-pnps serotype-specific igg gmcs of the 2 unique v114 serotypes compared with the lowest igg gmc of any of the shared serotypes in prevnar 13™, excluding serotype 3, at 30 days following dose 3; 5) v114 is non-inferior to prevnar 13™ for the 13 shared serotypes between v114 and prevnar 13™ based on anti-pnps serotype-specific igg gmcs at 30 days following dose 4; and 6) v114 is non-inferior to prevnar 13™ for the 2 unique v114 serotypes based on anti-pnps serotype-specific igg gmcs of the 2 unique v114 serotypes compared with the lowest igg gmc of any of the shared serotypes in prevnar 13, excluding serotype 3, at 30 days following dose 4.


Eligibility criteria:
inclusion criteria: * is healthy (based on a review of medical history and physical examination) in the clinical judgement of the investigator * has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent. exclusion criteria: * has a history of invasive pneumococcal disease (ipd; positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. * has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (pcv), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine. * has any contraindication to the concomitant study vaccines being administered in the study. * had a recent febrile illness (rectal temperature ≥38.1°c \[=100.5°f\] or axillary temperature ≥37.8°c \[=100.0°f\]) occurring within 72 hours prior to receipt of study vaccine.
a study of the antioxidant probucol combined with valsartan in patients with iga nephropathy

Conditions: Glomerulonephritis; IGA Nephropathy

Summary: a statement of the study hypothesis:the effect of valsartan in patients with iga nephropathy have been proved,and the efficacy of probucol in combination with valsartan is to be proved in patients with iga nephropathy. this is a prospective randomized controlled, double blinded pilot study to identify the efficacy of probucol in combination with valsartan in patients with iga nephropathy. the renal function deterioration will be the primary outcome studied. the expected study duration will be 36 months.


Eligibility criteria:
inclusion criteria: * patients who fulfill the clinical and pathological criteria for iga nephropathy * age: 18-60 years * renal biopsy diagnostic for iga nephropathy based on immunohistologic staining for iga that is greater than or equal to staining for igg and igm * urinary protein excretion rate is within the range of 1-2.5g/day * serum creatinine \<265.2umol/l at the time of randomization exclusion criteria: * patients who refuse to be randomized for treatment * patients who prefer treatment with conventional agents * patients who are pregnant or plan for pregnancy * patients who are pathologically proven severely or diffusely proliferative iga nephropathy or crescent glomerulonephritis with \>= 50% segmental involvement of the glomeruli and should be treated with other agents,such as immunosuppressive agents or steroid * clinical and histologic evidence of: * systemic lupus erythematosus * henoch-schonlein purpura * cirrhosis * chronic active liver disease * hepatitis b * hepatitis c * severe chronic diarrhea * active peptic ulcer disease * hiv * acute renal failure * malignant hypertension * severe heart diseases * malignant tumor * any systemic infection * pregnancy * known contraindication to the administration of probucol and valsartan

Keywords: iga nephropathy probucol valsartan treatment antioxidant iga nephropathy：a kind of glomerulonephritis,which iga is the dominant immunodeposit in mesangial areas
tdcs and co-op in chronic stroke

Conditions: Chronic Stroke

Summary: this project seeks to evaluate the acceptability feasibility, practicality feasibility, and preliminary effect of combining transcranial direct current stimulation (tdcs) and metacognitive strategy training (mcst) in individuals with chronic stroke.

currently seven million people are living in the united states post stroke, making stroke the leading cause of long term disability. almost half of the people living in the community following stroke have problems that challenge the activities that support their daily lives. this is in part due to the rehabilitation community's focus on short term stroke recovery and not on supporting survivors' need to actively manage their long-term disability and the environment around them so they can return to full participation in communities of their choice post-rehabilitation. the rehabilitation community is in need of evidence-based interventions for addressing post-stroke functional limitations. metacognitive strategy training is a performance-based, problem-solving approach to task performance difficulties. participants are taught to identify when to apply a cognitive strategy, how to apply it, and how to monitor and adapt usage of cognitive strategies within task performance. metacognitive strategy training is recognized as a practice standard for addressing functional limitations post-stroke. transcranial direct current stimulation is a method that has been used for over 15 years to modulate the excitability of targeted brain regions. while it does not directly stimulate neurons, it results in changes to polarity of neuronal membranes and is thought to facilitate or inhibit neuroplasticity. combination of these approaches may result in an interaction of effects and a greater effect on function in individuals post-stroke than either approach used alone.

Eligibility criteria:
inclusion criteria: * \> 6 months post mild to moderate ischemic stroke * self-reported functional limitations * age 30-80 exclusion criteria: * history of other neurological diagnoses * cognitive impairment (less than or equal to 21 on the montreal cognitive assessment) * severe aphasia (greater than or equal to 2 on the nihss language item * non-english speaking * any additional condition where the pi deems participation unsafe * pregnancy, 7) * history of seizures * medications that influence cortical excitability * metallic implants above the chest * history of welding or metalwork * severe depressive symptoms (\>21 on patient health questionnaire)

Keywords: stroke metacognitive strategy training brain stimulation co-op tdcs
tubeless vats for peripheral lung nodule

Conditions: Solitary Pulmonary Nodule

Summary: chest tube placement after thoracoscopy surgery had been generally accepted as routine procedure for removal of the residual intrapleural fluid and air, however, it would cause post-operative pain, prohibit ambulation after surgery, and prolong the hospital stay. according to the recent studies, omission of chest tube placement after minor thoracoscopic procedures (such as pulmonary wedge resection) had been safe and feasible, and it also reduced the post-operative pain and shortened the hospital stay. we will conduct a prospective randomized trial in national taiwan university hospital.

we will enroll 100 patients with peripheral lung nodule who will be randomly assigned to no chest tube placement (tubeless group) or chest tube placement (control group) after thoracoscopic wedge resection with out without lymph adenectomy. the primary endpoints are to compare the post-operative hospital stay and post-operative pain sale between the two groups. the secondary endpoints are to compare the intercostal neuralgia and wound satisfaction one month after surgery between the two groups.

Eligibility criteria:
inclusion criteria: * ct revealed peripheral lung nodule, with both size and depth less than 2 cm * aged 20 to 80 years exclusion criteria: * patients with ventilatory defect * previous ipsilateral thoracic surgery * bleeding tendency or anticoagulant use * comorbidity including congestive heart failure, liver cirrhosis, chronic renal disease * pregnancy or breast feeding * immunocompromised or long-term steroid use * severe infected patient * patient who can not sign permit
evaluation of mri for prostate cancer

Conditions: Prostatic Neoplasms

Summary: the objective of this study is to evaluate imaging quality and correlation with histopathology in prostate cancer.

the objective of this study is to evaluate of the potential of endorectal 3t mri for the staging of prostate cancer before prostatectomy or recurrence of prostate cancer after prostatectomy

Eligibility criteria:
inclusion criteria: * age of patients: up to 80 years. * men scheduled for radical prostatectomy due to prostate cancer or men post radical prostatectomy with suspicion of recurrence. * patients who are able and willing to give consent and able to have an mri examination. exclusion criteria: * contraindications to mri including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the mri contrast agent (e.g. gadolinium or dotarem) * individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hr.) * any rectal pathology preventing probe insertion, (as active proctitis, active ulcerative colitis, fissure ani) * any spinal pathology that prohibits maintaining supine position for an hour * patients with documented myocardial infarction within one month of protocol entry, and patients with cardiac pacemakers * severe cerebrovascular disease (multiple cva or cva within 6 months)