Kornimate/medical-research-clean huggingface dataset:
repetitive transcranial magnetic stimulation in sca3 patients

Conditions: Spinocerebellar Ataxia Type 3

Summary: machado-joseph disease (mjd) or spinocerebellar ataxia type 3 (sca3) is the most common spinocerebellar ataxia worldwide.repetitive transcranial magnetic stimulation (rtms) is a form of brain stimulation therapy used to treat depression and cerebellar ataxias. in this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a 15 day treatment with 1 hz of repetitive transcranial magnetic stimulation (rtms) can improve symptoms (motor symptoms and non-motor symptoms) in patients with mjd.

machado-joseph disease (mjd) or spinocerebellar ataxia type 3 (sca3) is the most common spinocerebellar ataxia worldwide. mjd shows remarked clinical heterogeneity and presents with various clinical manifestations, including cerebellar ataxia, limb incoordination, dysarthria, sleep disorders, axonal neuropathy, dystonia, pyramidal signs and, diplopia. no effective treatment is currently available for mjd. repetitive transcranial magnetic stimulation (rtms)enables non-invasive modulation of cortical excitability. rtms targeting cerebellar structures is capable of inducing long-lasting changes in the excitability of cerebello-thalamocortical pathways. subjects will be randomized in two groups, one receiving a consecutive 15-day treatment with 1 hz of repetitive transcranial magnetic stimulation and the other receiving sham stimulation with identical parameters. patients will be clinically assessed at baseline, during intervention period at 7 days and 15 days immediate after treatment.

Eligibility criteria:
inclusion criteria: 1 .patients with detectable clinical signs and confirmed genetic diagnosis with sca3. 2. sca3 patients aged 20 - 80 years 3. patients or their family members have informed consent to the study and signed relevant documents exclusion criteria: * 1. patients who have concomitant epilepsy. 2. history of seizure or heat convulsion. 3. patients on neuroleptics. 4. history or current unstable hypertension. 5. history of head injury or neurosurgical interventions. 6. history of any metal in the head (outside the mouth). 7. known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps. 8. history of frequent or severe headaches. 9. history of migraine. 10. history of hearing loss. 11. history of cochlear implants 12. history of drug abuse or alcoholism. 13. pregnancy or not using a reliable method of birth control. 14. participation in current clinical study.

Keywords: device:active repetitive transcranial magnetic stimulation device:sham repetitive transcranial magnetic stimulation
pneumacare slp validation in infants and in clinical bronchiolitis

Conditions: Bronchiolitis

Summary: a cohort observational study to characterise baseline structured light plethysmography (slp) outputs in infants with bronchiolitis and examine response to treatment using the thora3ditm

viral illness, particularly chest infection causing breathing difficulty in infants and children is the commonest reason for admission to hospital. at present, there are no objective measurements of the degree of breathing difficulty. this is because current objective tests of breathing difficulty requires the patient to cooperate and actively perform the tests. this is not possible in babies and very challenging in young children. slp is a noncontact, effort independent technique for measuring the rate of breathing, the amount of chest expansion and the relative contribution of chest and abdomen to the work of breathing. measuring these parameters which are known to vary with increasing breathing difficulty will allow us to make objective assessments of breathing difficulty. this study proposes to validate this technique in babies aged 02 years who are healthy and in babies with clinical viral bronchiolitis. the investigators intend to demonstrate that the technique is feasible in this young age group and that the investigators will be able to demonstrate clinically valid differences between normal and ill babies and also demonstrate measurable differences with the evolution of the clinical illness.

Eligibility criteria:
inclusion criteria * aged between 0 and 1 years * doctor diagnosis of avb * admitted to hospital within last 24hrs (avb participants only) * or healthy term infant aged up to 2yrs with no current respiratory illness exclusion criteria: * patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only): * an acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study * parents unable to consent/comply with trial protocol * an inpatient for over 24hrs (avb patients only)
a study to evaluate the use and safety of cardiolite® in pediatric patients with kawasaki disease

Conditions: Kawasaki Disease

Summary: determine the predictive value of cardiolite® rest and stress myocardial perfusion imaging (mpi) to define a pediatric population with kawasaki disease (kd) at high and low risk of developing cardiac events.

the purpose of this clinical research study is to determine how well cardiolite® rest and stress myocardial (heart) imaging can define the pediatric kawasaki disease (kd) population into high and low risk categories of developing cardiac (heart) events (complications) from 1 year through 3 years after image completion. the safety of cardiolite® rest and stress heart imaging will also be studied.

Eligibility criteria:
inclusion criteria: * males or females between 4 and 16 * meet the epidemiological definition of kawasaki disease or have a diagnosis of incomplete kd, including evidence of coronary artery disease as determined by their physician. * be able to exercise adequately to achieve 85% age predicted maximum heart rate exclusion criteria: * terminal illness where expected survival is \< 6 months
a randomized controlled trial of bilateral movement-based computer games training to improve motor function of upper limb and quality of life in sub-acute stroke patient

Conditions: Stroke

Summary: this study aims at investigating whether bilateral movement-based training with computer games could augment motor function of paretic upper limb and improve quality of life in sub-acute stroke patients.


Eligibility criteria:
inclusion criteria: * age between 45-85 * diagnosis of ischaemic brain injury or intracerebral hemorrhage by mri or computed tomography 1 week to 6 months after the onset of current stroke * scoring \> 6 of 10 of abbreviated mental test * ability of the paretic hand to hold the game controller (minimal control) * able to give informed consent of the study * can understand instructions given by english or cantonese exclusion criteria: * any additional medical, cardiovascular and orthopaedic condition that would hinder the proper assessment and treatment * having cardiac pacemaker * receptive dysphasia * undergoing drug studies or other clinical trials

Keywords: stroke upper limb motor control function bilateral movement virtual reality
a phase i study of tas-102 in solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: the primary objective of this study is to evaluate the pharmacokinetics of tas-102 after single and multiple dose in chinese patients with solid tumor.

this is an open-label, non-randomized, single group phase 1 study of tas-102, evaluating the pharmacokinetics, safety, and antitumor activity. blood sampling will be performed during the first cycle (day1 and day 12) of therapy in all consenting patients.

Eligibility criteria:
inclusion criteria: * 1. has provided written informed consent prior to performance of any study procedure. * 2. has definitive histologically or cytologically confirmed advanced or metastatic solid tumor. * 3. is able to take medications orally. * 4. has adequate organ function (bone marrow, kidney and liver). * 5. has eastern cooperative group (ecog) performance status of 0 or 1. exclusion criteria: * 1. has received tas-102. * 2. has suffered serious complications. * 3. has unresolved toxicity of greater than or equal to ctcae grade 2 attributed to any prior therapies. * 4. has had prior gastrectomy. * 5. is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.
role of eplerenone in reducing recurrence of atrial fibrillation in patients with structural heart disease

Conditions: Atrial Fibrillation

Summary: this is a prospective comparative study, conducted at cardiology department, aswan university hospital on af patients with structural heart disease. eplerenone 25 mg daily will be given and searching for af recurrence among study population.

this is a prospective comparative study, conducted at cardiology department, aswan university hospital, on 100 patients with af and structural heart disease. af is confirmed by electrocardiography. the patients were divided into 2 groups: group a (study group): 50 patients received eplerenon 25 mg daily plus amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin. group b (control group): 50 patients received amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

Eligibility criteria:
inclusion criteria: * patients with non-valvular af who underwent cardioversion to sinus rhythm either medical, electrical or even spontaneously exclusion criteria: * patients with rheumatic heart disease. * thyroid dysfunction. * wolf-parkinson-white (wpw) syndrome. * renal impairment. * hyperkalemia. * acute coronary syndrome. * pregnancy. * left ventricular (lv) dysfunction with ejection fraction (ef) less than 40%. * on current use of eplerenone.
induction chemotherapy,radiochemotherapy, consolidation chemotherapy in preoperative treatment of rectal cancer

Conditions: Rectal Cancer

Summary: the use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is standard treatment of locally advanced rectal cancer. it has reduced local recurrence rate to less than 10%, but has only had limited effect on overall survival due to the constantly high (more than 30%) rate of distant metastasis. complete eradication of the primary tumour observed in the histopathological specimen (pathological complete response, pcr) correlates with a favourable overall prognosis so obtaining a pcr might be beneficial. the aim of the study is to investigate whether the addition of capecitabine based chemotherapy before preoperative chemoradiation and also before the operation improves pathological complete remission rate in locally advanced rectal cancer with acceptable toxicity. secondary objectives are to evaluate pathological downstaging rate, histopathological r0 resection rate,sphincter preservation rate, perioperative surgical complication rate, local control, dfs, os, late toxicity and quality of life.


Eligibility criteria:
inclusion criteria: * male or female patients with histologically proven adenocarcinoma of the rectum (tumour located below the peritoneum), * t3/4 or any node positive disease (clinical stage according the tnm classification system) * no evidence of metastatic disease. * the disease must be considered either resectable at the time of entry or thought to become resectable after preoperative chemoradiation. * age 18 years and more * who performance status 0-2 * no prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer * adequate hematological, hepatic and renal function ability to swallow tablets * signed informed consent * patients must be willing and able to comply with the protocol for duration of the study exclusion criteria: * malignancy of the rectum other than adenocarcinoma * any unrested synchronous colon cancer * other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin * significant heart disease (uncontrolled hypertension despite of medication (\> 150/100 mmhg), nyha class iii or iv heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment) * pregnant or lactating patient * females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)

Keywords: rectal cancer capecitabine radiotherapy locally advanced rectal cancer
a study of subcutaneous (sc) mircera in dialysis patients with chronic renal anemia.

Conditions: Anemia

Summary: this study will determine the appropriate dose and frequency of administration of sc mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. the anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * chronic renal anemia; * on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months; * receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period. exclusion criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.
topic trial for copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study is a randomized, double-blind, placebo-controlled, multiple-dose, pilot study of orally-administered ivacaftor in subjects with chronic obstructive pulmonary disease. subjects will be administered the study drug ivacaftor 150 mg (or placebo) twice daily (bid).


Eligibility criteria:
inclusion criteria: * male or female age 40-65 * a clinical diagnosis of copd as defined by gold * at least a 10 pack year smoking history * exhibit symptoms of chronic bronchitis defined by mrc * fev1% predicted ≥ 35% and ≤70% post bronchodilator * clinically stable in the last 4 weeks with no evidence of copd exacerbation * weight of 40 kg-120 kg * willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives * willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy exclusion criteria: * current diagnosis of asthma * daytime use of oxygen therapy * documented history of drug abuse within the last year * subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug. * cirrhosis or elevated liver transaminases \> 3x uln * gfr \< 50 estimated by cockcroft-gault * any illness of abnormal lab finding that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug to the subject. * pregnant or breastfeeding * subjects taking any inhibitors or inducers of cyp3a4, including certain herbal medications and grapefruit/grapefruit juice. * uncontrolled diabetes * excluded medications and foods include the drugs and foods provided in the appendix document. * clinically significant arrhythmias or conduction abnormalities that in the opinion of the investigator affect patient safety have been added as exclusion criteria and criteria for withdrawal. patients who have not been stable or have been hospitalized in the past 3 months with any clinically significant cardiac conditions. subjects with history of cancer (current or past, unless remote (\>5years))except for localized non-melanomatous skin cancers history of stroke/cva history of myocardial infarction/acute coronary syndrome cardiac failure nyhc grade iii-iv diabetes type i uncontrolled hypertension primary or secondary pulmonary hypertension -

Keywords: chronic obstructive pulmonary disease, ivacaftor
prevalence study of the etiology of pregnancy anemia

Conditions: Pregnancy Anemia

Summary: anemia during pregnancy occurs in 41% of women. the most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. however, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. specific management of anemia is so needed.


Eligibility criteria:
inclusion criteria: * woman 18-years or older * woman with a normal pregnancy * anemia with accidental or symptomatic discovery, whatever the term of pregnancy * non opposition collected exclusion criteria: * refuse to participate * stopped pregnancy whatever the term * medical abortion of pregnancy

Keywords: pregnancy anemia
epicardial delivery of xc001 gene therapy for refractory angina coronary treatment (the exact trial)

Conditions: Coronary Artery Disease; Ischemia; Angina Refractory; Cardiovascular Diseases; Heart Diseases

Summary: the primary purpose of this trial is to determine the safety of xc001 (advegfxc1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. subjects in this study will receive one of four intramyocardial doses of xc001 that expresses human vascular endothelial growth factor (vegf) which induces therapeutic angiogenesis (revascularization).

this is a phase 1/2, first-in-human, multicenter, open-label, single arm dose escalation trial of xc001. approximately 12 subjects (n=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose with 32 additional subjects. xc001 will be administered by a transthoracic epicardial procedure. safety will be the focus for the initial 6 months after xc001 administration followed by one safety focused telephone evaluation at month 12.

Eligibility criteria:
inclusion criteria: * males and females, age 18 to 80 years * diagnosis of chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft or percutaneous coronary intervention * angina class ii-iv based on canadian cardiovascular society classification of angina pectoris * adequate hematologic (hemoglobin ≥ 10 g/dl, absolute neutrophil count \> 1.2 × 10\^3 per μl and platelet count ≥ 75,000 per μl), hepatic (alanine aminotransferase and aspartate aminotransferase ≤ 3 x uln; total bilirubin ≤ 2 x uln), and renal function (glomerular filtration rate \> 29 ml/minute/1.73 m2) * adequate birth control if of child-bearing potential * must be willing and able to provide informed consent exclusion criteria: * st elevation myocardial infarction (stemi) or non-st elevation myocardial infarction (nstemi) not requiring revascularization, transmural myocardial infarction or cerebral vascular accident within the past 30 days * new york heart association function class iii or iv or left ventricular ejection fraction \< 25% within the 6 weeks prior to the screening visit * hba1c ≥ 8.5%, sbp \ 180 mmhg, dbp \>100 mmhg * other concurrent medical conditions that could jeopardize the safety of the subject or objectives of the study

Keywords: refractory angina coronary artery disease gene therapy
understanding the implementation of cued exercise using wearable devices and a custom smartphone application following bone marrow transplant.

Conditions: Blood Cancer; Bone Marrow Transplant (BMT)

Summary: the purpose of this study is to pilot test the feasibility of providing patients diagnosed with a hematologic malignancy, undergoing an allogeneic bone marrow transplant, a wearable device and smartphone app (similar to a fitbit), that would send personalized reminders to move during their post-transplant inpatient hospital stay to promote physical recovery and well-being.

enrolled patients who have been diagnosed with a hematologic malignancy and are scheduled to undergo an allogeneic bone marrow transplant will use a custom-designed wearable device and smartphone application as a behavioral intervention to cue exercise. participants will be asked to wear the wearable device for the duration of their post-transplant inpatient hospital stay. aim 1. to examine the potential efficacy of the wearable device + smartphone application to prompt allobmt patients to move. aim 2. to receive participant feedback on their experience participating in the study.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosed with hematologic malignancy * scheduled to receive an allobmt * physician consent to participate in the study exclusion criteria: • inability to complete 15 minutes walking unassisted
effectiveness of divalproex sodium (depakote) in treating children with temper outbursts and severe mood swings

Conditions: Mood Disorders

Summary: the purpose of this study is to determine the effectiveness of divalproex sodium (depakote) versus placebo in treating children with temper outbursts and severe mood disorders.

depakote has been used to treat seizures in children for more than 20 years. the purpose of this study is to determine the effectiveness of divalproex sodium (depakote) in treating children with temper outbursts and severe mood disorders. this study will last 12 weeks. participants will be randomly assigned to receive either 250 mg depakote or placebo. the dose of medication will increase at the end of week 1 to 500 mg of either depakote or placebo; participants will remain on this dose through week 5. at week 6, participants will cross-over and receive the other treatment (either depakote or placebo), which they will take through week 12. study visits will occur weekly and will include a physical exam, blood and urine tests, and self-reports of adverse events. in addition, caregivers will complete reports about mood swings throughout the study.

Eligibility criteria:
inclusion criteria: * meets criteria for explosive mood disorder (emd) * explosive temper as evidenced by four or more outbursts of rage, property destruction, or fighting per month * mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant * history of an emd for one year without treatment * emd symptoms resulting in impairment in two or more of the following areas: school, the law, family, substance use, peers, or work * emd symptoms do not occur only during substance toxicity or withdrawal * emd symptoms are not confined to a single setting or context * parent and child willing to consent to study * inadequate response to an adequate trial (8 weeks) of psychotherapy and/or family therapy exclusion criteria: * meets criteria for pervasive developmental disorder or childhood schizophrenia * seizure or other neurologic disturbance * pregnant * moderate to severe mental retardation * physical exam or laboratory results with significant abnormalities * positive hepatitis screen test * liver dysfunction * active suicidal or homicidal ideation * history of suicide attempts * history of barbiturate use * unequivocal manic or hypomanic episode * meets criteria for attention deficit hyperactivity disorder (adhd) and has not failed a trial of psychostimulants for adhd * meets criteria for major depression in prepuberty * if female, unwilling to use an effective method of contraception for the duration of the study * mitochondrial disease or family history of mitochondrial disease

Keywords: behavioral disorders