Kornimate/medical-research-clean huggingface dataset:
a gene transfer therapy study to evaluate the safety and efficacy of delandistrogene moxeparvovec (srp-9001) following imlifidase infusion in participants with duchenne muscular dystrophy (dmd) determined to have pre-existing antibodies to recombinant adeno-associated virus serotype (raavrh74)

Conditions: Duchenne Muscular Dystrophy

Summary: this is a gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec and delandistrogene moxeparvovec dystrophin expression in association with imlifidase, in participants with dmd with pre-existing antibodies to raavrh74 over a period of 104 weeks.


Eligibility criteria:
inclusion criteria: * ambulatory per protocol specified criteria. * has a definitive diagnosis of dmd prior to screening based on documentation of clinical findings and confirmatory genetic testing. * ability to cooperate with motor assessment testing. * has elevated raavrh74 antibody titers per protocol-specified requirements. * a pathogenic frameshift mutation, nonsense mutation or premature stop codon or pathogenic variant in the dmd gene that is expected to lead to absence of dystrophin protein. * stable daily dose of oral corticosteroids for at least 12 weeks prior to screening, and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight). exclusion criteria: * previous treatment with imlifidase. * presence of any other clinically significant illness, including cardiac, pulmonary, hepatic, renal, hematologic, immunologic, or behavioral disease, or infection or malignancy or concomitant illness or requirement for chronic drug treatment that in the opinion of the investigator creates unnecessary risks for receiving the study drugs or a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the participant's ability to comply with the protocol required testing or procedures or compromise the participant's wellbeing, safety, or clinical interpretability. * exposure to gene therapy, investigational medication, or other protocol-specified treatment within the protocol specified time limits. * abnormality in protocol-specified diagnostic evaluations or laboratory tests. note: other inclusion or exclusion criteria could apply.

Keywords: gene-delivery dmd ambulatory pediatric duchenne pre-existing antibodies raavrh74 antibody seropositive seropositivity titer
diva - the effects of 12 weeks of treatment with high dose valsartan (320 mg) to amlodipine on endothelial function in hypertensive subjects with the metabolic syndrome

Conditions: Hypertension; Metabolic Syndrome

Summary: a study on whether an antihypertensive medication prevents damage to walls of veins in female patients with the metabolic syndrome (overweight and other disorders).


Eligibility criteria:
inclusion criteria: subjects must meet the following inclusion criteria at visit 1, visit 2 and visit 3. inclusion criteria for group a (overweight postmenopausal females with high-normal blood pressure/ mild stage i hypertension) 1. non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year. 2. mean blood pressure between 130 - 149 mm hg systolic and/or 85 - 94 mm hg diastolic • when systolic blood pressure and diastolic blood pressure fall into different categories (high normal versus mild stage i hypertension), the higher category should be selected to classify or group the subject. 3. body mass index greater than or equal to 26 but less than or equal to 41 kg/m2 4. subjects who agree not to alter their diet or exercise routine during the study and comply with study specific restrictions 24 hours prior to the next scheduled study visit 5. subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study exclusion criteria: * 1. non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year. 2. mean blood pressure between 90 - 129 mm hg systolic and/or 50 - 84 mm hg diastolic. 3. body mass index greater than or equal to 26 but less than or equal to 41 kg/m2

Keywords: valsartan hypertension metabolic syndrome endothelial function
effect of oral feeding in infants with pierre robin syndrome

Conditions: Pierre Robin Syndrome

Summary: this was a randomized controlled study. the infants enrolled were randomly divided into the ioe group (with intermittent oro-esophageal tube feeding) and the png group (with nasogastric tube feeding), all receiving systemic therapy. before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

pierre robin syndrome (prs) can cause dysphagia. in china, persistent nasogastric tube feeding (png) is the mainstream choice as nutrition support in the dysphagic infants with prs. however, png is associated with various complications, necessitating the exploration for a safer and more effective nutritional support approach. therefore, this study aims to observe the clinical effect of intermittent oro-esophageal tube feeding (ioe) compared to png in the dysphagic infants with prs who received systemic therapy. this was a randomized controlled study. the infants enrolled were randomly divided into the ioe group (with ioe) and the png group (with png), all receiving systemic therapy. before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for pierre robin sequence based on ct and x-ray examinations, combined with clinical manifestations and physical signs. * with spontaneous vaginal birth, aged 1 to 12 months. * with dysphagia screened by the water drinking test and further confirmed by the assessment of dysphagia disorders survey (dds), dysphagia severity scale (dss), or schedule for oral motor assessment (soma) * before the treatment, the tube feeding was required and feasible after evaluation. * stable vital signs. * with nasogastric tubes placed before the treatment. * sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device). exclusion criteria: * abnormalities in brain development or other neurological lesions revealed by ct or mri scans. * dysphagia caused by other diseases. * other congenital malformations, such as down syndrome, cleft lip, and palate, etc. * severe systemic disease (such as severe infection, severe hepatic and renal dysfunction). * participants who need to receive other therapy which would potentially affect the result of this study
economisation of whipple resection using an ultrasonic dissection device

Conditions: Resectable Pancreatic Head Neoplasm; Resectable Periampullary Neoplasm; Chronic Pancreatitis

Summary: including 150 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an ultrasonic dissection device versus traditional surgical methods such as stitches an ligations.the study is performed for patients undergoing partial pancreatoduodenectomy.


Eligibility criteria:
inclusion criteria: resectable tumor exclusion criteria: palliative resection
dose-titration study of sevelamer carbonate in chronic kidney disease (ckd) patients on hemodialysis

Conditions: Chronic Kidney Disease; Chronic Kidney Disease on Hemodialysis

Summary: the study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and ldl-cholesterol) in chronic kidney disease patients on dialysis.


Eligibility criteria:
inclusion criteria: * on hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to visit 1 and throughout the study * have a central laboratory serum ipth measurement less than 1000 pg/ml at visit 1 * have a central laboratory serum phosphorus measurement greater than 5.5 mg/dl at visit 1a exclusion criteria: * active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (gi) motility disorders including severe constipation * documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition

Keywords: hemodialysis
the rodeo micro mapping catheter in cryoablation procedures

Conditions: Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases; Heart Diseases

Summary: this clinical investigation evaluates the feasibility of the rodeo micro mapping catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted). further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and legal capacity. * atrial fibrillation, diagnosed in accordance with the guidelines of the esc (version 2016) - permanent af excluded. * patient planned for a pulmonary vein isolation catheter ablation procedure using cryoenergy and suitable for treatment according to the respective instructions for use (ifu). * signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrolment (patient has received a copy of the icf). exclusion criteria: * indication that the vascular system is not accessible through the left or right groin. * indication that a transseptal puncture cannot be performed. * any previous ablation or surgery due to af. * important comorbidities such as cardiovascular events within six months of enrolment or high-risk surgical patients. * left atrial diameter \> 50 mm in the short axis. * advanced structural heart disease including * moderate-to-severe valvular stenosis or regurgitation, * previous valve replacement or valve repair, * congenital heart disease, * left ventricular ejection fraction \< 45% during sinus rhythm, * congestive heart failure nyha iii or iv, * coronary artery bypass graft surgery within the last 3 months. * permanent pacemaker. * pregnant women at the time of the cryoablation procedure. * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * participation in interventional trials for cardiovascular devices or drugs.

Keywords: atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation cryoablation cryosurgery mapping catheter
tolerance and effect of a prophylactical treatment with ivy leaves dry extract in recurrent wheezy bronchitis

Conditions: Acute Wheezy Bronchitis; Recurrent Bronchitis

Summary: to evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. a prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.


Eligibility criteria:
inclusion criteria: 1. medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months 2. children aged from 1 to 3 years (girls and boys) 3. signed informed consent of the legal guardians to participate in the trial after written and verbal briefing by the investigator 4. no allergic sensitization 5. allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes exclusion criteria: 1. anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure 2. participation of the patient in another clinical trial within the last four weeks before enrollment in this trial 3. evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance) 4. inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly 5. any regular therapy except vitamin d or fluoride 6. chronic illnesses of different aetiology 7. premature birth or diagnosis of bronchopulmonary dysplasia 8. gastro-oesophageal reflux 9. hereditary fructose intolerance
study of anlotinib in patients with medullary thyroid carcinoma(alter01031)

Conditions: Medullary Thyroid Carcinoma

Summary: to compare the effects and safety of anlotinib with placebo in patients with medullary thyroid carcinoma.


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent 2. histological documentation of medullary thyroid carcinoma(mtc),unable to surgery(stage iv) or metastasis ,with measurable disease (using recist1.1) 3. ecog ps:0-1,life expectancy of more than 6 months 4. main organs function is normal exclusion criteria: 1. prior treatment with anlotinib or vegfr-targeted therapies(such as vandetanib,cabozantinib,lenvatinib,sunitinib,sorafenib etc.) 2. subjects received radiotherapy external exposure within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study 3. patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ ta (non-invasive carcinoma), tis (carcinoma in situ) and t1 (carcinoma invasion into lamina propria) \] 4. ctcae(4.0) grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and grade 2 or lower neurotoxicity induced by oxaliplatin 5. patients with factors that could affect oral medication (such as dysphagia etc.) 6. patients with pleural effusion or ascites, causing respiratory syndrome (ctcae grade 2 or higher dyspnea \[grade 2 dyspnea refers to shortness of breath with a small amount of activities, affecting instrumental activities of daily life\]) 7. patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment
efficacy of music listening to shortening time for biophysical profile

Conditions: Fetal Status, Nonreassuring

Summary: the goal of this clinical trial is to compare the timeing which assume for assesment of bpp in low risk pregnancy. the main question is the music can be shoetening the timing for bpp? participants will in study froup will listening the music via headphone before and during the assessment and compre to control gruop which not listening to music during asseeement.

a single-blind randomized controlled trial conducted from february 2021 to december 2022. the study population consisted of 60 pregnant women with between 18 and 35 years old with gestational age of 32 weeks. an abdominal ultrasound was performed while listening to one song while wearing headphones in the experimental group preceding the biophysical profile assessment. as part of the control group, the same equipment was used and the same assessment protocol was followed, but music was not played during the test.

Eligibility criteria:
inclusion criteria: * single pregnancy (singleton) * gestational age from 32 weeks onward * pregnant women do not have underlying diseases such as pre-gestational diabetes. high blood pressure * no abnormalities in the fetus were found, such as fetal deformities. exclusion criteria: * pregnant women receiving certain drugs or substances that affect the interpretation of the biophysical profile (bpp), e.g., sleeping pills, cigarettes. * pregnant women have hearing problems. or hearing impaired * pregnant women who are unable to wear headphones, e.g., otitis externa - pregnant women with body mass index greater than 30 kg/m2 prior to pregnancy * uterine contractions were observed during the examination

Keywords: fetal biophysical profile music duration
hypofractionated radiotherapy with concomitant tumor bed boost for breast cancer

Conditions: Early Breast Cancer; Ductal Breast Carcinoma In Situ

Summary: hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy


Eligibility criteria:
inclusion criteria: * female patients with histologically confirmed early-stage breast cancer (t1-2 and n0-1) or ductal carcinoma in situ (dcis). * patients undergoing breast-conserving surgery * age ≥ 20 years * karnofsky performance status (kps) ≥70% * life expectancy ≥ 5 years * adequate renal and hepatic function exclusion criteria: * pregnant patients * patients requiring re-irradiation of the thoracic region

Keywords: breast cancer concomitant boost tumor bed intensity-modulated radiation therapy hypofractionated breast radiotherapy
imatinib mesylate (gleevec) and paclitaxel in recurrent patients of ovarian and other cancers of mullerian origin

Conditions: Ovarian Cancer

Summary: this study is designed to determine whether the combination treatment of paclitaxel and gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will generate better clinical response than paclitaxel alone.


Eligibility criteria:
inclusion criteria: * patients at least 18 years of age. * histologically documented diagnosis of epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, of any stage or grade at diagnosis. \*patients must have received initial cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen. \*eligible platinum resistant patients will have failed no more than two additional non platinum cytotoxic regimens for their persistent or recurrent disease. * measurable disease. * performance status 0, 1, 2 (eastern cooperative oncology group) . * adequate end organ function, defined as the following: total bilirubin \ 1.0 x 10e9/l, platelets \> 100 x 10e9/l. * written, voluntary informed consent. exclusion criteria: * patient has received any other anticancer treatment within 21 days of first day of study drug dosing and shown recovery of any recent drug-induced neutropenia and thrombocytopenia. * patient has another primary malignancy that has required active intervention within 5 years, with the exception of basal cell skin cancer or a cervical carcinoma in situ. * patient with grade iii/iv cardiac problems as defined by the new york heart association criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study). * patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). * patients on coumadin-derived anticoagulants. * patient with brain metastasis. * chronic liver disease, hep b or c. * patient has a known diagnosis of human immunodeficiency virus (hiv) infection. * patient received chemotherapy within 3 weeks -unless the disease is rapidly progressing. * patient previously received radiotherapy to at least 25 % of the bone marrow. * patient had a major surgery within 2 weeks prior to study entry. * patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. * patient is on any drug that may interfere with gleevec (e.g., dilantin, coumadin,or others on the list on page 33-37 of the protocol).

Keywords: ovarian cancer recurrent gleevec paclitaxel taxane mullerian
type 2 diabetes: risk perceptions and self-management behaviour

Conditions: Type 2 Diabetes Mellitus

Summary: this pilot randomised controlled trial (rct) aims to assess the feasibility of using a new type of risk communication intervention for people with type 2 diabetes mellitus (t2dm) in primary care and to evaluate its potential impact on risk perceptions and self-management behaviour. the study comprises 40 participants with t2dm randomly allocated to usual care supported by the risk communication intervention or usual care only.

diabetes self-management, which includes self-care behaviours such as healthy eating and physical exercise, has become the cornerstone for treating type-2 diabetes mellitus (t2dm). however, although self-management education (sme) is necessary to equip patients with the knowledge, skills and attitudes required to manage their diabetes care, the most effective method to do so is still unclear. recent studies have shown that people with t2dm underestimated their risks of developing complications. although behavioural processes are complex, wrong risk perceptions are a major impediment to the adoption of self-care behaviours and, as a result, an additional risk for the occurrence of adverse outcomes. existing risk communication interventions have shown mixed results, with many participants barely understanding the explanations of health professionals about risks and having poor recall of risk information. in this context, there is a need for better risk communication interventions. based on the results of recent studies investigating the risk perceptions and risk attitudes of people with t2dm, we have developed a new, tailored risk communication intervention. the objectives of this intervention are: * to increase the awareness of risks for complications associated with type 2 diabetes. * to encourage the adoption of recommended self-care behaviours. the intervention has been developed in collaboration with both health professionals and patients. we have designed a pilot study to assess the feasibility of using the intervention in primary care and to evaluate its potential impact on patients' risk perceptions and self-management behaviour, in order to inform the design of a largest study (rct to be conducted in the future) the intervention lasts 5 minutes on average, conducted by the general practitioner (gp) during patients' routine primary care consultation. the study involves 40 participants with t2dm randomly allocated to usual care supported by the risk communication intervention or usual care only. the research is supported by the national institute for health research (nihr) collaboration for leadership in applied health research and care oxford at oxford health nhs foundation trust.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * diagnosed with type-2 diabetes. exclusion criteria: * unable to provide informed consent. * non-english speaker. * not suitable for the study according to gp.

Keywords: type 2 diabetes mellitus