Kornimate/medical-research-clean huggingface dataset:
a long-term follow up study of exg102-031 in participants with wamd

Conditions: Wet Age-related Macular Degeneration

Summary: this is a long-term, safety and efficacy follow-up study of patients in the exg102-031-111 gene therapy clinical trial for wamd. patients will complete visits from the parent study, and then into this long-term follow-up study for continuous safety monitoring for up to 5 years.

this study will enroll patients with wet age-related macular degeneration (wamd) who have previously be treated with exg102-031 injection, those patients will voluntary join this long-term follow-up study to be evaluated the long-term safety and efficacy. the first two years of long-term follow-up will be conducted every 2 months; from 3 years to 5 years after administration,follow-up visits will be conducted every six months.

Eligibility criteria:
inclusion criteria: 1. previously received treatment with exg102-031 in the study (exg102-031-111); 2. paticipantes are informed consent and willingness to follow protocol procedures. exclusion criteria: 1. paticipantes are unwilling or unable to participate in long-term follow-up

Keywords: aav wamd
immunogenicity study of a reduced (4-dose) vaccine schedule and rabies immunoglobulins

Conditions: Rabies

Summary: reduced 4-dose intramuscular rabies vaccination schedule was announced by us-acip and who to be one of the post-exposure prophylaxis regimens. however, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by who (0.5 iu/ml) for at least a year period. this study would access this subject.

* controlled trial study * all 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups. group 1 : 25 healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had who category iii exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 iu/kg of equine rabies immune globulin (erig). group 2 : 25 healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 iu/kg of equine rabies immune globulin (erig). group 3 : 25 healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 iu/kg of equine rabies immune globulin (erig). 5 cc - blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (rnab). the gmts of rnab among both groups would be analyzed and compared.

Eligibility criteria:
inclusion criteria: * healthy volunteers age 18-60 years. exclusion criteria: * received prior rabies immunization * pregnancy * immunocompromised conditions

Keywords: rabies rabies immunoglobulin
topiramate as adjunctive therapy in infants 1-24 months for the control of partial onset seizures

Conditions: Partial Seizure Disorder; Epilepsy; Seizures

Summary: the purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (pos).

this is a world wide, multicenter, randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures (pos). there are 4 phases to the study, a screening phase of 3 days, a double blind treatment phase of 20 days, a one year open label extension phase and a posttreatment (taper and withdrawal) phase. the oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25 mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the four phases of the study.

Eligibility criteria:
inclusion criteria: * 1-24 months, inclusive * concurrent 1 or 2 antiepileptic drugs * receiving regular enteral feedings * weigh between 3.5 and 15 kg * clinical or eeg evidence of simple or complex pos exclusion criteria: * exclusively breast fed and cannot take medicine by mouth * surgically implanted and functioning vagus nerve stimulator * renal stones * medically uncontrolled illnesses or conditions * infantile seizures as a result of a correctable medical condition * progressive neurologic disorder

Keywords: partial seizure disorder topiramate epilepsy infants
researches about proximal humerus fractures

Conditions: Proximal Humeral Fracture

Summary: majority of previous classifications based on two-dimensional images to analyze these complicated 3-d fractures. small or delicate changes in rotation and positioning can result to considerable disagreement in the interpretation of standard radiographs. therefore, a classification system which had a better reliability and reproducibility for the fractures is warranted and helpful for orthopedic surgeons. furthermore, ct and 3-d ct construction images with high resolution give a much clearer view of the pattern of proximal humeral fractures. edelson proposed a new three-dimensional classification for fractures of the proximal humerus. the results concluded that it was a useful in classifying these injuries with reasonable interobserver reliability. it could be hypothesized that patients with proximal humeral fractures would benefit from this 3d classification, but there is a scarcity of application of the classification in large samples. t


Eligibility criteria:
inclusion criteria: * whole imaging data ; * clear record of demographic data; * three dimensional construction with mimics (with ct of b30); * patients older than 17 years with displaced phf occurring less than 3 weeks before allocation and treatment. exclusion criteria: * patients with the presence of neurological disease (syringomyelia and); * open fractures; * pathological fracture (other than osteoporotic); * not a resident in the hospital catchment area

Keywords: proximal humeral fracture classifications
abbott sensor based glucose monitoring system paediatric study

Conditions: Diabetes Mellitus

Summary: to evaluate the point accuracy of the abbott sensor based glucose monitoring system when used at home by children with diabetes.


Eligibility criteria:
inclusion criteria: * age ≥ 4 years, ≤17 years * each participant has an identified caregiver of ≥18 years * type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (csii) * currently testing blood glucose, on average at least 2 times per day * in the investigator's opinion, technically capable of using device (participant and/or caregiver). exclusion criteria: * concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition * currently prescribed oral steroid therapy for any acute or chronic condition * currently receiving dialysis treatment or planning to receive dialysis during the study * female participant known to be pregnant * participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management * currently using a continuous glucose monitoring (cgm) device * known (or suspected) allergy to medical grade adhesives * in the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered)

Keywords: diabetes mellitus sensing technology
a double blind, double dummy, randomized, comparative study of the efficacy and safety of valdecoxib 40 mg twice daily, as needed in the first menstrual cycle day and then once a day, and piroxicam 40 mg once a day in the treatment of patients with primary dysmenorrhea

Conditions: Dysmenorrhea

Summary: to compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in subjects with moderate to severe menstrual cramping pain associated with primary dysmenorrhea.


Eligibility criteria:
inclusion criteria: * history of primary dysmenorrhea with moderate to severe menstrual cramping pain for which the patient took analgesic medication for at least three of six previous menstrual cycles before enrollment * subjects were to have been in good health and were to have had a complete physical exam (including a pap smear and an endovaginal or pelvic ultrasound, unless the subject had had these examinations performed within 6 months prior to the screening visit and the results were normal) prior to inclusion exclusion criteria: * subjects who were pregnant, lactating, breastfeeding or not using adequate methods of birth control
the safety management of cardiac toxicity in breast cancer patients under multidiscipline therapy.

Conditions: Breast Neoplasms; Cardiotoxicity

Summary: this trial is to explore the optimal strategies for guaranteeing the cardiac safety of breast cancer patients following adjuvant radiotherapy in the modern era of multidisciplinary treatment.

with the development of modern radiotherapy techniques, the dose-volume of heart irradiated could be kept in much low level. however, until now, the optimal dose-volume parameters for limiting heart irradiation, the optimal follow-up interval for cardiac safety after adjuvant radiotherapy, the optimal screening examinations and treatments for irradiation-induced cardiac toxicity are unclear. we designed this trial to find answer for above questions to establish rationalization proposal for prevention, treatment and follow-up for cardiac toxicity associated with adjuvant radiotherapy for breast cancer.

Eligibility criteria:
inclusion criteria: * patients willing to participate the research and sign the informed consent file; * patients aged 18-80 years; * kps≥70; * pathological diagnosis for invasive breast cancer; * patients received anthracycline/paclitaxel based chemotherapy, or herceptin based targeted therapy; * no functional heart disease; * lvef≥50%; * patients received breast conserving surgery; * patients received modified radical mastectomy: t1-2 with n1-3 or t3-4 with any n; * tumor margin negative; * no metastases; * no other malignant tumor history. exclusion criteria: * patients with metastases; * tumor margin positive; * patients received modified radical mastectomy with t1-2 and n0; * patients have other malignant tumor; * patients have a history of heart disease; * patients received chest radiotherapy previously; * patients with severe organic and functional disease; * unqualified patients with sufficient reasons; * cannot or no willing to sign the informed consent file; * patients with autoimmune disease; * women with pregnancy, planned pregnancy or lactating.
low fat milk intake and cardio vascular risk (cvr) indicators in children

Conditions: Cardiovascular Diseases

Summary: substituting whole milk intake for defatted milk will improve indicators of cardiovascular risk, i.e. total cholesterol, triglycerides, low density lipoprotein (ldl) and high density lipoprotein (hdl)cholesterol, apolipoproteins: apob100, lp(a) and apoa in a sample of mexican children 6-13 years of age.

double blind trial in 600 children 6-13 years of age residing in 12 boarding schools. schools will be randomized to distribute three types of milk namely: full fat milk (3% fat), partially defatted milk (2% fat) or defatted milk (1% fat) for 90 days of effective exposure (4 months total duration). subjects will receive 400 ml of the corresponding milk every day (200 ml breakfast and 200 ml night meal) from monday through friday. during week ends they will eat a freely chosen diet at home. milk intake will be measured every day. diet by 24 h-recall. will be evaluated every month. blood samples will be obtained at the beginning and at the end of the intervention.

Eligibility criteria:
inclusion criteria: * attending selected boarding schools exclusion criteria: * no lactose intolerance

Keywords: epidemiological risk diet fat intake
nesfatin-1 level in patients with type 2 diabetes, insulin resistance and obesity

Conditions: Type 2 Diabetes; Insulin Resistance; Obesity; Nesfatin-1

Summary: this research was planned to determine the level of nesfatin-1, known as satiety hormone, in type 2 diabetes, insulin diabetes and obesity patients and to determine whether there is a relationship between patients' energy intake levels. additionally, it was aimed to evaluate the relationship between patients' nesfatin-1 values and serum glucose, insulin, lipid concentrations.

nesfatin-1 levels of patients with type 2 diabetes, insulin resistance and obesity will be measured. in addition, patients' daily food consumption will be taken and the amount of energy they receive will be calculated daily. the relationship between the level of nesfatin-1 in the blood and the energy received will be examined.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * insulin resistance * obesity disease exclusion criteria: * pediatric individuals * all patients who are hospitalized, * liver disease * cancer patients * disease related to the gastrointestinal tract * nephrological disease such as chronic kidney failure, acute kidney failure, nephrotic syndrome * neurological disease

Keywords: type 2 diabetes insulin resistance obesity nesfatin-1
international multicentric observational study to characterize subpopulations of patients with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: to determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication


Eligibility criteria:
inclusion criteria: * participants previously diagnosed with asd (dsm-5) * available well-documented health records within the first 2 years of life * participants must have a parent or reliable caregiver who agrees to provide information about the participant * participants willing and consenting or assenting to participate. exclusion criteria: * episode of fever (i.e. ≥100.5 °f or ≥ 38 °c) or clinically significant illness without fever (as judged by the investigator), within 10 days before any study assessment. * if the investigator assesses any unwillingness or any medical condition that may prevent the subject from completing this study.
a study of subcutaneous (sc) pembrolizumab coformulated with berahyaluronidase alfa (mk-3475a) vs intravenous pembrolizumab in adult participants with metastatic non-small cell lung cancer (nsclc) (mk-3475a-d77)

Conditions: Metastatic Non-small Cell Lung Cancer

Summary: this study is to assess the pharmacokinetics (pk) and safety of sc pembrolizumab formulated with berahyaluronidase alfa (mk-3475a) versus (vs) intravenous (iv) pembrolizumab (mk-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. the primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (sc) is noninferior to pembrolizumab iv with respect to pk parameters.


Eligibility criteria:
the key inclusion and exclusion criteria include but are not limited to the following: inclusion criteria: * has histologically or cytologically confirmed diagnosis of squamous or non-squamous non-small cell lung cancer (nsclc) * must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated * has a life expectancy of at least 3 months exclusion criteria: * has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * has received prior systemic anticancer therapy for metastatic nsclc * has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids * has received radiation therapy to the lung (\>30 gray) within 6 months of start of study intervention * has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * has a known additional malignancy that is progressing or has required active treatment within the past 3 years * has an active autoimmune disease that has required systemic treatment in past 2 years * has an active infection requiring systemic therapy * has a history of human immunodeficiency virus (hiv) infection * has a history of hepatitis b or c * has not adequately recovered from major surgery or has ongoing surgical complications * has a history of allogenic tissue/solid organ transplant
influence of intensive lipid lowering treatment compared to moderate lipid lowering treatment on plaque composition in patients with st-segment elevation myocardial infarction (mi)

Conditions: Acute Coronary Syndrome

Summary: in patients with st-segment elevation acute myocardial infarction (stemi) increased ldl-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization (changes in plaque composition) and plaque regression over 12 months beyond the benefit of moderate ldl-cholesterol reduction (rosuvastatin 5 mg) (assessed by ivus and vh).


Eligibility criteria:
inclusion criteria: * st segment elevation acute myocardial infarction * 20% \< angiographic diameter stenosis \< 50% on a not previously revascularized native coronary artery * statin naïve exclusion criteria: * pharmacologic lipid lowering treatment before index hospitalization * atrial fibrillation, not well rate-controlled * ventricle frequency variation with more than a factor 2 over 1 minute * unconscious patients * total cholesterol \> 7.0 mmol/l * history of statin induced myopathy, or serious hypersensitivity reaction to other hmg-coa reductase inhibitors (statins) including rosuvastatin * pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test (a serum-human chorionic gonadotrophin \[beta-hcg\] analysis) * history of malignancy (unless a documented disease free period exceeding 5-years is present) with the exception of basal cell or squamous cell carcinoma of the skin, or in the case of a study designed to investigate antineoplastic properties of rosuvastatin. women with a history of cervical dysplasia would be permitted to enter the study provided they had 3 consecutive clear papanicolaou (pap) smears * uncontrolled hypothyroidism (tsh \> 1.5xuln) * abnormal lft's * history of alcohol or drug abuse within the last 5 years (this may affect compliance) * current active liver disease (alt/sgpt \>2xuln or severe hepatic impairment (to protect patient safety as directed on the labels of currently approved statins) * unexplained creatine kinase (ck \> 3xuln) (to protect patient safety) (will be increased at baseline because of acute st segment elevation myocardial infarction a few days before enrolment) * serum creatinine \>176mmol/l (2.0mg/dl) (unless the protocol specifically aims to investigate a chronic renal disease population) * participation in another investigational drug study less than 4 weeks before enrolment in the study, or according to subjects local ethics committee requirements where a larger period is stipulated (to avoid potential misinterpretation of overlapping adverse events) * treatments with cyclosporine * treatment with gemfibrozil

Keywords: st-segment elevation myocardial infarction
european cure-af study

Conditions: Atrial Fibrillation

Summary: a prospective, non-randomized, multi-center clinical trial. the patient population includes patients with permanent or persistent af requiring valve replacements or repairs, asd repairs, pfo closure or coronary artery bypass grafts (cabg) procedures. patients are not allowed to have had previous atrial ablation, av-nodal ablation, or surgical maze procedure.

the cardioblate surgical ablation system is cleared in canada and europe for ablation of cardiac tissue for the treatment of cardiac arrhythmias. in the united states, the cardioblate bipolar is approved for soft tissue ablation, while the cardioblate pen is approved for cardiac tissue ablation. the purpose of the clinical study is to obtain a labeling claim for the us market that the cardioblate surgical ablation system can be used for ablation of cardiac tissue in the treatment of cardiac arrhythmias such as atrial fibrillation among permanent and persistent af patients.

Eligibility criteria:
inclusion criteria: * patients must meet all of the following criteria to be enrolled in the study: 1. documented history of af a for inclusion in permanent af arm: patients must have a documented history of permanent af (cardioversion failure) as defined by the acc/aha/esc guidelines; documentation of af must include one or more chart references to af and/or one or more ecg's with af prior to the patient's surgery. other supporting information could include references to cardioversion attempts using either drugs or electrical shock. b for inclusion in persistent af arm: patients must have a documented history of persistent af as defined by the acc/aha/esc guidelines: characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days 2. concomitant indication (other than af) for open-heart surgery for one or more of the following: a mitral valve repair or replacement, b aortic valve repair or replacement, c tricuspid valve repair or replacement, d asd repair, e pfo closure, or f cabg procedures; 3 able to take the anticoagulant warfarin or other acc/aha/esc-recommended anticoagulant medication; 4 greater than or equal to 18 years of age; 5 able and willing to comply with study requirements by signing a patient informed consent form. exclusion criteria: * patients who meet any of the following criteria may not be enrolled in the study: 1 wolff-parkinson-white syndrome, 2 nyha functional class = iv, 3 left ventricular ejection fraction ≤ 30%, 4 left atrial diameter \> 7.0 cm, 5. need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery, 6 preoperative need for an intra-aortic balloon pump or intravenous inotropes, 7 previous atrial ablation, av-nodal ablation, or surgical maze procedure, 8 contraindication for anticoagulation therapy, 9 current diagnosis of active systemic infection, 10 renal failure requiring dialysis or hepatic failure, 11 documented myocardial infarction 6 weeks prior to study enrollment, 12 life expectancy of less than one year, or 13 pregnancy or desire to be pregnant within 12-months of the study treatment.