Kornimate/medical-research-clean huggingface dataset:
long term follow-up for rgx-202

Conditions: Duchenne Muscular Dystrophy

Summary: rgx-202-5101 is a long-term follow up study that evaluates the long term safety and efficacy of rgx-202 in participants who have received rgx-202 (a gene therapy designed to deliver a transgene for novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the c-terminal (ct) domain) in a separate parent study.

this is a multicenter, prospective, observational study to evaluate the long-term safety and efficacy of rgx-202. eligible participants are those who have undergone evaluation in a previous (parent) clinical study following a single intravenous infusion of rgx-202 for the treatment of dmd. enrollment in the current long-term follow-up (ltfu) study will occur after the participant has completed or discontinued from the parent study. participants will be followed in this study cumulatively for up to 5 years after rgx-202 administration (inclusive of the parent study). no investigational treatment will be administered under this protocol. the total study duration for each participant may vary depending on when he enrolls in the current study following rgx-202 administration in the parent study.

Eligibility criteria:
inclusion criteria: * the parent(s) or legal guardian(s) of the participant has/(have) provided written informed consent and (where applicable) health insurance portability and accountability act (hipaa) authorization after the nature of the study has been explained, prior to any research-related procedures; and, where applicable, the minor participant has provided written or verbal assent according to local requirements. * must have undergone evaluation in a previous clinical study following a single iv infusion of rgx-202 for the treatment of dmd and either completed or withdrawn early from that study. * participant and parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, and study procedures. * sexually active participants must be willing to use a medically accepted method of contraception from the time of the screening visit through 5 years after rgx-202 administration. exclusion criteria: * no exclusion criteria apply in this observational follow up study.

Keywords: gene therapy dmd duchenne duchenne muscular dystrophy
cognitive training video game to target subclinical depressive symptoms in youth

Conditions: Depression; Subclinical Depressive Symptoms

Summary: the purpose of the study is to determine how cognitive control training (cct) changes behavior in youth with subclinical depressive symptoms. this research will show what types of behavior changes are important for cct to help reduce depressive symptoms. in the future, this information will be used to try to improve prevention of the development of depression, so that it can help more patients.

the primary study investigator acknowledges contributions from kate fitzgerald, emily bilek, christopher monk, and adriene beltz.

Eligibility criteria:
inclusion criteria: 1. parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study. 2. males and females (age 9 - 17.99) 3. participant is willing to engage in a technology-based intervention (technology will be provided to participants who live in the state of michigan, if not already accessible to participant). 4. self-reported depressive symptoms (children's depression inventory \[cdi\] score between 3-19 at assessment 1) 5. participants will be required to maintain a stable dose of medications exclusion criteria 1. color blindness 2. unable to play the video game for any reason 3. current kiddie schedule for affective disorders and schizophrenia (k-sads) diagnosis of clinical depression, psychosis, or autism spectrum disorder 4. has enrolled in new psychotherapy (for the treatment of a mood or anxiety disorder) or had changes to their psychotherapy in the 4-weeks prior to study enrollment 5. endorses items #1, #2, #3, #4, #5, or #6 on the columbia suicide severity rating scale (c-ssrs) screener (past-month); i.e., has present suicidal intention/behavior. 6. has had any changes to their medication in the 4-weeks prior to study enrollment

Keywords: cognitive training video game
study to determine the effectiveness of gsk1120212 in braf mutation-positive melanoma previously treated with or without a braf inhibitor

Conditions: Cancer

Summary: mek113583 is a phase ii open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of gsk1120212 in subjects with braf mutation-positive melanoma who were previously treated with or without a braf inhibitor. gsk1120212 is a potent and highly selective inhibitor of mek activation and kinase activity.


Eligibility criteria:
inclusion criteria: * metastatic cutaneous melanoma that was previously treated with: (cohort a) a braf inhibitor either with or without other prior therapy. (cohort b) at least 1 prior chemotherapy or immunotherapy, without treatment with a braf inhibitor. * documented positive braf mutation (v600e, v600k, or v600d). * subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to enrollment. * the subject must have a radiographically measurable tumor. * the subject is able to carry out daily life activities without significant difficulty (ecog performance status score of 0 or 1). * able to swallow and retain oral medication. * sexually active subjects must use acceptable methods of contraception during the course of the study. * adequate organ system function and blood cell counts. exclusion criteria: * the subject has had major surgery or received certain types of cancer therapy within 21 days before starting the study. * previous treatment with a mek inhibitor. * current use of a prohibited medication listed in the protocol. * uncontrolled glaucoma. * brain metastasis, unless previously treated with surgery or stereotactic radiosurgery, and the disease has been stable for at least 2 months prior to enrollment. * current severe or uncontrolled systemic disease. * history of clinically significant heart, lung, or eye/vision problems. * significant unresolved side effects from previous anti-cancer therapy. * the subject is pregnant or breastfeeding.

Keywords: gsk1120212 braf inhibitor melanoma mek inhibitor
trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma

Conditions: Osteosarcoma

Summary: multicenter and prospective phase ii trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. the study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.

the trial seeks to analyze progression free survival (pfs), measured as pfs rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). the treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. rapamycin is given at 5 mg per day during treatment duration.

Eligibility criteria:
inclusion criteria: * informed consent signed before any trial test * age equal or less than 80 years * histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression * previous treatment with drugs used in first line: methotrexate, adriamycin, platinum * measurable disease, acoording to recist criteria * ecog 0-2 exclusion criteria: * patients who have been irradiated on target lesions * ecog \>2 * bilirubin levels over normal values. creatinine over 1.6 mg/dl * history of other cancers except basal cell cancer or cervical cancer adequately treated * serious cardiovascular disease

Keywords: osteosarcoma
cardiovascular diseases in hiv-infected patients hiv-heart study: 5 years follow-up

Conditions: Coronary Heart Disease; Heart Failure; HIV; AIDS; Metabolic Syndrome

Summary: hiv-infection is associated not only with a reduced function of the immune system, but also linked with diseases of other organ systems, in particular with the heart. heart conditions that have been described with hiv include * pericarditis, * pleural effusion * pulmonary hypertension (venedic classification typ ii) * dilated cardiomyopathy * heart failure * myocarditis * bacterial endocarditis * heart valve disorders in addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most hiv-researchers and physicians. premature atherosclerosis of coronary arteries results in coronary calcification, angina pectoris, myocardial infarction and sudden death. hiv-positive patients are at greater risk for a variety of heart-related conditions, including coronary artery disease. it is assumed, that hiv infection doubles the risk of a heart attack, according to recent research. the reason for this link between hiv and heart-related conditions is unknown, but secondary infections that affect the heart muscle and coronary arteries have a greater chance of occurring in people with compromised immune systems. in addition, the hi-virus itself had been detected in the myocardium and might have an impact on the premature of cardiovascular diseases. furthermore, some of the medications used to treat hiv patients (antiretroviral therapy, art) are assumed to have heart-related side effects. therefore, current treatment regimens for hiv infection have to be balanced against the marked benefits of antiretroviral treatment. nevertheless, prevention of coronary heart disease should be integrated into current treatment procedures of hiv-infected patients. the link between the heart and hiv is well established but not well understood. therefore, further results are needed for efficient guidelines for the prevention, diagnostic and therapy of hiv-associated cardiovascular diseases.

a comprehensive detailed description of the study procedures had been previously published (european journal of medical research 2007;12:243-248).

Eligibility criteria:
inclusion criteria: * age \> 18 years * known hiv-infection * written informed consent exclusion criteria: * acute cardiovascular disease * unstable hemodynamic status in the three weeks before inclusion * pregnancy

Keywords: cardiac diseases, hiv-infection, aids, antiretroviral therapy, cardiovascular medication, risk factors, coronary heart disease, heart failure, metabolic syndrome
a cross-sectional survey to evaluate diabetes management, control, complications, psychosocial aspects of patients with type 2 diabetes in malaysia

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in subjects with type 2 diabetes in malaysia.


Eligibility criteria:
inclusion criteria: * people with type 2 diabetes mellitus (dm) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 2 years and who have visited the centre within the last 3-6 months * patients willing to sign informed consent form exclusion criteria: * previous participation in this study * unable to comply with protocol requirements * confirmed or suspected pregnancy
a phase 1/2 multicenter, randomized, study to evaluate the safety and efficacy of vs101 subconjunctival latanoprost insert in subjects with open-angle glaucoma or ocular hypertension

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension


Eligibility criteria:
inclusion criteria: * age \> 18 * open angle glaucoma or ocular hypertension exclusion criteria: * uncontrolled medical conditions * wearing of contact lenses

Keywords: glaucoma intra-ocular pressure slow release controlled release
first-line treatment with rc48 plus sintilimab and s-1 in advanced gastric cancer (rcts2)

Conditions: HER2-positive Gastric Cancer; Metastatic Gastric Cancer; Unresectable Gastric Carcinoma

Summary: this is a phase ii, randomized, multicenter, open-label clinical trial designed to compare disitamab vedotin plus sintilimab and s-1 with trastuzumab plus chemotherapy ± sintilimab for first-line treatment of her2-positive advanced gastric or gastroesophageal junction adenocarcinoma.


Eligibility criteria:
inclusion criteria: 1. aged18-75 years, gender is not limited; 2. pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis; 3. her2-positive (ihc3+or ihc2+/fish+) ; 4. has at least 1 measurable lesion as determined by recist 1.1; 5. there is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment; 6. eastern cooperative oncology group (ecog) performance status of 0-1; 7. adequate organ function; 8. the life expectancy is at least 3 months; exclusion criteria: 1. allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug; 2. cardiovascular and cerebrovascular events that are not well controlled; 3. has received systematic treatment with chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks. 4. have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.); 5. have a history of active immune deficiency or autoimmune diseases, including hiv positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases; 6. severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment; 7. brain metastasis or leptomeningeal metastasis; 8. clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug; 9. has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ); 10. any major surgery was performed ≤ 28 days before the first trial drug administration; 11. history of allogeneic stem cell transplantation or organ transplantation;
effectivenes of cyanoacrylate (glubran 2®) in reducing seroma formation in breast cancer patients post-axillary dissection

Conditions: Breast Cancer

Summary: glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.


Eligibility criteria:
inclusion criteria: * the patient should be above 18 years old * the patients has node positive breast cancer * the patient is eligible for axillary dissection in addition to a surgical intervention for the primary tumor * patients whose sentinel lymph nodes test positive during surgery. * the patient is willing to sign an informed consent to participation exclusion criteria: * platelet count is less than 100000 * obese patients with a bmi of more than 35 * patients who need immediate breast reconstruction surgery * patients who are receiving anticoagulation therapy or have coagulation disorders * pregnant or lactating patients * patients who are on steroid therapy * patients who received chest radiotherapy * patients who received neoadjuvant chemotherapy

Keywords: seroma axillary dissection
direct oral anticoagulant management for cardiac device implantation

Conditions: Anticoagulant, Perioperative

Summary: each year, tens of thousands of cardiac rhythm devices including pacemaker (pm) or implantable cardioverter-defibrillator (icd) are implanted in france. more than 25% of patients undergoing cardiac device implantation receive long-term anticoagulation therapy, that increases the incidence of pocket hematoma with potential serious consequences for patients. although more and more patients receive direct oral anticoagulants (doacs), limited data currently exist on the perioperative management of doac-treated patients undergoing cardiac device implantation and the optimal strategy remains unclear. especially, the time of doac resumption after the procedure is controversial. we hypothesize that the time of doac resumption is the main risk factor of bleeding event in doac-treated patients undergoing cardiac device implantation, that is to say that a delayed doac resumption \> 48 hours following the procedure will reduce pocket hematoma incidence compared with an early resumption, ≤ 48 hours, without increasing thromboembolic events. we propose here an observational multicentre national study to find out the optimal strategy.


Eligibility criteria:
inclusion criteria: * receiving doac (apixaban, rivaroxaban, dabigatran) for stroke prevention in atrial fibrillation at least 5 days prior to enrolment * undergoing a cardiac rhythm device implantation (implantation or replacement of pm (1 or 2 leads) and icd (1or 2 leads) with or without cardiac-resynchronization therapy * informed
long-term efficacy and safety of hms5552 add-on to metformin in t2dm subjects

Conditions: Diabetes Mellitus, Type 2

Summary: this study evaluates the efficacy and safety and population pk of hms5552 add-on to metformin in adult type 2 diabetic subjects. there will be 2 groups in the first 24 weeks, one group will receive hms5552 plus metformin, while the other group will receive placebo plus metformin; after 24 weeks, all subjects will receive hms5552 plus metformin for 28 weeks.

this study is a phase iii study in subjects with t2dm. as designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects, meanwhile, subjects are treated with metformin (glucophage) at 1500mg/day as basic therapy throughout the treatment period. 3 weeks after run-in, eligibility is confirmed with required laboratory tests at -5±2 days prior to randomization. the eligible subjects are randomly assigned to hms5552 75mg bid group or placebo bid group with ratio 1:1 to receive a 24-week double-blind treatment. then all subjects receive 28-week open-label treatment of hms5552 75mg bid add-on to metformin. after 52-week treatment, all investigational drugs should be discontinued, followed by 1 week for safety evaluation. the dosage of metformin (glucophage) should be maintained at 1500 mg/day from run-in period to treatment completion.

Eligibility criteria:
inclusion criteria: 1. male or female, aged 18\~75 years old; 2. t2dm and treated with metformin ≥ 1500mg/day constantly for at least 12 consecutive weeks; 3. 7.5% ≤ hba1c ≤ 10.0% at screening; 4. 18.5 kg/m2 \< bmi \< 35.0 kg/m2 at screening; exclusion criteria: 1. any anti-diabetic therapy other than metformin within 12 weeks before screening; 2. received insulin therapy more than 30 days within 1 year before screening; 3. fasting c-peptide \<0.81 ng/ml (0.27 nmol/l) at screening; 4. medical history of severe hypoglycemia or frequent hypoglycemia, diabetic ketoacidosis, diabetes lactic acidosis or hyperosmotic nonketotic diabetic coma, severe cardio-cerebrovascular, unstable or rapidly progressive kidney disease, active liver diseases, diagnosed mental disease etc. 5. t1dm;

Keywords: gka t2dm hms5552 add-on therapy metformin
high quality evidence of chinese lupus nephritis (help)

Conditions: Lupus Nephritis

Summary: the investigators are registering ln patients at recruited hospitals and developing a ln database in china. patients will be follow-up every year, and both baseline and follow-up information will be entered into the registration system.

the investigators are registering lupus nephritis (ln) and developing a ln database in china. patients' demographic characteristics (including age, gender, height, weight, bmi, smoking, drinking, and education etc.), clinical characteristics (including systolic blood pressure, diastolic blood pressure, and lab measurements of whole blood, serum, urine etc.), complications, drug information at the baseline will be collected. patients will be follow-up every year, the demographic and clinical characteristics, complications; drug information of patients will be collected at each visit. we will also record the outcome at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), end-stage renal disease (esrd) or serum creatinine doubling. the patient survival and renal survival will be compared using the ln database.

Eligibility criteria:
inclusion criteria: * patients who diagnosis as lupus nephritis exclusion criteria: * no

Keywords: lupus nephritis patient survival renal survival
long term follow-up of food and cash assistance for hiv-positive men and women on antiretroviral therapy in tanzania

Conditions: Hiv

Summary: this protocol is for the long term follow-up study of "comparing food and cash assistance for hiv-positive men and women on antiretroviral therapy (art) in tanzania", a 3-arm randomized controlled trial led by professor sandra mccoy at the university of california berkeley and dr. prosper njau at the tanzanian ministry of health and social welfare. the investigators will determine the long-term effectiveness of short-term incentives for art adherence and retention in care. the study will also determine whether incentives can also be used to re-engage plhiv with hiv care after they have fallen out of care.

this study will build on preliminary data from a randomized study conducted in shinyanga, tanzania which found that short-term cash and food assistance improved art adherence and retention in care among food insecure people living with hiv infection (plhiv) after 6 and 12 months of follow-up. the investigators will now determine the long-term effectiveness of these incentive strategies. in this 2-year study, investigators will first determine 24-month adherence and retention outcomes using medical and pharmacy records for the 781 plhiv who were alive at the end of the previous study, which concluded after 12 months of follow-up (aim 1). then, leveraging an existing program of home based care, investigators will determine the prevalence of undocumented transfers and deaths among the subset of patients found to be lost to follow-up or transferred in clinic records. investigators will use these data from home visits to adjust estimates of the interventions' effectiveness on retention in hiv care and mortality (aim 2). among the plhiv found to be disengaged from care, investigators will conduct a pilot study of a one-time cash incentive to encourage plhiv to re-engage with care, with the goal of mitigating the barriers posed by transportation and opportunity costs (aim 3). at the conclusion of the project, investigators will understand the long-term effectiveness of cash and food incentives for adherence and retention, and whether they can also be used for re-linking plhiv to care, data highly relevant to 'treat all' programs in fast track countries.

Eligibility criteria:
inclusion criteria: * study participant in the prior study "comparing food and cash assistance for hiv-positive men and women on antiretroviral therapy in tanzania" (nct01957917) * alive and willing to provide written informed consent * not currently enrolled in hiv care services exclusion criteria: - none

Keywords: hiv food insecurities antiretroviral therapy