Kornimate/medical-research-clean huggingface dataset:
a dose escalation study of ibi333 in subjects with neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: this study is designed for multi-center, open-label, dose escalation phase i trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of ibi333 in subjects with neovascular age-related macular degeneration (namd).


Eligibility criteria:
inclusion criteria: 1. willing and able to sign informed consent form and comply with visit and study procedures per protocol. 2. male or female patients ≥ 50 yrs. of age. 3. active cnv lesions secondary to neovascular amd. 4. bcva score of 19-78 letters using etdrs charts in the study eye. 5. female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment. exclusion criteria: 1. concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results; 2. tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye; 3. active ocular or periocular inflammation/infection in either eye; 4. prior any treatment of following in the study eye: 1. anti-vegf therapy within 90 days prior to screening; 2. intraocular glucocorticoid injection within 180 days prior to screening; 3. laser photocoagulation or photodynamic therapy within 90 days prior to screening; 4. intraocular surgery within 90 days prior to screening; 5. laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening; 5. glycated hemoglobin (hba1c) \> 8% within 28 days prior to screening; 6. uncontrolled hypertension (defined as systolic blood pressure \>160 mmhg or diastolic blood pressure \>100 mmhg); 7. systemic administration of steroids within 30 days prior to screening; 8. systemic administration of anti-vegf drugs within 90 days prior to screening; 9. history of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine; 10. participated in any clinical study of any other drug within 90 days prior to enrollment, or attempted to participate in other drug trials during the study; 11. other conditions unsuitable for enrollment judged by investigators.
vaccinia immune globulin in treating or preventing vaccinal infection

Conditions: Healthy; Communicable Diseases

Summary: the purpose of this study is to follow responses to treatment with vaccinia immune globulin (vig) for safety and clinical benefit \[during hiv vaccine research\]. vig is purified from human blood and used to treat serious infections of the vaccinia (smallpox vaccine) virus or similar viruses. it is the only treatment available for those viruses. the only available supply of vig has developed a discoloration over time and therefore is considered an investigational new drug by the fda. this study will allow it to be used for intramuscular injection in a controlled setting for people who may need it \[during hiv vaccine research\].

vig (human) is a component of plasma from persons vaccinated with vaccinia vaccine. it is the only product available for the treatment of vaccinia and other orthopox infections. the only lot currently available was released as a licensed product in 1995 but is being treated as an investigational new drug because of slight discoloration in the solution. this study makes existing stocks of vig available as a short-term solution for the lack of a licensed immune globulin to treat vaccinal infections. before receiving injections and 3 and 6 months after injections, patients are tested for hiv, hepatitis b, and hepatitis c with pre- and post-test counseling. referrals for appropriate medical care are provided. participants have multiple injections (depending on body weight) of vig at 1 or 2 clinic visits. following administration of vig, participants are observed for 1/2 hour at the clinic. participants return to the clinic for as many as 10 visits to monitor for any adverse reactions and signs and symptoms of vaccinia infections. on days 7, 84, and 168 participants return to the clinic for evaluations and have blood drawn to check for the response to the vig injections.

Eligibility criteria:
inclusion criteria participants may be eligible for this study if they: * sign a consent form including consent for pre/post hiv counseling. if under 18 years or unable to sign a consent form, the next of kin or a legal guardian must sign. * experience complications from prior administration of vaccinia virus vaccinations or accidental exposure to vaccinia or similar viruses. * have a pregnancy test. exclusion criteria participants will not be eligible for this study if they: * have eye complications. note: * caution should be noted if participants are allergic to thimerosal (a preservative in the study drug). precautions can be taken if participants experience a reaction during vig administration. * women who are pregnant will be counseled about risks.

Keywords: smallpox vaccine injections, intramuscular immunoglobulins orthopoxvirus
diabetes homeless medication support

Conditions: Diabetes Mellitus, Type 2; Housing Problems; Psychological Distress

Summary: this randomized pilot trial of the diabetes homeless medication support intervention vs. brief diabetes education will test the perception and feasibility of anticipated study procedures and refine randomization and blinding.

this study has an overall goal to develop and pilot test a collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (dh). the investigators' central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of dh. this study will involve addition of a randomization schema to compare d-homes to brief diabetes education. the study team will enroll participants (n=54), and refine procedures for the randomized trial outcome measures. this includes an assessment of sustained impact of the program at 24-weeks post-treatment. these will complement 12-week post-treatment primary outcome measures.

Eligibility criteria:
inclusion criteria: 1. age 18 yrs. or older 2. english-speaking 3. homelessness by federal definition (hearth act) in the past 24 mos. 4. self-reported diagnosis of type 2 diabetes with a1c \>7.5%, later verified in medical record and study point-of-care lab test. 5. plan to stay in local area or be reachable by phone for the next 24 weeks 6. willingness to work on medication adherence and diabetes self-care exclusion criteria: 1. inability to provide informed consent (e.g., presence of a legal guardian, prisoners) 2. active psychosis or intoxication precluding ability to give informed consent 3. pregnant or lactating people
non-surgical treatment for rotator-cuff tears using platelet-rich-plasma

Conditions: Partial Tear of Rotator Cuff; Tendinopathy of Rotator Cuff

Summary: the goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (ptrct) that otherwise would end with a surgical correction needed.

based off literature and clinical practice, the majority of rotator cuff tears continue to progress to surgical correction despite conservative measures. these include physical therapy, medication management and minimally invasive procedures such as subacromial bursa injections and intra-articular injections with steroids. recently a popular treatment of common musculoskeletal injuries (including tendinopathies) has emerged throughout the us and has been utilized worldwide for many years with good empiric evidence known as platelet-rich plasma (prp) injections. in partnership with uab orthopedics and radiology, the uab department of physical medicine and rehabilitation aims to compare prp to corticosteroid injections for patients with partial rotator cuff tears or tendinopathy. outcome measures are ultrasound imaging, pain and disability over the course of 6 months.

Eligibility criteria:
inclusion criteria: 1. subjects between ages 19 to 75, both male and female 2. radiologic imaging which can include either magnetic resonance imaging (mri) or ultrasound (us) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears 3. failed a trial of physical therapy of at least 4 weeks exclusion criteria: 1. full thickness tears (well documented need for surgical correction) 2. sensory or neurologic complaint affecting the shoulder of interest 3. coagulation disorder, platelet disorder 4. pregnancy: pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study 5. any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy 6. prior surgery to either cervical spine or shoulder 7. active military 8. injury part of worker compensation claim
step test and six minute walk test in stroke

Conditions: Stroke

Summary: the purpose of this study is to investigate the viability of using the step test (st) in stroke patients, and to compare the functional performance of the physiologic variables in stroke patients during st and six minute walk test (6mwt).

to accomplish the study it was assessed a group of 12 post-stroke patients who were admitted in the rehabilitation clinic inside the university. as inclusion criteria it was established to be able to walk alone without supervision and with no aids.

Eligibility criteria:
inclusion criteria: * to be able to walk alone without supervision and with no aids. exclusion criteria: * there were no.

Keywords: exercise tolerance step test stroke walking
inferior vena cava collapsibility index in severe sepsis

Conditions: Sepsis; Severe Sepsis; Septic Shock

Summary: there is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid volume status in patients with sepsis. to establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we first need to define the inferior vena cava collapsibility index in this population of patients. the research question is: in adult patients with sepsis, severe sepsis and septic shock what is the mean baseline inferior vena cava collapsibility index (ivcci) prior to fluid resuscitation.

the study is an interventional cohort study using a convenience sample of adult patients in a university teaching hospital emergency department. eligible participants who consent to partake in the trial will have an ultrasound assessment of their inferior vena cava performed and the ivcci will be calculated at enrolment. care will be provided in line with the published guidelines on sepsis management from the surviving sepsis campaign and the college of emergency medicine. a sample size calculation has been performed which indicates that 112 patient with severe sepsis or septic shock will need to be enrolled.

Eligibility criteria:
inclusion criteria: * adult patients * signs and symptoms of infection with 2 or more sirs criteria (pulse rate \>90/min, temp \> 38 celsius \ 20 breaths per minute, or white cell count \>12 or \<4 x 10\^9/l) exclusion criteria: * in relation to this episode of care: prior cardio pulmonary resuscitation, acute myocardial infarction, trauma, pregnancy or patient requiring immediate surgery. * patients who have received more than 20ml/kg of iv fluid in the pre hospital environment * patients with known tricuspid regurgitation, congestive heart failure or pulmonary hypertension * patients receiving palliative terminal supportive care

Keywords: sepsis ultrasound inferior vena cava collapsibility
a phase i study of oral mek162 in japanese patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: in this study, mek162 will be administered to japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. the trial will investigate the safety and tolerability and determine the mtd of mek162 in japanese patients.


Eligibility criteria:
inclusion criteria: * patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit. * availability of a representative formalin fixed paraffin embedded tumor tissue sample. * at least one measurable or non-measurable lesion * age ≥ 18 years * eastern cooperative oncology group (ecog) performance status ≤ 2 * good organ (hepatic, kidney, bm) function at screening/baseline visit. exclusion criteria: * brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy. * impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and acute myocardial infarction (ami) ≤ 3 months prior to starting study drug. * women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. other protocol-defined inclusion/exclusion criteria may apply

Keywords: mek, advanced solid tumor
intervention with n-3 polyunsaturated fatty acids (pufa)-supplemented products in moderate hypertriglyceridemic patients

Conditions: Hypertriglyceridemia

Summary: the study was performed to investigate the effects of a daily consumption of n-3 pufa supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk factors in hypertriglyceridemic patients.

recent studies suggest that n-3 lc-pufa intake might be useful to prevent coronary heart diseases. as a precondition for participating in this study, the patients were provided information in writing and verbally about the details of the study. written informed consent was obtained from all volunteers. before the beginning of the study, all participants were subject to a medical examination by their general practitioners. sixty hypertriglyceridemic patients (with triacylglyceride (tag) values ≥ 150 mg/dl or ≥ 1.7 mmol/l) should entered the study. the placebo-controlled, randomized double-blind cross-over study consists of two investigation periods of 10 weeks, with a ten-week washout period in between. after the washout period the intervention was crossed between the groups and the respective products were consumed for another 10 weeks. patients in the placebo period receive 60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage daily. these products were enriched with sunflower oil (20g/d). in the intervention period, the products (60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage) were enriched with a) 20g linseed oil, b) 20g echium oil, and c)12g microalgae powder. the daily dose of special n-3 fatty acid amounted to a) 10g alpha linolenic acid (ala), b 2g stearidonic acid (sda)+6g ala, or c) 2g docosahexaenoic acid (dha). venous blood is collected at the beginning and at the end of each period.

Eligibility criteria:
inclusion criteria: * tag values ≥ 150 mg/dl or ≥ 1.7 mmol/l exclusion criteria: * lipid lowering medications * glucocorticoids * gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyperthyroidism or hypothyroidism, hypercholesteremic patients with familial previous impacts) * daily alcohol abuse * taking dietary supplements (e. g., fish oil capsules, vitamin e) * known allergies or foodstuff indigestibility

Keywords: n-3 lc-pufa hypertriglyceridemic human tag
evaluation of the pharmacokinetics, safety, and tolerability of tpm xr as adjunctive therapy in pediatric subjects with epilepsy

Conditions: Epilepsy

Summary: multidose, open-label, multi-center study to examine the steady state pharmacokinetics of tpm xr, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.


Eligibility criteria:
inclusion criteria: 1. able to provide written iaf, as appropriate, with written informed permission (including icf where required by regional laws or regulations) from the parent or lar. 2. male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generalized epilepsy. 3. current aed therapy including a stable dose of tpm ir as either adjunctive or monotherapy. all aed therapy (including a vagal nerve stimulator) must have been initiated more than one month prior to visit 1 and doses must be stable for at least two weeks prior to visit 1. 4. no diagnosis of a progressive neurological disorder based on previous imaging. 5. weight within the 25 - 80% weight-for-age percentiles based on the national center for health statistics growth charts, and not less than 15.0kg. 6. able and willing to swallow whole capsules. 7. focp should either be sexually inactive for two weeks prior to the first dose and throughout the study or, if sexually active, will be using an effective birth control method. exclusion criteria: 1. a documented history of status epilepticus in the past year or seizures secondary to conditions other than epilepsy. 2. use of either phenytoin or carbamazepine as current aeds. 3. diagnosis or an electroencephalogram consistent with a diagnosis of seizure disorders other than partial onset or primary generalized epilepsy. 4. current diagnosis of major depressive disorder or any history of suicide intent and/or attempt. 5. history or presence of clinically significant, chronic medical condition which, in the opinion of the investigator, would preclude the subject from entering the study. 6. history of substance abuse or dependence. 7. females who are pregnant or lactating. 8. use of an investigational drug or device or participation in an investigational study within 30 days prior to the first dose of sm.

Keywords: epilepsy pediatrics young adults
effect of nusinersen on adults with spinal muscular atrophy

Conditions: Adult Spinal Muscular Atrophy

Summary: observational study of adult patients with spinal muscular atrophy types 2 and 3 receiving nusinersen

observational study to assess effects of nusinersen on motor function in adult patients with spinal muscular atrophy who are both ambulatory and non-ambulatory. subjects will receive standard of care with nusinersen intrathecal injection and undergo baseline and every 6 month motor assessments and pulmonary function testing during the first two years of treatment with nusinersen.

Eligibility criteria:
inclusion criteria: * genetically confirmed 5q sma * ability to access intrathecal space for nusinersen injection exclusion criteria: * renal impairment * thrombocytopenia * inability to access intrathecal space by ct or flouro guided injection
pharmacologic study of oseltamivir in healthy volunteers

Conditions: Avian Influenza A Virus

Summary: "pharmacologic study of oseltamivir in healthy volunteers" is a phase i study in which 8 to 32 adult healthy thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. the study is being conducted at the bangkok hospital of tropical diseases research unit, faculty of tropical medicine, and commenced enrolling healthy volunteers on 23 november 2006. the duration of the study is expected to be approximately four months. the goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in thai subjects.


Eligibility criteria:
inclusion criteria: * healthy with no underlying chronic disease * normal baseline laboratory screening * no regular prescribed medication used in the past 30 days and no over-the-counter medication in the past week * agree to abstain from self-medication during the study * negative urine pregnancy test for females and agreement that they will not try to become pregnant until 1 month after the study is completed * only use non-hormonal methods of contraception for females * non-smoker for the last 30 days and for duration of the study * no consumption of alcohol for the last 30 days and for duration of the study * no use of recreational drugs for the last 30 days and for duration of the study exclusion criteria: * known hypersensitivity to oseltamivir and/or probenecid * hepatitis b virus surface antigen positive * presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study

Keywords: oseltamivir pharmacokinetics probenecid avian influenza
the canadian follow-up program for the attract study (p04868)(terminated)

Conditions: Arthritis, Rheumatoid

Summary: this is a phase 4, retrospective chart review of subjects that participated in the attract study. site investigators will conduct a chart review and complete a data collection form. the purpose of this study is to describe the treatment used and clinical outcomes of these subjects following completion of the attract trial up until their most recent assessment by the treating physicians.

subjects were selected for this study using a non-probability sampling method.

Eligibility criteria:
inclusion criteria: * patients must have been enrolled in the two year follow-up phase of attract and have continued treatment with the site investigator * signature of informed consent. exclusion criteria: * not specified in the protocol.
improving neuroprotective strategy for ischemic stroke after thrombectomy followed by delp (insist-delp)

Conditions: Ischemic Stroke

Summary: delipid extracorporeal lipoprotein filter from plasma (delp) has been found to improve neurological function and life ability of ais patients and approved for the treatment of ais by china food and drug administration (cfda). our recent study imply that the neuroprotective effect of delp involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing mmp-9. based on the multiple mechanisms, delp was used to investigate the effect on acute ischemic stroke receiving endovascular treatment.


Eligibility criteria:
inclusion criteria: * age ≥18 years; * acute anterior circulatory cerebral infarction with large vessel occlusion; * nihss≥6 before endovascular treatment; * good recanalization (tici 2b-3); * time from onset to groin puncture is less than 8 hours; * time from recanalization to delp is less than 2 hours; * premorbid mrs 0 or 1; * signed informed consent. exclusion criteria: * poor recanalization (tici 1-2a); * coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3; * severe hepatic or renal dysfunction, increase in alt or ast (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; * severe hypertension (systolic blood pressure over 200mmhg or diastolic blood pressure over 110 mmhg); * previous allergy to heparin or calcium; * hypoproteinemia; * unsuitable for this clinical studies assessed by researcher.