Kornimate/medical-research-clean huggingface dataset:
central vein occlusion study (cvos)

Conditions: Retinal Vein Occlusion; Retinal Diseases

Summary: to determine whether photocoagulation therapy can help prevent iris neovascularization in eyes with central vein occlusion (cvo) and evidence of ischemic retina. to assess whether grid-pattern photocoagulation therapy will reduce loss of central visual acuity due to macular edema secondary to cvo. to develop new data describing the course and prognosis for eyes with cvo.

central vein occlusion is a common retinal vascular disorder with potentially blinding complications. the two major complications are reduced central vision caused by macular edema and neovascular glaucoma caused by iris neovascularization. other clinical trials have shown that laser photocoagulation is an effective treatment for complications found in diabetic retinopathy and branch vein occlusion, which have some features in common with cvo: neovascularization and reduced visual acuity caused by macular edema occur in all three disorders. evidence from small-scale studies suggests that a grid pattern of photocoagulation reduces macular edema in cvo patients, although the associated changes in visual acuity are variable. the cvos is a detailed investigation of grid pattern photocoagulation in a larger randomized group of patients. eligible patients were divided into four groups: group n: eyes with extensive retinal ischemia (at least 10 disc areas of nonperfusion) were randomly assigned to receive panretinal photocoagulation or nontreatment unless iris neovascularization developed. group m: eyes with visual loss ascribable to macular edema were randomly assigned to receive grid-pattern photocoagulation or nontreatment. group p: eyes with relatively perfused retinas were followed to provide information about the natural history of the disease. group i: indeterminate eyes in which the retina could not be visualized accurately because of hemorrhage were followed in a natural history study. green argon laser with a slit lamp delivery system was used for all treatments. photographic documentation of retinal changes was obtained at entry, post-treatment, and at specified followup visits for a period of at least 3 years. the frequency of followup visits varied according to the group to which the cvo patient was assigned. visual acuity, the primary outcome factor in the group with macular edema, was measured according to a modified early treatment diabetic retinopathy study protocol at each visit.

Eligibility criteria:
men and women must have been age 21 or older and willing to return for followup visits for 3 years following assignment into the appropriate group and randomization. each of the four groups has specific eligibility criteria. patients with retinal vascular disease other than that specified in the criteria, such as diabetic retinopathy, were ineligible. patients with macular disease other than that due to cvo were ineligible for that portion of the study.

Keywords: central vein occlusion ischemic retina
a phase i randomized trial to evaluate the safety and immunogenicity of vaccinia-hiv envelope recombinant vaccine (hivac-1e) in combination with soluble recombinant envelope vaccine (vaxsyn)

Conditions: HIV Infections

Summary: primary: to determine whether additional boosting with soluble recombinant gp160 vaccine (vaxsyn) after priming with a vaccinia-hiv envelope recombinant (hivac-1e) provides a significant advantage in the degree and duration of immunogenicity. secondary: to learn more about the safety of the combination use of the two hiv envelope vaccines in the study (vaxsyn and hivac-1e). recent phase i trials conducted at the aids vaccine units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of hivac-1e alone. this study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.

recent phase i trials conducted at the aids vaccine units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of hivac-1e alone. this study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration. twelve volunteers who have previously received two doses of hivac-1e (or dryvax) and two doses of gp160 receive an additional boost of gp160 at 12-20 months after the last boost and an additional dose of hivac-1e at least 9 months after the final gp160 boost.

Eligibility criteria:
inclusion criteria patients must have: * normal history and physical exam. * negative elisa for hiv. * negative hiv p24 antigen test. * normal urinalysis. prior medication: required: * two prior doses of hivac-1e (or dryvax) and two prior doses of gp160 vaccine. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * risk factors for hiv infection including active intravenous drug use and more than 2 sexual partners. * history of immunodeficiency or chronic illness. * hypersensitivity to insects. * medical or psychiatric condition that makes it unlikely the patient will comply with the protocol. patients with the following prior conditions are excluded: * history of immunodeficiency or chronic illness. prior medication: excluded: * immunosuppressive medications. prior treatment: excluded: * blood or blood product transfusion within the past 6 months. risk behavior: excluded: * intravenous drug use. * more than 2 sexual partners.

Keywords: vaccines, synthetic vaccinia virus viral envelope proteins viral vaccines aids vaccines hiv seronegativity hiv preventive vaccine
impact of cognitive control training on anger symptoms and reactive aggression

Conditions: Anger

Summary: high trait anger is a personality construct characterized by elevations in the frequency, duration, and intensity of anger episodes. according to many social cognitive theories, hostile interpretations of everyday situations contribute to the development and maintenance of anger symptoms. this study will examine the effectiveness of a computer-based cognitive control training task.

difficulties with anger control are reported in a number of psychological conditions and are associated with social problems, such as dating violence and workplace violence. high trait anger is a personality construct characterized by elevations in the frequency, duration, and intensity of anger episodes. however, the cognitive processes contributing to high trait anger are still poorly understood. according to the integrative cognitive model of anger and reactive aggression (icm), three cognitive processes jointly contribute to the experience of high trait anger and reactive aggression: 1) hostile interpretation biases; 2) cognitive control; and 3) anger rumination. the proposed study will evaluate the validity of this model in relation to cognitive control using a computer-based cognitive control training (cct) program.

Eligibility criteria:
inclusion criteria: 1. score of 22 or higher on the trait anger scale. exclusion criteria: 1. reports currently receiving psychological treatment or counseling for anger management difficulties. 2. reports changes in psychiatric medication within the last month. 3. endorsement of current psychosis or bipolar disorder symptoms. 4. indicates poor english language proficiency. 5. reports clinically significant suicidal ideation, intent, or plan.

Keywords: reactive aggression anger cognitive control training anger rumination
pharmacokinetic and pharmacodynamic study of emixustat in subjects with geographic atrophy associated with dry age-related macular degeneration

Conditions: Geographic Atrophy; Age-Related Macular Degeneration

Summary: the purpose of this study is to characterize emixustat hydrochloride pharmacokinetic and pharmacodynamic parameters in subjects with geographic atrophy associated with dry age-related macular degeneration.

this is a multi-center, randomized, masked, multiple-dose, crossover study of the pharmacokinetics of emixustat hydrochloride (hcl) in subjects with geographic atrophy (ga) associated with dry age-related macular degeneration (amd). subjects will receive study drug during multiple dose periods in a crossover design, and serve as their own controls. there is a 21-28 day washout period between dose periods. the final study exit visit is 21 to 28 days after the subject's last dose of study drug at the end of the final dosing period.

Eligibility criteria:
inclusion criteria: * males or females age ≥65 years * clinical diagnosis of ga associated with amd * able and willing to provide written informed consent * able to reliably administer oral medication by self or with available assistance exclusion criteria: * geographic atrophy associated with a condition other than amd * history of, active or high risk of developing choroidal neovascularization (cnv) in either eye * known serious allergy to the fluorescein sodium for injection in angiography * pre-specified laboratory abnormalities at screening * treatment with any investigational study drug within 30 days of screening or device within 60 days of screening * prior participation in any clinical study of emixustat * history of other disease, metabolic dysfunction, chronic immunosuppression, physical examination finding * male subjects who are not surgically sterile and are not willing to practice a medically accepted method of birth control with their female partner of childbearing potential from screening through 21 days after the last dose of study drug
the effect of systematic assessment of functional ability, development of rehabilitation plan and follow-up at home for elderly medical patients

Conditions: Geriatric Disorder

Summary: the aim of this study is to examine the effect of systematic assessment of functional ability, development of rehabilitation plan and follow-up at home for elderly medical patient's risk of readmission. the effect of the intervention is examined in a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * patients admitted to, medical visitation section (mva) aarhus university hospital * aged 65+ * resident in city of aarhus. exclusion criteria: * patients admitted from a psychiatric institution or nursing home * patients without walking ability * patients who do not speak or read danish * terminally ill patients * patients transferred to other hospital departments

Keywords: functional assessment acute care older medical patients
evaluation of a smartphone application to reduce adverse pregnancy outcomes in ethiopia

Conditions: Maternal Mortality; Perinatal Mortality

Summary: the purpose of this trial is to determine if the safe delivery smartphone application distributed to health workers in ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage. it is also the purpose to determine if the safe delivery smartphone application distributed to health workers in ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation.

abstract hypothesis a safe delivery smartphone application distributed to health workers in ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage a safe delivery smartphone application distributed to health workers in ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation intervention a safe delivery smartphone application with animated videos to improve clinical management during delivery will be introduced in the intervention clusters design cluster randomized controlled trial with health facilities as the unit of randomization area nole kaba, haru, homa, genji and gimbie districts in ethiopia population pregnant women and their newborns delivered in a randomized health facility. for secondary outcomes health workers at randomized health facilities. sample size 77 health facilities with minimum 2 health workers per facility and 30 deliveries per health worker duration pregnant women will be enrolled at delivery and followed to 7 days postpartum outcomes primary outcomes are perinatal mortality and postpartum haemorrhage. secondary outcomes are health workers knowledge and skills study time data collection expected from september 2013 to september 2014

Eligibility criteria:
inclusion criteria: • women in active labor exclusion criteria: • none

Keywords: maternal health perinatal health mhealth smartphone mobile phone ethiopia
attain performa™ left ventricular (lv) quadripolar leads chronic performance study

Conditions: Heart Failure

Summary: lead survivability will be summarized.

the purpose of this study is to evaluate long-term performance of the attain performa™ lv leads. this evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. the leads will be followed for 5 years after implant. this study is required by fda as a condition of approval of the attain performa™ lv leads. this study is conducted within medtronic's post-market surveillance platform.

Eligibility criteria:
patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. inclusion criteria * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has or is intended to receive an attain performa™ lv lead * patient within 30 day post implant enrollment window exclusion criteria * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
experience in being with advanced heart failure patients

Conditions: Heart Failure

Summary: the purpose of this study is to explore the experience in being with advanced heart failure patients.

the aim is to explore the experience of advanced heart failure patients during the disease trajectory in taiwan.

Eligibility criteria:
inclusion criteria: * the patients' conscious must be clear, * vital sign is stable, * and can communicate in mandarin chinese or taiwanese. exclusion criteria: * consciousness is unclear * and can't have effective communication to interviewer. * the patient reject to join this study.

Keywords: advanced heart failure diseased experience
histopathological techniques and pcr on tissues included in paraffin for the diagnosis of tuberculosis

Conditions: Tuberculosis; Diagnostic Techniques and Procedures; Sensitivity and Specificity; Polymerase Chain Reaction; Immunohistochemistry; Histochemistry

Summary: tuberculosis (tb) remains a major public health problem nowadays. about 30% of the world population is infected with mycobacterium tuberculosis. there is an increase in the number of cases of classic tuberculosis in developing countries, even if number of cases are declining in developed countries. however, in developed countries this decrease is counterbalanced by the emergence of multidrug resistant (mdr) strains of the bacteria. there are also latent forms (1/3 of the world population) of the infection that can be reactivated in one case out of ten. each year, about 2 million people die of tuberculosis and 9 million new cases are identified, including about 500,000 cases of mdr tb. the spread of this disease as well as the increasing number of cases of mdr tuberculosis, reinforce the need for research and development of strategies of diagnosis and management of this affection. nowadays, the culture is the gold standard for the tb diagnosis but this technique needs at least three weeks to be performed. the objective of this study is to evaluate the sensitivity and specificity of histopathological and molecular techniques (pcr) on paraformaldehyde fixed and embedded in paraffin tissues for a faster diagnosis of tuberculosis in current practice, in order to administrate an efficient treatment as soon as possible.


Eligibility criteria:
inclusion criteria: * positive tb patients * patients who performed biopsy before inclusion exclusion criteria: * anti-tuberculosis drugs administered before biopsy * patients who refuse to participate

Keywords: tuberculosis sensitivity and specificity polymerase chain reaction immunohistochemistry histochemistry paraformaldehyde and paraffin embedded tissues
movement control exercises and fascial manipulation in chronic low back pain

Conditions: Low Back Pain; Low Back Pain, Recurrent

Summary: subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in university hospital of oulu at physical and rehabilitation medicine (prm) unit. subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. subjects to rehabilitation are picked by doctor at prm unit. the volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. after that the subjects are measured at baseline measurement. subjects are randomized into the five groups. after the 3 months treatment and training the follow-up measurements are performed. same questionnaires are filled in at that point as well. at 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.

subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in university hospital of oulu at physical and rehabilitation medicine (prm) unit. subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. subjects to rehabilitation are picked by doctor at prm unit. the volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. after that the subjects are measured at baseline measurement. subjects are randomized into the five groups: 1) control group, 2) fascial manipulation (fm) and movement control exercises (mce), 3) sham-fm and mce, 4) fm and sham-mce and 5) sham-fm and sham-mce. physical therapists who perform treatments (fm), prescribing mce and performing the measurements are blinded to each other. physical therapist who is performing measurements is also blinded for the baseline measurements. there and 4 treatments of sham-fm, 4-5 treatments of fm, 4 treatments of sham-mce and 4-6 treatments of mce. control group will receive only university hospital rehabilitation and will participate into the baseline and follow-up measurements. after the 3 months treatment and training the follow-up measurements are performed. same questionnaires are filled in as at baseline. at 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.

Eligibility criteria:
inclusion criteria: * chronic non-operatively treated low back pain or pain after the low back operation. participation in multidisciplinary rehabilitation at university hospital of oulu. exclusion criteria: * specific low back pain cause and earlier fascial manipulation treatment given.
a study to evaluate the effect of mk-8669 (ridaforolimus) on qtc interval in participants with advanced cancer (mk-8669-037)

Conditions: Metastatic or Locally Advanced Cancer

Summary: to assess the potential for ridaforolimus to prolong the qtc interval (an effect on the electrical activity of the heart) in participants with advanced cancer. this study will be done in 2 parts. part 1 (pt 1) will evaluate the effect of a single 100 mg dose of ridaforolimus on qt interval in participants with advanced cancer. fridericias's correction (qtcf) will be used. in part 2 (pt 2), participants will receive ridaforolimus at the current therapeutic dose (40 mg x 5 days).


Eligibility criteria:
inclusion criteria: * participant must have metastatic or locally advanced cancer which has failed to respond to standard therapy or no therapy exists. * if the participant is a female, she must be postmenopausal or if she is of childbearing potential she must have blood pregnancy tests during the study and be willing to use 2 methods of contraception. * if the participant is male and has female partners of child-bearing potential, he must agree to use a medically acceptable method of contraception during the study and for 30 days after the last dose of study drug. exclusion criteria: * participant has had chemotherapy, radiotherapy or biological therapy within the past 4 weeks. * participant is currently receiving other anti-cancer therapy. * participant is currently participating or has participated in a study with an investigation drug or device within the last 30 days. * participant has a primary central nervous system tumor or active brain metastases. * participant has a psychiatric disorder. * participant uses illegal drugs. * participant is pregnant or breastfeeding. * participant is known to be human immunodeficiency virus (hiv) positive. * participant has a known history of hepatitis b or c. * participant has newly diagnosed diabetes. * participant has an active infection. * participant is unable to swallow capsules. * participant has received a blood transfusion with one week of study entry. * participant has a history of cardiac problems including heart failure, myocardial infarction, unstable angina, congestive heart failure or cardiac arrhythmia. * participant has a known sensitivity to the components of the study drug. * participant has not adequately recovered from any prior surgical procedure. * participant does not agree to refrain from use of herbal remedies and consumption of grapefruit juice for 2 weeks prior to and during the study.
alert-hf: adherence to guidelines in the treatment of patients with chronic heart failure

Conditions: Chronic Heart Failure

Summary: alert-hf is an observational study aimed to evaluate the diagnostic criteria adopted and the adherence to the current therapeutic guidelines in a large series of patients affected with chronic heart failure. secondary objective is to evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district.


Eligibility criteria:
inclusion criteria: * diagnosis of heart failure * signature of informed consent * age older than 65 years exclusion criteria: * indication for cardiac surgery or cardiac surgery by less than 3 months * age less than 65 years * inability to perform periodic checks * presence of malignant neoplasms and other severe diseases.