Kornimate/medical-research-clean huggingface dataset:
an expanded access study of abiraterone acetate in patients with advanced prostate cancer who have completed clinical study cou-aa-001

Conditions: Prostate Neoplasms

Summary: the purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in clinical study cou-aa-001 and continue to receive clinical benefit from this treatment.

this is an open-label (identity of study drug will be known) extended access study to evaluate the safety and efficacy of continued administration of abiraterone acetate in patients who have completed 12 cycles of abiraterone acetate treatment in clinical study cou-aa-001 and continue to receive clinical benefit from this treatment. patients will continue with the same dose regimen administered at the end of study cou-aa-001 and will receive a low-dose glucocorticoid daily. patients will be followed every 3 months for disease progression and survival for up to 3 years following study entry. safety will be monitored throughout the study up to 30 days after the last dose of study medication.

Eligibility criteria:
inclusion criteria: * completed 12 cycles of abiraterone acetate under study cou-aa-001 * last dose of abiraterone acetate within 14 days prior to treatment in this study * demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment * serum potassium level \>=3.5 mmol/l * eastern cooperative oncology group performance status of \ =30%) * agrees to protocol-defined use of effective contraception exclusion criteria: * serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * uncontrolled hypertension * abnormal liver function * clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease (patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable) * condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

Keywords: prostate neoplasms hormone refractory prostate cancer castration resistant prostate cancer castration refractory prostate cancer abiraterone acetate cb7630
isotretinoin for proliferative vitreoretinopathy

Conditions: Proliferative Vitreoretinopathy

Summary: proliferative vitreoretinopathy (pvr), or secondary scarring on and around the retina, is an important cause of retinal re-detachment. the purpose of this study is to evaluate the effect of oral isotretinoin, which inhibits the growth of cells responsible for proliferative vitreoretinopathy (pvr), on recurrent retinal detachment.

small retrospective studies have shown isotretinoin to be effective in reducing the rate of recurrent retinal detachment in patients with or at high risk for developing pvr. this is a prospective study to evaluate a low dose of oral isotretinoin in this regard. there are two arms to the study: 1) eyes with recurrent retinal detachment due to existing pvr, and 2) eyes with primary detachment and features associated with a high risk of pvr formation. eligible and willing patients will receive a 12-week course of isotretinoin, and will be followed for retinal attachment rate, and pvr and/or erm (epiretinal membrane) formation.

Eligibility criteria:
inclusion criteria: * 18-70 year-old men or 50-70 year-old, post-menopausal women. * healthy enough to participate in the study. * willing and able to consent to participation. * recurrent pvr-associated rd occurring at least 2 weeks after rd repair or * primary rd (retinal detachment) associated with one or more high-risk features exclusion criteria: * history of hypersensitivity to isotretinoin. * current use of a corticosteroid (excluding topical). * any history of depression, anorexia, liver or pancreatic disease. * more than one prior surgical rd repair. * patients with closed funnel retinal detachments. * patients with chronic retinal detachment, defined as longer than 12 weeks. * any use an oral retinoid within 6 months. * systemic chemotherapy within 6 months. * patients taking supplemental vitamin a. * corneal opacity sufficient to impair surgical view. * proliferative diabetic retinopathy.
analysis of endotoxin activity in patients with ecmo

Conditions: Cardiovascular Shock; Respiratory Failure

Summary: extra-corporeal membrane oxygenation (ecmo) can temporarily help patients gain time to wait for cardiopulmonary recovery or further treatment in patients with cardiopulmonary failure. whether the blood flow provided by the ecmo can maintain the perfusion of various organs is an important factor affecting survival. some ecmo patients died after the complication of sepsis. our previous pilot analysis has recognized several ecmo patients with complicated sepsis has high endotoxin activity level. endotoxemia can also occur in heart surgery and after cardiopulmonary bypass, trauma, organ transplantation, and out-of-hospital cardiac arrest patients. these trials used endotoxin activity analysis (eaa, eaatm, spectral diagnostics inc., canada) to analyze endotoxin activity. in addition, studies have indicated that the combination of procalcitonin (pct) concentration and eaa activity can improve the accuracy of predicting sepsis. the primary aim of this study is to detect endotoxin activity in patients with ecmo support and compare whether the prognosis was associated with different level of eaa activity. the secondary aims are to analyze the risk factors leading to high eaa activity and investigate the diagnostic value of septic shock combining pct examination. we suggest that the results of this study may help the ecmo medical team identify patients at high risk for septic shock and conduct adequate managements to improve patient survival and quality of life after survival.


Eligibility criteria:
inclusion criteria: * patients with ecmo support exclusion criteria: * \ 90 years old * not be able to collect blood sample within 48 hours after placement of ecmo * change plan to palliative care and plan to remove ecmo * non-native speakers
expanded access protocol for stomp-ii patients who were unable to receive treatment subsequent to adipose tissue collection

Conditions: Perianal Fistula Due to Crohn's Disease

Summary: the goal of this expanded access protocol is to provide expanded access of avb-114 to patients who had their fat tissue collected as part of a clinical trial (stomp-ii), but who were subsequently not treated with avb-114 because they did not meet all eligibility criteria or the investigational product was not successfully manufactured.

avb-114 is an autologous investigational product under evaluation in seeded cells on matrix plug treating crohn's perianal fistulas (stomp-ii; a prospective, multicenter, randomized, blinded outcome assessment, controlled, add-on therapy phase ii study) for the treatment of complex perianal fistulas in subjects with crohn's disease. eap-stomp2 is an expanded access protocol for patients who had adipose tissue collected per the stomp-ii protocol, but who were subsequently unable to receive avb-114 treatment due to screen failure or product manufacturing issues and thus withdrew from the study. patients will receive avb-114 as deemed appropriate by investigator and avobis bio.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated icf. 2. adipose tissue previously collected per the stomp-ii protocol, but were subsequently unable to receive avb-114 treatment due to screen failure or product manufacturing issues and thus withdrew. 3. diagnosed with crohn's disease and a target perianal fistula with one internal opening and at least one external opening. exclusion criteria: 1. suffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety. 2. pregnant, trying to become pregnant, or are breast feeding. women of childbearing potential (wcbp) and males who have sexual partners that are wcbp must agree to use an adequate method of contraception while participating in this eap. 3. known allergies or hypersensitivity to aminoglycosides. 4. history of clinically significant fat-directed autoimmunity. 5. active, unresolved infection requiring parenteral antibiotics. 6. unresolved abscess at time of treatment (if screening pelvic mri identifies an abscess, it must be resolved before treatment). 7. target fistula with any of the following characteristics (note that presence of a second fistula tract that is distinctly separate from the target fistula, or a target fistula with a single internal opening and multiple external openings is not exclusionary): 1. target fistula has a branching blind ending sinus tract (no external opening) that investigator assesses to be at elevated risk of abscess formation if treated with avb-114. 2. target fistula is a genito-urinary fistula, including rectovaginal (i.e., fistulae that transverse the vaginal canal). 3. any anatomical limitation to successfully securing the fistula plug disk.

Keywords: matrix plug mesenchymal stem cells fistula plug refractory recurrent stomp autologous
a study to evaluate the effect of lansoprazole on hospitalized neonates with gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to understand how quickly lansoprazole, once daily (qd), improves feeding in premature babies or babies less than 28 days of age.

a phase 1, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansoprazole pediatric suspension 1.0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day orally. on dosing days 1 and 5, blood samples will be obtained for drug assay. all subjects will be evaluated for inclusion in the ph monitoring portion of the study and will undergo ph monitoring, provided it is clinically indicated, at the discretion of the investigator. intragastric ph monitoring (up to 24 hours) will be performed at baseline, on dosing day 1 (or day 2) and on dosing day 5 (or day 6). intraesophageal ph may be done in addition to intragastric ph at the discretion of the investigator. subjects will be evaluated for safety, including a follow-up visit on post-dosing day 14.

Eligibility criteria:
inclusion criteria: * neonates in the neonatal intensive care or special care nursery who have been fed orally or by feeding tube. * term or post-term infants with a body weight of \>800 gms. * pre-term infants with a corrected age of less than 44 weeks. * clinically-evident gerd (feeding intolerance, regurgitation, wheezing or stridor with feedings) * at least 7 days post-surgery without anticipated need for surgery during study * no significant laboratory abnormalities exclusion criteria: * unstable, clinically significant disease or abnormality * congenital anomaly of the upper gastrointestinal tract * clinical evidence of acute sepsis * cystic fibrosis * medical condition requiring subject to not be fed by mouth/gastric tube

Keywords: pediatric gerd pediatric gastroesophageal reflux disease neonates lansoprazole
the efficiency of robotic hand exoskeleton system in stroke patients

Conditions: Stroke

Summary: the aim of our study is to investigate the effects of the robotic hand exoskeleton, on the spasticity, motor control skills, level of daily living activity, quality of life and functional independence of stroke patients.

stroke is a condition that occurs as a result of an ischemic or hemorrhagic intracranial vascular event, is the third leading cause of death in the world and can lead to disability. depending on the localization of brain damage after stroke, it is possible to talk about different prognoses and therefore different functional losses in the lower extremities, upper extremities and hand and wrist. today, various neurophysiological approaches, exercise strategies, electrotherapy modalities and assistive devices are used in the rehabilitation program suitable for the patient after stroke. in addition to these, robot-assisted therapy is gaining a place as an innovative approach in stroke rehabilitation with the developments in technology. robot-assisted therapy is thought to both facilitate and intensify treatment after stroke and increase motor development. the normal functions of the hand, which has many abilities and a complex structure, is extremely important to lead a free and active life. when the literature is examined, the success rate in the recovery of skills and functional recovery of the hand in stroke rehabilitation is low compared to the lower extremity and shoulder joint. more interventions are needed to increase the functional recovery of the hand. studies should be conducted on robot-assisted treatment methods that allow active and passive exercises in the hand after stroke and contribute to neuroplasticity with an intensified and standardized program. our aim in this study is to investigate the efficacy of the robotic hand exoskeleton system developed at marmara university in order to reduce the physiotherapy process and increase the responses of patients who have partially lost their hand functions due to stroke and need rehabilitation in stroke patients.

Eligibility criteria:
inclusion criteria: * being diagnosed with stroke by a neurologist * at least 3 months have passed after the stroke * mini mental state examination score of at least 24 * to be able to maintain sitting balance during working with the robot, * having full range of motion in the metacarpophalangeal (mcp), proximal interphalangeal (pif) and distal interphalangeal (dif) joints, * spasticity in finger flexor and extensor muscles ≤ 3 according to the modified ashworth scale (mas) * being between the ages of 35-85 exclusion criteria: * other neurological or orthopedic problems that may affect upper extremity function, * cardiovascular vulnerability (severe uncontrolled hypertension, severe coronary artery disease, unstable angina) * behavioral and cognitive conditions that affect treatment and make compliance difficult * having botulinum toxin procedure in the last 6 months * cardiac pacemakers * those with skin ulcers * pregnancy * history of metastatic cancer

Keywords: stroke hemiplegia exoskeleton device muscle spasticity quality of life
air optix night and day aqua (aonda) retrospective study 1

Conditions: Refractive Ametropia; Hyperopia; Myopia

Summary: the purpose of this study is to assess long term performance and safety of aonda in a real world setting when worn as daily wear or continuous wear for vision correction. this study will be used to support aonda's marketability in europe and other locations.

in this retrospective observational study, the subject used aonda for at least approximately 1 year in either a daily wear (dw) or continuous wear (cw) modality with monthly replacement. for the cw cohort only, 3-year data will be collected, if available.

Eligibility criteria:
key inclusion criteria: * normal eyes, as determined or known by the investigator; * manifest refraction cylinder less than or equal to 0.75 diopter (d) in each eye at baseline; * best corrected visual acuity (bcva) of 20/25 snellen or better in each eye at baseline; * at the time of the 1-year visit, subject was prescribed and wearing aonda in both eyes in either a dw or cw modality for at least approximately 1 without changing modality; * baseline and 1-year visit chart available; * other protocol-specified inclusion criteria may apply. key exclusion criteria: * any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline; * the use of systemic or ocular medications contraindicating regular contact lens wear at baseline; * history of refractive surgery or irregular cornea; * slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline; * other protocol-specified exclusion criteria may apply.
combined effects of meal frequency and protein load on cardiometabolic risk factors

Conditions: Metabolic Disease; Cardiovascular Disease

Summary: this study examines the effect of meal frequency and meal composition on risk factors of cardiometabolic disease.

cardio-metabolic disease (cmd) is the leading cause of death globally \& in singapore. large scale epidemiological evidence confirmed that elevated postprandial glucose, insulin, triglycerides are major risk factors for cmd. recent evidence suggests benefits from high protein diets but the health effects of eating smaller meals remain enigmatic. the aim of this study is to examine meal frequency (2-large vs 6-smaller isocaloric meals), under high or low protein loads on acute postprandial health biomarkers . the investigators hypothesized that higher protein \& higher meal frequency would be beneficial for cardiometabolic health.

Eligibility criteria:
inclusion criteria: * chinese males * age: 21 - 50 years. * body mass stable within the last 2 months by self-report. * body mass index (bmi): \< 30kg/m2. * normal fasting blood glucose level≤ 6.0 mmol/l * blood pressure ≤ 140/90 mmhg * not participating in any dietary interventions in the past 2-months. exclusion criteria: * special dietary practice (e.g. vegetarians, atkins diet) or diets due to religious reasons during the study period (e.g. fasting for ramadan) * smoking. * excessive alcohol consumption: consuming alcohol on \>4 days per week with ≥5 alcoholic drinks (males) and ≥4 alcoholic drinks (females) per time (national health survey, 2010). * metabolic diseases (including thyroid dysfunction) * using medication affecting carbohydrate and fat metabolism * allergy to any components of the provided meals (gluten, nuts, milk, dairy)
platelet rich plasma injection into ovary of patients with premature ovarian insufficiency

Conditions: Premature Ovarian Failure

Summary: all encountered cases with poi will be assessed and examined then investigated. eligible cases will be included in the study

patients will be subjected to injection of autologous prp inside the ovary about 0.5-1 mml by laparoscopy

Eligibility criteria:
inclusion criteria: * premature ovarian insufficiency diagnosed by: * fsh\> 40 amenorrhea menopuasal symptoms infertility exclusion criteria: * refusal to participate secondary poi due chemotherapy, surgery, or radiotherapy previous treatment with prp

Keywords: premature ovarian insuffiency infertility prp
therapy targeting depression and hiv treatment adherence (the triad study)

Conditions: HIV; Depression; HIV Infections

Summary: this study will test a therapy for both helping people adhere to their hiv medication regimens and treating them for depression.

people infected with hiv are more likely to suffer from depression than those not infected, with studies finding anywhere from 20% to 50% of hiv-infected individuals having significant depressive symptoms. depression, in addition to causing persistent sadness and inability to feel pleasure, is related to a lack of hiv treatment adherence. treatment adherence (making sure to take every pill as prescribed by doctors) is critically important to successful treatment of hiv, because missing even a few doses gives the hiv virus an opportunity to develop immunity to the medication. poor adherence is related to worse medical outcomes, but even a small, 10% improvement rate in adherence may improve these outcomes. this study will test the efficacy of cognitive behavioral therapy (cbt) that addresses both depression and treatment adherence for hiv-infected people. participation in this study will last 1 year, including follow-up visits. all participants will complete an initial one-visit intervention addressing treatment adherence. then after 2 weeks, participants will be randomly assigned to one of three conditions: cbt for hiv medication adherence and depression (cbt-ad), information and supportive psychotherapy for hiv medication adherence and depression (isp-ad), or enhanced treatment as usual (etau). participants receiving cbt-ad and isp-ad will complete 12 therapy sessions over 4 months and will be asked to report any changes to their psychological or hiv treatments. cbt-ad will involve learning to identify and change problematic patterns of thought and behavior, while isp-ad will involve education and supportive psychotherapy. participants receiving etau will receive only the initial session on hiv medication adherence and will be asked about their psychological and hiv treatment every other week for 4 months. major study assessments will take place at baseline and after 4, 8, and 12 months. assessments will include completing diagnostic interviews and questionnaires, measuring medication adherence through an electronic pill cap, and determining cd4 cell count and viral load (indicators of hiv treatment effectiveness).

Eligibility criteria:
inclusion criteria: * hiv-infected * current diagnosis of depression or prescribed an antidepressant medication with at least some residual symptoms (e.g., clinical global impressions \[cgi\] scale score of 2 or greater) * prescribed a stable regimen of highly active antiretroviral therapy (haart) for hiv for at least 2 months exclusion criteria: * active, untreated, and unstable major mental illness (i.e., untreated psychosis or mania) that would interfere with cognitive behavioral therapy (cbt) treatment for depression * diagnosis with any primary psychotic disorder, even if treated * treatment with cbt within the past year

Keywords: adherence