Kornimate/medical-research-clean huggingface dataset:
alk21-003: study of medisorb® naltrexone (vivitrol®) in alcohol-dependent adults

Conditions: Alcoholism

Summary: this was a phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the diagnostic and statistical manual of mental disorders, 4th ed. (dsm-iv). subjects were randomized (2:2:1:1) to receive intramuscular (im) injections of medisorb® naltrexone 190 mg, medisorb naltrexone 380 mg, placebo for medisorb naltrexone 190 mg, or placebo for medisorb naltrexone 380 mg (vivitrol®). study drug was administered every 4 weeks for a total of 6 injections.

all subjects received standardized biopsychosocial support therapy (brenda approach \[volpicelli, jr \[2001\]; guilford press: new york\]) at each visit. subjects who completed this study (ie, received 6 injections of study drug and completed all study visits) and continued to meet eligibility criteria were given the option to enroll in extension study alk21-003ext (nct01218971). a second extension, study alk21-010 (nct00156923), was conducted subsequent to alk21-003ext.

Eligibility criteria:
primary inclusion criteria: * diagnosis of alcohol dependence based on diagnostic and statistical manual of mental disorders, 4th ed. (dsm-iv) criteria * male or non-pregnant, non-lactating female * able to provide timeline follow-back (tlfb) alcohol consumption information for 90-day period before detoxification and/or screening * at least 2 episodes of heavy alcohol drinking per week during the 30 days before detoxification and/or screening * negative urine toxicological screen for opiates on day of randomization * noncustodial, stable residence and phone plus 1 contact with verifiable address and phone primary exclusion criteria: * evidence of hepatic failure including: ascites, prolonged prothrombin time (pt) (international normalized ratio \[inr\] ≥1.7), bilirubin \>10% above upper limit of normal (uln) and/or esophageal variceal disease * active hepatitis and/or aspartate aminotransferase (ast) or alanine aminotransferase (alt) higher than 3xuln * history of pancreatitis * major depression with suicidal ideation, psychosis, bipolar disorder, or psychiatric disorders that would compromise subject's ability to complete the study * current dependence (within past year) per dsm-iv criteria to benzodiazepines, opioids or cocaine * use of benzodiazepines and/or ambien® (zolpidem tartrate) within 7 days prior to first dose of study medication * greater than 7 days inpatient treatment for substance use disorders within 30 days of randomization * use of any opioids and/or methadone within 14 days of screening, or likely requiring opioid therapy during study period * use of oral naltrexone or disulfiram within 14 days of screening * known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (plg)

Keywords: alcoholism
a study of bbi608 in adult patients with advanced, refractory hematologic malignancies

Conditions: Hematologic Malignancy

Summary: this is a multicenter, open label, phase 1 dose-escalation study of bbi608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others.


Eligibility criteria:
major inclusion criteria: 1. signed written informed consent must be obtained and documented according to the international conference on harmonisation (ich) and be in accordance with local regulatory requirements 2. a histologically confirmed hematologic malignancy that is advanced, relapsed, or refractory to standard, currently available anti-cancer treatment options 3. ≥ 18 years of age 4. eastern cooperative oncology group (ecog) performance status of ≤ 1 at dose escalation phase and of ≤ 2 at dose expansion phase 5. male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after their last dose 6. females of childbearing potential must have a negative serum pregnancy test 7. aspartate transaminase (ast) ≤ 2.5 x upper limit of normal (uln) and alanine transaminase (alt) ≤ 2.5 × upper limit of normal (uln). patients whose disease involves the liver and who have laboratory values of ast ≤ 3.5 uln, ast ≤ 3.5 uln, and albumin ≥ 35g/l may be enrolled if agreed upon by the principal investigator and medical monitor for the sponsor 8. total bilirubin \< 1.5 x uln, except for cases in which elevation of total bilirubin is due to elevated levels of unconjugated bilirubin consistent with a diagnosis of gilbert's syndrome 9. life expectancy ≥ 3 months

Keywords: multiple myeloma lymphoma acute myeloid leukemia myelo-dysplastic syndrome chronic myeloid leukemia chronic lymphocytic leukemia
initial evaluation of the cellie coping kit for children with injury

Conditions: Injuries

Summary: the purpose of this study is to assess the feasibility (fidelity, acceptability, implementation, cost) of the cellie coping kit for children with injury as well as to determine the intervention's efficacy (mechanisms of action and health outcomes).

the goal of this study is to assess the cellie coping kit for injury intervention feasibility and initial efficacy. aim 1: intervention feasibility assess intervention feasibility (implementation, cost, fidelity). aim 2: intervention efficacy (mechanisms of action and health outcomes): conduct initial efficacy evaluation of the cellie intervention on mechanisms of action (adherence and coping behaviors) and health outcomes (physical recovery, hrqol, emotional health). hypotheses: at 6-week follow-up (t2), compared to a treatment as usual (tau) control group, parents in the intervention group will report greater adherence to medical discharge instructions (h2.1) and encourage their child to use a higher number of adaptive coping strategies (cognitive, active, support seeking; h2.2); children in the intervention group will generate a greater number of adaptive coping strategies (h2.3). hypotheses: at a 12-week follow-up (t3), compared to tau, children in the intervention group will report better hrqol and emotional health (h2.4); parents in the intervention group will report better child hrqol and child emotional health (h2.5). objective injury recovery scores will be higher for the intervention group (h2.6). method: 80 children with injury and one parent per child will participate in a pilot rct with a wait-list control design. participants will complete baseline assessments of targeted study variables prior to randomization (40 to the intervention; 40 to usual care) and then repeat measures 6 (t2), 12 (t3), and 18 weeks (t4) later. those in the immediate intervention condition will initiate the intervention following the t1 assessment. those in the wait-list condition will initiate the intervention following the t3 assessment.

Eligibility criteria:
inclusion criteria: * child has incurred an injury within the last month requiring medical attention * one caregiver per child willing to participate * sufficient english language skills to understand intervention and assessment materials * access to internet or telephone for follow-up assessments exclusion criteria: * injury resulting from family violence
french national observatory of patients with thymic epithelial tumor

Conditions: Thymic Epithelial Tumor

Summary: rythmic (réseau tumeurs thymiques et cancer) is a french nationwide network for tet with the objective of territorial coverage by regional expert centers and systematic discussion of patients management at national tumor board.

rythmic (réseau tumeurs thymiques et cancer) is a nationwide network for tet appointed in 2012 by the french national cancer institute. the objectives of the network are management of clinical tumor boards and central pathologic review of all cases. rythmic tumor board is based on initial histopathological diagnosis. rythmic is a comprehensive tool for research: * to improve the management of patients * to monitor dedicated actions * to screen patients for future translational and clinical trials

Eligibility criteria:
inclusion criteria: * patient with thymic epithelial tumors exclusion criteria: * histology other than thymic epithelial tumors

Keywords: thymic epithelial tumor cohort study ifct
can remote ischaemic preconditioning reduce contrast induced nephropathy in patients receiving contrast for computed tomography?

Conditions: Contrast Induced Nephropathy; Remote Ischaemic Preconditioning

Summary: computated tomography (ct) is an invaluable medical resource for both physicians and surgeons. contrast media are an aid to improve the diagnostic yield of ct. while an incredibly powerful means of imaging the human body, there are possible complications to the use of contrast including a hypersensitive response and contract induced nephropathy (cin). the latter will typically occur 48-72 hours after administration. one recent meta - analysis of serum creatinine levels following contrast enhanced ct found 6.4% of those undergoing this investigation developed cin. although typically transient, 1 % had a persisting reduced renal function, with a small minority needing renal replacement therapy (rrt). the development of cin was influenced by co morbidities and by the amount of contrast given. the mechanism of injury to the kidney is not definitively established, but is thought most likely due to hypoxia resulting from reduced blood flow, thereby giving rise to oxygen free radicals causing direct damage to the kidney and also direct tubular damage. remote conditioning ischaemia has been hypothesized to be nephroprotective, whereby induced transient ischaemia at another site could buffer the impact of the contrast medium's effects. this was first demonstrated during cardiac angiograms, with those patients whom received multiple balloon inflations in the coronary arteries were found to have a lower incidence of cin than those with fewer balloon inflations. thus it could be hypothesised that any ischaemia temporarily induced could be nephroprotective. this can be at a point of extremity, rather than involving central organs, such as the arm, with ischaemia induced by the use of a blood pressure cuff, inflated to above systolic blood pressure levels. no studies have been found in the literature attempting to demonstrate this effect in relation to contrast ct studies. consequently, a randomised control clinical trial of patients to assess the effectiveness of remote ischaemic preconditioning is proposed. study hypothesis: that performing remote ischaemic preconditioning on those undergoing cts involving iv contrast is nephroprotective.


Eligibility criteria:
inclusion criteria: * hospital inpatients undergoing contrast enhanced abdomino-pelvic ct scanning. exclusion criteria: * those with an allergy/hypersensitivity to the contrast solution * those with a cr of above 150μmol/dl on admission, as is a contraindication to iv contrast. * patients who are not getting iv contrast * any patients with a history of renal transplantation * any patients with a history of previous acute kidney injury necessitating management by a nephrologist * patients taking either a sulphonlurea or nicorandil.
the effect of back muscles activation on idiopathic scoliosis using surface electromyography

Conditions: Idiopathic Scoliosis

Summary: the purpose of this study is to evaluate the effect of back muscle activations on idiopathic scoliosis

* design: prospective study * setting: hospital rehabilitation department * intervention: participants were asked to walk with a surface electromyography(emg) attached to their back muscles. after repeating the same process with different leg lengths discrepancy (0cm, 0.5cm, 1cm), participants are compared the main outcome measures. * main outcome measures: surface electromyography(emg)

Eligibility criteria:
inclusion criteria: * healthy children (5 to 12 years old) exclusion criteria: * children with leg length discrepancy over 0.5cm * children complaining of acute low back pain * children with spinal scoliosis * children with cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities * children who underwent spinal surgery
antibodies production after covid-19 vaccination among patients with medical history of cancer and anti-cd-20 treatment

Conditions: Covid19; Cancer; HIV Infections

Summary: this is a phase ii study designed to investigate if the covid 19 vaccines are capable of eliciting production of antibodies against s protein of sar-s-cov-2 virus among patients with medical history of cancer previously treated with monoclonal anti cd-20 antibodies. the antibody production is defined based on the detection of antibodies in the serologic covid-19 rapid test against s protein or with semiquantitative assay when it becomes available.


Eligibility criteria:
inclusion criteria: * all patients either diagnosed with cancer or with hiv positivity or treated with an antineoplastic regimen including anti cd-20 after covid-19 vaccine will be registered on the study regardless of their type of cancer or type of antineoplastic regimen. * patients 21 years or older diagnosed with cancer treated with antineoplastic regimen or anti cd-20, or with hiv infection vaccinated with 2 doses of anti covid-19 vaccine. * eligible patients will be registered on study after a covid -19 vaccine has been scheduled. * in order to be screened for covid 19 antibodies, they must be tested at least two weeks after the second dose of covid-19 vaccination. exclusion criteria: * anyone who has not been treated with anti-cd20 antibodies or with chemotherapy who doesn't have hiv infection or who has not received chemotherapy for cancer.
a phase 2, controlled, double blind, randomized and multicenter study to compare efficacy and safety of a novel topical therapy (apt-001, spinosad 1.8%) in patients with blepharitis.

Conditions: Blepharitis

Summary: the purpose of this study is to establish the clinical efficacy of apt-001 topical therapy 1.8% in patients with blepharitis as compared to its vehicle control, and to establish that the therapeutic is safe and generally well tolerated by patients.

this phase 2 study is a randomized, controlled, double-blind trial to compare the safety and efficacy of apt-001 1.8% to vehicle control for the treatment of blepharitis. the primary objective of the study is to compare the safety and efficacy of apt-001 compared to its vehicle from day 1 to day 43 in patients with blepharitis. the primary efficacy endpoint will be cure based upon collarettes. safety will be determined by assessing adverse effects related to the treatment.

Eligibility criteria:
inclusion criteria: * symptomatic blepharitis. * at least 6 years of age. * eyelid collarette count (minimum score 2). * willing and able to follow all instructions and attend all study visits. * able to avoid prohibited medication for the duration of the study. * patients can willingly provide consent or have a legal authorized representative provide consent on the informed consent (ic) form. exclusion criteria: * women with confirmed pregnancies. * utilizing any current medical therapy for the eye. * history of allergic reaction to spinosad or any formulation component. * patients using eyelid hygiene or other treatment(s) for blepharitis within 14 days of screening. * history of ocular surgery within the past 1 year. * presence of other ocular diseases that may affect study outcomes (corneal dystrophies, salzmanns disease, severe dry eye, keratoconus, glaucoma filtering blebs). * use of investigational drug, chronic glaucoma medications, steroid. * uncontrolled systemic disease. * acute or chronic illness that would confound study results.

Keywords: blepharitis
a study to learn about novel hormonal therapies in people with metastatic castration-sensitive prostate cancer (mcspc)

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mcspc. novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide. prostate cancer is one of the most common cancers in men. the prostate is a gland in the male body that helps make semen. metastatic cancer is a cancer that has spread to other parts of the body. castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery. this is a real-world study, not a clinical trial. this means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. in this study, researchers will use insurance claim information from medicare claims data. the study will include patients' information from the database for men who: * were identified to have mcspc. * started treatment with novel hormonal therapy (index date) for mcspc. * were 65 years of age or older one year before index date. men in this study will be taking novel hormonal therapy for treatment of their mcspc. we will describe how long men take novel hormonal therapy. this study will use patient information from insurance claims. it will take information one year before start of novel hormonal treatment until the end of insurance period or until information is available.


Eligibility criteria:
inclusion criteria: * male with ≥ 1 diagnosis claim for prostate cancer * have documented secondary metastasis code on or after the initial prostate cancer diagnosis * have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 days prior to the metastasis date or on or after the metastasis date. the initiation date of the earliest novel hormonal therapy will be defined as the index date. * have a claim for androgen deprivation therapy (adt) within 90 days prior to or within 30 days after the index date * ≥65 years old 12 months prior to the index date * continuous enrollment in medicare parts a, b, and d for ≥12 months prior to the index date and ≥6 months following the index date (unless death) exclusion criteria: * claims indicating ≥8 weeks of continuous adt use between 90 and 365 days prior to the index date, which may indicate castration-resistance * received chemotherapy, novel hormonal therapy, radium-223, parp inhibitor, immunotherapy, or surgical castration prior to the index date * had a prior history of other cancers

Keywords: metastatic castration-sensitive prostate cancer mcspc metastatic hormone-sensitive prostate cancer mhspc enzalutamide abiraterone treatment duration
relationship between vestibular function and topographic memory

Conditions: Normal Elderly Population

Summary: the purpose of this study is to evaluate visual and nonvisual topographic memory impairment and its relationship to vestibular function in humans. topographic memory refers to the ability to remember current and past locations in topographic (navigational) space and to make and/or adjust to spatial transformations using such memories. performance on each of these topographic memory tasks will be compared to performance on a set of comparable nontopographic memory tasks. topographic impairments represent some of the earliest cognitive deficits observed in alzheimer's disease, and the brain areas involved in topographic memory are the first to show degenerative changes.


Eligibility criteria:
inclusion criteria: * males or females of all racial and ethnic groups between the ages of 70 and 85 years of age; * montreal cognitive assessment (moca) (http://www.mocatest.org) score of \>24; * no known history or current evidence of stroke, trauma, psychiatric illness, or other insult to the brain; * no current use of psychoactive medicine other than caffeine (100 mg/day) or alcohol (1-2 drinks per night); * normal sleep (at least an average of 7 hours for four days prior to participation); * able and willing to comply with study requirements including following instructions to complete vestibular and neuropsychological testing; and * have full understanding of all elements of provide signature and dating of the written informed consent prior to the initiation of procedures specified in protocol. exclusion criteria: * \ 85 yrs of age; * moca score of \<25; * history, or current evidence, of stroke, trauma, psychiatric illness, or other insult to the brain; * prior history of inner-ear balance problems; * current use of psychoactive medicine other than moderate caffeine or alcohol use; * acute or chronic sleep deprivation during the week prior to participation (\<7 hours/night on average for four nights prior to participation). other restrictions: * no alcohol use on the night before the vestibular testing * 7 hours minimum sleep the night before vestibular testing * no eye make-up can be worn on the day of the vestibular test due to possible interference with vestibular-ocular reflex testing apparatus

Keywords: topographical memory non-topographical memory vestibular function alzheimer's disease
tep with 68-dotanoc in gastroenteropancreatic neuroendocrine tumors

Conditions: Patients With Gastroenteropancreatic Neuroendocrine Tumors

Summary: evaluation of the diagnostic performance of pet / ct with 68ga-dotanoc in gastroenteropancreatic neuroendocrine tumors with comparison with other techniques used in routine clinical practice (octreoscan ® ; multiphase spect / ct, mri or endoscopy). therapeutic impact and safety of pet / ct with 68ga-dotanoc will also be assessed. expected results are a confirmation of the superiority of 68ga-pet dotanoc versus scintigraphy octreoscan ®, with a potential impact on the therapeutic management of patients.


Eligibility criteria:
inclusion criteria: * age over 18 years * effective contraception or exclusion of pregnancy dosage of beta-hcg in women of childbearing age * fortuitous discovery of suggestive tumors of te-gep with well documented conventional imaging (multiphase ct; mri, us endoscopy) associated or not associated with clinical or biological signs of te-gep tumors (increase in tumor markers) or * histologically proven gep-te (who classification 2010 (26) well differentiated in the initial staging or * suspicion of recurrence or progression of well differentiated te-gep tumors on conventional imaging or laboratory tests (increase in tumor markers) or * clinical or biological syndrome strongly suggestive of digestive endocrine disease without identification of lesions with conventional imaging * informed consent and patient's written * affiliation to an insurance exclusion criteria: * multiple endocrine neoplasia * te gep tumor not differentiated * pregnancy and lactation * persons protected by law * restlessness, inability to lie still hold at least 1 hour; claustrophobia * poor compliance predictable or inability to undergo medical test for geographical, social or psychological * treatment with radiotherapy, chemotherapy or other antitumor treatment within 6 weeks of previous morphological and scintigraphic examinations. in case of treatment with somatostatin analogues delayed, scans will be performed 4 weeks after the last injection. however, a shorter period may be observed to avoid to do again the initial assessment exams. * malignancy except basal cell cancers and cancer in situ of the cervix * contraindication of injection of a contrast agent necessary for the production of multiphase scanner. * patients who had a ct scan without injection of contrast material can not participate in the study

Keywords: gastroenteropancreatic neuroendocrine tumors immuno pet (ipet) gallium (68-ga) dotanoc