Kornimate/medical-research-clean huggingface dataset:
image-guided (68ga-psma-11 pet/ct) prostate biopsy for the diagnosis of prostate cancer in men with prior negative/inconclusive biopsy

Conditions: Prostate Carcinoma

Summary: this early phase i trial studies how well an image-guided prostate biopsy using the imaging agent 68ga-prostate-specific membrane antigen (psma)-11 with a positron emission tomography/computed tomography (pet/ct) scan works in diagnosing prostate cancer in men with a prior negative or inconclusive prostate biopsy. psma is a protein that is found on the surface of prostate cancer cells. 68ga-psma-11 is made up of a substance that binds to psma on tumor cells, linked with a radioactive substance that can then be seen on imaging scans such as pet/ct. 68ga-psma-11 pet/ct-guided biopsy may help improve the detection rate of prostate cancer. this may help reduce over-diagnosis and over-treatment in men with low-risk prostate cancer and under-treatment in men with high-risk prostate cancer.

primary objective: i. to assess the detection rate of clinically significant prostate cancer (gleason score 7 or more) in patients with focal gallium ga 68 gozetotide (68ga-psma-11) uptake within the prostate. outline: screening procedure: patients receive 68ga-psma-11 intravenously (iv) and 50-100 minutes later, undergo a pet/ct scan. only patients with 68ga-psma-11 uptake within the prostate proceed to image-guided biopsy. image-guided biopsy: patients undergo experimental image-guided prostate biopsy using pet/ct images obtained during screening procedure during a standard of care transrectal ultrasonography guided biopsy (trus).

Eligibility criteria:
inclusion criteria: * men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (mri/us) fusion prostate biopsy * scheduled for a repeat transrectal ultrasound (trus) prostate biopsy by standard of care * focal 68ga-psma-11 uptake within the prostate exclusion criteria: * negative 68ga-psma-11 uptake within the prostate (screening failure) * age \ 90 years * recurrent prostate cancer * inability to provide written informed consent * known inability to remain still and lie flat for the duration of the pet/ct (about 30 minutes)
prevenar special use-result surveillance in japan (regulatory postmarketing commitment plan)

Conditions: Pneumococcal Vaccine; Streptococcus Pneumoniae

Summary: this surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive prevenar at the age of more than 2 and less than 7 months in routine medical practice. this surveillance will specifically focus on the occurrence of the following: 1. local reactions at the injection site 2. systemic reactions for each concomitant vaccine (especially fever more than 39c°)

this surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached.

Eligibility criteria:
inclusion criteria: * infants at the age of more than 2 and less than 7 months * infants who have been vaccinated with prevenar for the first time * infants expected to complete four vaccinations with prevenar exclusion criteria: vaccination with prevenar must not be given to any of the following; * history of evident anaphylactic reaction to any component of prevenar or diphtheria toxoid * evident pyrexia * evident serious acute disease * any other infants or children ineligible for vaccination

Keywords: pneumococcal vaccine prevenar 7-valent special use-result surveillance
preoperative bevacizumab for vitreous hemorrhage

Conditions: Diabetic Retinopathy; Vitreous Hemorrhage

Summary: the purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.


Eligibility criteria:
inclusion criteria: * diabetic retinopathy causing significant vitreous hemorrhage with visual acuity loss lasting more than three months in patients not previously treated and four months in those previously laser treated. exclusion criteria: * previous intra-ocular surgery other than cataract surgery * retinal detachment * use of anticoagulants drugs other than aspirin * vitreous hemorrhage clearance at week-3 study period * history of previous thromboembolic events

Keywords: diabetic retinopathy vitreous hemorrhage bevacizumab pars plana vitrectomy preoperative
evaluate long-term safety and efficacy wc3011 (estradiol vaginal cream)

Conditions: Vulvovaginal Atrophy

Summary: this is an open-label extension study evaluating the long-term safety and efficacy of wc3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.


Eligibility criteria:
inclusion criteria: * completed study pr-04409.3 (nct01400776) exclusion criteria: developed any of the following during study-pr04409.3 or has begun taking hormone therapy other than wc3011: * hypersensitivity to estrogen and/or progestin therapy * known or suspected premalignant or malignant disease (except successfully treated skin cancers) * manifestation of or treatment for significant cardiovascular disease, stroke or ischemic attack * insulin-dependent diabetes mellitus * smoking ≥ 15 cigarettes daily * uncontrolled hypertension - systolic blood pressure (bp) ≥ 160 mmhg or diastolic ≥ 95 mmhg

Keywords: postmenopausal women vaginal dryness postmenopausal vulvovaginal atrophy
implementing, evaluating, and scaling up of the strengthening a palliative approach in long term care (spa-ltc) program

Conditions: Frail Elderly Syndrome

Summary: this study will evaluate the implementation of the strengthening a palliative approach in long-term care (spa-ltc) program using a cross-jurisdictional, effectiveness-implementation type ii hybrid design (dual testing of clinical and implementation interventions) to assess the implementation (feasibility, fidelity, reach, sustainability) and effectiveness (family satisfaction, staff knowledge and confidence implementing a palliative approach to care, hospital use).

the spa-ltc program has been developed and refined through prior participatory action based studies. evidence-based components of the program include: palliative champion teams; palliative care education, including illness-trajectory pamphlets for staff and family members; comfort care rounds with staff; prognostic tools to trigger end-of-life discussions; palliative care conferences; bereavement pamphlets for families; and post-bereavement follow-up for families, and staff the goal is to implement and assess this program across three provinces in canada (ontario, saskatchewan, manitoba). the investigators will use the findings to revise the program and inform the scaling up of the program across diverse settings and provinces.

Eligibility criteria:
inclusion criteria: * english-speaking ltc residents with a score of 50% or less on the palliative performance scale. exclusion criteria: * non-english speaking ltc residents * residents with a score of more than 50% on the palliative performance scale.

Keywords: palliative care end of life care long-term care nursing home
lyon granulomatous hepatitis study

Conditions: Patient Diagnosed or Treated for Granulomatous Hepatitis Followed in the Internal Medicine (and or) Hepato-gastroenterology Departments

Summary: granulomatous hepatitis are histopathologically defined by the presence of epithelioid and gigantocellular granulomas within the hepatic parenchyma. hepatic granulomas are observed in 2 to 15% of liver biopsies. causes of granulomatous hepatitis can be related to ethnic and environmental factors and in western countries granulomatous hepatitis are mostly related to sarcoidosis and autoimmune cholangitis. infections (mycobacteria, coxiella burnetii, hepatitis c) and medications also provide granulomatous hepatitis. sarcoidosis is a systemic disease of unknown etiology, which in third of cases has a chronic course. five percent of patients die of their disease, mainly because of respiratory distress. hepatic involvement is most often asymptomatic or pauci-symptomatic (moderate cholestasis and conglomerates of granulomas visible on imaging). more rarely, it can cause portal hypertension and its complications and be life-threatening. the aim of the lyon hepatitis granulomatous (lhg) study is to better characterize granulomatous hepatitis and within these, severe hepatic sarcoidosis. this is a retrospective study conducted from january 2008 to december 2016 proposed to all patients with granulomatous hepatitis followed in the internal medicine and / or hepato-gastroenterology departments (croix-rousse hospital, edouard-herriot hospital, lyon sud hospital center). this study will cover 596 patients who had a liver biopsy showing granulomas. the main objectives of the lyon hepatitis granulomatous (lhg) study are to analyze i) the etiology of the disease and the contribution of molecular biology for infectious etiologies, ii) the contribution of nuclear imaging for sarcoidosis diagnosis versus conventional imaging, iii) treatment used and prognosis. this study will permit a better characterization of granulomatous hepatitis, and liver sarcoidosis in terms of prognosis as well as therapeutic management.


Eligibility criteria:
inclusion criteria: * diagnosis of granulomatous hepatitis * patient followed in the internal medicine and / or hepato-gastroenterology departments (croix-rousse hospital, edouard-herriot hospital, lyon sud hospital center) * collection of non-opposition exclusion criteria: -

Keywords: hepatitis granulomatous liver sarcoidosis prognosis
a study of sunitinib compared to placebo for patients with advanced pancreatic islet cell tumors

Conditions: Carcinoma, Islet Cell; Carcinoma, Pancreas

Summary: this study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug. the study was designed to detect a 50% improvement in median pfs\[progression free survival\] with 90% power and was to enroll 340 subjects. an interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred. study a6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the dmc \[data monitoring committee\]. the actual number of subjects enrolled was 171 and the actual number of pfs events recorded was 81 pfs events. the decision to terminate the study was not based on safety concerns related to sunitinib administration.

the study was terminated on 11 march 2009 because the independent data monitoring committee determined that the study had met its primary endpoint in demonstrating improvement in progression-free survival. the decision to terminate the trial was not based on safety concerns related to sunitinib administration.

Eligibility criteria:
inclusion criteria: * well-differentiated advanced/metastatic pancreatic islet cell tumor * tumor has shown progression within the past year. exclusion criteria: * current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues * prior treatment with any tyrosine kinase inhibitors or anti-vegf\[vascular endothelial growth factor\] angiogenic inhibitors. * prior treatment with non-vegf-targeted angiogenic inhibitors is permitted
comparison of cognitive processing therapy (cpt) and dialogical exposure therapy (det) for posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorder

Summary: this study aims to compare two active psychological treatments for ptsd. one is an established therapy, cognitive processing therapy (cpt) which operates as a control condition for a newly developed intervention, an integrative gestalt-based trauma therapy, dialogical exposure therapy (det). there is no inactive control condition. we expect the two therapies to perform on a similar level, which would constitute evidence for the efficacy of det.


Eligibility criteria:
inclusion criteria: * main diagnosis of posttraumatic stress disorder * time since trauma is at least three months exclusion criteria: * acute suicidal ideation * severe personality pathology * substance dependence * early childhood trauma (e.g. child sexual abuse) * history of psychosis * dissociative identity disorder * neurological impairment (e.g. craniocerebral injury with functional impairment) * severe pre-traumatic depression * ongoing psychotherapy * lack of motivation * lack of german language skills

Keywords: posttraumatic stress disorder ptsd psychotherapy randomized trial gestalt
rutgers university study of the genetics of breast cancer.

Conditions: Breast Cancer Risk; Breast Cancer Prevention; Breast Cancer

Summary: the goal of this observational study is to learn more about how genes impact the risk of breast cancer. anyone 18 or older living in the us is eligible, and a diagnosis of cancer is not required. study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through us mail. in return, study participants may opt to receive information about their genetic ancestry at no cost.

this is an online research study to learn more about how genes affect the risk of breast cancer. no office visit is required and in return, participants may receive information about their genetic ancestry for free. brca1 and brca2 explain only about 25% of the genetic cause of breast cancer. this study will increase our understanding of the genetic basis of breast cancer, which is a crucial step in drug development to improve current treatment options. the study investigators seek a diverse population because men can also get breast cancer and diversity among participants maximizes the usefulness of the data. participants will use our online study portal to answer questions about their health and provide their dna via a saliva sample using a pre-paid mailer. participation takes approximately 20 minutes. participants will be invited to share data from their electronic health records, but this is not required for study participation. the study investigators keep participants engaged with short monthly newsletters.

Eligibility criteria:
inclusion criteria: * age 18 years or older * currently living in the united states * able to understand and follow written instructions in english * have access to the internet and a computer, laptop, tablet or smart phone * willing to provide written informed consent for participation * willing to provide dna via a saliva sample using a collection kit mailed to the study participant's home * willing to complete a survey with questions about health related to the study of breast cancer. exclusion criteria: * not able to meet or fulfill any of the inclusion criteria
elastography in patients with hemiplegia

Conditions: Hemiplegia; Elastography; Shoulder; Muscles

Summary: in our study, we aimed to examine the muscles and tendons of the shoulder region on the plegic side of patients with hemiplegia by elastography and to investigate whether there is a relationship between the course of the disease and the course of the lesions that will occur in the shoulder.

patients over the age of 18 who apply to our clinic and have hemiplegia complaints will be evaluated. patients' age, gender, occupation, habits, disease duration, upper extremity with complaints, dominant upper extremity, additional disease, weight and height values will be recorded. in the physical medicine and rehabilitation department examination of the patients, the patients will be evaluated with the brunnstrom staging used in hemiplegic patients. the elastography of the shoulder on the side with hemiplegia and the elastography of the shoulder on the side without complaints will be examined. thus, the patient's side with the complaint will be checked by comparing the healthy side.

Eligibility criteria:
inclusion criteria: 1. volunteer patients 2. patients over 18 years old 3. patients with hemiplegia 4. patients without any rheumatic disease 5. patients without any neurological deficit and muscle disease 6. not having received ftr treatment to the shoulder area in the last 3 months 7. no injection to the shoulder area in the last 3 months 8. not having any surgical procedure on the shoulder area 9. not to be pregnant exclusion criteria: 1. patients with any rheumatic disease 2. patients with any neurological deficit and muscle disease 3. to have received ftr treatment to the shoulder area in the last 3 months 4. being under 18 years old 5. having an infectious disease 6. having any benign or malignant disease 7. any surgical procedure to the shoulder area 8. pregnancy
the effect of an eyelid warming device for the management of meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction (MGD)

Summary: along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver oils (meibum) onto the tear film. these oils serve to slow down the evaporation of tears. the meibomian glands may become obstructed due to change in meibum quality. when meibum thickens and solidifies, it plugs the gland openings and oils can no longer reach the tear film. the blockage of the glands is the primary cause of meibomian gland dysfunction (mgd), and may result in symptoms of dry eye (burning, stinging, grittiness, etc.). the typical treatment for mgd is a procedure called "warm compresses". it is a combination of applying heat and pressure to the eyelids for approximately 10 minutes to melt the meibum, unplug the gland openings, and allow oils to flow normally onto the tear film once again. one way to apply heat to the eyelids is by using the mgdrx® eyebag. the eyebag is microwaved for 30-40 seconds under full power, and is placed over the closed eyes for approximately 10 minutes. the eyes are gently massaged afterwards. the purpose of this study is to determine how effective the eyebag is at improving mgd and dry eye symptoms.


Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study if he/she: 1. is at least 17 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. osdi score ≥ 23; 5. meibomian gland score of ≤ 9 (out of 15). 6. is on a stable dry eye regimen (if applicable) within the past 4 weeks, and is willing to maintain this regimen 7. agree to using metricwire for online data entry 8. is not a contact lens wearer (infrequent soft contact lens wearer is acceptable (wear contact lenses for maximum 2 days of the week)). exclusion criteria: a person will be excluded from the study if he/she: 1. is participating in any concurrent clinical or research study; 2. has any known hypersensitivity to flax, linseed or any of the other constituents of the eyebag 3. has any known active\* ocular disease and/or infection; 4. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 5. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable 6. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 7. is pregnant, lactating or planning a pregnancy at the time of enrolment, as determined verbally; 8. is aphakic; 9. has undergone refractive error surgery; \* for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. an exception is made for lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
randomized study of the use of intravenous choline supplementation in long term total parenteral nutrition

Conditions: Fatty Liver

Summary: objectives: i. determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.

protocol outline: this is a randomized, double blind, placebo controlled study. patients receive either daily choline chloride in their total parenteral nutrition (tpn) solution or their usual tpn. the tpn is given intravenously over a 12 hour period beginning at approximately 9 pm nightly. therapy continues for 24 weeks. adjustments in the daily dose of choline provided may be required based on plasma free choline levels and patient tolerance. additionally, all patients record the type and amount of their food intake on a daily basis. patients are followed every 2 weeks during the first 6 weeks, then every 4 weeks beginning with week 12 for the remainder of the 24 weeks, and then again at week 34. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- receiving nightly total parenteral nutrition (tpn) for greater than 70% of nutritional needs for a minimum of 8 weeks prior to study entry; receiving no greater than 38 kcal/kg/day/ideal body weight; receiving lipid emulsion as part of tpn regimen expected to require tpn for at least 34 weeks after study entry hepatic steatosis documented by prestudy ct scan consistent daily amount of intravenous amino acids, dextrose, or lipid received for 3 weeks prior to study entry --prior/concurrent therapy-- no concurrent cholinergic medications --patient characteristics-- hepatic: albumin at least 3.5 g/dl; no hepatic failure; pt no greater than 2 times upper limit of normal renal: no renal failure requiring hemo- or peritoneal dialysis other: no aids; not pregnant or nursing; negative pregnancy test; fertile patients must use effective contraception

Keywords: gastrointestinal disorders hepatic steatosis rare disease