Kornimate/medical-research-clean huggingface dataset:
clinical and imaging trial of uridine for veterans with suicidal ideation

Conditions: Suicidal Ideation

Summary: this is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for suicidal ideation in veterans. the investigators hypothesize that the administration of a naturally occurring dietary supplement, uridine, will rapidly reduce suicidal ideation in veterans. the purpose of this study is to determine whether 4 weeks of uridine supplementation is an effective treatment for suicidal ideation in veterans, when compared to a group taking a placebo.

veteran suicides, attempts and suicidal ideation (si) remain an urgent concern for the veterans health administration (vha). research indicates that approximately half of veteran suicides take place within 1 month of the decedent's final vha encounter, with one quarter occurring within 1 week. this provides a temporal window of opportunity to intervene, and necessitates development of a rapid-acting treatment for veterans with si. uridine shares similar brain mechanisms and neural effects with ketamin and lithium, treatments commonly used to reduce suicidal ideation. this study will test the novel intervention uridine as a rapid-acting oral treatment for veterans with suicidal ideation. the purpose of this study is to investigate whether uridine can decrease suicidal ideation in veterans when taken daily for 4 weeks. in addition to treatment with the investigational drug versus placebo, the study includes a translational neuroimaging component: magnetic resonance spectroscopy (1h-mrs) brain scans are performed at baseline, and then repeated following 1 week of treatment with uridine or placebo. the scans do not use radiation, and are performed on a 3 tesla mri system that is approved for clinical use. the scans allow researchers to measure the concentrations of several chemicals in the brain that are may be involved in suicidal ideation.

Eligibility criteria:
inclusion criteria: * must be able to provide informed consent. * must be a veteran of the u.s. armed forces. * columbia-suicide severity rating scale indicates current suicidal ideation * beck scale for suicide ideation score \> 3 (i.e. "greater than or equal to 4"). * history of \> 1 suicide attempt or hospitalization to prevent suicide in past 12 months; or functionally impairing suicidal ideation not due to a dsm axis ii diagnosis, in the past 12 months. * females and males ages 18-55 inclusive. * willing and able to identify an alternative contact person, e.g. family member, friend or neighbor. exclusion criteria: * schizophrenia or other psychotic disorder. * active substance use disorder requiring stabilization (n.b. does not include nicotine). * unstable medical condition(s). * pregnancy or breastfeeding. * contraindication to mri (e.g. ferrometallic implant or claustrophobic anxiety). * concurrent enrollment in another clinical trial. * significant risk of protocol non-adherence (e.g. resides \> 50 miles from the hospital, and has no automobile or alternate transportation).

Keywords: suicidal ideation veteran uridine neuroimaging
harvoni in patients with chronic hepatitis c virus (hcv) infection in korea

Conditions: Hepatitis C Virus

Summary: the primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of harvoni® (ledipasvir/sofosbuvir (ldv/sof)) treatment regimen, per the approved korea prescribing information for harvoni, in routine clinical practice in korea and to report the results to the ministry of food and drug safety (mfds). participants will be treated as part of routine practice at korean healthcare centers by accredited physicians.


Eligibility criteria:
key inclusion criteria: * individuals aged 12 years and older who are living in korea * adult individuals who have been informed of all pertinent aspects of the study and have voluntarily signed a personal information protection act (pipa) consent form; pediatric individuals who have the individuals' legally authorized representatives sign the pipa consent form key exclusion criteria: * individuals treated with harvoni outside of the approved prescribing information in korea * individuals who have a contra-indication to harvoni * individuals who have a contra-indication to ribavirin * pregnant or breastfeeding women * individuals who have previously been administered harvoni * individuals participating in a concurrent hcv clinical trial * individuals planning on leaving the country during the study period note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: observational
identify barriers to allogeneic hematopoietic stem cell transplantation in patients with newly diagnosed and relapsed acute leukemia

Conditions: Acute Leukemia; Newly Diagnosed; Relapsed

Summary: the investigators are doing this research study to assess the percentage of patients receiving stem cell transplantation for the type of blood cancer you have. they want to know how many patients get a transplant and why some patients do get a transplant while others do not. also they want to explore why some patients elect not to undergo stem cell transplantation, when it is recommended by their physicians.

additional arms have been added for msk patients only. patients with mds and mpn patients with post-transplant relapse of acute leukemia, mds or mpn

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed or relapsed acute leukemia. patients undergoing reinduction due to primary induction failure are also eligible. patients with acute leukemia will be enrolled to arm a * patients with diagnosis of mds, mpn and mds/mpn overlap who meet any of the following criteria (based on nccn guidelines): * clinically significant cytopenia of at least 2 cell lines affected; hgb\<10, * platelet\<100,000, absolute neutrophil count\<1000 * bone marrow blasts \>5% and any level of circulating blasts * evidence of disease progression or no response to hypomethylating agents/immunosuppressive treatment or a clinical trial. * ipss intermediate-1 and higher * ipss-r intermediate and higher * all cases of therapy related mds with excess blasts * in patients with myelofibrosis: low risk disease by dipss with either refractory, transfusion dependent anemia, circulating blasts cells greater than 2%; or adverse cytogenetics and any patient with dipss-intermidiate 1 and higher. * patients with acute leukemia or mds/mpn who relapse after first allografts. patients with post-transplant relapse will be enrolled to arm c. * patients 18 years of age or older and 80 years of age or younger * for the purposes of this protocol "relapse" is defined as re-emergence of the initial abnormal myeloid blast population (or blast equivalent) comprising 5% or more of marrow wbc or any amount prompting a therapeutic intervention targeting relapsed disease, including, but not limited to withdrawal of immunosuppression, targeted therapies, chemotherapy, etc. exclusion criteria: * patients with polycythemia vera (pv) and essential thrombocytosis (et)

Keywords: allogeneic hematopoietic stem cell transplantation identify barriers 16-024
computer aided screening for tuberculosis in low resource environments

Conditions: Tuberculosis Infection; HIV Infections

Summary: people living with hiv (plhiv) who require admission to hospital in who africa region have poor outcomes. tb is very common in this group, but can be difficult to diagnose. the castle trial aims to determine whether systematic screening for tuberculosis using digital chest x-ray with computer-aided diagnosis (dcxr-cad) plus urine lipoarabinomannan testing with fujifilm silvamp tb lam (fujilam) plus usual care can improve admission outcomes for hospitalised plhiv, compared to usual care alone. our study is a single centre, unblinded, cluster-randomised (by day of admission) trial of dcxr-cad plus fujilam plus usual care vs. usual care alone for screening for tb in unselected adult plhiv admitted to a district general hospital in malawi. the primary outcome is the proportion of people starting tb treatment by the time of death or hospital discharge. the secondary outcomes are all-cause mortality at 56 days from enrolment, proportion of people starting tb treatment within 24 hours from enrolment, and proportion of people with undiagnosed tb. in the castle study we collect a single sputum sample for m. tb culture from participants and undiagnosed tb specifically refers to a person who did not start tb treatment by the time of death or discharge from hospital and has a m. tb cultured from their sputum sample. alongside the two trial arms, a third smaller diagnostic cohort arm (1 in 9 of admission days / trial clusters) will explore the range of underlying infectious pathology. the diagnostic cohort does not contribute to trial outcomes.

castle is funded by wellcome, grant reference 203905/z/16/z

Eligibility criteria:
inclusion criteria: * requires acute admission to a hospital medical ward at zomba central hospital for any reason * is living with hiv (existing or new diagnosis, irrespective of art status) * willing and able to give informed consent exclusion criteria: * aged \<18 years * has been admitted to a medical ward for longer than 18 hours * taking tb treatment before admission or has received treatment for tb within the preceding 6 months. * has already been in the study during an earlier hospital admission.
evaluation of the pharmacokinetics and safety of vx-548 in participants with mild or moderate hepatic impairment

Conditions: Pain

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of vx-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * cohorts 1 and 3: participants with mild or moderate hepatic impairment * participants will satisfy the criteria for mild (cohort 1) and moderate hepatic impairment (cohort 3) defined as a child-pugh total score of 5 to 6 and 7 to 9 points, respectively at the screening visit * participants will have chronic (greater than or equal to (≥) 6 months) documented liver disease * cohorts 2 and 4: matched healthy participants * participants will be matched (cohort 2 matched to cohort 1; and cohort 4 matched to cohort 3) during screening to participants with hepatic impairment for age, sex, and weight key exclusion criteria: * cohorts 1 and 3: participants with mild or moderate hepatic impairment * history of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug * severe portal hypertension * history or presence of severe hepatic encephalopathy (grade \>2) * any condition possibly affecting drug absorption * significant renal dysfunction (creatinine clearance \<60 milliliter per minute \[ml/min\] ) estimated according to the method of cockcroft and gault at the screening visit or day-1 * history of solid organ or bone marrow transplantation * cohorts 2 and 4: matched healthy participants * history of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
effects of lutein on visual function

Conditions: Healthy; Nutrition Poor

Summary: randomized, double blind, placebo-controlled intervention trial on the ocular benefits and inflammatory markers improvements of taking floraglo lutein for 9 months. the population of interest is middle-aged men and women who have low levels of carotenoids in their eyes.

the participants will be given a brief explanation of the study and asked to sign an informed consent form. during the screening visit, pre-study parameters will be measured in order to assess the subjects' eligibility to participate. these include: 1. medical history 2. vital signs, height and weight and bmi calculation 3. visual parameters 4. blood draw for clinical chemistry and hematological safety intervention period: at baseline visual parameters and a serum sample for analysis of inflammatory markers will be taken. supplements will be dispensed. study visits will then be conducted every 3 months. at these visits, subjects will have visual parameters, adverse events, study diary, vitals, a questionnaire evaluating health/diet/exercise/alcohol, product distribution and compliance checked. a final serum/plasma sample will be taken at the final visit for re-assessment of safety parameters and inflammatory markers. compliance check: the number of tablets dispensed at baseline and returned, as well as all intake information from a subject diary. per protocol population is defined apriori as \>80%.

Eligibility criteria:
inclusion criteria: * men and women age 40-60 years * corrected visual acuity of 20/20 to 20/25 * mpod 0.05- 0.30 od units * must be able to give written informed consent in english * bmi \< or = 30 kg/m2 * subject is willing to maintain a habitual diet and physical activity patterns throughout the study period exclusion criteria: * use of carotenoid, fish oil, or n-3 fatty acid supplements (within 2 months of study start) * ocular pathologies * history of active small bowel disease or resection * uncontrolled hypertension * diabetes mellitus * pancreatic disease * pregnancy (or planning to become pregnant) or lactation * diseases that interfere with fat absorption * medication or supplements that contain a significant level of carotenoids * medications that interfere with fat absorption * use of drugs suspected of interfering with metabolism of blood clotting * chronic alcohol intake * stroke, head injury with loss of consciousness or seizures * severe amblyopia resulting in visual acuity worse than 0.4 mar * subject is a heavy smoker (\> 1 pack/day) * a regular consumer of lutein rich foods or lutein supplements * a regular consumer of foods high in dha intake or dha supplements * subject has donated more than 300 ml of blood during the last three months prior to screening

Keywords: vision eye health lutein carotenoids
safety, tolerability, pk & pd study of jtz-951 in anemic subjects with end-stage renal disease

Conditions: Anemia of Chronic Kidney Disease

Summary: the purpose of this study is to determine the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of sequential ascending doses of jtz-951 administered for 15 days in anemic subjects with end-stage renal disease (esrd) receiving hemodialysis.


Eligibility criteria:
inclusion criteria: * subjects who have esrd and have been receiving maintenance hemodialysis for at least 12 weeks prior to the screening visit * body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the screening visit * hemoglobin value as defined in the protocol * meet the erythropoiesis-stimulating agent (esa) therapy criteria at the screening visit as defined in the protocol exclusion criteria: * transferrin saturation and ferritin levels at the screening visit as defined in the protocol * anemia due to known causes other than chronic kidney disease * known history of hyporesponsiveness to esas * acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to screening visit

Keywords: anemia chronic kidney disease hemodialysis
tear analysis by isoelectric focusing in clinically isolated syndrome as multiple sclerosis criterion

Conditions: Clinically Isolated Syndrome; Multiple Sclerosis

Summary: this is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. these results will help in the identification of markers of this disease.


Eligibility criteria:
inclusion criteria: * 18 years old or more * clinically isolated syndrome of less than 3 months of onset * informed consent to participate exclusion criteria: * progressive primary multiple sclerosis * relapsing remitting multiple sclerosis * persons wearing contact lenses * ocular infection * corticoid treatment at least 30 days before sampling * immunosuppressive or immunomodulatory treatment at least 3 months before sampling * pregnancy or breast feeding * no coverage by the social insurance

Keywords: multiple sclerosis clinically isolated syndrome tears isoelectric focusing oligoclonal profile
retrospective data collection on the use of motiva flora te in breast reconstruction

Conditions: Breast Cancer

Summary: the motiva flora® te are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months. all motiva flora® te's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. after the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander. the study collects retrospective data on the use of the motiva flora te, from patients who had a tissue expander-based-breast reconstruction using the motiva flora® te since market introduction in may 2020.


Eligibility criteria:
inclusion criteria: * patient has completed a tissue expander-based breast reconstruction with the motiva flora® te . * patient has been informed correctly according to to the applicable national and local regulations. exclusion criteria: * not applicable
labial frenulum surgery - a comparative study of conventional scalpel and er-yag laser technique

Conditions: Labial Tie

Summary: the aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. a prospective, single-blind, randomized and controlled study was performed. wound healing was assessed five and ten days after after surgery. the long-term outcome were assessed blinded by a dentist not earlier involved in the study.

children referred to a pediatric clinic to surgically remove a labial frenulum were randomized to treatment with conventional scalpel or laser treatment technology after parents and children had given consent to participate. during the surgery the time required for the procedure and the amount of bleeding the different techniques caused were measured. wound healing was assessed five and ten days after surgery by a clinical judgement and by analysing photos. three months after surgery an independent dentist assessed the long-term outcome by a clinical examination. the patients´ view of the treatment were assessed directly after the surgery and five days, ten days and three months after the surgery.

Eligibility criteria:
inclusion criteria: * patients in need of frenulum labials surgery exclusion criteria: * patients with severe general diseases (asa\>2) * patients who required general anaesthesia for treatment

Keywords: labial frenulum surgery scalpel technique er:yag laser
probiotics for liver cirrhosis with portal hypertension

Conditions: Liver Cirrhosis; Portal Hypertension

Summary: recent studies indicate that probiotics can stimulate intestinal immunity and tighten the junctions of epithelial cells. by these ways, probiotics can reduce bacterial translocation; hence, they can ameliorate systemic inflammatory status. because cirrhotic patients with portal hypertension often suffer from infections from intestinal flora, the investigators speculate that probiotics will be beneficial to those patients.

the investigators will recruit appropriate patients, 120 in number, randomly allocate into control and experimental arms. they will be given gk#10 or placebo for 8 weeks. clinical parameters, such as liver function, renal function, and general conditions will be evaluated at specific time points, week 0, 5, 9, and 13 weeks. primary outcome measurement will be survival and major complications analysis, and secondary outcome measurement will be liver function evaluation. the investigators anticipate providing our sponsor with useful results about gk#10. the investigators will make clear the impacts from individual strains, the investigators will validate our speculation that probiotics do no harm to cirrhotic patients with portal hypertension, even be beneficial to them. if the investigators can validate the anticipation, patients can enjoy benefits from our study, and the probiotics may have the potential to sell to the patients in the world.

Eligibility criteria:
inclusion criteria: 1. patients with history of complications related to liver cirrhosis, including hepatic encephalopathy, variceal bleeding, and spontaneous bacterial peritonitis 2. patients with evidences of portal hypertension, such as hepatosplenomegaly, thrombocytopenia (\< 100,000/ml) exclusion criteria: 1. active infection 2. dialysis patients, myocardial infarction, life-threatening cardiac arrythmia and stroke 3. hepatocellular carcinoma with life expectancy \< 6 months 4. portal vein thrombosis 5. in hepatic encephalopathy or liver function alt \> 3 x unl, t-bilirubin \> 4.0 mg/dl 6. gi tract bleeding in recent 1 weeks 7. drug abuser 8. no informed consent