Kornimate/medical-research-clean huggingface dataset:
implementation of a depression screening intervention at a transgender health clinic in thailand

Conditions: Depressive Symptoms

Summary: the study aims to develop and implement a depression screening intervention into routine hiv and sexual health service provision at a transgender health clinic in thailand, and to explore the facilitators, barriers, feasibility and acceptability of the screening implementation.

the study will follow a mixed-methods approach that will incorporate quantitative and qualitative components. aim 1 will involve the development and implementation of depression screening intervention at tangerine clinic. aim 2 will involve semi-structured interviews with a purposive subset of participants who received the intervention and healthcare providers to explore the multilevel facilitators, barriers, feasibility and acceptability of the screening implementation. aim 3 will evaluate the proportion of participants who are offered, accept, and receive the peer-led depression screening intervention, and the proportion who screen positive.

Eligibility criteria:
inclusion criteria: 1. thai nationality 2. transgender women ≥18 years 3. attending the tangerine clinic for routine care visits during the intervention period. 4. can be a new or returning clients. exclusion criteria: 1. transgender women currently receiving care for a mental health diagnosis will be excluded from participating in this study. inclusion criteria for healthcare providers: 1. currently working at the tangerine clinic 2. can be medical doctors, nurses, peer counselors and other members of the clinic management team involved in the routine delivery of hiv and health services to transgender women. exclusion criteria for healthcare providers 1. not willing to participate in this study

Keywords: depression transgender women
individualized response to vitamin d treatment study

Conditions: Characteristics That Modify the Response to Cholecalciferol Treatment

Summary: the goal of this clinical trial is to determine individual-level genetic and metabolic characteristics that modify the response to cholecalciferol treatment. this study is double blind, parallel design, randomized clinical trial that will assess genetic and metabolic characteristics that modify the response to cholecalciferol treatment. . eligible participants will be randomly assigned to receive cholecalciferol treatment (2,000 international units of cholecalciferol daily by mouth) or placebo in a 3:1 ratio for a total duration of 16-weeks. the planned sample size is 1,600. the primary aim of this study is to identify genetic polymorphisms, clinical characteristics, and biomarkers that modify the biologic response to vitamin d3 treatment, assessed by changes in serum concentrations of parathyroid hormone (pth) and 1,25(oh)2d and urine calcium excretion.


Eligibility criteria:
inclusion criteria: 1,600 participants from the multi-ethnic study of atherosclerosis (mesa) study who are returning for their scheduled 6th mesa study visit. participants will be recruited from four field centers: wake forest university, winston-salem, nc; columbia university, new york, ny; northwestern university, evanston, il; and johns hopkins university, baltimore, md. exclusion criteria: 1. current use of \>1,000 international units (iu) of cholecalciferol daily 2. current use of any activated vitamin d product (calcitriol, paricalcitol, hectorol) 3. known history of allergy or adverse reaction to vitamin d treatment 4. known clinical history of primary hyperparathyroidism 5. known clinical history of kidney stones within the previous 5 years 6. current participation in another interventional study 7. inability to provide written informed consent

Keywords: vitamin d cardiovascular disease mesa genetics pharmacogenetics blood pressure biomarkers
postoperative recurrence and dynamics of t cell subsets in crohn's disease

Conditions: Crohn Disease

Summary: it is assumed that gut inflammation and lesions characterizing flares of crohn's disease (cd) result from an aberrant t-cell mediated immune responses characterized by a complex balance between peripheral and lamina propria regulatory and effector t cell subsets. because most of cd patients who undergo a surgery experienced a postoperative endoscopic recurrence of the disease (70 % at one year) leading to a clinical recurrence (10 % per year), the "model" of postoperative recurrence in cd represents a privileged situation that mimicks what happens in the gut of cd patients in clinical remission before the occurrence of further flares. it is likely that the same factors which underlie the immunopathogenesis of cd at its early stages also contribute to disease recurrence in the postoperative setting. indeed, the postoperative state is performed for intent of disease remission and this situation represents probably an ideal setting to investigate the dynamics of most of t cell subsets in the peripheral and mucosal compartments because one may argue that removal of the diseased segment of bowel resets the disease to its earliest phases, providing an interesting window to better understand which t cell subsets predispose to disease recurrence. that is the reason why this model will be used in the present project i) to understand better the immunopathogenesis of cd relapse; ii) to identify novel and promising immune cell-associated biomarkers capable to predict relapse of the disease and finally iii) to identify potential specific therapeutic target associated with t cell subsets involved in the initiation of disease.


Eligibility criteria:
inclusion criteria: * aged over 18 years * men or non-pregnant women * patients with a diagnosis of crohn's disease who undergo an ileo-colonic curative resection * no change of the postoperative treatment before assessing an endoscopic recurrence during the one-year post surgery follow-up period * informed consent given exclusion criteria: * pregnancy * history of disease, including mental/emotional disorder, that might interfere with their participation in the study * inability to comply with the protocol requirements * inability to fill in the diary cards
role of multi-modality imaging in the assessment of chemotherapy related cardiac dysfunction among cancer patients

Conditions: 2D Speckle Tracking Echocardiography; Breast Cancer; Cardiac Magnetic Resonance

Summary: the field of oncology has advanced remarkably. some of the old and new emerging cancer therapies are associated with development of cardiovascular toxicities , which may have the potential to offset the gains in survival obtained with this cancer treatment advances. much of the focus on cardiovascular toxicities has been in the early detection of myocardial damage and prediction of cancer therapeutics-related cardiac dysfunction (ctrcd). the main strategy for these patients is timely diagnosis and treatment of high-risk individual cardiac dysfunction associated with cancer treatment is the main cause of mortality in cancer survivors. the mortality rate is recorded to be up to 60% in the first two years after therapy. the most commonly associated drugs with cardiotoxicity are anthracycline (ac) and monoclonal antibodies (such as trastuzumab). other new agents, such as vascular endothelial growth factor (vegf) inhibitors, immunotherapies, and proteasome inhibitors, can also cause cardiac dysfunction .


Eligibility criteria:
inclusion criteria: * cancer patients ≥ 18 years of age, and scheduled to receive chemotherapy will be included. exclusion criteria: * contraindications to cmr (e.g.: patients with pacemakers, defibrillators or other implanted electronic devices). * life expectancy ≤ 12 months. * participating in another oncology clinical trial; * prior exposure to chemotherapy; * history of active or prior cardiac disease (e.g., myocardial infarction, heart failure or base line left ventricular ejection fraction less than 55%).
clinical implementation of a novel decision support tool in patients with ischemic heart disease

Conditions: Ischemic Heart Disease

Summary: the pm-heart algorithm (pmheartihd) is an in-house developed software that predict the survival prognosis for the individual patient hospitalized with ischemic heart disease (ihd) after a coronary arteriography has been performed. the software is intended to be used as a clinical decision support system i.e. the calculated survival prognosis is expected to enhance the quality of the treating physician's therapeutic considerations concerning (minor) adjustments to the patients treatment and follow-up - all within the framework of the current medical guidelines. thus, the algorithm does not "show the physician specifically what to do", but rather ensures a better knowledgebase for the overall interpretation and choice of management of the patient.

to investigate the clinical usefulness of the developed clinical decision support system - the pmheartihd algorithm - we wish to investigate whether the clinical use of the algorithm will; * improve patient prognosis and, * minimize the risk of re-hospitalization, compared to patients who are treated without the attending/treating physician knowing the algorithm's prognosis?

Eligibility criteria:
inclusion criteria: * hospitalized patients in one of the involved departments of cardiology (see below) with; * ischemic heart disease; the clinical presentation may be stable, worsening/unstable angina, non-st-elevation myocardial infarction or st-elevation myocardial infarction, and with - significant coronary artery lesions or diffuse coronary artery disease on invasive coronary angiography during the admission exclusion criteria: * \<18 years of age * living outside denmark
a study of lebrikizumab (ly3650150) in combination with topical corticosteroids in japanese participants with moderate-to-severe atopic dermatitis

Conditions: Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic

Summary: the main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in japanese participants with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * have chronic atopic dermatitis (ad) that has been present for ≥1 year before the screening. * have moderate-to-severe ad, including all of the following: * easi score ≥16 at the baseline * iga score ≥3 (scale of 0 to 4) at the baseline * ad involvement on ≥10% of body surface area (bsa) at the baseline * have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following: * inability to achieve good disease control, defined as mild disease or better (for example, iga ≤2) after use of at least a medium-potency topical corticosteroids (tcs) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (for example, 14 days for super-potent tcs), whichever is shorter. topical corticosteroids may be used with or without topical calcineurin inhibitors (tci) and/or topical janus kinase (jak) inhibitors. * participants who failed systemic therapies intended to treat ad within 6 months preceding screening, such as cyclosporine, methotrexate (mtx), azathioprine, and mycophenolate mofetil (mmf), will also be considered as surrogates for having inadequate response to topical therapy. * body weight ≥40 kilogram (kg) exclusion criteria: * have a history of anaphylaxis * have uncontrolled chronic disease that might require bursts of oral corticosteroids for example, comorbid severe uncontrolled asthma within the past 12 months requiring systemic corticosteroid treatment or hospitalization for \>24 hours at baseline. * have an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline or superficial skin infections within 1 week before the baseline. * evidence of acute or chronic hepatitis or known liver cirrhosis. * have a history of pneumocystis pneumonia (pcp) or a positive beta-d-glucan test at screening and a confirmed diagnosis of pcp. * have a history of human immunodeficiency virus (hiv) infection or positive hiv serology at screening. * have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus erythematosus) that may interfere with study assessments. * have presence of significant uncontrolled neuropsychiatric disorder. * have been exposed to a live vaccine within 12 weeks prior to baseline or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug.

Keywords: corticosteroids
treatment of young permanent teeth with different adjuvant approaches

Conditions: Treatment; Periodontitis, Apical; Necrotic Pulp

Summary: to determine microbiology assessment of infected root canal in young permanent teeth, as well as antimicrobial efficiency of different adjuvant treatment modalities including photodynamic therapy (pdt), high-power diode laser, and essential oils following mechanic-chemical treatment in the treatment of periapical periodontitis in these teeth.

to determine antimicrobial efficiency of adjuvant photodynamic therapy (pdt) and high-power diode laser, and essential oils in the treatment of chronic periapical periodontitis in young permanent teeth. material and methods: young permanent teeth with chronic periapical periodontitis were selected and randomly divided into tests and control groups. adjuvant treatment approaches were randomly performed following standard mechanical-chemical endodontic treatment: 1. experimental laser-device 1, pdt group: adjuvant pdt (n=10) 2. experimental laser-device 2, diode laser (940 nm, 1w) (n=10) 3. experimental essential oil (n=10) 4. experimental sodium hypochlorite (naocl) group (n= 10) solely mechanical instrumentation with 1.5 % of naocl irrigation was performed (positive control). afterwards, each root canal was filled with calcium hydroxide, and definitive obturation was done seven days respectively. microbiological analyses of root canals were assessed after accessing the canal (sample 1), following mechanical-chemical treatment (sample 2), and adjuvant treatment approaches (sample 3). the microbiological identification and quantification were provided by maldi -tof spectrometry and plate count assay. to evaluate the efficiency of treatment modalities, radiography records were additionally used.

Eligibility criteria:
inclusion criteria: * had signed informed consent by the parents or legal guardian ; * systemically healthy children; * had not been submitted to antibiotic therapy in the previous 3 months; * had a least one young permanent anterior tooth (incisor or canine) or the first premolar with pulp necrosis and presence of a chronic periapical lesion (cpp); * had no endodontic treatment of the selected tooth; * had no signs of an acute condition; exclusion criteria: * presence of systemic diseases such as diabetes mellitus, asthma, chronic infections, immunosuppressive diseases or other that could compromise the patient immune system * use anti-inflammatory or immunosuppressive therapy in the last 6 months; * patients with antibiotic prophylactic requirements before dental treatment;

Keywords: young permanent teeth periodontitis apical treatment
treatment of patients with major depressive disorder with mk0869 (0869-061)

Conditions: Major Depressive Disorder

Summary: a clinical study to determine the efficacy and safety of an treatment of mk0869 in the treatment of depression.

the duration of treatment is 8 weeks.

Eligibility criteria:
patients with major depressive disorder
phase iii study of asp2151 in herpes simplex patients

Conditions: Herpes Simplex

Summary: to evaluate the efficacy and safety of asp2151 in patients with herpes simplex.

a double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of asp2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). the efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by day 8 of study treatment" to demonstrate the superiority of asp2151 to placebo. the safety will be evaluated based on adverse events, laboratory tests, vital signs, and ecgs.

Eligibility criteria:
inclusion criteria: 1. patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated * labial/facial herpes: patients with at least 10 papulae or vesicles/pustules * recurrent genital herpes: patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region 2. patients who can start receiving the study drug within 48 hours after onset of rash 3. age: 20 years or older, but younger than 80 years exclusion criteria: 1. patients who are not expected to have an adequate response to oral antiviral medication 2. an extreme decline in immune function 3. presence of serious complications 4. patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent: * ast or alt ≥ 2.5 x upper limit of normal * platelet count \< lower limit of normal * serum creatinine ≥ 1.5 mg/dl * creatinine clearance \< 30 ml/min 5. current or previous history of malignant tumor within 5 years before informed consent 6. diagnosis of autoimmune disease 7. evidence of bone marrow suppression
developing non-communicable disease registries in africa : a step towards providing quality data for improving patient outcomes

Conditions: Non-Communicable Disease

Summary: this umbrella protocol seeks to develop robust data registries for non-communicable diseases (ncds) in sub-saharan africa (ssa) with the aim of providing accurate and comprehensive data for the evaluation of such diseases in sub-saharan african countries.healthy volunteers will be included in the study for comparison. additionally, the investigators aim to describe the gut microbiome community diversity of a cohort of community dwelling nigerians and compare with crc patients in nigerian and at msk. we will collect stool for microbiome and metabolomic analysis from community dwelling persons in the catchment area of argo facilities in nigeria while contemporaneously administering an extensive medical and environmental exposure questionnaire.


Eligibility criteria:
inclusion criteria: * age 18 and older. * suspected or confirmed diagnosis of a non-communicable disease. or * healthy volunteers/no confirmed diagnosis for comparison. exclusion criteria: * participants unwilling to sign consent. * participants under the age of 18

Keywords: patient outcomes 18-114
a phase ii study to assess changes in physical function in elderly patients with chronic anemia

Conditions: Anemia; Aged; Hemoglobins

Summary: the purpose of this study is to assess changes in physical function in elderly patients (\>= 65 years of age) with chronic anemia (hb \<= 11.0 g/dl) due to anemia of unknown cause and receiving weekly subcutaneous doses of epoetin alfa (procritâ®) versus placebo.

.some elderly patients have anemia (reduction in hemoglobin level, or low red cell count) without obvious cause. anemia occurs commonly with aging and is a frequent medical condition in individuals over the age of 65. physical performance and function is worse in individuals who are anemic. this is a randomized, double-blind, placebo-controlled, multi-center study to assess physical function (to include falls) and fatigue in approximately 80 elderly patients with chronic anemia (anemia present for at least 3 months) and who are receiving weekly epoetin alfa. the study will also evaluate hemoglobin levels (oxygen carrying protein in red blood cells), safety, fatigue and cognitive function. the study hypothesis is to demonstrate the study drug will be more effective in treatment of chronic anemia than placebo, resulting in the improvement of physical function and subsequent disabilities, with minimal adverse events and the study drug is generally well-tolerated. the patients will receive weekly injections of epoetin alfa (procrit®) or placebo at a starting dose of 10,000 units administered subcutaneously (under the skin).

Eligibility criteria:
inclusion criteria: * patients with a history of chronic anemia defined as a documented hb value of \<= 11.0 g/dl * no active cancer * at least 65 years of age with life expectancy of \> 6 months * community dwelling patients * patients with a short physical performance (sppb) summary score of 4-10 at screening and baseline * patients with a mini mental state examination (mmse) score \>= 24 exclusion criteria: * positive stool guaiac test * diagnosis of multiple myeloma and/or mgus * history of venous thromboembolytic disease * previous treatment with epoetin alfa, darbepoetin or any form of erythropoietin recently * uncontrolled or severe cardiovascular disease

Keywords: anemia subcutaneous injection procrit erythropoietin epoetin alfa hemoglobin level elderly
satavaptan for the prevention of ascites recurrence in patients with ascites due to cirrhosis of the liver

Conditions: Ascites; Liver Cirrhosis

Summary: primary: to evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites. secondary: to evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites. the one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (pasccal-2).


Eligibility criteria:
inclusion criteria: * patients with cirrhosis of the liver. * patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator. * patients with recurrent ascites having undergone both of the following: * therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of = or \> 4 litres of fluid. * at least one other therapeutic paracentesis in the previous 3 months. exclusion criteria: * patients with an existing functional transjugular intrahepatic portosystemic shunt (tips) or other shunt. * known hepatocellular carcinoma. * patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma * patients previously exposed to satavaptan in the past 12 months.
proximal tibial osteotomy osteoclasis in infantile genu-varum

Conditions: Deformity Knee; Deformity of Limb

Summary: genu-varum is a common problem encountered in pediatric orthopedic. correction of pathological deformity is mandatory to ensure normal load transfer through the knee. in this study, the investigators describe a new technique of osteotomy osteoclasis in order to evaluate if it is an effective and reliable method in management of infantile genu varum

seventy children with 122 legs suffering significant infantile genu-varum were treated by percutaneous osteotomy-osteoclasis technique. the mean age was 46 months. genu varum was bilateral in 52 children and unilateral in 18 with a mean preoperative proximal medial tibial angle 66.67 ± 2.670. under general anesthesia, transverse osteotomy osteoclasis was performed below the tibial tuberosity. follow-up radiograph was done within the first post-operative week and then every two weeks to assess alignment and consolidation.

Eligibility criteria:
inclusion criteria: * infantile genu-varum * pmta≤70 not spontaneously corrected exclusion criteria: * active rickets or other metabolic disease * patients in whom the femur or the joint is the main site of the deformity

Keywords: genu varum, mini-invasive, osteotomy, osteoclasis