Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety, pharmacokinetics, and antiviral activity of abi-4334 in subjects with chronic hepatitis b virus infection

Conditions: Chronic Hepatitis B

Summary: this is a randomized, blinded, placebo-controlled, dose-ranging phase 1b study of the safety, pk, and antiviral activity of abi-4334 in treatment-naïve or off-treatment chronic hepatitis b virus (chbv) subjects that are hepatitis b e antigen (hbeag) positive or negative. the study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive abi-4334 or placebo.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≥ 18.0 and \< 35.0 kg/m(2), where bmi = weight (kg)/(height \[m\])(2) with a minimum body weight of 45 kg 2. chronic hepatitis b infection, defined as hbv infection for ≥ 6 months documented 3. treatment-naïve or off-antiviral therapy for ≥ 24 weeks prior to screening 4. lack of bridging fibrosis or cirrhosis exclusion criteria: 1. co-infection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), hepatitis d virus (hdv), acute hepatitis a virus (hav), or acute hepatitis e virus (hev) 2. history of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation 3. clinically significant diseases or conditions 4. history of hepatocellular carcinoma

Keywords: chbv hbv hepatitis b
clinical study to evaluate the exercise capacity in patients with severe emphysema treated with coils

Conditions: Pulmonary Emphysema

Summary: the study hypothesis is that patients with homogeneous emphysema behave differently compared to heterogeneous emphysema with respect to exercise capacity. a better understanding of this difference will allow the investigators to choose the best treatment for each type of patient. the main purpose of this study is to evaluate the change in exercise capacity measured by cycle ergometry in patients with severe emphysema after endoscopic lung volume reduction with coils (elvr). as a secondary purpose, the investigators want to perform an exploratory, randomized study to compare the results of two different therapeutic approaches in a small sample of patients with homogeneous emphysema.

the study plans to include patients with severe emphysema candidates to go through elvr with coils that fulfill all inclusion criteria and none of the exclusion criteria. patients with both homogeneous and heterogeneous emphysema will be included. the main study intervention is the performance of a cyclo ergometry (not included in daily clinical practice) before (basal) and 6 months after going through the elvr with coils. the subgroup of patients with homogeneous emphysema will be randomly assigned to the following therapeutic approaches: * group a: treatment with 10 coils in upper lobes * group b: treatment with 15 coils spared in upper and lower lobes thus, the study includes: * for all patients, the performance of two cycloergometries, before and 6 months after the elvr * also, for the subset of homogeneous emphysema patients, an open label, randomized, parallel, two arm exploratory clinical trial. sample size has not been formally calculated as there are no previous available data for the primary endpoint (change inspiratory capacity). thus, 35 patients will be included according to the expected number of patients. recruitment period will be 24 months and patient follow up will be 6 months.

Eligibility criteria:
inclusion criteria: * emphysematous patient * fev1 \< 50% * rv \> 200% * diffusion \ 20% * psp \<55 mmhg exclusion criteria: * anticoagulants/antiplatelets * giant bullae (\> 8 cm , 1/3 hemithorax) * more tan three moderate/severe exacerbation per year * negative to sign informed consent

Keywords: pulmonary emphysema coils cycloergometry lung volume reduction
antineoplaston therapy in treating patients with stage iv pancreatic cancer

Conditions: Stage IV Pancreatic Cancer

Summary: current therapies for stage iv pancreatic cancer provide very limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of stage iv pancreatic cancer. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with stage iv pancreatic cancer.

stage iv pancreatic cancer patients receive gradually escalating doses of intravenous antineoplaston therapy (atengenal + astugenal) until the maximum tolerated dose is reached. treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. objectives: * to determine the efficacy of antineoplaston therapy in patients with stage iv pancreatic cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * to determine the safety and tolerance of antineoplaston therapy in patients with stage iv pancreatic cancer. * to determine objective response, tumor size is measured utilizing mri scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed stage iv adenocarcinoma of the pancreas that is unlikely to respond to existing therapy * measurable disease by mri or ct scan * tumor must be at least 2 cm patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * at least 2 months hematopoietic: * wbc at least 2,000/mm\^3 * platelet count at least 50,000/mm\^3 hepatic: * no hepatic insufficiency * bilirubin no greater than 2.5 mg/dl * sgot and sgpt no greater than 5 times upper limit of normal renal: * no renal insufficiency * creatinine no greater than 2.5 mg/dl * no history of renal conditions that contraindicate high dosages of sodium cardiovascular: * no uncontrolled hypertension * no history of congestive heart failure * no history of other cardiovascular conditions that contraindicate high dosages of sodium pulmonary: * no serious lung disease, such as chronic obstructive pulmonary disease other: * not pregnant or nursing * fertile patients must use effective contraception during and for 4 weeks after study participation * no active infection * no nonmalignant systemic disease * not a high medical or psychiatric risk prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy * no concurrent immunomodulating agents chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) endocrine therapy: * concurrent corticosteroids allowed radiotherapy: * at least 8 weeks since prior radiotherapy surgery: * recovered from prior surgery other: * prior cytodifferentiating agents allowed * no prior antineoplastons * no other concurrent antineoplastic agents

Keywords: adenocarcinoma of the pancreas
a phase 2, multicenter, open-label study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of pefcalcitol ointment, 0.005%, applied topically twice daily (bid) for 8 weeks in adolescent subjects 12 to < 17 years of age with plaque psoriasis

Conditions: Psoriasis

Summary: a multi-center, open-label study that will evaluate the safety/tolerability and pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50 evaluable adolescents 12 to \< 17 years of age.


Eligibility criteria:
inclusion criteria: * male or females 12 to \< 17 years of age * have a confirmed diagnosis of plaque psoriasis * negative pregnancy test * group 1: have plaque psoriasis with an iga score of ≥ 2 (mild), with at least one lesion ) and up to 20% body surface area (bsa) involvement not including psoriasis on the face and scalp * group 2: have plaque psoriasis with a iga score of ≥ 2 (mild), with plaque psoriasis involving at least 10% and up to 20% body surface area (bsa) not including psoriasis on the face and scalp exclusion criteria: * known allergy or intolerance to the study drug or other vitamin d3 analogs or any of its components * history of or active generalized guttate, pustular or erythrodermic exfoliative psoriasis * history or presence of contact dermatitis induced by a topical medicine or other serious skin condition that is not well controlled * use topical treatments known to have beneficial effects on psoriasis * use phototherapy, oral corticosteroids, oral retinoid, oral immunosuppressive/immunomodulate drugs, cytostatics, cyclosporine or methotrexate within 30 days prior to the first dose of study drug * use any approved biologics for psoriasis within 30 days or 5 half-lives of the biologic before the first dose of study drug * are treated with medications known to worsen psoriasis * are taking an oral vitamin d * are taking medications that affect calcium metabolism; * subjects who have an average of three (3) qtcf measurements of \> 450 milliseconds as shown on the ecg (group 2 only); * have clinically significant abnormal calcium homeostasis parameters at visit 1; * have clinically significant liver or renal dysfunction * have any other clinically significant laboratory abnormalities, co-morbidities or psychiatric conditions which that would place the subject at increased risk or would confound the primary or secondary objectives of the study; * use of any investigational drugs or biologics and/or participated in any clinical trial within the last 60 days before the day of the first dose of study drug or are taking part in a non-medication study which, that would interfere with study compliance or outcome assessments; * are pregnant or lactating females; * have a known history of congenital or acquired immunodeficiency.
non-invasive evaluation of liver fibrosis, steatosis, and nash in nafld

Conditions: Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis

Summary: 1. to evaluate hepatic fibrosis and steatosis using mr imaging, transient elastography (te), and serum biomarker 2. to develop non-invasive diagnosis marker for nash and advanced fibrosis

as nonalcoholic fatty liver disease (nafld) is becoming a leading cause of chronic liver disease, non-invasive diagnosis of disease severity in nafld is urgently needed. in this study, the investigators compared hepatic fibrosis and steatosis using mr imaging and transient elastography (te) and tried to find non-invasive diagnostic marker for nash and advanced fibrosis. this is a multicenter prospective study of patients with biopsy-proven nafld. the patients were underwent laboratory test, liver biopsy, mri and te within 6 months of enrollment. mri examination included mr spectroscopy (mrs), and mr elastography (mre). te measured liver stiffness and controlled attenuation parameter (cap).

Eligibility criteria:
inclusion criteria: * patients \>19 years age * patients who had elevated aspartate transaminase(ast)/alanine transaminase(alt) or fatty liver on abdominal ultrasonography * patients who are clinically suspected to have nonalcoholic steatohepatitis(nash): \>40 years age, bmi \>25, multiple features of the metabolic syndrome, presence of diabetes mellitus (dm) , fibroscan \> 6 kilopascal (kpa), platelet count \< 150,000 /ml, and other patients suspected to progress clinically or requiring diagnosis * patients who underwent (\<6 months) or will undergo us-guided liver biopsy exclusion criteria: * chronic liver disease other than nonalcoholic fatty liver disease(nafld) (chronic hepatitis b or c, autoimmune hepatitis, primary biliary cholangitis) * excessive alcohol consumption (weekly men \>140g and women \>70g) * fatty liver due to medication * decompensated liver cirrhosis * contraindication to magnetic resonance imager(mri) * malignancy or other systemic disease * pregnancy

Keywords: magnetic resonance imager(mri) nonalcoholic fatty liver disease(nafld) biomarker
cannabidiol treatment of cognitive dysfunction in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study is a six-week, randomized, placebo-controlled, fixed dose trial comparing cannabidiol vs. placebo added to a stable dose of antipsychotic medications in patients diagnosed with schizophrenia.


Eligibility criteria:
inclusion criteria: * schizophrenia or schizoaffective disorder (dsm-iv scid-confirmed), exclusion criteria: * women who are pregnant, nursing or unwilling to use appropriate birth control measures during study participation.
l-citrulline and metformin in becker's muscular dystrophy

Conditions: Becker's Muscular Dystrophy (BMD)

Summary: the purpose of the study is to compare the effects of l-citrulline and metformin and their combination therapy on muscle function and force in patients with becker muscular dystrophy (bmd).

this is a single center, not-randomized open study. the study medication consists of l-citrulline and metformin administered orally; 5g citrulline and 500mg metformin tablets will be given 3 times daily. half of the patients will be treated with metformin during the first 6 weeks of the study. the other patients will receive initially l-citrulline for 6 weeks, before all patients will be treated with the combination therapy (metformin and l-citrulline) for another 6 week period. the study lasts 12 weeks and includes the screening visit and 3 further visits at baseline, week 6 and week 12.

Eligibility criteria:
inclusion criteria: * 18 years or older * molecular or immunohistochemical diagnosis of bmd * ambulant at the time point of screening exclusion criteria: * participation in another therapeutic bmd study within the last 3 months * use of l-arginine, l-citrulline or metformin within the last 3 months * other chronic disease or relevant limitation of renal, liver, heart function according to discretion of investigator * known hypersensitivity to l-citrulline or metformin

Keywords: becker's muscular dystrophy bmd metformin l-citrulline
effects of narrative enhancement and cognitive therapy (nect) on self-stigma in patients with schizophrenia

Conditions: Schizophrenia

Summary: this study aims to explore the effect of narrative enhancement and cognitive therapy in improving self-stigma, self-esteem, depression and hope of patients with chronic schizophrenia.

86 participants with chronic schizophrenia in two different hospitals in northern taiwan were recruited in this study. all participants were randomized into experimental and control groups through block randomization. after randomization, the participants in control group received routine care and the others in experimental group received narrative enhancement and cognitive therapy(nect) which contains 20 times group meetings. the research tools include demographic data, the internalized stigma of mental illness scale (ismis), the discrimination and stigma scale (disc), rosenberg self-esteem scale (rses), beck depression inventory (bdi-ii) and herth hope index (hhi). the questionnaires were collected for three times, including before the intervention, 12 weeks after intervention, and after the end of intervention. the collected data were analyzed by ibm spss 24.0 statistical software. the descriptive statistics include mean, standard deviation, minimum, maximum, frequency distribution, and percentages; the generalized estimating equations (gee) were used to explore the effect of narrative enhancement and cognitive therapy on self-stigma, self-esteem, depressive symptoms and hope in patients with schizophrenia after controlling demographic data.

Eligibility criteria:
inclusion criteria: * people with schizophrenia for more than two years. * the age is between 20(included) and 64(included). * can communicate with mandarin or taiwanese. * the score of the mini-mental state examination (mmse) is above 24(included). * the score of the positive and negative syndrome scale(panss) is below 60(included). * people are willing to participate in this study, can read and know the consent and can sign on the consent by their own. exclusion criteria: * exclude people with a personality disorder, brain injury, cognitive impairment, intellectual developmental disorder or substance use disorder. * people who are not willing to sign the consent. * people can not read. * people can not communicate with mandarin or taiwanese.
the implementation of computer-aided detection in training improves the quality of future colonoscopies

Conditions: Quality Indicators, Health Care; Colonoscopy Diagnostic Techniques and Procedures; Artificial Intelligence (AI)

Summary: computer-aided detection (cade) based on artificial intelligence (ai) may improve colonoscopy quality. an increasing number of young endoscopists are trained in an ai environment. however its impact on trainees' future outcomes remains unclear. the study aimed to evaluate the quality indicators of endoscopists trained in an ai environment compared to those trained conventionally.

computer-aided detection (cade) based on artificial intelligence (ai) may improve colonoscopy quality. an increasing number of young endoscopists are trained in an ai environment. however its impact on trainees' future outcomes remains unclear. the study aimed to evaluate the quality indicators of endoscopists trained in an ai environment compared to those trained conventionally. a study included 6,000 adult patients who underwent a colonoscopy for various reasons. the study retrospectively evaluated the first 1,000 procedures performed by six endoscopists after completing training relying entirely on endoscopists' detection skills without ai enhancement. three of those young endoscopists were trained with cade, and three without additional assistance. quality indicators were assessed in both groups. the morphology of detected polyps was evaluated to determine the influence of ai-enhanced training on laterally spreading tumors (lst) detection rate.

Eligibility criteria:
inclusion criteria: * adult participants who underwent a colonoscopy for various reasons performed by specific endoscopists that were assessed in terms of quality indicators exclusion criteria: * a history of bowel resection * confirmed inflammatory bowel disease * suspicion of polyps or cancer in other imaging tests * suspicion of familial adenomatous polyposis

Keywords: quality indicators colonoscopy artificial intelligence (ai) computer-aided detection (cade) adenoma detection rate (adr)
evaluation of biomarkers levels in gingival crevicular fluid, saliva and serum for different periodontal diseases

Conditions: Mouth Diseases; Periodontal Inflammation; Periodontal Diseases

Summary: the aim of this study is; detection of interleukin(il)-38, il-36 gamma(γ) , il-17 and matrix metalloproteinase(mmp)-9 levels in gingival crevicular fluid (gcf), saliva and serum samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. materials and methods: samples were obtained from 90 systemically healthy non-smoker individuals with periodontitis (p, n=30), gingivitis(g, n=30) and healthy periodontium (s, n=30). full-mouth clinical periodontal measurements including probing depth (pd), clinical attachment level (cal), bleeding on probing (bop), gingival index (gi) and plaque index (pi) were also recorded. enzyme-linked immunosorbent assay (elisa) was used to determine il-38, il-36γ, il-17 and mmp-9 levels in the biological samples.


Eligibility criteria:
inclusion criteria: * systemically healthy (the determination of healthy volunteers will be based on the statements of the patients in the anamnesis. no additional examinations will be made.) * at least twenty permanent teeth in the mouth * non-smoker * no medication for continuous use * those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months. * not in pregnancy or lactation period. * for the periodontitis group that has not received periodontal treatment in the last 6 months exclusion criteria: * any oral or systemic disease * regularly using a systemic medication * during pregnancy or lactation * received periodontal treatment within the last 6 months. * those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months * smokers
68ga-ha-dotatate pet/ct in adults with neuroendocrine tumors

Conditions: Neuroendocrine Tumors (NET)

Summary: to determine if 68ga-ha-dotatate pet/ct imaging is effective at diagnosing somatostatin positive tumors compared to conventional imaging \[including ct, mri, 111 in-pentetreotide scans, 18f-fdg pet/ct, as available\]

the purpose of the current study will be to evaluate the usefulness of 68ga-ha-dotatate compared to current standard anatomical imaging including ct, mri, 111 in-pentetreotide scans, 18f-fdg pet/ct, as available. specifically, we aim to assess the utility of 68ga-ha-dotatate in primary workup of neuroendocrine tumours, including suspected neuroendocrine tumours that do not have a cross-sectional imaging correlate. an additional aim is to assess the role of 68ga-ha-dotatate in surveillance of completely resected neuroendocrine tumours, which is a point of disagreement amongst current society guidelines . finally, we will assess utility of 68ga-ha-dotatate for localization of functioning neuroendocrine tumors including insulinoma and gastrinoma.

Eligibility criteria:
inclusion criteria: 1. male or female. if female of child-bearing potential and outside of the window of 10 days since the last menstrual period, a negative pregnancy test will be required. 2. age greater than or equal to 18 years. 3. able and willing to follow instructions and comply with the protocol. 4. provide written informed consent prior to participation in the study. 5. clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of neuroendocrine tumor) or biopsy proven neuroendocrine tumor exclusion criteria: 1. nursing or pregnant females. 2. age less than 18 years. 3. surgery in the area of interest within the preceding 2 months.
optimizing research with diverse families - feasibility and acceptability study (fast)

Conditions: Attention Deficit/Hyperactivity Disorder; Emotional Dysfunction; Irritable Mood

Summary: evaluate feasibility and acceptability of recruiting black and hispanic families for an open label clinical trial of multinutrients while collecting real-time parent-reported child behavior data and collecting at-home biospecimens to explore their potential as biomarkers, in a study of pediatric adhd.

this study will test the feasibility of recruiting and completing a multinutrient trial with racially and ethnically diverse participants (n=30), focused on black and hispanic families, and the acceptability of the intervention, and refined collection methods. the 8-week, open-label, study will evaluate the feasibility and acceptability of collecting (a) real-time ecological momentary assessment (ema) data on child's target behavior problem, as identified by parent and (b) two types of bio-specimens (blood and urine) collected at home while taking the multinutrients daily.

Eligibility criteria:
inclusion criteria: * children, ages 6-17 years at enrollment, with suspected or definite adhd based on parent report in a majority of families that identify as black or hispanic or multicultural * meet criteria on child and adolescent symptom inventory-5 (casi-5) adhd scale (6+ symptoms ≥ 2), occurring in \>1 setting, plus one impairing irritability symptom (≥2) from oppositional defiant disorder (odd) or disruptive mood dysregulation disorder (dmdd) subscale * able and willing to swallow up to 8 pills per day * medication free for 2 weeks prior to baseline * willing to use tasso® ondemand sst+ to collect blood at home and filter cards to provide urine samples * able to communicate in english * parent/care giver identifies child as black/african american or hispanic/latina/o or more than one race (target 70-100%) exclusion criteria: * neurological disorders * medical conditions (e.g. cancer, kidney or liver disease, diabetes, hyperthyroidism) * psychiatric conditions requiring hospitalization * allergy to any supplement ingredient * in people with a uterus: sexually active, pregnancy or suspected pregnancy * abnormality of mineral metabolism