Kornimate/medical-research-clean huggingface dataset:
rifaximin modify the pathogenesis of non-alcoholic fatty liver disease (nafld)

Conditions: Non-alcoholic Fatty Liver Disease

Summary: in this multicentric, double-blind, randomized,placebo-controlled study, the investigators hypothesized that rifaximin might act on gram-negative bacteria and intestinal bacterial overgrowth(ibo) thereby inhibiting lipopolysaccharides(lps)-mediated proinflammatory cytokine production. this work evaluates the efficacy of 6 months administration of rifaximin in nafld patients.

the investigators aimed to study the effect of rifaximin on nash. 50 patients with biopsy-proven nash were enrolled in this double-blind, randomized,placebo-controlled study. bmi, ast, alt, gamma glutamyl transferase (γ-ggt), lipid profile, homeostatic model assessment (homa), serum endotoxin, toll-like receptor 4 (tlr4), interleukin-6 (il-6), il-10, tumor necrosis factor-α (tnf-α) and cytokeratin-18 (ck-18) levels were measured before and after a 6 month administration of rifaximin (1100mg/day, 550 mg tablets 1 × 2 before meals).

Eligibility criteria:
inclusion criteria: 1. women or men aged 18-65 years. 2. biopsy-proven nash without or with mild to moderate fibrosis (fibrosis stage 0-3)in the preceding year. 3. persistently abnormal alt on 2 occasions. 4. participants have provided written informed consent before screening. 5. all patients counseled about the standard of care treatment (e.g., diet andexercise). 6. strict requirements for weight stability between the time of biopsy and study entry. exclusion criteria: 1. cirrhotic nafld (metavir stage 4). 2. combined viral hepatitis b and c infection. 3. increased alcohol intake (\>20 g/day) and hypothyroidism. 4. co-existence of another type of biliary tract or pancreatic or liver diseases 5. lactating or pregnant women. 6. allergy to rifamycin or rifaximin. 7. systemic inflammatory conditions (e.g. connective tissue diseases and inflammatory bowel diseases). 8. bariatric surgery and blind loop. 9. evidence of hepatic decompensation (ascites, hepatic encephalopathy, and varices), 10. history of myocardial infarction and/ or stroke within 6 months. 11. drugs that alter the gut flora e.g. lactulose, systemic antibiotic, cholestyramine within three months, (l) cancers especially hcc, and (m)patients with renal impairment (estimated gfr \<60ml/min/1.73m2). (n) major dose change orintiation of biguanides, metformin, thiazolidinediones, insulin, fibrates, statins, and anti-obesity medications within three months before the onset of the study.

Keywords: nafld rifaximin endotoxin and homeostatic model assessment
feasibility of the latella implant system for medial osteoarthritis (oa)

Conditions: Osteoarthritis

Summary: the objective of this study is to evaluate the safety and technical feasibility of implanting the latella implant system in the treatment of patients with medial osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * history of pain as due to medial osteoarthritis exclusion criteria: * rheumatoid arthritis * joint or ligament instability * metal ion allergy
subclinical thyroid dysfunction and risk of myocardial infarction and stroke

Conditions: Cardiovascular Diseases; Heart Diseases; Hypothyroidism; Myocardial Infarction; Cerebrovascular Accident

Summary: to examine the association of subclinical hypothyroidism and risk of myocardial infarction and stroke in a large prospective cohort of post-menopausal women.

background: cardiovascular disease, including myocardial infarction (mi) and stroke, is the leading cause of death for women in the united states. subclinical hypothyroidism (sch), in which thyroid hormone levels are in the normal range but thyroid stimulating hormone (tsh) is elevated, has been linked to abnormal lipid profiles, atherosclerosis, and mi. the literature is scant however, and the evidence constrained by small studies, many of cross-sectional design. both the us preventive services task force and the institute of medicine recently concluded that current data are insufficient to inform clinical decision-making about the need for screening or treatment for sch. design narrative: this is a case-cohort study within the 93,676-member observational study of the women's health initiative, including 800 women who have experienced an mi, 750 with thrombotic/embolic stroke, and a randomly selected subcohort of 3,200 women density-matched for age, race/ethnicity, and clinical center. participants have extensive baseline demographic, health, behavioral, and physical exam data and stored serum available. the investigators will measure tsh and thyroid hormone levels in order to identify sch at entry. follow-up includes annual health status updates and a physical exam in the third year; \>=5 years have passed since enrollment for all women. thus, using new laboratory studies and existing women's health initiative (whi) data, they will be able to answer these primary research questions: among women without a history of thyroid disease, mi, or stroke: 1) is subclinical hypothyroidism at baseline independently associated with risk of mi? 2) is subclinical hypothyroidism at baseline independently associated with risk of ischemic stroke? 3) what form of association best describes the relationship between tsh, as a continuous measure, and risk of mi and stroke? 4) what are the population correlates (i.e., race/ethnicity, body mass index (bmi), hormone therapy, comorbidity) of sch? this information - currently unavailable for middle-aged and older women - is germane to public health and health care policy to define the burden of illness associated with sch, and to quantify the benefits and costs of eventual population screening and treatment

Eligibility criteria:
no eligibility criteria
early use of airway pressure release ventilation (aprv) in ards

Conditions: Acute Respiratory Distress Syndrome

Summary: airway pressure release ventilation (aprv) is a time-cycled, pressure controlled, intermittent mandatory ventilation mode with extreme inverse i:e ratios. currently it is considered as a non-conventional ventilatory mode. the investigators aim to compare aprv with conventional mechanical ventilation (mv) in patients with acute respiratory distress syndrome (ards).

despite the advances in technology and ventilatory modes, mortality of ards is still around 40%. besides prone positioning, the best approach of management is low tidal volume ventilation (ltv). this 'protective ventilation' strategy is not aways effective to improve oxygenation and is associated with an increased requirement of sedation and neuromuscular blocking agents, which increase length of stay and morbidity. aprv is a ventilatory mode based on relatively high and sustained continuous positive pressure, combined with a short phase of release to allow carbon dioxide removal. it also allows unrestricted spontaneous breathing throughout respiration, independent of the ventilator cycle. providing sustained inflation while limiting duration and frequency of release phase permits limiting volume loss, resulting in progressive and improved alveolar recruitment, an increased alveolar surface area available for gas exchange and improved ventilation-perfusion matching. in this multi-center, prospective, randomized, controlled, open trial, the investigators aim to compare the effects and safety of the early application of time-controlled adaptive method of aprv and conventional ventilation with ltv strategy in patients with severe to moderate ards.

Eligibility criteria:
inclusion criteria: * acute respiratory distress syndrome, according to the berlin definition of ards, with adjusted po2/fio2 for altitude \<300, and less than 48 h of endotracheal mechanical ventilation exclusion criteria: * pregnancy * less than 18 years-old * expected duration of mechanical ventilation less than 48 h * preexisting conditions with an expected 3-month mortality exceeding 50% * concurrent chemotherapy * confirmed intracranial hypertension * catastrophic cranial trauma or neuromuscular disorders that are known to prolong mechanical ventilation * pneumothorax at enrollment (resolved or not) * do-not-resuscitate order

Keywords: acute respiratory distress syndrome acute lung injury mechanical ventilation aprv
dose-finding study of vadadustat in japanese subjects with anemia secondary to non-dialysis dependent chronic kidney disease (ndd-ckd)

Conditions: Anemia; Non-dialysis Dependent Chronic Kidney Disease

Summary: this is a phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (pk), and pharmacodynamic (pd) of orally administered vadadustat in japanese participants with anemia secondary to non-dialysis dependent chronic kidney disease (ndd-ckd).


Eligibility criteria:
inclusion criteria: * male and female japanese participants ≥20 years of age * diagnosis of chronic kidney disease (ckd) based on an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 meters squared (ml/min/1.73 m\^2) * hemoglobin (hb) ≤10.5 grams per deciliter (g/dl) * not currently being treated with dialysis and not expected to start dialysis within 3 months of screening exclusion criteria: * anemia due to a cause other than ckd or presence of active bleeding or recent blood loss * sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia * red blood cell transfusion within 4 weeks prior to or during screening * intravenous iron within 4 weeks prior to or during screening * any use of erythropoiesis-stimulating agents within 6 weeks prior to or during screening

Keywords: anemia kidney non-dialysis dependent chronic kidney disease ckd ndd-ckd renal vadadustat akb-6548 hypoxia-inducible factor hypoxia-inducible factor (hif) hif prolyl-hydroxylase inhibitor (phi) phi japan japanese akebia (akb)
a registry to observe the treatment of prostate cancer under routine medical care

Conditions: Prostate Cancer

Summary: the purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mcrpc) in routine clinical practice, independent of treatment used. given the rapidly evolving landscape in mcrpc treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mcrpc, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. this will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (mru) and quality-of-life parameters and follow-up for survival.

this is a non-interventional, multicenter, prospective registry of patients with a confirmed diagnosis of adenocarcinoma of the prostate presenting with mcrpc, based on documented metastatic prostate cancer and documented castration resistance. castrate-resistant prostate cancer is defined by disease progression despite testosterone \ 3 months, data collection will be performed at a minimum frequency of 3-monthly intervals during that period. survival data will be collected for all patients 3 years after their enrollment or at the close of the registry, whichever occurs first, except for those patients who withdraw their consent prior to completing the observation period.

Eligibility criteria:
inclusion criteria: patients with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate patients with documented metastatic prostate cancer patients with documented castration resistance patients either: initiating a new systemic mcrpc treatment; or considered to be in surveillance according to clinical practice sign (or their legally-acceptable representatives must sign) a participation agreement or informed consent form (icf), per local regulations. exclusion criteria: any patient who is withdrawn from the registry for any reason may not re-enter the registry

Keywords: adenocarcinoma of the prostate registry metastatic castration-resistant prostate cancer
dose-ranging study to assess the safety, pk and initial antiviral efficacy of nvr 3-778 in chronic hbv patients

Conditions: Chronic Hepatitis B

Summary: this phase 1b trial will assess the dose-related safety and pk profile of different doses of nvr 3-778 in patients with chronic hepatitis b. additionally,changes in patients' serum hbv dna levels and other virologic efficacy parameters will be assessed.

the phase 1b assessments of the dose-related safety, pk, and initial antiviral efficacy of nvr 3-778 in hepatitis b patients will also be conducted at approximately 14 different sites to meet enrollment goals of 54-84 chronic hepatitis b patients. to promote objective safety and tolerance assessments during this trial, study subjects, and site personnel administering the study drug and performing the clinical assessments on the subjects, will be blinded to individual subjects' treatments assignments (active nvr 3-778 or placebo doses), for all treatment cohorts in the study. study advancement to subsequent patient cohorts will require satisfactory interim reviews of available cumulative safety data by the safety review committees (src), using the safety criteria and review procedures described in the protocol. also, there will be one interim review of safety data by an independent safety monitoring board (smb), as described in the protocol.

Eligibility criteria:
patients may be male or female between 18 and 65 years of age, with a bmi of 18-35kg/m2. patients must be hbeag positive and have chronic hepatitis b with no history of clinical decompensation.

Keywords: hepatitis b
safety, tolerability and the pharmacokinetics of ridinilazole in adolescent subjects

Conditions: Clostridioides Difficile Infection

Summary: study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.


Eligibility criteria:
inclusion criteria: * is aged 12 to \<18 years. * has signs and symptoms of cdi including diarrhea such that in the investigator's opinion cdi antimicrobial therapy is required, and the subject has tested positive for toxin a and/or b of c. difficile in the stool. diarrhea is defined as ≥ 3 unformed bowel movements (ubms) based on types 5, 6, 7 on the bristol stool chart and diarrhea information is within 24 hours prior to randomization. exclusion criteria: * has had more than the equivalent of 48 hours of dosing of antimicrobial treatment active against the current episode of cdi prior to randomization. * has received ridinilazole or an investigational vaccine against c. difficile any time in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or any other investigational medicinal product for treatment of cdi or fecal microbiota replacement therapy within the past 3 months. * has a clinically relevant positive stool test for pathogens other than c. difficile, within 48 hours of randomization. * has life-threatening or fulminant cdi with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus. * has had major gi surgery (e.g. significant bowel resection or pancreatectomy but not including appendectomy or cholecystectomy) within past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study. * is receiving treatment that generally is associated with severe diarrhea, intractable vomiting, severe nausea, or inability to swallow that cannot be managed with antiemetics or antidiarrheals and that limits the ability to take oral medications. cancer treatment that does not comprise ability to take study medication or cause severe diarrhea is allowed.

Keywords: clostridioides difficile infection (cdi) ridinilazole adolescents vancomycin c. diff clostridium difficile diarrhea infection pediatric
zithandani stepping stones and creating futures - phase 2 pilot

Conditions: Intimate Partner Violence (IPV); Earning Outcomes; Mental Health; Couple Communication; Couple Conflict; Couples; Livelihoods

Summary: the goal of this uncontrolled intervention study is to assess whether zithandani stepping stones and creating futures is feasible to deliver, acceptable for participants, safe for participants and to estimate effect sizes, in young (ages 18-40 years) heterosexual couples, living in urban informal settlements in ethekwini municipality, south africa. the main questions it aims to answer are: 1. is zithandani sscf feasible to deliver to young couples, and what are the barriers and opportunities in intervention delivery? 2. is zithandani sscf acceptable to participants? what do they like and what do they not like about the intervention? 3. is zithandani sscf safe for female participants and do they engage adequately? 4. does zithandani sscf show indication of positive change on key indicators and what are the effect sizes? participants will be recruited as heterosexual couples and participate in 14 sessions, each approximately 3 hours long, with between 4 and 6 other couples, focused on gender norms, livelihoods and communication.


Eligibility criteria:
individual inclusion: * aged 18-40 years, * reside in the selected community * not in full time permanent employment, or in full-time education * able to communicate in the main languages of the study (english, isixhosa or isizulu) * able and willing to provide informed consent to participate joint inclusion criteria: * be a heterosexual couple * been together in a relationship for a minimum of 6 months * relationship is public knowledge * willing to participate in an intervention exclusion criteria individuals is as follows: * under 18 or 41+ years old * planning on leaving the community in the next 3 months * unable or unwilling to provide informed consent * unable to communicate in the main study languages joint couples exclusion criteria * relationship is not public knowledge * have been together for less than 6 months

Keywords: informal settlements south africa couples intimate partner violence couples communication mental health livelihoods
study evaluating the safety, efficacy and pharmacokinetics of ca-008 (vocacapsaicin)

Conditions: Postsurgical Pain

Summary: in the pilot (part a) of this study, multiple doses of ca-008 (vocacapsaicin) were evaluated for safety, tolerability, and pk. doses were then selected for the expanded part (part b) of the study, where ca-008 was compared to placebo. patients had serial assessments of safety, pk, and drug effect.

not provided

Eligibility criteria:
inclusion criteria: * scheduled elective total knee arthroplasty (tka) under spinal anesthesia * aged 18-80 years old * asa physical class 1, 2, or 3 * bmi \</= 42 kg/m2 * generally healthy exclusion criteria: * concurrent condition requiring analgesic treatment during study period * opioid tolerant * known allergy to capsaicin or other study medication * use of prohibited medications
a trial investigating the pharmacokinetic and pharmacodynamic properties of fiasp in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of fiasp (faster-acting insulin aspart) in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.5-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period inpatient period
rebeccamycin analog in treating children with relapsed or refractory neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of rebeccamycin analog in treating children who have relapsed or refractory neuroblastoma.

objectives: * determine the response rate to rebeccamycin analogue in children with relapsed or refractory neuroblastoma. * determine the toxicity of this drug in these patients. * identify and establish in vitro biologic correlates of clinical responses and toxicity of this drug in these patients. outline: patients receive rebeccamycin analogue iv over 1 hour once on days 1-5. treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. projected accrual: this study will accrue up to 30 patients within 1.5 years.

Eligibility criteria:
disease characteristics: * histologically proven relapsed or refractory neuroblastoma * measurable disease patient characteristics: age: * children performance status: * ecog 0-2 life expectancy: * at least 2 months hematopoietic: * not specified hepatic: * bilirubin less than 1.5 mg/dl * sgot and sgpt less than 2.5 times upper limit of normal (uln) * adequate liver function unless due to disease renal: * creatinine no greater than 1.5 times uln or * creatinine clearance at least 60 ml/min * adequate renal function unless due to disease other: * no other serious concurrent illness * no active uncontrolled infection * not pregnant * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * recovered from prior immunotherapy * prior autologous bone marrow transplantation allowed * no concurrent immunotherapy chemotherapy: * at least 4 weeks since prior chemotherapy and recovered * no other concurrent systemic chemotherapy endocrine therapy: * not specified radiotherapy: * recovered from prior radiotherapy surgery: * not specified

Keywords: recurrent neuroblastoma
incisional negative pressure wound therapy in high risk patients undergoing panniculectomy: a prospective randomized controlled trial

Conditions: Complications Wounds; Negative Pressure Wound Therapy; Wound Healing Delayed; Incisional; Panniculectomy; Incisional Negative Pressure Wound Therapy; Incisional Vac; Wound Vac; Obese; Renal Failure; Kidney Transplant; Complications; Wound Healing Complication

Summary: incisional negative pressure therapy (inpwt) has previously been shown in certain patient populations to decrease wound healing complications, decrease the rate of hematomas and seromas, as well as have better scar quality. we have found a group of patients, those who have panniculectomies in preparation for renal transplant, with significantly higher rates of wound healing complications. we believe the best way to demonstrate benefits of incisional negative pressure wound therapy will be in this group of patients known to have significantly higher rates of wound complications.


Eligibility criteria:
inclusion criteria: * all patients undergoing panniculectomy in preparation for renal transplantation at the university of california davis medical center. patients who are entered into the trial and have 30 days of follow up, and those in the inpwt study arm who successfully complete 7 days of treatment, will be included. exclusion criteria: * all patients who previously demonstrated a hypersensitivity reaction to adhesives and qualify for panniculectomy in preparation for renal transplantation, or all patients who are undergoing panniculectomy for reasons other than in preparation for renal transplantation (i.e. after massive weight loss or for cosmetic reasons). patients who do not complete the duration of treatment of negative pressure wound therapy (7 days), or patients who do not follow up for a minimum of 30 days from the date of surgery will be excluded. adults unable to consent, infants, children, teenagers, pregnant patients and prisoners will be excluded. it is also extremely unlikely, based on our study population, that we will encounter any of these patients.