Kornimate/medical-research-clean huggingface dataset:
cholangioscopy using narrow band imaging (nbi) in patients with primary sclerosing cholangitis (psc) undergoing endoscopic retrograde cholangiopancreatogram (ercp)

Conditions: Primary Sclerosing Cholangitis

Summary: patients with primary sclerosing cholangitis (psc) are affected by an inflammatory condition of the bile ducts. unfortunately, patients with psc have a 10 to 15 percent lifetime risk of developing gallbladder and bile duct cancers. gallbladder and bile duct cancers have a five-year survival of only 5 to 10 percent. surgery to provide a cure must remove all cancer confined to one area. in order to increase survival rates there is a need to identify cancer and pre-cancer early. this has been difficult to do. patients who have lab tests, positive imaging tests or obstructions will usually have a test called ercp (endoscopic retrograde cholangiopancreatogram) to take biopsies and enlarge bile ducts or opening bile ducts with stents. patients usually have cells in the bile ducts removed and analyzed, but there are not studies to show how sensitive this may be to determine if the cells are cancer or pre-cancerous. a new scope with a system using light filters called narrow band imaging (nbi) may help detect cancer and pre-cancer more often and at an earlier stage.


Eligibility criteria:
inclusion criteria: * patients with psc presenting for ercp where tissue sampling is indicated * adults age 18 to 75 years old * able to give informed written consent * either male or female exclusion criteria: * psc with acute cholangitis * patients with acute or chronic, debilitating cardiopulmonary disease who are unable to safely undergo prolonged conscious sedation * patients with a prior history of liver transplant * prisoners * unable or unwilling to give informed consents

Keywords: primary sclerosing cholangitis
comparison of polyethyleneglycol and placebo for relief of constipation from constipating medications

Conditions: Constipation

Summary: the purpose of this study is to assess treatment responses comparing a newly fda-approved peg laxative versus placebo.


Eligibility criteria:
inclusion criteria: * adult male or female ambulatory outpatient age 19 or older. * patients meet rome ii criteria * patients not meeting rome ibs criteria * use of a constipating medication (\>= 3% in pdr) * if female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study * written informed consent. exclusion criteria: * known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease. * prior small bowel or colonic resection or colostomy. * weight \< 80 lbs. * unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications. * positive stool hemoccult. * significant cardiac, renal or hepatic insufficiency. * pregnant or expecting to become pregnant within 120 days of study enrollment. * lactating or breast feeding. * subjects who in the opinion of the investigator would be unable to comply adequately with the study plan. * use of investigational drugs in the last 30 days. * patients with known allergy to peg or peg medications such as peg or sulfate-free electrolyte lavage solutions
investigating the physiological effects of weight loss on male fertility

Conditions: Male Infertility; Obesity; Weight Loss

Summary: the purpose of this study is to determine the physiological effects of weight loss on seminal parameters in male participants with reduced reproductive capacity. learning more about the physiological role of weight loss on reproductive function and metabolic profile of overweight and obese men may give us a better understanding of male fertility and improve the management of patients with reduced fertility. the effects of weight loss on seminal quality are not well understood.

participants will receive dietary supplements or national health service (nhs) advice on healthy eating to achieve weight loss.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 30 kg/m\^2 \[part: 1, 2\& 3\] * evidence of reduced reproductive capacity (e.g. reduced sperm concentration \[applicable for study b\] exclusion criteria: * history of undescended testes, testicular surgery or mumps infection * hormonal therapy such as testosterone or selective oestrogen receptor modulators * history of systemic cytotoxic therapy or pelvic radiotherapy * chronic systemic disease, such as cardiac, renal or liver failure * at least one of the following: alcohol intake \>30 units per week smoking daily recreational drug use at a frequency not less than weekly * acute illness likely to affect the result of study * impaired ability to provide full consent to take part in the study * an occupation requiring strenuous physical exercise that may require a high energy diet

Keywords: male infertility obesity
ketamine infusion as sedative analgesic in severe ards

Conditions: Intensive Care Unit Syndrome; Mechanical Ventilation Complication; Sedatives and Hypnotics Causing Adverse Effects in Therapeutic Use; Delirium

Summary: to evaluate whether ketamine is a safe sedative-analgesic agent to be used in an intensive care unit (icu) setting as compared to traditionally used agents such as propofol, opioids, and midazolam

according to the 2018 clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the intensive care unit (icu), nonbenzodiazepine sedatives (such as propofol and dexmedetomidine) are preferable to benzodiazepine sedatives (such as midazolam and lorazepam) in critically ill, mechanically ventilated patients. moreover, continuous use of benzodiazepine (more than 48 hours) has been associated with a risk of prolonged sedation and delirium. on the other hand, though propofol has a remarkable safety profile, it carries unfavorable side effects such as dose-dependent hypotension, hypertriglyceridemia, pancreatitis, and propofol syndrome (which is a rare but potentially fatal complication, associated with high-dose propofol infusions, and characterized by severe metabolic acidosis and circulatory collapse). during the coronavirus disease 2019 (covid-19) pandemic, an enormous number of patients required mechanical ventilation, which led to the shortage of traditional sedatives such as propofol, dexmedetomidine, midazolam, and lorazepam in the hospitals. in this challenging time, ketamine was used as an alternative sedative infusion. this study is to evaluate whether ketamine is safer compared to other sedatives in severe covid related ards patients.

Eligibility criteria:
inclusion criteria: * moderate to severe acute respiratory distress syndrome (ards) due to covid-19 with an arterial partial pressure of oxygen divided by the inspired oxygen concentration (p/f) ratio \< 150 with a minimum 5 cm of positive end-expiratory pressure on a mechanical ventilator exclusion criteria: * post-cardiac arrest status, * premorbid diagnosis of dementia, * dependency on extra-corporeal therapies prior to or during icu stay

Keywords: ketamine mechanical ventilation sedative analgesic hospital length of stay number of ventilator days mortality
study to evaluate the aio-001 in healthy participants

Conditions: Respiratory Disease

Summary: this goal of the open-label single dose study is to evaluate and compare the safety, tolerability, pharmacokinetic (pk), and immunogenicity of aio-001 using two different formulations in 16 healthy volunteers.

this is an open-label single dose, parallel group, 24-week, phase 1 study in 16 healthy participants. the study is designed to evaluate and compare the safety, tolerability, pk, and immunogenicity of aio-001 using two different formulations (formulation a and formulation b) in 16 healthy volunteers (8 receiving each formulation). the study will include a screening visit from day -28 to day -2. eligible participants will be admitted to the clinical site on day -1 and will be confined until completion of the assessments on day 3. participants will return to the clinical site for outpatient visits for study assessments and laboratory tests.

Eligibility criteria:
inclusion criteria: 1. able to understand the study procedures and provide signed informed consent to participate in the study. 2. male or female. 3. non-smokers. light smokers (no more than 5 cigarettes daily \[approximately 50 to 60 mg of nicotine per day\], or products with equivalent amount of nicotine within 3 months prior to screening) may be permitted. 4. ≥18 and ≤55 years of age. 5. bmi \>18.5 and \<32.0 kg/m2 and body weight ≥45.0 kg. 6. healthy participants. exclusion criteria: 1. any clinically significant abnormal finding at physical examination at screening. 2. clinically significant abnormal laboratory test results or positive serology test results for hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibody, or human immunodeficiency virus (hiv) antigen and antibody, or quantiferon®-tb tuberculosis (tb) test at screening. 3. positive pregnancy test or lactating female participant. 4. positive urine drug screen or alcohol breath test. 5. history of anaphylaxis, or severe allergy. 6. previous exposure to thymic stromal lymphopoietin antibody.
selenium in the treatment of arsenic toxicity and cancers

Conditions: Arsenical Melanosis; Arsenical Keratosis; Arsenical Cancers; Arsenicosis; Arsenic Exposure; Arsenic Toxicity; Arsenic Poisoning

Summary: context: approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. there are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. selenium has been known to counter arsenic toxicity in a variety of animal models. the investigators have recently shown in animals and humans that this effect is mediated by the formation of \[(gs)2asse\]- , the seleno-bis(s-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. concurrently, two phase ii studies in china and bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients. objective: to assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. if proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.


Eligibility criteria:
inclusion criteria: * resident of bangladesh in an arsenic-affected region (chandpur) * age between 12 and 55 * exposure to arsenic in home drinking water greater than 50 ug/l. * arsenical melanosis on the torso confirmed by epiluminescence microscopy exclusion criteria: * recent history or plans to consume selenium-containing supplements * anticipated change in home drinking water supply during study period

Keywords: arsenical melanosis arsenical melanoses arsenical keratosis arsenical keratoses arsenical cancer arsenic cancers arsenic arsenicosis arsenic exposure arsenic toxicity arsenic poisoning drinking water selenium selenite sodium selenite
cyclosporine dose adjustment according to calcineurin activity after allogeneic hematopoietic stem-cell transplantation

Conditions: Hematopoietic Stem Cell Transplantation; Graft Versus Host Disease

Summary: the purpose of this trial is to assess whether an adaptation of cyclosporine (csa) dose according to a longitudinal calcineurin (cn) activity monitoring would prevent the onset of graft-versus-host disease (gvhd).

our previous studies established a correlation between increased calcineurin (cn) activity and the risk of developing severe acute gvhd in allogeneic stem cell transplant recipients receiving immunosuppressive therapy with calcineurin inhibitors. this proof-of-concept trial is aiming at evaluating calcineurin activity as a monitoring biomarker of efficacy of cyclosporine - (calciclo) - for the prophylaxis of acute gvhd. our aim is to assess whether a longitudinal monitoring of cn activity would permit to adapt and optimize the dose of csa that would prevent the onset of severe acute gvhd, yet still maintaining an acceptable tolerability profile.

Eligibility criteria:
inclusion criteria: * patients were between the age of 12 and 60 years * patients planned to receive an allogeneic hsct following a myeloablative conditioning regimen exclusion criteria: * transplant from a syngeneic donor * evidence of refractory disease * nonmyeloablative conditioning * any participation to a study with a new investigational drug within the previous 3 months
comparison of coenzyme a and fenofibrate for safety and efficacy on patients with hyperlipidemia

Conditions: Hyperlipoproteinemia

Summary: the purpose of this study is to compare the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme a capsule with a marketed drug, fenofibrate, in chinese patients with moderate dyslipidemia.

although lowering cholesterol and low-density lipoprotein-cholesterol (ldl-c) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (tg) and low high-density lipoprotein cholesterol (hdl-c) concentrations in the residual cardiovascular risk on statin treatment. fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers tg and raises hdl-c through multifaceted mechanism by pparα activation. however, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. coenzyme a (coa) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. it is also involved in the oxidation and catabolism of fatty acids. animal studies have proved its lipid-lowering effects. in a previous multicenter study we conducted in 2008, it was found that oral coa 400u/d effectively lowered serum tg levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. so, the present study was performed to further investigate the lipid-lowing effects and safety of coa capsule by comparing with fenofibrate.

Eligibility criteria:
inclusion criteria: * tg 2.3～6.5mmol/l * 18-75 years of age exclusion criteria: * tc \>7.0 mmol/l; * body mass index \> 30 kg/m2 * drug induced secondary hypercholesterolemia (such as dibenzothiazine, contraceptive agent or adrenal cortex hormone) * pregnancy * acute coronary syndrome, acute myocardial infarction or undergone a revascularization procedure within 6 months * acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (alt) or aspartate aminotransferase levels (ast) more than 3-fold the upper normal limit * nephrotic syndrome or serum creatinine (cr) (≥179 µmol/l) and creatine •phosphokinase (ck) more than 3-fold the upper normal limit * primary hypothyroidism * psychiatric patients * poorly controlled hypertension, as indicated by a systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg * type i diabetes mellitus（dm）, poorly controlled type ii dm (bs\>11.0 mmol/l ) or type ii dm with ldl-c \>2.6 mmol/l. * using immunosuppressive drugs, prohibited medication or other lipid-lowing drugs
the efficacy of surgical site treatment with ropivacaine in laparoscopic surgery

Conditions: Pain

Summary: using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs.

at the end of laparoscopic surgery the investigators will spray ropivacaine in the surgical site; and later the investigators will monitor pain intensity and use of analgesic drugs

Eligibility criteria:
inclusion criteria: * laparoscopic bariatric surgery * laparoscopic inguinal hernia surgery exclusion criteria: * cardiac arrythmias * active ischemic heart disease * pregnancy

Keywords: laparoscopic surgery
adult and adolescent hemophilia patients treated with marstacimab: a patient experience registry

Conditions: Hemophilia

Summary: research title：adult and adolescent hemophilia patients treated with marstacimab: a patient experience registry (amber) protocol number：94250855 protocol version number：version 0.3 date：15-november-2024 leading site：institution of hematology \& blood diseases hospital, chinese academy of medical sciences active pharmaceutical ingredient：a human igg1 monoclonal antibody that targets the tissue factor pathway inhibitor (tfpi) drug name generic name: marstacimab-hncq purpose of the study primary objectives:to quantify patient preferences for subcutaneous versus intravenous (iv) injection using the marstacimab-patient preference questionnaire (m-ppq) after 1 month of marstacimab for routine prophylaxis treatment. to assess the treatment burden using the hemophilia treatment experience measure (hemo-tem) in hemophilia patients after 6 months of marstacimab for routine prophylaxis treatment. exploratory objectives: to evaluate the annualized bleeding rate (abr) of different types of bleeds after 6 months of subcutaneous marstacimab injections in hemophilia patients. to assess changes in joint status scores between baseline and the final visit after 6 months of subcutaneous marstacimab injections in hemophilia patients, using the hemophilia early arthropathy detection with ultrasound in china (head-us-c). to evaluate patient preferences regarding treatment experience via m-ppq after 6 months


Eligibility criteria:
inclusion criteria: - participants with a diagnosis of hemophilia a or hemophilia b eligible to receive prophylaxis. clinical physicians prescribe marstacimab for routine prophylaxis treatment of hemophilia patients based on the actual conditions of the patients and in accordance with the approved indications of marstacimab. adolescent patients(12 to less than 18 years) and adult (18 years and older) patients. signed consent obtained before the study, participant or legally authorized representative, or participant's caregiver capable of giving signed informed consent. exclusion criteria: - those who are unable to complete at least one month follow-up based on the investigator's judgment. severe impairment of speech, vision, memory or cognition that affects communication and ability to complete questionnaires and follow-up visits. women of childbearing age who plan to become pregnant within the next 2 months, as well as women who are pregnant or breastfeeding. patients are participating in other clinical trials. there are other conditions that the investigator deems unsuitable for participation in this study.
a study to evaluate the safety, tolerability, and drug levels of bms-963272 in participants with nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, and drug levels of bms-963272 compared to placebo in participants with nonalcoholic fatty liver disease (nafld) and high probability of advanced fibrosis.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 30 kg/m\^2 * magnetic resonance imaging-proton density fat fraction (mri-pdff) ≥ 10% as evaluated by central review * fibroscan-based transient elastography ≥ 9.9 kpa * alanine aminotransferase (alt): \> 30 u/l * if available, historical diagnosis of non-alcoholic steatohepatitis (nash) according to nash clinical research network classification by liver biopsy within 6 months before screening will be recorded * must agree to follow specific methods of contraception, if applicable exclusion criteria: * women who are breastfeeding * inability to tolerate the mixed meal or the testing conditions, oral medication, venipuncture and/or inadequate venous access * history or current diagnosis of cirrhosis, hepatocellular carcinoma (hcc), or hepatic decompensation * recent history (within 2 years before screening) of drug or alcohol abuse or excessive alcohol intake, defined as 30 g/day (men) or 20 g/day (women) * use of lipase inhibitors such as orlistat within 4 weeks before screening or during screening * use of glucagon-like peptide-1 (glp-1) receptor agonists within 12 weeks before screening or during screening * uncontrolled hypertension (systolic blood pressure \> 160 mmhg and/or diastolic blood pressure \> 100 mmhg) during screening, unless discussed with the medical monitor * glycated hemoglobin (hba1c) ≥ 9.5% * nash-modifying therapies including investigational therapies (e.g., obeticholic acid, ursodeoxycholic acid) within 90 days before screening or during screening * medications for obesity within 12 weeks before screening, or during screening * if taking vitamin e at a dose ≥ 800 mg/day, the dose must be stable beginning at least 6 months before screening and should remain stable during screening * if taking a thiazolidinedione, the dose must be stable beginning at least 12 weeks before screening and should remain stable during screening * if taking a dipeptidyl peptidase (dpp)-4 inhibitor or other medications for diabetes, the dose must be stable beginning at least 12 weeks before screening and should remain stable during screening * if taking insulin, the dose may be altered by up to 10% within 12 weeks before screening and during the screening period * if taking a statin or other prescription or over-the-counter lipid-lowering drug, the dose must be stable beginning at least 6 weeks before screening and should remain stable during screening other protocol-defined inclusion/exclusion criteria apply

Keywords: bms-963272 liver fibrosis nonalcoholic fatty liver disease (nafld) nonalcoholic steatohepatitis (nash) phase 1b