Kornimate/medical-research-clean huggingface dataset:
a study of the change in early and sustained pain control in axial spondylarthritis in adult participants receiving upadacitinib

Conditions: Axial Spondylarthritis (axSpA)

Summary: axial spondyloarthritis (axspa) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. the most frequent axspa symptom is chronic, often inflammatory back pain (ibp) that might be difficult to distinguish from other causes of chronic back pain (cbp). many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. this study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in axspa participants. upadacitinib is being developed for the treatment of axspa. approximately 650 adult participants with active-axspa will be enrolled across approximately 19 countries in europe, north america, south america, and asia-pacific. participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. participants will be followed for 12 months. there may be a higher burden for participants in this study compared to usual standard of care. participants will attend regular visits per routine clinical practice. the effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of axial spondylarthritis (axspa) according to the asas criteria. * bath ankylosing spondylitis disease activity index (basdai) score \>= 4 at baseline. * total back pain score \>= 4 at baseline. * inadequate response to at least two nonsteroidal anti-inflammatory drugs (nsaids) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to contraindication for nsaids as defined by the investigator. * upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies. exclusion criteria: * prior exposure to any janus kinase (jak) inhibitor. * participants demonstrating active symptoms of fibromyalgia as per clinical diagnosis. * participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. * unwillingness or inability to comply with the study requirements, including completion of patient reported outcome questionnaires. * participants who cannot be treated with upadacitinib according to the applicable approved label (e.g., contraindications). * vulnerable or protected adult patients with lack of capability to give informed consent.

Keywords: axial spondylarthritis (axspa) upadacitinib rinvoq
safety and pharmacokinetics of mmx mesalamine in children and adolescents with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine the safety and pharmacokinetics of mmx mesalamine following administration in children and adolescents with ulcerative colitis.


Eligibility criteria:
inclusion criteria: 1. subjects aged 5-17 years, with appropriately obtained informed consent and assent. 2. subject has a documented history of ulcerative colitis for at least 3 months. 3. subjects who are currently on 5-asa or product(s) containing or metabolized to mesalamine must have been on a stable regimen for at least 4 weeks prior to first dose of investigational medicinal product. 4. subjects who are not currently on a drug regimen, or on a 5-asa or product containing or metabolized to mesalamine, must have been on a stable regimen for at least 4 weeks prior to first dose at least 4 weeks prior first dose of investigational medicinal product. 5. body weight of 18kg-82kg inclusive. exclusion criteria: 1. current or recurrent disease (eg cardiovascular, renal, liver, malignancy or other conditions) that could affect the colon, the action, absorption or disposition of the imp, or clinical or laboratory assessments with the exception of their existing ulcerative colitis. 2. ulcerative colitis known to be confined to the rectum (isolated rectal proctitis). 3. any history of hepatic impairment or moderate to severe renal impairment. 4. the use of systemic or rectal steroids within the last 4 weeks, immunomodulators within the last 6 weeks, biologics within 6 months, antibiotic use within the last 7 days prior to the first dose of investigational medicinal product.
a study of administration of peginterferon alfa-2a [pegasys] by autoinjector versus pre-filled syringe in patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this randomized, cross-over, open label study will compare the tolerability and handling of application of peginterferon alfa-2a \[pegasys\] by autoinjector versus pre-filled syringe in patients with chronic hepatitis c, either on treatment with peginterferon alfa-2a for at least 12 weeks or treatment-naïve for peginterferon alfa-2a. patients will be randomized to self-injection of 180mcg peginterferon alfa-2a once a week using either an autoinjector or a prefilled syringe for 3 weeks, then switch to use the other method of injection for another 3 weeks. anticipated time on study treatment is 6 weeks. target sample size is \<100 patients.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * chronic hepatitis c * on treatment with peginterferon alfa-2a for \>/= 12 weeks at baseline, or treatment-naïve for peginterferon alfa-2a exclusion criteria: * history or evidence of decompensated liver disease * autoimmune hepatitis * hypersensitivity to peginterferon alfa-2a or any of its components * concomitant treatment that requires administration by self-injection, or prior use of an autoinjector
safety and pharmacology study of bms-866949

Conditions: Major Depression

Summary: the main purpose of this study is to determine whether multiple doses.of bms-886949 are safe and tolerable


Eligibility criteria:
inclusion criteria: * panels 1-6: healthy male subjects * panel 7: females * ages 21 to 55, inclusive * body mass index (bmi) of 18 to 32 kg/m², inclusive * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations exclusion criteria: * history of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (normal iop \<21 mmhg) * history or family history of psychiatric disorder * current treatment with prescription medication * exposure to any investigational drug or placebo within 12 weeks of study drug administration
first-in-human study of orally administered gs-441524 for covid-19

Conditions: COVID-19

Summary: this is a two-part study is to evaluate the multi-day safety, tolerability, and pharmacokinetics (pk) of orally administered gs-441524 in a healthy human volunteer.

part 1: 750 mg gs-441524 administered once daily (qd) for 7 days. part 2: 750 mg gs-441524 administered three times daily (tid) for 3 days.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * negative pregnancy test at screening and prior to dosing * minimum body weight of 50 kg and body mass index (bmi) of 18-32 kg/m2 exclusion criteria: * use of other investigational drugs within 28 days of dosing * positive pregnancy test * abuse of alcohol or drugs * other clinically significant medical conditions or laboratory abnormalities

Keywords: gs-441524 remdesivir gs-5734 copycat sciences gilead sciences covid-19 antiviral
resveratrol and human hepatocyte function in cancer

Conditions: Liver Cancer

Summary: the purpose of this study is to determine if resveratrol, a nutritional supplement, shows a beneficial effect in the cellular function of normal liver cells and diseased liver cells (cancer cells) in samples of liver tissue taken during elective liver surgery. outcomes based on 3 measures will test the hypothesis that resveratrol when used as a nutritional supplement will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation of cancer cells, 3)decrease inflammation in the liver.

hepatic function will be assessed by standard laboratory techniques. hepatocyte signaling pathway proteins will be measured using western blot analysis for protein expression and polymerase chain reaction for gene expression. activation of signaling pathways in both native hepatocytes and carcinoma will be analyzed by multi-plex signal array. the effect on transcription factors that may be important in gene expression will be analyzed by transcription factor array. the effect of resveratrol in altering hepatocyte and cancer cell metabolism will be analyzed by proteomic analysis.

Eligibility criteria:
inclusion criteria: * undergoing elective liver resection for liver cancer exclusion criteria: * inability to speak or read english * sclerosing cholangitis, hemochromatosis, hepatic encephalopathy, acute hepatic failure * history of daily alcohol intake * presence of human immunodeficiency virus * presence of significant renal dysfunction as defined by baseline serum creatinine \> 2.0 mg/dl or need/impending need for chronic dialysis therapy * known allergy to the study medication * pregnancy, lactating women, women contemplating pregnancy during the study period

Keywords: hepatocellular carcinoma metastatic colorectal cancer metabolism hepatic function
the pilot study of foscarnet cream in the treatment of mucocutaneous herpes simplex virus infections in immunocompromised patients unresponsive to acyclovir treatment

Conditions: Herpes Simplex; HIV Infections

Summary: primary: to evaluate the clinical activity of foscarnet cream on the index lesion of mucocutaneous herpes simplex virus (hsv) infections in immunocompromised patients previously unresponsive to acyclovir treatment. secondary: to evaluate the clinical activity and virologic activity of foscarnet cream on all treated lesions in this patient population. to evaluate the local tolerance and side effects of treatment with foscarnet cream in this patient population.

patients receive topical applications of one percent foscarnet cream five times daily for up to 6 weeks; those who show no evidence of epithelialization of the index lesion after 3 or more weeks are removed from study and offered intravenous foscarnet. patients who show a good response to topical foscarnet cream at the end of 6 weeks may continue receiving treatment at the discretion of the investigator.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * ganciclovir (provided drug was administered for at least 14 days prior to study entry, and the hsv isolate exhibits resistance against acyclovir). * other medication considered necessary for patient's welfare, at the discretion of the investigator. patients must have: * hiv infection or aids. * mucocutaneous hsv infection with at least one clinically evaluable lesion. * prior acyclovir without clinical benefit. * life expectancy of at least 3 months. * consent of parent or guardian if less than 18 years of age. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * known hypersensitivity to the study drug. * any medical, psychiatric, or other condition that would preclude study compliance. * incapable of self administration of medication or presence of a care provider administering medication. concurrent medication: excluded: * intravenous foscarnet for current episode of hsv. * acyclovir, interferon, or any investigational drug that might have anti-hsv activity (e.g., 256u87, hpmpc, bvdarau, trifluridine). patients with the following prior condition are excluded: previous participation in the study. prior medication: excluded: * intravenous foscarnet within 2 months prior to study entry.

Keywords: herpes simplex foscarnet acquired immunodeficiency syndrome
impact of milk fat globule membrane supplementation on heart and brain health

Conditions: Cardiovascular Diseases; Overweight and Obesity; Cognition

Summary: in a randomised, controlled cross-over manner, this trial aims to determine how short-term daily supplementation with a milk fat globule membrane-enriched ingredient impacts on cardiometabolic health and cognitive outcomes.


Eligibility criteria:
inclusion criteria: * aged 40 - 70 years * bmi: 25-45 kg/m2 * recreationally active (\> 3 x 30 min moderate exercise per week) * understands and is willing and able to comply with all study procedures, including changes to diet * fluent in written and spoken english * access to, and able to use, the internet/computer/tablet device exclusion criteria: * smoking (including vaping) * unstable weight history (≥3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme * currently taking part or have participated in another research study in the last two months (e.g., dietary intervention) * diagnosed with cardiovascular disease or suffered myocardial infarction/stroke in the past twelve months * existing or significant past medical history of any medical condition likely to affect the study outcomes. * prescribed medications or supplements likely to interfere with study outcomes or prescribed antibiotics within the last three months * use of antidepressant/anti-anxiety medication if it has changed in the last three months or expected to change within the 3-month study period. * known allergy or intolerance to study food (lactose intolerance, dairy) * being vegan or any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention or metabolic study * excessive alcohol consumption: \>21 unit/wk * pregnancy, seeking to become pregnant or active lactation

Keywords: milk fat globule membrane milk polar lipids cholesterol cardiometabolic risk
safety and dose-finding study of dtx301 (scaav8otc) in adults with late-onset ornithine transcarbamylase (otc) deficiency

Conditions: Ornithine Transcarbamylase (OTC) Deficiency

Summary: this is a phase 1/2, open-label, single arm, multicenter, safety and dose finding study of dtx301 in adults with late-onset otc deficiency. the primary objective of the study is to determine the safety of single intravenous (iv) doses of dtx301.

eligible participants will receive a single iv infusion of dtx301. dose escalation will be conducted according to a model that uses the collected data to predict the safety profile of the dose in order to determine the optimal biological dose (obd). the decision to proceed to the next dose cohort will be made after the data monitoring committee (dmc) has evaluated the safety data for all participants in a dosing cohort. participants will be followed for 52 weeks after dosing. after completion of this study, participants will be asked to enroll in a 4-year extension study to evaluate the long term (a total of 5 years) safety and efficacy of dtx301. this study was previously posted by dimension therapeutics, which has been acquired by ultragenyx.

Eligibility criteria:
key inclusion criteria: 1. males and females ≥18 years of age with documented diagnosis of late onset (defined as first manifestation of signs and symptoms at ≥1 month of age) otc deficiency, confirmed via enzymatic, biochemical, or molecular testing 2. documented history of ≥1 symptomatic hyperammonemia event with ammonia ≥100 µmol/l. 3. subject's otc deficiency is stable as evidenced by either a) no clinical symptoms of hyperammonemia or b) an ammonia level \<100 µmol/l within the 4 week period preceding the screening visit. 4. on ongoing daily stable dose of ammonia scavenger therapy for ≥4 weeks. 5. males and all females of childbearing potential must be willing to use effective contraception at the time of administration of gene transfer and for the 52 weeks following administration of dtx301 key exclusion criteria: 1. at screening or baseline (day 0), plasma ammonia level ≥ 100 μmol/l for patients who historically maintain normal ammonia levels; or plasma ammonia level ≥ 200 μmol/l for patients who historically are not able to fully control ammonia levels with baseline management; or signs and symptoms of hyperammonemia. 2. liver transplant, including hepatocyte cell therapy/transplant. 3. history of liver disease 4. significant hepatic inflammation or cirrhosis 5. serum creatinine \>2.0 mg/dl. 6. participation in another investigational medicine study (including another gene transfer trial) within 3 months of screening 7. pregnant or nursing note additional inclusion/exclusion criteria may apply, per protocol.

Keywords: gene transfer otc deficiency urea cycle disorder
a comparison of exparel to bupivacaine in tap block for abdominal gynecologic surgery

Conditions: Gynecologic Cancer; Post Operative Pain

Summary: this study evaluates the comparison between liposomal bupivacaine versus bupivacaine hcl in transversus abdominis plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates.

the proposed pilot study is evaluating the use of exparel ™ in an anesthesia protocol for patients undergoing major lower abdominal gynecologic surgery. exparel ™ is a formulation of liposomal bupivicaine that is reputed to have a much longer duration of action compares to bupivacaine. exparel™ has been originally demonstrated to be safe and effective in bunionectomy and hemorrhoidectomy. it has recently gained fda approval for all surgical site infiltration including tap (transversus abdominis planus block) blocks. exparel™ has also been studied in other procedures and demonstrated reduction in opioid use and median length of stay (los). currently, patients on the gynecologic oncology service undergoing major abdominal surgery are receiving a type of regional anesthesia using bupivacaine hcl known as a tap block as part of an effort to decrease narcotic use post-operatively and decrease hospital length of stay. bupivacaine has a known eight to twelve hour duration of action, thus addressing immediate post operative pain. as exparel™ is anticipated to have a longer duration of action, the purpose of this study is to determine if tap blocks with exparel™ have an advantage over standard tap blocks with bupivacaine hcl in reducing length of hospital stay in a randomized controlled trial. our hypothesis is that tap blocks with exparel™ will result in reduced length of stay contributing to significant hospital cost savings. secondary outcomes include total narcotic use (hypothesized to be reduced) and overall complication rates (hypothesized to remain unchanged). given there are no published data on the efficacy and safety of using exparel™ in open gynecologic abdominal surgery, this will be a pilot study.

Eligibility criteria:
inclusion criteria: * all patients undergoing planned exploratory laparotomy * tap blocks placed after the laparotomy incision is closed, but before the patient is awake, and placed under ultrasound guidance with correct identification of the correct abdominal plane. * consent for tap block signed by patients preoperatively by anesthesiology exclusion criteria: * all pregnant patients * all patients under 18 years of age * minimally invasive surgery such as laparoscopy or robotic assisted laparoscopy * medical contraindications to use of bupivacaine or liposomal bupivacaine such as severe hepatic and/or renal disease
prospective study of the influence of the diffuse noxious inhibitory controls of the pain on the efficacy of milnacipran in fibromyalgia therapy

Conditions: Fibromylagia

Summary: fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men. in france, the prevalence is 1.6% according to a french study conducted in 2009 and published in 2011 by serge perrot et al. the definition of fibromyalgia was recently amended with particular consideration of cognitive and somatic symptoms, factors not involved in the initial criteria of the acr classification. several factors are in favor of a malfunction of the central modulation of pain and poorer performance noxious inhibitory controls descendants (dnic: diffuse noxious inhibitory controls) have been demonstrated. in fibromyalgia patients, the dnic (diffuse noxious inhibitory controls) are altered with less pain inhibition than controls. dysfunction of the central pain modulation is widely described in the literature and contributes to pain complained of fibromyalgia. according to the recommendations of the european league against rheumatism (eular) 2006, antidepressants have a genuine analgesic efficacy in controlled studies. milnacipran is an antidepressant known and used in major depressive disorder according to its marketing authorization but is also part of the molecules used in the treatment of chronic neuropathic pain and fibromyalgia according to the recommendations of the eular. a review included five double-blind studies on 4,000 participants who took 100 mg or 200 mg milnacipran or placebo over a period of 8 weeks to 24 weeks. a moderate response was obtained for 40% of participants treated for each dose of milnacipran on the criteria of "at least 30% pain relief" impression and global change. substantial improvement with milnacipran compared to placebo has been shown. to date, the link between the weakening of dnic in fibromyalgia and effectiveness of drug treatment has not been shown. this study aims to assess the degree of impairment of dnic in fibromyalgia patients may be predictive of the efficacy of milnacipran.

visit 1 inclusion of the patient, clinical examination, evaluation of pain, basal pain and cognitive tests visit 2 (can be coupled with visit 1 if necessary) randomisation of the patient and allocation of the treatment for 1 month. phone contact visit 2 +7 days, + 15 days, +21 days follow-up of the compliance of the treatment and collection of adverse events. visit 3 (follow up at 1 month) evaluation of pain, pain and cognitive tests end of study

Eligibility criteria:
inclusion criteria: * patient of more than 18 years old, * patient with fibromyalgia exclusion criteria: * patient with a contraindication to the administration of the milnacipran, * patient with a concomitant spontaneous pain not attributable of fibromyalgia, * patient with medical and/or surgical histories judged by the investigator not compatible with the trial.

Keywords: fibromyalgia diffuse noxious inhibitory controls milnacipran