Kornimate/medical-research-clean huggingface dataset:
rifaximin soluble solid dispersion (ssd) tablets plus lactulose for the treatment of overt hepatic encephalopathy (ohe)

Conditions: Overt Hepatic Encephalopathy

Summary: study to assess the efficacy and safety of rifaximin soluble solid dispersion (ssd) tablets plus lactulose for the treatment of overt hepatic encephalopathy (ohe).

the primary objective of this study is to assess the efficacy of rifaximin ssd plus lactulose versus placebo plus lactulose for the treatment of overt hepatic encephalopathy (ohe). the secondary objectives of this study are to assess the safety of rifaximin ssd in subjects with ohe and to assess the effects of treatment with rifaximin ssd on key secondary endpoints.

Eligibility criteria:
inclusion criteria: * male or female age 18 to 75 years of age (inclusive) at the time of screening. * females of childbearing potential, defined as a female who is fertile following menarche, must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study. note: female subjects who have been surgically sterilized (e.g., hysterectomy or bilateral tubal ligation) or who are postmenopausal (defined as total cessation of menses for \> 1 year) will not be considered "female subjects of childbearing potential". * subject is hospitalized with liver cirrhosis and/or ohe and has a confirmed diagnosis of ohe at baseline. * subject has a grade 2 or grade 3 he episode according to the he grading instrument (hegi) following 8 to 12 hours of intravenous (iv) hydration and lactulose treatment. exclusion criteria: * subject has an uncontrolled major psychiatric disorder including major depression or psychoses as determined by the investigator. * subject has been diagnosed with an infection for which they are currently taking oral or parenteral antibiotics, which cannot be discontinued at time of enrollment. note: subjects currently taking rifaximin are not excluded * subject shows presence of intestinal obstruction or has inflammatory bowel disease. * subject has uncontrolled type 1 or type 2 diabetes. note: subjects with controlled diabetes may be enrolled if they are on stable doses of oral hypoglycemic drugs for at least 3 months prior to screening, and demonstrate clinically acceptable blood glucose control at baseline, as determined by the investigator. * subject has an active malignancy (exceptions: non-melanoma skin cancers).
intensive postpartum antihypertensive treatment

Conditions: Hypertensive Disorder of Pregnancy

Summary: the long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.

the ipat will randomize 60 postpartum patients with hdp at the medical college of wisconsin (mcw) to intensive bp control with nifedipine extended release (er) (target bp \<140/90 mmhg) versus usual care (target bp \<150/100 mmhg). oversampling of black patients with hdp will be done to ensure they comprise 50% of study participants. patients enrolled in both arms will undergo education on healthy lifestyle following aha "life's essential 8" (le8) of tobacco cessation, physical activity, healthy sleep, and healthy diet with detailed overview of dash throughout the first year postpartum with monthly virtual educational session delivered by a registered dietician and a life coach. assessment of le8 cvh score will be done after delivery, 6 weeks postpartum, and 12 months postpartum. participants will also undergo vascular function assessment: endothelial dysfunction with brachial artery flow mediated dilation (fmd), arterial stiffness with carotid-femoral pulse wave velocity (cfpwv) and anti-angiogenic and inflammatory cvd biomarker with soluble fms-like tyrosine kinase (sflt-1), at baseline, 6 weeks, and 12 months postpartum. the primary outcome is feasibility of all study procedures, including recruitment, retention, and adherence. secondary outcomes are change in bp, cvh score, fmd, pwv, and sflt-1 from baseline to 12 months postpartum.

Eligibility criteria:
inclusion criteria: * hdp diagnosis (gestational hypertension or preeclampsia) according to acog guidelines * postpartum day 0-3 and prior to discharge * able to communicate in english or in spanish * age 18 - 45 exclusion criteria: * pre-gestational hypertension * pre-gestational diabetes ( type 1 or type 2) * intent to transfer postpartum to an outside institution of the participating centers * known allergy to nifedipine or other significant contraindication to nifedipine * inability or unwillingness to provide informed consent
autoantibodies against specific cytokines in adults with severe mycobacterial infection

Conditions: Mycobacterium Infection

Summary: in adult, the prevalence of mycobacterial infections is increased with age is largely unknown. ifn-gamma-il-12/23 axis or nf-kappab pathways might also plays crucial roles in adult against mycobacteria. based on this hypothesis, the investigators had applied a functional assay to these pathways in patients with mycobacterial infection.


Eligibility criteria:
inclusion criteria: * patients with mycobacterial infection exclusion criteria: * malignancy * severe autoimmune * hiv infection
a study to investigate vamikibart (ro7200220) in combination with ranibizumab in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: study bp43464 is a phase ii, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of vamikibart in combination with, anti-vascular endothelial growth factor (vegf) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. only one eye will be chosen as the study eye. the duration of the study will be 76 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus (type 1 or type 2) * macular thickening secondary to diabetic macular edema (dme) involving the center of the macula * decreased visual acuity attributable primarily to dme * ability and willingness to provide written informed consent and to comply with the study protocol * willingness to allow aqueous humor collection * for women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of \<1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment exclusion criteria: * hemoglobin a1c (hba1c) of greater than (\>) 12% * uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmhg) and/or a diastolic value \>100 mmhg while a patient is at rest * currently pregnant or breastfeeding, or intend to become pregnant during the study * prior treatment with panretinal photocoagulation or macular laser to the study eye * any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to day 1 to the study eye * prior iluvien or retisert implants within 3 years prior to day 1 to the study eye * prior or concomitant treatment with anti-vegf therapy within 8 weeks prior to day 1 to the study eye; vabysmo\^tm within 16 weeks prior to day 1, prior beovu® is not permitted * prior administration of ivt brolucizumab (beovu®): ever; vamikibart: \</=24 weeks prior to day 1) in either eye * any proliferative diabetic retinopathy * active intraocular or periocular infection or active intraocular inflammation in the study eye * any current or history of ocular disease other than dme that may confound assessment of the macula or affect central vision in the study eye * any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than dme in the study eye * other protocol-specified inclusion/exclusion criteria may apply
effect of curcumin in treatment of squamous cervical intraepithelial neoplasias (cins)

Conditions: Cervical Intraepithelial Neoplasia

Summary: the purpose of this study is to determine the safety, feasibility, and regression rate of using curcumin in patients with cervical intraepithelial neoplasias (cin3). the secondary objectives of this study is to evaluate patients with cin3 for the presence of high-risk human papillomavirus (hpv) and to perform an inflammatory panel on dysplasia biopsies from patients with cin3 to determine which factors play a role in persistence of cin3.

fourteen women with a biopsy-confirmed cin3 diagnosis will be enrolled. the participants will receive 500mg of curcumin orally twice daily for 12 weeks. colposcopies will be performed at the participants' baseline, 6 week, and 12 week visits. two biopsies will be performed at the baseline and 12 week visit, and if there is suspicion for cancer formation or invasion, at the 6-week visit. one sample will be used for histologic examination, while the other sample will be used for p65 assays. based on the biopsy, if cancer is present, then the patient will be referred to gynecologic oncology for further care and the trial will be terminated. at the end of the 12 week period, if cin3 persists, loop electrosurgical excision procedure (leep) or cold knife conisation (ckc) will be performed to remove the dysplastic cells as this is considered standard of care.

Eligibility criteria:
inclusion criteria: a patient will be eligible for inclusion in this study if she meets all of the following criteria: 1. the patient must be 21 or older and able to give informed consent. 2. patient must have histologically confirmed squamous cin3. 3. there must be an adequate colposcopy. 4. patient must have no abnormal cells in their endocervical curettage (ecc). 5. there must be no suspicion of invasion. exclusion criteria: a patient will be ineligible for inclusion in this study if she meets any of the following criteria: 1. women who are pregnant or lactating. 2. hiv+ status 3. adenocarcinoma in situ or any invasive cancer of the cervix. 4. gallstones or bile duct obstructions. 5. patients on anti-coagulant/anti-platelet therapies. 6. patients on immunosuppressive therapies. 7. patients may not receive any other investigational treatments while participating in this study. 8. concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.

Keywords: cin3 squamous cin3
use of continuous wound infusion of bupivacaine for analgesia following axillary clearance surgery

Conditions: Breast Cancer

Summary: axillary clearance forms part of the surgical armamentarium for the treatment of breast cancer. although the introduction of sentinel lymph node mapping and dissection has allowed for the decreased use of axillary clearance, it remains a frequently performed operation. axillary clearance is associated with moderate postoperative pain. we hypothesize that a continuous wound infusion of 0.2% bupivacaine at 4ml/hr would provide superior analgesia, when compared to standard opioid-based analgesia, in patients undergoing axillary lymph node clearance surgery.

the study will take the form of a prospective randomised clinical trial. the following assessment tools will be used * the visual analogue scale (vas) consists of a 100 mm horizontal line with the two end points labelled "no pain" and "worst pain ever". patients are asked to mark on the line a point that corresponds to the level of pain intensity they feel. the score is obtained by measuring the distance (mm) from the left end of the line. * the short-form mcgill pain questionnaire (sf-mpq) consists of 15 representative words from the sensory and affective categories of the standard mcgill pain questionnaire. it also includes the present pain intensity and a vas to provide overall indices of pain intensity. it has been shown to be sensitive to clinical changes brought about by various interventions, postoperative analgesic drugs (6). * the pain catastrophising score (pcs) is a 13 item instrument which asks patient to reflect on past painful experiences, and to indicate the degree to which they experienced each of these 13 thoughts or feelings, on 5-point scales with the end points; 0 = not at all, 4 = all the time. the pcs yields a total score and three subscale scores assessing rumination, magnification and helplessness (7). * the hospital anxiety and depression score (hads) is a 14-item scale, which screens for these, the two most common disturbances encountered in a medical setting (8).

Eligibility criteria:
inclusion criteria: * patients undergoing axillary clearance surgery * asa physical status i - iii exclusion criteria: * patient refusal * pre-existing pain conditions * regular use of opioid analgesia * pregnancy * severe cardiac, renal or hepatic disease * psychiatric illness precluding ability to give informed consent * intercurrent neurological disease * contraindications to bupivacaine or morphine use

Keywords: axillary clearance wound infiltration wound infusion local anaesthetic wound infusion
simvatstatin used to treat pulmonary hypertension

Conditions: Hypertension, Pulmonary

Summary: we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.

advanced pulmonary hypertension is refractory to the medication in use nowaday, especially pulmonary hypertension secondary to congenital heart disease or chronic pulmonary embolism.it is revealed that statins may intefere the pathogenisis of the pulmonary hypertension in many key poing, such as improving apotosis or inhiting the proliferation of pulmonary vascular smooth muscle cell. so we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.

Eligibility criteria:
inclusion criteria: * pasp\>50mmhg exclusion criteria: * pasp\<50mmhg

Keywords: pulmonary hypertension simvastatin advanced pulmonary hypertension secondary to congenital heart disease advanced pulmonary hypertension secondary to chronic pulmonary embolism
acetaminophen versus ibuprofen for the control of immediate and delayed pain following orthodontic separator placement

Conditions: Orthodontic Pain

Summary: the purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. the research hypothesis is that there will be a significant difference in pain as measured by visual analogue scales (vas) over time and that this effect will differ for acetaminophen versus ibuprofen.


Eligibility criteria:
inclusion criteria: * orthodontic treatment requires banding of posterior teeth * orthodontic treatment requires the placement of two or more separators * able to swallow analgesic pills * english speaking * age 9-17 * minimum weight requirement of 88 pounds exclusion criteria: * orthodontic appliances are present in the mouth * use of acetaminophen or ibuprofen is contraindicated (allergy, gi problems) * antibiotics or analgesics are currently in use * history of systemic disease exists (arthritis, diabetes, cystic fibrosis) * significant cognitive impairment

Keywords: pain orthodontic acetaminophen ibuprofen separator
reduced content of gluten diet on patients with irritable bowel syndrome (pro.ali.fun.)

Conditions: Irritable Bowel Syndrome; Gluten Sensitivity

Summary: this study aim to manufacture bread and pasta with an reduced content of gluten and to assess the impact of reducing the daily intake of gluten by 50% in irritable bowel syndrome (ibs) patients. fungal proteases and selected sourdough lactic acid bacteria will be used for making wheat bread and pasta with a reduced content of gluten (rg) (-50% of traditional products). from a technological point of view, the chemical, structural and sensory features of the rg products approached those of the bread and pasta made with normal level of gluten. the efficacy and safety of new products will be compared to traditional bread and pasta by using a double blind randomized, crossover-controlled trial in ibs patients with persistent gastrointestinal symptoms. patients will follow two weeks of a gfd diet containing rg bread and pasta and two weeks of gfd diet containing normal gluten bread and pasta symptoms severity will be assessed by irritable bowel syndrome severity score (ibs-ss), visual analogue scale (vas), hospital anxiety and depression scale (hads) and irritable bowel syndrome quality of life (ibs-qol).


Eligibility criteria:
inclusion criteria: 1. age above 18 years; 2. having bowel symptoms (altered bowel habit, lower abdominal pain, bloating, or distention suggestive of ibs), as determined by rome iii criteria. 3. previous exclusion of cd and wheat allergy exclusion criteria: 1. previous gi malignancy and/or surgery; 2. clinically significant cardiovascular, respiratory, endocrine, renal, hematologic or hepatic disease. 3. other clinically significant medical condition; pregnancy or lactation; alcohol abuse; drug addiction; severe neurologic or psychiatric disorders; long-term use of corticosteroids or anti-inflammatory drugs 4. participation in another clinical trial within 6 months before the onset of this trial. -
hunger, satiety, and metabolic responses to high-fat meals of varying fatty acid composition

Conditions: Body Weight Changes

Summary: this study evaluates the effects of dietary fatty acid composition from high fat meals on markers of hunger, satiety and metabolism.


Eligibility criteria:
inclusion criteria: * bmi of \>18.5-24.9kg/m2 * woman * 18-40yrs of age exclusion criteria: * evidence of weight loss or gain exceeding 5% of their body weight within the past 3 months. * plans to lose weight or begin a weight loss program between initiation of study and final testing. * plans to begin an exercise program or change current exercise routines between initiation of study and final testing. * is on a medically prescribed diet * does not consume breakfast regularly * rate less than 80% of foods offered in the buffet at 50mm or more on the 100mm vas as palatable * medications that could influence appetite or sensory function * reports of metabolic or endocrine disease, gastrointestinal disorders, or history of medical or surgical events that could affect fat digestion and hormone signaling. * any chronic disease including type ii diabetes, hypothyroidism, hyperthyroidism, cardiovascular disease, and cancer * any supplements that a subject begins taking between initiation of study and final testing. * anyone who is currently pregnant, lactating, or planning on becoming pregnant before the conclusion of this study. * anyone who has allergies to any of the components of the liquid meals * anyone who has donated blood in the last 20 days
study to evaluate organic anion transporting polypeptide (oatp) transporter-mediated drug-drug interactions between filgotinib and statins as probe drugs in healthy participants

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to evaluate the effect of filgotinib on a mixed organic anion transporting polypeptide/cytochrome p450 3a (oatp/cyp3a), oatp/ breast cancer resistance protein (bcrp), and oatp substrates using phenotypic probes.


Eligibility criteria:
key inclusion criteria: * be a nonsmoker. the use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug. * have a calculated body mass index (bmi) of greater than or equal to (≥) 19.0 and less than or equal to (≤) 30.0 kilogram per meter square (kg/m\^2) at screening. * have a creatinine clearance (clcr) ≥ 90 milliliters per minute (ml/min) (using the cockcroft-gault method) based on serum creatinine and actual body weight as measured at screening and upon admission. * female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at clinic admission. * male participants must be surgically sterile. * male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * screening laboratory evaluations and 12-lead electrocardiogram (ecg) evaluations must be without clinically significant abnormalities as assessed by the investigator. * have liver biometric tests such as alanine aminotransferase (alt), aspartate aminotransferase (ast), alkaline phosphatase, and total bilirubin below the upper limit of normal at screening. * must be willing and able to comply with all study requirements. * must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs. * participants must not have donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug. key exclusion criteria: * positive serum pregnancy test (female participants). * lactating female. * have received any investigational drug/device within 30 days prior to study dosing (or within 5 half-lives of the drug, whichever is longer). * have current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance or participant safety, or a positive drug or alcohol test at screening or admission. * have a positive test result for human immunodeficiency virus type 1 (hiv-1) antibody, hepatitis b virus (hbv) surface antigen (hbsag), or hepatitis c virus (hcv) antibody at screening. * have positive coronavirus disease 2019 (covid-19) real-time reverse. * transcriptase-polymerase chain reaction (rt-pcr) testing on screening and admission. * have poor venous access that limits phlebotomy. note: other protocol defined inclusion/exclusion criteria may apply.