Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of switching from dolutegravir and abc/3tc or abc/dtg/3tc to b/f/taf in hiv-1 infected adults who are virologically suppressed

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (dtg) and abacavir/lamivudine (abc/3tc) or a fixed dose combination (fdc) of abacavir/dolutegravir/lamivudine (abc/dtg/3tc) to a fdc of bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) versus continuing dtg and abc/3tc as the fdc abc/dtg/3tc in virologically suppressed human immunodeficiency virus- 1 (hiv-1) infected adults.


Eligibility criteria:
key inclusion criteria: * estimated glomerular filtration rate ≥ 50 ml/min (≥ 0.83 ml/sec). * currently receiving an antiretroviral regimen of dtg + abc/3tc, or abc/dtg/3tc fdc for ≥ 3 months prior to the screening visit. * hiv ribonucleic acid (rna) \< 50 copies/ml at the screening visit. * currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma hiv-1 rna \< 50 copies/ml for ≥ 3 months preceding the screening visit (or undetectable hiv-1 rna level according to the local assay being used if the limit of detection is ≥ 50 copies/ml). * have no documented or suspected resistance to emtricitabine (ftc), tenofovir (tfv), dtg, abc or 3tc. key exclusion criteria: * current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance. * active tuberculosis infection. * individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding). * females who are pregnant. * females who are breastfeeding. * acute hepatitis in the 30 days prior to study entry. * chronic hepatitis b virus (hbv) infection. note: other protocol defined inclusion/exclusion criteria may apply.
phase 3 study of daraxonrasib (rmc-6236) in patients with previously treated metastatic pancreatic ductal adenocarcinoma (pdac)

Conditions: Pancreatic Cancer; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma

Summary: the purpose of this study is to evaluate the safety and efficacy of a novel ras(on) inhibitor compared to standard(s) of care (soc) treatment.

this is a global, randomized, open-label, phase 3 study designed to evaluate whether treatment with rmc-6236 will improve progression free survival (pfs) or overall survival (os) compared to investigator's choice of standard of care chemotherapy in patients with metastatic pdac who were previously treated with one prior line of therapy with 5-fluorouracil (5-fu) based or gemcitabine-based regimen. patients will be randomized in a 1:1 ratio to receive rmc-6236 (arm a) or investigator's choice of standard of care chemotherapy (arm b).

Eligibility criteria:
inclusion criteria: * at least 18 years old and has provided informed consent. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * histologically or cytologically confirmed pdac with metastatic disease. * measurable disease per recist 1.1. * adequate organ function (bone marrow, liver, kidney, coagulation) * documented ras mutation status, either mutant or wild-type. ras mutations defined as nonsynonymous mutations in kras, nras, or hras at codons 12, 13, or 61 (g12, g13, or q61). * able to take oral medications. exclusion criteria: * prior therapy with direct ras-targeted therapy (eg. degraders and/or inhibitors). * history of or known central nervous system metastatic disease. * any conditions that may affect the ability to take or absorb study treatment * major surgery within 4 weeks prior to randomization. * patient is unable or unwilling to comply with protocol-required study visits or procedures

Keywords: pancreatic cancer pdac pancreatic ductal adenocarcinoma ras kras nras hras ras wild-type ras q61 mutation ras g12 mutation ras g13 mutation
a study to evaluate the safety and tolerability of sage-718 in participants with huntington's disease

Conditions: Huntington's Disease

Summary: the primary purpose of the study is to evaluate the safety and tolerability of sage-718 softgel lipid capsule in participants with huntington's disease (hd)


Eligibility criteria:
inclusion criteria: for all participants: * completed 718-cih-201 (nct05107128) or 718-cih-202 (nct05358821) studies or meet eligibility criteria for the de novo cohort. * agree to refrain from drugs of abuse for the duration of the study and from alcohol during the 48 hours preceding each study visit. * be willing to invite a study partner, if available, who is reliable, competent, and at least 18 years of age to participate in the study. * be able to travel to the study center, and, judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study. additional inclusion criteria for the de novo cohort (cohort 3): * be at least 25 years old, but not older than 65 years of age at screening. * genetically confirmed disease with cytosine-adenine-guanine (cag) expansion ≥40 * no features of juvenile hd * cag-age-product (cap) score ≥90, as calculated using the cap formula: age × (cag - 30) / 6.49. * at screening, scores of either: a) unified huntington's disease rating scale (uhdrs) -total functional capacity (tfc)=13 and montreal cognitive assessment (moca) ≤25 score, or b) uhdrs-tfc ≤12 and moca \>25 exclusion criteria: for all participants * have a diagnosis of an ongoing neurodegenerative condition other than hd, including but not limited to, alzheimer's disease, vascular dementia, dementia with lewy bodies, or parkinson's disease. * had gastric bypass surgery, has a gastric sleeve or lap band, or has had any related procedures that interfere with gastrointestinal transit. * is known to be allergic to any of sage-718 excipients, including soy lecithin. * receive any prohibited medications within 30 days of screening and during participation in the study. additional exclusion criteria for the de novo cohort (cohort 3): * have previous exposure to gene therapy, or have participated in any other hd investigational drug, biologic, or device trial within 180 days or a non-hd drug, biologic or device trial within 30 days or 5 half-lives (whichever is longer). additionally, participants who have received treatment with antisense oligonucleotides or a messenger ribonucleic acid (mrna) splicing modifier will be excluded. note: participants with confirmation of enrolment in the placebo arm of these investigational trials would not be excluded. additional exclusion criteria for 718-cih-201/202 completers (cohorts 1 and 2): * have one or more ongoing serious adverse events (saes) from the parent study. * have ongoing, unresolved ae(s), which in the opinion of the investigator or sponsor, is likely to interfere with study conduct or compliance.

Keywords: huntington's disease sage-718
dolce: determining the impact of optellum's lung cancer prediction solution

Conditions: AI (Artificial Intelligence); Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple; Lung Cancer

Summary: this study is a multi-centre prospective observational cohort study recruiting patients with 5-30mm solid and part-solid pulmonary nodules that have been detected on ct chest scans performed as part of routine practice. the aim is to determine whether physician decision making with the ai-based lcp tool, generates clinical and health-economic benefits over the current standard of care of these patients.


Eligibility criteria:
inclusion criteria: patients are eligible for the study if all of the following apply: * are aged 35 years or above * have baseline ct study with at least one incidentally detected solid or part-solid (must have a solid component \>=80%) pulmonary nodule that: * is not fully calcified * is 5-30mm inclusive in maximum axial diameter for the whole lesion measured using manual electronic callipers * have baseline ct study that includes at least one series that meets all of the following (training for this will be provided): * is of a type that meets vnc instructions for use * comprises at least one full-inspiration breath-hold scans without a high degree of contrast media and does not exhibit quality issues (e.g., motion artefacts) exclusion criteria: patients will be excluded from the study if any of the following apply: * have received a diagnosis for cancer in the last 5 years * have thoracic implants that impact the image appearance of the nodule * have more than five reported pulmonary nodules of any size or type excluding fully calcified nodules (this criterion is used as a proxy due to the risk of being an infection or metastasis) * have one or more additional nodules where any of the following applies: * are already undergoing follow-up according to pulmonary nodule management standard care * pure ground glass opacity (ggo) of \>=5mm in maximum axial diameter for the whole lesion measured using manual electronic callipers * \>30mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
nitrocamptothecin in treating patients with soft tissue sarcomas

Conditions: Gastrointestinal Stromal Tumor; Sarcoma; Small Intestine Cancer

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 nitrocamptothecin in treating patients who have locally advanced or metastatic soft tissue sarcomas.

objectives: i. assess the efficacy and toxicity of nitrocamptothecin in patients with locally advanced or metastatic gastrointestinal leiomyosarcomas or other soft tissue sarcomas. outline: patients are stratified by disease (gastrointestinal leiomyosarcomas vs other soft tissue sarcomas). patients receive oral nitrocamptothecin daily on days 1-5. treatment continues weekly in the absence of disease progression or unacceptable toxicity. responding patients who undergo surgery then receive an additional 4-6 courses (4 weeks/course). projected accrual: a total of 34-78 patients (17-39 per stratum) will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed locally advanced or metastatic inoperable soft tissue sarcoma measurable or evaluable disease that has not been irradiated must have received, refused, or be not eligible for doxorubicin/ifosfamide treatment previously untreated gastrointestinal leiomyosarcoma allowed patient characteristics: age: not specified performance status: zubrod 0-2 life expectancy: at least 12 weeks hematopoietic: absolute granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl transaminases no greater than 3 times normal renal: creatinine less than 2.0 mg/dl cardiovascular: no new york heart association class iii or iv heart disease no active coronary disease requiring therapy pulmonary: no severe pulmonary insufficiency other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception during and for 3 months after study no other prior malignancy in past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix no concurrent active infections no psychosis or mental disability that would preclude study prior concurrent therapy: biologic therapy: at least 7 days since prior biological therapy and recovered no concurrent immunotherapy chemotherapy: see disease characteristics at least 3 weeks since prior chemotherapy and recovered no other concurrent chemotherapy endocrine therapy: at least 7 days since prior hormonal therapy and recovered radiotherapy: see disease characteristics surgery: not specified

Keywords: adult leiomyosarcoma stage iii adult soft tissue sarcoma recurrent adult soft tissue sarcoma small intestine leiomyosarcoma metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma childhood leiomyosarcoma gastrointestinal stromal tumor stage iv adult soft tissue sarcoma
a study of omalizumab (xolair) in subjects with moderate to severe persistent asthma (extra)

Conditions: Asthma

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ics)+ long-acting beta-agonists (laba) with or without additional controller therapy.


Eligibility criteria:
inclusion criteria: * signed informed consent form and an informed assent, if applicable * be between the ages of 12 to 75 years * have had a history of moderate to severe asthma for at least one year prior to screening * have had treatment with a stable regimen of of salmeterol 50 µg twice a day (bid) or formoterol 12 µg bid for at least 8 weeks prior to screening * have had treatment with a stable regimen of high-dose inhaled corticosteroids (ics) for at least 8 weeks prior to screening * have inadequately controlled asthma * have had at least one asthma exacerbation requiring systemic corticosteroid rescue in the 12 months prior to the screening visit while receiving treatment with high-dose ics * have less than 10 pack-years smoking history * have a positive skin test for or a positive, in vitro response to one relevant perennial aeroallergen documented within the 12 months prior to screening * if a subject has not had a positive skin test or in vitro reactivity in the 12 months prior to screening, the subject must demonstrate a positive response to at least one relevant perennial aeroallergen in a skin or in vitro test prior to randomization * female subjects of childbearing potential must use an effective method of contraception from screening through their duration of participation in the study * for the collection of additional blood samples for future research (optional), provide signed consent and an informed assent, if applicable. exclusion criteria: * have had an asthma exacerbation requiring intubation within 12 months prior to screening * have active lung disease other than asthma * have had an asthma exacerbation requiring treatment with the addition of systemic (oral or intravenous) corticosteroids or an increase in systemic corticosteroids within 30 days prior to screening * require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc. * have significant medical illness other than asthma * have taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics, within 3 months prior to screening * have taken other investigational drugs within 30 days prior to screening * have been treated with xolair within the 12 months prior to screening * have a history of drug or alcohol abuse that, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study * have elevated serum ige levels for reasons other than allergy * are pregnant or lactating

Keywords: persistent asthma extra xolair difficult breathing
korean red ginseng and metabolic syndrome

Conditions: Metabolic Syndrome

Summary: five factor consisting of metabolic syndrome is closely linked by insulin resistance. until now, several studies have been performed about effects of korea red ginseng on hypertension, diabetes, and hyperlipidemia, but not metabolic syndrome. the investigators hypothesize that korean red ginseng could improve each constituents of metabolic syndrome, arterial stiffness, and inflammatory markers. the aim of this study is to determine effects of korean red ginseng on cardiovascular risks in subjects with metabolic syndrome.

the details of study objective are followed by these: * comparison of blood pressure before and after korean red ginseng administration * comparison of metabolic indicator before and after korean red ginseng administration * comparison of oxidative stress and inflammatory markers before and after korean red ginseng administration * comparison of arterial stiffness before and after korean red ginseng administration

Eligibility criteria:
inclusion criteria:(three or more of following five factors) * waist circumference(male: more than 90cm, female: more than 80cm) * blood pressure(systolic: more than 130mmhg, diastolic: more than 85mmhg) * fasting plasma glucose: more than 100mg/dl * fasting triglycerides: more than 150mg/dl * high-density lipoprotein(hdl)-cholesterol(male: less than 40mg/dl, female: less than 50mg/dl) exclusion criteria: (any one of following factors) * uncontrolled blood pressure(systolic: more than 160mmhg, diastolic: more than 100mmhg) or subjects taking blood pressure lowering drug * type 2 diabetes patients or fasting plasma glucose more than 126mg/dl * triglyceride more than 400mg/dl, total cholesterol more than 250mg/dl * subjects taking antilipidemic drug * past history of coronary heart disease or cerebrovascular disease

Keywords: korean red ginseng metabolic syndrome blood pressure arterial stiffness inflammation oxidative stress
comparison of the efficiency of tissue adhesive (periacryl 90) and silk suture in mandibular impacted wisdom surgery

Conditions: Impacted Mandibular Third Molar Extraction

Summary: in this study, bilateral it is aimed to compare the efficacy of tissue adhesive (periacryl 90) and silk suture in mandibular impacted wisdom tooth surgery.

in the study carried out on a total of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. one of the bilateral bilateral teeth of the patients was randomly selected and tissue adhesive (periacryl 90) was applied for wound closure as the experimental group, while the other tooth was determined as the control group and the wound was closed with silk suture. the selected party was determined by the closed envelope method. after the first impacted tooth was extracted, it was waited until the wound healed and the symptoms disappeared completely, then the other tooth was extracted. in both tooth extractions, wound healing, edema and trismus were evaluated on the 3rd and 7th days. wound healing was evaluated as good, acceptable and bad. vas (visual analog scale) was used for pain assessment and assessment was made at 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.

Eligibility criteria:
inclusion criteria: * healthy individuals aged 18-35 years who accepted the study conditions and had bilateral, bone or mucosal retention, and completely impacted wisdom teeth in the similar position with an indication for extraction due to prophylactic or orthodontic treatment in the lower jaw were included in the study. exclusion criteria: * individuals with any systemic disease * individuals with a history of allergy to the drugs to be used in the study * pregnant and breastfeeding individuals * individuals with pain, swelling or trismus in the last 10 days * individuals with different positions on the right and left sides * individuals who did not sign the voluntary consent form * individuals with pathology in the impacted tooth area * individuals with limited mouth opening

Keywords: tissue adhesive impacted wisdom tooth silk suture
post-chikungunya rheumatism - rheumatology follow-up of patients after 15 years

Conditions: Chikungunya

Summary: reunion island was struck by a severe chikungunya outbreak in 2005-2006. three hundred and seven chikungunya patients were evaluated by 4 rheumatologists 2 months after the initial infection (rhumatochik study). eighty-three percents still reported joint pain and 43% joint swelling in telephone interviews after 32 months (bouquillard et al., 2018). the primary objective of the present study is to assess and classify precisely persistent chi-related joint diseases after 15 years, in a second rheumatology examination.

reunion island was struck in 2005-2006 by the most severe chikungunya outbreak (seroprevalence 38% (gérardin et al., 2013)) in a developed but previously non-immunized country, providing an unique opportunity for studying chikungunya-related joint symptoms and their long-term evolution. in a previous study, the investigators demonstrated that at least 17/73 patients initially classified as chikungunya-related inflammatory joint diseases after 40 months still suffered from inflammatory joint symptoms fullfilling validated classification criteria after 13 years (guillot et al., 2020). however, in this monocentric study, the investigators did not consider the full spectrum of chikungunya-related rheumatic diseases, the population was not fully representative and the sample size was not sufficient to perform statistical analyses nor identify poor prognosis markers. in the rhumatochik cohort study, 307 patients were evaluated by 4 rheumatologists 2 months after the infection, 83% and 43% reported persistent joint pain and joint swelling respectively after 32 months in potentially biased telephone interviews (bouquillard et al., 2018). in this context, the present study aims at performing a systematic clinical rheumatologic re-evaluation of the rhumatochik patients after 15 years, in order to precisely describe and classify the full spectrum of persistent chikungunya-related joint diseases in a larger population. after a telephone interview and screening questionnaire, these patients will be clinically re-evaluated by a second rheumatologist in a multicenter transversal follow-up study.

Eligibility criteria:
inclusion criteria: * patients previously included in the rhumatochik study (n=307), or diagnosed as chikungunya-related rheumatoid arthritis (n=21) after telephonic screening and given their oral consent * chikungunya infection (positive serology and/or evocative symptoms in the epidemic context) exclusion criteria: * impossible informed consent (cognitive impairment,...). * lost-to-follow-up patients, refusal to participate. -pre-existing chronic inflammatory rheumatic disease (prior to chikv infection)-
study of npo-13 during colonoscopy

Conditions: Bowel Disease

Summary: this study will investigate the safety, efficacy and dose-response of npo-13 in subjects with moderate to severe colonic spasm during colonoscopy. an intraluminal spraying of npo-13 dosed up to twice into ascending or sigmoid colon. the colonic spasm will be assessed by an independent committee using recorded video images. the study consists of a screening visit window, 1-day treatment phase and 1-week follow-up phase.


Eligibility criteria:
inclusion criteria: 1. patients who are between 20 and 85 years at the time of consent 2. patients who need colonoscopy exclusion criteria: 1. patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation 2. patients with contraindication to colonoscopy including the paralytic ileus 3. patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil) 4. patient with contraindication to bowel cleansing preparation 5. patient with contraindication to pain medicine and sedative medicine 6. patient with contraindication to butylscopolamine bromide and glucagon 7. patients on cancer treatment (chemotherapy or radiotherapy) 8. patient with active inflammatory bowel disease or infectious enteritis 9. patients who need sedative in colonoscopy 10. patients who receives a therapeutic colonoscopy 11. pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study 12. patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies 13. patients otherwise ineligible for participation in the study in the investigator's or coinvestigator's opinion