Kornimate/medical-research-clean huggingface dataset:
mri-guided brachytherapy in treating participants with hpv-associated stage ib2-iva cervical or stage ii-iva vaginal cancer

Conditions: Human Papillomavirus-Related Carcinoma; Human Papillomavirus-Related Cervical Carcinoma; Stage IB2 Cervical Cancer AJCC v8; Stage II Cervical Cancer AJCC v8; Stage II Vaginal Cancer AJCC v8; Stage IIA Cervical Cancer AJCC v8; Stage IIA Vaginal Cancer AJCC v8; Stage IIA1 Cervical Cancer AJCC v8; Stage IIA2 Cervical Cancer AJCC v8; Stage IIB Cervical Cancer AJCC v8; Stage IIB Vaginal Cancer AJCC v8; Stage III Cervical Cancer AJCC v8; Stage III Vaginal Cancer AJCC v8; Stage IIIA Cervical Cancer AJCC v8; Stage IIIB Cervical Cancer AJCC v8; Stage IVA Cervical Cancer AJCC v8; Stage IVA Vaginal Cancer AJCC v8

Summary: this trial studies how well magnetic resonance imaging (mri)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (hpv) associated stage ib2-iv cervical or stage ii-iva vaginal cancer. using mri guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.

primary objectives: i. determine whether mri guidance during internal radiation therapy applicator placement improves the high-risk clinical target volume (hr-ctv) d90 (dose to 90% of the high-risk clinical target volume) rate compared to conventional guidance, with ultrasound and freehand technique, for patients with cervical and vaginal cancer. secondary objectives: i. identify diffusion weighted mri image features that can be used to identify sites of viable tumor following external beam radiotherapy as assessed by tumor aspirate cytology. ii. determine if diffusion weighted mri findings are associated with immune infiltration as assessed by multi-spectral flow cytometry. iii. identify potential correlates between clinical outcomes (survival, progression) and these data objectives (brachytherapy dosimetry/therapeutic ratio, diffusion-weighted mri imaging features, tumor aspirate cytology findings). iv. define the financial costs and feasibility of an mri-guided brachytherapy approach to determine the overall healthcare quality value (outcomes/cost) of this novel approach for application at other brachytherapy centers. outline: participants undergo mri scan during internal radiation therapy applicator placement.

Eligibility criteria:
inclusion criteria: * women with stage 1b2-iva cervical cancer recommended to receive definitive chemoradiation including brachytherapy; or * women with stage ii-iva vaginal cancer recommended to receive definitive chemoradiation including brachytherapy. exclusion criteria: * patient or tumor anatomy that requires use of a non-mri-compatible applicator. * patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes mri acquisition.
efficacy and safety of endovascular recanalization for acute basilar artery occlusion with extended time window (angel-bao)

Conditions: Acute Ischemic Stroke; Basilar Artery Occlusion

Summary: the aim of this study is to assess the efficacy and safety of endovascular treatment versus medical management in patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset.

the angel-bao is a multicentered, prospective, randomized, open-label, blinded end-point clinical trial. a total of 224 patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset will be enrolled. patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (endovascular treatment or medical management) after offering informed content.

Eligibility criteria:
inclusion criteria: 1. age≥18 years 2. acute basilar artery occlusion confirmed by cta, mra, or dsa 3. pre-stroke mrs of 0-2 4. nihss score ≥ 10 before randomization 5. time interval from symptom onset (or last known well) to randomization within 24-72 hours 6. diffusion-weighted imaging(dwi)-based pc-aspects ≥ 6 and pons-midbrain index (pmi) ≤3 7. time from completion of dwi imaging to randomization is ≤3 hours 8. each patient or their legal representative must provide written informed consent before enrolment exclusion criteria: 1. any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization 2. complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging 3. ct or mri evidence of intracranial tumor (except small meningioma and cerebral aneurysm \< 3mm in diameter) 4. known or highly suspected chronic occlusion of basilar artery 5. history of contraindication for contrast medium (except mild rash) 6. current pregnant or breast-feeding 7. known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up 8. life expectancy is less than 3 months 9. enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months. 10. any other condition (in the opinion of the site investigator) that inappropriate to participate this study

Keywords: acute ischemic stroke basilar artery occlusion extended time window endovascular treatment
evaluation of the effects of medicaments used after free gingival graft on postoperative complications.

Conditions: Pain, Postoperative; Healing Wound; Hemorrhage; Analgesia

Summary: in our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting (fgg).

in our study, three different medicaments were evaluated in terms of postoperative complications after free gingival grafting. the effectiveness of these 3 different commercially available agents containing flurbiprofen, hyaluronic acid, and hypochlorous acid, after use 2., 4.7. and on the 14th day, wound healing and pain perception was compared with the control group. primary observation was obtained by visual analog scale, wound healing index, bleeding of tissue, color match, and amount of painkiller used by the patient were also recorded

Eligibility criteria:
inclusion criteria:- patients with systematic conditions are classified as the american society of anesthesiologists class i - exclusion criteria: * pregnancy, lactation, and taking contraceptive pills. * oversensitivity or anaphylactic reactions which contraindicate the intervention. * orofacial neurological symptoms. * infections at operation zone. * psychotropic medicine, sedative, or non-steroid anti-inflammatory drugs use which can alter the sense of pain. * pathological mental conditions (dementia, psychosis) and lack of cooperation. * smoking * excessive gag reflex * operations are carried out with conscious sedation. * patients who do not want to sign consent.
taso-001 in combination with recombinant interleukin-2(aldesleukin) in advanced or metastatic solid tumor

Conditions: Solid Tumor

Summary: to evaluate safety, tolerance and efficacy of taso(tgf-β2 targeting anti-sense oligonucleotide)-001 in combination with recombinant interleukin-2(aldesleukin) in advanced or metastatic solid tumor and to find appropriate dose for phase 2 clinical trial.

this clinical trial is conducted by dividing into two cohorts according to the dose of the test drug, starting with cohort 1, and confirming whether dlt occurs until 14 days after the 2nd cycle of the test drug administration and proceed with cohort 2 after discussion by dmc. recruitment of each cohort is applied with a 3+3 design.

Eligibility criteria:
inclusion criteria: 1. adults over 19 years old on the day of consent 2. pathologically confirmed solid cancer 3. patients with advanced or metastatic solid timour failed or tolerable with standard therapy. 4. a person who has a tumor lesion that can safely undergo tissue biopsy during administration of the test drug and can provide tissues stored at the clinical trial agency or tissue obtained from a tissue biopsy conducted before the first administration of the test drug exclusion criteria: 1. those who have been treated with il-2 or tgf-β inhibitors other than test drugs (e.g., anti-sense oligonucleotide, antibody, tgf-b receptor inhibitor) 2. chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment. 3. immunotherapy within 2 weeks prior to first dose of study treatment. 4. major surgery within 4 weeks prior to first dose of study treatment.

Keywords: autotelicbio taso atb-301 tgf-β2 anti-sense oligonucleotide interleukin-2 aldesleukin
a preliminary exploratory study to evaluate the safety and immunogenicity of omicron variant bivalent vaccine v-01-b5

Conditions: COVID-19 Pandemic

Summary: it is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of recombinant sars-cov-2 fusion protein bivalent vaccine v-01-b5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.


Eligibility criteria:
inclusion criteria: * adults aged 18 -59 years old at time of consent, male or female; * normal body temperature; * participants who have completed 3-dose regimen of inactive vaccination (coronavac) against sars-cov-2 wild type in the past 5-9 months; * female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment; * be able and willing to complete the study during the entire study and follow-up period; * participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol. exclusion criteria: * serious chronic diseases or uncontrolled diseases; * uncontrolled neurological disorders, epilepsy; * received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks; * patients with congenital or acquired immunodeficiency; * history of severe allergy or be allergic to any components of the test vaccines; * history of hereditary hemorrhagic tendency or coagulation dysfunction; * patients with malignant tumors and other patients have a life expectancy less than 1 year; * refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol; * history of previous covid-19 infection; * pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study; * participants who have participated in other clinical trials within 3 months or are participating in other clinical trials; * those considered by the investigator as inappropriate to participate in the study.
economic outcomes in patients with stage iii ovarian cancer receiving paclitaxel and cisplatin on clinical trial gog-172

Conditions: Ovarian Cancer

Summary: rationale: gathering information about patients with ovarian cancer over time may help doctors learn more about a patient's use of medical services and the cost of these services. purpose: this clinical trial is collecting information about the patient's health and use of medical resources over time in patients with stage iii ovarian cancer receiving paclitaxel and cisplatin on clinical trial gog-172.

objectives: * determine the feasibility of collecting data on medical resource utilization and costs incurred in the care of patients with stage iii ovarian cancer treated with intravenous (iv) paclitaxel and cisplatin vs iv paclitaxel, intraperitoneal (ip) paclitaxel, and ip cisplatin on a randomized, controlled clinical trial. * determine the feasibility of collecting data on resource utilization incurred outside gog institutions through the use of patient diaries. * assess the work load required to collect this data, in terms of mean number of hours required to complete medical resource utilization forms. outline: data on medical resource units consumed (including length of hospital stay, length of time using operating room, units of drugs and blood products administered, number of diagnostic tests received, and number of physician visits needed) are collected on all patients. quality of life is assessed prior to randomization on clinical trial gog-172, prior to the fourth course of chemotherapy, after the sixth course of chemotherapy, and at 3 months and 6 months after the sixth course of chemotherapy. patients complete diaries throughout treatment with chemotherapy and for 12 months after treatment. data collected are used for analysis of economic impact, quality of life, neurotoxicity, and sociologic characteristics associated with these treatment regimens. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 40 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * diagnosis of stage iii ovarian cancer * concurrent enrollment on clinical trial gog-172 required patient characteristics: age: * not specified performance status: * gog 0-3 life expectancy: * not specified other: * able to communicate in english or spanish prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: stage iii ovarian epithelial cancer
compassionate use of iv fish oil for parenteral nutrition (pn) liver injury

Conditions: Liver Disease

Summary: to establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (omegaven®) for compassionate use when no satisfactory alternative treatments are available.

patients who meet the inclusion criteria (having a direct bilirubin ≥4.0 mg/dl) and are consented will be discontinued from standard soybean-based lipid emulsion and started on omegaven®. omegaven® will be infused continuously via either a peripheral or central catheter at a dose of 1 gm/kg/day along with parenteral nutrition (pn).

Eligibility criteria:
inclusion criteria : - \>14 days \ or = 4 mg/dl or severe dysmotility of gut reflecting non functional gut with total bilirubin \> or = 4 mg/dl receiving at least 60 % calories by intravenous infusion requires iv nutrition an additional 28 days \* patients with direct bilirubin \> or = 6 mg/dl who do not meet criteria above but meet criteria with \* if infants qualify for high risk arm (gastroschisis, ileal atresia, \ 1 mg/dl but less than 4 mg/dl. exclusion criteria: congenital lethal condition (e.g. trisomy 13) clinically severe bleeding evidence of viral hepatitis or primary liver disease as etiology of their cholestasis other health problems such as survival extremely unlikely even if cholestasis improves known allergies to eggs or shellfish

Keywords: cholestasis parenteral nutrition
real-world clinical outcomes in patients with relapsed/refractory multiple myeloma

Conditions: Relapsed and Refractory Multiple Myeloma (RRMM)

Summary: primary objective: 1. to describe the distribution of treatment regimens and objective response rate (orr) in a benchmark cohort of real-world patients with relapsed/refractory multiple myeloma (rrmm) who initiate treatment after meeting the following criteria: (1) have either (a) at least three prior lines (3l) and are triple-class exposed (tce), or (b) are triple-class refractory (tcr), and (2) meet similar inclusion/exclusion criteria to patients in phase 2 cohort 2 of the r5458-onc-1826 (nct03761108) trial. secondary objectives: 1. to describe additional outcomes (duration of response \[dor\], progression-free survival \[pfs\], overall survival \[os\], and time to next treatment \[ttnt\]) in the same benchmark cohort population described in the primary objective. 2. to describe distribution of treatment regimens, orr, dor, pfs, os, and to compare orr, pfs, os, and ttnt in an analysis cohort consisting of real-world patients derived from the benchmark cohort described above who are weighted to align with the characteristics of patients in phase 2 cohort 2 of the r5458-onc-1826 (nct03761108) trial. comparative analyses of pfs and os will be performed conditional on sufficient maturity of survival data in the r5458-onc-1826 (nct03761108) trial at the time of analysis.


Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status ≤1 at baseline 2. confirmed diagnosis of active mm by imwg diagnostic criteria 3. have myeloma that is response-evaluable with measurable disease by m-protein in serum or urine as specified in the imwg response criteria. 4. triple-class exposed or refractory exclusion criteria: 1. diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), waldenström macroglobulinemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin (poems) changes syndrome 2. known mm brain lesions or meningeal involvement 3. history of neurodegenerative condition, central nervous system (cns) movement disorder, or seizure 4. cardiac ejection fraction \<40% by echocardiogram or multi-gated acquisition scan (muga) (or a diagnosis of congestive heart failure, cardiomyopathy, or valvular heart disease as a potential proxy) 5. continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent 6. live or live attenuated vaccines 7. treated with b-cell maturation antigen (bcma)-directed immunotherapies (bcma antibody-drug conjugates are not excluded). note: other protocol-defined inclusion/exclusion criteria apply

Keywords: real-world outcomes multiple myeloma (mm) objective response rate (orr) triple-class exposed (tce) triple-class refractory (tcr) progression-free survival (pfs) overall survival (os)
predictive markers of response and toxicity in patients with a haematological malignancy treated with immunotherapy.

Conditions: Blood Cancer

Summary: immunotherapies have substantially improved the prognosis of patients with haematological malignancies. while clinical trial data suggest durable complete response rates, markers associated with non-response to treatment are still poorly described. the identification of predictive markers using demographic, physiologic, biologic, immunologic data as well as patients' treatment history, might enable the optimization of therapeutic sequences and the reduction of treatment toxicity. this study aim to assess markers of toxicity and response following an immunotherapy in patients with a haematological malignancy using real life data. it will allow the development of clinical and therapeutic benchmarks to guide medical decisions in relation to the therapeutic strategies to be implemented for patients benefiting from real-life conditions, in addition to the results obtained in randomized studies.


Eligibility criteria:
inclusion criteria : * adult \>or= 18 years old, * suffering from one of the following pathologies: hodgkin's lymphoma, diffuse large b-cell lymphoma, mantle b-cell lymphoma, acute myeloid leukemia, acute lymphoid leukemia, peripheral t-cell lymphoma, * patients treated wuth any of the following immunotherapy : nivolumab, pembrolizumab, brentuximab vedotin, axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, gentuzumab ozogamicine, polatuzumab vedotin and blinatumomab, exclusion criteria : - patients opposed to the collection of their personnal data

Keywords: haematologic malignancies immunotherapy response predictor immune-related adverse event
vitamin d supplementation in adult crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether vitamin d supplementation is effective in the prevention of relapse in crohn's disease.


Eligibility criteria:
inclusion criteria: * all patients must fulfill the clinical criteria for diagnosis of crohn's disease. * subjects must have inactive cd as defined by cdai \< 150 * crp \</=10 mg/l. exclusion criteria: * pregnant and lactating women. * known hypersensitivity to vitamin d. * hypercalcaemia * current supplemental intake of vitamin d3 \>800 iu/d. * diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active tb, sarcoidosis, lymphoma. * participation in a concurrent clinical trial.
the effect of obesity in dexmedetomidine metabolic clearance

Conditions: Obesity

Summary: the purpose of this study is to study the effect of obesity in dexmedetomidine pharmacokinetics and pharmacodynamic profile.

the investigators expect to find an inverse correlation between the amount of fat mass and liver blood flow or with the enzymatic metabolic capacity. results will be based on a population pharmacokinetic modeling analysis performed in nonmem program. the investigators will first account for the effect of different measured size scalars on volumes and clearances and then they will search for plausible covariates (liver blood flow, enzymatic capacity, degree of hepatic steatosis, etc) on dexmedetomidine metabolic clearance. a pharmacokinetic model capable of characterizing clearance changes in the obese using more plausible biological covariates will be tried to be defined.

Eligibility criteria:
inclusion criteria for obese patients: * american society of anesthesiology classification i-iii patients. * both genders. * age between 18 - 60 years. * body mass index higher than 40 kg/m2. inclusion criteria for non-obese patients: * american society of anesthesiology classification i-ii patients * both genders. * age between 18 - 60 years * body mass index lower than 30 kg/m2. exclusion criteria: * known allergy to study drugs * uncontrolled hypertension. * heart block greater than first degree. * chronic hepatic and kidney disease. * patients taking any drug acting in the central nervous system within 24 hrs before surgery. * patients taking drugs that induce overexpression of liver cytochrome p450-complex enzymes (carbamazepine, phenytoin, phenobarbital, rifampicin, dexamethasone, griseofulvin, terbinafine, prednisone, hydrocortisone, modafinil).) * known addiction to illicit drugs. * pregnancy. * current or past oncologic disease.

Keywords: dexmedetomidine pharmacokinetic obesity