Kornimate/medical-research-clean huggingface dataset:
broad spectrum hpv (human papillomavirus) vaccine study in 16-to 26-year-old women (v503-001)

Conditions: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection

Summary: the purpose of this study was to evaluate the safety, efficacy, and immunogenicity of v503 in comparison to gardasil. the primary hypotheses tested in the study were 1) v503 administered to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) v503 reduces combined incidence of human papillomavirus (hpv) type 31/33/45/52/58-related disease compared with gardasil, and 3) v503 induces non-inferior geometric mean titers for hpv type 6/11/16/18 antibodies compared with gardasil.

the study included a dose-finding evaluation of a 3-dose regimen of v503 and gardasil, a safety/efficacy evaluation of a 3-dose regimen of the selected v503 dose formulation and gardasil, and an extension consisting of 2 substudies: an evaluation of immune memory in participants receiving a fourth vaccination with v503 (cohort 1), and an opportunity for participants who received gardasil in the base study to receive a 3-dose regimen of v503 (cohort 2).

Eligibility criteria:
inclusion criteria: * female between 16- to 26-years-old * has never had pap testing or has only had normal pap (papanicolaou) test results * for the immune memory substudy in the extension (cohort 1): was randomized to v503 in the base study and was in the per-protocol immunogenicity population for ≥1 hpv type * for the 3-dose v503 vaccination substudy in the extension (cohort 2): was randomized to gardasil in the base study and received ≥1 dose of gardasil exclusion criteria: * history of an abnormal cervical biopsy result * history of a positive test for hpv * history of external genital/vaginal warts * currently a user of any illegal drugs or an alcohol abuser * history of severe allergic reaction that required medical attention * are pregnant * received marketed hpv vaccine or participated in an hpv trial * currently enrolled in a clinical trial * currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent.)
a study of the real-world use of an adalimumab biosimilar and evaluation of nutritional status on the therapeutic response

Conditions: Crohn Disease; Ulcerative Colitis; Psoriasis; Ankylosing Spondylitis; Rheumatoid Arthritis; Psoriatic Arthritis

Summary: the aim of the study is to describe the real-world profile of patients treated with adalimumab fk in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.


Eligibility criteria:
inclusion criteria: * patients at least 18 years old who agree to participate in the study and do not object to the use of their health data * a disorder treated with anti-tnf therapy * whose physician made the decision to initiate adalimumab treatment prior to the study exclusion criteria: * patients participating in an interventional therapeutic trial at the time of inclusion * patients who are unwilling or unable to fulfil follow-up requirements (patients who cannot be reached by phone or complete the self-administered questionnaire or not fluent in french

Keywords: nutrition
efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis taking methotrexate

Conditions: Rheumatoid Arthritis

Summary: the study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active rheumatoid arthritis (ra) despite treatment with methotrexate.


Eligibility criteria:
inclusion criteria: * presence of ra classified by acr 2010 revised criteria for at least 3 months before screening * must have been taking mtx for at least 3 months before randomization and must currently be on a stable dose of mtx for at least 4 weeks before randomization. * at baseline: disease activity criteria defined by \>6 tender joints out of 68 and \>6 swollen joints out of 66 and with at least 1 of the following at screening: anti-ccp antibodies positive or rheumatoid factor positive and with at least 1 of the following at screening: hscrp ≥ 10 mg/l or esr ≥ 28 exclusion criteria: * ra patients functional status class iv according to the acr 1991 revised criteria * previous exposure to secukinumab or any other biologic drug directly targeting il-17 or il-17 receptor * previous exposure ever to an anti-tnf-a agent or any other immunomodulatory biologic agent (experimental or approved) * patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine) * any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required for treatment of arthritis within 4 weeks before randomization * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: rheumatoid arthritis ra secukinumab ain457 inflammatory joints american college of rheumatology acr
milk matters in malnutrition, is it the lactose or dairy protein?

Conditions: Malnutrition, Child

Summary: this study is to look at the types of sugar and protein composition in the treatment of moderate acute malnutrition and its effects on gut health. the study will use 4 different types of ready to use supplementary foods to see which one if any has better recovery rate along with looking into the gut health. children will be treated using one food for up to 12 weeks. a subset of about 400 will be tested for intestinal permeability using the dual sugar test.


Eligibility criteria:
inclusion criteria: * muac \< 12.5 cm and ≥ 11.5 cm without bipedal oedema exclusion criteria: * if they are involved in another research trial * in another supplemental feeding program * debilitating illness * history of peanut or milk allergy
pharmacoepidemiology treatment of symptomatic pulmonary embolism in hospitalized patients aged 75 years or more: peage

Conditions: Elderly; Pulmonary Embolism; Anticoagulants

Summary: the treatment of the venous thromboembolic disease, including pulmonary embolism (pe), is based on anticoagulants. during the last decade, all the randomized clinical trials evaluating these anticoagulants have included pe patients with an average age below 60 years. but in clinical pratice, approximately 50% of pe patients are older than 75 years. so the investigators want to perform a french multicentre prospective cohort of consecutive patients receiving an anticoagulant treatment for a symptomatic and confirmed pe. all the validated and available anticoagulant treatments are authorized in this cohort (unfractionnated and low molecular weight heparins, fondaparinux, vitamin k antagonists and direct oral anticoagulants). this cohort will provide data regarding the bleeding risk and the risk of pe recurrences and regarding the pharmacokinetic (pk) and pharmacodynamic (pd) properties of these anticoagulants in this older population. using population approach modelling , the investigators will pay particular attention to the sources of pk/pd variability pk / pd such as genetic polymorphisms of p-glycoprotein and cytochrome p450. using all these data , the investigators will try to identify significant risk factors for bleeding and venous thromboembolic events.


Eligibility criteria:
inclusion criteria: * symptomatic pulmonary embolism confirmed by objective paraclinical examination with or without dvt associated * confirmation of pulmonary embolism within 3 days * administration possible according to the recommended dosages of anticoagulant treatment : (unfractionnated and low molecular weight heparins, fondaparinux, vitamin k antagonists and direct oral anticoagulants) * indication of anticoagulant treatment for at least 6 months exclusion criteria: * on therapeutic dose of anticoagulant treatment over 72 hours * indication to therapeutic dose of anticoagulant treatment for another reason. * inability for whatever reasons, to prescribe recommended anticoagulant treatment * pe treatment on heparin-induced thrombocytopenia requiring argatroban, lepirudin or danaparoid treatment, * ongoing bleeding * pe occurring despite well conducted anticoagulant treatment * contraindications to recommended dose of anticoagulant treatment

Keywords: elderly patients pulmonary embolism anticoagulant treatments
piloting a biomarker-augmented alcohol screening, brief intervention, and referral to treatment (sbirt) program among hiv-affected adolescents and young adults in zambia

Conditions: Alcohol

Summary: this will be a pilot study of an alcohol screening, brief intervention, and referral to treatment (sbirt) program conducted within existing hiv prevention and treatment services for adolescents and young adults (aya) in lusaka, zambia. the screening component of the program will feature both a self-report and a urine biomarker (ethyl glucuronide; etg) to evaluate recent alcohol use. we will recruit 60 aya to participate in the pilot. the specific aims of this pilot are to: specific aims: 1. explore implementation factors of the sbirt program within hiv prevention and treatment services through a process evaluation. we will quantitatively track the number of aya in the sbirt care cascade: 1) the number screened who have recent alcohol use; 2) the number of those with recent alcohol use who receive the brief intervention (bi); 3) the number of those who are referred for additional treatment; and 4) among those who are referred, the number who successfully link and complete treatment. we will collect time use data from clinic staff and counselors to estimate the time burden required for the sbirt program. we will conduct 30 in-depth interviews with aya three months after the screening. the sample will include adolescents who: (1) did not recently use alcohol; (2) received bi due to recent alcohol use that was low/moderate risk; and (3) were referred for treatment due to higher risk alcohol use. interviews will focus on: (1) implementation factors (e.g., acceptability, feasibility) of the sbirt program and (2) barriers and facilitators to the program's implementation. focus group discussions and in-depth interviews will also be conducted with program staff (e.g., counselors, clinic staff) and other stakeholders (e.g., community leaders, policy-makers). 2. evaluate the preliminary impact of the sbirt program on aya alcohol use. among aya who have recent alcohol use at screening, we will measure change in use at a three-month follow-up visit.


Eligibility criteria:
inclusion criteria: * 16-24 years of age * residing in lusaka, zambia * meets definition of hiv-affected as evidenced as being involved in hiv testing and treatment and adolescent friendly spaces programs at the three sites (we will not ask adolescents direct questions about hiv during screening; see recruitment section). exclusion criteria: • unable or unwilling to provide informed assent/consent
comparison of disease modifying antirheumatic drugs therapy in patients with ra failing methotrexate monotherapy

Conditions: Rheumatoid Arthritis

Summary: ra (rheuatoid arthritis) is a multisystem disease that mainly involves joints resulting in destructive arthritis if not treated rapidly. inspite of various advances in field of early diagnosis and treatment of ra, there is still a need for better understanding of the efficacy and safety of various combinations of conventional dmards, and to rank them in order accordingly, so as to give a clearer vision for further management of ra once mtx monotherapy fails, so as to achieve remission as soon as possible. the study will be conducted at the department of clinical immunology, jipmer (jawaharlal institute of postgraduate medical education \& research). patients who fail methotrexate monotherapy will be randomised to 2 treatment arms - either a combination of sulfasalazine (ssz), hydroxychloroquine (hcq) and methotrexate (mtx) or leflunomide (lef), hydroxychloroquine (hcq) and methotrexate (mtx)

patients aged ≥18 years, fulfilling the 2010 acr eular criteria for ra (symptom duration less than two years) , having more than 4 joints involved \& having moderate to severe disease activity (das28≥3.2) will be invited to participate. after providing written informed consent, eligible patients will be first started on mtx monotherapy \& only patients who have persistant moderate disease activity (das28 esr \> 3.2) will be randomized into two groups. block randomization will be done to generate random allocation sequence group 1 - will receive mtx+lef+hcq group 2- will receive mtx+ssz+hcq dmard dosages used are: mtx 25 mg/week orally (dosage after 6 weeks),ssz 2g/d (after 4 weeks) lef 20 mg/day (dosage after 2 weeks) and hcq 200 mg/day. glucocorticoids will be given in an oral tapering scheme. all patients will be prescribed folic acid (10 mg/week) during mtx prescription.

Eligibility criteria:
inclusion criteria: age \>18 years satisfying acr-eular criteria for ra 1. polyarthritis (\>4 joints) 2. disease duration of less than 2 years 3. patients with moderate to severe disease activity (das28\>3.2) 4. patients who have failed to respond to initial methotrexate monotherapy exclusion criteria: 1. end stage disease (deformed fixed joints) 2. patients with vasculitis, extra-articular features like interstitial lung disease8 3. contraindications to dmard therapy (chronic alcoholism, chronic liver disease, evidence of acute/chronic infection, chronic kidney disease, patients with leucopenia (\ 2× upper normal value and creatinine clearance \<30ml/minute ) 4. pregnant, lactating women ; patients (both men and women) of reproductive age group unwilling for contraceptive use who have not completed the family 5. patients unable to come for regular follow up
german pediatric hemophilia research database

Conditions: Hemophilia A; Hemophilia B; Children; Drug Specific Antibodies

Summary: the german pediatric hemophilia research database will collect data on the prophylactic and therapeutic use of factor concentrates, complications, outcome measures (joint scores, qol) and living circumstances in newly diagnosed children with hemophilia.


Eligibility criteria:
inclusion criteria: * hemophilia a or b * fviii/fix \<1% to 25% * informed consent exclusion criteria: * no consent
neoadjuvant treatment modalities in esophageal cancer

Conditions: Esophageal Cancer; Chemotherapy Effect; Chemoradiation; Surgery; Targeted Therapy; Immunotherapy; Esophagogastric Juction Cancer

Summary: esophageal cancer is the most prevalent cancer globally with poor survival outcome. the prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. either neoadjuvant chemotherapy (nct) or chemoradiotherapy (ncrt) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. the purpose of this study was to explore the optimal neoadjuvant treatment modalities including pd-1/pd-l1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.


Eligibility criteria:
inclusion criteria: * ≥18 years； * esophageal or esophagogastric cancer； * histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as i-iva (ajcc 8th)； * primary treatment performed in cancer hospital, chinese academy of medical sciences； * ecog ps score: 0\~1； * estimated survival time ≥3 months； * normal organ and marrow function as defined below:hemoglobin: greater than or equal to 100g/l ;leukocytes: greater than or equal to 4,000 g/l; neutrophil: greater than or equal to 2,000 g/l; platelets: greater than or equal to 100,000/mm3 ; creatinine: less than or equal to 1.5 times the upper limit or ccr greater than or equal to 60 ml/min; ast/alt: less than or equal to 2.5 times the upper limit; total bilirubin: less than or equal to 1.5 times the upper limit; inr: less than or equal to 1.5 times the upper limit; aptt: less than or equal to 1.5 times the upper limit; pt: less than or equal to 1.5 times the upper limit； * informed consent； exclusion criteria: * with any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, cns, etc； * patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer； * existing active infection such as active tuberculosis and hepatitis； * history of myocardial infarction within the past 6 months or history of ventricular arrhythmia； * uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness history of allergic reactions attributed to paclitaxel, albumin or cisplatin； * participation in other clinical trials currently or within 4 weeks of selection； * pregnant or lactating females； * absence of medical records.
vorasidenib expanded access program

Conditions: Glioma; Recurrence; Disease Attributes; Pathologic Processes; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Summary: this is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with idh1- or idh2-mutated glioma.

this expanded access program is designed to provide access to vorasidenib for patients with idh1- or idh2-mutated glioma who are not eligible for other vorasidenib clinical trials, and who in the opinion of the treating oncologist would potentially benefit from treatment with vorasidenib. safety assessments (including vital signs, hematology, and serum chemistry) occur every two weeks for the first two cycles (28 day each cycle), then monthly for the duration of treatment. treatment with vorasidenib will continue until, in the clinical judgement of the treating physician, the patient is no longer benefiting from the treatment, vorasidenib is approved and available by prescription, or the study is terminated. requests by treating physicians to file a single patient investigational new drug application as part of the expanded access program for vorasidenib will be considered on a case-by-case basis.

Eligibility criteria:
inclusion criteria: 1. male and females; ages ≥ 12 years old. 2. idh-mutant oligodendroglioma or astrocytoma with the idh1 or idh2 gene mutation confirmed by tissue-based diagnosis. 3. at least 1 prior surgery for glioma (including biopsy). 4. adequate bone marrow function as evidenced by: * absolute neutrophil count ≥ 1.5 x 109/l * hemoglobin ≥ 9 g/dl * platelets ≥ 100 x 109/l 5. adequate hepatic function as evidenced by: * serum total bilirubin ≤ 1.5 x upper limit of normal (uln) * aspartate aminotransferase and alanine aminotransferase: at or below the uln * alkaline phosphatase ≤ 2.5 x uln 6. adequate renal function as evidenced by a creatinine clearance (crcl) ≥ 40 ml/min exclusion criteria: 7. patient is eligible for a clinical trial with vorasidenib. 8. patients who are enrolled in a servier-sponsored clinical trial and have completed all requirements of the trial may be eligible if the patient continues to benefit from vorasidenib and does not meet criteria for discontinuation of treatment. 9. pregnant or breastfeeding. 10. patients who require or who cannot withhold strong inhibitors of cyp1a2 (ciprofloxacin and fluvoxamine). consider alternative therapies that are not strong cyp1a2 inhibitors.

Keywords: vorasidenib ag-881 s95032 glioma oligodendroglioma astrocytoma idh-1 idh-2
a study to evaluate safety, tolerability, pharmacokinetics and activity of oraxol in subjects with advanced malignancies

Conditions: Solid Tumor

Summary: this is a standard "3+3" phase 1b study to determine the mtd of oraxol (paclitaxel + hm30181 methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per recist version 1.1 criteria.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. ≥ 18 years of age 3. histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. 4. measurable disease as per recist version 1.1 criteria. 5. adequate bone marrow reserve as demonstrated by * absolute neutrophil count (anc) ≥1.5 x 10⁹/l * platelet count ≥ 100 x 10⁹/l * hemoglobin (hgb) ≥ 9 g/l 6. adequate liver function as demonstrated by * total bilirubin of ≤ 1.5 mg/dl or ≤ 2.0 mg/dl for subjects with liver metastasis * alanine aminotransferase (alt)≤ 3 x upper limit of normal (uln) or ≤ 5x uln if liver metastasis is present * alp ≤ 3 x uln or ≤ 5 x uln if bone metastasis is present 7. adequate renal function as demonstrated by serum creatinine ≤ 1.5 x uln, or 24-hr urine creatinine clearance calculation \>60 ml/min 8. eastern cooperative oncology group (ecog) performance status of 0 to 1 9. life expectancy of at least 3 months 10. subjects who are not currently taking prohibited medication 11. women must be postmenopausal (\> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception exclusion criteria: 1. have not recovered to ≤ grade 1 toxicity from previous anticancer treatments or previous investigational agents 2. received investigational agents within 14 days or 5 half-lives of the first study dosing day, whichever is longer. 3. women of childbearing potential who are pregnant or breast feeding. 4. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or psychiatric illness/social situations that would limit compliance with study requirements 5. significant or uncontrolled cardiovascular disease or bleeding disorder 6. major surgery to the upper gastrointestinal (gi) tract, or have a history of gi disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption 7. subjects with a known history of allergy to paclitaxel. subjects whose allergy was due to the iv solvent (such as cremophor®) and not paclitaxel will be eligible for this study.