Kornimate/medical-research-clean huggingface dataset:
ivosidenib, nivolumab, and ipilimumab combination in previously treated subjects with nonresectable or metastatic idh1 mutant cholangiocarcinoma

Conditions: IDH1-mutant Cholangiocarcinoma

Summary: this is a phase 1/2 study evaluating the safety, tolerability, and activity of ivosidenib in combination with immunotherapy in participants with nonresectable or metastatic cholangiocarcinoma. the study includes two phases: the safety lead-in phase to determine the recommended combination dose (rcd) of ivosidenib in combination with immunotherapy and the dose expansion phase to assess the efficacy of ivosidenib in combination with immunotherapy. study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met.


Eligibility criteria:
inclusion criteria: * male of female participant age ≥ 18 years old * have documented idh1 gene-mutated disease based on local testing procedure (r132c/l/g/h/s mutations variants tested) * eastern cooperative oncology group performance status (ecog ps) score of 0 or 1 * has a histopathological diagnosis consistent with nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies * participants must have at least one measurable lesion as defined by recist version 1.1. subjects who have received prior local therapy (including but not limited to embolization, chemoembolization, radiofrequency ablation, or radiation therapy) are eligible provided measurable disease falls outside of the treatment field or if within the field but has shown ≥ 20% growth in size post-treatment assessment. exclusion criteria: * received prior treatment with an idh inhibitor or prior treatment with an immune checkpoint inhibitor other than anti-pd1/l1 * have active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment * participants who have not recovered from toxicity of previous anticancer therapy, including grade ≥ 1 non-hematologic toxicity, according to the national cancer institute common terminology criteria for adverse events v5.0, prior to the first imp administration. residual grade ≤ 2 toxicity from chemotherapy (e.g., alopecia, neuropathy) may be allowed. * have known symptomatic brain metastases requiring steroids. subjects with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and have radiographically stable disease for at least 3 months prior to study entry. note: up to 10 mg per day of prednisone equivalent will be allowed.
bacteriological evaluation of children with otorrhea

Conditions: Otorrhea

Summary: after pneumococcal conjugate vaccine implementation, the number of acute otitis media (aom) episodes has decreased, but aom still remains among the most common diagnoses in childhood. from 2% to 17% of cases of aom feature spontaneous perforation of the tympanic membrane (sptm). the aim of this study was to describe the bacteriological causes of sptm several years after pcv13 implementation, in 2010.

since october 2015, children with spontaneous perforation of the tympanic membrane (sptm) are prospectively enrolled by 41 pediatricians who are part of a research and teaching network (activ, association clinique et thérapeutique infantile du val de marne \[clinical and therapeutic association of val de marne\]) throughout france. for some patients, otorrhea is the first manifestation of aom; for others, otorrhea occurred after aom treatment failure or recurrence. failure (non-responsive aom) is defined as otorrhea appearing despite at least 48 hr of antibiotics or recurring less than 4 days after the end of antibiotic treatment. recurrence is defined by the appearance of otorrhea 4 to 30 days after the end of antibiotic treatment for aom. middle ear fluid (mef) is obtained by sampling spontaneous discharge according to clinical practice guidelines. mef specimens are obtained with cotton-tipped wire swabs, immediately placed in transport medium (copan venturi transystem®, brescia, italy), and transported within 48 hr to one of the two centralized microbiology laboratories (robert debré hospital or national centre for pneumococci at european georges pompidou hospital, paris, france).

Eligibility criteria:
inclusion criteria: * children from 3 months to 15 years old * with otorrhea * signed parents consent exclusion criteria: * children under 3 months * children \> 15 years old

Keywords: otorrrhea children spontaneous perforation of the tympanic membrane ambulatory streptococcus pneumoniae heamophilus influenzae moraxella catarrhalis streptococcus pyogenes
a cross-sectional study of copd and symptom variability in mea countries

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this non-interventional study aims at assessing stable gold c and d copd patient's perception of daily and weekly symptoms variability and their impact on daily activities. it will also explore the current practice in management of stable gold c and d copd patients.

1. primary objective: to assess perception of daily and weekly variability of symptoms in stable gold c and d copd patients and their impact on daily life activities 2. secondary objectives: * to describe the current treatment practice for the management of gold c and d copd in mea countries and their adherence to the gold 2015 guidelines * to compare patients' perception of symptoms variability and their impact on activities between gold categories c and d * to identify demographic, behavioral and clinical factors associated with symptoms variability.

Eligibility criteria:
inclusion criteria: * patients eligible for inclusion have to fulfill all of the following criteria: 1. stable gold c or d copd patient under maintenance treatment, over 45 years, who provided signed informed consent; 2. copd diagnosis documented by spirometry performed in the past 12 months with an fev1/fvc \< 0.7 and an fev1 \< 50% predicted. exclusion criteria: patients are not eligible for inclusion if they meet one of the following criteria: 1. patient with an ongoing copd exacerbation\*; 2. patient who has experienced an exacerbation\* in the previous 3 months; 3. history of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis; 4. inability to understand the study related questions; 5. mentally disabled patient or unable to read and write; 6. pregnant. 7. current participation in a clinical trial;
efficacy of the use of bortezomib for the treatment of relapsed leukemia or positive mrd

Conditions: Acute Lymphoblastic Leukemia, in Relapse; Chemotherapeutic Toxicity; Minimal Residual Disease

Summary: various drugs have been added to different treatment regimens in order to improve the response rate in patients with acute lymphoblastic leukemia, however, it has been shown that adding bortezomib to the relapsing regimen improves the proportion of second complete remissions without increasing chemotherapy toxicity. therefore, proteasome inhibitors can drastically modify the prognosis of patients, since their synergy with drugs such as steroids has positioned them as an attractive strategy.

mortality associated with leukemia has decreased due to the use of various chemotherapy combinations, the addition of new agents, or the chemical modification of existing drugs. despite advances in treatment, the prognosis in the adult population continues to be unfavorable. about 25% of the patients will be refractory to the first treatment regimen and the rest will have a disease-free survival below 40%. the chemotherapy intensity reduction strategy based on risk stratification according to minimal residual disease (mrd) is a strategy used by various pediatric centers in order to detect patients at high risk of relapse.

Eligibility criteria:
inclusion criteria: * patients with a confirmatory diagnosis of acute lymphoblastic leukemia relapsed to bone marrow described with more than 5% blasts in bone marrow at any stage of treatment or positivity of minimal residual disease at any stage of treatment. * patients who have signed their informed consent from the institution for hospitalization, and accepted the performance of the bone marrow study, and the administration of chemotherapy. exclusion criteria: * patients with a diagnosis of phenotypic leukemia or bilinear leukemia * patients treated only with palliative regimen or transfusion support * patients without the administration of prophylaxis to the central nervous system by intrathecal chemotherapy * patients with lymphoblastic leukemia with a positive philadelphia chromosome * patients with severe comorbidities may put treatment therapy at risk. * patient with a history of cardiac toxicity or arrhythmias associated with treatment

Keywords: acute lymphoblastic leukemia bortezomib relapse minimal residual disease toxicity
the evaluation of oral acitretin in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases

Conditions: Basal Cell Carcinoma; Keratosis Palmaris et Plantaris; Psoriasis

Summary: this is a continuing study which evaluates the long-term safety and efficacy of oral acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases.

this is a continuing study which evaluates the long-term safety and efficacy of oral acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases.

Eligibility criteria:
patients with widespread involvement (e.g. psoriasis patients with 10 percent or more of body surface area involved) or with severe, recalcitrant localized involvement with a cutaneous disorder (e.g. keratoderma palmaris et plantaris). patients (and parents of patients who are less than 18 years old) must be advised of presently available alternative forms of therapy. patient must be available for and agreeable to regular follow up examinations in the clinic for clinical evaluation, blood tests, diagnostic x-rays and possibly skin biopsies. the patient (and parent, guardian, or surrogate where appropriate) must give written informed consent after protocol, including its limitations and risks, are thoroughly discussed with the patients (and parents). patients who have multiple skin cancers because of xeroderma pigmentosum (xp). no patients with persistently abnormal (sgot or sgpt greater than 3 times the upper limit of normal) liver function tests. no patients with persistent pre-treatment hypertriglyceridemia (greater than 300 mg/dl). no patients with persistently abnormal (creatinine greater than 3 times the upper limit of normal) renal function tests. no patients with presence of a significant neurological, musculoskeletal or other internal medical disorder which may be aggravated by the addition of retinoid therapy. patient must not be pregnant or anticipate such an event. because of the long-term storage of etretinate, a known teratogen, fertile women who may be treated in this protocol, must have skin disease that is severe and recalcitrant to all other standard modalities. these women must also use an effective form of contraception (oral contraceptives or an intrauterine device) while on treatment and at least for 3 years post treatment. no patients with chronic intake of excessive dietary vitamin a (more than 25,000 iu/day).

Keywords: hypertriglyceridemia teratogenicity ichthyosis darier's disease retinoids skin psoriasis basal cell carcinoma skin cancer
study to estimate the burden of herpes zoster (hz) and post-herpetic neuralgia (phn) in italy

Conditions: Herpes Zoster; Herpes Zoster Vaccine

Summary: the purpose of this study is to collect data on the incidence, complications, economic burden and impact on the quality of life in adults aged ≥ 50 years with hz disease in italy.

the surveillance/recruitment period will take approximately 2 years and once the enrolment of hz patients has ended, the study will continue for a maximum of 9 months to allow for completion of the follow-up of potential phn cases. the data will be captured at protocol specified time-points based on the time of enrolment of each subject.

Eligibility criteria:
inclusion criteria: * a male or female ≥ 50 years of age at the time of study enrolment presenting with acute hz. * hz diagnosis for this hz episode: * is his/her first outpatient diagnosis (i.e. initial consultation), or * took place at another site/centre (e.g. emergency room or dermatologist/specialist practice) provided the hz diagnosis is not more than 7 days before the initial visit for the present study (i.e. secondary consultation). * written informed consent obtained from the patient. * ability to comply with study procedures. exclusion criteria: • patient participating in another clinical study (participation in another observational, non-interventional trial is allowed).

Keywords: adults italy herpes zoster complications quality of life surveillance burden cost incidence
apalutamiapalutamide and stereotactic body radiation therapy for metastatic prostate cancer

Conditions: Oligometastatic Hormone Sensitive Prostate Cancer

Summary: final results from titan trial showed that apalutamide plus adt improved os in a population of patients with metastatic hormone sensitive prostate cancer (mhspc), if compared to adt alone. however, stereotactic body radiotherapy (sbrt) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. however, there are no trials specifically exploring the benefit offered by sbrt in oligometastatic mhspc treated with apalutamide if compared to apalutamide alone associated to androgen deprivation therapy. thus, a randomized trial was designed to test specifically the hypotesis that sbrt will improve outcome in a selected population of oligometastatic mhspc treated with apalutamide and adt, undergoing baseline staging according to local reimbursability.

prospective phase ii randomized superiority study, open label, multicentric. patients with oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions and treated with androgen deprivation treatment associated with apalutamide will be randomized to receive standard systemic treatment alone or concomitant sbrt on all sites of metastatic disease.

Eligibility criteria:
inclusion criteria: * patients who have signed written informed consent * adult patients ≥ 18 years * oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions \*, \*\* * all lesions must be amenable to sbrt in judgment of treating radiation oncologist \*\*\* * patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administered * androgen deprivation therapy (adt) started ≤ 6 months before enrollment * patients should be eligible to apalutamide treatment exclusion criteria: * presence of visceral disease * de novo metastatic disease * any contraindication to the use of apalutamide * any condition for which, in the opinion of the treating physician, sbrt should not be proposed or could be contraindicated
augmenting response to entecavir with peginterferon a-2a for the treatment of hbeag-positive chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to investigate whether it is possible to augment the response of patients with hbeag-positive chronic hepatitis b to entecavir by using a temporary peginterferon alpha-2a add-on strategy


Eligibility criteria:
inclusion criteria: * chronic hepatitis b (hbsag positive \> 6 months) * hbeag positive, anti-hbe negative at screening * alt \> 1.3 x uln within 60 days prior to screening and during screening * liver biopsy performed within 2 years prior to screening or during screening * age \> 18 years * written informed consent * adequate contraception for males and females during treatment and follow up; negative pregnancy test (for women of childbearing potential) exclusion criteria: * antiviral therapy against hbv within the previous 6 months * treatment with any investigational drug within 30 days of screening * previous treatment with lamivudine or telbivudine for more than six months * severe hepatitis activity as documented by alt\>10 x uln * history of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy) * pre-existent neutropenia (neutrophils \< 1,500/mm3) or thrombocytopenia (platelets \< 90,000/mm3) * co-infection with hepatitis c virus or human immunodeficiency virus (hiv) * other acquired or inherited causes of liver disease (i.e. alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, wilson's disease or alpha-1 antitrypsin deficiency) * alpha fetoprotein \> 50 ng/ml * hyper- or hypothyroidism (subjects requiring medication to maintain tsh levels in the normal range are eligible if all other inclusion/exclusion criteria are met) * immune suppressive treatment within the previous 6 months * contra-indications for alpha-interferon therapy like suspected hypersensitivity to interferon or peg-interferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study. * pregnancy, lactation * other significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. hiv positivity, auto-immune diseases, organ transplants other than cornea and hair transplant) * any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study * substance abuse, such as alcohol (\> 80 g/day), i.v. drugs and inhaled drugs in the past 2 years. * any other condition which in the opinion of the principal investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study

Keywords: hepatitis b entecavir pegylated interferon a-2a
endoscopic capillary oximetry for tumor diagnosis in head and neck cancer

Conditions: Head and Neck Cancer

Summary: endoscopy is a standard part of the evaluation of patients with head and neck cancer used for determining the extent of tumor involvement. however, not all areas involved by tumor are apparent visually. preliminary results indicate that compared with normal tissues, tumors have abnormal levels of capillary oxygenation. the purpose of this study is to determine the ability of non-pulsatile visible light tissue oxygen monitoring to differentiate normal and tumor tissue based on capillary oxygenation during endoscopy should this be possible, this method could be used to mark tumor extent and invasion, even when that invasion is up to 5mm blow the tissue surface.


Eligibility criteria:
inclusion criteria:all patients with newly diagnosed head and neck cancer as well as those being seen for routine follow up with no evidence of current disease and healthy volunteers are eligible for this study.
observational study of the use of 8% capsaicin patch in children 0 to 18 years old

Conditions: Neuropathic Pain; Chronic Pain

Summary: patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. if they accept it as well as their parents, they will be included in the study . medical data will be recorded and at home, the child or his family will collect pain assessment data. tolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.

children and teenagers aged less than 18-y, with chronic localized neuropathic pain, may be treated by capsaicin 8% patch. if this indication is validated in pediatric chronic pain consultation, they will be offered to participate the study. if they accept it as well as their parents, they will be included in the study. treatment application will follow recommendations and be realized in out patient clinic with trained nurses. tolerance will be assessed by phone call every 24 hours by investigational team until normalization. expected duration is less than 24 hours for 75% patients and 100 % at 72 hours, from unpublished personal data. efficacy will be monitored with usual pain and neuropathic pain tools, adapted to age and cognitive capacities, one month after application. treatment may be done three times if needed with a three month interval between each capsaicin patch application.

Eligibility criteria:
inclusion criteria: * chronic localized neuropathic pain * capsaicin 8% patch treatment indication validated in a pediatric chronic pain center * agreement for participation by child and parents exclusion criteria: * already treated with capsaicin 8% patch in the same body area * already treated in the same study in an other investigation center * non willing to participate or parents not willing participation to the study

Keywords: neuropathic pain pediatric capsaicin
knee osteoarthritis and ipack

Conditions: Osteoarthritis, Knee

Summary: interspace between the popliteal artery and capsule of the posterior knee (ipack) block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule. the purpose of the study; to investigate the effectiveness of this block applied to knee osteoarthritis in clinical practice. in this study, patients who underwent ipack block by the practitioner; demographic data, medications used, block success, block characteristics and block-related complications will be recorded observationally. before and after the block procedure, patients' pain was measured with the numeric rating scale (nrs) at 1st and 3rd months, their disability levels were measured with the western ontario and mcmaster universities osteoarthritis index (womac) questionnaire and short form-12 (short form). quality of life will be measured with the -sf-12) survey.


Eligibility criteria:
inclusion criteria: * patients suffering from grade 3 and 4 knee osteoarthritis exclusion criteria: * patients who have had previous knee surgery * patients who have had any knee injection in the last 3 months * malignancy * inflammatory disease * infectious disease (local or general)