Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma who failed previous therapy - (fight-202)

Conditions: Cholangiocarcinoma

Summary: the purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with fgfr2 translocation who have failed at least 1 previous treatment.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed cholangiocarcinoma. * radiographically measurable or evaluable disease per recist v1.1. * tumor assessment for fgf/fgfr gene alteration status. * documented disease progression after at least 1 line of prior systemic therapy. * eastern cooperative oncology group (ecog) performance status of 0 to 2. * life expectancy ≥ 12 weeks. exclusion criteria: * prior receipt of a selective fgfr inhibitor. * history of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications. * current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination. * use of any potent cyp3a4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. topical ketoconazole will be allowed.

Keywords: cholangiocarcinoma fibroblast growth factor (fgf) fibroblast growth factor receptor (fgfr) fgf/fgfr alterations
a study of cd19 redirected autologous t cells for cd19 positive systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus (SLE)

Summary: car-t therapy was therefore proposed and has been recently used for cancer treatment. it has been hailed for its promising remission rates after early stage clinical trials for acute lymphoblastic leukemia. however, car-t therapy is seldom used for autoimmune diseases. researchers only use it for the treatment of multiple sclerosis (ms, an autoimmune disease of the central nervous system). sle is a kind of autoimmune diseases which involving multiple systems, organs and with the present of a variety of autoantibodies. in the conventional treatment options, sle could be treated with chemotherapy drugs or hormone drugs. but chemotherapy and hormone drugs could barely cured sle. and now, chimeric antigen receptor modified t cell infusion maybe an effective treatment to solve these problems. the investigators use a 2nd car- t with the optimized hinge and transmembrane domain to treat patients with sle. the purpose of this study is to assess the safety and efficacy of this 2nd car-t cells in the treatment of sle.

this study is being conducted to assess anti-cd19-car-t cells safety and efficacy in treating patients with systemic lupus erythematosus（sle）.the investigators constructed a 2nd car, using cd19 as target, using 4-1bb as co-stimulator, and optimized the spatial conformation by a suitable hinge and transmembrane domain sequences. the infusion dose is (1-10)e6 car positive t cells/kg, and the specific cells numbers depends on the situation of individual car-t cells preparation.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of systemic lupus erythematosus (sle) patients * patients with cd19+ b-cell sle as confirmed by flow cytometry * age: 18-69 years old * creatinine \< 1.5 mg/dl * cardiac ejection fraction\>55% * hemoglobin\>9g/dl * bilirubin \<2.0 mg/dl * successful test expansion of t-cells * adequate venous access for apheresis, and no other contraindications for leukapheresis * voluntary informed consent is given exclusion criteria: * pregnant or lactating women * uncontrolled active infection * concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary * previously treatment with any gene therapy products * feasibility assessment during screening demonstrates\<5% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to cd3/cd28 costimulation * any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, serious arrhythmia)

Keywords: cd19 car-t sle
effectiveness of a guided mental health chatbot stars for youth living in lithuania

Conditions: Symptoms of Depression and Anxiety

Summary: the study aims to assess the effectiveness of a guided mental health chatbot stars for youth living in lithuania.

the intervention is a guided mental health chatbot stars developed by the world health organization (who). it consists of 10 sessions which include: introduction (1), psychoeducation (2), emotion regulation (3, 4), behavior activation (5, 6), managing problems (7), thought challenging (8, 9), and relapse prevention (10). each session consists of psychoeducation and exercise parts. trained e-helpers contact participants to support them individually on a weekly basis. the effect of the intervention will be compared against a control group which gets basic psychoeducation. the intervention is provided in lithuanian.

Eligibility criteria:
inclusion criteria: * age of 18-25 years * understanding the lithuanian language * having access to a device for intervention delivery * experiencing moderate levels of psychological distress exclusion criteria: * people at imminent risk of suicide * people currently experiencing a psychotic episode * people currently experiencing interpersonal violence * current dependency on alcohol/drugs

Keywords: intervention chatbot mental health youth stars effectiveness
a study of the use of text message reminders to take palbociclib

Conditions: Breast Cancer

Summary: the purpose of this study is to find out whether it is feasible (acceptable to participants) to use a smartphone app to send text message reminders to take palbociclib, and whether these reminders are effective at helping people remember to take palbociclib according to the treatment schedule.


Eligibility criteria:
inclusion criteria: * patients with a breast cancer diagnosis who are initiating therapy on palbociclib (ibrance) * \>/= 18 years of age * able to speak, read and write english * willingness and ability to send and receive text messages with intervention app * own a mobile telephone "smartphone" with text messaging capabilities. only iphone or android operating systems support ohmd application * criteria applicable for both control and intervention groups * flip-phones do not support ohmd application and thus ineligible to participate * initiation palbociclib (ibrance) for the first time, either as monotherapy or in conjunction with other medication such as lstrozole (femara) or fulvestrant (faslodex) exclusion criteria: * history of taking palbociclib (ibrance) * patients whose caregivers coordinate their health care

Keywords: breast cancer palbociclib memorial sloan kettering cancer center 19-458
safety and immunogenicity of non-live, recombinant subunit herpes zoster vaccine before and after lung transplantation

Conditions: Varicella Zoster Vaccine

Summary: the investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. patients (at least 50 years old) before and after lung transplantation will be enrolled. the investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.

solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for reactivation of all herpesviruses including vzv. epidemiologic studies show the cumulative incidence in lung transplant recipients of reactivation to be 15-20%. a non-live, recombinant subunit vaccine (shingrix; gsk vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older. the investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. patients (at least 50 years old) before and after lung transplantation will be enrolled. the investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.

Eligibility criteria:
inclusion criteria post-transplant vaccine group: * single or double lung transplant recipient. * age ≥50 years exclusion criteria post-transplant vaccine group: * has already received varicella zoster subunit vaccine in the past * shingles within the last 12 months * ongoing cmv viremia \> 200 iu/ml * hiv infection * diagnosis of malignancy (eg ptld) inclusion criteria pre-transplant vaccine group: * on waiting list for lung transplantation * age ≥50 years exclusion criteria pre-transplant vaccine group: * has already received shingrix or zostavax (live shingles vaccine) in the past * systemic prednisone ≥20 mg per day (or equivalent dose of any corticosteroid) * other (than prednisone \< 20mg per day or equivalent dose of any corticosteroid) systemic immunosuppressive therapy such as mycophenolate or tacrolimus * shingles within the last 12 months * hiv infection
treatment and prevention of middle ear morbidity in head and neck cancer patients following radiotherapy

Conditions: Otitis Media With Effusion; Chronic Otitis Media; Hearing Loss

Summary: to investigate the incidence of tuba dysfunction (td) and middle ear (me) morbidity after radiotherapy (rt) to the head \& neck and test the effect of auto-inflation of the eustachian tube (et) on middle ear effusion with a special designed balloon (otovent®) and thereby better hearing and ear related quality of life after cancer treatment.

middle ear complications and td are common following rt to the head \& neck, where the radiation field involves the et and me. these are due to mucositis and swelling in the surrounding pharyngeal tissue and on the long-term fibrosis. the et is a small channel from the middle ear to the upper part of the pharynx. it is normally closed but briefly opens while swallowing or yawning. the me pressure then equalizes and optimize sound conduction to the inner ear. if the function of the et is impaired it can lead to negative pressure and effusion. this causes pain, tinnitus, otitis media with effusion (ome), chronic otitis media (com) and hearing loss. last can be none reversible. almost everyone experience middle ear morbidity short after rt, but on the long-term up to 20 % have chronic otitis media and td with significant hearing impairment and the need for hearing aid. conventional treatment with insertion of ventilation tubes in to the tympanic membrane is not recommended for radiation-induced me problems. methods and materials: the investigators will by randomized controlled trials examine the effect of auto-inflation of the et on me morbidity with a custom-made balloon called otovent®. examination of the ear is conducted by otoscopy, pure tone and impedance audiometry and questionnaires.

Eligibility criteria:
inclusion criteria: * head and neck cancer patients in zealand region, capital region and north jutland region. * only patients who received or is going to receive radiotherapy or chemoradiotherapy as curative intended treatment. * the irradiated volume involve the nasopharynx. exclusion criteria: * patients with documented history of otitis media with effusion or chronic otitis media that is not related to the cancer diagnosis. * performance status \> 3. * surgery in the middle ear, eustachian tube and surrounding tissue area. (biopsies during diagnosis is accepted).

Keywords: head and neck neoplasms radiotherapy otitis media
efficacy and safety of imatinib and vinorelbine in patients with advanced breast cancer

Conditions: Breast Cancer

Summary: this study is designed to investigate the safety and efficacy of the combination of imatinib and vinorelbine in patients with advanced, anthracycline resistant breast cancer


Eligibility criteria:
inclusion criteria: * histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic * previous anthracycline containing chemotherapy * presence of a certain protein on the cell surface (c-kit (cd117) and /or pdgf-receptor) * preferably tumor samples should be taken within 6 weeks of study entry. most recent primary tumor tissue has to be available for analysis * acceptable health status (eastern cooperative oncology group \[ecog\]-performance status 0,1, 2 or 3) exclusion criteria: (for the second-line therapy) * patient with grade iii/iv cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). * patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (hiv) infection. * patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing. * patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry. * patient received either vinorelbine or imatinib in previous treatment regimens other protocol-defined inclusion/exclusion criteria may apply

Keywords: breast cancer tyrosine inhibitor chemotherapy imatinib
study of aee788 in patients with recurrent/relapse glioblastoma multiforme (gbm)

Conditions: Glioblastoma Multiforme

Summary: aee788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the erbb and vegf receptor family of tyrosine kinases. it has an ic50 of less than 100 nm against p-egfr, p-erbb2, and p-kdr (vegfr2). this study will assess the safety, pharmacokinetic/pharmacodynamic (pk/pd) profiles and clinical activity of aee788 in a recurrent gbm population.


Eligibility criteria:
inclusion criteria: * histologically confirmed gbm in first or second recurrence or relapse * adequate hematologic, hepatic and renal function * age ≥ 18 years * karnofsky performance status score ≥ 70% * life expectancy ≥ 12 weeks exclusion criteria: * peripheral neuropathy \> grade 1 * diarrhea \> grade 1 * gastrointestinal dysfunction * compromised cardiac function * concurrent severe and/or uncontrolled medical conditions

Keywords: gbm recurrent/relapse egfr vegfr
rosiglitazone and exercise in patients with type 2 diabetes mellitus

Conditions: Type II Diabetes Mellitus

Summary: the aim of the present study is to investigate the influence of systemic exercise, rosiglitazone administration and combined pharmaceutical and lifestyle intervention on cardiovascular risk factors


Eligibility criteria:
inclusion criteria: * type ii diabetes mellitus * poor glycemic control exclusion criteria: * heart failure * renal disease * liver disease * cardiovascular event

Keywords: rosiglitazone,exercise,cardiovascular risk factors
efficacy study of tepso® socks in improving palmoplantar psoriasis

Conditions: Palmoplantar Psoriasis

Summary: the purpose of this study is to evaluate the efficacy of a special sock, manufactured using tepso®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar psoriasis present for at least one year.

the clinical manifestations of palmoplantar psoriasis have an important impact on well being and quality of life. the manifestation of the disease is often exacerbated by factors such as significant physical and mechanical stress resulting from repeated and prolonged pressure over the affected areas and by everyday clothing. these problems have led the textile industry lenzi egisto s.p.a. to conduct some preliminary analyses to find a fabric that meets the specific needs of psoriatic patients in relation to everyday clothing. this preliminary study led to the creation of a particular fabric, tepso®, with features specific to the identified needs. this material consists essentially of ptfe (commercially known as teflon®) and thus presents interesting characteristics that make it suitable for creating garments for patients with psoriasis: * excellent flow properties and low surface friction * non-stick * complete biocompatibility and chemical inertness we can therefore speculate that in palmoplantar psoriasis high smoothness of the fabric and low coefficient of friction may translate into less discomfort felt by patients during normal physical activities, and into improved clinical course of the disease. in the end, it is expected that reduced mechanical compression and friction, would result into partial or complete clinical remission within a few weeks of use. therefore we propose to conduct a randomized controlled, double-blind, left-right clinical trial to assess the hypothesis that in palmoplantar psoriasis the use of tepso® could induce an improvement of disease and overall quality of life. to better assess the effects of treatment, the use of clothing in the study will be limited to symmetrical psoriatic lesions of feets in order to include areas that are comparable and relevant from a functional point of view.

Eligibility criteria:
inclusion criteria: * palmoplantar psoriasis present for at least one year * symmetrical foot lesions with at least 5% of the skin surface involvement * difference less than or equal to 10% extension of lesions on both sides of the body * suspension for over 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporine, systemic steroids), psoralen plus ultraviolet a irradiation (puva) or ultraviolet b phototherapy (uvb) exclusion criteria: * nonsymmetrical foot lesions or less than 5% of the skin surface involvement * difference of more than 10% extension of lesions on both sides of the body * patients who have performed, within 3 months before inclusion in the study, treatments with systemic drugs for psoriasis, immunosuppressive treatments (cyclosporine, systemic steroids), psoralen plus ultraviolet a irradiation (puva) or ultraviolet b phototherapy (uvb)

Keywords: psoriasis soles teflon
phase i study of ucart123 in patient with adverse genetic risk acute myeloid leukemia

Conditions: Acute Myeloid Leukaemia

Summary: this is a phase i, open-label, dose escalation study of ucart123 administered intravenously to patients with newly diagnosed cd123 positive adverse genetic risk acute myeloid leukaemia (aml) defined in the eln adverse genetic risk group (2017). the purpose of this study is to evaluate the safety and clinical activity of multiple infusions of ucart123 and to determine the maximum tolerated dose (mtd).


Eligibility criteria:
main inclusion criteria: * patients newly diagnosed with cd123 positive adverse genetic risk acute myeloid leukaemia (aml) defined as per eln guidelines (döhner et al., 2017) * eastern cooperative oncology group performance status of 0 or 1 * no prior gene or experimental cellular therapy * no organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy

Keywords: acute myeloid leukaemia newly diagnosed aml eln adverse genetic risk group chimeric antigen receptor t-cell (car-t) therapy allogeneic transcription activator-like effector nuclease (talen)
magnesphere for autonomic alteration

Conditions: Hart Failure With Reduced Ejection Fraction

Summary: to evaluate the physiologic effects of an electromagnetic resonator(emf) on autonomic nervous system tone modulation through measurement of heart rate variability(hrv). null hypothesis: an emf resonator will not change autonomic nervous system tone and no demonstrable difference in physiological parameters will recorded. alternative hypothesis: using an emf resonator will enhance parasympathetic activty as supported by hrv.

during the initial encounter, participants will be randomized to either therapy or sham. the randomization scheme will be blinded to all investigators, will be devoid of patient information, and will be programmed by a non·investigator third party. all patients will receive the same total duration of therapy, and all patients will receive a sham and a treatment session. participants will wear head phones to reduce effects of any outside noises and will lay supine in a chair at approximately 40 degrees which is inside the fda approved resonator® emf field. the active treatment session will be a160 which is a narrow range but variable magnetic field. this ranged from 3.1 x10·8 to 3.2 x 10-8 amplitude with a frequency of 0.857-0.859. eligible participants will arrive for testing in the morning and will be randomized to either treatment sequence. randomization will be predetermined. mobile phones and pagers will be placed into airplane mode during the study on a table in the room. the patient will be connected to hrv measurement systems. a bp reading will be taken in each arm. patients will then lay supine in a standardized relaxation chair at approximately 40 degrees at which time the headphones will be placed. ambient room light will remain powered on during therapy and will remain unchanged regardless of randomization. the researcher will then start either arm a or b (based on randomization). during the session, each participant will be given a short novel/magazine to read to reduce the chance of sleeping. all hrv monitors will be disconnect and the subject's electronics will be returned.

Eligibility criteria:
inclusion criteria: 1. male and female patients more than 18 years old with lvef of \< 40%(n=20) 2. healthy age matched controls (n=20) 3. ability to lay in a reclining chair for at least 60 minutes exclusion criteria: * 1. inability to provide consent 2. significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases) 3. recent (\<6 months) stroke or myocardial infarction 4. severe heart failure (nyha iv) 5. hemodialysis 6. recurrent vaso-vagal syncopal episodes 7. unilateral or bilateral vagotomy 8. pregnancy or breast feeding
efficacy of high dose olanzapine for the treatment of schizophrenia and schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the food and drug administration and higher (not fda approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.


Eligibility criteria:
inclusion criteria: * you must be 18 to 60 years old * you must have been diagnosed with schizophrenia or schizoaffective disorder * you must be able to visit the doctor's office 8 times over a 9 week period * you must agree to participate with all tests and examinations that are required for this study exclusion criteria: * you are a woman and are pregnant or breastfeeding * you presently have an acute or unstable medical illness * you have a history of an allergic reaction to olanzapine * you are taking medications that are not permitted in this study. your physician will discuss these with you * you have taken part in another clinical research trial within the last 30 days or you have received treatment with a drug in the last 30 days that has not received regulatory approval.