Kornimate/medical-research-clean huggingface dataset:
vactosertib with durvalumab in urothelial carcinoma failing checkpoint inhibition

Conditions: Urothelial Carcinoma Recurrent; Advanced Urothelial Carcinoma

Summary: this is phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the overall response rate (orr) in patients with urothelial cancers that fail to achieve a response with anti-pd-1/pd-l1 based regimens

this is a phase 2, open-label, non-randomized, two-cohort multi center study with a safety run-in of 6 patients in cohort 1. it is anticipated that a total of 48 patients will be enrolled. durvalumab will be administered with the standard regimen of 1500 mg intravenously (iv) every four weeks. vactosertib will be administered at a dose of 300 mg po bid for 5 days per week all treatment will be administered up to two years and the trial is anticipated to be completed over a period of 36 months.

Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 at enrollment 2. histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (ubc), including renal pelvis, ureters, urinary bladder, and urethra. 3. prior anti-pd-(l)1 treatment. 4. measurable disease per recist 1.1 assessed by computed tomography (ct) scan or mri. 5. recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy. 6. adequate organ and marrow function as defined 7. must have a life expectancy of at least 12 weeks. 8. body weight \> 30 kg exclusion criteria: 1. history of allogeneic organ transplantation. 2. active or prior documented autoimmune or inflammatory disorders 3. uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure . 4. history of another primary malignancy 5. history of leptomeningeal carcinomatosis. 6. history of active primary immunodeficiency. 7. active infection including tuberculosis, hepatitis b (known positive hbv surface antigen \[hbsag\] result), hepatitis c, or human immunodeficiency virus . 8. any unresolved toxicity nci ctcae grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
study of exparel in patients undergoing breast augmentation

Conditions: Mammoplasty; Postoperative Pain

Summary: this is a phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for exparel administration (instillation or infiltration).

each subject underwent bilateral augmentation mammoplasty and received the same dose of exparel. this primary objective of this study was to assess the efficacy of exparel when administered via infiltration versus instillation as part of bilateral augmentation mammoplasty. the secondary objectives were to further assess other efficacy measures and the safety profile of exparel.

Eligibility criteria:
inclusion criteria: * female, 18-75 years of age inclusive. * american society of anesthesiologists (asa) physical status 1-3. * undergoing bilateral augmentation mammoplasty without any concurrent surgical procedure(s). * physically and mentally able to participate in the study and complete all study assessments. * able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the study components. exclusion criteria: * history of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics. * any subject whose anatomy or surgical procedure might, in the opinion of the investigator, preclude the potential successful local administration of exparel. * subjects currently pregnant or who may become pregnant during the course of the study. * any subject who in the opinion of the investigator might be harmed or be a poor candidate for participation in the study. * subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

Keywords: mammoplasty postoperative pain analgesia
comparison between transcranial stimulation protocols with continuous current in the chronic migraine

Conditions: Chronic Migraine

Summary: this study aims to compare the effects of transcranial direct current stimulation on the clinical and cognitive function in patients with chronic migraine.

the patients will be randomized into 1 of 3 groups: active tdcs for 15 minutes, active tdcs for 15 minutes, with an interval of 20 minutes and more 15 minutes os stimulation, sham tdcs for 15 minutes. the tdcs will be applied for 10 days over 2 weeks.

Eligibility criteria:
inclusion criteria: * females * clinical diagnosis of chronic migraine according to the international classification of headaches disorders (ichd-3 beta). exclusion criteria: * headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease * use of central nervous system modulating drugs * pregnancy * metallic head implants * use of a cardiac pacemaker

Keywords: transcranial direct current stimulation migraine disorders cognitive symptoms
trial comparing metformin versus placebo in non alcoholic steatohepatitis (nash) patients receiving bariatric surgery for obesity

Conditions: Obesity

Summary: this is a comparison of metformin versus placebo in nash patients receiving bariatric surgery for obesity.

in patients receiving bariatric surgery, a preoperative liver biopsy will confirm the presence of nash. those patients with nash (histologically defined according the brunt's criteria) will be randomized to receive metformin (2 times 850 mg orally daily) or placebo for a time period of 1 year. a control liver biopsy will be performed after one year.

Eligibility criteria:
inclusion criteria: * patients receiving bariatric surgery for obesity exclusion criteria: * other causes of liver disease (hepatitis b virus \[hbv\], hepatitis c virus \[hcv\], primary biliary cirrhosis \[pbc\], etc.) * patients with diabetes type i * patients with endocrinological reasons for obesity (eg. cushing, etc.)
the association of baseline characteristics of male patients presented with luts and long term clinical outcomes

Conditions: Lower Urinary Tract Symptoms

Summary: non-neurogenic male lower urinary tract symptom (luts) is one of the most common symptom presented in urological clinic. male luts could be a result of a combination of many different conditions, including benign prostate hypertrophy, overactive bladder, diabetes, noctural polyuria, sleep apnoea etc. also male luts has shown to have close relationship with metabolic and cardiovascular conditions. because of the increasing evidences to suggest a close relationship of cardiovascular condition and metabolic problems and male luts, this is a study to retrospective review of the patients assessed in this urology clinic and have a more in-depth assessment of the relationship of the baseline characteristics of these medical conditions with the presenting symptoms, as well as the long term urological and overall clinical outcomes of these patients.

this is a retrospective study.male patients who presented with lower urinary tract symptom to our centre and assessed in the urology clinic from 2005 to 2019 would be enrolled to the study. this study will be conducted by observation; that is, data will be captured from medical records and central medical system (cms), but patients will not be contacted. all the demographic and medical background, as well as investigations performed during the assessment including uroflowmetry, post-voiding residual, questionnaires, blood pressure, pulse, vascular assessment and blood result will be collected. follow-up data including usage of medication, clinical outcomes (such as development of urinary retention, cardiovascular events, need of surgical intervention, mortality etc.) will be captured from the medical records.

Eligibility criteria:
inclusion criteria: * men aged between 35 and 90 years old with luts/nocturia and received assessment at urology centre. exclusion criteria: * men having history of prostatic surgery, prostate cancer, active urinary tract infection, aortic aneurysm, marked cardiac arrhythmia and severe peripheral vascular disease
maintenance after induction chemotherapy in elderly patients with advanced non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer (Squamous or Non Squamous)

Summary: for elderly patient, the treatment of non small cell lung cancer was based on monotherapy but ifct-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. the current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). after the treatment is stopped until progression and initiation of a second line treatment. the risk of this strategy is to be confronted to a rapid disease progression during the free interval. indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. the concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy). there is two types of maintenance : * continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression. * switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy the two types are validated by several trials. the marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma. gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. several trials evaluated maintenance with this product and some show benefits in term of progression free survival. the objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented non small cell lung cancer non resectable or non irradiable stage iii or stage iv * egfr wild type or non feasible egfr * 90 \>age ≥ 70 * ecog performance status : 0, 1 or 2 * mini-mental test status (mms) \> 23 exclusion criteria: * mixed non-small cell and small cell tumors * patients with egfr mutated tumor * patient with eml4-alk translocation * evolutive or symptomatic metastasis of central nervous system * superior vena cava syndrome * calcemia \> 2,70 mmol/l

Keywords: elderly lung cancer switch maintenance elderly patients (between 70 and 89 years) nsclc ifct
impact of emicizumab on activated clotting time using the i-stat alinity analyzer

Conditions: Hemophilia A

Summary: emicizumab (hemlibra®) is a subcutaneous hemostatic treatment approved in 2019 for the prophylaxis in severe hemophilia a. emicizumab is a bispecific monoclonal antibody mimicking factor viiia that provides a constant level of coagulation similar to that observed in minor haemophilia a patients whose factor viii level is 10-15%. although the correction of plasma coagulation in vivo is only partial, emicizumab strongly shortens the in vitro coagulation times involving the intrinsic pathway such as aptt(activated partial thromboplastin time). the investigators will evaluate the effect of emicizumab on a coagulation test (activating clotting time (act i-stat alinity)) used as a point of care device to monitor heparin therapies during cardiac surgeries (cardiopulmonary bypass) and cardiac catheterizations. because act is activated through the intrinsic pathway, it may also be shortened by emicizumab. prophylactic treatment with emicizumab would make it impossible to use act for heparin therapy in a hemophiliac patient benefiting from this treatment. the aim of this in vitro study is to assess the effect of emicizumab on the in vitro heparin-induced act increase in severe hemophilia a patients treated with emicizumab and in healthy volunteers (measurement on the i- stat alinity) thanks to in vitro blood spiking experiments. some data have already been published with other act devices (hemochron..) but never with the i-stat alinity device which uses a different technology and other reagents.


Eligibility criteria:
inclusion criteria: * severe hemophiliacs under emicizumab ( \> 4 weeks) exclusion criteria: * infusion of factor viii \< 5 days * patients refusing to participate in the study * protected persons * anticoagulants

Keywords: activated clotting time hemophilia emicizumab
perspectives on cppd outcome domains

Conditions: CPPD - Calcium Pyrophosphate Deposition Disease

Summary: the purpose of this study is to obtain patient and stakeholder perspectives on what outcome measures should be included in future trials on cppd (calcium pyrophosphate deposition), a common form of inflammatory arthritis. this will form part of a wider omeract (outcome measures in rheumatology) study, involving multiple international sites, to determine a core domain set (an agreed set of outcome measures) for this disease. in the uk, up to 10 patients with cppd and their caregivers, healthcare professionals who care for patients with cppd, and other stakeholders, which may include government organisations, non-government organisations, pharmaceutical representatives and health advocacy groups, will be invited to participate in a single, semi-structured interview. interviews will be face-to-face or telephone, last up to one hour and digitally audio-recorded. for patients and their caregivers, interviews will explore their lived experience of cppd, its impact on their daily lives, and the perceived relevance of outcome measures used in previous studies. for healthcare professionals and other stakeholders, interviews will explore their experience dealing with patients with cppd, how they perceive cppd impacts patient lives, and the perceived relevance of the outcome measures used in previous studies. following analysis of the data, participants will be sent a short report with the researchers' findings, and asked to check the accuracy of these and provide brief written feedback. interviews will also take place with patients, caregivers, healthcare practitioners and stakeholders at the other international sites where ethics committee approval will be sought locally. it is anticipated that around 30 participants will be recruited across all sites. analysis of all interviews will be primarily conducted and managed at the uk site.


Eligibility criteria:
inclusion criteria: patients: * people with a diagnosis of cppd of any form and/or their caregiver (includes acute cpp crystal arthritis (pseudogout), chronic cpp crystal arthritis, crowned dens syndrome, and osteoarthritis with cppd) * ability to give informed consent * age over 18 years healthcare professionals: * a healthcare professional (nurse, gp or hospital doctor) who cares or has cared for patients with cppd other stakeholders: * government organisations, non-government organisations, pharmaceutical representatives and health advocacy groups exclusion criteria: * dementia * terminal illness * unable to give informed consent * stroke with receptive or expressive dysphasia * severe enduring mental illness * autoimmune rheumatic disease such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout * total joint replacement in the previous 3 months

Keywords: calcium pyrophosphate deposition disease outcome measures qualitative research
memantine and constraint-induced language therapy in chronic poststroke aphasia:a randomized controlled trial

Conditions: Aphasia; Stroke

Summary: * aphasia, the loss or impairment of language caused by brain damage, is one of the most devastating cognitive impairments of stroke. aphasia can be treated with combination of speech-language therapy and drugs. conventional speech-language therapy in chronic aphasic subjects is of little help and several drugs have been studied with limited success. therefore other therapeutic strategies are warranted. * recent data suggest that drugs (memantine) acting on the brain chemical glutamate may help the recovery of cognitive deficits, included language, in subjects with vascular dementia. the present study examines the safety profile and efficacy of memantine paired with intensive language therapy in subjects with stroke-related chronic aphasia (more than 1 yr. of evolution).

* the efficacy of drugs that act on glutamate such as the n-methyl-d-aspartic acid (nmda) receptor antagonist memantine requires to be explored in this population. the rationale for using memantine in post-stroke aphasia comes from recent studies on vascular dementia. data extracted from a recent cochrane review of randomized controlled trials of memantine in different types of dementia (vascular dementia, alzheimer's disease, mixed dementia) reveal, after 6 weeks of treatment, beneficial effects on cognition (including language), activities of daily living, behavior and global scales as well as in the global impression of change. * recovery from aphasia is possible even in severe cases. while speech-language therapy remains as the mainstay treatment of aphasia, its effectiveness has not been conclusively proved. this has motivated the planning of more rational therapies (e.g., constraint-induced language therapy \[pulvermüller et al., 2001; 32: 1621-1626\]). * in addition, the neural correlates of improvement of language function can now be readily detectable with event-related potentials. this is a noninvasive technique that can detect in real time functional brain changes during recovery promoted by the combined action of memantine and constraint-induced language therapy. * the aim of the present study is to assess the efficacy, safety profile, and functional correlates of memantine paired with massed language therapy in a sample of patients with chronic poststroke aphasia.

Eligibility criteria:
inclusion criteria: * chronic aphasia of more than one year duration * must be able to complete protocol exclusion criteria: * dementia * major psychiatric illness * severe global aphasia (precludes participation in constraint-induced language therapy)

Keywords: aphasia memantine constraint-induced language therapy event-related potentials
fecal transplant for crohn's disease

Conditions: Crohn Disease

Summary: to determine the efficacy and safety of serial fmt at inducing and maintaining clinical and endoscopic response in patients with mild to moderate crohn's disease

double blind study will randomize patients with mild to moderate crohn's 1:1 (fmt : water) stratified by disease duration and current use of biologic therapy. first fmt/placebo at week 0 by colonoscopy plus weekly fmt/placebo by capsules for 7 weeks. at week 8, a repeat colonoscopy will be done and endoscopy score repeated. responders in fmt arm are eligible to enter open label phase to receive fmt by capsules q2 weeks. blood, stool and urine samples, colonic biopsies will be collected. quality of life as measured by short inflammatory bowel disease questionnaire, euroqol five dimensions, and work productivity and activity impairment questionnaire: crohns disease and dietary intake diary collected. colonoscopies recorded and reviewed by a central reader.

Eligibility criteria:
inclusion criteria: * mild to moderate ileal, ileo-colonic or colonic crohns disease * active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. c-reactive protein \>8mg/l, elevated fecal calprotectin \>250 ug/g * if applicable, meds stable as follows: 5-asa for 4 weeks, prednisone up to 20mg qd for 4 weeks, budesonide up to 6mg qd for 4 weeks, azathioprine, 6-mp and methotrexate for 12 weeks * use of effective contraception exclusion criteria: * antibiotic exposure within 30 days and probiotic exposure within 14 days * topical inflammatory bowel disease therapy within 2 weeks * active perianal disease * requirement for concurrent antibiotic therapy * ses-cd score \<5 * severe cd hbi \>25 or need for hospitalization * abdominal abscess * extensive colonic resection, subtotal or total colectomy * ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae * evidence of or treatment for c. difficile or other intestinal pathogen including cytomegalovirus within 28 days * requiring or expected to require surgical intervention * history or evidence of adenomatous colonic polyps not removed * history of evidence of colonic dysplasia * active substance abuse or psychiatric problems that may interfere with study * chronic hep b, c, or hiv infection * pregnancy or planning to become pregnant * upper cd * history of adhesions preventing colonoscopy to cecum * planned bowel resection within 3 mon of enrollment

Keywords: fecal transplant inflammatory bowel disease
efficacy of ipomea pes-caprae ointment as an add-on therapy in patient with jellyfish dermatitis

Conditions: Jellyfish Dermatitis; Jellyfish Venoms

Summary: this is an open label, prospective, test of superiority efficacy trial of ipomea pes-caprae ointment as an add-on therapy in patient with jellyfish dermatitis. each patient will receive standard medical treatment depend on the severity of the disease. the doctor will divide the dermatitis area of each patient into two parts. ipomea pes-caprae ointment will be applied as an add-on therapy to the "test area", while the ointment will not be applied to the "control area". patients will be asked to come for follow up 6 times in the 28-days study period. primary objective is to compare the healing time of dermatitis in both areas.

the "test area" and "control area" are allocated in each participant. we use the internal control fashion. the healing time of each area will be collected as an outcome measure.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of jellyfish dermatitis * total lesion area is more than 4 square centimeter exclusion criteria: * expose to jellyfish more than 7 days * severe systemic reaction to jellyfish * allergy to ipomea pes-caprae or the component of the ointments

Keywords: jellyfish jellyfish venom jellyfish dermatitis jellyfish stings ipomea pes-caprae