Kornimate/medical-research-clean huggingface dataset:
masitinib in patients with mastocytosis with handicap and bearing the d816v mutation

Conditions: Mastocytosis

Summary: the objective is to compare efficacy and safety of ab1010 at 3 or 6 mg/kg/day in treatment of patients with mastocytosis with handicap and bearing activating point mutations in the phosphotransferase domain of c-kit such as the main mutation asp-816-val (d816v).


Eligibility criteria:
inclusion criteria: 1. patients with one of the following documented mastocytosis: * smouldering systemic mastocytosis * indolent systemic mastocytosis with organomegaly * indolent systemic mastocytosis having 2 infiltrated organs (skin and bone-marrow) * any mastocytosis with in the last 6 months at least 3 anaphylactic shocks or syncops requiring either use of adrenaline or medical assistance * cutaneous mastocytosis (cm) 2. skin biopsy-documented mastocytosis and evaluable disease based upon: * histological criteria: typical infiltrates of mast cells in a multifocal or diffuse pattern in skin biopsy * clinical criteria: typical skin lesions (maculopapular, urticaria pigmentosa, mastocytoma) 3. missing data (c-kit molecular analysis not done) or documented presence of an activating point mutation in the phosphotransferase domain of c-kit such as d816v c-kit mutation in at least one infiltrated organ (bone marrow or skin) 4. refractory to at least one of the symptomatic treatments such as: * anti h1 * anti h2 * proton pump inhibitor * osteoclast inhibitor * cromoglycate sodium * antileukotriene * other therapies used for the symptomatic care 5. handicap defined as at least one of the following handicaps: * pruritus score ≥ 6 * number of flushes per week ≥ 7 * number of stools per day ≥ 4 , * number of mictions per day ≥ 8 , * qlq-c30 score ≥ 60, * hamilton score ≥ 10 exclusion criteria: 1. patients with one of the following mastocytosis: * systemic mastocytosis with an associated clonal hematologic non mast cell lineage disease (sm-ahnmd) * mast cell leukemia (mcl) * aggressive systemic mastocytosis (asm) 2. patient with a major surgery within 2 weeks prior to study entry 3. no vulnerable population will be included in this study * life expectancy \< 6 months. * patient is \< 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ. * patient with grade iii/iv cardiac problems as defined by the new york heart association criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) * patient has a severe and/or uncontrolled medical disease. * patient has a known diagnosis of human immunodeficiency virus (hiv) infection

Keywords: mastocytosis d816v handicaps
starflo european safety and efficacy study

Conditions: Open Angle Glaucoma

Summary: prospective, non-comparative, multi-center clinical trial to evaluate the safety and efficacy of the starflo glaucoma implant in patients with refractory open angle glaucoma.

this is a prospective, multicenter clinical trial to assess the efficacy and the safety of the starflo™ glaucoma implant. patients will enter the study after providing written informed consent. patients will be screened to confirm that they are eligible for study participation. when eligibility has been established using the in/exclusion criteria, surgery will be scheduled. pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.

Eligibility criteria:
main inclusion criteria: * diagnosis of refractory open angle glaucoma * documented 21 mmhg \< iop ≤ 40 mmhg, under medication * patient must provide written informed consent main exclusion criteria: * patients with diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye * patients who failed one or more cilio ablative procedure in the study eye if these cilio ablative procedures were performed as a consequence of previous failed filtering surgery * clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye

Keywords: glaucoma glaucoma drainage device glaucoma shunt
pd-1 combined with pyrotinib for chemotherapy failure her2 insertion mutation advanced nsclc

Conditions: HER2 Insertion Mutation Positive Advanced NSCLC

Summary: the purpose of this study is to assess the safety and effectiveness of pd-1 combined with pyrotinib for first-line chemotherapy failed her2 insertion mutation positive advanced non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * advanced non-small cell lung cancer confirmed by histology or cytology * her2 insertion mutation-positive * failure with first-line standard chemotherapy * with measurable lesions. exclusion criteria: * no measurable tumor lesions * patients received pd-1 or pyrotinib before
evaluate safety and efficacy of an oc preparation vs placebo for 6 treatment cycles in women with moderate acne.

Conditions: Acne Vulgaris

Summary: the objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (drsp/ee) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.


Eligibility criteria:
inclusion criteria: * female age 14-45, with 10 to 100 comedones (noninflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), and not more than 35 nodules (\<5mm) on the face). exclusion criteria: * standard contraindications for use of combined oral contraceptives (class label) plus * subjects with acne and atopia, comedonal acne or acne conglobate, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts * use of comedogenic covering cream, comedogenic sunscreens, other sex hormone preparations or any other anti-acne therapy (eg, light therapy, oleic acids, chemical pellings, mechanical extraction of comedones) * acne therapy with sex hormone preparations given over 3 months or longer and proved to be unsuccessful * preparations that have had an acne-inducing effect, eg, iodinated or bromated drugs, tuberculostatics, lithium, vitamin b1, b6, b12, d3, corticoids, acth, anabolics, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics

Keywords: moderate acne vulgaris acne
microsleep 1, micro-sleep during maintenance wakefulness tests

Conditions: Lobectomy; Hepatectomy; Pancreaticoduodenectomy

Summary: during general anesthesia, intraoperative hypotension (ioh) is associated with increased morbidity and mortality. mean arterial pressure (map) \< 65mmhg is the most common definition of hypotension. in order to reduce ioh, a complex method using machine learning called hypotensive prediction index (hpi) was shown to be superior to changes in map (δmap) to predict hypotension (map between 65 and 75 excluded). linear extrapolation of map (lepmap) is also very simple and could be a better approach than δmap. the main objective of the present study was to investigate whether lepmap could predict ioh during anesthesia 1, 2 or 5 minutes before.

hypothesis : the area under the roc curves (roc aucs) at 1, 2 and 5 minutes of lepmap would be superior to amap

Eligibility criteria:
inclusion criteria: * patients suffering from sleep pathologies (apneas, narcolepsy, etc.) hospitalized for polysomnography and mwt, in order to evaluate their sleepiness (usually before they resume driving) * hospitalized in the center for sleep medicine (hôpital lyon croix rousse) between september 2017 and january 2019 exclusion criteria: * patient with active encephalopathy or epilepsy whose eeg was abnormal * denial of study participation * availability of all the recordings (n=4 tests) of the mwt

Keywords: maintenance wakefulness tests micro-sleep sleepiness latency eeg
green tea extracts for the prevention of colorectal adenomas and colorectal cancer

Conditions: Neoplasms, Colorectal

Summary: experimental studies have shown the chemopreventive properties of green tea extract (gte) on colorectal cancer. and colorectal adenomas are precursors to colorectal cancers. the aim of this study is to determine the preventive effect of gte supplements on metachronous colorectal adenomas by giving gte tablets of which are equivalent of 9 cup-of-green tea per day (0.9 g/day gte, 0.6 g/day epigallocatechin gallate (egcg).

the subjects who had undergone complete removal of colorectal adenomas by endoscopic polypectomy have been enrolled since june 2010. they were then randomized into two groups as follows: supplementation group (0.9 g gte per day for 12 months) or control group without gte supplementation. follow-up colonoscopy was conducted in 12 months. a structured 72-h recall at baseline and the 1-year follow-up was used to assess dietary factors, and to evaluate rectal mucosal proliferation index (rmpi) using known proliferation markers (ki-67/pcna), at least 2 random biopsies of rectal mucosa were taken. a sample size of 176 patients (88 per each group) was calculated to give the study 80% power to detect a difference, assuming a two-sided significance test at the 0.05 level.

Eligibility criteria:
inclusion criteria: - subjects who present one or more adenomatous polyps on colonoscopy. exclusion criteria: * subjects who denied to participate in this study * subjects who present inflammatory bowel diseases such as ulcerative colitis or crohn's disease * subjects who received partial or total colectomy due to colon cancer or other colonic diseases. * subjects who are pregnant * subjects who are on aspirin or nsaids for any reasons * subjects who have received a transplant of any major organ or who are on immunosuppressants for any reason * subjects who are unable to perform a bowel prep or who present poor bowel prep for colonoscopy

Keywords: chemoprevention colorectal adenomatous polyp green tea extract
uplc-ms/ms monitoring of emicizumab therapy

Conditions: Hemophilia A

Summary: emicizumab is a monoclonal bispecific antibody with a terminal half-life of 28 days which is now licensed in the treatment of severe haemophilia a with or without inhibitors. some heterogeneity in residual emicizumab concentrations have been reported according to age, body mass index or drug therapeutic regimen. some cases of neutralizing antidrug antibodies have been also reported. whether monitoring emicizumab plasma concentration could predict the residual bleeding risk under emicizumab is unknown. as conventional coagulation assays are not adapted for emicizumab monitoring, this study aims to assess the value of monitoring residual emicizumab plasma concentration by uplc-ms/ms in bleeding risk prediction.


Eligibility criteria:
inclusion criteria: * adult or child with clinical diagnosis of severe hemophilia a (fviii activity \< 1%) with or without inhibitor * clinical indication to emicizumab therapy exclusion criteria: * refusal to give informed consent * acquired hemophilia a * other inherited or acquired bleeding disorder * bodyweight \< 10 kgs

Keywords: drug monitoring severe hemophilia a emicizumab
creatine and ubiquinol for sperm quality

Conditions: Oligospermia; Sperm Count, Low

Summary: this randomized controlled double-blind parallel-group interventional trial explores the impact of 8-week creatine supplementation, with or without ubiquinol, on sperm quality biomarkers in normospermic and oligospermic men. it aims to determine potential enhancements in sperm health to provide insights into male fertility and reproductive health improvement strategies.


Eligibility criteria:
inclusion criteria: * age 18 - 35 years * sperm quality test available (at least half will have low sperm quality) * informed consent * healthy bmi (18.5 - 24.9 kg/m2) exclusion criteria: * major chronic disease and acute injuries * history of dietary supplement use during the past 28 days * no consent to randomization * participation in other studies
diagnosis of active and latent tb infection with ifn-y assays in african children

Conditions: Tuberculosis

Summary: study based in southern ethiopia purpose - to explore if children in contact with adults with tb have positive acute reactants such as ifn-y and other cytokine responses; if these responses discriminate between high and low risk of disease progression and whether these could be incorporated into improved diagnostic approaches.

the study follows children in contact with tb. those with positive tst will be offered chemoprophylaxis and all children will be followed for 2 years to describe ifn-y responses over time, identify symptoms of active tb and if these symptoms are associated with ifn-y and other cytokine responses. children with suspicion of tb attending health centres will also be investigated using routine diagnostic tests and ifn-y and other cytokines responses to evaluate if the latter could be used in improved diagnostic approaches.

Eligibility criteria:
inclusion criteria: - children - 1 to 14 years old in contact with adults with smear positive tb or: - children with suspicion of tb admitted to the hospital for investigations exclusion criteria: - residency \> 10 km from recruitment center or: - patient severely to undergo diagnostic procedures.

Keywords: tb latent infection ethiopia
egd vs eus in diagnosing portal hypertension in cirrhotic patients.

Conditions: Liver Cirrhoses; Portal Hypertension

Summary: liver cirrhosis with the further development of portal hypertension implies structural and vasculature alteration in the portosplenic circulation. esophagogastroduodenoscopy is the standard of care for the detection and treatment of esophageal varices, as esophageal varices serve as a surrogate for estimating a portal pressure gradient \> 10 mmhg. endoscopic ultrasound evaluation allows the detection of peri-esophageal collateral veins, perforating veins and para-esophageal collateral veins, which has demonstrated to be effective for the prediction of esophageal varices recurrence after variceal eradication. the investigators aimed to compare esophagogastroduodenoscopy versus endoscopic ultrasound evaluation for the early diagnosis of portal hypertension in cirrhotic patients.

a randomized control trial of 70 cirrhotic patients randomly submitted for esophagogastroduodenoscopy (35 patients) or eus evaluation (35 patients) for the diagnosis of portal hypertension. the portal pressure gradient will be defined based on portal vein catheterization via interventional radiology. esophagogastroduodenoscopy will evaluate the presence and grade of esophageal varices, presence and type of gastric varices, presence and signs of hypertensive gastropathy. endoscopic ultrasound will evaluate the presence of esophageal varices, the presence of gastric varices and the eus- signs og hypertensive gastropathy, azygos vein diameter, mean velocity and blood flow volume index.

Eligibility criteria:
inclusion criteria: * above 18 years old * willingness to participate in the study * compensated liver cirrhosis based on clinical and imaging findings * written informed consent provided exclusion criteria: * decompensated liver cirrhosis: ascitis, encephalopathy, gastrointestinal bleeding, infection * hemodynamic instability * pregant or nursing patients * patients with history of esophageal, gastric, liver, pancreas and spleen tumors * severe uncontrolled coagulopathy * any contraindication for portal pressure gradient meassurement via radiological evaluation.
study on improvement of blood glucose control in patients with diabetes type 2 using smbg

Conditions: Diabetes

Summary: this clinical study is to determine if the use of structured testing, which is a blood glucose monitoring, via the accu-chek 360° view blood glucose analysis tool has a positive effect on the subjects overall glycemic control.


Eligibility criteria:
inclusion criteria: 1. age:= and \>20 years. 2. intend to paticipate in this study after education of structured testing. 3.hba1c:= and \>7.5% in the recect 2 months. exclusion criteria: 1.pregancy. 2. heavy complication 3. judged unsuitable by doctor
studying biomarkers in samples from young patients with rhabdoid tumors

Conditions: Kidney Cancer

Summary: rationale: studying samples of tissue from patients with rhabdoid tumors in the laboratory may help doctor learn more about changes that occur in dna and identify genes related to cancer. purpose: this research trial studies biomarkers in samples from young patients with rhabdoid tumors.

objectives: * to investigate the expression and function of transposons in 50 primary rhabdoid tumors. outline: freshly frozen rhabdoid tumors will be studied using fluorescence in situ hybridization (fish) and polymerase chain reaction (pcr) to establish the genomic location of transposons. protein expression in rhabdoid tumor tissue microarrays is also analyzed.

Eligibility criteria:
disease characteristics: * freshly frozen rhabdoid tumors from either renal or extra-renal sites from children younger than 2 years of age * clinical patient information (age, gender, comorbidities, tumor stage, size, pathology, therapy, outcome) available patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: rhabdoid tumor of the kidney
association between s-laao and adverse cardiovascular events among patients undergoing coronary artery bypass grafting.

Conditions: Heart Surgery

Summary: this is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (laa) in patients undergoing coronary artery bypass graft.


Eligibility criteria:
inclusion criteria: 1. subject undergoing coronary artery bypass grafting according to clinical indications; 2. age is more than 18 and less than 80 years old; 3. male and non pregnancy female; 4. subject understands study requirements and agrees to sign an informed consent from prior to study procedures. exclusion criteria: 1. pregnancy female; 2. participate in other clinical trial in the last 1 month. 3. subject doesn't agree to sign an informed consent from prior to study procedures. 4. subject undergoing repeat cabg, concomitant valve or other cardiac surgery. 5. new york heart association (nyha) class iv heart failure.

Keywords: coronary artery bypass graft left atrial appendage occlusion stroke prevention
improving mobility and reducing fatigue in people with multiple sclerosis by electrical stimulation therapy

Conditions: Multiple Sclerosis

Summary: the objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (tens) to improve walking performance and self-reported disabilities of persons with ms. the hypothesis is that activation of sensory nerve fibers with augmented tens promotes recovery of sensorimotor function and improves the disability status of individuals with ms. the rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with ms to manage walking limitations and fatigue.

the study will involve a randomized, double-blind, controlled trial. randomization will be accomplished by recruiting two individuals with a similar level of disability at a time and flipping a coin (two persons present) to determine the group assignment (a or b) of the person who contacted the investigators first. the participants and outcome assessors will be blinded to group assignment. both groups will receive the treatment (real or sham) during the first 4 weeks (3 sessions/week)and then there will be an 8-week follow-up period. participants will be evaluated at weeks 0, 4, 8, and 12.

Eligibility criteria:
inclusion criteria: * able to read, write, and speak english to ensure safe participation in the project * clinical diagnosis of multiple sclerosis * mild-to-moderate level of disability * on stable doses of symptom-treating medications * no ms exacerbations within the last 30 day * healthy enough to complete the protocol as indicated by the absence of a medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in tests that involve electrical nerve stimulation (e.g., not implanted devices or internal metal) * able to arrange own transportation to boulder campus exclusion criteria: * documented ms-related relapse within the last 30 days * medical diagnosis or condition that is considered to be a contraindication to participating in the intervention, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, hiv, cancer (other than basal cell cancer), other neurological disorders, or pregnancy. * vestibular disorder * musculoskeletal disorder * history of seizure disorders * \>2 alcoholic drinks/day,or present history (last 6 months) of drug abuse * spasticity that requires the individual to change an activity more than once a week * skin disease or sensation problems in the legs or hands that influence some activities more than once a week * claustrophobia * metallic implants * inability to attend treatment sessions 3 days per week for 6 weeks

Keywords: walking balance fatigue
a study of creon (pancrelipase) in resected and non-resected pancreatic cancer participants with exocrine pancreatic insufficiency (epi)

Conditions: Exocrine Pancreatic Insufficiency (EPI)

Summary: this is a study in participants with exocrine pancreatic insufficiency (epi) due to pancreatic cancer. this study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.


Eligibility criteria:
inclusion criteria: * participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a life expectancy of at least 5 months at screening * participant's pancreatic cancer must involve the head and/or neck of the pancreas * confirmed exocrine pancreatic insufficiency (epi) as evidenced by fecal elastase-1 (fe-1) ≤ 150 µg/g stool at screening * a positive sudan stain for participants without history of fat malabsorption (fat malabsorption is defined as clinical steatorrhea, or measured stool fat \> 7 g/day, or positive stool results by sudan stain) within 1 week of screening -- positive stool results are defined as increased level of neutral or total fats exclusion criteria: * participant has neuroendocrine pancreatic cancer * participant has fibrosing colonopathy * participant has any other malignancy within 1 year of screening * participant has uncontrolled gout, including those with a recent flare within 60 days of screening * participant has other significant organ or bone marrow abnormality within 60 days of screening

Keywords: exocrine pancreatic insufficiency (epi) pancreatic cancer creon pancrelipase