Kornimate/medical-research-clean huggingface dataset:
irreversible electroporation ablation for colorectal metastases to the lung

Conditions: Colorectal Metastases to the Lung

Summary: the investigators are investigating the use of a new cancer treatment called irreversible electroporation (ire). this treatment delivers electrical energy between two needles placed in a cancer. the electrical energy causes cells to die. while this has been used in patients for different applications, the investigators are trying to understand how safe and well it works in colon cancer that has spread to the lung. once the irreversible electroporation procedure is completed during the operation, the surgeon will then remove the cancer according to standard procedure. as part of the study, they will be measuring safety of the electrical energy delivered and will be reviewing the resected specimen under the microscope.


Eligibility criteria:
inclusion criteria: * diagnosed colorectal cancer with oligometastatic colorectal cancer in the lung * lung lesion size is greater than 1 cm * patient will undergo surgical resection as per consultation with their thoracic surgeon and medical oncologist * patient is cleared to undergo paralytic anesthesia. * patients 18 years old and older exclusion criteria: * patients with history of cardiac dysrhythmia * known heart failure (ef \< 40%) * pacemaker/defibrillator * patient's with any metallic cardiac implant * patient on anti-coagulation therapy and are unable to stop therapy for the perioperative period * women who are pregnant and/or nursing

Keywords: irreversible electroporation ablation 15-001
assessing cervical dystonia

Conditions: Dystonia

Summary: the study involves the use of a novel, non-invasive, monitoring device to measure the response to treatment with botulinum toxin injections in 24 (16 intervention and 8 control) patients with cervical dystonia. a baseline assessment, prior to botulinum treatment,will be structured around validated clinical rating scales for cervical dystonia and questionnaires and the performance of simple neck movements, and will be undertaken while the patient wears a movement sensor attached to the head with an elastic strap. the same assessments will be undertaken at 0, 3, 6, 9 and 12 weeks following treatment to assess response. the patients' treatment will not be affected by their participation in the research. the device readings will then be compared with the clinical ratings to establish whether it might be used as a more sensitive measure of treatment response than clinical assessment alone. this will help clinicians to plan and execute botulinum injections more effectively in future


Eligibility criteria:
inclusion criteria: * male or female participants aged 18 years or older (no upper age limit) and willing and able to provide informed consent. * participant is able and willing to comply with the follow-up schedule and protocol. * participants diagnosed with cervical dystonia. * participant has previously received botulinum toxin therapy for cervical dystonia without adverse side effects or is naïve to botulinum toxin therapy but is suitable to participate in the investigator's opinion exclusion criteria: * -participated in another clinical investigation within 30 days. * allergy to device components or botulinum toxin. * medical co-morbidities that preclude botulinum toxin therapy. * patient is incapable of understanding or responding to the study
turbinate volume reduction under local anesthesia: randomized clinical trial; our experience

Conditions: Nasal Obstruction; Turbinate Surgery

Summary: the purpose of this trial is to know which method is better in delivering radiofrequency waves for hypertrophied turbinates: coblation or ravor technique? researchers will compare both techniques in randomized blinded manner patients will have subjective outcomes like nose score, pain objective outcomes like turbinate size over long term clinical follow up visits for 1 year


Eligibility criteria:
inclusion criteria: all patients with the following criteria were eligible for inclusion: 1. age group: 18-60 years old. 2. patients complaining of chronic nasal obstruction because of bilateral (hit) diagnosed by our former protocol refractory to medical treatment for at least three months. 3. evident (hit) on the ct nose and paranasal sinuses with mainly soft tissue component hypertrophy with or without minimal septal deviation without any other cause for the obstruction. 4. patients who are unfit for general anesthesia exclusion criteria: * all patients with: marked septal deviation or concha bullosa, nasal polyps, sinonasal tumors, any previous nasal surgeries or radiotherapy, chronic sinusitis or cystic fibrosis, pregnancy, patients with severe bleeding tendency, coagulopathy disorder, and patients who refuse participation in this study were excluded from our study

Keywords: turbinate hypertrophy coblation radiofrequency nasal obstruction
study of pharmacodynamics and safety of dgat2i and acci coadministered in participants with sponsor-defined presumed non alcoholic steatohepatitis

Conditions: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease

Summary: the study will evaluate the effect of coadministration of a range of doses of dgat2i with 1 dose of acci, on hepatic steatosis and the ability of dgat2i to mitigate acci-induced elevations in serum triglycerides. the study has a 2-part design with sequential conduct of part 1 and part 2 with each part conducted in distinct/separate cohorts of participants. the overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned to be identical, however, data from part 1 will be used to determine whether to conduct part 2.


Eligibility criteria:
inclusion criteria: * bmi ≥25 and ≤ 40 kg/m2 * concomitant medical conditions associated with nafld exclusion criteria: * evidence of other causes of liver disease such as alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis * any condition possibly affecting drug absorption * unstable liver function tests * recent cardiovascular event(s), * malignancies
a novel conditioning regimen for myelodysplastic syndrome with moderate high ipss-m score

Conditions: Myelodysplastic Syndromes

Summary: figure out the efficacy and safety of azacitidine combined with bucy2 conditioning regimen before allogeneic hematopoietic stem cell transplantation for myelodysplastic syndrome with moderate high ipss-m score

this study is a prospective, single-center, single-arm clinical study, which plans to enroll 40 patients with high-risk myelodysplastic syndrome (mds) to be given azacitidine (aza) combined with busulfan and cyclophosphamide (bucy2) conditioning regimen to evaluate 18-month progression-free survival (pfs), aiming to evaluate the efficacy and safety of azacitidine plus bucy2 pretreatment regimen.

Eligibility criteria:
inclusion criteria: * patients fully understand this study, voluntarily participate and sign the informed consent form * age equal or more than 18 years old * patients with moderate high-risk mds with an ipss-m score which is higher than 0 * patients planning to undergo allogeneic hematopoietic stem cell transplantation, hct-ci ≤ 3 or kps ≥ 80% exclusion criteria: * patients who refuse to participate in this clinical study * patients with central nervous system involvement * patients with hiv seropositive * patients with other serious medical conditions with a life expectancy of less than six months * patients with severe psychiatric or psychological disorders

Keywords: allogeneic hematopoietic stem cell transplantation molecular international prognostic scoring system (ipss-m) azacitidine
efficacy and safety of recombinant asparaginase in infants with previously untreated acute lymphoid leukemia (all)

Conditions: Acute Lymphoid Leukemia

Summary: this non-controlled multicentre phase ii study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant asnase (rasnase) for first-line treatment of infants (\< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia


Eligibility criteria:
inclusion criteria: * previously untreated t-lineage or precursor b-lineage all or biphenotypic leukaemia according to egil criteria. * morphological verification of the diagnosis, confirmed with cyto¬chemistry and immunophenotyping. * age \< 1 year at diagnosis. * written informed consent of the parents or other legally authorised guardian of the patient. * treatment according to protocol interfant 06 exclusion criteria: * mature b-lineage all, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in b-all. * the presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells. * systemic use of corticosteroids less than 4 weeks before diagnosis. patients who received corticosteroids by aerosol are eligible. * known allergy to any asnase preparation. * pre-existing known coagulopathy (e.g. haemophilia). * pre-existing pancreatitis. * liver insufficiency (bilirubin \> 50 µmol/l; sgot/sgpt \> 10 x the upper limit of normal).
beta-thalassemia and microparticles

Conditions: Thalassemia Major (TM); Thalassemia Intermedia (TI); Microparticles (MP)Originating From Platelets, Endothelial Cells and Monocytes

Summary: the results will allow us to evaluate the role of mp in the thrombo-embolic risk observed in thalassemic patients and to underline a possible difference between tm and ti. the in vitro and in vivo study of mp in erythrocytes concentrates is a new approach to explore the consequence of transfusion in polytransfused patients. finally, the identification of a possible relationship between the oxidative stress and the production of mp may lead to the development of specific therapeutical approaches

microparticles (mp) are intact vesicles derived from cell membranes which arise mainly through cell membrane activation processes and from apoptosis. mp originating from platelets, endothelial cells and monocytes have been most extensively studied, though similar particles can arise from red cells and granulocytes. the ability to form microparticles is an essential part of physiological coagulation.however, mp may play an important procoagulant role in several diseases including sickle cell disease, and paroxysmal nocturnal haemoglobinuria (pnh). several studies reported the presence of mp in ti and their potential role in the hypercoagulable state. the investigators propose in this study to investigate the presence and origin of mp in tm patients.

Eligibility criteria:
inclusion criteria: * patient recorded in the national register of the patients attained by beta-thalassemia (ti) or (tm) * patient monitoring in one of 5 recruiters centers * patient more than 15 years * patient consented and informed exclusion criteria: * blood transfusion dating from less than 3 months for ti * composite heterozygotes hbe /beta-thalassemia * pregnant women * other disease

Keywords: tm ti mp
periodontal phenotype and scaling and root planing

Conditions: Periodontitis

Summary: periodontal phenotype has been recognized as one of the key factors that may potentially impact the outcome of a variety of periodontal surgical and non-surgical procedures. taking into consideration the inconsistent findings of the studies done in this regard,outcomes of scaling and root planing with respect to periodontal phenotype. with this aim, the present study would be conducted to assess the influence of periodontal phenotype on outcome of scaling and root planing in periodontitis patients.

aim: to evaluate the influence of periodontal phenotype on the outcomes of scaling and root planing in periodontitis patients. objectives: to assess the improvement in pocket probing depth (ppd), clinical attachment level (cal), bleeding in pocket probing (bopp), bleeding on marginal probing (bomp), gingival marginal position (gmp), gingival recession (gr), plaque index (pi), and gingival index (gi) after scaling and root planing (srp) in periodontitis patients with thin or thick periodontal phenotype. setting: department of periodontics and oral implantology, pgids, rohtak, haryana. study design: comparative interventional study. time frame: 12 months (september 2021- august 2022) population: systemically healthy patients with periodontitis (periodontitis stage ii and stage iii) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included.

Eligibility criteria:
inclusion criteria: * systemically healthy patients with periodontitis (periodontitis stage 2 and stage 3) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included. exclusion criteria: * systemic condition known to affect the course of periodontal disease like diabetes mellitus or immunogenic disorders. * patient on anti-inflammatory drugs or antibiotics or history of treatment with medication known to influence periodontal status or healing within last 2 years. * current or former smoker or use of tobacco in any form * history of periodontal treatment in last 2 years * crowding in anterior teeth. * pregnant or lactating females. * individuals with restorations on anterior teeth.
the impact of food advertisements on brain response and eating behavior in children

Conditions: Pediatric Obesity

Summary: the purpose of this project is to examine the impact that television food advertisements have on brain responses and eating behavior in children. food advertisements enhance children's liking and intake of foods that tend to be high in energy content and low in nutritional value. although several studies have measured the differences in children's food intake after watching advertisements, none have shown the brain mechanisms associated with this change in behavior. in order to clarify the relationship between food advertising and eating behavior, the investigators have assembled a team with expertise in functional imaging, eating behaviors, and clinical pediatric research. first, the investigators will observe the differences in children's eating behaviors after being exposed to food commercials or non-food commercials. second, the investigators will measure the difference in child brain response to high and low energy foods after being exposed to food commercials or non-food commercials. these data will allow us to identify which areas of the brain are specifically affected by exposure to food commercials and correlate activity in these areas with children's measured food intake in the laboratory. children ages 7-9 will participate in this 5-visit study which will be completed over the course of 12 months. understanding how food advertisements impact children's brain responses and subsequent eating behaviors will have implications for understanding why some children respond differently to these cues than others. these outcomes may also inform the development of more effective programs and policies to prevent childhood obesity.


Eligibility criteria:
inclusion criteria: * right-handed * english as native language * reading at/above grade level * not claustrophobic * generally healthy exclusion criteria: * left-handedness * metal in or on body that cannot be removed * claustrophobic * medication usage that may alter brain activity or blood flow * medical disorder that may impact comfort or safety in mri scanner * food allergies

Keywords: magnetic resonance imaging energy intake commercials children
post market clinical follow-up (pmcf) study of the a.l.p.s. proximal humerus plating system

Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-Traumatic Arthritis; Psoriatic Arthritis; Proximal Humeral Fracture

Summary: this study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. the primary objective of this study is to confirm the safety and performance of the a.l.p.s. proximal humerus plating system applied in proximal humerus fracture treatment.

the a.l.p.s. proximal humerus plating system was developed to provide another surgical option for proximal humerus fracture fixation. the aim of the a.l.p.s. proximal humerus plating system is to provide increased fracture stability while simultaneously increasing range of motion and decreasing the likelihood of screw perforation. a minimum of 7 and maximum of 10 sites globally will be involved in this study. this number of clinical sites will allow for a better generalization of study data as well as allow for consistency to be developed across multiple regions. 135 implants will be included into the study. each site will be allowed to enroll 27 humeri. enrollment is competitive. all potential study subjects will be required to participate in the informed consent process.

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older. * patient must have a primary proximal humerus fracture (orthopaedic trauma association/ american orthopedic 11-a, b, c) requiring surgical intervention and be eligible for fixation by plate and screws. * patients with failed conservative treatment within 3 weeks since injury. * patient must be able and willing to complete the protocol required follow-up. * patient must have a signed institutional review board/ethics committee approved informed consent. * patient must be in a good nutritional state exclusion criteria: * delay of surgery for more than 3 weeks. * tumor induced fractures * patient is a prisoner. * pregnancy/ breast feeding * patient is a current alcohol or drug abuser. * patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program. * patient has an active infection. * patient conditions including limitations in blood supply, obesity, or insufficient quantity or quality of bone stock. * patient is sensitive to foreign body material.

Keywords: trauma medical device performance safety proximal humeral fracture
dor/tdf/3tc switch with m184v/i in people with controlled hiv (drive off-road)

Conditions: Hiv

Summary: the goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination doravirine (dor)/lamivudine (3tc)/tenofovir disproxyl fumarate (tdf) in participants with suppressed hiv who previously developed m184v/i mutation that confers resistance to 3tc. the main question it aims to answer is to explore the rate of hiv suppression 24 weeks after the switch to dor/3tc/tdf. the study follow-up will continue until 48 weeks. other endpoints will be metabolic changes, weight changes, modification in the hiv-dna mutations overtime. eligible participants will switch from their prior regimen to dor/3tc/tdf with careful hiv-rna monitoring.


Eligibility criteria:
inclusion criteria: * adult living with hiv * receiving stable antiretroviral treatment for at least 3 months * hiv rna vl\<50cp/ml for at least 6 months * presence of the m184v/i mutation in at least one previous genotype performed on plasma hiv rna but absent from the genotype on current standard pro-viral dna (sanger technique) * signed informed consent exclusion criteria: * history of genotypic mutation associated with resistance to dor or tdf according to the anrs version 32 algorithm, i.e. : * for dor : v106a/m; y188l; g190e/s; m230l; l100i + k103n; k103n + y181c; k103n + p225h; f227c; at least 3 amongst: a98g, l100i, k101e, v106i, e138k, y181c/v, g190a or h221y * for tdf : at least 3 mutations among: m41l, e44d, d67n, t69d/n/s, l74v/i, l210w, t215a/c/d/e/g/h/i/l/n/s/v/y/f; k65r/e/n ; insertion at codon 69; k70e * contraindications to the use of dor/tdf/3tc * hypersensitivity to doravirine, tenofovir, lamivudine or any of the excipients (lactose in particular) * current or recent treatment with a strong cyp3a4 inducer * breast-feeding * patients already on dor * pregnant or breast-feeding women * patients under guardianship or trusteeship

Keywords: doravirine m184 mutation maintenance therapy plwh
the incidence,factors,and importance of brown adipose tissue in chinese adults

Conditions: Obesity

Summary: previous studies have shown that active brown adipose tissue (bat) is present in adults and may play important roles in material and energy metabolism. however, most of these studies were tumor-based populations and retrospective study. due to the large amount in our cohort, the investigators are able to promote a cross-sectional study of the incidence and factors of bat in adult chinese. in addition, the investigators can analyse the metabolic profiles in healthy adults with active bat.

the investigators will perform a cross sectional analysis on the chinese adults who use 18f-fluorodeoxyglucose positron emission tomography/computed tomography (pet/ct) to scan the whole body at huashan hospital from 2009 to 2013. bat activity will be measured by pet/ct. not only demographic data on sex, age, medication and medical history,but also data on body composition and physical examination will be collected for all subjects. imaging date,outdoor temperature and fasting blood samples will be collected as well. in addition, the investigators will analyse the metabolic profiles in healthy adults with active bat and their negative controls,such as lipid profiles,fasting glucose and insulin sensitivity, adipokines and other biochemical markers.

Eligibility criteria:
inclusion criteria: * subjects with detectable brown adipose tissue * negative controls,consisting of one subject who underwent pet/ct scans at the same day but without detectable bat exclusion criteria: * younger than 18 years * pregnant women * with implantable medical electronic instrument

Keywords: brown adipose tissue cross sectional study chinese adults factor
the effect of「gtt-egcg」on acne women

Conditions: Acne Lesion Counts

Summary: the aim of this study is to investigate the therapeutic effects of green tea extract on acne treatment and related hormone peptides by a double-blinded, randomized and controlled clinical trial.

change in acne lesions counts, hormone, quality of life

Eligibility criteria:
inclusion criteria: * female patient * 20 to 45 years of age * moderate or severe acne vulgaris as defined by the investigator's global assessment (iga; score of 3 or 4 on a scale from 0 to 5) exclusion criteria: * received systemic retinoid or hormone treatment in the previous 3 months. * abnormal liver enzymes or kidney function tests (1.5 times higher than the upper normal limit) * abnormal blood chemistry * pregnant or breast feeding women or the intention of becoming pregnant * concurrent systemic illness * pcos * very severe acne(iga score5)

Keywords: acne, egcg, green tea
vela china study: in cutting and hemostasis for gastrointestinal epithelial neoplasia in chinese population

Conditions: Indication for Modification of Patient Physical Status

Summary: prospective, multicenter, single-arm, non-controlled, 60 subjects enrolled and 14 days follow up for evaluate the safety and utility of velatm xl thulium laser.

this study aimed to evaluate the safety and utility of velatm xl thulium laser in cutting and hemostasis for gastrointestinal epithelial neoplasia in chinese population. vela china study will enroll at least 60 patients. follow up points are 72 ±3 hours post procedure, 7±2 days post procedure, 14 days(±2 days) post procedure.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent to participate in the study and comply with the study procedures. * diagnosed as gastrointestinal epithelial neoplasia and admitted to hospital for gastrointestinal esd procedure. * eus and/or ct are performed to confirm the absence of regional lymph node or distant metastasis. exclusion criteria: * endoscopic techniques or treatment are contraindicated. * requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure. * based on doctor's evaluation, the patient's medical condition doesn't fit for this study.