Kornimate/medical-research-clean huggingface dataset:
efficacy of peginterferon alpha 2a therapy in chronic hepatitis b patients being treated with nucleoside(acid) analogues

Conditions: Chronic Hepatitis B

Summary: antiviral therapy is the most important method to slow and stop the progress of the disease in patients with chronic hepatitis b (chb). nucleoside (acid) analogues (na) can effectively suppress hbv replication, but it should be continue used and relapse would happen in most patients after withdrawal of therapy. however, long-term use of na could induce viral resistance mutation lead to loss of efficacy. interferon treatment can enhance specific and non-specific immune function in chronic hepatitis b patients, make patients get immune control to hbv infection and obtain sustained response after treatment. thus the chb patients on the treatment of na should be stop na treatment after interferon treatment. in this study, the effects of interferon treatment in chb patients who were on the na treatment and obtained hbsag level≤250 iu/ml.

in this trial, patients who were chb and treated with na more than 6 months, still on the treatment and achieved hbsag level ≤250 iu/ml with hbv dna undetectable will be randomized enrolled into group a (intervention group), in which patients switch to interferon therapy for 72 weeks, group b(control group), patients continue treated with na for 72 weeks. serum hbv dna load, hbsag/anti-hbs level, hbeag/anti-hbe will be tested at enrollment and every 3 months during the treatment course. parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. the efficacies of interferon treatment were devalued by the rate of hbsag clearance and decline of hbsag levels on the 72 weeks of interferon treatment compared with control group.

Eligibility criteria:
inclusion criteria: * patients who were chronic hepatitis b and had achieved hbsag level ≤250 iu/ml on treatment of nucleoside (acid) analogues exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: chronic hepatitis b interferon nucleotide analogues hbsag
systemic hypothermia in acute cervical spinal cord injury

Conditions: Spinal Cord Injury, Acute

Summary: this study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºc) intravascular hypothermia following acute cervical (c1 to c8) spinal cord injury (sci).

the purpose of the proposed clinical trial is to demonstrate the safety and efficacy of intravascular hypothermia as part of the early hospital management and treatment for acute cervical sci. each year in the us, there are over 11,000 new cases of para- and quadriplegia and 100,000 new cases of partial but permanent neurological losses due to acute sci. thus the potential for clinical hypothermia following sci to improve neurological outcome has significant value. many patients suffering sci become permanently dependent on caretakers and become a financial liability to both the family and society. hypothermia has the potential to improve outcome so that more patients suffering sci can regain independent motor and sensory function and remain economically productive members of society. the use of modest hypothermia through intravascular cooling may ultimately lead to better care of the patient with acute sci and may also have more widespread uses in patients presenting with stroke or cardiac arrest. in the long-term, this research may lend support to the use of hypothermia that could in turn save money for the patients, hospitals, the government and society as a whole.

Eligibility criteria:
inclusion criteria: * 18 - 70 years of age * ais grade a - c * glasgow coma scale ≥14 * able to start hypothermia treatment within 24 hours of injury * non-penetrating injury. patients urgently taken to the operating room for surgical reduction may also be included. exclusion criteria: * age \> 70 years * ais grade d * hyperthermia on admission (\>38.5ºc) * severe systemic injury * severe bleeding * pregnancy * coagulopathy * thrombocytopenia * known prior severe cardiac history * blood dyscrasia * pancreatitis * reynaud's syndrome * cord transection

Keywords: hypothermia cervical spinal cord injury trauma
lumbar puncture in emergency under nitrous oxide

Conditions: Pain; Anxiety

Summary: lumbar puncture (lp) is a frequent exam that can cause pain and anxiety. in a scheduled setting, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety. the goal of this trial is to confirm these results in a more heterogeneous group of patients having a lp, in an emergency setting.

nitrous oxide (n2o) has analgesic and anxiolytic properties that are known for more than a century. nonetheless, it's use during lumbar puncture in adults has only been investigated in a scheduled setting.thus, this study is designed to evaluate the analgesic effect of n2o on the pain induced during lumbar puncture. patients with urgent lumbar puncture realized for diagnosis purposes will be randomized in 2 groups. one group will inhale n2o for the 5 minutes before the puncture and during the rest of the procedure. the second group will inhale compressed air during the same period. neither the investigator realizing the lumbar puncture, nor the patient will know which type of gaz they are inhaling (double-blinding). the maximal pain level that occurred during the procedure will be evaluated on a numerical rating scale (nrs). nrs will also be used to evaluate the maximal anxiety induced by the procedure.

Eligibility criteria:
inclusion criteria: * adult patients coming in emergency service who need a lumbar puncture in emergency for a diagnostic purpose * at least 18 * affiliated to the french state healthcare insurance system * able to give consent to participation exclusion criteria: * previous use of nitrous oxide (medical or recreational) * contra-indication to nitrous oxide use * face mask phobia * stage ii obesity (bmi \> 35) * hemodynamic instability and/or any case when coagulation results cannot be waited * cognitive condition defined by a previous mini mental state examination \< 24/30 * confusion or any consciousness disorder that might interfere with judgment or consent * patient unable to communicate verbally * patient placed under a legal protection measure (tutorship, curatorship or a mandate) * any medical condition that might contra-indicate medical research, in physician's opinion

Keywords: spinal puncture nitrous oxide pain anxiety emergency
impact of 5-fluorouracil (5-fu) on cancer cells from liver metastases of colon cancer

Conditions: Cancer of Colon; Metastasis to Liver

Summary: analyze the dynamics of incorporation of 5-fluorouracil into cancer cell ribosomes from liver metastases of patient with metastatic colon cancer.

this is a monocentric, prospective, non-interventional cohort study in adult patients with metastatic colon cancer with hepatics metastasis. tumour samples collected for this study include: * a fragment of the previously operated primary tumor: ffip block and/or archived frozen tumor if available. * a fragment of the liver metastasis(s) performed as part of standard metastasis surgery, this fragment will include a tumor area and a healthy area within the margin of excision. these samples collected in a fresh state will be analyzed immediately.

Eligibility criteria:
inclusion criteria: * patient with metastatic colon cancer operated on and followed up at the centre leon berard for liver metastasis. * patient affiliated to social security exclusion criteria: * other pathologies that may interfere with biological evaluation, in particular known hepatic cirrhosis, whatever its origin, other liver overload diseases (hemochromatosis, wilson's disease), but excluding steatosis (which can be chemo-induced).
intrapleural bevacizumab and cisplatin therapy for malignant pleural effusion caused by non-small cell lung cancer

Conditions: Malignant Pleural Effusion

Summary: to determine the efficacy and safety of intrapleural bevacizumab and cisplatin as a treatment for malignant pleural effusions (mpe) in patients with non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * patients with advanced recurrent or progressive nsclc proven cytohistologically * karnofsky performance status (kps) ≥60 * life expectancy ≥ 2 months * no history of severe diseases of major organs including liver, heart, and kidney * no previous intrapleural therapy * written informed consent exclusion criteria: * active thoracic cavity or systemic bleeding * active pleural or systemic infection. * known sensitivity to bevacizumab or cisplatin * refusal to participate in the study.

Keywords: bevacizumab; non-small cell lung cancer; malignant pleural effusion; intrapleural administration
impact of inhaled pt003 on complexity and variability of tidal breathing and oscillatory mechanics in stable copd patient

Conditions: Copd

Summary: prospective, single-arm, open label, multicentre, phase ii pilot study to evaluate the immediate and short term (one month) impact of a new long acting double bronchodilator on innovative parameters in stable and moderate to severe copd patients. * variability and complexity of resting tidal breathing * oscillatory resistance and reactance of airways tidal volume variability and complexity is decreased in airway obstruction and is expected to improve with a bronchodilator treatment, together with lung mechanics. the relationship with changes in dyspnea and conventional pulmonary function tests is the second aim of study. after baseline assessment of these parameters, clinical and lung function evaluation will be performed 2 hours post-drug (peak drug effects). patients will continue treatment with pt003 for 4 weeks. on day 30, the same clinical and lung function assessments will be performed pre (trough) and 2h-post dose in order to obtain after-treatment measurements.


Eligibility criteria:
inclusion criteria: * female or male subjects aged 40-75 years documented copd in stable condition fev1 between 30 % and 70 % predicted (post bronchodilator) significant dyspnea with a mmrc dyspnea scale exclusion criteria: * history or current diagnosis of asthma or aco (asthma-copd overlap syndrome) * respiratory infection or copd exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening * clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ecg) parameters * severe renal impairment egfr \< 30 * narrow-angle glaucoma that, in the opinion of the investigator, has not been adequately treated. * symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant

Keywords: long acting bronchodilator tidal breathing variability impulse oscillometry spirometry plethysmography dyspnea
study to assess safety, tolerability and efficacy of sc administered mbl949 in obese participants with or without t2dm

Conditions: Obesity

Summary: this was a multi-center, randomized, placebo-controlled, participant-and-investigator-blinded, sponsor open-label study in obese participants with or without type 2 diabetes mellitus.

the study comprised a screening/baseline period of up to 35 days (5 weeks), a 14-week treatment period in which participants were administered mbl949 or placebo at 8 biweekly intervals starting on day 1 and a 10-week follow-up period. participants were to be enrolled to: * mbl949 arm 1, mbl949 arm 2 and placebo in a 1:1:1 ratio * mbl949 arm 3, mbl949 arm 4 and placebo in a 1:1:1 ratio * if mbl949 arm 1 was tolerated, mbl949 arm 5 was enrolled with a 2:1 ratio (mbl:placebo) within each stratum.

Eligibility criteria:
inclusion criteria: * body mass index: ≥ 32 kg/m2, weight ≥ 77 kg, stable body weight i.e., less than 1.5 kg self-reported change within 90 days * diagnosed t2dm as documented by medical history and confirmed by investigator and with diagnosed duration \< 10 yrs, hba1c ≤ 9%, and fasting c-peptide ≥ 0.2 ng/ml * if treated for t2dm, treatment must be limited to diet and exercise and treatment with one of the following anti-diabetic agents (stable for 90 days prior to randomization): * metformin * sglt2i inhibitors (if prescribed as the first line, ie. single agent) * ddp4 inhibitors * acarbose exclusion criteria: * vitals at screening: * systolic blood pressure less than 95 mm hg or greater than 155 mm hg * diastolic blood pressure less than 60 mg hg or greater than 95 mm hg * pulse rate less than 56 or greater than 110 bpm * history of bariatric surgery, roux-en-y gastric bypass, sleeve gastrectomy, gastric banding, and any other intrabdominal procedures designed for weight loss at screening * history of myocardial infarction with 2 years of screening * diet attempts within 90 days before screening * participation in organized weight reduction program within 6 months of screening

Keywords: type 2 diabetes mellitus weight loss
covid-19 seroconversion study among ghdc staff members - summer 2020

Conditions: Covid19

Summary: the management of the grand hôpital de charleroi hospital authorized the performance of a serology for each member of the establishment's staff in order to better characterize the proportion of its employees who have already been in contact with the sars cov-2 virus for organizational and evaluation purposes symptoms.

at the start of the sars-cov-2 pandemic, several workers had symptoms compatible with covid-19 at a time when pcr (smear) testing was only allowed for hospitalized people. in addition, the pcr test has a fairly low sensitivity. in this context, serology can make it possible to determine whether the symptoms are indeed linked to exposure to sars-cov-2. as a hospital, and in order to prepare for a possible second epidemic wave, it is also useful to know the proportion of staff members who have already been in contact with the virus for organizational purposes and symptom assessment. .

Eligibility criteria:
inclusion criteria: * be a member of the staff of the grand hôpital de charleroi who wishes to participate in order to know their immunity related to sars cov-2 after the first wave of pandemic. exclusion criteria: * not be part of the staff of the grand hôpital de charleroi.
detection of pressure areas for two elastomeric impressions

Conditions: Diabetes Free Completely Edentulous Patients

Summary: forty completely edentulous patients were selected and randomly distributed into two groups 20 patients each.group i received complete dentures constructed from elastomeric impression with wax spacer,group ii received complete dentures constructed from elastomeric impression with no wax spacer.then on time of denture insertion pressure areas were detected using pressure indicating paste and the denture retention was detected.the results showed less pressure areas in group i and more denture retention values than group ii.

this study was conducted to evaluate the significance of using wax spacer in the impression technique regarding the pressure areas and retention of the complete dentures constructed. forty patients with edentulous maxillary arches were selected from the outpatient clinic of removable prosthodontics department, faculty of oral and dental medicine, cairo university .the patients were randomly divided into two groups. group i received dentures constructed from impression technique with wax spacer while group ii received dentures constructed from impression technique with no spacer. on the day of denture insertion pressure areas were detected using pressure indicating paste and denture retention was measured using force gauge. the data was collected and analyzed using student's t-test.

Eligibility criteria:
inclusion criteria: - completely edentulous upper and lower arches. well to moderately developed ridges saliva of average viscosity and amount with normal temporomandibular joint exclusion criteria: diabetic patients radiation therapy signs of inflammation, ulceration or hyperplasia neurological disorders clicking or mandibular deviation.

Keywords: pressure area polyether elastomeric impression wax spacer
a single-dose study of the safety, tolerability, and pharmacokinetics of odanacatib (mk0822) in healthy volunteers

Conditions: Osteoporosis

Summary: this study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (mk0822) with and without food.


Eligibility criteria:
inclusion criteria: * subject is in good health * subject is a male between the ages of 18 and 45 years or (for part i only) a female 60 years or younger * female subject is postmenopausal * subject is within 20% of ideal body weight * subject is a nonsmoker exclusion criteria: * subject has multiple or severe allergies to food or medications * subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates * subject has any infections, including hiv * subject consumes excessive amounts of caffeine or alcohol * subject has donated blood or taken another investigational drug in the last month * subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug
rosiglitazone (extended release tablets) as monotherapy in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: rosiglitazone (rsg) has been tested and is approved as a treatment for type ii diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. rsg xr, the investigational drug, is an extended-release form of rsg. this study tests whether rsg xr safely provides benefit to people with mild to moderate alzheimer's disease (ad). rsg xr is a new approach to ad therapy and this study tests whether one's genes alter the effectiveness of rsg xr. glucose is used by cells to make energy that they need to live. changes in the ability of cells to use of glucose can lead to diseases like diabetes. glucose levels may be lower in the brains of ad patients, and their brain cells may also use glucose less well than in unaffected people. the proper function of brain cells may be critical to memory and thought. if brain cells use glucose poorly, this might impact ad. drugs that help brain cells properly use glucose may help a person maintain normal memory and thinking. data suggesting that rsg may help ad patients was first seen in a small study at the univ. of washington and then from a larger international gsk study. in the first study, those receiving rsg once daily for 6 months scored better on 3 tests of memory and thought than those who did not receive rsg. in the gsk study, those that benefited most from therapy with rsg xr had a specific genetic pattern. they lacked the gene that caused them to produce apolipoprotein e e4 (apoe e4). subjects who have the apoe e4 gene may have two copies, one from each parent, or they may have only one apoe e4 gene meaning that they inherited either the apoe e2 or apoe e3 version of the gene from one parent. subjects with one copy of the apoe e4 gene remained fairly stable while those with two copies of apoe e4 continued to worsen during the 6-month treatment. this study will directly test the effect of rsg xr on people who either have or lack the apoe e4 gene.

a 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in apoe e4-stratified subjects with mild to moderate alzheimer's disease. (reflect-1)

Eligibility criteria:
inclusion criteria: * clinical diagnosis of probable alzheimer's disease (ad). * mmse score 10 to 23 * has not taken an approved ad therapy in last 30 days. * no previous hypersensitivity/intolerance to acheis * have a regular caregiver. exclusion criteria: * diagnosis of vascular dementia. * type i or secondary diabetes mellitus. * type ii diabetes mellitus treated with insulin, sulfonylurea or glipizide. * history or evidence of congestive heart failure, clinically significant peripheral edema or anemia. * history of significant psychiatric illness, major depressive disorder or current depression needing initiation of treatment.

Keywords: apolipoprotein e monotherapy cognition mild rosiglitazone alzheimer's disease moderate
primary care internet-based depression prevention for adolescents (catch-it)

Conditions: Depression; Anxiety; Externalizing Symptoms; Substance Abuse

Summary: in this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the catch-it primary care/internet based depression prevention intervention against attention monitoring psychoeducation (ampe) in preventing the onset of depressive episodes in an intermediate to high risk group of adolescents aged 13-17. we plan to (a) identify high risk adolescents based on elevated scores on the phq-a, a screening measure of depressive symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into either the catch-it or the ampe group; (c) assess outcomes at 2, 8, 12, 18, and 24 months post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders, and on measures of role impairment in education, quality of life, attainment of educational milestones, and family functioning; and (d) conduct exploratory analyses to examine the effectiveness of this intervention program, moderators of protection, and potential ethnic and cultural differences in intervention response.


Eligibility criteria:
inclusion criteria: * youth ages 13 through 17. * youth must be experiencing elevated level of depressive symptoms on the center for epidemiologic studies depression46 (ces-d) scale (score \>/= 16) and have at least two core symptoms of major depression on the patient health questionnaire, adolescents. * youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse. exclusion criteria: * current dsm-iv diagnosis (kiddie schedule of affective disorders) of major depressive disorder, current therapy for depression, or be taking antidepressants (e.g., ssris, tcas, maois, bupropion, nefazodone, mirtazapine, venlafaxine). * current ces-d score \>35 * dsm-iv diagnosis of schizophrenia (current or past) or bipolar affective disorder * current serious medical illness that causes significant disability or dysfunction * significant reading impairment (a minimum sixth-grade reading level based on parental report), mental retardation, or developmental disabilities * serious imminent suicidal risk (as determined by endorsement of current suicidality on ces-d or in ksads interview) or other conditions that may require immediate psychiatric hospitalization * psychotic features or disorders, or currently be receiving psychotropic medication * extreme, current drug/alcohol abuse (greater than or equal to 2 on the crafft).