Kornimate/medical-research-clean huggingface dataset:
a trial of casdozokitug in combination with toripalimab plus bevacizumab in participants with unresectable and/or locally advanced or metastatic hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.


Eligibility criteria:
key inclusion criteria: * unresectable locally advanced or metastatic hcc with diagnosis confirmed by histology/cytology or clinically by american association for the study of liver diseases criteria in cirrhotic participants. * disease that is not amenable to curative surgical and/or locoregional therapies or progressive disease (pd) after surgical and/or locoregional therapies. * ≥ 1 measurable lesion (per recist v1.1) that is untreated. exclusion criteria: * has received prior systemic therapy for hcc. * has previously received an anti-il-27 antibody (ab) or anti-il-27-targeted therapy. * has known fibrolamellar hcc histology, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc. * has moderate or severe ascites. * has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). additional protocol-defined inclusion/exclusion criteria apply.

Keywords: unresectable hepatocellular carcinoma locally advanced hepatocellular carcinoma metastatic hepatocellular carcinoma casdozokitug toripalimab bevacizumab hcc liver cancer il-27 pd-1
the efficacy and safety of the loading dose of tranexamic acid in scoliosis surgery during perioperative

Conditions: Tranexamic Acid

Summary: this study intends to make full use of the advantage of spinal orthopedic surgery in our medical center.analyze the blood loss and blood coagulation function and the influence of safety of load dose tranexamic acid (txa) in scoliosis surgery during perioperative.


Eligibility criteria:
inclusion criteria: * age:18-60 years old * american society of anesthesiologists (asa):i-ii * the spinal orthopedic undergoing elective surgery exclusion criteria: * severe cardiopulmonary dysfunction * blood coagulation dysfunction * disorders of liver and kidney function * tranexamic acid allergies * the history of pulmonary embolism and venous thrombosis of lower limbs * anticoagulant drugs and nonsteroidal anti-inflammatory drugs in 7 days

Keywords: tranexamic acid blood conservation
psychological symptoms in patients with behcet's disease by scl90-r

Conditions: Behcet's Syndrome

Summary: to find the overall psychological profile of patients with behcet's disease (bd) and compare it with non-bd patients.patients were checked for psychological symptoms by symptom check list 90 revised (scl90-r)

200 bd and 200 non-bd patients were checked for psychological symptoms by symptom check list 90 revised (scl90-r). bd diagnosis was based on the new international criteria for behcet's disease (icbd). non-bd patients were patients mimicking bd. all patients were asked to complete the scl90-r when they attended the clinic for their routine follow-up. the demographic information and disease manifestations including ocular and neurological involvement were registered. for those with visual impairment, scl90-r was applied by an interviewer. frequencies and descriptive analysis were measured in both bd and non-bd groups. means and standard deviations (sd) of visual acuity were calculated. data collected from scl90-r did not have normal distribution in any dimension. the mean values of raw numbers, global severity index (gsi), the positive symptoms total (pst) and the positive symptom distress index (psdi), were compared by mann-whitney u (m-w u) test.).to detect any bias in results due to data collection method, self reported data and reviewer collected data were compared.

Eligibility criteria:
inclusion criteria: * behcet's disease patients that their diagnosis was based on the new international criteria for behcet's disease (icbd). * non-behcet's disease patients were patients mimicking bd. exclusion criteria: * probable behcet's disease

Keywords: psychological symptoms behcet's disease
this study will evaluate the safety, tolerability, and efficacy of anb032 in subjects with moderate to severe atopic dermatitis (ad).

Conditions: Atopic Dermatitis Eczema

Summary: this study will evaluate the safety, tolerability, and efficacy of anb032 in subjects with moderate to severe atopic dermatitis (ad).

this is a phase 2, randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of anb032 in subjects with moderate to severe atopic dermatitis (ad).

Eligibility criteria:
key inclusion criteria: * male or female aged 18 to 65 years and in good general health * moderate to severe ad for at least 6 months prior to randomization * history of inadequate response to treatment for ad with topical medications or for whom topical treatments are otherwise medically inadvisable * easi score ≥ 16 at screening and at randomization * viga ad score ≥ 3 at screening and at randomization * ad involved bsa ≥ 10% at screening and at randomization key exclusion criteria: * any factors that in the investigator's opinion would predispose the subject to develop an infection * known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status * not able to tolerate sc drug administration * tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before randomization

Keywords: anb032, b and t lymphocyte attenuator btla
proactive and reactive balance training effects on balance and functional performance among chronic stroke survivors

Conditions: Stroke; Chronic Stroke; Balance

Summary: the study is an rct study, comparing the proactive and reactive balance training among stroke survivors, the participants will be chronic stroke patients aged between 50- 75 years old, and the participants will receive a balance training program for 8 weeks 3 sessions in the week, the participants will randomly be allocated in two groups proactive group and the reactive group, at the end of the study will compare the different effects between proactive and reactive balance training

the objectives of the study are: (1) to investigate the effect of reactive balance training on balance and functional performance, (2) to investigate the effect of proactive balance training on functional activity and balance stroke survivors, and (3) to study the reactive balance training versus the proactive balance on balance and functional performance among stroke survivors. the study will be a single-blinded rct study will consist of 40 chronic stroke patients and will allocate randomly into 2 groups, the first intervention group n=20 will have proactive-balance training, and the second group n= 20 will have reactive balance training, the two groups will be blinded. the study population will be chronic stroke patients discharged from bethlehem arab society for rehabilitation (basr), alahli hospital, al mezan hospital, and alehsan society for rehabilitation, and lives in hebron city and their villages. the program will consist of 24 sessions in 8 weeks, through 3 sessions weekly. the sessions will be 45 minutes, starting with a 10 min warm-up exercise and then the balance training and the sessions will end with 5 min cool-down exercise. the session will be individualized, the program has sequences depending on the patient's ability. the program consists of: 1. sitting training 2. standing training 3. walking training the sequences of the training will be based on a balance training protocol.

Eligibility criteria:
inclusion criteria: 1. chronic stroke patients 2. males and females 3. age from 50-75 years old 4. able to follow up on instructions 5. able to walk at least 10 meters continuously 6. able to perform sub-maximal physical activity 7. stable health condition exclusion criteria: 1. acute stage or subacute stage (less than 3 months) 2. stroke patients with other severe diseases 3. head injuries 4. patients with mental problems 5. patients with vestibular problems 6. patients refuse to sign the consent form
healey als platform trial - regimen e sls-005 - trehalose

Conditions: Amyotrophic Lateral Sclerosis

Summary: the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. regimen e will evaluate the safety and efficacy of a single study drug, sls-005 (trehalose injection, 90.5 mg/ml for intravenous infusion) in participants with als.

the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. this trial is designed as a perpetual platform trial. this means that there is a single master protocol dictating the conduct of the trial. the healey als platform trial master protocol is registered as nct04297683. once a participant enrolls into the master protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. all participants will have an equal chance of being randomized to any currently enrolling regimen. if a participant is randomized to regimen e sls-005 - trehalose, the participant will complete a screening visit to assess additional regimen e eligibility criteria. once regimen e eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active sls-005 or matching placebo. regimen e will enroll by invitation, as participants may not choose to enroll in regimen e. participants must first enroll into the master protocol and be eligible to participate in the master protocol before being able to be randomly assigned to regimen e. for a list of enrolling sites, please see the healey als platform trial master protocol under nct04297683.

Eligibility criteria:
inclusion criteria: * no additional inclusion criteria beyond the inclusion criteria specified in the master protocol (nct nct04297683). exclusion criteria: * the following exclusion criteria are in addition to the exclusion criteria specified in the master protocol (nct nct04297683). 1. current diagnosis or healthcare professional-recommended treatment (medication, exercise or diet) of diabetes mellitus 2. master protocol screening glucose \>140 mg/dl 3. prior treatment with iv trehalose or known hypersensitivity to trehalose 4. current use of oral trehalose (see prohibited medication section 5.9) 5. inability for participant to return to site for weekly drug administration, until approved for home infusions

Keywords: als placebo-controlled double-blind regimen specific appendix lou gehrig's disease trehalose seelos therapeutics
a phase 3 study comparing 2 doses of cp-690,550 and the active comparator, humira (adalimumab) vs. placebo for treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a comparative study of cp 690,550, humira (adalimumab) and placebo on background methotrexate in patients with rheumatoid arthritis. the study is intended to provide evidence of the efficacy and safety of cp 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe rheumatoid arthritis. it is intended to confirm the benefits of cp-690,550 in improving signs and symptoms and physical function that were observed in rheumatoid arthritis. an active comparator, adalimumab, is also included.


Eligibility criteria:
inclusion criteria: * the patient has a diagnosis of ra based upon the american college of rheumatology (acr) 1987 revised criteria. * the patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at screening: 1.esr (westergren method) \>28 mm in the local laboratory. 2. crp \>7 mg/l in the central laboratory. * no evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis. * the patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other dmards. exclusion criteria: * blood dyscrasias including confirmed: 1. hemoglobin \<9 g/dl or hematocrit \<30%; 2. white blood cell count \<3,000 cu.mm. absolute neutrophil count \<1,200 cu.mm; 4. platelet count \<100,000/l * history of any other autoimmune rheumatic disease other than sjogren's syndrome * no malignancy or history of malignancy. * history of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug * patients who have failed any tnfi for either lack of efficacy or a tnfi mechanism related adverse event. * patients who have previously received adalimumab therapy for any reason. * patients who are contraindicated for treatment with adalimumab in accordance with the approved local label. * patients meeting the new york heart association class iii and class iv congestive heart failure

Keywords: oral dmard jak inhibitor clinical trial
study of the feasibility to derive vaccine from tumor tissue in patients with non-small cell lung cancer

Conditions: Non-Small-Cell Lung Carcinoma; Lung Cancer; Pulmonary Cancer

Summary: antigenics is enrolling patients in a phase ii study testing the feasibility to derive an autologous investigational vaccine (hsppc-96) from the tumor tissue of patients with resectable non-small cell lung cancer. vaccine production will be attempted on all patients who undergo surgery and meet all inclusion/exclusion criteria.

antigenics is enrolling patients in a phase ii study testing the feasibility to derive an autologous investigational vaccine (hsppc-96) from the tumor tissue of patients with resectable non-small cell lung cancer. all patients will undergo surgery to remove the tumor and will be followed for recurrence and overall survival. the primary goal of this trial is to determine if hsppc-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer. the secondary goals are to further characterize the safety and efficacy profile, to evaluate disease recurrence in patients receiving, and to evaluate overall survival in patients receiving hsppc-96. hsppc-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. a portion of the tumor tissue is sent to antigenics' manufacturing facility where it will undergo processing to create a vaccine. this vaccine may help the patient's immune system attack cancerous cells while leaving healthy cells alone.

Eligibility criteria:
this is a summary of criteria. only the principal investigator can determine eligibility. inclusion criteria: * suspected non-small cell lung cancer, stage ib, stage ii, or stage iiia * tumor size \> 3x3 cm or equivalent to a 9 cm² lesion * scheduled surgery with curative intent * at least 18 years of age * must not be pregnant or breast feeding * agree to not receive any other investigative agent at any time while enrolled in this study exclusion criteria: * previous treatment for non-small cell lung cancer * clinical signs or symptoms of brain metastases * history of immune suppression or autoimmune disorder * severe active infection or other serious medical illness, that in the opinion of the principal investigator, would prevent study completion * other malignancies in the past 5 years, except adequately treated in situ cervix carcinoma or non-melanoma skin cancer

Keywords: lung cancer non-small cell lung cancer pulmonary immunotherapy vaccine
examination of cardiovascular function/ cardio respiratory interaction on spontaneous breathing trials in patients in the prolonged weaning

Conditions: Cardiovascular Disease

Summary: the aim of the present study is to determine the cardiovascular function/ cardio respiratory interaction on spontaneous breathing trials in patients with prolonged weaning.


Eligibility criteria:
inclusion criteria: * legal age (≥18 years) * written informed consent prior to study participation * patient in prolonged weaning with nyha i-ii and an actual positive ventilator screening test: 1. pao2 ≥ 60 mmhg at fio2 ≤ 0.4 2. peep ≤ 8 cmh2o 3. glasgow coma scale \> 13 4. temp. \< 38°c 5. hb \> 80-100 g/l 6. less requirement on catecholamines (\<0.1µg/kg/min) * and on these patients are already performed a spontaneous breathing trial with following result: 1. abortion this spontaneous breathing trial \ 10min 2. reason for an abortion was not hypercapnia exclusion criteria: * weaning patients are assigned on group 1-2 * patient with heart failure (nyha iii-iv) and/ or other cardiac comorbidity * acute nstemi (non-st-segment elevation myocardial infarction) * pregnancy and breast-feeding

Keywords: weaning tte patients in prolonged weaning
an open label non-interventional evaluation of the effect of adjuvant hormonal treatment of postmenopausal women wih early breast cancer with aromatase inhibitors on bone mineral density and bone fracture rate in daily practice

Conditions: Breast Cancer; Osteoporosis

Summary: the aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.


Eligibility criteria:
inclusion criteria: * women aged 55-65 years, diagnosed with invasive early breast cancer: - surgery, chemo- and/or radiotherapy concluded less than 6 months ago * women with hormone-independent breast cancer: - surgery, chemo- and/or radiotherapy concluded before 24-36 months or 54-66 months * women with hormone-dependent breast cancer:- adjuvant therapy with tamoxifen initiated before 24-36 and 54-66 months or - adjuvant therapy with aromatase inhibitor initiated before 24-36 and 54-66 months or - switch from tamoxifen to aromatase inhibitor initiated before 24-36 months exclusion criteria: * women receiving active treatment for osteoporosis * women with any evidence of breast cancer recurrence

Keywords: breast cancer aromatase inhibitors bone mineral density osteoporosis
interfascial infiltration for acute unspecific low back pain in the emergency department

Conditions: Low Back Pain; Acute

Summary: pain relief and functional impairment have been shown to remain poor to moderate over weeks after emergency department discharge, in patients who seek ed management for acute nontraumatic, nonradicular low back pain. the investigators made the hypothesis that ultrasound-guided interfascial infiltration of local anesthesics and corticoid is efficient and safe in treating patients presenting to the ed with acute non specific low back pain. the investigators aimed to compare early and short term functional impairment and pain relief one day and 1 week after interfacial infiltration, as compared to standard medical treatment

this is a single center observational feasibility study enrolling ed patients presenting with acute unspecific low back pain. ultrasound-guided interfascial infiltration is proposed to eligible patients presenting to our ed with low back pain and disability, as part of routine care. patients receive standard medical treatment if they refuse interfascial infiltration or in case of absence or unavailability of a trained operator. patients were followed-up at 1 day and 7-days pots ed discharge by telephone interview conducted by an independent member of our research team not involved in patient's management

Eligibility criteria:
inclusion criteria: * adults aged between 18 and 70 years old * presenting to the ed for low back pain from musculoskeletal origin, with symptoms evolving for less than 6 weeks, * a score of 3 or more in the numeric pain scale (0-10) * a score of 5 or greater on the rolland morris disability questionary (scale 0-24, rmdq). exclusion criteria: * traumatic or radicular pain or low back pain from alternative etiology * allergy to local anesthetics * blood coagulation disorders * patients for whom follow-up by telephone interview was not possible * patients already enrolled in the study

Keywords: low back pain pain disability interfascial infiltration anti-inflammatory agents, non-steroidal analgesics emergency department / emergency room / emergency management
collection of biological samples with clinical characterization of covid-19 patients

Conditions: Covid-19

Summary: biological collection (blood sample) associated with clinical data from covid-19 patients

sars-cov2 is an emerging respiratory virus in the coronavirus family, responsible of the pandemic since november 2019. france, which has more than 17,000 deaths from the virus, is one of the main outbreaks. as of 16 april 2020, more than 76,000 individuals in france have been hospitalized, corresponding to 69% of confirmed cases (https://www.santepubliquefrance.fr). most affected patients have more or less marked clinical signs associating fever, cough, dyspnea, myalgia, anosmia, ageusia, digestive disorders. in some cases, the progression is worse with lung disease of varying severity. indications for hospitalization are essentially the severe forms of covid-19 disease, characterized by hypoxemic lung disease. risk factors for developing severe covid-19 disease have been identified already: age, co-morbidity such as diabetes, obesity-overweight or cardiovascular diseases. it is assumed that other host-related factors, including genetics, may contribute to the existence of this phenotypic heterogeneity. at present, these factors are not known. the objective of this research is to constitute a dna collection from patients with covid-19, in order to be able to search for genetic factors modulating the clinical phenotype.

Eligibility criteria:
inclusion criteria: * diagnosis of covid-19 confirmed on rt-pcr test or chest scanner * any age * membership in the general social security system * inform consent signed by the patient or by legal representatives for minors exclusion criteria: * refusal of the patient or one of the legal representatives

Keywords: blood samples adn arn plasma
primary failure of eruption (pfe) : highlighting of clinical, radiological and genetic diagnostic criteria: consequences on the therapeutic management

Conditions: Primary Failure of Eruption

Summary: the primary purpose of the study is to identify clinical, radiological and genetic diagnostic criteria for primary failure of eruption (pfe). the secondary purposes are to highlight the genotype-phenotype correlations in the pthr1 and non-pthr1 forms and analyze the therapeutic failures.


Eligibility criteria:
inclusion criteria: * people over 6 years old * people with primary failure eruption exclusion criteria: * children under 6 years old * endocrine pathology that may interfere with dental eruption * rickets * chemotherapy / radiotherapy * bisphosphonate treatment