Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and pharmacokinetic profile of m108 monoclonal antibody in patients with advanced unresectable solid tumors in china

Conditions: Advanced Unresectable Solid Tumors

Summary: m108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. the aim of this phase i study is to establish safety and tolerability of different dosage regimen in patients with advanced unresectable solid tumors in china.


Eligibility criteria:
inclusion criteria: 1. written informed consent. 2. advanced unresectable solid tumors proven by histology 3. at least 1 measurable site of the disease according recist 1.1 criteria 4. ecog performance status (ps) 0-1 5. life expectancy \> 3 months 6. age ≥ 18 years and ≤75 years 7. adequate haematological function; absolute neutrophil count ≥1.5 x 109/l; white blood cell count ≥3.0 x 109/l; platelets ≥100 x 109/l; haemoglobin ≥9 g/dl. 8. adequate coagulation function; international normalized ratio ( inr) ≤ 1.5 x upper limit of normal (uln), or activated partial thromboplastin time (aptt) ≤ 1.5 x uln. 9. adequate hepatic function; bilirubin ≤1.5 x uln, aspartate aminotransferase (ast), and alanine aminotransferase (alt) ≤2.5 x uln. 10. adequate renal function; creatinine ≤1.5 x uln, or reatinine clearance rate ≥60 ml/minute calculated. exclusion criteria: 1. previous received or planned to be vaccinated with 2019-ncov vaccine or other vaccines within 3 months prior to the start of study treatment or during the study or within 3 months after the end of the study; 2. previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastatic side peripherally and the patient recovered from acute toxicity was allowed). 3. previous anti-tumor therapy within 4 weeks prior to the start of study treatment. 4. previous major operation within 8 weeks prior to the start of study treatment. 5. prior severe allergic reaction or intolerance to a monoclonal antibody, including humanised or chimeric antibodies. 6. symptomatic cerebral metastases. 7. uncontrolled or severe illness. 8. known human immunodeficiency virus infection or known symptomatic hepatitis 9. other clinically significant disease which may have adversely affected the safe delivery of treatment within this study
cross-linked and non-cross-linked hyaluronic acid in subdeltoid bursitis

Conditions: Subdeltoid Bursitis; Hyaluronic Acid

Summary: this study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.

a double-blind, randomized clinical trial will be conducted to collect 52 patients with subdeltoid bursitis. the patients will be injected with cross-linked or non-cross-linked hyaluronic acid under ultrasound guidance. before treatment, one week after treatment (i.e., one week after injection), one month after treatment, and three months after treatment to detect shoulder pain (visual analog scale; pressure ergometer to measure pain pressure threshold), function (including disabilities of the arm, shoulder, and hand: dash and shoulder pain and disability index: spadi), quality of life (brief version of the world health organization quality of life scale: whoqol-bref) will be arranged.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of subdeltoid bursitis * age 20 or older 20 * at least one positive in the painful arc, neer test, or hawkins test * can attend three months of intervention and follow-up exclusion criteria: * history of malignancy * previous shoulder operation or injury * previous shoulder injections in the past three months

Keywords: subdeltoid bursitis hyaluronic acid cross linked
assessing effectiveness of adalimumab for treating ulcerative colitis in real life conditions

Conditions: Ulcerative Colitis (UC)

Summary: this study assesses the long?term effectiveness of adalimumab in subjects starting a treatment for ulcerative colitis in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach.


Eligibility criteria:
inclusion criteria: * suffering from ulcerative colitis * naïve from adalimumab * starting a treatment with adalimumab * capable of and willing to grant authorization for use/disclosure of data collected * able to read, understand, and complete patients questionnaires exclusion criteria: - none

Keywords: adalimumab ulcerative colitis sothis effectiveness
air pollution exposure on acute coronary syndrome in two cohorts of industrial and non-industrial areas

Conditions: Acute Coronary Syndrome; Air Pollution

Summary: background: there is a lack of data on the effect of air pollution on acute coronary syndrome (acs) in industrial and non-industrial areas. objectives: a comparison of association of air pollution exposure with acs in two cohorts of industrially different areas. materials and methods: the study covered 6,000,000 person-years of follow-up and five types of air pollution between 2008 and 2017. a time series regression analysis with 7-lag was used to assess the effects air pollution on acs.


Eligibility criteria:
the study covered all residents from industrial (katowice) and non-industrial (białystok) areas.

Keywords: acute coronary syndrome air pollution
home-based exercise training in cardiac patients

Conditions: Physical Fitness; Patient Adherence; Quality of Life; Autonomic Nervous System Imbalance

Summary: the investigators hypothesize that exercise training program guided by virtual augmented reality glasses or by video from computer screen used at home will improve motivation into exercise training and results in superior adherence to exercise training compared to current practice. the primary objectives of this research project are to study the effects of exercise training guidance by novel technology on 1) exercise capacity, 2) adherence to exercise training, 3) changes in cardiac autonomic function and 4) quality of life in acute coronary syndrome (acs) patients.

the subjects of the study will be recruited from the consecutive series of patients of men and women admitted to oulu university hospital due to an acute coronary syndrome (acs). the study population will be randomized into control group (n=25) and study group (n=25) matched with age and gender. for all subjects, clinical status including quality of life questionnaire, exercise capacity and autonomic function measurements will be performed at baseline and after exercise training. exercise training program is six months for both groups according to current guidelines. all the patients will have a detailed and personalized training prescription. study group will have virtual augmented reality glasses or computer with training video to motivate and control exercise training prescription at home.

Eligibility criteria:
inclusion criteria: * recent (\< 1 month) acute coronary syndrome exclusion criteria: * new york heart association (nyha) functional classification class iv (heart failure) * unstable chest pain (angina pectoris, canadian cardiovascular society grading of angina pectoris class 4) * st-segment elevation myocardial infarction (stemi) * implanted cardioverter defibrillation or pacemaker (or planned) * chronic atrial fibrillation * musculoskeletal disorder (unable to participate exercise training) * participation in competing clinical trial * severe peripheral atherosclerosis * retinopathy or neuropathy * dementia * life-expectancy due to other serious disease \< 2 years or any other reason why patient is unable or unwilling to provide written informed consent.

Keywords: exercise tolerance heart rate variability baroreflex sensitivity
pharmacokinetics and pharmacodynamics study of oral salmon calcitonin in healthy postmenopausal women

Conditions: Postmenopausal Osteoporosis

Summary: this is a phase i study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (smc021) in postmenopausal women


Eligibility criteria:
inclusion criteria: * healthy postmenopausal women exclusion criteria: * previous treatment with other osteoporosis medication other protocol-defined inclusion/exclusion criteria may apply.

Keywords: postmenopausal osteoporosis pharmacokinetics/dynamics calcitonin
safety, tolerability and activity study of multiple doses of isis-sglt2rx in healthy volunteers

Conditions: Type 2 Diabetes Mellitus

Summary: the primary purpose of this trial is to assess the safety and tolerability of isis-sglt2rx when given at increasing single doses and to assess the safety and tolerability of the same doses when given multiple times.

to evaluate the safety and tolerability of a single subcutaneous injection of isis-sglt2rx administered at four increasing dose levels (50, 100, 200, 400 mg) and to evaluate the safety and tolerability of multiple doses of isis 388626 administered subcutaneously of either 6 or 13 weeks.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years * male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophorectomy or tubal ligation) * give written informed consent to participate in the study and availability for all study requirements * fasting plasma glucose \</= the upper limit of the laboratory's reference range (uln) * hba1c \</= uln * bmi \< 30 kg/m² * agree to maintain steady hydration throughout study participation and agree not to fluid restrict exclusion criteria: * pregnant women, nursing mothers or women of childbearing potential * clinically significant abnormalities in medical history or physical examination * clinically significant abnormalities in laboratory examination (including alt \> uln, ast \> uln, bilirubin \> uln, creatinine \> uln, urine protein positive by urine dipstick, platelets \< lower limit of normal and any other clinically significant laboratory findings) * estimated gfr \< 60 ml/min per 1.73m² * history of clinically significant abnormalities in coagulation parameters * positive test result for hiv, hepatitis b virus, and/or hepatitis c virus * active infection requiring antiviral or antimicrobial therapy * subjects on chronic or acute prescription medication may be permitted after discussion with the isis medical monitor * malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> 1 year) * any other concurrent condition which, in the opinion of the investigator, would preclude participation in this study or interfere with compliance * past and present history of alcohol or drug abuse (defined as \> 3 units daily) * undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to screening * blood donation within three months of screening

Keywords: diabetes sglt2 inhibitor
prognostic indicators of survival following cardiopulmonary resuscitation in patients with cardiac arrest

Conditions: Cardiopulmonary Resuscitation

Summary: cardiopulmonary resuscitation (cpr) occurs approximately 200,000 times/yr in hospitals in the unitedstates, with 18% of patients surviving to discharge. just over half of these survivors are neurologically intact or with mild defiits at the time of discharge. do-not-resuscitate (dnr) orders are used to withhold cpr from patients who are unlikely to benefi or for whom it is inconsistent with their treatment goals or personal preferences. it would be helpful to identify patients with a very low likelihood of survival to discharge neurologically intact or with mild defiits were they to experience cardiopulmonary arrest (cpa), so their physician can present the option of a dnr order. this information would also be useful anytime a patient raises the question of the likelihood of survival should they undergo cpa.the objective of this study was to determine key indicators for good outcome in patients with sudden cardiac arrest undergoing cpr and develop a prediction model to predict survival to hospital discharge in these patients.

a cpr coordinator prospectively collected data for the cpr registry according to the utstein-style guidelines. te registry included the following information: demographic data, comorbidities, whether the arrest was witnessed, the incidence of suspected or confrmed trauma, presumed arrest time; presence of bystander cpr, frst documented arrest rhythm by the emergency medical service (ems) provider, any return of spontaneous circulation (rosc), presence of ecpr, the presence of return of spontaneous heart beating (rosb) after cpr, presumed cause of arrest; the application of therapeutic hypothermia and the use of coronary angiography(cag) or percutaneous coronary intervention (pci),24-hour survival, the presence of rosc more than 20 min, hospital length of stay (los), survival to hospital discharge,glasgow-pittsburgh cerebral performance category (cpc) score at discharge, and the fnal diagnosis at discharge. te comorbidity score was calculated using the charlson comorbidity index. te duration of cpr was defned as the time interval from the frst chest compression provided by healthcare providers to the termination of resuscitation eforts due to rosc (more than 20 min),rosb after cpr, or a declaration of death. a favorable neurologic outcome was defned as a cpc score of 1 or 2 on the fve-category scale.

Eligibility criteria:
inclusion criteria: * age more than 18 years, * sudden arrest with potentially reversible causes, * a short no fow time (time interval from presumed arrest to cpr initiation) * even for unwitnessed arrests exclusion criteria: * presence of a terminal illness or malignancy, severe irreversible neurologic defcit, * suspected or confrmed traumatic origin of arrest, * no informed consent from the family

Keywords: cardiac arrest cardiopulmonary resuscitation survival prediction
qt-prolongation in psychiatric hospitals

Conditions: QT-prolongation

Summary: observational study in 6 psychiatric hospitals in flanders. patients are included when a qt-prolonging drug is added to a medication profile that already contains a potential qt-prolonging drug. an ecg is taken before the administration of the new drug and a week after starting the new drug to investigate the change in duration of the qtc-interval. risk factors for developing qt-prolongation and blood concentrations of potassium and creatinine are documented.


Eligibility criteria:
inclusion criteria: * inpatient in one of the 6 participating psychiatric hospitals * qt-prolonging drug in the medication profile and the doctor prescribes another qt-prolonging drug exclusion criteria: * age \< 18 year

Keywords: qt-prolongation torsade de pointes drug interactions psychiatry
clinical, neurophysiological and radiological evaluation of patients with basal ganglia lesions

Conditions: Basal Ganglia Lesions

Summary: basal ganglia are involved in the control of motor, cognitive and emotional behaviours. the aim of this study is to precisely evaluate patients with basal ganglia focal lesions both with or without loss of psychic-self activation.


Eligibility criteria:
inclusion criteria: * basal ganglia lesions exclusion criteria: * contraindication to magnetic resonance imaging (mri) * dementia

Keywords: basal ganglia loss of psychic self-activation
validity and reliability of the 6 minute pegboard ring test

Conditions: Duchenne Muscular Dystrophy

Summary: this study aimed to investigate the validity and reliability of 6pbrt in individuals with dmd and its applicability on these patients.

duchenne muscular dystrophy (dmd) is the most common type of progressive muscular dystrophies and is an x-linked recessive, rarely autosomal dominant, muscle disease. dmd begins in childhood and progresses until they become unable to walk. individuals with dmd experience skeletal muscle weakness, difficulty breathing, and decreased exercise capacity. in these patients, traditionally lower extremity tests are; 6-minute walk tests, treadmill tests and cardiopulmonary exercise tests are used. however, it is reported that the upper extremity is also affected in individuals with dmd. the 6-minute pegboard and ring test (6pbrt), which is valid and reliable in most disease groups, is also a test that can be applied to the upper extremities. it is important to use 6pbrt frequently in clinical research practice for patients with dmd and to know its validity and reliability. to our knowledge, the validity and reliability of this test in individuals with dmd has not been established in the literature. this study aimed to investigate the validity and reliability of 6pbrt in individuals with dmd and its applicability on these patients.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the research, * being diagnosed with duchenne muscular dystrophy between the ages of 6-17, * being level 1 and 2 according to the brooke upper extremity functional classification scale * having no problems reading and/or understanding the scales and cooperating with the tests to be. * ability to sit independently for approximately 15 minutes during the evaluation exclusion criteria: * not volunteering to participate in the research, * having any orthopedic problem in the upper extremity, * a neurological disease or other clinical condition that may affect cognitive status having a diagnosis, * having had surgery on the upper extremities in the last 6 months and any having an injury * at a level that prevents functional activities in the upper extremity having severe contractures (joint restriction)

Keywords: duchenne muscular dystrophy 6 minute pegboard and ring test arm exercise endurance upper extremity
treatment intensification with temozolomide in adults with a glioblastoma

Conditions: Glioblastoma

Summary: due to conflicting data on the optimal moment to start tmz chemotherapy and the impact of prolongation of the adjuvant phase with tmz, the anocef (association des neuro-oncologues d'expression francophone) group proposes this randomized trial comparing an intensified arm (early tmz and extended adjuvant tmz until toxicity, progression or patient refusal) versus the classical eortc regimen as control (rt and concomitant tmz started 4-6 weeks after surgery followed by a number of adjuvant tmz cycles strictly limited to 6) for primary gbm adult patients.


Eligibility criteria:
inclusion criteria: * patient ≥18 years old * histological diagnosis of de novo gbm (extemporaneous diagnosis or standard pathological examination). in case of extemporaneous diagnosis, the patient can be included. if the diagnosis is not confirmed, the patient will be withdrawn from study. * time between initial surgery/biopsy and planned start of treatment (if allocated to the experimental arm) ≤ 15 days (ideally in the first 7 days) * karnofsky performance status (kps) ≥ 60%, or kps \<60% only related to glioma-related motor paresis. * adequate biological functions * common toxicity criteria (ctc) non hematological adverse events ≤ grade 1 (except for alopecia, nausea, vomiting and neurological symptoms) * females of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 6 months after stopping the study drug. * standard radiation therapy deemed feasible (60 gy, 30 fractions) * time interval of less than 43 days between initial surgery/biopsy and planned start of radiation therapy * written informed consent exclusion criteria: * secondary or recurrent glioblastoma (gbm) * planned use of tumor-treating electric fields * planned use of carmustine implants * prior malignancy in the last 5 years before inclusion or concomitant * severe myelosuppression * known hypersensitivity to any of the study drugs, study drug classes, excipients in the formulation or to dacarbazine (dtic) * current or recent treatment with another experimental drug or patients included in a clinical therapeutic trial (in the 30 days prior to inclusion). * known current viral hepatitis, hiv infection or current active infectious disease * inability to swallow oral medications or any mal-absorption condition * pregnant or breastfeeding patients. * inability to comply with medical follow-up of the trial (geographical, social or psychic reasons) * person under guardianship or curatorship

Keywords: temozolomide stupp protocol
intron-a/aldara combination therapy for basal cell carcinoma (bcc)

Conditions: Basal Cell Carcinoma

Summary: a trial to see if bcc excluding the scalp and face can be treated successfully with a combination therapy of intron-a and aldara.


Eligibility criteria:
inclusion criteria: * nodular or superficial basal cell carcinoma on the skin excluding scalp or face exclusion criteria: * pregnancy

Keywords: bcc basal cell carcinoma intron-a aldara basal cell carcinoma excluding scalp and face
dom-innate: study of sgx942 for the treatment of oral mucositis in patients with concomitant chemoradiation therapy for head and neck cancer

Conditions: Squamous Cell Carcinoma of the Oral Cavity and Oropharynx; Oral Mucositis

Summary: to assess the efficacy of sgx942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer


Eligibility criteria:
inclusion criteria: * biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases * scheduled to receive cisplatin chemotherapy of 80-100 mg/m² * scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiation dose between 55 and 72 gy at each site exclusion criteria: * current mucositis * current, clinically significant, active infection that in the opinion of the investigator would make them an unfit participant in the trial * planned to receive erbitux™ (cetuximab) or similar targeted therapy between baseline and 6 weeks post-rt * prior radiation to the head and neck * chemotherapy treatment within the previous 12 months * tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx * evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: estimated creatinine clearance \<30 ml/min; alt or ast level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; thrombocytopenia; or cd4+ t cell count below 200 cells per μl * evidence of immediate life-threatening disease or a life expectancy of less than 3 months * women who are pregnant or breast-feeding * participation in any study involving administration of an investigational agent within 30 days of randomization into this study

Keywords: om head and neck cancer sgx942 dusquetide squamous cell carcinoma