Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of max-40279 and toripalimab in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: this include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.

this study is a study of max-40279-01 in combination with toripalimab in patients with advanced solid tumors. this study includes two parts, the part 1 will assess the safety and efficacy of the preset several dose levels of max-40279-01 and toripalimab, and recommend a dose level of max-40279-01 combined toripalimab for stage 2. the part 2 is designed to study the efficacy and safety of max-40279-01 combined toripalimab in advanced solid tumors or certain specific tumors.

Eligibility criteria:
inclusion criteria: 1. males and/or females over age 18 2. histologically and/or cytologically documented local advanced or metastatic solid tumor. 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. expected survival \>3 months. 5. signed informed consent form. exclusion criteria: 1. known uncontrolled or symptomatic central nervous system metastatic disease. 2. adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade \>1 (national cancer institute common terminology criteria \[nci ctcae\] v.5.0) at the time of randomization. 3. inadequate organ or bone marrow function. 4. medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product. 5. pregnant or breast-feeding woman. 6. known allergies, hypersensitivity, or intolerance to max-40279-01 the excipients of these treatments.
european study of dronedarone in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (af) and to assess the tolerability of dronedarone in the target population.


Eligibility criteria:
inclusion criteria: * patients with symptomatic permanent af (\>6 months) for which cardioversion is not considered and resting ventricular rate \> or equal 80 bpm at screening measured on a 6-seconds rhythm strip, exclusion criteria: * unstable angina pectoris, recent myocardial infarction or history of torsades de pointes * third degree atrioventricular block at the screening ecg or significant sinus node disease without a permanent pacemaker implanted * clinically overt congestive heart failure at randomization * patients treated with amiodarone, other antiarrhythmic drugs or previous participation in this trial or in other dronedarone trials or taking an investigational drug * clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease * pregnant and/or breastfeeding women or women of child-bearing potential with no adequate birth control the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: heart disease
p53 gene in treatment of recurrent ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer

Conditions: Ovarian Epithelial Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Summary: the study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer.

the study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer. study design: open-labeled, active controlled, randomized, phase 2 treatments: experiment group will consist of intraperitoneal p53 (2 x 10\^12 viral particles) plus cisplatin 150 mg/m\^2, and paclitaxel 175 mg/m\^2 iv over 3 h on day 1; every 21 d for 6 cycles. study end points: response rate, progression-free survival, overall survival and karnofsky score（kps).

Eligibility criteria:
inclusion criteria: 1. histopathologically diagnosed ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer 2. recurrent 3. 18 years or older 4. with normal tests of hemogram, blood coagulation, liver and kidney function 5. signed the informed consent form. exclusion criteria: 1. serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/l; 2. have serious heart, lung function abnormalities or severe diabetes patients; 3. active infection; 4. severe atherosclerosis; 5. aids patients; 6. serious thrombotic or embolic events within 6 months; 7. renal insufficiency requiring hemodialysis or peritoneal dialysis; 8. pregnant or lactating women; 9. mental disorder or disease.

Keywords: p53 gene chemotherapy recurrent epithelial ovarian cancer fallopian tube cancer primary peritoneal cancer
the effects of aerobic exercise training on cardiorespiratory fitness in stroke patients

Conditions: Stroke, Cardiovascular

Summary: background: aerobic exercise training has favorable effects on quality of life, motor recovery, and aerobic endurance after stroke. objectives: in this study, the investigators aimed to explore the effects of anti-gravity treadmill gait training and underwater walking therapy on cardiorespiratory fitness in stroke survivors.

methods: seventy patients with a history of stroke were admitted to our center between july 2017 and january 2018. subjects who participated in the study were randomly assigned to anti-gravity treadmill training, underwater walking therapy, and control group. investigators examined the aerobic capacity of participants by using the 6-minute walk test and cycle ergometer testing before starting the treatment along with a one-month follow-up. the patient's balance was examined by using the berg balance scale (bbs).

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 80 and diagnosed with stroke and time from stroke onset to admission were longer than three months * independent walking ability more than 10 meters with or without assistance * patients whose cognitive and functional status were suitable for the training program exclusion criteria: * had a previous history of stroke * bilateral hemiplegia * leg-length difference \>2.0 cm * fixed flexion contracture or severe joint deformity * bladder or bowel incontinence * open wound * cardiovascular complaints and can not tolerate exercise training * other neurological comorbidities including, multiple sclerosis (ms), spinal cord injury (sci), traumatic brain injury (tbi), parkinson's disease, and intracranial tumors * congestive heart failure * atrial fibrillation (af), use of antiarrhythmic drugs affecting qt duration, any type of bundle branch block on electrocardiogram (ecg)

Keywords: underwater walking theraphy anti-gravity treadmill training
pain treatment after tka with lia and intra-articular continuous infusion pump

Conditions: Postoperative Pain Management

Summary: the purpose of this study is to evaluate the effect on postoperative pain and function by adding intraarticular continuous infusion pump with local anesthetic after total knee arthroplasty where local infiltration analgesia has already been given.

200 patients with osteoarthritis (oa) of the knee necessitating total knee arthroplasty are entered into the study. all patients are given a standard protocol of analgesics pre- and postoperatively. all patients get periarticular lia-injection (150 ml) with a total of 300 mg ropivacaine, 30 mg toradol and 0.5 mg adrenalin. in the end of the operation all patients get an epidural type of catheter intraarticular with a coupled continuous infusion pump that delivers 2 ml per hour and are disconnected after 48 hours. the university hospital pharmacy has prepared 200 pumps; 100 active substance pumps with 100 ml ropivacaine (10mg/ml) and 100 placebo pumps with 100 ml sodium chloride (nacl). all patients are by computer software randomized to receive either active or placebo pump. only one nurse, not involved in neither the operation nor the after treatment, has the key to what substance it is in the numbered pumps. thus, it is a double blinded trial during the whole follow up period. before the operation the patients are asked to fill out a knee specific outcome questionnaire, the knee injury and osteoarthritis outcome score (koos), and a general outcome questionnaire, the euroqol (eq-5d), and the knee range of motion is measured by a physiotherapist. after the operation the patients are monitored at the ward by the nurses and physiotherapists. the level of pain is measured twice daily (noon and 8 pm) according to the visual-analog-scale (vas). the range of motion and is measured on day 4 and at the day 14 and day 30 follow up. the number of days the patients need to stay in hospital after operation are registered. the amount of extra doses of analgesics the patient requires are registered as well as the complications (illness, wound problems, infections etc). the patients are to be followed clinically for 2 years as well as with outcome questionnaires.

Eligibility criteria:
inclusion criteria: * primary osteoarthritis of the knee necessitating total knee replacement * patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up exclusion criteria: * known allergy to local anaesthetics or other contraindication for the use of local anaesthetics. * treatment with warfarin. * bilateral operation

Keywords: total knee arthroplasty
most effective stimulation site in transcranial direct current stimulation for gait recovery after stoke

Conditions: Stroke; Gait Disorders, Neurologic

Summary: the aim of this study is to investigate the most effective stimulation site in transcranial direct current stimulation for gait recovery after stroke. all subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. four conditions are 1) bihemispheric stimulation - anodal stimulation on both ipsilesional and contralesional leg area of primary motor cortex and supplementary motor area. 2) ipsilesional stimulation - anodal stimulation on ipsilesional leg area of primary motor cortex and supplementary motor area. 3) contralesional stimulation - anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area. 4) sham stimulation. subjects will walk on treadmill for 10 minutes during transcranial direct current stimulation. motor evoked potential and functional evaluations will be done before and after stimulation to measure the changes.


Eligibility criteria:
inclusion criteria: * chronic stroke patients with 6 months after onset. * functional ambulation category ≥ 3 exclusion criteria: * patients who needs assist in surface level walking * patients with mini mental status exam score under 9 * patients with implantable electronic device * metal device inside skull * history of epilepsy * pregnancy

Keywords: transcranial direct current stimulation
improving integration of mentally burdened young adults in the labour market

Conditions: Mental Disorder

Summary: young adults who do not successfully transition from compulsory education to upper secondary level are at increased risk of developing mental illness, as compared with their working peers. the causality is unclear: they are either unable to find a job due to a pre-existing mental illness, or their failure in finding a job has contributed to the mental illness. the zurich university of applied sciences has developed an innovative intervention that includes psychotherapeutic support in a work integration programme. recognising and treating mental illness early increases the chances of a successful transition to the labour market.

unemployed young people with severe psychological impairments often find no training or workplace, despite the support of various existing services. many of these young people suffer from a mental illness, but they are often neither diagnosed nor treated. in switzerland, this is reflected in the increasing number of young people who receive a disability pension. to make matters worse, young people often do not use the necessary psychotherapeutic treatment. an explanation for this may be the fear of being stigmatized or the lack of insight that help is needed al all. a group of researchers has analyzed the dossiers of 400 young people who were given a disability pension 2010 and 2013 due to mental problems. they have found that the consultation often took place before the 23rd year of age and in 84% of the cases whole disability pensions were given. in the analysed cases only 14% had completed vocational training. the authors propose various measures, including prioritizing the completion of a professional apprenticeship, a systematic interdisciplinary assessment, a joint, longer-lasting integration management, as well as early detection and intervention in psychological disorders in school and vocational training. our intervention meets these requirements. together with lifetime health, a provider work working integrations programs, we have developed a low-threshold psychotherapeutic offer in addition to the existing work integration program. with this intervention we hope to reach the following goals. first: facilitate the transition into a professional apprenticeship by increasing work ability and other variables. secondly, the integration and cooperation of a psychotherapist in the work integration program allows for a systematic interdisciplinary assessment; third, the support of a psychotherapist offers a joint, longer-lasting integration management.

Eligibility criteria:
inclusion criteria: * age 16 to 25 * participation in work integration programme "lifetimehealth" exclusion criteria: * insufficient knowledge of german * participant is under guardianship which doesn't allow legal capacity to act
single session pain psychology treatment: comparative efficacy & mechanisms

Conditions: Chronic Low Back Pain

Summary: this study aims to compare the efficacy of a single session psychological treatment, "empowered relief" (er), with the current standard of care, group cognitive behavioral therapy (cbt) specifically on individuals with chronic low back pain who have pain-specific distress as indexed by pain catastrophizing scores.

this is a randomized 3-arm study comprised of 2 active psychological treatments (er \& cbt) and a health education (he) arm that controls for time and attention. study goals are to provide scientific evidence to demonstrate the efficacy of er, and also provide a comparison of said efficacy against the current gold standard group treatment for pc -- manualized 8-session pain-cbt.

Eligibility criteria:
inclusion criteria: * axial low back pain without radicular symptoms * pain duration ≥ 6 months (per recent nih task force on research standards for chronic low back pain based on participant self-report * average pain intensity ≥4/10 for the past month at screening visit * english fluency * males and females 18-70 years of age * pain catastrophizing score (pcs) ≥20 exclusion criteria: * gross cognitive impairment * active suicidal ideation or severe depression * previous attendance in the active treatment groups (any er classes ever taken or cbt in the past 3 years) * participating in any interventional research study or completed participation in the last 2 months; enrollment in an observational study is acceptable * current substance abuse * clear likelihood to disrupt fellow class participants (e.g., personality disorder) at the discretion of the study team
a clinical study to evaluate the safety and effectiveness of performing 0.50 diopter astigmatism correction on the commercially available rxsight light adjustable lens (lal)

Conditions: Aphakia; Cataract

Summary: the primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 d cylinder correction on the rxsight light adjustable lens (lal) in patients who have undergone implantation with the fda approved, commercially available lal.


Eligibility criteria:
inclusion criteria: * a study eye implanted with the commercially approved lal that has not undergone any previous ldd treatments * a study eye with manifest refraction cylinder of 0.50 d measured by two independent examiners at the adjustment #1 visit prior to the first light adjustment treatment. * sign a written informed consent form and be willing to receive light treatment for their 0.50 d of cylinder. * between the ages of 40 and 80 inclusive on the day the informed consent form is signed. * good vision in the fellow eye with best corrected distance visual acuity (bcdva) 20/40 or better. * willing and able to comply with the requirements for study specific procedures and visits exclusion criteria: * pre-existing macular disease in the study eye. * history of uveitis in the study eye. * has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus. * subjects taking systemic medication that may increase sensitivity to uv light. * subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen. * history of ocular herpes simplex virus in the study eye. * subject who has participated within another ophthalmic clinical trial within the last 3 months. * sutures used at the time of surgery to close the incision wound in the study eye

Keywords: light delivery device ldd intraocular lens light adjustable lens lal
low level laser therapy for better wound healing

Conditions: Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy

Summary: prospective randomized double blind study. intervention 1: low-level laser therapy ca. 72 joules vs. intervention 2: no low-level laser therapy. outcome: pain score \& would healing at discharge, 1 months \& 3 months

after surgical suture application of low level laser therapy of ca. 72 joules / cm2. evaluation at discharge, after 1 months \& 3 months.

Eligibility criteria:
inclusion criteria: * caesarean section or perineal tear grade 1-4 or episiotomy * competent in german language exclusion criteria: * no caesarean section or birth without perineal tear grad 1-4 / episiotomy * no consent given
management of suspected preeclampsia based on 6-hour versus 24-hour urine protein collection

Conditions: Pre-Eclampsia

Summary: in this trial - the investigators plan to study the efficacy of pregnancy management in cases of suspcted preeclampsia, based on a 6-hour urine collection for protein, as compared to the standard 24-hour collection. for participants hospitalized at the maternal fetal unit at our institution, one sample of urine collected over 6 hours will be analyzed, and a second one following an additional 18 hours. participants will be blinded to the urine collection result used to manage their pregnancy (actual 24 hour collection versus calculated 24-hour collection), as will be their attending physicians. an external physician will compare the two urine collection results, and in case only one is pathological (\>300 mg), will notify the research team and the attending physician.


Eligibility criteria:
inclusion criteria: * patients referred to the edith wolfson medical center for suspected preeclampsia, for whom hospitalization was recommended for urine collection for protein and blood pressure follow up * gestational age \>24+0 weeks and \< 42+0 weeks * consent to participation exclusion criteria: * patients with features of severe preeclampsia at presentation - blood pressure \>160/110, headache, blurred vision, right upper quadrant pain, liver transaminase abnormality, increased creatinine level, thrombocytopenia. * patients whom were decided to be delivered (regardless of protein collection) * multiple gestation * chronic hypertension * pre-gestational diabetes mellitus * thrombophilia (apla) * intrauterine growth retardation * lack of prenatal care
a study of onartuzumab in combination with erlotinib in patients with met-positive stage iiib or iv non-small cell lung cancer carrying an activating epidermal growth factor receptor (egfr) mutation

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage iiib or iv non-small cell lung cancer identified to carry and activating egfr mutation and met-positive. patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patient, \>/= 18 years of age * histologically confirmed, unresectable stage iiib or iv non-small cell lung cancer (nsclc) * no prior treatment for unresectable stage iiib or iv nsclc * measurable radiographic evidence of disease according to recist v1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * prior exposure to agents targeting either the hepatocyte growth factor (hgf) or met pathway * exposure to an investigational or marketed agent that can act by egfr inhibition * pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently * brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (cns) metastases or spinal cord compression without evidence of clinically stable disease for \>/=4 days. note: patients with treated cns metastases who are asymptomatic and on a stable dose of corticosteroids for \>/= 14 days prior to randomization are eligible. * history of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free * radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions * inadequate hematologic, biochemical, and organ function * pregnant or lactating women * life expectancy of \< 12 weeks * receipt of an investigational drug within 28 days prior to initiation of study treatment
contrast between traditional regression model and ai in predicting prolonged stay stay after head and neck tumors

Conditions: Head and Neck Cancer

Summary: this experiment is an observational study of cohort. by establishing a cohort of patients with head and neck tumors transferred to icu after surgery, investigators compared the prediction effect of ai and the traditional prediction model on whether patients can be transferred to icu within 24 hours of head and neck tumors. first retrospective analysis of patients after head and neck tumor surgery, medical records were collected, the test results are divided into training group and validation group according to 7:3, divided into 2 groups according to the patient icu stay time is greater than 24 hours, the prediction model after the icu duration of head and neck tumor surgery after more than 24 hours. at the same time, clean the data, train the ai with the data, and compare the effectiveness of both sides with the roc. after the establishment of prediction model and ai training, the patients included in the cohort were evaluated by prediction model and ai immediately after being transferred to the icu, predicting the possibility of transferring out of the icu within 24 hours.


Eligibility criteria:
inclusion criteria: 1. patients after head and neck tumors; 2. older than 18 years. exclusion criteria: 1. patients transferred to icu twice after head and neck tumors; 2. patients with unplanned transfer to the icu.