Kornimate/medical-research-clean huggingface dataset:
a study to evaluate safety, pharmacokinetics and anti-tumor activity of ro7300490, as single agent or in combination with atezolizumab in participants with advanced solid tumors

Conditions: Solid Tumors

Summary: a study to evaluate the safety, pharmacokinetics and anti-tumor activity of ro7300490 as a single agent or in combination with atezolizumab. the study will consist of 3 parts: \[part 1\] dose-escalation of ro7300490 as a single agent; \[part 2\] dose-escalation of ro7300490 in combination with atezolizumab and \[part 3\] dose-expansion of ro7300490 in combination with atezolizumab in selected cancer types.


Eligibility criteria:
inclusion criteria: * life expectancy of \>= 12 weeks. * histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors that are not amenable to standard therapy. * radiologically measurable disease as defined by response evaluation criteria in solid tumors (recist) v1.1. * agreement to provide protocol-specific biopsy material. * adverse events (aes) from prior anti-cancer therapy resolved to grade =\<1. * adequate performance status and cardiovascular, hematological, liver, renal and coagulation function. * for female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs. * for male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm. exclusion criteria: * known central nervous system (cns) primary tumors or metastases, including leptomeningeal metastases, unless protocol-specific conditions are met. * active second invasive malignancy within two years prior to screening. * significant cardiovascular/cerebrovascular disease within 6 months prior to study treatment start. * any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug. * prior allogeneic bone marrow transplantation or prior solid organ transplantation. * active or history of autoimmune disease. * known hypersensitivity to any of the components of ro7300490 formulation or to components of atezolizumab formulation. * pregnancy, lactation or breastfeeding. * dementia or altered mental status that would prohibit informed consent. * major surgery or significant traumatic injury within 28 days prior to the first study drug administration (excluding biopsies) or anticipation of the need for major surgery during study treatment. * treatment with radiotherapy, chemotherapy, hormonal therapy, targeted therapy, immunotherapy or investigational drug concurrent or within 28 days or 5 half-lives of the drug (whichever is shorter) before the first study drug administration.
camrelizumab in combination with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this study aims to evaluate the efficacy of camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma


Eligibility criteria:
inclusion criteria: * histological diagnosis of thoracic esophageal squamous cell carcinoma * ecog performance status 0-1 * age 18-75 years * resectable disease, ct2-4ananym0 or ct1-3n+m0 * life expectancy more than 6 months * use of an effective contraceptive for adults to prevent pregnancy exclusion criteria: * not suitable for surgery * prior chemotherapy, radiotherapy and immune-oncology therapies for escc * prior esophageal, gastric, or gastro-esophageal junction surgery * esophageal ulcer, esophageal perforation，chest pain（≥middle level） * pregnant or lactating women
lung ultrasound to diagnose covid-19

Conditions: Covid-19; Lung Ultrasound; Respiratory Complication

Summary: covid-19 (english acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called sars-cov-2. the current pandemic has resulted in a significant number of admissions in the emergency room (er) due to suspicion of covid-19 infection. use of lung ultrasound is standard practice to diagnose acute respiratory failure in er. recently, typical lung ultrasonographic characteristics of covid-19 disease has been described. during the covid-19 pandemic, the use of this tool could be of interest in order to allow an early, simple and reliable triage in patients with suspected covid-19 infection admitted in er. in addition, the visualization of early signs in specific areas could be a predictive marker of the severity of the disease. the objective of this project will be to study the association between the signs on lung ultrasound and the result of rt-pcr in patients with suspected covid-19 infection in the er.


Eligibility criteria:
inclusion criteria: * patients admitted to emergency room for suspicion of covid-19 infection with has a sars-cov-2 rt-pcr test and for whom the emergency doctor decide to perform a lung ultrasound exclusion criteria: * patients \< 18 years of age or under guardianship or curators, * pregnancy * poor echogenicity due to the presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, etc.) * patients with a suspected or proven acute lung disease (pneumonitis, acute respiratory distress syndrome (ards)) * chronic interstitial lung disease * patients who will refuse to give their consent.

Keywords: covid-19 lung ultrasound respiratory complication
long term outcomes of patients with covid-19

Conditions: Critical Illness; Corona Virus Infection; Respiratory Failure; Covid-19

Summary: the investigators hypothesize that those with respiratory failure due to covid-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have covid-19. detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

the aim of this proposal to is to understand the extent and degree of physical disability, psychological sequelae, and cognitive dysfunction survivors of covid-19 related critical illness will have upon hospital discharge, 6 months, and up to one year post discharge. these outcomes of interest will be evaluated prospectively. the investigators will perform these measures in covid-19 patients with respiratory failure and compare them to non-covid-19 patients with respiratory failure. the investigators also seek to determine the risk factors of these long-term complications in order to guide providers as to which patients should be screened for these deficits. finally, the investigators will examine the association of various critical care interventions such as invasive versus noninvasive mechanical ventilation or use of sedatives and their effects on disability and cognitive dysfunction.

Eligibility criteria:
inclusion criteria: * adult patients admitted to the icu exclusion criteria: * none

Keywords: long term outcomes mechanical ventilation noninvasive ventilation
si-6603 (condoliase) study for lumbar disc herniation (discovery 6603 study)

Conditions: Lumbar Disc Herniation

Summary: this study is to evaluate the effectiveness of a single-dose intervertebral disc injection of si-6603 in subjects with lumbar disc herniation (ldh)


Eligibility criteria:
inclusion criteria: * subjects with single-level ldh (l4-l5 or l5-s1 (or l5-l6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (mri) and clinical symptoms corresponding to position of the impaired nerve root. * subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less. * subjects with positive result of straight leg raise (slr) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy * subjects with inadequate improvement in pain caused by ldh despite 6 weeks or more of conservative treatment. exclusion criteria: * subjects who have 2 or more lumbar disc herniations as assessed by mri. * subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine. * subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of ldh, oral or injectable corticosteroids within 28 days prior to randomization. * subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization. * subjects with a body mass index (bmi) ≥40. * subjects who are receiving compensation according to the workers' compensation act or are involved in personal injury litigation due to a lumbar-related injury.

Keywords: lumbar disc herniation radiculopathy sciatica intradiscal injection chemonucleolysis
protocol to monitor the neurological development of infants with exposure in utero from birth to 15 months in tanezumab clinical studies

Conditions: Osteoarthritis; Cancer Pain; Recurrent Low Back Pain

Summary: a4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.

a4091065 is a long term observational follow up study of subjects from tanezumab interventional studies a4091056, a4091057, a4091058, a4091059, a4091061 or a4091063

Eligibility criteria:
inclusion criteria: * subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study. * the infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. where local regulations mandate, the male parent would also review and sign the informed consent. * parents or legal guardian must be willing and able to comply with scheduled visits and study procedures. exclusion criteria: * there are no exclusion criteria for participating in this study.

Keywords: exposure in utero in tanezumab program
the effect of oral isosorbide mononitrate therapy on umbilical artery doppler resistance index in pregnancies with intrauterine growth restriction: prospective randomized control trial

Conditions: Intrauterine Growth Restriction

Summary: will follow up umblical artery doppler indices for pregnancies with iugr taking placebo and oral isosorbide mononitrate to study its efficacy on the intrauterine growth restricted fetuses

patients meeting these criteria are to be randomized into one of the following two groups: * group a (n=23): the isosorbide mononitrate group: will receive (imdur®, 30 mg, tablet, astrazeneca, egypt) (isosorbide-5-mononitrate biphasic) twice daily for 4-6 weeks (according to xpharm: the comprehensive pharmacology reference, 2007, pages 1-4). * group b (n=23): the placebo group will receive (osteocare®, tab, vitabiotics, egypt) twice daily for 4-6 weeks justification: using pass 11 program for sample size calculation, setting power at 80% and alpha error at 0.05 and according to "trapani et al., 2015", the expected change in uta-pi in isosorbide mononitrate group=21% compared to no change in placebo group. sample size of 23 women per group will be needed to detect difference between two groups. the study is to be double-blinded, where neither the researcher, nor the participants will know what type of medication each participant will receive, as a nurse will give each patient a closed envelope containing 21 tablets of one of the above two medications in a randomized fashion.

Eligibility criteria:
inclusion criteria: * age : 18-34 bmi: 18-30 singleton pregnancy gestational age between 28-30 criteria of iugr exclusion criteria: had known or suspected chromosomal or structural anomaly had a condition which will require delivery multiple pregnancy -
detection of brain metastasis by mri in metastatic colorectal cancer patients

Conditions: Metastatic Colon Cancer

Summary: the aim of this study is to prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients using systematic annual screening by mri.


Eligibility criteria:
inclusion criteria: * patients with histologically proven colorectal adenocarcinoma * metastases from colorectal cancer diagnosed since less than 6 months * indication of an oncologic treatment exclusion criteria: * patient with contraindication for mri * diagnosis of cancer other than colorectal cancer in the last three years, except in situ cancers, basal-cell skin cancer or squamous-cell skin cancer, and other cancer with low risk of brain dissemination according to the investigator * pregnant or breastfeeding women, women of childbearing potential without effective contraception

Keywords: brain metastasis magnetic resonance imaging
68ga pet/ct versus 99mtc spect/ct for lung perfusion and ventilation scintigraphy; a technical and practical feasibility study

Conditions: Pulmonary Embolism; Ventilation Perfusion Mismatch

Summary: lung perfusion scintigraphy with 99mtc-maa and ventilation scintigraphy with technegas (v/q spect/ct) has been the cornerstone for the detection of pulmonary embolisms (pe) for many decades. in last two decades after the introduction of pulmonary cta, general pe detection has shifted towards cta and v/q spect/ct has become the modality of choice for specific patient populations (iodine contrast allergy, poor kidney function, pregnancy, etc.) or indications (pre-operative risk stratification, chronic embolism detection, pulmonary hypertension). v/q spect/ct acquisition is performed on a gamma camera, but this technique has distinct challenges and/or disadvantages. a potential alternative is the nowadays broadly available. 68ga as a positron emitter allows pet/ct imaging. replacing 99mtc with 68ga in both maa and aerosol suspension is easy and requires no modifications. however, 68ga-v/q with pet/ct will resolve many of the disadvantages of v/q spect/ct. international studies have proven safety and feasibility of replacing 99mtc with 68ga and preliminary work by international colleagues and our institute have shown validated preparations of the radiopharmaceuticals. however, in our institution, clinical translation is hampered by lack of data on technical acquisition parameters for our scanners. the aim of this small study is to get more insights into technical parameters for image acquisition, logistical feasibility of v/q pet/ct, and confirm preliminary non-inferiority of this new technique over the current clinical standard (v/q spect/ct).


Eligibility criteria:
inclusion criteria: * adult ≥18 years and declared competent * provided written informed consent * referred to the nuclear medicine department for a conventional v/q-spect/ct * indication for conventional v/q-spect/ct includes known or suspected pulmonary embolism exclusion criteria: - pregnancy

Keywords: ga-68-maa galligas tc-99m-maa technegas pet/ct spect/ct
exercise training in patients with left ventricular assist device

Conditions: Heart Failure

Summary: the objective of the study is to test whether 12 weeks of structured supervised exercise training on top of usual care improves functional capacity in patients with end-stage heart failure with continuous flow left ventricular assist device (lvad).


Eligibility criteria:
inclusion criteria: * chronic end-stage systolic heart failure * stable on left ventricular assist device, meaning 1. no major change in therapeutic regime within past 4 weeks: no new additional disease modifying drug (ace inhibitor, arb, sacubitril, beta-blocker), no change in disease modifying drug dosage more than 50% (excluded: diuretics), no initiation of a cardiac rehabilitation for a minimum of 4 weeks 2. post implantation ≥ 3 months 3. expected further period on the device for a minimum of 3 months after recruitment into the study * ability to complete the study in compliance with the protocol. * general ability of the patient to declare willingness to participate in the trial. * written informed consent exclusion criteria: * acute illness that does not allow exercise, including unstable heart failure, acute myocarditis, acute pericarditis, stroke * untreated life-threatening cardiac arrhythmias * uncontrolled hypertension * intracardiac thrombus * inability to perform cardiopulmonary exercise testing at least 1 minute at 20w * uncontrolled diabetes * uncontrolled kidney disease * recent embolism * concurrent, continuous, or intermittent dobutamine therapy * complex ventricular arrhythmia at rest or appearing with exertion * supine resting heart rate \> 100 beats per minute * severe pulmonary instability * hemodynamically relevant valvular disorders * significant change in cardiovascular medication within the previous 4 weeks (see inclusion criteria) * severe anemia (hemoglobin \<8 g/dl), however patients with moderate anemia (hemoglobin \<11 g/dl) may be recruited if clinically stable (investigator assessment) * clinically relevant musculoskeletal disease

Keywords: left ventricular assist device exercise training
comparison of quality of life in moderate acne vulgaris patients based on acne-qol-ina using standard therapy with and without acne lesions extraction

Conditions: Acne Vulgaris; Quality of Life

Summary: this study will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions.

the group allocation will be randomized. outcome of the study is the quality of life score based on acne-qol-ina questionnaire. the study duration is 8 weeks, consists of baseline visit and 2 follow ups at 4th and 8th weeks.

Eligibility criteria:
inclusion criteria: * clinically diagnosed as moderate acne vulgaris * able to read and speak in indonesia * indonesian citizen * sign the consent form exclusion criteria: * pregnant of breastfeeding women * acne vulgaris lesion located only outside of face * experiencing covid-19 symptoms * using retinoid acid containing cream or benzoil peroxide in the last 2 weeks * consume any oral antibiotics in the last 1 month * injected with intralesional steroid or having acne lesions extracted in the last 2 weeks * having laser or chemical peeling in the last 1 month
sofa: study on omega-3 fatty acids and ventricular arrhythmia

Conditions: Arrhythmia

Summary: the objective of the sofa trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 pufa) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (icd).

previous human observational studies and clinical trials provide strong indications that n-3 pufa from fish can prevent cardiovascular disease. striking is that these studies show a strong relation between n-3 pufa and sudden death, but not between n-3 pufa and non-fatal heart disease. sudden death is one of the most common and often the first manifestation of coronary heart disease. the majority of sudden deaths are directly caused by acute ventricular arrhythmia. our hypothesis is that n-3 pufa prevents sudden death by suppressing life-threatening cardiac arrhythmia. therefore, we investigate in a randomized controlled clinical trial whether supplemental intake of n-3 pufa from fish can reduce the incidence of life-threatening cardiac arrhythmias. our population consists of patients with an implantable cardioverter defibrillator (icd), because this device records all arrhythmic events in a memory chip. as the icd enables continuous monitoring of events in nonhospitalised patients, this population is very suitable for testing a possible antiarrhythmic effect of n-3 pufa. the objective of the sofa trial is to investigate the effect of fish oil on the incidence of recurrent ventricular arrhythmia in patients with an icd. the sofa is a randomised, parallel, placebo-controlled, double-blind intervention study which is currently being carried out in 26 cardiology centers in europe. five hundred forty six patients with an icd are randomised to receive either 2g/d of fish oil or placebo oil for a period up to 12 months. the primary outcome is spontaneous ventricular tachyarrhythmias as detected by the icd or all-cause mortality within 12 months.

Eligibility criteria:
inclusion criteria: * icd is capable of recording ecg strips for at least 10 of its (attempted) therapeutic interventions * 18 years or older * written informed consent exclusion criteria: * primary prophylactic indication * icd implantation as a 'bridge' to heart transplantation * refractory supraventricular arrhythmias with rapid ventricular rates despite antiarrhythmic therapy * a projected lifespan of less than 1 year * participation in another trial (during or within 30 days before sofa) * use of any supplemental n-3 fatty acid during the last 3 months * intake of more than 8g of n-3 fatty acids from fish per month as judged by a fish frequency questionnaire * pregnant women and women of childbearing potential who do not use adequate contraception * patients known to have a history of recent drug or alcohol abuse

Keywords: fish oil n-3 fatty acids n-3 pufa omega-3 fatty acids arrhythmia icd human patients with an implantable cardioverter defibrillator
quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic stent

Conditions: Unresectable Hilar Cholangiocarcinoma

Summary: the purpose of this study is to compare the quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic stent.

in the patient with unresectable hilar cholangiocarcinoma,palliative biliary stent is the one way to help him. the aim of palliative treatment is to improve quality of life and relief symptom,or sometime ,extended survival rate. there are two types of biliary stent: 1. plastic stent made from polyethylene or polytetrafluoroethylene 2. metalic stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10mm. the main drawback of plastic stent is relatively high occlusion rate, but its advantage is the lower cost. in the reasons of higher occlusion rate , the lower cost of plastic stent versus metallic stent that should be stent exchange when occluded, so we would to know about quality of life in both group.

Eligibility criteria:
inclusion criteria: * all patient with diagnosis of hilar cholangiocarcinoma and/or radiological diagnosis * patient considered having an unresectable tumor or unfit of operation because of advanced age or medical illness exclusion criteria: * patient with asa 4 or 5 * patient who inability to comply with follow up * patient refused to join the research

Keywords: hilar cholangiocarcinoma biliary stent plastic stent metallic stent quality of life