Kornimate/medical-research-clean huggingface dataset:
a placebo-controlled trial of percutaneous coronary intervention for the relief of stable angina

Conditions: Stable Angina

Summary: orbita-2 is a double blinded randomised placebo-controlled trial comparing the effects of coronary angioplasty versus placebo procedure on symptoms of stable angina without background anti-anginal therapy. follow-up will be at 12 weeks.


Eligibility criteria:
inclusion criteria: orbita-2 will enrol patients who meet all 3 of the following criteria: 1. angina or angina-equivalent symptoms 2. anatomical evidence of significant coronary stenosis in at least one vessel, either: a. invasive diagnostic coronary angiogram indicating ≥ 70% stenosis b. ct coronary angiography indicating ≥ 90% stenosis 3. evidence of ischaemia, arising from at least one of the following options: 1. positive dobutamine stress echocardiography 2. positive cardiac mri perfusion scan 3. positive nuclear medicine myocardial perfusion scan 4. invasive pressure wire assessment suggestive of ischaemia, as judged by the interventional cardiologist, at the time of diagnostic angiogram or research angiogram exclusion criteria: 1. age younger than 18 2. age older than 85 3. recent acute coronary event 4. previous coronary artery bypass graft surgery 5. significant left main stem coronary disease 6. chronic total occlusion in the target vessel 7. contraindication to percutaneous coronary intervention or drug-eluting stent implantation 8. contraindication to antiplatelet therapy 9. severe valvular disease 10. severe lv systolic impairment 11. severe respiratory disease 12. life expectancy less than 2 years, pregnancy, unable to consent

Keywords: stable angina
united coronary biobanks

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction; Stable Angina

Summary: the unicorn consists of two collaborating biobanks, one in utrecht and one in singapore. from these two sites we include all patients who undergo a coronary catheterization for any reason. at the moment of catheterization we draw blood, which will be stored in a biobank and we collect clinical characteristics. patients are followed-up for 5 years for the occurrence of major cardiovascular events. by including from two sites in the world we include 4 major ethnic groups: caucasians, chinese, indians and malays. we aim at including at least 2000 patients per ethnic group. our hypothesis is that there are differences in the risk factor burden, clinical presentation of cad, and biochemical patterns in the blood among the ethnic groups. furthermore, this biobank offers a platform for multi-ethnic biomarker discovery.


Eligibility criteria:
inclusion criteria: * patients undergoing coronary angiography exclusion criteria: * \< 21 years of age * hemoglobin levels \<7 g/dl in women, or hemoglobin levels \<8 g/dl in men
intact cord resuscitation in cdh

Conditions: Rare Diseases; Congenital Diaphragmatic Hernia

Summary: isolated cdh is a rare disease (1/3500) and displays a wide range of severity and outcome. despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20 to 50% according to different hospitals in france and abroad. several studies already showed the benefice of late cord clamping at birth on biological and physiological adaptation of newborns to life. previous works also suggest a possible benefit of this procedure for babies with cdh. this multicenter randomized clinical study aims to investigate the efficacy of intact cord resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in full term newborn infants with isolated cdh.


Eligibility criteria:
inclusion criteria: * antenatal diagnosis of cdh * no severe additional malformation or chromosomal diseases * full term (\>36 weeks gestational age) * no inclusion in another antenatal trial * written informed consents from the parents exclusion criteria: * preterm birth less than 37 weeks gestational age * other severe malformation(s) or chromosomal diseases * twin * parents who may have french language understanding difficulties may not participate to the study unless they receive appropriate assistance regarding the understanding of the formal consent forms needed to get included in the study. if included in the study, regarding their french understanding level, the parents may not be proposed the auto questionnaires and interviews led by the psychologist

Keywords: congenital diaphragmatic hernia resuscitation delayed cord clamping newborn
phase ii study dcvac/ovca plus carboplatin gemcitabine relapsed platinum (pt)-sensitive epithelial ovarian carcinoma

Conditions: Ovarian Neoplasms; Ovarian Cancer (OvCa); Ovarian Epithelial Cancer

Summary: the purpose of this study is to determine whether dcvac/ovca added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (pfs).

the purpose of this study is to determine whether dcvac/ovca added to standard of care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (pfs).

Eligibility criteria:
inclusion criteria: * females 18 years old and older * patients with histologically confirmed, international federation of gynecology and obstetrics (figo) stage iii or iv epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (pt)-based chemotherapy and are selected to receive second line standard of care chemotherapy * radiologically confirmed relapse after \>6 months of remission (platinum-sensitive patients), found up to 4 weeks prior study entry. * the patient must have at least one measureable target lesion as defined by the response evaluation criteria in solid tumors (recist) 1.1 criteria to be eligible for enrolment in the study exclusion criteria: * figo i,ii epithelial ovarian cancer * figo iii, iv clear cells epithelial ovarian cancer * non-epithelial ovarian cancer * borderline tumors (tumors of low malignant potential) * prior or current systemic anti-cancer therapy for ovarian cancer \[for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (vegf) therapy or hormonal therapy\] except first line platinum-based chemotherapy (with or without bevacizumab) * previous radiotherapy to the abdomen and pelvis * malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (cr) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas

Keywords: ovarian platinum sensitive epithelial
study of dabrafenib, trametinib and metformin for melanoma patients

Conditions: Melanoma

Summary: the main purpose is to evaluate the clinical response, safety and survival of the fda approved drugs dabrafenib, trametinib in combination with metformin. investigators hypothesize that the combination of an fda approved non toxic dose of oral metformin with the b-raf inhibitor, dabrafenib and the mek inhibitor, trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.

the study will be a single-arm, single center, uncontrolled phase i/ii trial to estimate the safety of the combined treatments and then estimate the efficacy in terms of objective response rate in patients with stage iiic and stage iv melanoma treated with dabrafenib/trametinib and metformin.

Eligibility criteria:
inclusion criteria: * male or female patients \> 18 years of age * patients with histologically confirmed brafv600e melanoma (stage iiic or * stage iv, american joint commission on cancer) * eastern cooperative oncology group performance status of 0 to 2 * life expectancy \> 3 months * at least 1 site of radiographically measurable disease by recist 1.1 * adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing: * absolute neutrophil count \> 1.0 x 10⁹/l * platelet count \> 50 x 10⁹/l * hemoglobin \> 8 g/dl * serum creatinine \< 2 x upper limit of normal * total serum bilirubin \< 3 x uln * serum aspartate transaminase or serum alanine transaminase \< 3 x uln, and \< 4 x uln if liver metastases are present * fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician * pre-menopausal females and females \< 2 years after the onset of menopause should have a negative pregnancy test at screening. pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of the study drug * females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for \> 1 year * before study entry, written informed consent must be obtained from the patient prior to performing any study related procedures exclusion criteria: * prior treatment with vemurafenib or dabrafenib * known hypersensitivity to metformin or any of its components * received radiotherapy for non cns disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation related toxicities to grade \< 1, except for alopecia * pregnant, breast feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures * have any other uncontrolled infection or medical condition that could interfere with the conduct of the study

Keywords: unresectable melanoma stage iiic and stage iv braf v600e+
hemodynamics and extravascular lung water in acute lung injury

Conditions: Acute Lung Injury

Summary: the purpose of this study is to test a treatment that tries to reduce the amount of fluid in the lungs of subjects with acute lung injury to see if this is helpful.

the objective of this study is to conduct a randomized, controlled trial of a goal directed therapy designed to improve outcome in patients with acute lung injury (ali). the investigators are comparing two algorithmic approaches in managing patients with ali - one, the control arm, attempts to reduce the amount of fluid in the lung in patients with ali by diuresis based on central venous pressure and urine output, the other the treatment arm attempting to reduce lung water by directing therapy to measured lung water and using more sensitive indicators of preload status than cvp. the protocol uses measured extravascular lung water (evlw) to direct diuresis and appropriate fluid restriction in a goal directed fashion in order to lower evlw towards the normal range.

Eligibility criteria:
inclusion criteria: acute onset of: 1. pao2/fio2 less than or equal to 300. 2. bilateral infiltrates consistent with pulmonary edema on the frontal chest radiograph. 3. requirement for positive pressure ventilation through an endotracheal tube or tracheostomy. 4. no clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates. if measured, pulmonary arterial wedge pressure less than or equal to 18 mmhg. exclusion criteria: 1. age younger than 18 years old. 2. greater than 24 hours since all inclusion criteria first met. 3. neuromuscular disease that impairs ability to ventilate without assistance, such as c5 or higher spinal cord injury, amyotrophic lateral sclerosis, guillain-barré syndrome, myasthenia gravis, or kyphoscoliosis (see appendix i.a). 4. pregnancy (negative pregnancy test required for women of child-bearing potential). 5. severe chronic respiratory disease (see appendix i.c). 6. severe chronic liver disease (child-pugh 11 - 15, see appendix i.e) 7. weight \> 160 kg. 8. burns greater than 70% total body surface area. 9. malignancy or other irreversible disease or conditions for which 6-month mortality is estimated to be greater than 50 % (see appendix i.a). 10. known cardiac or vascular aneurysm. 11. contraindications to femoral arterial puncture - platelets \ 3.0. 12. not committed to full support. 13. participation in other experimental medication trial within 30 days. 14. allergy to intravenous lasix or any components of its carrier. 15. history of severe chf - nyha class ≥ iii, previously documented ef \< 30%. 16. diffuse alveolar hemorrhage. 17. presence of reactive airway disease (active will be defined based on recent frequency and amounts of mdi's use and steroids to control the disease).

Keywords: acute lung injury extravascular lung water acute respiratory distress syndrome
integrating quantitative mri and artificial intelligence to improve prostate cancer classification

Conditions: Prostate Carcinoma

Summary: this study evaluates how new magnetic resonance imaging (mri) and artificial intelligence techniques improve the image quality and quantitative information for future prostate mri exams in patients with suspicious of confirmed prostate cancer. the mri and artificial intelligence techniques developed in this study may improve the accuracy in diagnosing prostate cancer in the future using less invasive techniques than what is currently used.

primary objectives: i. to develop and evaluate quantitative dynamic contrast-enhanced (dce)-mri analysis techniques that minimize patient- and scanner-specific variabilities in the calculation of quantitative parameters. ii. to develop and evaluate diffusion weighted imaging (dwi) methods that reduce prostate geometric distortion due to patient- and scanner-specific susceptibility and eddy current effects. iii. to develop and evaluate multi-class deep learning models that systematically integrate quantitative multi-parametric (mp)-mri features for accurate detection and classification of clinically significant prostate cancer (cspca). outline: retrospective: patients' medical records are reviewed. prospective: patients undergo additional 3 tesla (t) mri imaging over 30 minutes before, during, or after their standard of care 3t mri for a total of 1.5 hours.

Eligibility criteria:
inclusion criteria: * male patients 18 years of age and older * clinical suspicion of prostate cancer or biopsy-confirmed prostate cancer * undergone or undergoing multi-parametric 3 t prostate mri at the university of california at los angeles (ucla) * ability to provide consent exclusion criteria: * contraindications to mri (e.g., cardiac devices, prosthetic valves, severe claustrophobia) * contraindications to gadolinium contrast-based agents other than the possibility of an allergic reaction to the gadolinium contrast-based agent * prior radiotherapy
web-based support for people with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this project will address vital questions regarding how best to design web-based materials for the growing population of patients with basic literacy and computer skills but lower levels of health literacy, building on our previous experience of developing web-based materials for people with lower levels of literacy and health literacy. this study will be carried out two phases. phase 1 will use qualitative methods to understand user experiences of the web-based materials through observational 'think-aloud' interviews with users. phase 2 will test the newly developed web-based materials to a static (non-interactive) version of the materials online.


Eligibility criteria:
inclusion criteria: * potential participants are patients with type 2 diabetes aged 18 years or more, who are able to consent. exclusion criteria: * severe mental health problems, palliative care, recent bereavement, known opposition to involvement in research or inability to complete research measures, e.g. learning disability, inability to read / speak english.

Keywords: diabetes health literacy web intervention
rtms for auditory hallucinations guided by magnetoencephalography

Conditions: Schizophrenia

Summary: rtms and meg for auditory hallucinations via self controlled clinical trials. repetitive transcranial magnetic stimulation (rtms) can increase or decrease cortical excitability in patients with psychosis (such as schizophrenia). here, we conducted an open clinical trial on 60 schizophrenics with auditory hallucinations. we searched for targets through magnetoencephalography and then intervened to prove that rtms guided by magnetoencephalography is effective for auditory hallucinations.

before intervention, each patient was scheduled to collect three magnetoencephalogram data sessions. apply meg technology to calculate possible locations and determine three intervention targets. pseudo stimulation in the first week, 5-day intervention, 3 targets per day, each target for 23 minutes, with a 30 minute interval between each target. evaluate the scale after the first week of pseudo stimulation. week 2-4 real stimulation, intervention 5 days a week, 3 targets per day, each target for 23 minutes, with a 30 minute interval between each target. after the end of the fourth week, evaluate the scale. and follow-up evaluations will be conducted on the 7th, 14th, 30th, 60th, and 90th days after the intervention.

Eligibility criteria:
inclusion criteria: * schizophrenia with auditory hallucinations was diagnosed by dsm-iv, ahrs \>12, take sufficient antipsychotics for at least 1 month. exclusion criteria: * current pregnancy, major medical illness affecting the central nervous system, significant neurologic disorders, intake of drugs including supplements like essential fatty acids that influence prostaglandins or niacin skin flush flash pathway metabolism, a history of suicide risk, or alcohol or drug abuse.
observational study for the evaluation of incidence of familial aml/mdss in patients with myeloid neoplasms

Conditions: Acute Myeloid Leukemia; Familial Acute Myeloid Leukemia; Myelodysplastic Syndromes

Summary: observational study aimed at evaluating the incidence of familial aml/mdss in patients with de novo mdss or aml with almost one relative affected by hematologic neoplasms and/or other cancers at young age (\< 40 years)

this is a multicenter, retrospective and prospective, observational study aims to collect clinical information on patients with familial aml/mdss from january 2014 to december 2022. no intervention is expected. the purpose of this study is to identify and characterize the patients with familial mdss or aml (i.e. with relatives affected by hematologic neoplasms and/or other cancers at young age (\< 40 years)) or presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to aml/mdss. in order to estimate the incidence of familial aml/mdss, a survey will be sent every year to all participating sites to collect only the number of the all diagnosis of aml/mds. all patients will be followed until december 2023 in order to have at least 1 year of observation.

Eligibility criteria:
inclusion criteria: * patient age \> 18 years old * diagnosis of aml or mdss from january 2014 to december 2022 * suspected familiarity for myeloid neoplasm: at least one family member of first or second degree affected by myeloid neoplasm or other hematological malignancy, or by solid tumors with onset at age \< 40 years or presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to aml/mdss * signed written informed consent according to ich/eu/gcp and national local laws. exclusion criteria: * none
lentivirus transduced acute myeloid leukaemia blasts expressing b7.1 (cd80) and il-2

Conditions: Leukemia, Myeloid, Acute

Summary: the purpose of this study is to assess the safety and tolerability of an 'aml cell vaccine' in patients with poor prognosis acute myeloid leukaemia (aml).


Eligibility criteria:
inclusion criteria: * diagnosis of aml defined according to the who classification * age ≥ 18 years * new presentation or relapsed aml * patients must be able to give written informed consent * failure to enter complete morphological remission (\>5% bone marrow aml cells) or persistence of cytogenetic abnormality following intensive combination chemotherapy at day+100 post-transplant * hiv negative * no gvhd * no continuing use of immunosuppressive drugs * absence of active systemic fungal or viral infection including htlv-1, hepatitis b or c. * adequate renal and liver function confirmed by: creatinine clearance \>30mls/min; bilirubin \<3.0 x upper limit of normal; ast \<3.0 x upper limit of normal; prothrombin time \<2.0 x upper limit of normal. performance status of 1 or less by ecog criteria or \>80% by the karnovsky score * patient must provide written informed consent and be willing to comply for the duration of the study. * life expectancy \>36 weeks * women of childbearing potential (wcbp) must have a negative serum or urine pregnancy test within 10 - 14 days and again within 24 hours of starting the study. in addition, sexually active wcbp must agree continued abstinence from heterosexual intercourse or to use adequate contraceptive methods starting 4 weeks prior to the initiation of therapy (see appendix g for pregnancy testing and birth control guidelines while on study). wcbp must agree to have pregnancy tests every 3 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug. men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy. exclusion criteria: * age \< 18 years * patients not fit for intensive chemotherapy * complete morphological and cytogenetic remission following intensive combination chemotherapy * absence of hla compatible donor * hiv positive * evidence of graft versus host disease at day+100 post transplant * evidence of relapse of leukaemia (≥5% bone marrow blasts) * concurrent use of other forms of anti-leukaemic therapy * other malignancy with the exception of carcinoma in situ. * significant history of heart disease (unstable angina, myocardial within the past six months, congestive cardiac failure requiring daily treatment) * evidence of active lung disease determined by chest x-ray and absence of chronic lung disease (fev1\<60% predicted, vital capacity \<60%, tlco\<50%)

Keywords: acute myeloid leukaemia cancer vaccines immunotherapy
carotid ultrasound in the evaluation of heart failure

Conditions: Coronary Artery Disease; Cardiomyopathy; Heart Failure

Summary: coronary artery disease (cad, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). the standard test to find coronary artery disease is coronary angiography. this test is highly accurate but is invasive and carries a small risk of complications. this study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. it is hypothesized that carotid ultrasound will have excellent negative predictive value for severe cad.

coronary artery disease (cad, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). the standard test to find coronary artery disease is coronary angiography. this test is highly accurate but is invasive and carries a small risk of complications. this study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. it is hypothesized that carotid ultrasound will have excellent negative predictive value for severe cad.

Eligibility criteria:
inclusion criteria: * lvef 40% or less exclusion criteria: * prior diagnosis of coronary or carotid obstructive atherosclerosis