Kornimate/medical-research-clean huggingface dataset:
amniotic fluid optical density determination as a test for assessment of fetal lung maturity.

Conditions: Respiratory Distress Syndrome, Newborn

Summary: to determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.


Eligibility criteria:
inclusion criteria: * pregnancy between 26 and 36 6/7 weeks. exclusion criteria: * problems in the handling of the amniotic fluid sample that prevented the calculation of the optical density.

Keywords: respiratory distress syndrome, newborn
hypercoagulability and thromboembolic risk in patients with malignant disease, evaluated by thrombelastograph (teg®)

Conditions: Cancer

Summary: patients with malignancies are at high risk of developing a thromboembolic complication and their treatment with chemo- and or radiation therapy further enhances this risk. conventional haemostatic tests are not suitable as a screening tool of a hypercoagulable state. a hypercoagulable profile identified with the whole blood thrombelastograph (teg) analyzer parameter maximal amplitude (ma) is reported to correlate with thrombotic events in patients undergoing major non-cardial surgery and recurrent ischemic events in patients undergoing percutaneous coronary intervention. in this study we investigate the correlation between teg measurements and thromboembolic events in patients with newly diagnosed malignancies. the hypotheses of this study are: 1. patients with malignancies and hypercoagulability, defined as a teg ma\>69 mm and /or r\ 4 min. 2. hypercoagulability and hence teg r and ma values are affected by the treatment instituted in these patients (chemo and radiation therapy) rendering the patients more hypercoagulable and hence at increased risk of developing thrombotic complications.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cancer exclusion criteria: * mamma cancer

Keywords: thrombelastograph cancer thromboembolism hypercoagulable
coated mongolian aneurysm treatment study 2

Conditions: Intracranial Aneurysm; Aneurysm; Vascular Diseases

Summary: the purpose of this study is to assess safety and effectiveness of the p64 mw hpc or p48 mw hpc flow modulation device under prasugrel.

title: observational registry with p64 mw hpc in unruptured anterior circulation aneurysms under prasugrel purpose: to assess safety and effectiveness of p64 mw hpc or p48 mw hpc under prasugrel in consecutive patients with unruptured anterior circulation aneurysms. follow-up intervals: independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.

Eligibility criteria:
inclusion criteria: * at least one unruptured sidewall aneurysm in the anterior circulation * no implant (e.g., stent) in the target vessel segment * age \>18 years and \<80 years * not pregnant and in women of childbearing age, on oral contraception for two years following the procedure * no participation in another trial * no concomitant disease limiting the life expectancy to \<2 years * no allergy to non-ionic contrast medium or to asa and p2y12 receptor antagonists * no other neurovascular disorder in the same vascular territory requiring treatment in the foreseeable future * ability and willingness to comply with the medication requirements within the study, * ability to understand the goal and risks of this study. exclusion criteria: * intracranial aneurysm considered not suitable for fd using p64 mw hpc or p48 mw hpc. * aneurysm previously treated with a device in the parent vessel (e.g., stent, flow diverter). * another intracranial procedure scheduled for the following 6 months. * age \ 80 years. * pregnancy possible or confirmed. patient not able or willing to arrange contraception for 12 months after treatment. * patient not able or willing to adhere to the study protocol. * patient not able or willing to undergo the scheduled follow-up examinations.

Keywords: p64 mw hpc p48 mw hpc flow diverter hpc outcome occlusion stroke
mesothelioma and radical surgery 2

Conditions: Mesothelioma

Summary: mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. around 2500 people in the uk are diagnosed with mesothelioma each year and the median survival is approximately 8.5 months. exposure to asbestos is the most common cause although the cancer does not usually become apparent until 40-60 years after exposure. anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) is undertaken. however, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. the aim of the mars2 study is to compare surgery - (extended) pleurectomy decortication - with no surgery with respect to overall survival, cost-effectiveness and quality of life. patients will be followed up by phone at regular intervals for 2 years. patients will be asked to complete and return a quality of life questionnaire at these time points. mars 2 also includes an optional 'information study', where consenting patients may be interviewed or have their consultations audio-recorded. the aim of the information study is to explore how a patient makes a decision to take part in research or not, with the overall aim of improving recruitment to clinical trials.


Eligibility criteria:
inclusion criteria: 1. 16 years of age or over 2. tissue (cytology or histology) confirmed epithelioid, sarcomatoid or biphasic mesothelioma 3. disease confined to one hemi-thorax based on ct assessment 4. disease deemed surgically resectable 5. fit for surgery 6. capacity to provide written informed consent to participate in the trial exclusion criteria: 1. severe shortness of breath (this is defined as an eastern cooperative oncology group (ecog) status ≥ 2, or if lung function tests are performed: pre-operative forced expiratory volume after one second (fev1) or transfer factor of the lung for carbon monoxide (tlco) less than 20%) 2. serious concomitant disorder that would compromise participant safety during surgery (e.g. evidence of end organ failure) 3. severe heart failure (this is defined as nyha iii or iv or if an echocardiogram is performed an ejection fraction less than 30%) 4. end stage kidney failure requiring dialysis 5. liver failure (e.g. encephalopathy and/or coagulation abnormalities) 6. prisoner 7. patient lacks capacity to consent 8. existing co-enrolment in another interventional clinical trial that aims to improve survival
opioid use after urogynecologic procedures: using a predictive calculator

Conditions: Post Operative Pain; Opioid Use; Prolapse Genital

Summary: the purpose of this study is to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose.


Eligibility criteria:
inclusion criteria: * age 18-89 * able to provide informed consent * patients undergoing any of below urogynecologic procedures included urogynecologic procedures: 1. sacrocolpopexy - robotic or laparoscopic 1. with or without hysterectomy 2. with or without salpingo-oophorectomy 3. with or without anterior colporrhaphy 4. with or without posterior colporrhaphy/perineorrhaphy 5. with or without midurethral sling 2. sacrospinous ligament fixation 1. with or without hysterectomy 2. with or without salpingo-oophorectomy 3. with or without anterior colporrhaphy 4. with or without posterior colporrhaphy/perineorrhaphy 5. with or without midurethral sling 3. uterosacral ligament suspension - robotic, laparoscopic, or vaginal 1. with or without hysterectomy 2. with or without salpingo-oophorectomy 3. with or without anterior colporrhaphy 4. with or without posterior colporrhaphy/perineorrhaphy 5. with or without midurethral sling 4. colpocleisis 1. lefort colpocleisis 2. complete colpectomy with colpocleisis 5. isolated anterior and/or posterior colporrhaphy exclusion criteria: * non-english speakers * pre-operative diagnosis of cancer * scheduled for any concurrent non-urogynecologic procedure (ex: abdominoplasty) * \ 89 years of age * unable to provide informed consent

Keywords: post operative pain opioid use urogynecologic surgery
extension study of apd334-003 in patients with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine whether etrasimod (apd334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.


Eligibility criteria:
inclusion criteria: * participants who completed the apd334-003 (nct02447302) study exclusion criteria: * participants who did not complete the apd334-003 study
critical illness myopathy and trajectory of recovery in aki requiring crrt

Conditions: Acute Kidney Injury; Critical Illness Myopathy; Dialysis; Complications

Summary: the purpose of this study is to determine whether patients with acute kidney injury requiring renal replacement therapy have a higher incidence of muscle wasting than controls and whether the course of recovery is longer compared to controls.

acute kidney injury (aki), the abrupt loss of kidney function, is a common complication that affects more than half of all intensive care unit (icu) admissions, and it is associated with substantially higher rates of morbidity and mortality in both the short- and the long-term. this is especially true in patients with aki requiring renal replacement therapy (aki-rrt), also known as dialysis. an understudied mechanism by which aki-rrt may contribute to poor clinical outcomes, both in the hospital and after discharge, is through its impact on muscle mass and muscle function. aki of any severity is known to alter tissue utilization of amino acids, and preliminary data suggest that rrt in the icu may exacerbate muscle dysfunction through the removal of large quantities of amino acids from the patient's plasma. this study will determine whether patients with aki-rrt have greater lean muscle loss over 1 week than historical critically ill controls, whether patients with aki-rrt have diminished recovery of muscle mass and function at 1-3 months following discharge compared to controls, and whether changes in plasma levels of amino acids during hospitalization correlate with loss of muscle function or lack of recovery.

Eligibility criteria:
inclusion criteria: * \>18 years old * aki requiring crrt, with enrollment within 48 hours of crrt initiation exclusion criteria: * icu admission for \>7 days * rrt of any kind at any time prior to icu admission * chronic kidney disease (ckd) with estimated glomerular filtration rate \<20 ml/min/1.73 m2 as calculated by the 2021 ckd-epi equation * underlying muscle disorders or muscle atrophy such as quadriplegia or hemiplegia, stroke with residual motor deficits, end-stage liver disease, active alcohol use disorder, active malignancy (other than non-melanoma skin cancer) within 1 year, burns, or other baseline neuromuscular disease * pregnancy * concomitant use of other extracorporeal support devices such as ventricular assist devices or extracorporeal membrane oxygenation * anticipated inability to engage in weight-bearing testing after discharge (e.g., trauma or orthopedic surgery) * subjects will be ineligible for outpatient testing if they remain on rrt in the week prior to the research appointment
trial of ag-013736, cisplatin, and gemcitabine for patients with squamous non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung (NSCLC)

Summary: this study will evaluate whether ag-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * histologically- or cytologically-confirmed diagnosis of squamous nsclc stage iiib with malignant effusion (fluid cytology demonstrating malignant cells required), stage iv, or recurrent disease after definitive local therapy * candidate for primary treatment with cisplatin and gemcitabine * presence of measurable disease by recist * adequate organ function as defined by the following criteria: ecog performance status of 0 or 1 exclusion criteria: * prior systemic treatment for stage iiib (with malignant effusion) or stage iv nsclc. * one or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by ct or mri. * history of hemoptysis \> ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or grade 3 or 4 hemoptysis within 4 weeks of study treatment * nci ctcae grade 3 hemorrhage from any cause within 4 weeks of study treatment * preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. * untreated brain metastases. * need for therapeutic anticoagulation, regular use of aspirin (\> 325 mg/day), nsaid or other medications known to inhibit platelet function.

Keywords: ag-013736 axitinib cisplatin gemcitabine nsclc squamous cell lung cancer
multicenter assessment of the pda-fit system in type 1 diabetic patients

Conditions: Type 1 Diabetes

Summary: telediab-1 is a national, multicenter, controlled, randomised trial. the primary objective of the telediab-1 study is to demonstrate that the pda-fit system (pda-phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care. main judgment criteria: comparison of hba1c means between the 3 groups at 6 months

secondary objectives : 1. to assess the improvement of blood glucose control and quality of life in patients using the pda-fit system 2. to assess the improvement in diabetes care provided by the use of the pda-fit system 3. satisfaction of patients and physicians towards the pda-fit system

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for ≥ 12 months or more (including c-peptide negative secondary diabetes) * age \> 18 y.o. * intensive insulin basal-bolus therapy for ≥ 6 months. at inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump * chronically uncontrolled diabetes with hba1c ≥ 8 % during the past 12 months and at inclusion exclusion criteria: * patient with unstable associated evolutive pathology * patient who need a more frequent diabetic follow up (than in the protocol) * patient with a education teaching within the 3 months before inclusion * patient with a hemoglobinopathy * patient with toxicomania, alcoholism or psychological troubles * type 2 diabetes patients * patient who don't need strict metabolic objectives * pregnant or parturient women * person with no freedom (prisoner)

Keywords: type 1 diabetes pda phone (personal digital assistant) hba1c
a phase iii study of en bloc versus non-en bloc esophagectomy in esophageal cancer

Conditions: Esophageal Neoplasms

Summary: the purpose of this study is to test 2 different methods of surgery to remove cancer in the esophagus. this research is being done to see whether removing more tissue and lymph nodes surrounding the tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers better control of the cancer than removing less tissue and lymph nodes (known as non-en bloc esophagectomy).

the aim of this study is to determine the 5-year disease-free survival, overall survival, and time to progression comparing (arm a) transthoracic en bloc esophagectomy and (arm b) transhiatal or transthoracic non-en bloc esophagectomy. randomization to the two surgical arms will take place after the patient has given written informed consent and eligibility has been established. patients will be informed of their randomized arm prior to the day of surgery. preoperative chemotherapy may be administered at the discretion of the treating physician. adjuvant chemotherapy and/or radiotherapy will be prescribed at the discretion of the treating physician. all patients will be followed for recurrence and survival for 5 years.

Eligibility criteria:
inclusion criteria: * patients with ct2-t3/n0-n1-m1a-m1b(lymph node metastasis only) esophageal squamous cell and adenocarcinoma who have potentially resectable disease. * karnofsky performance status greater than or equal to 80%. * pulmonary and cardiac function must be acceptable for surgery according to institutional standards. * acceptable hepatic, renal and bone marrow function. * age 18 or older. * patients may receive preoperative chemotherapy and/or radiation therapy as part of their clinical care. exclusion criteria: * patients with clearly unresectable or metastatic esophageal cancer or clinical stage i esophageal cancer. * significant psychiatric illness that would interfere with patient compliance. * patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment. * patients with a significant history of unstable cardiovascular disease (e.g., inadequately controlled hypertension, or angina; myocardial infarction within the previous 6 months; ventricular cardiac arrhythmias requiring medication; congestive heart failure that in the opinion of the treating physician should preclude the patient from protocol treatment. * uncontrolled diabetes mellitus or uncontrolled infection, including hiv or interstitial pneumonia or interstitial fibrosis.

Keywords: esophageal neoplasms esophagectomy
analgetic and anxiolytic effect of preoperative pregabalin

Conditions: Intervertebral Disk Displacement; Disk Prolapse

Summary: the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain. furthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.

the mechanism of development of postoperative pain is complex. central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. several studies have shown, that gabapentin can be effective to reduce sensitization and postoperative pain. pregabalin (s-aminomethyl-5-methylhexaninacid) is a further development of gabapentin. pregabalin has a fewer side-effects compared with gabapentin. the purpose of this study is to compare the analgetic and anxiolytic effect of pregabalin and placebo used as premedication. the hypothesis is that a single-dose pregabalin (150 mg postoperatively (p.o.)) gives significant better anxiolysis and analgesia than placebo. the study is including patients undergoing surgery of the vertebral columna.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of disc prolapse * age 18+ * asa (american association in anesthesiology) i-iii * written consent exclusion criteria: * age \< 18 * asa \> iii * liver failure * renal failure * allergic reaction against gabapentin and/or pregabalin * pregnancy

Keywords: intervertebral disk displacement disk prolapse pregabalin
diet interventions in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of this study is to learn whether changing diet impacts psoriatic arthritis (psa).

the study asks if dietary change and nutritional support improves disease activity and if patients are better able to improve or sustain progress with additional incentives. the study will use an online program to communicate with participants through text and online surveys. this 24-week trial will enroll 90 patients in the us and canada with new york university as a back-up site.

Eligibility criteria:
inclusion criteria: * age 18-80 * required rheumatologist-confirmed diagnosis of psa fulfilling classification of psoriatic arthritis criteria (caspar) * willing to alter diet and participate for 24 weeks * able to attend follow-up visits * body mass index (bmi) \> 25 and \<40 * no history of eating disorders such as anorexia or bulimia * disease activity in psoriatic arthritis assessment (dapsa) \> 10 * stable treatment for psa for ≥3 months prior to enrollment (patients may be on any disease modifying anti-rheumatic drugs (dmards) or they can be free of systemic medications * owns and uses an iphone or android smart phone, or is willing to use a device provided by the study team exclusion criteria: * inability to provide informed consent * plan to change systemic treatment for psoriasis or psa in the next 4-8 weeks * use of systemic corticosteroids * all persons who would be placed at an increased risk including any medical condition that will impair the ability of the person to participate in a nutritional intervention study (e.g. insulin dependent diabetes, use of coumadin, advanced malignancy, inflammatory bowel disease, dementia) * history of food allergy to any of the components of olive oil or nuts * inability to read and write in english * unwillingness to change dietary habits * known pregnancy (pregnancy testing will be performed for women of childbearing age; weight changes will not accurately reflect the changes we would anticipate in pregnant patients and weight loss may be detrimental to maternal and/or fetal outcomes). * participation in another physical activity study and/or diet trial

Keywords: psa (psoriatic arthritis), diet, food, nutrition
moist study: multi-organ imaging with serial testing in covid-19 infected patients

Conditions: Covid19; Coronavirus Infection; SARS-CoV Infection

Summary: while many people with covid-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. the purpose of this study is to better understand the effects of covid-19 on the lungs and other organs. the study investigators have developed new techniques in magnetic resonance imaging (mri) to scan the lungs, heart, brain and liver. the study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from covid-19 illness. the study aims to enroll 228 people in alberta. participants will undergo one or more mri scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test). the study investigators hope this study will help us learn more about the long-term risks of covid-19 disease.

participants with newly or recently diagnosed covid-19 infection (inpatients and outpatients) will undergo multi-organ mri (heart, brain, lungs, liver), blood work, and functional testing at one or more time points. functional testing will include olfaction testing, cognitive testing, spiromety, and a walk test.

Eligibility criteria:
troponin substudy inclusion criteria: 1. 18 years of age or older 2. willing and able to provide informed consent 3. covid-19 positive test (within 14 days of positive test date) 4. high-sensitivity troponin-i \>100ng/l or troponin t \> 52ng/l 5. ability to obtain baseline mri imaging within 7 days (up to 14 days maximum) of troponin result troponin substudy exclusion criteria: 1. contraindication to mri or mri contrast 2. gfr \< 30ml/kg/min/1.73m2 3. hemodynamic instability requiring inotropic agents 4. active ventilatory support late cross-sectional substudy inclusion criteria: 1. 18 years of age or older 2. willing and able to provide informed consent 3. previously diagnosed with covid-19 \> 3 months ago 4. ability to obtain mri imaging at minimum 12 weeks from covid-19 diagnosis late cross-sectional substudy exclusion criteria: 1. contraindication to mri or mri contrast