Kornimate/medical-research-clean huggingface dataset:
prognostic value of the immunoscore® colon test for disease free survival stratification in stage iii patients under oxaliplatin treatment

Conditions: Colorectal Cancer; Stage III Colon Cancer

Summary: the primary objective is to validate that the immunoscore® test (is0 to is4) is able to identify patients with high risk (is 0-1) of relapse or death whichever occurs first among stage iii patients under oxaliplatin-based adjuvant therapy. then the prognostic value of immunoscore® colon to predict disease free survival (dfs) will be assessed in stage iii patients under oxaliplatin treatment in each arm of the idea trial (6- months and 3-months treatment). finally, the additive value of the immunoscore® test to stratify the dfs will be evaluated among standard clinical and biological parameters and tumor features.

adult patients of both genders who have underwent surgical resection of stage iii colon carcinoma and randomised to receive a 6-month or 3-month adjuvant therapy with modified folfox 6 or capox in the idea france trial.

Eligibility criteria:
inclusion criteria: * patient and tumor characteristics; 3-year clinical follow-up * data regarding other markers (eg. msi) * ffpe blocks available, including core tumor + invasive margin regions exclusion criteria: • bouin fixative sample type: • adjacent ffpe slices (4 μm each) per case (although only one slide is required for cd3 and one for cd8, with center of tumor (ct) and the invasive margin(im) cut from ffpe blocks no more than 4 months before the immunoscore® testing
effect of chronic pde5-inhibition on endothelial function in diabetics

Conditions: Diabetes

Summary: chronic pde5-inhibition improves endothelial function in diabetics

evaluation of endothelial function at baseline and after chronic administration of sildenafil in male subjects with diabetes

Eligibility criteria:
inclusion criteria: * type 2 diabetes * males exclusion criteria: * females, nitrate use, pde5-inhibitors intolerance

Keywords: function inhibition
hyperinflation assessment after treatment by lung volume reduction coil

Conditions: Emphysema

Summary: hyperinflation assessment after treatment by lung volume reduction coil (heat-lvrc) on hyperinflation in severe emphysema

two sequences (around 30 minutes) are necessary by patient. under general anesthesia, two lobs treatment ( 10 coil by lob) successively introduced by a bronchoscope.

Eligibility criteria:
inclusion criteria: * severe emphysema (recent ct-scan (\< 6 mois) ) * age \> 35 ans * modified medical research council scale (mmrc) \> 2 * forced expiratory volume in one second (fev1) post-bronchodilatator \< 45% * residual volume \> 175% * total pulmonary capacity \> 100% exclusion criteria: * forced expiratory volume in one second (fev1) variability \> 20% after bronchodilatator * carbon monoxide diffusing capacity (tlco) \< 20% * recurrent respiratory infection infections with clinics symptoms * pulmonary arterial hypertension (pah) with pulmonary arterial systolic pressure (paps) estimated with echography \> 50 mm hg * impossibility to walk more that 140 meter (6 min test) * surgery history of volume reduction or pulmonary transplantation * broncho-dilatation with clinic symptoms
a real-world study of jt001 for covid-19

Conditions: COVID-19

Summary: real-world disease outcomes and safety in patients with mild to moderate covid-19 treated with jt001


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old. 2. the novel coronavirus infection (covid-19) meets at least one of the following five criteria: 1) diagnosis of novel coronavirus infection; 2) diagnosed with novel coronavirus pneumonia; 3) the novel coronavirus nucleic acid test is positive; 4) test positive for novel coronavirus antigen; 5) culture positive for novel coronavirus. 3. patients who have not developed severe covid-19 or died within 28 days of covid-19 diagnosis, or who have developed severe covid-19 or died within 28 days of covid-19 diagnosis, were treated with deuterimodivir hydrobromide tablets or were not treated with anti-novel coronavirus before disease progression. exclusion criteria: · patients who have not developed severe covid-19 or died within 28 days of covid-19 diagnosis, or those who have developed severe covid-19 or died within 28 days of covid-19 diagnosis, received the following anti-novel coronavirus treatments before disease progression, including: nematavir tablet/ritonavir tablet, azvudine tablet, monoravir capsule, zenotavir tablet/ritonavir tablet, leritvir tablet, ambavirzumab/romisivir injection, human immunoglobulin for covid-19 or convalescent plasma for covid-19 survivors.
alternations of intestinal microbiota and health impact in ckd

Conditions: Chronic Kidney Disease

Summary: this study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with ckd stage 3-5.


Eligibility criteria:
inclusion criteria: * patients with ckd stage 3-5 defined as egfr \<60 ml/min/1.73 m2 calculated with the use of the four-variable modification of diet in renal disease formula who have not yet on dialysis therapy. exclusion criteria: * patients with active cancer * patients with liver cirrhosis * patients have taken antibiotics within three months before screening for inclusion. * patients with a cardiac pacemaker or metallic implants, * patients are amputees * pregnant women * patients with inherited renal diseases

Keywords: body composition chronic kidney disease dietary pattern gut microbiot
first-in-human study to evaluate safety, tolerability, and pharmacokinetics following single ascending and multiple ascending doses of pf-07304814 in hospitalized participants with covid-19.

Conditions: Viral Disease

Summary: it is phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of pf-07304814, in patients hospitalized with sars-cov-2 virus infection.

it is a 2-part study in hospitalized covid-19 patients. * part 1 is to evaluate safety, tolerability, pk and markers of clinical activity of escalating doses of pf-07304814 given as 24-hour iv infusion. 2 planned and 3 optional cohorts with 8 participants each are planned. * part 2 is to evaluate safety, tolerability, pk and markers of clinical activity of escalating doses of pf- 07304814 given as 120-hour infusion. 2 planned and 2 optional cohorts with 8 participants each are planned

Eligibility criteria:
* inclusion criteria: 1. male or female participants between the ages of 18 and 79 years. 2. confirmed sars-cov-2 infection. 3. hospitalized for covid-19. 4. symptoms consistent with covid-19 indicated by at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, new loss of taste and smell, nausea, chills, fatigue, rhinorrhea, diarrhea, vomiting or radiographic infiltrates by imaging consistent with covid-19 5. total body weight \>=50 kg (110 lb), bmi \<40 kg/m2; bmi \<35 kg/m2 for 76- 79 years. * exclusion criteria: 1. evidence of critical illness, defined by at least one of the following: respiratory failure, multi-organ dysfunction/failure, cardiac failure or septic shock 2. participants that are anticipated by the study investigator to progress to critical disease, including mechanical ventilation, within 24 hours of enrolment 3. participants with pre-existing moderate to severe cardiovascular disease, uncontrolled diabetes, or severe asthma or severe copd. 3.participants with a known medical history of recent acute or chronic liver disease (other than nash), chronic or active hepatitis b or c infection, or primary biliary cirrhosis. 4.participants with a known medical history of ischemic heart disease, heart failure, dysrhythmia or other pre-existing cardiac condition. 5. participants with known hiv infection, acute or chronic history of hepatitis b or c. 6.participants with a known medical history of recurrent seizures. 7. participants with history of venous thromboembolic event, including deep venous thrombosis or pulmonary embolism 8.confirmed concurrent active systemic infection other than covid-19. 9.current diagnosis of cancer, unless in remission and untreated. 10.other medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation 11.females who are pregnant or breastfeeding.

Keywords: covid-19 sars-cov-2
comparison between two different protocols in polycystic ovary symdrome women undergoing intra-cytoplasmic injection

Conditions: Polycystic Ovary Syndrome

Summary: stein and leventhal were the first to recognize an association between the presence of polycystic ovaries and signs of hirsutism and amenorrhea (eg,oligomenorrhea, obesity), after women diagnosed with stein-leventhal syndrome underwent successful wedge resection of the ovaries, their menstrual cycles became regular, and they were able to conceive. as a consequence, a primary ovarian defect was thought to be the main culprit, and the disorder came to be known as polycystic ovarian disease.


Eligibility criteria:
inclusion criteria: 1. women under 35 years with polycystic ovary syndrome criteria 2. normal male semen parameters 3. normal tubes either by hysterosalpingography \&/or laparoscopy 4. free from other endocrine abnormalities exclusion criteria: 1. non polycystic ovary syndrome criteria 2. more than 35 years 3. abnormal semen parameters 4. pathological tube\& pelvic factor 5. other endocrine disorders
effect of virtual reality glasses use during episiotomy repair related

Conditions: Midwifery; Labor Delivery

Summary: h1-1: watching video with virtual reality glasses during episiotomy repair reduces the level of pain. h1-2 watching video with virtual reality glasses during episiotomy repair reduces the level of anxiety. h1-3: watching video with virtual reality glasses during episiotomy repair increases the level of satisfaction.


Eligibility criteria:
inclusion criteria: * 18 years and over, * able to speak turkish and express himself in turkish, * there is no visual or hearing impairment, * being open to communication, spiritually and mentally healthy, * 37- 42 weeks of gestation * single pregnancy, * primiparity, * vaginal delivery, * vertexpresentation * media lateral episiotomy, * uncomplicated newborn * newborns between 2500 and 4000 g. * those with episiotomy between 4-8 cm exclusion criteria: * presence of obstetric or non-obstetric complications, * presence of bleeding requiring urgent measures, * administration of sedative drugs before and during episiotomy repair, spinal anesthesia, epidural anesthesia, pudendal block (except for local infiltration of the perineum), * lacerations other than episiotomy (anal sphincter injury or grade 3 or 4 tear), * instrument delivery (with vacuum or forceps), * postpartum complications in newborns, * chronic disease (diabetes mellitus, thyroid disease and hypertension), * having a psychiatric diagnosis

Keywords: episiotomy virtual reality pain satisfaction anxiety
apathy in late life depression: new biomarkers using actimetry and magnetic resonance imaging

Conditions: Depression

Summary: old age (\> 60 years) is at high risk to develop major depression disorders (mdd). mdd doubles the risk for subsequent cognitive disorders and dementia. apathy (i.e. the lack of motivation) is a core problem in depression in older age and is frequently associated with cognitive decline in people who have mild cognitive disorders. the investigator propose here to combine actimetry (the measurement of motor activity using a simple device worn at the wrist) and brain imaging to show that it's possible to measure apathy using actimetry in a population of elders with mdd. having shown that apathy can reliably be measured with actimetry and that it is associated with brain abnormalities, the investigator will be able to test whether actimetry can predict cognitive decline in elders with mdd and can be routinely used in a day-to-day medical practice.


Eligibility criteria:
inclusion criteria: patients: * 60 years and above * major depressive disorder (either late-onset or early onset) * ambulatory settings * both uni and bipolar depression will be considered healthy controls * 60 years and above * no psychiatric disorders, including no major depressive disorder * no non-inclusion criteria exclusion criteria: * patients and healthy controls * major cognitive disorders (\< 125 on the mattis dementia rating scale and a major cognitive disorders diagnostic according to the dsm5 (diagnostic and statistical manual of mental disorders) criteria). * other neurological conditions (stroke, parkinson's disease and seizures), severe and inflammatory disorders (ex: severe arthroses which limits movements, spondylarthritis) * severe sarcopenia: speed walk \< 1 meter/second * extrapyramidal syndrome * high suicidal risk * anti-psychotic prescription * participant who are unable to provide clear consent, under legal protection * mri contra-indication
amitriptyline vs gon and son blocks in migraine

Conditions: Migraine; Headache

Summary: comparison of efficacy and safety of amitriptyline and nerve blocks

this study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater occipital nerve and supraorbital nerve)

Eligibility criteria:
inclusion criteria: * diagnosed with migraine according to ichd-3 exclusion criteria: * being over 50 years or under 18 years * malignancy and other systemic diseases

Keywords: greater occipital nerve supraorbital nerve nerve blocks
melatonin in adhd and sleep problems

Conditions: Attention Deficit Hyperactivity Disorder; Sleep Disorder

Summary: treatment with melatonin is often initiated on an insufficient basis as it has not been established prior to starting the treatment whether or not the child had delayed release of endogenous melatonin. at the clinic, it has furthermore been observed that the length of time a child experiences an effect of melatonin treatment varies substantially. in a clinical context, treatment with melatonin is used increasingly (www.medstat.dk). however, there is no tradition in denmark for measuring the endogenous melatonin level before initiating such treatment. hence there is no way of knowing to what extent the sleep problems were indeed caused by delayed melatonin release. there seem to be no studies on the difference in the effect of melatonin treatment of children and adolescents depending on whether or not they have delayed dlmo. likewise, there are no studies including adolescents. as can be seen, it is important to gain more knowledge about the normal release of melatonin, and the release of melatonin in a group of children and adolescents with a variety of psychiatric diagnoses. it is also essential to investigate whether there are any differences in the release of melatonin in children and adolescents with chronic sleep onset problem and children and adolescents who do not have sleep problems.


Eligibility criteria:
inclusion criteria: * children aged 6-13 years referred to the child and adolescent psychiatric department for examination/treatment for adhd * verified cronical sleep problems * measured dim light melatonin onset exclusion criteria: * iq below 70 * autism disorder * actual or former treated with melatonin * allergy to melatonin

Keywords: melatonin attention deficit hyperactivity disorder sleep problems dim light melatonin onset
observational study of oral cariprazine capsules to assess change in disease activity in adult participants with bipolar i disorder

Conditions: Bipolar I Disorder

Summary: bipolar i disorder (bp-i) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). this prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with bp-i experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. it will examine outcomes of cariprazine treatment in a real-world setting in patients with bp-i commonly seen in clinical practices. cariprazine (vraylar) is a medication indicated in the united states and canada to treat adult patients experiencing manic, mixed or depressive episodes associated with bp-i. this study plans to enroll approximately 170 adult patients with bp-i from the united states and canada. cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. the decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient's decision to participate in the study. participants will receive cariprazine as prescribed by their physician. observational data will be collected during visits which should align to routine standard of care for a duration of up to 24 weeks.


Eligibility criteria:
inclusion criteria: * have a physician-confirmed diagnosis of bp-i, with or without comorbidities. * prescribed cariprazine as part of routine clinical practice with the intention of treating as per the approved market label, respective country indications, and by the physician under usual and customary practice of physician prescription. * have a montgomery-åsberg depression rating scale (madrs) score \>= 20 at baseline. * have a functioning assessment short test (fast) score \>= 21 at baseline. * naïve to cariprazine in the current major depressive episode. exclusion criteria: * have a medical or psychiatric condition, or planned surgical procedure, which will interfere with study participation, as judged by the investigator. * have a known contraindication to cariprazine including any of the following: * hypersensitivity to cariprazine or any ingredient in the formulation * for all sites, concomitant use of strong cytochrome p450 (cyp) 3a4 inhibitors and inducers * for canadian sites, as per country label, concomitant use of moderate cyp 3a4 inhibitors and inducers * current major depressive episode duration \> 12 months.

Keywords: bipolar i disorder cariprazine crew bp-i
lipoprotein effects of substituting beef protein for carbohydrate

Conditions: Healthy; Cardiovascular Disease; Atherogenic Dyslipidemia

Summary: the purpose of this study is to test whether replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will improve risk factors for cardiovascular disease.

the primary aim of this study is to test the hypothesis that replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will have beneficial effects on components of atherogenic dyslipidemia and postprandial lipoprotein response and that these effects will be independent of saturated fat intake.

Eligibility criteria:
inclusion criteria: * blood pressure less than 150/90 * body mass index (bmi)≥ 20 and ≤ 35 kg/m2 * non-smoker * agrees not to consume alcohol during the study * agrees to abstain from taking dietary supplements during the study * ldl-cholesterol and total cholesterol \< 95th percentile for age and sex * fasting triglycerides \< 500 mg/dl * fasting glucose concentration \< 126 mg/dl * hematocrit (hct) ≥ 36% * at least three months of a weight-stable state (± 3% of body weight) exclusion criteria: * personal history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, diabetes, lung disease, bleeding disorder, liver or renal disease, hiv or of cancer (other than skin cancer) in the last five years * taking drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent warfarin * abnormal thyroid stimulating hormone (tsh) * strength trains with resistance weights more than four hours per week

Keywords: cholesterol diet protein carbohydrate saturated fat ldl subclass healthy volunteers
study of pregnancy regulation of insulin and glucose

Conditions: Gestational Diabetes Mellitus

Summary: it is unknown whether beta cell dysfunction and insulin resistance in gestational diabetes mellitus (gdm) is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of gdm. to elucidate the pathophysiology underlying gdm, the investigators will attempt to discover these factors and characterize pregnancy-associated changes in insulin secretion and sensitivity in women with and without gdm.

gestational diabetes mellitus (gdm) complicates 3-7% of pregnancies in the united states and is associated with perinatal morbidity and a high risk of future maternal type 2 diabetes. current prevention and treatment of gdm relies on techniques developed in the type 2 diabetes population, without regard to unique physiology in pregnancy. gdm occurs in the setting of profound pregnancy changes in glucose metabolism: late pregnancy is normally characterized by marked insulin resistance. in order to maintain normal glucose levels and avoid gdm, pancreatic beta cells must augment insulin secretion to compensate. women with gdm have inadequate beta-cell compensation for pregnancy-induced insulin resistance, resulting in hyperglycemia. it is unknown whether beta cell dysfunction and insulin resistance in gdm is representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the result of an imbalance of a placental hormones. undiscovered placental factors which vary between pregnancies likely contribute to the pathogenesis of gdm. discovery of these factors and elucidation of the pathophysiology underlying gdm will allow for the development better gdm-specific prevention and treatment strategies.

Eligibility criteria:
inclusion criteria: * women, age 18-44, non-pregnant or in the 1st trimester of pregnancy (4-14 weeks gestation), * who had gdm in a previous pregnancy * at risk for diabetes mellitus, as specified by the american diabetes association (ada): * bmi ≥ 25 kg/m2 (or bmi ≥ 23 kg/m2 if asian-american) plus one or more of the following: * history of giving birth to a neonate weighing \> 9 lbs * first-degree family member with diabetes mellitus * high-risk ethnic or racial group (african-american, hispanic, native american, asian-american, or pacific islander) * polycystic ovary syndrome * hypertension, dyslipidemia if known (hdl\ 250), or cardiovascular disease * physical inactivity exclusion criteria: * known pre-existing diabetes mellitus, based on patient report or medical record review * a1c ≥ 6.5%, detected at study visit 1 * use of medications known to affect glucose tolerance including corticosteroids, metformin, sulfonylureas, and others as determined by the investigators.

Keywords: insulin sensitivity insulin secretion pregnancy placental proteins