Kornimate/medical-research-clean huggingface dataset:
hba1c and outcomes in the critically ill

Conditions: Critical Illness

Summary: background: glycated hemoglobin a1c (hba1c) has been linked to poor outcomes in the cardiac surgery, septic and critically ill patient population. it is a promising test to understand the complex relationship between glycemia, diabetes and outcomes in patients admitted to the intensive care unit. hypothesis: an elevated hba1c value on admission to an intensive care unit (icu) is associated with poor outcomes.

objectives: the primary objective of this study is to determine hospital mortality of all newcomers admitted to the icu, and to compare it between patients with hba1c \<6.5% and ≥6.5%. other outcomes that will be measured include icu and one year mortality, icu and hospital length of stay (los), days on mechanical ventilation, serious infection during hospitalization and renal failure requiring dialysis during hospitalization and at 6 months. the investigators will also determine the prevalence of pre-diabetes (hba1c 6.0-6.4%) and diabetes (≥6.5%) in the critically ill population based on hba1c levels and monitor glucose control and insulin requirements during the first three days of icu admission. methods: this project is a prospective observational study at the mcgill university health center adult medical and surgical icus. hba1c is measured at the admission to the icu. the data are being collected prospectively using microsoft access data entry. the following parameters will be recorded on admission: admitting diagnosis, sex, age, height, weight, body mass index (bmi), acute physiology and chronic health evaluation (apache) ii score, previous diagnosis of dm, whole blood hba1c level, blood and plasma glucose levels. with power 80%, type i error 5% and with an expected 25% mortality difference between patients with hba1c≥6.5 and \<6.5, the required sample size is 1800 patients. the data will be presented as mean ± sd unless otherwise specified and statistical significance will be set as p \< 0.05. all p-values presented will be 2-tailed. significance: the investigators want to demonstrate that hba1c ≥6.5 on admission to an intensive care unit is associated with increased 6 month mortality and worse outcomes. the investigators will also determine the prevalence of pre-diabetes and diabetes in the critically ill based on hba1c.

Eligibility criteria:
inclusion criteria: * patients admitted to an intensive care unit within 48 hours exclusion criteria: * patients with known hemoglobinopathy(ies) * patients that have received ≥2 units of packed red blood cells 48 hours prior to hba1c sampling
paricalcitol in treating patients with myelodysplastic syndrome

Conditions: Leukemia; Myelodysplastic Syndromes

Summary: rationale: paricalcitol is a form of vitamin d that may help myelodysplastic cells develop into normal bone marrow cells. purpose: phase ii trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome.

objectives: * determine the clinical effects of paricalcitol in patients with myelodysplastic syndromes. * determine whether this drug can improve rbc, wbc, or platelet counts in these patients. * determine whether this drug can decrease the risk of development of leukemia without causing undue toxicity in these patients. outline: patients receive oral paricalcitol daily for 4 months in the absence of disease progression or unacceptable toxicity. patients are followed at 1 month. projected accrual: a total of 20 patients will be accrued for this study within 8 months.

Eligibility criteria:
disease characteristics: * clinical diagnosis of myelodysplastic syndromes according to the modified fab classification * confirmed by bone marrow aspiration showing blast and promyelocyte count no greater than 30% of the bone marrow differential * patients with refractory anemia with ringed sideroblasts are eligible provided there was no response to a 3-week course of prior high-dose pyridoxine patient characteristics: age * 25 to 100 performance status * karnofsky 60-100% life expectancy * at least 12 weeks hematopoietic * see disease characteristics hepatic * bilirubin less than 2.0 mg/dl renal * creatinine less than 2.5 mg/dl * calcium normal other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior sensitivity to paricalcitol or any component of its formulation * no prior cholecalciferol toxicity * no other concurrent acute illness prior concurrent therapy: biologic therapy * not specified chemotherapy * more than 5 weeks since prior chemotherapy endocrine therapy * not specified radiotherapy * more than 5 weeks since prior radiotherapy surgery * prior recent surgery allowed, if fully recovered other * more than 5 weeks since prior megadose vitamins * no concurrent cholecalciferol, phosphate, calcium, or cholestyramine * no concurrent digoxin

Keywords: de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory anemia with excess blasts in transformation refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia chronic myelomonocytic leukemia
acute treatment of bipolar ii depression

Conditions: Bipolar Disorder

Summary: this study will compare the medications lithium and lamotrigine (lamictal®) in treating depression in individuals with bipolar ii disorder.

bipolar ii disorder (bdii) is a serious condition characterized by depressive and hypomanic episodes. the disability and suicide risk associated with bdii is equal to bipolar i disorder. however, there are no clinical trials for bdii, nor is the treatment of bdii addressed in current treatment guidelines. data suggest that li and ltg may be effective treatment options for bdii. this study will determine the safety, effectiveness, and tolerability of the two drugs in people with bdii. participants in this study will be randomly assigned to receive either li or ltg for 16 weeks. participants will be assessed every 2 weeks. one week after study completion, participants will have a follow-up visit. measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.

Eligibility criteria:
inclusion criteria: * current diagnosis of bipolar ii disorder exclusion criteria: * use of lithium or lamotrigine * intolerance to lithium or lamotrigine * substance abuse or dependence within the last month * suicidal thoughts * unstable medical conditions * pregnancy or breast-feeding * stable on current medications * use of fluoxetine (prozac) within 2 weeks of study * require an antipsychotic medication * do not speak or read english

Keywords: bipolar depression
functional impairment in albinism

Conditions: Albinism, Ocular

Summary: albinism is a genetic and hereditary anomaly that affects pigmentation. this pathology is characterized by a deficit in melanin production. in humans, the clinical diagnosis of albinism is based on a number of factors, including : * in the integumentary region: fair skin tone, with white hair, eyelashes and eyebrows. * ophthalmological: reduced visual acuity, photophobia, nystagmus, transilluminated blue irises, hypopigmentation of the retina at the back of the eye with fovea plana. as treatment options begin to emerge for certain albinism-induced anomalies (including, for example, the depigmentation that causes photophobia), it is desirable to understand what these patients' complaints are, and to gather their views on the emergence of treatments targeting just one of their complaints, namely glare.


Eligibility criteria:
inclusion criteria: * all patients with albinism * patients \> 18 years of age * non-opposition to study participation exclusion criteria: no diagnosis according to kruijt et al. criteria impossibility (visual, technological) of completing questionnaire
multi-omics analysis of women with pcos and obesity compared with non-pcos obese controls

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a common endocrine and metabolic disorder in reproductive-aged women， which associated with increased risks to develop metabolic disorders, including cardiovascular diseases, diabetes mellitus, and cerebrovascular diseases. the precise pathogenesis of pcos remains unknown but is thought to be multifactorial, comprising genetic and environmental factors .

to study the pathogenesis of diseases, the study of multi-omics approach has been applied in various diseases researching . obesity and pcos are both metabolic disorders, and both have an impact on metagenomics, metabolomics and transcriptome. currently, multi-omics studies based on obese pcos are still limited. therefore, this study tried to use a multi-omics approach that integrates the gut microbiome, serum metabolomics, serum transcriptomics, and clinical indicators to distinguish obese pcos from obese non-pcos women. to investigate whether the specific composition of the gut microbiome is associated with pcos in obese women. serum metabolomics and transcriptomics were analyzed to explore potential metabolic pathways. meanwhile, gut microbiome and serum metabolomics are used to predict the occurrence of pcos. then, a new metabolite that could predict pcos were tested on female mice with high fat diet (hfd).

Eligibility criteria:
inclusion criteria: * patients with obesity (bmi\>28kg/m2) * aged 18-45 years * diagnosis of pcos * the rotterdam diagnosis criteria (2003) exclusion criteria: * pregnant women; * hyperthyroidism or hypothyroidism * severe liver and kidney function injury * cancer patients; * associated with severe infection, severe anemia, neutropenia and other blood system diseases; * have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes; * patients with mental illness or intellectual disability; * have taken drugs for pcos treatment in the last three months; * taking drugs or foods (antibiotics, probiotics, yogurt, etc.) that affect the intestinal flora for nearly one month; * have a long history of taking hormone therapy; * currently or recently participating in another clinical trial.

Keywords: gut microbiome metabolomics transcriptomic obesity
rygb al 150cm bpl 100cm vs rygb al 100cc bpl 150cm

Conditions: Weight Loss

Summary: a roux-en-y gastric bypass will be performed in all the cases. patients will be randomized according the limb lengths: * group 1: alimentary limb (al) 150cm and biliopancreatic limb (bpl) 100cm * group 2: al 100cm and bpl 150cm weight loss will be evaluated 1 year after surgery

a roux-en-y gastric bypass will be performed in all the cases. patients will be randomized according the limb lengths: * group 1: alimentary limb 150cm and biliopancreatic limb 100cm * group 2: alimentary limb 100cm and biliopancreatic limb 150cm weight loss will be evaluated 1 year after surgery

Eligibility criteria:
inclusion criteria: * bmi \> 40 kg/m2 * bmi \> 35 kg/m2, associated with obesity-related comorbidities * patients undergoing roux-en-y gastric bypass as bariatric procedure exclusion criteria: * patients undergoing roux-en-y gastric bypass as revisional procedure * patients lost to follow-up
art cycle outcomes when only 1 to 3 oocytes are retrieved

Conditions: Infertility Assisted Reproductive Technology; Oocyte Retrieval

Summary: this is a monocentric retrospective observational study. the study focuses on the women who underwent assisted reproductive technology (art) cycles with poor ovarian response (por), defined as \<4 oocytes retrieved. the objectives of the study are as follows: * evaluate clinical pregnancy rate (cpr) and cumulative live birth rate (clbr) in women with poor ovarian response. * evaluate abortion rate in women with poor ovarian response. * evaluate the influence of patient characteristics (age, anti-müllerian hormone \[amh\] levels, antral follicle count \[afc\], follicle stimulating hormone \[fsh\], body mass index \[bmi\]) on women with poor ovarian response. to address the study objectives, data will be collected using a specific internal web-based database. all oocyte retrieval procedures performed at the humanitas fertility center from january 2010 to december 2023 will be included in the evaluation. outcomes will be expressed in terms of clbr, cpr and abortion rate.


Eligibility criteria:
inclusion criteria: * the study database will include all women who underwent ivf treatment between 2010 and 2023 and were classified as poor ovarian responders, defined as those who retrieved fewer than 4 oocytes following controlled ovarian stimulation. exclusion criteria: * the study database will exclude women who underwent ivf treatment and retrieved more than 3 oocytes following controlled ovarian stimulation.
effect of mechanical loading with pth on cortical bone

Conditions: Osteoporosis, Postmenopausal

Summary: clinical trial to investigate effect of voluntary upper extremity loading in combination with anabolic osteoporosis therapy.


Eligibility criteria:
inclusion criteria: * women aged 45+ * postmenopausal * osteoporotic with high risk of fracture exclusion criteria: * no significant previous use of bone health modifying treatments
a comparison of us and evoked motor response-guided placement of continuous femoral nerve block following tka

Conditions: Anesthesia; Pain; Nerve Pain; Knee Arthroplasty; Nerve Block

Summary: the purpose of this study is to determine which technique for catheter placement in continuous femoral nerve block (fnb) is most successful - guidance with (1) ultrasound or (2) nerve stimulation and ultrasound. sensory and motor assessment scores will be obtained post-fnb. patient controlled analgesia and opiate consumption is also recorded along with pain scores for the first 48 hour post-fnb.

continuous femoral nerve block (cfnb) is a widely used regional anesthetic technique for many lower limb operations, such as total knee arthroplasty (tka), anterior cruciate ligament repair, tibial osteotomy and patellar surgery. it provides superior pain relief, faster ambulation, shorter hospital stays and less risk of side effects in comparison to patient controlled analgesia (pca), local anesthetic wound infiltration, or single shot femoral nerve block (fnb). stimulating catheters were introduced in 1999 to provide an objective end point to guide continuous nerve block catheter position by maintaining the desired evoked muscle response with nerve stimulation (ns). the main advantages of stimulating catheters are faster onset of sensory and motor block and reduction of local anesthetic drugs consumption. in recent years the precise insertion of continuous catheters has improved especially with the introduction of ultrasound (us)-guided imaging to regional anesthesia practice and advances in scanning techniques. that led to a call to reduce cost by switching to non-stimulating catheters. however, most studies comparing both catheters lacked anesthetic technique standardization and adequate sample size. in this prospective randomized controlled trial, we compared postoperative analgesic efficacy and opioids consumption in patients having cfnb insertion using us alone and that of us combined with ns.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i to iii patients * aged 18-75 scheduled for unilateral tka exclusion criteria: * history of significant psychiatric problems * bmi \> 40 kg/m\^2 * prior surgery in the inguinal region * neurological disease with sensory or motor deficit * diabetic neuropathy * contraindication to any study medications * daily opioid consumption \>10 mg po morphine (or equivalent) for 2 weeks prior to surgery
pre-approval single-patient expanded access for talazoparib (pf-06944076)

Conditions: Metastatic Castration-Resistant Prostate Cancer

Summary: provide pre-approval single-patient expanded access (compassionate use) of talazoparib for patients with metastatic castration-resistant prostate cancer.

in expanded access, treating physicians are the sponsors.. expanded access requests from treating physicians may be submitted at www.pfizercares.com; availability will depend on location/country.

Eligibility criteria:
talazoparib is not intended for monotherapy. talazoparib is intended for combination use with enzalutamide in first-line metastatic (m1) castration-resistant prostate cancer (mcrpc) only. must be a newly diagnosed mcrpc patient who has not yet received 1st line therapy (1st generation androgen receptor (ar)-inhibitors do not count). must have not received 2nd generation ar-inhibitors (enzalutamide, apalutamide, darolutamide), a poly \[adp-ribose\] polymerase (parp)-inhibitor, cyclophosphamide, or mitoxantrone as prior treatments in any prostate cancer disease setting. previous abiraterone and/or docetaxel for hormone-sensitive disease (cspc) is allowed (patient eligible). patients with identified need for use of potent p-glycoprotein (p-gp) inducer drugs within 7 days of onset/under duration of talazoparib plus enzalutamide treatment are at risk of drug-drug interactions (ddis) and are therefore ineligible. additional eligibility criteria may be required.

Keywords: prostate cancer metastatic* castration-resistant prostate cancer (mcrpc) enzalutamide combination therapy first-line mcrpc metastatic (m1)
long term postoperative cognitive dysfunction in the elderly patients

Conditions: Cognitive Impairment

Summary: the purposes of this study are to determine whether long-term postoperative cognitive dysfunction (pocd) is occured after general anesthesia and anesthetic drugs have an effect on the result about pocd.

in present aging society, a surgery in geriatric patient is increasing. patients older than 60 year are particularly affected for postoperative cognitive dysfunction (pocd) (26-41%). the patients experiencing pocd are at an increased risk of death in the first year after surgery. so, pocd is important because it can influence to patient's quality of life. in the investigator's hospital, laparoscopic cholecystectomy is performed with increasing frequency in aging patients. so the investigator's study will be conducted in elderly patients during laparoscopic cholecystectomy. the anesthetic methods are divided into the following 3 kinds: sevoflurane, propofol, dexmedetomidine. these anesthetic drugs are used in general anesthesia generally. the control group include a spouse of the patient which must be older than 60 year and does not have anesthetic history. after the surgery, the patients are discharged from the hospital, the investigators will check the postoperative cognitive function 4 times: 1week, 3months, 6months, 1 year later using the korean version of telephone interview for cognitive status (tics). the korean version of tics was validated tool for examination of cognitive function and this tool and mini-mental state examination (mmse) be linked directly. the test will be administered to spouse simultaneously by telephone. sample size was calculated for the primary outcome parameters (whether long-term postoperative cognitive dysfunction (pocd) is occured after general anesthesia), and the investigators hypothesized that two groups are in this study, one group is for postanesthetic patients, another is for their spouses. total sample size was calculated to 190.

Eligibility criteria:
inclusion criteria: * ≥ 60 years old, scheduled for laparoscopic cholecystectomy under general anesthesia exclusion criteria: * diseases of the central nervous system, including dementia (mini mental examination score \<24), * consumption of major tranquilizers or antidepressants * previous neuropsychological testing * the patient's inability to comply and follow procedures or poor comprehension of the language used in the study. * parkinson's disease * patients with a severe visual or auditory handicap, illiteracy * alcoholism (intake of \>5 units of alcohol daily during the last 3 months) * drug dependence * those not expected to complete the postoperative tests were excluded as well

Keywords: geriatrics; cognitive impairment; interviews, telephone
internal fit evaluation of indirect restorations using cone beam ct (cbct)

Conditions: Indirect Restoration of Badly Broken Vital Teeth

Summary: this study was conducted to evaluate the internal fit of indirect restoration fabricated from cad/cam composite blocks versus ceramic blocks in badly broken vital teeth using cone beam ct

two parallel groups (n=42 restorations), patient having badly broken vital teeth minimum of two remaining wall will be randomly enrolled in this trial and receive restoration fabricated either from grandio composite blocks or e-max ceramic blocks. internal fit evaluation of the fabricated restoration over their corresponding casts will be performed using cone beam ct just prior cementation of the restorations. data will be collected and statistically analyzed.

Eligibility criteria:
inclusion criteria: * patients with badly broken vital teeth young adult males or females (20-50 years) good oral hygeine cooperative patients approving to participate in the study exclusion criteria: * patients with acompromised medical history severe or active periodontal disease severe medical complications lack of compliance

Keywords: randomized clinical trial internal adaptation cad/cam composite restoration all ceramic restoration e-max cad cad/cam milling system cad/cad composite inlays onlays cone beam ct cbct
benefit of single port-surgery in sleeve gastrectomy

Conditions: Surgical Treatment of Obesity

Summary: demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch and mortality

the single port surgery is the natural evolution of laparoscopy. to date only few studies have evaluated the feasibility of this technique in sleeve gastrectomy. the investigators want to demonstrate the non-inferiority in terms of morbidity-mortality of use single trocar in sleeve gastrectomy compared the multiport technique. moreover it should highlight the non-inferiority in terms of anatomical quality, reduction of excess weight lost, reduction of comorbidities, decrease post operative pain, improved quality of life and evaluate medico-economic impact of these technique to validating this new surgical approach for bariatric surgery. the study will be multicentric with 6 university center (montpellier, amiens, lille, creteil, poissy and montsouris institut). 388 patients will be included in the tow group of the prospective randomise study.

Eligibility criteria:
inclusion criteria: * bmi\> 35 kg/m2 with comorbidity (s) or\> 40 kg/m2 * patients aged 18 to 65 years * discussion and decision sleeve gastrectomy multidisciplinary meeting * free, informed and written consent * affiliation to a social security or other assurance exclusion criteria - anesthetics exclusion criteria: * uncontrolled severe infection * liver disease other than obesity pathology * pregnancy (positive hcg) * large hiatal hernia * esophagitis uncontrolled * history of gastric bypass and gastric surgery other than gastric banding * saving justice guardianship * participation in another ongoing study * cognitive or severe mental illness * severe and non-stabilized eating disorders * addiction to alcohol and psychoactive substances"

Keywords: single port surgery bariatric surgery sleeve gastrectomy randomise prospective study complication rate