Kornimate/medical-research-clean huggingface dataset:
implementation of caring contacts

Conditions: Psychiatric Hospitalization

Summary: this quality improvement (qi) project will adapt and improve an evidence-based suicide-prevention initiative for sunnybrook patients at high risk of suicide following psychiatric inpatient discharge, targeting one of sunnybrook's qi plan goals of reducing suicide at sunnybrook. caring contacts, brief communications of hope, support and information sent to patients post-discharge, are a simple and low-cost intervention with proven effectiveness in reducing suicide attempts, suicidal ideation, and loneliness, while increasing hopefulness and feelings of connection to the health care system. pilot data provides some initial, promising evidence however additional patient input is required to improve the acceptability and effectiveness of the intervention to reduce suicide-related outcomes. feedback from patients and peer advisors will guide iterative improvements with the ultimate goal of implementing an improved version of caring contacts as a standard clinical practice for all patients discharged from the sunnybrook adult inpatient psychiatry unit. for phase one of this qi project, participants will be patients from the sunnybrook inpatient psychiatry unit with suicidality and community members with lived experience of psychiatric hospitalization and suicidality. investigators will conduct focus groups on the inpatient unit of 8-12 inpatient participants to gather feedback about the current caring contact intervention. for community members virtual focus groups will be conducted. for phase two, participants will be patients from the sunnybrook inpatient psychiatry unit with suicidality. the updated intervention will be sent to 8-12 participants. then investigators will host virtual focus groups to gather feedback from these participants about the intervention. for phase three, participants will be patients from the sunnybrook inpatient psychiatry unit with suicidality. investigators will send the revised intervention to 30-40 participants. participants will complete symptom and feedback questionnaires when they receive the intervention.


Eligibility criteria:
inclusion criteria: 1. provision of written informed consent 2. age 18 or above 3. ability to read and understand english 4. have an email address 5. the ability to understand and comply with the requirements of the project and capable of providing informed consent for inclusion in the outpatient focus groups participants must additionally have previous lived experience of psychiatric hospitalization with suicidal ideation or behaviour. for inclusion in the inpatient focus groups during phase one and for inclusion in the second and third phases of the project, participants must additionally 1) be an inpatient on the sunnybrook adult inpatient psychiatry unit at the time of recruitment and 2) they must have been admitted to the unit with suicidal ideation or behaviour as determined by their c-ssrs score at admission. exclusion criteria: * a primary diagnosis of a major neurocognitive disorder

Keywords: suicide prevention
magnesium sulfate to prevent brain injury in premature infants

Conditions: Brain Injuries; Cerebral Palsy

Summary: premature infants are at risk for acute brain injuries and long-term developmental problems such as cerebral palsy (cp). research suggests that high levels of magnesium at and around the time of birth may decrease the risk of brain injuries. this study will evaluate the effects of giving magnesium to premature infants.

premature infants weighing less than 1500 grams (3.3 lbs) represent approximately 1.3% of liveborn infants, yet comprise at least 25% of all children who are subsequently diagnosed with cp. antepartum exposure to magnesium (mg) may prevent or ameliorate early brain injury (intracranial hemorrhage and cystic periventricular leukomalacia), as well as long-term adverse neurodevelopmental outcomes (cp and mental retardation) in very low birthweight (vlbw) preterm infants. in preliminary studies, short- and long-term neuroprotection were associated with initial serum mg levels above 3.0 meq/l. this study will determine whether early abnormal neurosonographic findings and long-term adverse neurodevelopmental outcomes in vlbw premature infants are influenced by different levels of serum mg achieved during the first week of life. infants will be randomized to either "standard" mg therapy or "high" mg therapy. standard mg therapy consists of no supplemental mg for the first 3 days of life followed by intravenous magnesium sulfate (mgso4) aimed at attaining serum mg levels in the normal range of 1.2-2.3 meq/l. high mg therapy consists of using intravenous mgso4 to maintain higher (nonharmful) serum mg levels between 3.5-5.5 meq/l for the first 3 days of life and between 2.5-3.5 meq/l for the next 4 days. the high mg infants will subsequently have their serum mg levels maintained at 2.4+0.3 meq/l using oral magnesium gluconate for the remainder of their neonatal hospitalization. infants will be evaluated for early brain injury with head ultrasound studies 12 to 24 hours after birth, at 2 to 3 day intervals while ventilator support is required, and at weekly intervals until discharge. the infants will subsequently be assessed in the high-risk follow-up clinic for a minimum of 24 months (corrected for degree of prematurity). at 24 months of age, they will be evaluated by a pediatric neurologist for the presence of cerebral palsy. they will be tested serially for problems in early cognition (mental, language, and perceptual ability), as well as fine and gross motor skills.

Eligibility criteria:
inclusion criteria * born at 23 to 32 weeks' gestation * weighs 500 to 1500 grams (1.1 to 3.3 lbs) * requires mechanical ventilation * less than 12 hours of age at time of enrollment exclusion criteria * multiple congenital anomalies * single congenital anomaly of the central nervous system * unlikely to be available for duration of the study

Keywords: low birthweight infants magnesium supplementation intracranial hemorrhage cystic periventricular leukomalacia mental retardation
safety, tolerability and pharmacokinetics study of single doses of pnu-100480 in healthy adults

Conditions: Tuberculosis

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of pnu-100480 (pf-02341272) after a single dose in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * healthy adult volunteers willing and able to be confined to the clinical research unit and comply with study schedule. * women of non-childbearing potential only. exclusion criteria: * history of hypersensitivity to, or intolerance of, linezolid. * antibiotic treatment within 14 days prior to dosing.

Keywords: safety tolerability pharmacokinetics pk first in human fih
impact of covid-19 restrictive measure on anxiety, depression and ptsd for relatives of icu patients

Conditions: Covid-19; Family Members; Critical Illness

Summary: to limit the pandemic covid-19 infection, the french government imposed a closure of all intensive care unit (icu). the family's visitations are prohibited during active covid -19 pandemic in 2020 and in 2021. this restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of icu patients. the aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of icu patients during covid period with those during no covid period (2020 and 2021) with those no covid period (2022)

observational multicenter study three groups are compared: * no visitation group. enrollment during the application of national containment measures to limit covid pandemic in france: march to june 2020 * restrictive visitation group. enrollment during the application of national containment measures to limit covid pandemic in france: march to june 2021 * open visit group. enrollment during a no covid period without restrictive visitation: march to june 2022 the primary objective is to compare the hospital anxiety and depression scale (hads) for relative at 3-6 months after the icu patient discharge between the three groups the secondary objectives are * to compare the post-traumatic stress disorder (ptsd) for relative at 3-6 months after the icu patient discharge between the three groups * to compare the prevalence of significant symptoms of both anxiety and depression for relative at 3-6 months after the icu patient discharge between the three groups * to compare the prevalence of significant ptsd-related symptoms for relative at 3-6 months after the icu patient discharge between the three groups * to identify the factor associated with significant symptoms of both anxiety and depression * to identify the factor associated with significant ptsd-related symptoms

Eligibility criteria:
inclusion criteria: * relative of patient who was admitted in icu and treated with invasive mechanical ventilation administration during 24hours at least. exclusion criteria: * relative who declines the enrollment

Keywords: covid-19 family anxiety depression post-traumatic stress disorder intensive care unit visitation
comparison between partial nephrectomy and ablation for renal tumor

Conditions: Renal Cell Carcinoma

Summary: the therapeutic effectiveness of ultrasound guided cooled-probe microwave ablation and laparoscopic partial nephrectomy on t1a renal cell carcinoma is compared to find a better approach for renal tumor.


Eligibility criteria:
inclusion criteria: * patients with the rcc of ≤4 cm maximum diameter were included in the study. exclusion criteria: * patients having rccs with vascular invasion, extrarenal spread or with benign renal tumors were excluded.

Keywords: microwave ablation partial nephrectomy
coronavirus infection (covid-19) and radical surgery in patients with early-stage lung cancer

Conditions: Surgery; Corona Virus Infection

Summary: the goal of this observational study is to learn about the effects of coronavirus infection in patients with early-stage lung cancer. the main question it aims to answer is whether the interval of surgery and covid-19 infection will affect the surgery and prognosis of the patients.


Eligibility criteria:
inclusion criteria: * clinically diagnosed stage i and stage ii lung cancer, who are about to receive wedge resection, segmental resection, sleeve resection, lobectomy, or pneumonectomy under general anaesthesia. * volunteer to participate in the study with good compliance. able to complete the observation and follow-up and have signed the informed consent. * asa score: i-iii; * cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions. exclusion criteria: * neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response; * clinically diagnosed stage iii and stage iv lung cancer or patients who received neoadjuvant treatment before surgery; * patients developed symptoms alike coronavirus infection but are not confirmed by viral rna detection by quantitative rt-pcr or antigen testing kits. * serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation

Keywords: lung cancer surgery corona virus infection
the pk study of the jlp-1207 and solifenacin/tamsulosin in healthy male volunteers.

Conditions: LUTS(Lower Urinary Tract Symptoms); Benign Prostatic Hyperplasia; Overactive Bladder

Summary: the purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between jlp-1207(solifenacin/tamsulosin 5mg/0.2mg)and co-administration of solifenacin and tamsulosin between solifenacin and tamsulosin in healthy male volunteers.

a randomized, open-label, single dose, two-way crossover study.

Eligibility criteria:
inclusion criteria: * 19\~45 years healthy male * body weight is over 55kg, bmi measurement 18.0kg/m\^2\~ 27.0kg/m\^2 * signed informed consent form from to participate voluntarily and to comply with the trial requirements. * researchers determined suitable volunteers through physical examination, laboratory tests exclusion criteria: * history of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.) * sitting sbp\>150mmhg or \ 100mmhg or \<60mmhg, after 3 minutes break * an impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason. * have a gastrointestinal disease history that can affect drug absorption (crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery) * history of drug abuse * positive urine drug screening * administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study. * donated blood within 60 days prior to the first administration day in this study.

Keywords: α1-blockers antimuscarinic agent
treatment of osteomyelitis-associated pressure ulcers by surgical flaps and anti-bacterial agents

Conditions: Disability or Chronic Disease Leading to Disablement; Pressure Ulcer; Osteomyelitis

Summary: people with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at high risk of osteomyelitis-associated pressure ulcers. the management of osteomyelitis-associated pressure ulcers is controversial. in our center, patients benefit from a one stage surgical management with bone shaving and flap covering osteitis of pressure ulcer to perform wound closing. surgery is followed by an antibiotic treatment, secondarily adapted to intraoperative samples. the aim of this study is to describe the cohort and to identify factors associated with failure (or success) in this frail population.

this is a prospective, monocentric, cohort study of neurological disabled inpatients subjects treated in the perioperative disability unit (upoh) of our university hospital for osteomyelitis-associated pressure ulcer by surgical flaps and anti bacterial agents. all eligible inpatient subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps will be consecutively included. patients are followed up in consultation at 30 or 45 days after surgery, and in consultation or teleconsultation at 12 months after surgery. data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological, and physiological examinations. data related to sitting, nutrition, spasticity, bladder and bowel disorders, bacteriological sampling and antibiotic treatments will be collected. this is a routine care study; no procedures are added for research purposes. it is an ancillary study to the no-aging study.

Eligibility criteria:
inclusion criteria: * patients \>= 18 years old ; * treated in the perioperative disability unit (upoh) of the physical medicine and rehabilitation department of our university hospital; * admitted for the treatment of an osteomyelitis-associated pressure ulcer by surgical flap; * having a neuromotor disability; * no opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it; * affiliation to a social security scheme. exclusion criteria: * under court protection.

Keywords: disability, pressure ulcer, osteomyelitis, surgical flaps, anti-bacterial agents, posture
safety and pharmacokinetics study of linzagolix in female subjects with normal and impaired hepatic function

Conditions: Hepatic Impairment; Healthy Participants

Summary: the primary objective of this study is to assess the pharmacokinetics (pk) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function

this is a phase 1, non-randomized, open label, single-dose study to evaluate the effect of varying degrees of impaired hepatic function (i.e., mild, moderate, and severe hepatic impairment (hi)) on the pk, safety, and tolerability of linzagolix and its major metabolite, kp017. up to 28 adult female participants will be enrolled.

Eligibility criteria:
key inclusion criteria: hepatic impaired subjects 1. adult female, 18-75 years of age, inclusive, at screening 2. has a bmi ≥ 18.0 and ≤ 42.0 kg/m\^2 and weight ≥ 40 kg, at screening 3. aside from hi, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, electrocardiograms (ecgs), and screening clinical laboratory profiles, as deemed by the principal investigator (pi) or designee 4. has a score on the child-pugh scale at screening as follows: * severe hi: ≥ 10 and ≤ 15 * moderate hi: ≥ 7 and ≤ 9 * mild hi: ≥ 5 and ≤ 6 5. has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology healthy subjects 1. healthy adult female will be matched based upon age and bmi 2. medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ecgs, as deemed by the pi or designee. key exclusion criteria: hepatic impaired subjects 1. has a clinically active grade 3 or 4 encephalopathy 2. has fluctuating or rapidly deteriorating hepatic function within the screening period, and up to 30 days prior to day 1, in the opinion of the pi and sponsor 3. has history of liver or other solid organ transplant 4. had any major surgery within 4 weeks prior to dosing 5. has a surgical (e.g., hepatectomy, nephrectomy, digestive organ resection) or medical condition other than hi which might significantly alter the absorption, distribution, metabolism, or excretion of linzagolix and its metabolites, or which may jeopardize the subject's safety in case of participation in the study in the opinion of the pi or designee healthy subjects 1. has any clinically significant illness, as judged by the pi or designee, within 4 weeks prior to dosing 2. has laboratory values at screening or check-in which are deemed to be clinically significant (especially derangement within liver function test), unless agreed in advance by the pi and the sponsor

Keywords: linzagolix obe2109 hepatic impairment hepatic insufficiency liver diseases clinical pharmacology study
evaluation of the efficacy of novel biomarkers in predicting clopidogrel resistance in patients with ischemic stroke

Conditions: Ischemic Stroke; TIA (Transient Ischemic Attack); Clopidogrel Resistance

Summary: the goal of this observational study is to explore the potential efficacy of related biomakers in predicting clopidogrel resistance in patients with ischemic stroke. to be specific : 1. to investigate the relationship between the changes in adp induced platelet aggregation rate, human plasma c4bpα concentration, mrna expression levels of marc1 and abcc3-013 (splicing variant) in peripheral blood leukocytes, and the changes in the mrna expression levels of abcc3-013 (splicing variant) in selected hospitalized patients before and on the 3rd and 7th day after antiplatelet therapy, as well as on the 30th and 90th day after follow-up, in accordance with the current guidelines for secondary stroke prevention, and to explore the relative efficacy of each biomarker in predicting clopidogrel resistance; 2. to collect blood samples from patients, extract their dna samples, perform cyp2c19 genotyping, validate and evaluate the predictive efficacy and clinical application value of a biomarker "panel" composed of multiple new and old biomarkers for predicting clopidogrel resistance.


Eligibility criteria:
inclusion criteria: * age range: 18-80 years old. within 72 hours after symptom onset (admission), the patient has started receiving "standard" antiplatelet therapy (which must include plavix, taken alone or in combination) * diagnosed with mild, non cardiogenic, non disabling ais (nihss score ≤ 3) or high-risk tia (abcd2 stroke risk assessment ≥ 4) based on the patient's symptoms, signs (such as hemiplegia, hemianopia, hemiparesis, aphasia, etc.) and various routine diagnoses and tests (including but not limited to neuroimaging, such as cranial ct, mri, doppler, etc.) exclusion criteria: * 72 hours after the onset of symptoms (admission), the patient began receiving "standard" antiplatelet therapy (including polivix, taken alone or in combination) for moderate or severe ais (nihss score ≥ 5) * patients who require intravenous thrombolysis (using rt pa, urokinase, alteplase, or tiniprase, etc.) * mechanical intervention for thrombectomy * cardiogenic ais (with concomitant atrial fibrillation) * embolic stroke of unknown origin (esus) * perioperative stroke * use anticoagulant drugs (such as warfarin, rivaroxaban, dabigatran etexils, etc.) * individuals with severe liver and kidney dysfunction * individuals allergic to clopidogrel or aspirin * individuals with a tendency towards bleeding (such as low platelet count or active gastric or intestinal ulcers) * individuals with a history of easy miscarriage or who are currently pregnant * patients with malignant tumors or life expectancy of less than 1 year
laser in caries treatment - patients´view, pulpal reactions and survival of fillings

Conditions: Dental Caries

Summary: the aim of this study was to evaluate the excavation time, patients´ experiences, pulpal reactions and survival of fillings when carious tissue was removed with er:yag laser compared to rotary bur. a prospective, single-blind, randomized and controlled investigation was performed. patients with at least two primary caries lesions radiographically assessed as the same size were recruited. in each patient one cavity was excavated with rotary bur and one with er:yag laser technique. the time requested for excavation and local anaesthesia were measured. the prevalence of postoperative symptoms, pulpal vitality and the quality of fillings will be investigated during two years after the excavation occasion.

the study is a prospective, single-blind, randomized and controlled investigation. patients between 15-40 years with at least two primary caries lesions radiographically assessed as the same size were recruited. in each patient one cavity was excavated with rotary bur and one with er:yag laser technique after a randomized allocation of the lesions to one of the intervention methods. the time requested for excavation to hard/firm dentin and local anaesthesia were measured. directly after each treatment a questionnaire focusing on the experiences of the current treatment and if the laser method will be chosen in the future was answered. postoperative pain was measured with a questionnaire one week after the treatment. six, 12 and 24 months after the fillings were made an evaluation of pulpal status and the quality of the fillings will be performed.

Eligibility criteria:
inclusion criteria: * patients should be between 15 and 40 years, * at least two lesions with primary caries estimated as being of equal size, and needed to be treated, in bite-wing radiographs, and * comparable pairs of cavities should be located on either occlusal or approximal surfaces. * the lesions should not involve the inner third of the dentin. exclusion criteria: * patients with severe general diseases ( asa\>2) (30), * cognitive or intellectual disabilities, * patients who required sedation or general anaesthesia, and * teeth with periapical pathology, a root filling or non-vital teeth.

Keywords: dental caries, er:yag laser, rotary bur