louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03646578: Maternal Anxiety Related to How the Pediatrician Provided Prenatal Information About Preterm Birth
Official title: Maternal Anxiety Related to How the Pediatrician Provided Prenatal Information About Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: maternal anxiety
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 65
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 hospitalized patients at risk of preterm birth

Brief summary: Women hospitalized for preterm labor require clear information about prematurity.

This study assessed whether or not specific written information about prematurity delivered at admission to the unit combined with an oral explanation from a pediatrician would decrease women's anxiety compared to an oral explanation alone. This was a prospective, single-center observational study.Women were included in the high-risk pregnancies department and distributed into two groups: receiving ''only oral'' information for a prenatal clinical consultation with a senior pediatrician or receiving ''combined'' oral information + a booklet about prematurity given to the women at admission. The primary endpoint was the change in anxiety-state (before and after the information procedure) evaluated by the State Trait Anxiety Inventory-Y (STAI-Y).

Detailed description: Women hospitalized for preterm labor require clear information about prematurity.

This study assessed whether or not specific written information about prematurity delivered at admission to the unit combined with an oral explanation from a pediatrician would decrease women's anxiety compared to an oral explanation alone. Material and methods.This was a prospective, single-center observational study.Women were included in the high-risk pregnancies department and distributed into two groups: receiving ''only oral'' information for a prenatal clinical consultation with a senior pediatrician or receiving ''combined'' oral information

+ a booklet about prematurity given to the women at admission.

Eligibility criteria: Inclusion Criteria:

* patients hospitalized in the service of pregnancies and having a risk of premature delivery.
* Term \<34 SA

Exclusion Criteria:

* Term ≥ 34 SA
* no understanding of the questionnaire
* foetus presenting a pathology or malformation that is life-threatening
* patient presenting a risk of delivery before passing the pediatrician or presenting a risk of imminent delivery
* patient hospitalized without risk of premature delivery.

Primary outcomes:
measure: Mesure of the State of anxiety of patients with a risk of premature delivery
timeFrame: 3months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Pierre Tourneux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03278678: Nutritional Screening in Older Individuals
Official title: Nutritional Screening in Community Living Older Individuals at High Risk of Hospital Admission.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnourished
Keywords: Nutritional screening MNA-SF malnutrition Case Management
Lead sponsor: Sanjuan, Silvia Forcano, M.D.
Sponsor class: INDIV
Collaborators: name: Ministerio de Sanidad, Servicios Sociales e Igualdad
First posted: 2017-09-12
Enrollment: 791
Sex: ALL
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The final sample size was of 791 subjects.

The baseline characteristics were:

Mean age (years): 79.9 +/- 10.86 Female : 397 (50.2%) Mean Body Mass Index : 27.6 +/- 5.75

Brief summary: Hospital-based case management programs and home hospitalization services following the risk stratification model of Kaiser Permanente and Kings Fund select an estimated 5% of older individuals living in the community who are at high risk of hospitalization and adverse outcomes. The objective of these services is to avoid deterioration and hospital admissions or visits to the emergency services by regular follow-up, proactive home visits and support of self-care . The prevalence of malnutrition in patients selected using this model of care is unknown.

Detailed description: The aim of this study was to estimate the prevalence of malnutrition, using the MNA, in this high-risk community living population, and to explore risk factors that could identify subgroups of individuals at higher risk.

This study was performed in individuals included in a Case Management (CM) Program lead by the Telemedicine Unit of a tertiary university hospital in Valencia. Patients admitted to the hospital with two or more hospital admissions for medical reasons in the previous year are detected by a computerized system and included in the program, an integrated care intervention developed for patients with complex multimorbidity using patient-centred education activities and integrated care interventions, with the support of a Hospital at Home Unit (HHU). Telephone follow-ups by case manager nurses are focused on identifying problems and detecting disease exacerbations. The main aim of this program is to avoid hospital admissions and reduce the number of visits to emergency services

Eligibility criteria: Inclusion Criteria:

* Patients included at Case Management Program for complex chronic condition
* Must be able to answer questions on the telephone

Exclusion Criteria:

* Subjects with no telephone,
* Subjects unable to determine their usual weight
* End-of-life clinical situation

Primary outcomes:
measure: prevalence of malnutrition
timeFrame: 2 months
Secondary outcomes:
measure: sexBMI
timeFrame: 2 months
measure: age
timeFrame: 2 months
measure: BMI
timeFrame: 2 months
Other outcomes:
measure: Risk factors of malnutrition
timeFrame: 2 months
Locations:
Study officials:
References:
Clinical trial NCT03438578: Efficacy Safety Score in Postoperative Management
Official title: Use of Efficacy Safety Score in Postoperative Management: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Postoperative Nausea and Vomiting
Keywords: Patient safety
Postoperative care
Monitoring, physiologic
Safety management
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2018-02-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this project is to determine whether postoperative patients may benefit from the Efficacy Safety Score (ESS) as a tool for postoperative clinical decision support, with a special focus on the first 24 hours after discharge from the postoperative care unit.


Eligibility criteria: Inclusion Criteria:

* undergoing surgery
* expectedly to be treated and observed in hospital for more than 24 hours postoperatively

Exclusion Criteria:

* refusal of participation
* poor communication capabilities

Primary outcomes:
measure: Time to Mobilization
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Measurement, Verbal Numeric Rating Scale
timeFrame: 24 hours
measure: Patient Satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Orkdal
country: Norway
facility: St Olav University Hospital
Study officials:
affiliation: University of Oslo
name: Johan Raeder, Prof
role: STUDY_DIRECTOR
affiliation: St. Olavs Hospital
name: Erik Solligård, MD PhD
role: STUDY_DIRECTOR
References:
citation: Skraastad EJ, Borchgrevink PC, Nilsen TIL, Raeder J. Postoperative quality and safety using Efficacy Safety Score (ESS) and a wireless patient monitoring system at the ward: A randomised controlled study. Acta Anaesthesiol Scand. 2020 Mar;64(3):301-308. doi: 10.1111/aas.13492. Epub 2019 Nov 12.
Clinical trial NCT06048978: Blood Glucose Response of Processed Starch
Official title: The Effect of Starch Processing on Postprandial Blood Glucose in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Keywords: Postprandial Glycemia
Blood Glucose
Lead sponsor: INQUIS Clinical Research
Sponsor class: INDUSTRY
Collaborators: name: University of Saskatchewan
First posted: 2023-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to determine the postprandial glycemic response of the two starches in humans. Participants will be asked to consume 2 test foods on 2 separate occasions and provide blood glucose samples over 120 minutes postprandial.

Detailed description: Enrolled participants who are generally healthy and free of major chronic conditions will be randomized to receive either Commercial Native Starch or Extrusion Processed Starch first and then will be crossed over to receive the opposite Intervention. The study will consist of two clinical test visits of 120 minutes separated by a washout period of at least 24 hours.

Eligibility criteria: Inclusion Criteria:

* adult males or non-pregnant females.
* eligible to receive income in Canada.

Exclusion Criteria:

* age less than 18 years
* any known food allergies or intolerances to the investigational product
* medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable
* known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions
* any major medical or surgical events requiring hospitalization within the preceding 3 months
* the presence of disease or drug(s) which influence digestion and absorption of nutrients
* the short-term use of systemic steroids or atypical antipsychotics (\<4 weeks) (all of which have major effects on glucose and metabolism and body fat distribution)
* any other medications or conditions which might, in the opinion of the Medical Director of INQUIS Clinical Research Ltd. (INQUIS), either 1) make participation dangerous to the subject or to others, or 2) affect the results
* any subject who cannot or will not comply with the experimental procedures or do not follow INQUIS safety guidelines

Primary outcomes:
measure: Postprandial Glycemia
timeFrame: -5 to 120 minutes after intervention administration
Secondary outcomes:
measure: Incremental Blood Glucose
timeFrame: 0, 15, 30, 45, 60, 90, and 120 minutes after intervention administration
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: INQUIS Clinical Research Ltd.
state: Ontario
Study officials:
affiliation: INQUIS Clinical Research
name: Thomas MS Wolever, MD, PhD, DM (Oxon)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06344078: Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).
Official title: Surgical Italian Guide for the Management of Complicated Acute Diverticulitis in Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Diverticulitis
Stoma Colostomy
Stoma Ileostomy
Lead sponsor: Societa Italiana di Chirurgia ColoRettale
Sponsor class: NETWORK
First posted: 2024-04-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general population

Brief summary: This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months.


Eligibility criteria: Inclusion Criteria:

* 18 yo or older
* CT scan and WSES classification
* surgical intervention within 48 hours for acute diverticulitis

Exclusion Criteria:

* underaged
* conservative treatment for acute diverticulitis
* other treatment
* diagnosis of colorectal cancer at histology

Primary outcomes:
measure: adhesion to guidelines
timeFrame: 1 year follow-up
Secondary outcomes:
measure: stoma reversal
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Azienda ospedaliera universitaria paolo giaccone
Study officials:
References:
Clinical trial NCT00529178: Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease
Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine the Efficacy and Safety of Pravastatin 80 mg Administered Once Daily to Hypercholesterolemic Subjects With Chronic, Well Compensated Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Chronic, well-compensated stable liver
* Hypercholesterolemia

Exclusion Criteria:

* Signs or symptoms of ascites, jaundice, or cirrhosis with a Child-Pugh Score \> 5
* History of disorders affecting serum bilirubin levels, more than 1 chronic liver disease, significant endocrine, renal, or gastrointestinal disease, or uncontrolled hypertension
* Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol

Primary outcomes:
measure: serum LDL-C
timeFrame: at week 12
measure: ALT value
Secondary outcomes:
measure: change in HDL-C, TC and TG
timeFrame: at week 12
measure: clinical symptoms related to acute hepatic injury
Other outcomes:
Locations:
Study officials:
References:
citation: Lewis JH, Mortensen ME, Zweig S, Fusco MJ, Medoff JR, Belder R; Pravastatin in Chronic Liver Disease Study Investigators. Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease: Results of a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Hepatology. 2007 Nov;46(5):1453-63. doi: 10.1002/hep.21848.
Clinical trial NCT02277678: Comparison of Epidural Oxycodone and Epidural Morphine
Official title: Comparison of Epidural Oxycodone and Epidural Morphine for Post Caesarean Section Analgesia: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pruritus
Keywords: Pruritus
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2014-10-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to compare the efficacy of pain relief between epidural oxycodone and epidural morphine for postoperative analgesia after elective caesarean section and to compare the incidence and severity of pruritus. Secondary objectives are to compare other side effects of epidural administered oxycodone and morphine (nausea and vomiting, sedation, respiratory depression) and to investigate the safety and efficacy of epidural oxycodone and epidural morphine after use for postoperative analgesia in caesarean sections.

Detailed description: Undesirable side effects such as pruritus and nausea are common with epidural morphine and are thought to be due to mu-opioid receptor stimulation at the supra-spinal level. Recent studies of epidural oxycodone for abdominal and gynaecological surgery have shown that it is as effective as morphine with fewer side effects by this route. This has not been established in patients undergoing caesarean section. Oxycodone is a semi-synthetic opioid derivative that resembles morphine structurally and has similar lipid solubility. It has been reported that the analgesic action of oxycodone is more rapid in onset when compared with morphine and is mediated by kappa-opioid receptors in the spinal cord. The significance of our study would be to establish that epidural oxycodone reduces the side effects of pruritus of epidural morphine whilst still maintaining similar analgesia.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-2,
* aged between 21 to 50 years undergoing a term elective caesarean section and
* had consented for combined spinal-epidural (CSE) anaesthesia

Exclusion Criteria:

* concurrent opioid therapy,
* contraindications to CSE anaesthesia or any of the study medications,
* a history of pre-existing nausea and vomiting,
* failure to identify intrathecal space at time of anaesthesia,
* inadvertent dural puncture with the epidural needle and
* conversion of regional anaesthesia to general anaesthesia

Primary outcomes:
measure: Pruritus
timeFrame: 1 day
Secondary outcomes:
measure: Pain
timeFrame: 1 day
measure: Nausea and Vomiting
timeFrame: 1 day
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban L Sng, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03281278: A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China
Official title: A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombelastography,Acute on Chronic Liver Failure, Platelet
Keywords: Thrombelastography,acute on chronic liver failure, platelet
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HBV-related chronic liver disease, International Normalized Ratio (INR)≥1.5 and total bilirubin≥85μmol/L

Brief summary: Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels between plasma components and cellular component of coagulation. And through the platelet mapping, it can help provide a picture of patients' function of platelet. This study aims to explore the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.


Eligibility criteria: Inclusion Criteria:

* patient with previously diagnosed or undiagnosed HBV related chronic liver disease/cirrhosis
* INR≥1.5 and total bilirubin≥85μmol/L

Exclusion Criteria:

* INR≤1.5 or total bilirubin≤85μmol/L;
* underlying chronic liver disease was other than chronic HBV infection related;
* those who had hepatocellular carcinoma or other types of malignancies;
* obstructive biliary diseases or other disease lead to bilirubin evaluation;
* those who had acute hemorrhage one week before admission
* those who received platelet, cryo transfusion or plasmapheresis one week before admission
* using steroid or immunosuppressant or antiplatelet or anticoagulant drugs in 4 weeks
* any kind of decompensation which persisted over a month
* pregnancy and breastfeeding
* those who received liver transplantation or kidney transplantation;
* combine with other disease lead to organ failure including heart failure (NYHA IV),respiratory failure（PaO2\<60mmHg),renal insufficiency(CKD 5) and conscious disturbance (GCS\<8)
* readmission;
* death within 24 hours.

Primary outcomes:
measure: 28-day mortality
timeFrame: 28-day
Secondary outcomes:
measure: 28-day progression
timeFrame: 28-day
measure: 90-day mortality
timeFrame: 90-day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References: