louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06870604: Comparison of Laparoscopic Surgery and Open Surgery for Repair of Gastric Perforation
Official title: Comparison of Laparoscopic Surgery and Open Surgery for Repair of Gastric Perforation: a Multicenter, Propensity Score-matched Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Perforation
Keywords: gastric perforation
laparoscopic surgery
open surgery
PSM
overall complications
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 827
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with gastric perforation

Brief summary: Gastric perforation (GP) is a penetrating lesion of the gastric wall that accounts for 10-15% of all peptic ulcer perforations, and most GP are spontaneous perforations caused by ulcer disease. Due to the presence of gastric acid, most patients often present to the emergency department with severe abdominal or chest pain due to chemical peritonitis within a few hours of perforation. Emergency physicians often quickly diagnose GP by using a chest x-ray or CT in an upright position and the patient's symptoms. Studies have shown that about 80-85% of patients with GP had subphrenic free gas visible on x-ray in the upright position.

Surgery is currently the mainstay of treatment for most GP, and almost all cases require urgent surgical repair.2 Over the past few years, laparoscopic surgery has become increasingly popular in clinical practice due to its advantages of less pain, less scarring, and early mobility out of bed, and has become the standard treatment for many elective and emergency procedures.

Since the laparoscopic study of PPU was first published by Mouret P in 1990, investigators have launched extensive discussions on the effects of laparoscopic surgery and open surgery in patients with perforated ulcers. However, to our knowledge, there are few separate discussions on GP, and the postoperative prognosis of laparoscopic surgery for patients with GP is less clear. Therefore, the aim of this multicenter, large-scale retrospective study was to compare the clinical outcomes of laparoscopic surgery and open surgery in patients with GP, to investigate whether laparoscopic surgery is safe and feasible for patients with GP, and to provide reliable evidence for surgical strategies in patients with GP.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years;
* patients diagnosed with gastric perforation.

Exclusion Criteria:

* patients with incomplete clinical data;
* laparoscopic surgery transfer to open surgery.

Primary outcomes:
measure: overall survival
timeFrame: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03451604: PAC Time Assessment
Official title: Time Involved in Patient Information During Preoperative Assessment Clinic and Ratio Between Evaluation and Information Times
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Assessment Time
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 3000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo elective surgery under general or regional anaesthesia

Brief summary: The aim of the preoperative assessment clinic (PAC) is to ensure optimal anaesthesia, reduce the morbidity associated with surgery, to increase the quality and decrease the cost of perioperative care 1. In addition, the PAC is an appropriate time to educate the patient on anaesthesia, perioperative care, and pain treatments, to reduce anxiety, to develop care plans, and to obtain informed consent. Moreover, a strong correlation exists between the time spent at the PAC and patient satisfaction2,3.

A high variability of preoperative assessment clinic (PAC) times is a reason for waiting time for patient. A better match between the reserved PAC time and the real consultation time could improved efficiency in consultation theatre. The PAC time depends on various parameters. On average the preoperative assessment of patients with a higher American Society Anesthesiologists' (ASA) class requires more time 4. In other monocentric study, the mean (SD) procedure time was 13 (6) min for the physician. It was significantly longer for patients with a higher ASA class : 10 min for ASA I, 14 min for ASA II, 17 min for ASA III and 21 min for ASA IV patients. In this monocentric study, every patient had a nurse consultation before PAC by the anesthesiologist.

The primary endpoint of this study was to assess the time involved in preoperative assessment clinic included the time during patient's health status has to be assessed (this encompasses a medical history and physical examination) and the time during the patient education on anaesthesia, perioperative care and pain treatments, to reduce anxiety, to develop care plans and to obtain informed consent.


Eligibility criteria: Inclusion Criteria:

- Patients scheduled to undergo elective surgery under general or regional anaesthesia

Exclusion Criteria

* patients under 16 years of age
* emergency surgery

Primary outcomes:
measure: total time involved in preoperative anesthesia consultation (min)
timeFrame: 30 min
Secondary outcomes:
measure: anesthesia and surgery information and patient demographics
timeFrame: 30 min
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
Clinical trial NCT06466304: Inspiratory Muscle Training in Children With Beta Thalasemia
Official title: Inspiratory Muscle Training in Children With Beta Thalasemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Beta Thalassemia Major
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: respiratory complications are very prevalent in children with beta thalasemia major (BTM), so choosing inspiratory muscle trianing to decrease of prevent it and to improve pulmoanry funntions is important

Detailed description: children patients with BTM accounted 40 children will assigned to a group of inspiratory muscle training or waiting list group. the group will contain twenty children. the group of training will receive two session per day of training by threshold inspiratory muscle trainer ( for six day per week for 12 weeks)

Eligibility criteria: Inclusion Criteria:

* 40 beta thalassemia major children
* boys and girls

Exclusion Criteria:

* respiratory diseases
* cardiac diseases renal diseases liver diseases muscle and joint disease

Primary outcomes:
measure: forced expiratory volume t the first second of expiration
timeFrame: it will be assessed after 12 weeks
Secondary outcomes:
measure: forced vital capcity
timeFrame: it will be assessed after 12 weeks
measure: FEV1/FVC
timeFrame: it will be assessed after 12 weeks
measure: maximal inspiratory pressure
timeFrame: it will be assessed after 12 weeks
measure: six minute walk testing
timeFrame: it will be assessed after 12 weeks
measure: Pediatrics' Quality of Life Inventory (children proxy)
timeFrame: it will be assessed after 12 weeks
measure: Pediatrics' Quality of Life Inventory (parent proxy)
timeFrame: it will be assessed after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahram canadian university
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt
name: hagar el-hadidy, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00305604: Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)
Official title: A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-03-22
Enrollment: 206
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.


Eligibility criteria: Inclusion Criteria:

* Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise
* Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit

Exclusion Criteria:

* Patients with type 1 diabetes
* History of ketoacidosis or requires insulin use
* Alanine aminotransferase / aspartate aminotransferase \> 2.5 X ULN, triglycerides \> 600 mg/dL, creatinine clearance \< 35 mL/min
* Fasting plasma glucose consistently \> 260 mg/dL
* Poorly controlled hypertension

Primary outcomes:
measure: Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24
timeFrame: Baseline and Week 24
measure: Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week
timeFrame: Week 1
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Barzilai N, Guo H, Mahoney EM, Caporossi S, Golm GT, Langdon RB, Williams-Herman D, Kaufman KD, Amatruda JM, Goldstein BJ, Steinberg H. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011 May;27(5):1049-58. doi: 10.1185/03007995.2011.568059. Epub 2011 Mar 23.
Clinical trial NCT05145504: Evaluation of IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During PTA
Official title: Evaluation of Biomarker IL-6 in Synovial Fluid in Obese and Normal Weight Patients Suffering From Gonarthrosis During Knee Arthroplasty Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IL-6 Concentration in the Synovial Fluid of Obese Patients is 100% Higher Than the IL-6 Concentration of the Synovial Fluid in Normal Weight Patients
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 37
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is made up of obese and normal weight patients, of age, undergoing knee replacement surgery for gonarthrosis

Brief summary: Evaluate the concentration of IL-6 in the synovial fluid of obese patients suffering from gonarthrosis during knee arthroplasty surgery


Eligibility criteria: Inclusion Criteria:

* age between 55 and 85 years inclusive,
* Normal weight patients with BMI 18-24.9 included
* Obese patients with BMI ≥ 30
* Patients suffering from gonarthrosis awaiting knee arthroplasty surgery
* Patients awaiting knee replacement surgery
* Patients who agree to sign informed consent

Exclusion Criteria:

* Patients under 55 years of age.
* Patients over 85 years of age
* Patients suffering from diabetes mellitus
* Patients who are unable to understand
* Patients with severe neurological disorders or severe disability
* Rheumatoid arthritis patients
* Cancer patients
* Patients on immunosuppressive therapy

Primary outcomes:
measure: Evaluate whether the IL-6 concentration in the synovial fluid of obese patients is 100% higher than the IL-6 concentration of the synovial fluid in normal weight patients
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References:
Clinical trial NCT04474704: Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia
Official title: Use of Cheetah® Non-invasive Cardiac Monitoring System to Guide Discontinuation of Postpartum Magnesium Sulfate in Women With Severe Preeclampsia: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia With Severe Features
Keywords: preeclampsia with severe features
magnesium sulfate
Systemic Vascular Resistance
non-invasive cardiac monitoring
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a single site pilot randomized, controlled, trial randomizing patients with PE with severe features to one of 2 groups:

* 24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
* Using the Cheetah® device to aid in an individualized duration of magnesium sulfate.


Eligibility criteria: Inclusion Criteria:

* Preeclampsia with severe features, diagnosed using the American Congress of Obstetricians and Gynecologists (ACOG) standard criteria 4 requiring magnesium sulfate
* Females older than 18 years of age
* Singleton pregnancy
* Gestational age greater than 24 0/7 weeks
* The patient is physically and mentally able to understand the informed consent and is willing to participate in this study
* Able to speak English or Spanish

Exclusion Criteria:

* Multiple gestation
* Prisoners
* Patients with chronic renal insufficiency or epilepsy
* Known cardiovascular disease
* Patients with contraindications to magnesium sulfate use (e.g. myasthenia gravis)
* Patients with eclampsia or HELLP syndrome
* Contraindications for magnesium sulfate

Primary outcomes:
measure: Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.
timeFrame: up to 24 hours postpartum
Secondary outcomes:
measure: Composite of Postpartum Adverse Outcomes
timeFrame: up to 4 weeks after delivery
measure: Evaluating Incidence of Need to Restart Magnesium Sulfate
timeFrame: up to 1 week postpartum
measure: Evaluating Number of Participants With Hospital Readmission for Preeclampsia
timeFrame: up to 4 weeks postpartum
measure: Use of Acute Anti-hypertensive Medications
timeFrame: Up to 5 days after delivery
measure: Need for More Than 1 Dose of Anti-hypertensive Medication
timeFrame: Up to 5 days after delivery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
affiliation: Ohio State University
name: Maged Costantine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06471504: Use of Eye Tracking to Aid in Autism Risk Detection
Official title: Use of Eye Tracking to Aid in Autism Risk Detection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.

Detailed description: The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children ages 12-48 months. We will recruit children from Riley Hospital for Children at Indiana University Health clinics to determine whether these measures may help determine autism risk.

Eligibility criteria: Inclusion Criteria:

* Young children ages 12-48 months scheduled for health care visits at Riley Hospital for Children at Indiana University Health clinics (e.g., Pediatric Care Center clinics).
* Children must have English- or Spanish-speaking caregivers.
* Children must have a legal guardian that is able to provide consent.

Exclusion Criteria:

* Child is younger than 12 months or older than 48 months.
* Child's caregiver(s) is not English- or Spanish-speaking.

Primary outcomes:
measure: Agreement between eye-tracking biomarker score and diagnosis
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: IU School of Medicine
name: Rebecca R McNally Keehn, PhD, HSPP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456404: Effect of Peppermint Water on Breast Crack
Official title: Effect of Peppermint Water on Prevention of Nipple Crack in Lactating Primiparous Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Diseases
Keywords: peppermint water
nipple crack
lactating women
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 196
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effectiveness of a topical preparation of peppermint water in comparison with that of expressed breast milk for the prevention of nipple cracks in primiparous breastfeeding women.

Detailed description: One hundred and ninety-six primipara participants, who are breastfeeding after delivery at 38 or more week gestation, were assigned randomly to 2 groups, with one of 2 regimens (peppermint water, an old household remedy, and no treatment only using breast milk) to right and left sides. Each group was followed for a maximum of 3 visits within 14 days and until the 6 weeks postpartum by telephone call. The aerial parts of Mentha piperita were purchased from Hakim Momen Tabrizi Company, and the identity was confirmed by morphological characterization in comparison with the herbarium specimen retained in the School of Pharmacy, Tabriz University of Medical Sciences. Also, a voucher specimen has been generated in that herbarium.

Eligibility criteria: Inclusion Criteria:

* New mothers with healthy term infants (38 weeks gestation or more) are eligible for recruitment into the study. The sample of breastfeeding mothers were collected in two cohorts according delivery type. Each group consisted of 98 primipara mothers.

Exclusion Criteria:

* Mothers who didn't plan to use peppermint water
* Discharged before an interview or had preterm delivery
* Postpartum fever
* Breast infection
* Nipple abnormalities
* Age less than 18 years
* Twins
* Taking medications at night
* Mothers who didn't have telephone line, and who were illiterate.
* Infants who used bottle-feeding or pacifier, or who had mouth infection, or an abnormal short frenulum.

Primary outcomes:
measure: The primary outcome that the study was designed to evaluate: the presence and severity of sore nipples, nipple pain.
measure: The time at which the outcome is measured: nipple and areola cracks, and pain at days 4, 8, 14.
Secondary outcomes:
measure: The frequency and duration of breastfeeding at days 4, 8, 14 and the number of mothers who continued feeding at week 6 was used as the secondary outcome
Other outcomes:
Locations:
Study officials:
affiliation: Tabriz University of Medical Sciences
name: Manizheh Sayyah Melli, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02825004: Recognizing and Preventing Burnout
Official title: Recognizing and Preventing Burnout: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professionals
Keywords: Burnout
Health Care Workers
Coping Skills
Clinical Trial
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prevent burnout and offer the hospital staff a space for processing the emotional experiences.


Eligibility criteria: Inclusion Criteria:

* Doctors, physiotherapists, nurses and care workers
* Be a Professional Worker at the Rehabilitation Respiratory Unit
* Age \> 18 years old

Exclusion Criteria:

* Refusal at the Informed Consent

Primary outcomes:
measure: Changes in burnout, as assessed by the Maslach Burnout Inventory (MBI) (Maslach C., 1981) between baseline (T0), 6 months (T1) and 12 months (T2)
timeFrame: At the baseline (T0), 6 months (T1) and 12 months (T2)
Secondary outcomes:
measure: Changes in coping strategies as assessed by the Coping Orientation to Problems Experienced (COPE) (Carver et al., 1989) between baseline (T0), 6 months (T1) and 12 months (T2)
timeFrame: At the baseline (T0), 6 months (T1) and 12 months (T2)
measure: Changes in psychological symptoms as assessed by the Symptom Checklist-90-R (Prunas et al., 2012) between baseline (T0), 6 months (T1) and 12 months (T2)
timeFrame: At the baseline (T0), 6 months (T1) and 12 months (T2)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Paolo Banfi
Study officials:
References:
citation: Prunas A, Sarno I, Preti E, Madeddu F, Perugini M. Psychometric properties of the Italian version of the SCL-90-R: a study on a large community sample. Eur Psychiatry. 2012 Nov;27(8):591-7. doi: 10.1016/j.eurpsy.2010.12.006. Epub 2011 Feb 21.
citation: Kleijweg JH, Verbraak MJ, Van Dijk MK. The clinical utility of the Maslach Burnout Inventory in a clinical population. Psychol Assess. 2013 Jun;25(2):435-41. doi: 10.1037/a0031334. Epub 2013 Jan 28.
citation: Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.