louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06684080: The Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery
Official title: A Cluster Randomized Trial on the Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery (Re-Team)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Delivery
Keywords: Postpartum Hemorrhage
cesarean delivery
Randomized trial
Detection
treatment
Lead sponsor: The Third Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 52000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delays in the detection or inconsistent use of effective interventions of postpartum hemorrhage can result in complications or death. We designed a cluster-randomized trial to assess a multi-component strategy for the detection and treatment of postpartum hemorrhage after cesarean delivery.


Eligibility criteria: Inclusion Criteria:

* Hospital level

  1. Public hospitals
  2. There are more than 100 cesarean deliveries per year
* Patient level

  1. Cesarean delivery
  2. Sign informed consent

Exclusion Criteria:

* Hospital level

  1. Data verification information cannot be provided
* Pregnant woman level 1. No blood routine results within 2 weeks before surgery

Primary outcomes:
measure: Incidence of PPH
timeFrame: Day 2
Secondary outcomes:
measure: mean total calculated blood loss
timeFrame: Day 2
measure: Estimated blood loss
timeFrame: postpartum 24 hours
measure: Incidence of postpartum transfusion
timeFrame: baseline
measure: Incidence of additional operations performed outside cesarean section
timeFrame: baseline
measure: Incidence of transfer to intensive care unit
timeFrame: baseline
measure: Incidence of maternal death from any cause
timeFrame: Up to 42 days
measure: The adherence to the treatment bundle
timeFrame: intraoperation and postpartum 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05233280: Early Versus Delayed Oral Liquids and Soft Food After Elective Ceasarean Section
Official title: Early Versus Delayed Oral Liquids and Soft Food After Elective Ceasarean Section
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prevent Postopertive Nausea and Vomiting
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in child bearing period

Brief summary: To compare the safety of early versus delayed oral feeding after uncomplicated cesarean section under spinal anesthesia

Detailed description: Cesarean section is one of most common surgical procedures saving both for mother and newborn when medically indicated .traditionally patients are not given fluids or food afer abdominal surgery until bowel function return as evidenced by bowel sounds passage of flatus or stool or feeling of hunger the rationale of this practice is to prevent postoperative nausea , vomiting, distension and other complications

Eligibility criteria: Inclusion Criteria:

* previous 1,2,3 cs Uncomplicated elective cs Singletone pregnancy Spinal anesthesia

Exclusion Criteria:

* women with medical disorder HTN, DM History of bowel surgery or intraoprative complication Contraindication to spinal anesthesia

Primary outcomes:
measure: Time of passage of flatus
timeFrame: 6 hrs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03528980: Impact of Weight Loss Induced by Bariatric Surgery or Nutritional Management on Sexual Function in Men With Severe Obesity
Official title: Comparing the Impact of Weight Loss Induced by Bariatric Surgery or Through a Standard Nutritional Management on Sexual Function and Sperm Quality in Men With Severe Obesity - Multicenter, Prospective
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Bariatric Surgery Candidate
Keywords: fertility
bariatric surgery
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2018-05-18
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with morbid obesity,

Brief summary: Study of the impact of weight loss induced by surgery (interventional group) or optimal nutritional management (control group) on sexual function in men with severe obesity


Eligibility criteria: Inclusion Criteria:

* Severe obesity with BMI\> 25 kg / m2

Exclusion Criteria:

* Patient having undergone sterilization

Primary outcomes:
measure: Improvement of sexual function assessed by International Index for Erectile Dysfunction (IIED)
timeFrame: at 1 year
Secondary outcomes:
measure: Percentage of patients with normal sexual function (IIED> 25) with and without surgery.
timeFrame: ay 1 year
measure: Change the spermatic parameters before and after weight loss in both groups
timeFrame: at 1 year and 2 years
measure: Change the serum profile of sex hormones before and after weight loss in both groups a
timeFrame: at 1 year
measure: Correlate the spermatic profile to the different nutritional deficiencies high lighted after the bariatric surgery
timeFrame: at 1 year
Other outcomes:
Locations:
city: Caen
country: France
facility: Chu de Caen Normandie
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
city: Rouen
country: France
facility: Chu Rouen
Study officials:
affiliation: University Hospital, Lille
name: Robert Caiazzo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00234780: In Home Hospital Care Program
Official title: In Home Hospital Care Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Acute Problems
Keywords: acute home care
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2005-10-07
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the hypothesis that In Home Hospital Care (IHHC) is as safe and effective, less burdensome to families, and less expensive for care of common acute pediatric problems now managed with hospitalization.

Detailed description: A randomized trial compared health care systems with and without IHHC. Eligible children presented to the Emergency Department of our medical center, had common acute problems, and were considered for hospital admission.

Physicians decided disposition from the emergency department. Note that subjects were not randomized directly to IHHC but to a system of care that either included IHHC or did not. To allow best use of scarce home nursing resources, we used a disproportionate selection favoring the system with IHHC.

Quality measures included adverse events, parent anxiety and satisfaction with care, family disruption, and perceived child health.

Eligibility criteria: Inclusion Criteria:

Randomized from acute care clients presenting in Emergency Department to IHHC

Exclusion Criteria:

Randomized from acute care clients presenting in Emergency Department to inpatient hospital care.

Primary outcomes:
measure: IHHC delivers a more valuable service at lower cost.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kenneth M. McConnochie, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01074580: Contrast Enhanced Ultrasonography (CEUS) of Patients With Crohn's Disease
Official title: High Frequency Ultrasound and Contrast Enhanced Ultrasound of Patients Treated for Deterioration of Crohn's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn's Disease
Keywords: Crohn's disease
sonography
contrast enhanced ultrasound
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Abbott
First posted: 2010-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for deterioration of Crohn's disease either in the out patient clinic or the medical ward of Haukeland University Hospital.

Brief summary: The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.


Eligibility criteria: Inclusion Criteria:

* Deterioration of Crohn's disease
* CDAI\>150
* Treated with systemic steroids or TNF alfa inhibitors
* Lesion found on ultrasound

Exclusion Criteria:

* Disease location not reachable with ileocolonoscopy
* Pregnancy
* Acute coronary disease
* Unstable coronary disease
* Previous allergic reaction to SonoVue or its components

Primary outcomes:
measure: Remission defined by Crohns disease activity index (CDAI)<150
timeFrame: 52 weeks from inclusion
Secondary outcomes:
measure: Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.)
timeFrame: 52 weeks
measure: Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Medicine, Haukeland University Hospital
state: Hordaland
Study officials:
affiliation: Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway
name: Trygve Hausken, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01221480: What Influences Patient Outcome in Obstructive Airway Disease?
Official title: Beta-Blockers Reduce Mortality and Exacerbations When Added to Stepwise Inhaled Therapy for COPD Without Adverse Effects on Lung Function.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 5977
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients within NHS Tayside, UK

Brief summary: The aim of this observational study is to utilise the established record linkage data available in Tayside to investigate hospital admissions, exacerbations and mortality in COPD.


Eligibility criteria: Inclusion Criteria:

* Data collected through TARDIS database

Exclusion Criteria:

* History of asthma or malignancy. Less than 50 years of age

Primary outcomes:
measure: All-cause Mortality
timeFrame: 3000 days
Secondary outcomes:
measure: Hospital Admissions
timeFrame: 3000 days
measure: COPD exacerbations
timeFrame: 3000 days
Other outcomes:
Locations:
Study officials:
References:
citation: Short PM, Lipworth SI, Elder DH, Schembri S, Lipworth BJ. Effect of beta blockers in treatment of chronic obstructive pulmonary disease: a retrospective cohort study. BMJ. 2011 May 10;342:d2549. doi: 10.1136/bmj.d2549.
Clinical trial NCT04623580: Flemish Inguinal and Femoral Hernia Prospective Registry
Official title: Flemish Inguinal and Femoral Hernia Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inguinal Hernia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: INGUINAL HERNIA PATIENTS

Brief summary: Prospective registry. The purpose of this clinical trial will be to measure surgical outcome parameters (e.g. recurrence, chronic pain and other quality indicators) after inguinal hernia repair using Patient Reported Outcome Measures (PROMs) in the short- and long-term.

Detailed description: The primary objective is to investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities.

The secondary objectives are:

* Surgical Site Occurrence (SSO) after 30 days
* Scope and incidence of pre- and postoperative pain (NRS 0 to 10)
* The difference between pre- and postoperative NRS scores (relative NRS score)
* Presence of pain and impact of pain on daily life activities
* Satisfaction and quality of life
* Sexual function
* Anxiety and depression
* Catastrophizing
* Recurrence
* Development of a predictive model for chronic pain.

Eligibility criteria: Inclusion criteria

* Consecutively all patients with a groin hernia (inguinal and/or femoral hernia) operated starting 01.01.2018.
* Male and female
* 18 years or older
* Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of a hospital, but by specific surgeons)
* Elective and emergency surgery
* Primary and recurrent hernia
* Metachronous and synchronous hernia
* Signed informed consent form

Exclusion criteria

* Younger than 18 years
* Not operated or supervised by participating surgeon
* Pregnant at inclusion in the registry
* No signed informed consent form

Primary outcomes:
measure: Chronic pain after inguinal hernia repair
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Leuven
country: Belgium
facility: Colette Barlé
Study officials:
References:
Clinical trial NCT04596280: Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study
Official title: Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Diverticulitis
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
Collaborators: name: San Filippo Neri General Hospital
name: Hospital San Jacopo
name: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
First posted: 2020-10-22
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Colonic Diverticulitis

Brief summary: Even though Hinchey classification requires operative intervention, yet remains the established and most universally used scoring system for acute diverticulitis. Several other classifications have been described. The American Association for the Surgery of Trauma (AAST) developed a severity scale for surgical conditions, including diverticulitis. The same was done by the World Society of Emergency Surgery, that proposed a specific classification mainly based on the CT scan findings. This is a pilot study to compare the AAST and WSES classifications for acute colonic diverticulitis with the traditional Hinchey classification. We hypothesize that all the classifications are equivalent one each other in predicting outcomes


Eligibility criteria: Inclusion Criteria:

* acute colonic diverticulitis

Exclusion Criteria:

* Other severe conditions of end-life

Primary outcomes:
measure: Need for procedural intervention (operation or percutaneous drainage)
timeFrame: 30 day
Secondary outcomes:
measure: ICU requirement
timeFrame: 30 day
measure: Overall morbidity
timeFrame: 30 day
measure: Length of stay
timeFrame: 30 day
measure: in-hospital morbidity
timeFrame: 30 day
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: AOUPisana
state: Tuscany
Study officials:
References:
Clinical trial NCT02655380: Remifentanil Requirement for Acceptable Intubating Condition
Official title: Remifentanil Requirement for Acceptable Intubating Condition With Two Dose Ketamine Without Neuromuscular Blocking Agent in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubating Condition
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 51
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ketamine and opioid are known to improve the intubating condition, respectively. Combination of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in complementary manner. Therefore, the combination use of ketamine and remifentanil could be useful for acceptable intubating condition in the general anesthesia without the use of neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2 mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine induction dose for intubation without neuromuscular blocking agent. The investigators focus on remifentanil dose using Dixon's up and down method.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Undergoing general anesthesia with endotracheal tube

Exclusion Criteria:

* Anticipated difficult airway
* Patient with upper respiratory infection within 14 days
* Asthma

Primary outcomes:
measure: acceptability of intubation condition
timeFrame: during and after intubation, about 2 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Ajou universitiy school of medicine
state: Gyeong-gi Do
Study officials:
affiliation: Ajou University School of Medicine
name: yun jeong chae, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05407480: Thereapeutic Recommendantion for Children With a Hodgkin Lymphoma
Official title: Therapeutic Recommendations for Children Registered in the RFAOP Register and With a Hodgkin Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Staging
Therapeutic Recommendations
Lead sponsor: French Africa Pediatric Oncology Group
Sponsor class: OTHER
Collaborators: name: Gustave Roussy, Cancer Campus, Grand Paris
First posted: 2022-06-07
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children arriving in one of the participating units :

under 18 years of age at diagnosis and suffering from "classical" Hodgkin's disease according to the WHO classification.

Brief summary: The GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.

Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unites who will adapt these recommendations.

Detailed description: In high-income countries, therapeutic outcomes exceed 90% and therapeutic de-escalation is necessary to reduce mainly the effects of long-term radiotherapy. Within the same country, there are also differences between the therapeutic protocols used in the different centres.

The Experience of Sub-Saharan African Units of the Franco-African Paediatric Oncology Group (GFAOP) in the treatment of pediatric Hodgkin lymphoma in 104 patients was based on chemotherapy alone. The latter was based on COPP/ABV cures without complementary irradiation adapted to the initial stratification and modulated according to the morphological response. Overall survival at 5 years was 82% at 30 months after a median decrease of 17 months.

It seemed appropriate to bring together in a single committee the representatives of the various pilot units in order to standardize the therapeutic protocols in the African countries.

So with this recommendation the GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.

- Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unit.

Eligibility criteria: Inclusion Criteria:

under 18 years of age at diagnosis

* suffering from "classical" Hodgkin's disease according to the WHO classification.
* with no history of hematological malignancies or constitutional or acquired immune deficiencies

Exclusion Criteria:

* Over 18 years of age at diagnosis
* A history of hematological malignancies or a history of constitutional or a history of acquired immune deficiencies

Primary outcomes:
measure: Patient status
timeFrame: 24 months
measure: Drugs
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Brenda Mallon
Study officials:
affiliation: French Africa Pediatric Oncology Group
name: FATEN Ben Ayed, Professeur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01755780: Effect of the Side of Interscalene Block on Bradycardia and Hypotension in Beach Chair Position
Official title: The Effect of the Side of Interscalene Block on the Occurrence of Bradycardia and Hypotension During Shoulder Surgery in the Beach Chair Position
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Surgery
Beach Chair Position
Interscalene Block
Hypotension
Bradycardia
Autonomic Nervous System
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients for elective shoulder surgery

Brief summary: The Left interscalene block has a different effect on heart's autonomic nervous system, compared to Right interscalene block. This effect is evident on the occurrence of bradycardia and hypotension during shoulder surgery in the beach chair position


Eligibility criteria: Inclusion Criteria:

* elective shoulder surgery
* Age 50- 80 years old
* ASA II - IV

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the interscalene block
* Neurological deficit on the side to be operated
* Allergy to local anesthetics
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication
* Failure of the interscalene block

Primary outcomes:
measure: Interscalene block and beach chair positioning
timeFrame: Intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Larissa University Hospital
state: Thessally
Study officials:
affiliation: Larissa University Hospital
name: Marina Simaioforidou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Larissa University Hospital
name: George Vretzakis, Medicine
role: STUDY_DIRECTOR
affiliation: Larissa University Hospital
name: Katerina Tsiaka, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: George Basdekis, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: Athanasios Drakos, Medicine
role: STUDY_CHAIR
References: