louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04521933: Reliability of Subjective Assessment of the Heart by Cardiac Point-of-Care Ultrasound
Official title: Reliability of Subjective Qualitative Assessment of the Heart by Cardiac Point-of-Care Ultrasound in Comparison With Conventional Transthoracic Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transthoracic Echocardiography
Lead sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
Sponsor class: OTHER
Collaborators: name: Masaryk Hospital Usti nad Labem
First posted: 2020-08-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians with at least basic knowledge of cardiac Point-of-Care ultrasound.

Brief summary: The purpose of this study is to evaluate reliability of subjective qualitative assessment of the basic cardiac parameters by Point-pf-Care ultrasound.

Detailed description: Subjective qualitative assessment of ventricular function, diameter of the right ventricle and the size of inferior caval vein using cardiac Point-of-Care ultrasound is commonly performed by intensivists and emergency medicine physicians during the management of the patients with shock and/or acute respiratory failure. However, very little data is available to define the reliability of this qualitative examination. The presented study aims to assess this reliability.

Physicians meeting inclusion and exclusion criteria will be sent by a questionnaire consisting of 19 ultrasound cases. Participants will be asked to perform qualitative evaluation of ultrasound findings of each case. Then, the results will be compared with quantitative measurements made by conventional transthoracic echocardiography and validity testing will be performed.

Eligibility criteria: Inclusion Criteria:

* physician with at least basic knowledge of cardiac Point-of-Care ultrasound who agrees to complete the questionnaire

Exclusion Criteria:

* not meet the inclusion criteria

Primary outcomes:
measure: Reliability of subjective qualitative assessment of the heart by Point-of-Care ultrasound in comparison with conventional transthoracic echocardiography
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Usti nad Labem
country: Czechia
facility: Masaryk Hospital Usti nad Labem
Study officials:
affiliation: Masaryk Hospital Usti nad Labem
name: Roman Skulec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.
Clinical trial NCT03566433: Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
Official title: Early Postoperative Pain After Totally Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Hernia
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: North Karelia Central Hospital
name: Mikkeli Central Hospital
name: Päijänne Tavastia Central Hospital
First posted: 2018-06-25
Enrollment: 200
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: Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.

Detailed description: Patient characteristics are recorded before surgery. The adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical complications and use of pain killers are carefully recorded. Clinical examination is performed if necessary.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of symptomatic inguinal hernia Age 18-80

Exclusion Criteria:

Large scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3

Primary outcomes:
measure: Pain scores (0-100) after surgery
timeFrame: from day 1 to 1 month postoperatively
Secondary outcomes:
measure: Number of operative complications
timeFrame: from day 1 to 1 month postoperatively
measure: Number of re-operations
timeFrame: 1 month after the operation
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Hannu Paajanen, Prof
role: STUDY_DIRECTOR
References:
citation: Matikainen M, Vironen JH, Silvasti S, Ilves I, Kossi J, Kivivuori A, Paajanen H. A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia. Br J Surg. 2021 Dec 1;108(12):1433-1437. doi: 10.1093/bjs/znab354.
Clinical trial NCT02274233: Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia
Official title: Multicenter, Open-label, Dose-escalation Study of SP-420 in Subjects With Transfusion-dependent β-Thalassemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Iron Overload
Beta-Thalassemia
Keywords: Chelation
Iron Overload
Thalassemia
Transfusion
Iron Chelation
Lead sponsor: Sideris Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and amount of the study drug in the blood after increasing doses of SP-420. The study will be conducted in patients with β-thalassemia.


Eligibility criteria: Inclusion Criteria:

* Subject has iron-overload secondary to β-thalassemia requiring chronic red blood cell transfusions and iron chelation therapy
* Subject weighs ≥35 kg
* Subject is willing to discontinue current iron chelation therapy at least 7 days prior to the first dose of SP-420 and for the duration of the study
* Serum ferritin ≥700 ng/mL and iron saturation ≥70% within 3 weeks before Baseline (Day 1)
* Cardiac T2\* score \>20 msec within 6 months before Baseline (Day 1)
* Willing to use contraception during the study

Exclusion Criteria:

* Pregnant or breast-feeding
* Serum creatinine greater than the upper limit of normal
* Platelet count \<100 × 10\^9/L
* Use of another investigational drug within the last 30 days
* Significant cardiac, renal, hepatic dysfunction or other clinically significant conditions that, in the opinion of the Investigator, would exclude the subject

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 35 days
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of SP-420
timeFrame: Day 7
measure: Area under the plasma concentration versus time curve (AUC) of SP-420
timeFrame: Day 7
Other outcomes:
Locations:
city: Boston
country: United States
facility: Sideris Investigative Site
state: Massachusetts
city: New York
country: United States
facility: Sideris Investigative Site
state: New York
city: Philadelphia
country: United States
facility: Sideris Investigative Site
state: Pennsylvania
city: Toronto
country: Canada
facility: Sideris Investigative Site
state: Ontario
city: Beirut
country: Lebanon
facility: Sideris Investigative Site
city: Bangkok
country: Thailand
facility: Sideris Investigative Site
city: Izmir
country: Turkey
facility: Sideris Investigative Site
Study officials:
affiliation: Sideris Pharmaceuticals, Inc.
name: Sideris Pharmaceuticals, Inc. Sideris Pharmaceuticals, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04043533: The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women
Official title: The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled trial with a prospective pretest-posttest experimental design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: This study aims to identify the effectiveness of an exercise program in reducing the severity of postnatal depression in women who had a spontaneous vaginal delivery.

Methods: This randomized control trial was conducted with 65 postpartum women residing in a city located in the south-eastern Turkey. In the first postpartum month, following random assignment of subjects, the experimental group (n=40) performed exercises for four weeks, and the control group (n=40) received standard cares. The participating women were administered the Edinburgh Postpartum Depression Scale.

Detailed description: Postpartum depression is characterized by irritability, guilt, burnout, anxiety, sleep disorders, and somatic symptoms that could have negative effects on the mother, baby, and family.

In a meta-analysis study including 219 prevalence studies from 56 countries that investigated different phases of postpartum using various data collection tools, Hahn-Holbrook et al. (2018) found the depression prevalence at the global level as 17.7% (Hahn-Holbrook, 2018). In Turkey, 23.8% of women in the postpartum period were reported to be suffering from postpartum depression, which underlines the need for health professionals to be concerned about the health of the women in the postpartum period.

Exercises done in the postpartum period are reported to enable psychosocial well-being, less anxiety and depression, better cardiovascular adaptation, body fat/weight control, less bone loss caused by lactation, and less stress incontinence. Studies have generally indicated the importance of regular exercise in the postpartum period. Studies have generally indicated the importance of regular exercise in the postpartum period.

Eligibility criteria: Inclusion Criteria:

1. must be score of 13 and over in the Edinburgh Postpartum Depression Scale (EPDS),
2. must being between 19 and 40 years old,
3. must had a spontaneous vaginal delivery between the 38th and 42nd weeks of pregnancy,
4. must had a healthy newborn baby with 2500 gr and over

Exclusion Criteria:

1. postpartum obstetric complications
2. psychiatric disease history before or during pregnancy

Primary outcomes:
measure: Effect of exercise
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Adi̇yaman
country: Turkey
facility: Didem Şimşek Küçükkelepçe
Study officials:
References:
Clinical trial NCT00745433: Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide
Official title: REPAMET 2: Observational Study of the Switch From Metformin Monotherapy to Bitherapy With Metformin and Repaglinide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 906
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject with type 2 diabetes treated with metformin

Brief summary: This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Metformin monotreatment
* HbA1c greater than 7%
* Treatment according to SPC
* Informed consent obtained

Exclusion Criteria:

* Any contraindication to the use of repaglinide (according to the SPC)

Primary outcomes:
measure: HbA1c
timeFrame: After 12-20 weeks.
Secondary outcomes:
measure: PPG
timeFrame: After 12-20 weeks.
measure: Number of hypoglycemic events
timeFrame: After 12-20 weeks.
measure: Variability in FPG (Fasting Plasma Glucose)
timeFrame: After 12-20 weeks.
Other outcomes:
Locations:
city: Brussels
country: Belgium
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05649033: Work-related Stress Among Recently Graduated Midwives Practicing in the Delivery Room
Official title: Work-related Stress Among Recently Graduated Midwives Practicing in the Delivery Room
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recently Graduated Midwives Practicing in the Delivery Room
Keywords: midwives
Work-related stress
delivery room
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Midwives graduated for less than three years practicing in the delivery room

Brief summary: Work stress results from an imbalance between the worker's hopes and work's conditions.

Midwifes are exposed to emergency situations (newborn distress, neonatal resuscitation, foetal abnormal heart rythm, delivery hemorrhage, ...), which can cause stress and sometimes lead to burnout.

Detailed description: the aim of the study is to describe Work-related stress among recently graduated midwives practicing in the delivery room

Eligibility criteria: Inclusion Criteria:

* Midwives graduated for less than three years in France
* Practicing in the delivery room
* Whatever the duration of exercise in the delivery room
* Agreeing to participate in the study

Exclusion Criteria:

* No Agreeing to participate in the study

Primary outcomes:
measure: Work-related stress
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne Ardenne
Study officials:
affiliation: Université de Reims Champagne-Ardenne
name: Le Tarnec Louise Anne, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507933: Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children
Official title: Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children in a Retrospective Case Series
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Synovitis
Keywords: villo-nodular synovitis
Hip
Surgery
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 6
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children operated for villo-nodular synovitis of the hip

Brief summary: Villo-nodular synovitis can affect the joints, bursae or tendon sheaths. This condition is rare, with 1.8 cases per million inhabitants. The hip is affected in 3.6 to 18.1% of cases. The age of predilection is between 30 and 50 years old and this condition is rarely described in children.

Two articles report a case of villous-nodular synovitis of the child's hip. Surgical treatment by resection seems to be consensus but various adjuvant treatments are also proposed. A case of villous-nodular synovitis of the hip in children was treated without surgical intervention. The main objective of this study was to evaluate the efficacy of surgical treatment of villous nodular synovitis of the hip in children.

Detailed description: French multicentric cases serie

Eligibility criteria: Inclusion Criteria:

* Children with histologically villo-nodular synovitis of the hip
* Surgical procedures performed for the treatment of this synovitis

Exclusion Criteria:

* Degree of bone maturation and Risser test greater than 4 at the time of diagnosis
* Parents opposing the use of their child's data / Patient opposing the use of his/her data

Primary outcomes:
measure: Change from baseline in the range of motion of the hip in degrees
timeFrame: before surgery and 4 months after surgery
measure: Incidence of signal changes in the X-Ray
timeFrame: 4 months after surgery
measure: Incidence of signal changes in the MRI
timeFrame: 4 months after surgery
Secondary outcomes:
measure: Change from baseline in the scale measure of patient's pain intensity
timeFrame: before surgery and 4 months after surgery
measure: Incidence of complications after surgery
timeFrame: 4 month after surgery
measure: Number of additional treatments used in addition to surgery
timeFrame: 4 month after surgery
measure: Change from baseline in the physical activity evaluated by a questionnaire
timeFrame: before surgery and 4 months after surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille Catholic University
Study officials:
affiliation: Lille Catholic University
name: Raphael Coursier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04086433: Gastric Tissue Stapler Comparison Study
Official title: Gastric Tissue Stapler Comparison Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Resection
Lead sponsor: Standard Bariatrics
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects undergoing Laparoscopic Sleeve Gastrectomy

Brief summary: This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan").

The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.


Eligibility criteria: Inclusion Criteria:

1. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80

Exclusion Criteria:

1. Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)
2. Gastric lesion recognized during surgery (entire specimen would be sent to pathology)
3. Stomach damaged during extraction

Primary outcomes:
measure: Pressure Evaluation
timeFrame: immediately post operative
measure: Staple Malformation
timeFrame: through study completion, anticipate within 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Aaron B Hoffman, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03260933: Integrated Care for Frail Older People
Official title: A Qualitative Study to Investigate Patients', Carers' and Providers' Perspectives on Integrated Care and Integrated Care Pathways for Frail Older People in Lambeth and Southwark, South London
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly Syndrome
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Frail older people, their carers and a range of providers.

Brief summary: This is a qualitative interview study investigating patients', carers' and providers' perspectives on integrated care and integrated care pathways for frail older people in Lambeth and Southwark, south London.


Eligibility criteria: Inclusion Criteria:

1. Frail older people aged 65 years and over, including men and women with different levels of frailty.
2. Carers (family member, friend or neighbor) identified by the frail older participant as a main carer.
3. Health and social care professionals, care workers, service managers and commissioners working in different parts of the local health and care system (primary, secondary, community, social and voluntary care), reflecting a range of roles.

Exclusion Criteria:

1. Older people not identified as frail.
2. Frail older people who are unable to provide their informed consent to take part in the study, for example due to significant cognitive impairment.

Primary outcomes:
measure: Stakeholders perspectives as assessed by interview survey
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Dr Euan Sadler
Study officials:
References: