louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05273138: Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis
Official title: Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Sclerosis
Keywords: Systemic sclerosis
Fibrosis, fibroblasts.
Fibroblasts.
Immune system.
B lymphocytes.
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the University Hospital of Lille

Brief summary: The pathophysiology of systemic sclerosis (SSc) is still poorly understood and there are no effective treatments for this disease. SSc is a heterogeneous disease with varying severity. The heterogeneity of fibroblast profiles, observed in other fibrosing pathologies, has never been thoroughly explored in the skin of SSc patients. The immune system, and in particular B lymphocytes, plays a central role in the pathophysiology of SSc. The interactions between B lymphocytes and the cells responsible for excess collagen production, i.e. fibroblasts, are not fully elucidated The main objective is to analyze the heterogeneity of fibroblasts and infiltrating immune cells as well as their molecular signature in the skin of patients with SSc


Eligibility criteria: Inclusion Criteria:

* Man or woman over 18 years of age
* With a systemic sclerosis meeting the ACR-EULAR 2013 criteria Having signed an informed consent
* Being insured

Exclusion Criteria:

* Syndrome of overlap with another connective tissue disease according to the international diagnostic criteria
* Immunosuppressive treatment within 12 months
* Dosage of current corticosteroid therapy ≥10mg/d
* Protected minors or adults
* Pregnant or breastfeeding women
* Deprived of their liberty
* Persons in emergency situations
* Persons who have refused or are unable to give informed consent

Primary outcomes:
measure: Single cell RNAseq transcriptomic analysis of skin
timeFrame: At inclusion
Secondary outcomes:
measure: Single cell RNAseq transcriptomic analysis of the whole blood
timeFrame: At inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: David Launay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02513108: Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)
Official title: Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2015-07-31
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to provide information on safety of same day discharge after uncomplicated percutaneous intervention (PCI) for stable angina pectoris in Norwegian clinical practice. The investigators also think that is in patients interest to stay as short time as possible in hospital and this will be measured using standardised quality of life questionnaires.

Detailed description: The international literature has already provided documentation on the safety of same day discharge in various clinical scenario. In this particular study, the investigators focus on challenging the contemporary Norwegian practice where every body stays over night.

Only patients with stable angina pectoris will be included in the study. After informed consent and successful procedure, the patients will be randomised to same day discharge or standard care. Same day discharge patients will be contacted by telephone the day after the procedure for follow-up conversation with particular emphasis on access site complications.

Both groups will receive quality of life questionnaire within a month for assessment of difference between the two strategies.

Eligibility criteria: Inclusion Criteria:

* Elective procedures Monday through Thursday
* Patient consenting for same day discharge
* Operator has assessed the patient and is in agreement
* Adequate observational facility
* Uncomplicated procedure
* Acceptable social network at home
* Uneventful post PCI ECG
* Adequate hemostasis of puncture site

Exclusion Criteria:

* Angiographic

  * No-reflow/slow flow post PCI
  * Sub-optimal PCI result
  * Dissection type C-E
  * Rest dissection after stent deployment
  * Angiographic thrombus
  * Guidewire perforation
* Clinical

  * Advanced age
  * Severe renal failure (GFR \< 30ml/min)
  * Excessive bleeding risk
  * Symptomatic heart failure
  * Severe visual or hearing impairment
  * Multi-vessel PCI (2 main vessels or left main)
  * Use of GP IIb/IIIa inhibitors
* Social

  * Living alone or has no telephone
  * Long driving distance (\> 30-45 min)
  * Patient/next to keen can´t communicate with health personnel without a translator

Primary outcomes:
measure: number of complications (access site bleeding)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
Study officials:
affiliation: Helse Stavanger HF
name: Nigussie Bogale, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02744508: Comparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Surgery
Keywords: palonosetron, dexamethasone, PONV (postoperative nausea and vomiting)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 202
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative nausea and vomiting (PONV) is related with extended hospital day and risk factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is the most recent medication for prevention of PONV. Purpose of our study is comparison of PONV preventive effect of palonosetron and combination of palonosetron and dexamethasone.


Eligibility criteria: Inclusion Criteria:

* patients who are undergoing minor orthopedic surgery.
* IV patient controlled analgesia

Exclusion Criteria:

* 1. minority (0\~19 year)
* patients who are belongs to ASA class 3 or more, and have underlying complicated cardiovascular or psychological disease.
* Steroid medication
* Diabetes Mellitus medication

Primary outcomes:
measure: incidence of clinically significant PONV with PONV impact scale
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
Clinical trial NCT02004808: Neutrophil Extracellular Traps and Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sickle Cell Anemia
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-09
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants and children who suffer from sickle cell disease and/or Infants and children with sickle cell disease treated with hydroxyurea at the pediatric hemato-oncology department

Brief summary: NETs formation in vaso-occlusive events in sickle cell disease and the role of hydroxyurea treatment.The study hypothesis is that NETs formation by neutrophils has a role in the induction of vaso occlusive disease in blood vessels. It is possible that high leukocyte count in children with sickle cell anemia is a bad prognostic sign due to NETs formation supporting occlusion of peripheral and central blood vessels.Hydroxyurea treatment might prevent vaso occlusive syndrome not only by increasing HbF but also by decreasing neutrophil count and inhibiting NETs formation.


Eligibility criteria: Inclusion Criteria:

* children who suffer from sickle cell disease and/or children with sickle cell disease treated with hydroxyurea

Exclusion Criteria:

* none

Primary outcomes:
measure: measurements of neutrophil function
timeFrame: at first admition (day 1)
Secondary outcomes:
measure: measurements of neutrophil function
timeFrame: at sickle cell crisis while hospitalized
Other outcomes:
measure: measurements of neutrophil function
timeFrame: before and during treatment with hydroxyurea
Locations:
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Ronit Elhasid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06651008: The New Transition Factors to Surgery of Duodenal Perforation
Official title: The New Factors That Lead to Conversion Surgery in Patients with Duodenal Perforation When Initial Conservative Therapy is Not Completed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenum Ulcer Perforation
Keywords: conversion to surgery
conservative management,
Lead sponsor: Toho University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This was a retrospective study performed at our hospital between January 2012 and July 2023 with upper gastrointestinal perforation, and included 74 patients admitted to our hospital.

Brief summary: In this study,investigators sought to identify new transition factors in the initial evaluation of cases requiring conversion to surgery for duodenal ulcer perforation.

This was a retrospective study performed at investigators' hospital between January 2012 and July 2023 with upper gastrointestinal perforation. 27 patients, who underwent conservative management for the duodenal ulcer perforation, were extracted. Investigators researched the transition rate to surgery and the following factors: 1. Patient background, 2. Time from onset to hospital visit, 3. Vital signs and inflammatory findings on arrival, 4. CT findings of duodenal ulcer perforation and degree / shape of liver coverage for the perforation, and the extent of ascites.


Eligibility criteria: Inclusion Criteria:

* patients of upper gastrointestinal perforation

Exclusion Criteria:

* DNR patients

Primary outcomes:
measure: The rate of conversion to surgery from conservative management for duodenal ulcer perforation.
timeFrame: nearly within 3days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05113108: Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities
Official title: Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities in Assuit University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Abnormalities
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates undergoing CUS at nursery unit at university hospital

Brief summary: * To investigate the prevalence of cerebral abnormal findings in neonates admitted at nursery unit.{11}
* to identify the associated clinical features and to better target neonatal CUS investigations.{11}

Detailed description: Preterm birth is associated with various brain injuries. The earlier the period of gestation, more is the incidence of brain injuries. Brain injuries are known to be one of the most important factors leading to significant morbidity and mortality in these vulnerable preterm babies.{1} Cranial ultrasound (CUS) examinations have been performed on preterm infants to diagnose various perinatal brain injuries and for the prediction of long term outcomes.{2} Cranial ultrasonography (CUS) is the preferred modality to image the neonatal brain.{3} The advantages of CUS are numerous: it can be performed at the bedside with little disturbance to the infant, it is relatively safe, and can be repeated whenever needed, enabling visualization of ongoing brain maturation and the evolution of lesions.{4,5}

Eligibility criteria: Inclusion Criteria:

* All neonates suspected clinically to be suffered from brain lesions at nursery unit at assiut university hospitals

Exclusion Criteria:

* Patients above the age of 28 days

Primary outcomes:
measure: Investigate the preavalence of cerebral abnormal findings in neonates
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Maalouf EF, Duggan PJ, Counsell SJ, Rutherford MA, Cowan F, Azzopardi D, Edwards AD. Comparison of findings on cranial ultrasound and magnetic resonance imaging in preterm infants. Pediatrics. 2001 Apr;107(4):719-27. doi: 10.1542/peds.107.4.719.
Clinical trial NCT04755608: The Effect of Low-Intensity Resistance Exercise Training
Official title: The Effect OfF Low-Intensity Resistance Exercise Training Combined With Blood Flow Restruction On Triceps Brachii Muscle Volume And Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Onset Muscle Soreness
Keywords: muscle hypertrophy
triceps brachii
muscle strength
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Self Controlled Randomised Trial
Primary purpose: OTHER

Brief summary: It was to compare the effect of low-load resistance training with blood flow restriction (LL-BFR) and high-intensity resistance training (HI-RT) on muscle strength, endurance and volume, functional performance, and delayed onset muscle soreness (DOMS).

The study included 13 young women. It is a controlled study designed for individuals to perform two different exercise protocols unilaterally. The persons were randomly allocated into two groups as LI- BFR (Group I, n = 13) and HI-RT (Group II, n = 13). Both groups received training for 6 weeks and 3 days a week. Blood flow restriction was performed only in group I.

Detailed description: Both sides triceps muscle thickness, triceps and biceps strength and endurance, functional performances (upper extremity Y balance test (UQYBT)), delayed-onset muscle soreness (DOMS) were evaluated before and after training.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-26,
* Do not have a chronic disease history and do not use medication,
* Female individuals were included.

Exclusion Criteria:

* People who made resisted exercise in the last 6 months,
* Smoker,
* BMI above 30 kg / m2,
* Individuals with hypertension were excluded.

Primary outcomes:
measure: triceps muscle thickness
timeFrame: 6 weeks
measure: triceps and biceps strength
timeFrame: 6 weeks
measure: triceps and biceps endurance
timeFrame: 6 weeks
measure: functional performances
timeFrame: 6 weeks
measure: delayed-onset muscle soreness
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: University and Health Sciences Physical Therapy and Rehabilitation
state: Uskudar
Study officials:
affiliation: Istinye University
name: Yunus Emre Tütüneken, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03113708: The Effect of Heparinization Due to LBW
Official title: The Effect of Heparinization Due to LBW in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heparin
Heparin Overdose
Bleeding
Keywords: heparin
heparin antagonists
cardiac surgery
active clotting time
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB) and this may increase postoperative bleeding. The aim of this study is to evaluate the effect of heparin dose calculated according to lean body weight on intraoperative and postoperative bleeding.

Detailed description: Patients with preoperative demographic data such as age, gender, body weight, height, and additional disease, medications, previous surgery, preoperative Htc / Hb values were recorded in the operation room without medical premedication. Standard anesthesia induction was performed after arterial cannulation and peripheral venous route. Patients were randomly divided into two groups: 400 IU heparin / kg (Group I) and 400 IU heparin / kg (Group II) according to actual body weight and lean body weight respectively before CPB. Before and after heparin administration, CPB entry and ACT (Activated Clotting Time) values were counted every 30 minutes, after CPB exit and protamine. In both groups, supplemental heparin was administered when there was a failure to reach the pre-CPB target ACT value of 400 sec. Hemodynamic data and transfusion requirements were recorded during the operation. Patient's intraoperative CPB and crossover times, postoperative drainage volume and blood transfusion requirement were recorded.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old, first time valve surgeries which was done on-pump.

Exclusion Criteria:

* Revision valve surgeries
* Patients with coagulation deficits

Primary outcomes:
measure: ACT
timeFrame: Through study completion, an average of 48 hours
Secondary outcomes:
measure: Bleeding
timeFrame: Through study completion, an average of 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Yuksek Ihtisas Hospital
name: Ulku Sabuncu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02610608: Medical Assistance for the Procreation and Risk of Thrombosis.
Official title: Assistance Médicale à la Procréation et Risque Thrombotique
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ovarian Hyperstimulation Syndrome
Cardiovascular Diseases
Embolism and Thrombosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 129
Sex: FEMALE
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: Women undergoing assisted reproductive thechnology

Brief summary: This study aims at evaluating clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation.

Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and venous thrombosis in women undergoing assisted reproductive technology and 2)to identify the incidence and risk factors for ovarian hyperstimulation syndrome in these women

Detailed description: All women undergoing an assisted reproductive tecnology in order to receive an in vitro fertilization in French centers will be included in the study. These women will be followed up until 12 months after ovarian stimulation if they get pregnant or until 3 months if the stimulation does not lead to pregnancy. Risk factors for thrombosis and ovarian hyperstimulation syndrome will be collected in each woman. At each visit, women will be asked whether arterial and/or venous thrombosis had occured.

Eligibility criteria: Inclusion Criteria:

* All women undergoing ovarian stimulation in order to receive in vitro fertilization

Exclusion Criteria:

* Age\<18 years
* Women refusing to particpate in the study
* No health coverage
* Women under guardianship
* Women receiving therapeutic doses of anticoagulation

Primary outcomes:
measure: Evaluation of professional clinical practice for ovarian stimulation care
timeFrame: Until 12 months followin ovarian stimulation
Secondary outcomes:
measure: Arterial and/or venous thrombosis
timeFrame: until 12 months following ovarian stimulation
measure: Risk factors for thrombosis
timeFrame: until 12 months following ovarian stimulation
Other outcomes:
measure: Incidence and risk factors for ovarian hyperstimuation syndrome
timeFrame: until 12 months following ovarian stimulation
Locations:
city: Brest
country: France
facility: Clinique Pasteur
city: Ecully
country: France
facility: Medicentre- Clinique du Val d'Ouest
city: Grenoble
country: France
facility: SELARL Gynecologia
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet
city: Paris
country: France
facility: AP-HP - Hôpital Bichat
city: Rennes
country: France
facility: Clinique Multualiste La sagesse
city: Rouen
country: France
facility: Clinique Mathilde
city: Schiltigheine
country: France
facility: CHU de Strasbourg - CMCO
Study officials:
References:
Clinical trial NCT04160208: DNA Damage and Subfertility in Males - Impact on ART Outcome
Official title: DNA Damage and Subfertility in Males - Impact on Assisted Reproductive Treatment Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Keywords: male infertility
DNA fragmentation Index
DFI
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 1350
Sex: MALE
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: Males of couples attending Skive fertility Clinic

Brief summary: A obvational prospective cohort study of men undergoing IUI, IVF and ICSI treatment in Denmark. The aim is to asses the impact of sperm DNA damage, measured as DNA fragmentation index (DFI), on reproductive outcomes after assisted reproductive technology (ART).


Eligibility criteria: Inclusion Criteria:

* First cycle treatment

Exclusion Criteria:

* TESA/PESA, more than one cycle

Primary outcomes:
measure: Number of particpants achieving live birth
timeFrame: week 23-42 of pregnancy
Secondary outcomes:
measure: Number of participants with clinical pregnancy
timeFrame: week 7-8 of pregnancy
measure: Number of participants with biochemical pregnancy
timeFrame: Day 14-17 of pregnancy
measure: Cumulative live birth rate
timeFrame: 9-24 months after inclusion
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Fertility Clinic, Skive Regional Hospital
Study officials:
References: