louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03532503: Second Trimester Pregnancy Termination With Foley Catheter
Official title: Second Trimester Pregnancy Termination With Foley Catheter With 30 ml vs 50 ml: Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Termination
Keywords: pregnancy termination
second trimester
foley catheter
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: One of the methods used to induce second trimester pregnancy termination is the placement of a transcervical Foley catheter. The aim of this randomized controlled study was to assess in pregnant women with an unfavourable cervix, whether there is a difference in efficacy between the two most commonly used insufflation volumes of Foley catheter (30mL and 50mL).


Eligibility criteria: Inclusion Criteria:

* singleton pregnancies
* second trimester pregnancy ermination

Exclusion Criteria:

* multiple pregnancies

Primary outcomes:
measure: induction abortus interval
timeFrame: up to five days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
References:
Clinical trial NCT02353403: Glycaemic and Insulinaemic Responses After Consumption of FOS.
Official title: Postprandial Glycaemic and Insulinaemic Responses After Consumption of Dairy Desserts Containing Fructo-oligosaccharides in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycaemia
Keywords: Fructo-oligosaccharides
Sugar-reduced foods
Postprandial glucose response
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
Collaborators: name: Syral
First posted: 2015-02-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 25.0 kg/m² (included)
* Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit
* Be used to have breakfast
* Non-smoker for at least 3 months
* For the female participant: not being pregnant or breastfeeding and using efficient birth control
* Signed the consent form
* Able to follow the instructions of the study
* Health insured
* Accepted to be included in the National Registry for biomedical research Volunteers (Fichier VRB, Volontaires Recherches Biomédicales).

Exclusion Criteria:

* Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not)
* Fasting blood cholesterol over 6.35 mmol/L
* Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma)
* Fasting blood insulin under 20 mU/L
* Fasting HbA1c under 7%
* History of hypercholesterolemia, hypertension, diabetes or glucose intolerance treated or not
* History of dietary allergies or coeliac disease
* History of digestive system disease susceptible to modify digestion or absorption like Crohn's disease
* Somatic or psychiatric disorders
* Renal insufficiency (kidney failure)
* SGOT or ALAT over 52.5 U/L
* Smoker
* Consuming more than 3 alcoholic beverage a day
* Weight varied 3 kg the last 3 months

Primary outcomes:
measure: Glycaemic response
timeFrame: 2 hours and 5 minutes
Secondary outcomes:
measure: Insulinaemic response
timeFrame: 2 hours and 5 minutes
measure: Blood glucose peak (Cmax)
timeFrame: One-time data (the highest one) within the 2hrs 5mins kinetics.
measure: Blood insulin peak (Cmax)
timeFrame: One-time data (the highest one) within the 2hrs 5mins kinetics.
measure: Glucose Tmax : time to reach the peak of blood glucose
timeFrame: One time within the 2hrs 5mins kinetics.
measure: Insulin Tmax : time to reach the peak of blood insulin
timeFrame: One time within the 2hrs 5mins kinetics.
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
affiliation: Institut Pasteur de Lille
name: Jean-Michel Lecerf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05119543: Refractive Error in Chinese Students
Official title: Refractive Error in Chinese Primary and High School Students Before and Amidst COVID-19 in Tianjin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Keywords: COVID-19
Refractive error
China
Myopia
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 36452
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This large-scale cohort study was conducted in 36452 schoolchildren on myopia development among schoolchildren in 96 elementary and high schools in 16 districts of Tianjin in China.

Brief summary: This cohort study aimed to assess the change of refractive status in Chinese school children.

Detailed description: A cohort study was conducted in 96 primary and secondary schools in 16 districts of Tianjin from 2018 to 2020, including about 36452 people totally. The changes in myopia rate in 3 years were compared by a generalized estimation equation. The distribution of average equivalent spherical mirror and different regions and grades was evaluated by linear regression analysis, and the correlation between the equivalent spherical mirror and different gender, nationality, and age was evaluated.

Eligibility criteria: Inclusion Criteria:

* no concurrent eye disease
* age from 6 to 18 years old

Exclusion Criteria:

* significant systemic illnesses
* ocular conditions
* congenital corneal diseases
* pterygium, keratoconus
* corneal degeneration or dystrophy
* media opacity, uveitis, glaucoma
* history of ocular surgery
* neurologic diseases
* retinal disease.

Primary outcomes:
measure: refractive error
timeFrame: change from baseline at 36 months
measure: sex disparity
timeFrame: change from baseline at 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
affiliation: Tianjin Eye Hospital
name: Yan Wang, director
role: STUDY_CHAIR
References:
citation: Saw SM, Matsumura S, Hoang QV. Prevention and Management of Myopia and Myopic Pathology. Invest Ophthalmol Vis Sci. 2019 Feb 1;60(2):488-499. doi: 10.1167/iovs.18-25221.
citation: Wang J, Li Y, Musch DC, Wei N, Qi X, Ding G, Li X, Li J, Song L, Zhang Y, Ning Y, Zeng X, Hua N, Li S, Qian X. Progression of Myopia in School-Aged Children After COVID-19 Home Confinement. JAMA Ophthalmol. 2021 Mar 1;139(3):293-300. doi: 10.1001/jamaophthalmol.2020.6239.
citation: Wang W, Zhu L, Zheng S, Ji Y, Xiang Y, Lv B, Xiong L, Li Z, Yi S, Huang H, Zhang L, Liu F, Wan W, Hu K. Survey on the Progression of Myopia in Children and Adolescents in Chongqing During COVID-19 Pandemic. Front Public Health. 2021 Apr 28;9:646770. doi: 10.3389/fpubh.2021.646770. eCollection 2021.
Clinical trial NCT03998943: NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study
Official title: NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Pain, Postoperative
Prosthesis (Internal) Complications
Nocturnal Frequency
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 250
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: Adult Patients undergoing elective primary Total knee arthroplasty or unicompartimental knee arthroplasty due to knee joint osteoarthritis coming to elective surgery at Cliniques universitaires Saint-Luc, Brussels

Brief summary: In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain. The purpose of our study is to determine the impact of this problem and to better understand its risk factors.

Detailed description: In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain.

The purpose of our study is to determine the impact of this problem and to better understand its risk factors.

This is a poorly studied issue and the study could better detect, evaluate and treat painful patients after knee replacement surgery.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective primary Total knee arthroplasty or unicompartmental knee arthroplasty due to knee joint osteoarthritis
* Older than 18 years
* Willing and able to complete pre and postoperative surveys

Exclusion Criteria:

* History of drug abuse
* Previous knee arthroplasty
* Mental disorders
* Rheumatoid arthritis
* Chronic renal disease
* Chronic hematological diseases (sickle cell disease, haemochromatosis...)

Primary outcomes:
measure: nocturnal pain
timeFrame: from day 1 of surgery until 1 year post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Emmanuel Thienpont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03308643: Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy
Official title: Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myomectomy
Keywords: myomectomy
oxytocin
blood loss
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The abdominal myomectomy cases will be randomized into 2 separate groups in a parallel fashion using an online software at 1:1 ratio.
Primary purpose: PREVENTION

Brief summary: To evaluate the effects of oxytocin infusion during abdominal myomectomy.

Detailed description: Myomectomy is indicated for symptomatic uterine fibroids. Fibroids have blood supply and 20% of the abdominal myomectomy cases might require blood transfusion because of the nature of the surgery. Oxytocin infusion is one of the intervention to decrease blood loss during myomectomy. To evaluate the effects and benefits of oxytocin infusion during abdominal myomectomy we decide to conduct this randomized study.

Eligibility criteria: Inclusion Criteria:

* Age 18-50
* Patients who are candidate for abdominal myomectomy

Exclusion Criteria:

* History of previous myomectomy.
* Suspected malignancy
* Patients with preoperative anemia
* Patients using hormonal treatments before the surgery.

Primary outcomes:
measure: Blood loss during surgery
timeFrame: 2 hours
Secondary outcomes:
measure: Blood loss after abdominal myomectomy
timeFrame: 1 hour postoperatively
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni Sultan Suleyman Egitim ve Arastırma Hastanesi
Study officials:
affiliation: Kanuni Sultan Suleyman Research and Training Hospital
name: Berna Aslan
role: STUDY_DIRECTOR
References:
citation: Atashkhoei S, Fakhari S, Pourfathi H, Bilehjani E, Garabaghi PM, Asiaei A. Effect of oxytocin infusion on reducing the blood loss during abdominal myomectomy: a double-blind randomised controlled trial. BJOG. 2017 Jan;124(2):292-298. doi: 10.1111/1471-0528.14416. Epub 2016 Nov 15.
citation: Chang FW, Yu MH, Ku CH, Chen CH, Wu GJ, Liu JY. Effect of uterotonics on intra-operative blood loss during laparoscopy-assisted vaginal hysterectomy: a randomised controlled trial. BJOG. 2006 Jan;113(1):47-52. doi: 10.1111/j.1471-0528.2005.00804.x.
Clinical trial NCT04490343: Detection of Urinary Stones on ULDCT With Deep-learning Image Reconstruction Algorithm
Official title: Detection of Urinary Tract Stones on Ultra-low Dose Abdominopelvic CT Imaging With Deep-learning Image Reconstruction Algorithm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Urinary Tract Stones
Renal Colic
Deep Learning Reconstruction
Keywords: Urolithiasis
Urinary Tract Stones
Renal Colic
deep learning reconstruction
radiation dose
dose reduction
low dose CT
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Urolithiasis has an increasing incidence and prevalence worldwide, and some patients may have multiple recurrences. Because these stone-related episodes may lead to multiple diagnostic examinations requiring ionizing radiation, urolithiasis is a natural target for dose reduction efforts. Abdominopelvic low dose CT, which has the highest sensitivity and specificity among available imaging modalities, is the most appropriate diagnostic exam for this pathology. The main objective of this study is to evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in urolithiasis patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old,
* Patient referred for abdominopelvic CT to confirm urolithiasis or for follow-up,
* Affiliation to a social security program,
* Ability of the subject to understand and express opposition

Exclusion Criteria:

* Age \<18 years old,
* Person under guardianship or curators,
* Pregnant woman,
* Any contraindications to CT

Primary outcomes:
measure: Accuracy between low dose CT using DLIR reconstruction and low dose CT without DLIR reconstruction for the detection of urinary tract stones
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT01430143: Physical Activity for a Long and Healthy Life
Official title: Physical Activity for a Long and Healthy Life - Project FINE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Insulin Resistance
Diabetes Mellitus, Type 2
Keywords: Exercise
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Universitetssenteret på Kjeller
name: Center for Healthy Aging
name: The Novo Nordic Foundation
name: Copenhagen University Hospital, Denmark
name: Glostrup University Hospital, Copenhagen
First posted: 2011-09-07
Enrollment: 64
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to 1) delineate the molecular mechanisms behind the large variation in insulin sensitivity among apparently healthy subjects and to 2) establish the dose-response relationship between physical training and a) metabolic health, b) appetite and c) cultural health.


Eligibility criteria: Inclusion Criteria:

* Healthy according to interview
* Caucasian
* Sedentary, Vo2max \< 45 ml/kg/min
* BMI 25-30 kg/m2
* Fat percentage 25% \<
* Weight stable (+/- 2 kg within past 6 months)

Exclusion Criteria:

* First degree relatives with type 2 diabetes
* Hemoglobin concentration \< 8 mmol/l
* Fasting plasma glucose 6.1 mmol/l \<
* Blood pressure 140/90 mmHg \<
* Regular intake of medicine

Primary outcomes:
measure: Change from baseline in insulin sensitivity at 12 weeks
timeFrame: At baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline in body composition af 2, 6 and 12 weeks
timeFrame: At baseline, 2, 6 and 12 weeks
measure: Change from baseline in appetite at 12 weeks
timeFrame: At baseline and 12 weeks
measure: Motivational factors for exercise
timeFrame: During and for up to 1½ year after the intervention
measure: Diameter of t-tubuli in skeletal muscle
timeFrame: At baseline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Biomedical Sciences, The University of Copenhagen
Study officials:
References:
Clinical trial NCT04999943: Hypomemylating Agents Combination With eDC Therapy for Elderly Patients With Myelodysplastic Syndrome
Official title: A Randomized, Open-label, Clinical Trial to Compare the Safety and Efficacy of Hypomemylating Agents Monotherapy and Combination With eDC Therapy for Elderly Patients With Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Myelodysplastic Syndromes
Dendritic Cell
Hypomethylating Agents
Immunotherapy
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to optimize the traditional treatment scheme and explore the cure scheme for the elderly by combining the existing mature treatment technology. The primary aim of this innovative immunotherapy using WT1/hTERT/Survivin-loaded DCs is to determine whether this novel DC vaccination is safe and can significantly prevent clinical relapse and increase survival of MDS patients.

Detailed description: Objective Myelodysplastic syndrome (Myelodysplasticsyndromes,MDS) is a highly age-related malignant clonal disease of the hematological system, which is characterized by pancytopenia and transformation to leukemia. In China, the median age of onset of MDS is 70 years old, and the incidence increases with age. It is the most common malignant tumor in the elderly, which seriously threatens the health and survival of the elderly. The 3-year survival rate of traditional combination chemotherapy or demethylation therapy is less than 20%.

Eligibility criteria: Inclusion Criteria:

1. elderly MDS patients;
2. aged more than 60 years old, general condition, ECOG score less than 1;
3. normal function of heart, liver and kidney, serum bilirubin ≤ 35 umol / L; serum creatinine ≤ 150 umol / L;
4. patients are unsuitable or unwilling to receive hematopoietic stem cell transplantation;
5. subjects sign informed consent.

Exclusion criteria:

1. serious infection was not controlled before treatment;
2. contraindications for the use of dexitabine and azacytidine;
3. other cases that did not meet the admission criteria.

Primary outcomes:
measure: OS
timeFrame: at study completion, an average of 3 years
Secondary outcomes:
measure: the Incidence of Treatment Adverse Events
timeFrame: at study completion, an average of 3 years
measure: RR
timeFrame: at study completion, an average of 3 years
measure: RFS
timeFrame: at study completion, an average of 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of hematology
Study officials:
affiliation: the Fifth Medical Center the PLA General Hospital
name: Liangding Hu, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT02116543: TD-6450 MAD Study in HCV Infected Subjects
Official title: A Double-Blinded, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Activity of TD-6450, a NS5A Inhibitor, in Treatment Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
HCV
Keywords: Hepatitis C
HCV
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2014-04-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.


Eligibility criteria: Inclusion Criteria:

* Subject is HCV antibody positive
* Subject is treatment naïve, with no history of exposure (single or multiple dose) to interferon, ribavirin or direct acting antivirals.
* Subject has had a liver biopsy within 3 years or Fibroscan evaluation within 6 months prior to Screening that clearly excludes cirrhosis. If not available prior to Screening, the absence of cirrhosis must be confirmed prior to subject enrollment using either Fibroscan or Fibrosure®.
* Subject is negative for hepatitis A (HAV), hepatitis B (HBV), and human immunodeficiency virus (HIV).

Exclusion Criteria:

* Subject has prior histological evidence of cirrhosis or current clinical evidence of cirrhosis in the opinion of the investigator.
* Subject has a history or evidence of non-hepatitis C chronic liver disease.
* Subject has an estimated creatinine clearance of \<80 ml/min if 18-60 years of age, inclusive; or \<70 ml/min if \>60 years of age, calculated using the Cockcroft-Gault equation.

Primary outcomes:
measure: Adverse events
timeFrame: 28 Days
Secondary outcomes:
measure: Cmax
timeFrame: 28 Days
measure: Tmax
timeFrame: 28 Days
measure: AUC0-t
timeFrame: 28 Days
measure: AUC0-∞
timeFrame: 28 Days
measure: AUC0-24
timeFrame: 28 Days
measure: Antiviral Activity
timeFrame: 28 Days
measure: t1/2
timeFrame: 28 Days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: