louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03736928: Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Official title: A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines


Eligibility criteria: Inclusion Criteria:

* Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale
* Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale

Exclusion Criteria:

* Botulinum toxin treatment in the face within 9 months prior to study treatment

Primary outcomes:
measure: Number of Composite Responders at Month 1
timeFrame: Month 1 after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Galderma Research Site
state: California
city: Manhattan Beach
country: United States
facility: Galderma Research Site
state: California
city: Vista
country: United States
facility: Galderma Research Site
state: California
city: Coral Gables
country: United States
facility: Galderma Research Site
state: Florida
city: Chicago
country: United States
facility: Galderma Research Site
state: Illinois
city: New Orleans
country: United States
facility: Galderma Research Site
state: Louisiana
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: Chapel Hill
country: United States
facility: Galderma Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Galderma Research Site
state: North Carolina
city: Mequon
country: United States
facility: Galderma Research Site
state: Wisconsin
Study officials:
References:
Clinical trial NCT00745628: Chinese Cohort Study of Coronary Heart Disease
Official title: Cross-Sectional Investigation of Secondary Prevention on Coronary Heart Disease and Generalization of Standardized Secondary Prevention in Chinese Coronary Heart Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Diseases
Keywords: coronary heart disease
secondary prevention
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
First posted: 2008-09-03
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed coronary heart disease

Brief summary: Construction of coronary heart disease cohort of more than 10000 patients in China. Investigation on current situation of secondary prevention of CHD will be carried out and the effect of physician training and patient education will be evaluated.

Detailed description: More than 40 hospitals of 16 provinces will enroll patients for this study. The study will include patients with diagnosed coronary heart disease. Investigators and all the physicians who will involve in daily care of CHD patients will have a brief training on guideline of secondary prevention in CHD and take a test on that. Questionnaires are used to evaluate patient's cognition of their diseases and knowledge on coronary heart disease. Patient education will be carried out during a 2 years follow up of all the patient enrolled before they are required to fill out another questionnaire. Physicians will also take a second test on secondary prevention of CHD at that time. Patients will take blood lipids and glucose test according to their physician's requirement.The effect of physician training and patient education will be evaluated by comparing the results of questionnaires and tests at the beginning of the study and in the end of the 2 years follow up.

Eligibility criteria: Inclusion Criteria:

* Diagnosed coronary heart disease
* Confirmed by coronary angiography;
* Diagnosed myocardial infarction;
* Typical symptom of ischemic chest pain with positive stress test;
* Willing to sign an inform consent.

Exclusion Criteria

* Patients won't sign an inform consent or will not comply with the follow up.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Tao Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03838328: Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery
Official title: Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thromboses, Deep Vein
Tranexamic Acid Adverse Reaction
Keywords: dose effect
tranexamic acid
deep vein thromboses
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
* Written consent obtained

Exclusion Criteria:

* Allergy or contraindication to tranexamic acid
* Severe renal impairment (serum creatinine \>250 μmol/l, or estimated creatinine clearance \<25 ml/min)
* Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
* Thrombocytopenia defined as a platelet count \<100,000/ml
* Coagulopathy defined as an international normalized ratio \> 1.5 prior to surgery
* Currently enrolled in another perioperative interventional study
* Pregnancy or lactation

Primary outcomes:
measure: The incidence of deep venous thrombosis
timeFrame: Within 7 days postoperatively
Secondary outcomes:
measure: The rate of new-onset thrombotic events
timeFrame: Within 90 days postoperatively
measure: The rate of allogeneic RBC transfusion
timeFrame: Within 30 days postoperatively
measure: The volume of allogeneic RBC transfusion
timeFrame: Within 30 days postoperatively
measure: Length of stay in ICU and hospital
timeFrame: Within 90 days postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences， Fuwai Hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Jia Shi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03439228: To Brace or Not to Brace for Single Level Lumbar Fusion Pilot
Official title: To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Spondylosis
Fusion of Spine
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: McMaster University
name: DJO Incorporated
name: Stryker Canada LP
First posted: 2018-02-20
Enrollment: 50
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: The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not. There is a lack of guidelines and evidence to support either treatment option. The purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.


Eligibility criteria: Inclusion Criteria:

* Single-level lumbar instrumented postero-lateral fusion from L2-L5
* Life expectancy greater than 2 years

Exclusion Criteria:

* Previous lumbar surgery
* Spine tumour/cancer
* Documented osteoporosis
* High grade (3 or 4) spondylolisthesis

Primary outcomes:
measure: Rate of enrolment
timeFrame: 12 months
measure: Rate of study completion
timeFrame: 12 months
Secondary outcomes:
measure: Lumbar bone fusion
timeFrame: 12 months
measure: Functional Status
timeFrame: 3 months, 6 months, 12 months
measure: Pain Status
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences and McMaster University
name: Aleksa Cenic, MSc, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05647928: Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis
Official title: Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Redetachment After Silicone Oil Removal
Keywords: rhegmatogenous retinal detachment
silicone oil
proliferative vitreoretinopathy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 307
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent pars plana vitrectomy with silicone oil tamponade at the Nancy University Hospital from January 2015 to January 2022.

Brief summary: To report the rate of retinal redetachment after silicone oil removal (SOR) following rhegmatogenous retinal detachment (RRD) surgery and to determine potential risk factors


Eligibility criteria: Inclusion Criteria:

* patients with successfully repaired rhegmatogenous retinal detachment and subsequent silicone oil removal
* minimum follow-up period of 6 months after silicone oil removal

Exclusion Criteria:

* Silicone oil tamponade for indications other than rhegmatogenous retinal detachment
* Retinal redetachment during silicone oil tamponade
* Prior history of silicone oil tamponade

Primary outcomes:
measure: rate of retinal redetachment after silicone oil removal
timeFrame: a minimum period of 6 months after silicone oil removal
measure: pre- and intraoperative risk factors of retinal redetachment after silicone oil removal
timeFrame: a minimum period of 6 months after silicone oil removal
Secondary outcomes:
measure: final retinal reattachment rate
timeFrame: a minimum period of 6 months after silicone oil removal
measure: final best corrected visual acuity
timeFrame: a minimum period of 6 months after silicone oil removal
Other outcomes:
Locations:
city: Vandœuvre-lès-nancy
country: France
facility: CHRU Nancy Brabois
Study officials:
References:
Clinical trial NCT02721628: Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
Official title: Femtosecond Laser Assisted Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Progressive Keratoconus
Keywords: Keratoconus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Detailed description: Keratoconus is a bilateral corneal ecstatic disease which is not uncommon and always behaves progressively and results in visual impairment by inducing irregular astigmatism and corneal opacities.

Collagen Cross-Linking (CXL) is widely used in progressive keratoconus. The cornea is soaked with a riboflavin solution and then being exposed to ultraviolet-A radiation. The performance creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. However, the effectiveness is not satisfied and accompanied with risks of side effects and serious complications, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, infection and stromal opacity due to corneal scarring.

Epi-keratoplasty is a reversible technique in which a corneal graft is transplanted on the recipients' eye with only removal of the epithelium of the receptor cornea. The procedure was assisted by femtosecond laser which allows precisely and neatly cutting. The graft strengths the whole host corneal rigidity and roughness and therefore renders the progression of keratoconus.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Keratoconus
* Age ≥ 18 years old
* Corneal thickness ≥ 400 µm
* Progressive stage 1 to 3 keratoconus (Krumeich classification)

Exclusion Criteria:

* Corneal thickness \< 400µm
* Concomitant corneal disease
* History of corneal surgery

Primary outcomes:
measure: Changes of Spherical equivalent
timeFrame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Secondary outcomes:
measure: maximum keratometry (K-max) derived from computerized video keratography
timeFrame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
measure: minimum keratometry
timeFrame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
measure: Visual acuity
timeFrame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Other outcomes:
measure: Spherical equivalent
timeFrame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Locations:
city: GuangZhou
country: China
facility: ZhongShan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT06804928: Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Extracorporeal Shock Wave Lithotripsy
Official title: Investigation of the Effect of Virtual Reality Glasses Used During Extracorporeal Shock Wave Lithotripsy (ESWL) on Patients' Pain, Anxiety, and Comfort Levels: A Randomized Controlled
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ESWL
Anxiety
Pain
Comfort
Virtual Reality
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During ESWL


Eligibility criteria: Inclusion Criteria:

Being 18 years of age or older, Having no hearing or perception impairments, Having no visual impairments, Undergoing ESWL for the first time.

Exclusion Criteria:

Use of any analgesic or anxiolytic medication before the procedure, Having a psychiatric disorder, The procedure being performed on an emergency basis.

Primary outcomes:
measure: VAS
timeFrame: Data will be collected 10 minutes before the procedure.
measure: Visual Anxiety Scale (VAS-A)
timeFrame: Data will be collected 10 minutes before the procedure.
measure: Visual Comfort Scale
timeFrame: Data will be collected 10 minutes before the procedure.
measure: Spielberger Trait Anxiety Inventory (STAI-II)
timeFrame: The measurement will be conducted only once, 10 minutes before the procedure.
measure: VAS
timeFrame: Data will be collected 30 minutes after the procedure.
measure: Visual Anxiety Scale (VAS-A)
timeFrame: Data will be collected 30 minutes after the procedure.
measure: Visual Comfort Scale
timeFrame: Data will be collected 30 minutes after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Gazi State Hospital
state: Merkez
Study officials:
References:
Clinical trial NCT03764228: Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
Official title: Single Arm Clinical Study of Human Amniotic Epithelial Cells in Preventing Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute-graft-versus-host Disease
Keywords: human amniotic epithelial cells(hAECs)
Acute-graft-versus-host disease（aGVHD）
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
First posted: 2018-12-05
Enrollment: 27
Sex: ALL
Minimum age (years): 8
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a Single arm clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.

Detailed description: A dose escalation study evaluating the safety and efficacy of human amniotic epithelial cells( hAECs) in preventing acute graft-versus-host(aGVHD) disease after hematopoietic stem cell transplantation(HSCT). The doses were 1×10\^6、2×10\^6、5×\^6 cell/kg, successively.

Eligibility criteria: Inclusion Criteria:

* Standard risk GVHD patients with hematological malignancies;
* High risk GVHD patients with hematological malignancies: haplotype hematopoietic stem cell transplantation patients, donor is female or more than 30 years old;
* Well informed about this study and signed a consent form before the trial;
* Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion;
* No evidence of lung infection by X-rays examination;
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1, Hematopoietic cell transplantation - specific comorbidity index (HCT-CI) of 0, 1, 2;
* Normal liver and kidney function;

Exclusion Criteria:

* Reduce pretreatment dose or secondary transplantation;
* participate other clinical trials within 2 months before this study;
* Female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study period, or 3) have fertility and cannot take effective contraception;
* History of severe allergic disease or is allergic to one or more drugs;
* Patients who are considered unsuitable for the study by the investigator.

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: GVHD
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiaojun Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609361: Benefit of Rehabilitation Program in Colorectal Surgery
Official title: Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Rehabilitation program
Fast track surgery
Laparoscopic colorectal resection
Colorectal cancer
Morbidity
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.

Detailed description: The aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years old
* Colorectal cancer
* Inform and consent form signed
* Patient has valid health insurance/coverage
* Functional capacity ≥ 4 METs (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities)
* Patients with laparoscopic resection for colorectal cancer including abdominoperineal resection

Inclusion Criteria (arm : Laparoscopy + Rehabilitation program):

* Tobacco and alcohol weaning

Exclusion Criteria:

* MBI \< 18kg/m2
* severe malnutrition
* Metastatic colorectal cancer
* Buzby Index \<83
* Combined surgery (hepatic resection or segmental resection of small intestine)
* Urgent surgery
* Pregnancy or maternal breastfeeding
* Body mass index (BMI)\> 30 kg/m2
* Abdominoperineal resection
* Subtotal colectomy
* Total proctocolectomy
* Cons to Naropin Xylocaine, droperidol, ketamine
* Patient with a history of peptic ulcer

Primary outcomes:
measure: Post operative morbidity at 30 days according to DINDO CLAVIEN classification
timeFrame: 30 days
Secondary outcomes:
measure: Mortality according to DINDO CLAVIEN classification
timeFrame: up to 30 days
measure: Hospital stay and readmissions
timeFrame: up to first month
measure: Intravenous perfusion stay
timeFrame: participants will be followed until the end of hospitalization an expected average of 2 weeks
measure: Global (SF36) quality of life
timeFrame: Preoperative and at 1, 3, 6 months
measure: Specific (GIQLI) quality of life
timeFrame: Preoperative and at 1, 3, 6 months
measure: Duration of laxation (gas and stool)
timeFrame: up to hospital discharge
Other outcomes:
Locations:
city: Clichy
country: France
facility: Service de chirurgie Colorectale / Hôpital Beaujon
Study officials:
References: