louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02505776: Safety and Patient Satisfaction With GLASH VISTA™ (Bimatoprost 0.03%) in the Treatment of Eyelash Hypotrichosis in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eyelash Hypotrichosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-07-22
Enrollment: 1699
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: Patients with eyelash hypotrichosis

Brief summary: This is a post-marketing surveillance study in Japan that will evaluate the safety and patient satisfaction with GLASH VISTA™ (bimatoprost cutaneous solution 0.03%) in the treatment of hypotrichosis of the eyelashes.


Eligibility criteria: Inclusion Criteria:

-Patients who have been prescribed GLASH VISTA™ in clinical settings and filled at least one prescription for GLASH VISTA™.

Exclusion Criteria:

-None.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 12 Months
measure: Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey
timeFrame: Baseline, Month 1
measure: Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey
timeFrame: Baseline, Month 4
measure: Change from Baseline in Patient Satisfaction with Eyelashes As Measured by the 3-Item Patient Eyelash Satisfaction Survey
timeFrame: Baseline, Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Allergan
name: Suzanne St. Rose, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT04541576: The Merit WRAPSODY Central Feasibility Study
Official title: Prospective, Non-Randomized, Controlled, Multicenter Feasibility Study of the Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Central Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Venous Stenosis
Venous Occlusion
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ClinLogix. LLC
First posted: 2020-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit in the thoracic central veins


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent
* Subject is male or female, with an age ≥ 18 years at date of enrollment.
* Subject is willing to undergo all follow-up assessments.
* Subject has a life expectancy ≥ 12 months.
* Subject is undergoing chronic hemodialysis.
* Subject has either a mature AVF or AVG in the arm.
* Target lesion(s) involves a non-stented restenotic lesion.
* Target lesion has ≥50% stenosis.
* Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

Exclusion Criteria:

* Subject is unable or is unwilling to comply with the procedural requirements of the study protocol.
* Subject has a comorbidity that in the investigator's opinion would limit life expectancy to less than 12 months.
* Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
* Subject has a stroke diagnosis within 3 months prior to enrollment.
* Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
* Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
* Target lesion is located within a stent / stent graft.

Primary outcomes:
measure: Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint
timeFrame: 30 days
measure: Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of subjects with Target Lesion Primary Patency
timeFrame: 12 and 24 months
measure: Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
timeFrame: 6, 12 and 24 months
measure: Proportion of subjects with Access Circuit Primary Patency (ACPP)
timeFrame: 6, 12 and 24 months
measure: Proportion of subjects with Post-Procedure Secondary Patency
timeFrame: 6, 12 and 24 months
measure: Rates of procedure- and device-related adverse events involving the access circuit
timeFrame: Index procedure, 30 days, and months 6, 12 and 24.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01374776: Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance in Premenopausal Women
Official title: Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance In Non Anemic Premenopausal Women With Low Ferritin Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Anemic Patients With Iron Deficiency (Low Ferritin Value)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-06-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of intravenous iron substitution (iron carboxymaltose (Ferinject®), total dose 15 mg/ kg (maximal dose: 1000mg) in 250 ml 0.9 % NaCl; intravenous infusion in 20 min)in non-anemic premenopausal women with iron deficiency on

Primary objective:

- Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle)

Secondary objectives:

* Maximal oxygen uptake during a graded cycling exercise test and time to exhaustion at submaximal power during a constant-load cycling exercise test
* Plantarflexor muscle fatiguability as assessed by isokinetic dynamometry
* Trial with medicinal product


Eligibility criteria: Inclusion criteria: INCLUSION CRITERIA

* Healthy female subjects, Age \> 18 years, premenopausal, regularly menstruating
* BMI 18-25 kg/m2.
* Serum ferritin level \< 15ug/ml
* Recreationally active with = 1.5 h/w structured activity
* Adequate contraception during the study period
* Informed consent

Exclusion criteria: EXCLUSION CRITERIA

* Anemia with Hb level \< 120 g/l
* Known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate
* Intake of iron preparations (also multivitamins containing iron) during the last 8 weeks before the start of the trial protocol
* Pregnancy or lactation
* Any cardiovascular or pulmonary disease
* Any orthopaedic or rheumatologic disease which affects exercise performance
* Presence of muscle disease
* Acute or chronic infection/inflammation or malignancy
* Known mental disorders (e.g. depression)
* Intake of concurrent medication, except oral contraceptives
* CRP \> 10 mg/l
* TSH out of normal range
* Elevated CK (\> 167 U/l)
* Any concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
* Participation in any other therapeutic trial within the previous month

Primary outcomes:
measure: Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Clinic and Policlinic of Internal Medicine
state: ZH
Study officials:
affiliation: University of Zurich
name: Pierre-Alexandre Krayenbuehl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02832076: Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Wound Healing
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate the role of subcutaneous negative pressure drain placed for 10 days on wound healing in female obese patients undergoing midline exploratory laparotomies for ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* BMI more than 30kg/m2
* midline laparotomies
* ovarian cancer

Exclusion Criteria:

* associated medical disorders

Primary outcomes:
measure: presence of a break in the skin wound
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
References:
Clinical trial NCT06420427: Dynamic Monitoring of ctDNA and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery
Official title: Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: cfHPV DNA in Plasma of Cervical Cancer Patients
Keywords: cfHPV DNA
cervical cancer
Lead sponsor: The Third Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 150
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: Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.

Brief summary: Assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor DNA (ctDNA) combined with circulating HPV DNA (cfHPV DNA) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and disadvantages with existing diagnostic methods.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.
* Patients must be older than 18 years of age.
* Cervical cancer patients who are eligible for surgery and/or chemoradiotherapy.
* Estimated life expectancy of more than three months.
* Understands the study protocol and voluntarily participates in the research by signing the informed consent form.
* Able to provide specimens and corresponding clinical information at each time point.

Exclusion Criteria:

* Patients who are participating in other clinical trials.
* Pregnant or breastfeeding women.
* Patients with severe mental illness.
* Patients who voluntarily withdraw.
* Patients unable to complete the study protocol.

Primary outcomes:
measure: sensitivity
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The Third Affiliated Hospital of Guangzhou Medical University
name: Xiujie Sheng, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02736227: Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Official title: Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Keywords: liver transplantation
immunosuppression
everolimus
tacrolimus
kidney function
liver function
biomarkers
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2016-04-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug that may stabilize or improve kidney function for patients with chronic kidney disease (CKD) that has been caused by immunosuppressants. EVL is used for standard of care treatment to prevent transplant liver rejection in combination with other immunosuppressants, such as tacrolimus. The overall aim of this study is to examine a combination of two different immunosuppressants and EVL to determine if patients may have stabilized and/or improved kidney function without liver rejection. This study will look at how safe it is to slowly withdraw one anti-rejection medication while continuing to take the other medicine, and whether this can be done without liver rejection occurrence.


Eligibility criteria: Inclusion Criteria:

* Adult LT candidates ≥ 18 years of age
* Listed for or recent (within 1 month) recipient of deceased or living donor liver transplantation

Exclusion Criteria:

* Combined or previous organ transplantation
* Human immunodeficiency virus (HIV) infection
* Inability to provide informed consent or comply with the protocol.

Primary outcomes:
measure: Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection
timeFrame: Six months post transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Comprehensive Transplant Center
state: Illinois
Study officials:
affiliation: Northwestern University
name: Josh Levitsky, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02231827: Balance Control During Gait
Official title: A Study of the Balance Control During Gait : Comparison of Data Acquisition Between Force Plate and 3D Optoelectronic Gait Analysis System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: subjects
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Gait and balance disorders are important public health problem necessitating studies to try to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance during quiet standing (posturography). Nevertheless, falls occurred predominantly during gait, and rarely during quiet standing. We have developed a tool to measure balance during gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM recorded with a force plate.

In previous studies, we have shown that the braking of the CM was a physiological and a active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM measured on a force plate provide an important intra-individual variability.

The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The primary goal of this study is to compare intra-individual variability of the braking of the CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Between 20 and 40 years old
* Effective contraception for women of childbearing age

Exclusion Criteria:

* Neurological, vestibular, rheumatologic, orthopaedic disorders, which could influence gait and balance.
* Known spinal deformity
* Severe visual impairment : visual acuity less than 6/10
* Inability to stand and walk without assistance 15 meters
* Subjects without social security
* Subjects involved in another biomedical trial during this study
* Pregnant or breastfeeding women

Primary outcomes:
measure: Braking of the center of mass index during gait initiation
timeFrame: 1 day
Secondary outcomes:
measure: Braking of the center of mass index during locomotion
timeFrame: 1 day
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Nathalie CHASTAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04170127: Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser
Official title: Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser: Primary and Secondary Stability. A Randomized Clinical Split-Mouth Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II
Keywords: ATP, biostimulation, micro-screw, Periotest, semiconductor laser
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to estimate clinically an influence of 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. The randomized clinical split-mouth trial included 15 subjects, 30 implants (Dual Top Anchor System, Seoul, Korea) with a diameter 1.4mm and length of 10mm. Mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 15 patients.


Eligibility criteria: Inclusion Criteria:

* patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;
* the patients were treated first time using fixed orthodontic appliance;
* no systemic diseases;
* were not using anti-inflammatory drugs;

Exclusion Criteria:

* had used antibiotics in the previous 24 months;
* smokers;
* had history of radiotherapy,
* taking bisphosphonate medication

Primary outcomes:
measure: stability of orthodontic mini-implants
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
measure: Pain level
timeFrame: 24 hours
measure: mini-implants loss
timeFrame: 60 days
Locations:
city: Wschowa
country: Poland
facility: Private Dental Healtcare
Study officials:
References:
Clinical trial NCT01775527: IgA Nephropathy, Lymphocyte Homing and IgA Class Switch
Official title: IgA Nephropathy, Lymphocyte Homing and IgA Class Switch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IgA Nephropathy
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it represents an important cause of end-stage kidney failure. This disease was described as a distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis remain still obscure. Clinical observations and immunisation studies indicate that IgAN represents a dysregulation of the immune system, rather than an intrinsic renal abnormality. Twenty years ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the disease. Mucosal IgA plasmocytes are displaced and take up residence in systemic sites. The unusual characteristics featured by the IgA produced by these cells (charge, size, glycosylation) drive their accumulation, deposition and mesangial activation characteristic of IgAN.

Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant localization.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 and \< 70 years
* IgA nephropathy documented by the kidney biopsy in the six months preceding the inclusion
* Glomerular filtration rate (MDRD formula as simplified) \< 90 ml/mn and \> 30 ml/mn/1,73 m2
* Consent form signed

Exclusion Criteria:

* Patients with cirrhosis or chronic liver disease
* Patients with a history of Crohn's disease or celiac disease
* Patients who received treatment with corticosteroids or affiliates for six months
* Patients who received a live attenuated vaccine during the past 4 weeks
* Patients with a known infection such as HIV, hepatitis B or C
* Patients who presented with a serious infection during the last month
* Breastfeeding women
* Patients not affiliated with a social security scheme
* Under guardianship patient

Primary outcomes:
measure: The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization.
timeFrame: 30 minutes
Secondary outcomes:
measure: The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital, Limoges
Study officials:
affiliation: University Hospital, Limoges
name: Ahmed Boumediene, doctor
role: PRINCIPAL_INVESTIGATOR
References: