louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02490995: Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie.
Official title: Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Linked to the Surgery and / or Anesthesia
Keywords: children
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 80
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.

This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.


Eligibility criteria: Inclusion Criteria:

* Patient who need a surgery
* Patient that general condition fit with American Society of Anesthesiologists (ASA) I to III classification.
* Old patient under age 12
* Patient whose parents agreed to participate

Exclusion Criteria:

* Patient with psychomotor limitations
* Patient that had already been hospitalised for a surgery

Primary outcomes:
measure: The Yale Preoperative Anxiety Scale (m-YPAS)
timeFrame: the 1 surgery day at the time of the separation parents-children
Secondary outcomes:
measure: Induction Compliance Checklist (ICC)
timeFrame: intraoperative
measure: The agitation in recovery room
timeFrame: First 15 minutes of the arrival in recovery room
measure: psychometric validation of the SAS (self anxiety scale)
timeFrame: up to postoperative day 30
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier university hospital
Study officials:
affiliation: Montpellier University Hospital
name: Sophie SB Bringuier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01358695: Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet
Official title: Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Crow's Feet
Keywords: Lateral Canthal Lines
Crow's Feet
Lead sponsor: Anterios Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 111
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of Crow's Feet.


Eligibility criteria: Inclusion Criteria:

* mild to moderate Crow's Feet wrinkles (IGA 2-3) at rest
* moderate to severe Crow's Feet (IGA 3-4) on contraction
* willingness to refrain from any product affecting skin remodeling
* female subjects must be not pregnant and non-lactating

Exclusion Criteria:

* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child

Primary outcomes:
measure: Efficacy will be assessed by Investigator's Global Assessment Score
timeFrame: 2 weeks
Secondary outcomes:
measure: Subject Self Assessment (SSA) scale
timeFrame: 2 Weeks
measure: Investigator Global Assessment scale
timeFrame: Week 1, 2, 4, 8, 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center
state: Alabama
city: Miami Beach
country: United States
facility: Baumann Cosmetic & Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Esthetic Dermatology and Laser Center
state: Florida
city: Metairie
country: United States
facility: William Coleman III, MD, APMC
state: Louisiana
city: New York
country: United States
facility: Gramercy Park Dermatology
state: New York
city: Cary
country: United States
facility: Cary Skin Care
state: North Carolina
Study officials:
References:
Clinical trial NCT04151095: Examining The Effect of Blood Flow Restricted Aerobic Training on Mitochondrial Adaptations in Young Healthy Adults
Official title: Examining The Effect of Blood Flow Restricted Aerobic Training on Citrate Synthase Activity in Young Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitochondrial Biogenesis
Keywords: Mitochondria
Exercise training
VO2
Aerobic exercise
Citrate Synthase
Blood flow restriction
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This parallel-arm trial study investigates the effects of restricting arterial blood flow during cycling exercise on citrate synthase. Participants will be randomized to either a blood flow restricted or non-blood flow restricted exercise training group. Both groups will complete seven, 30-minute exercise sessions over a 14-day period.


Eligibility criteria: Inclusion Criteria:

* 3 hours of physical activity per week
* No previous cycling training
* No concurrent involvement in another training program
* Body mass index \< 30 kg/m2

Exclusion Criteria:

* Presence of cardiovascular disease
* Presence of metabolic disease
* Taking regular oral medication
* Current smoker

Primary outcomes:
measure: Citrate Synthase
timeFrame: 3 days prior to start of exercise training and 3 days after completing exercise training
Secondary outcomes:
measure: Transcription factor A, mitochondrial (TFAM)
timeFrame: 3 days before training to 3 days after training
measure: Nuclear respiratory factor, 1 (NRF1)
timeFrame: 3 days before training to 3 days after training
measure: Maximal oxygen consumption (VO2peak)
timeFrame: 3 days before training to 3 days after training
measure: Heart rate (HR)
timeFrame: Every 5 minutes during each of the 7, 30-minute exercise sessions
measure: Revolutions per minute (RPM)
timeFrame: Every 5 minutes during each of the 7, 30-minute exercise sessions
measure: Blood [lactate]
timeFrame: During all exercise sessions at 10 and 30 minutes
measure: Rating of perceived exertion (RPE)
timeFrame: Every 5 minutes during each of the 7, 30-minute exercise sessions
measure: Nuclear Factor, Erythroid 2 Like 2 (NFE2L2)
timeFrame: 3 days before training to 3 days after training
measure: Cytochrome c oxidase (COX)
timeFrame: 3 days before training to 3 days after training
measure: Electromyography (EMG)
timeFrame: Throughout each of the 7, 30-minute exercise sessions
measure: Near-infrared spectroscopy (NIRS)
timeFrame: Throughout each of the 7, 30-minute exercise sessions
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Brendon J Gurd, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00995995: Evaluation of the Duration of Oral Combination Therapy in Type 2 Diabetes, Prior to the Initiation of Insulin in the UK
Official title: Evaluation of the Duration of Oral Combination Therapy in Type 2 Diabetes, Prior to the Initiation of Insulin in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 7641
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults - obtainable from the literature

Brief summary: Carry out the cost-effectiveness analysis of rosiglitazone on a population in line with the rosiglitazone license and using UK costs


Eligibility criteria: Inclusion Criteria:

* Rosiglitazone Type II Diabetes studies

Exclusion Criteria:

* Studies without the required outcome

Primary outcomes:
measure: Cost-effectiveness of rosiglitazone
timeFrame: From literature
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01003795: Promus - Registry Experience at the Washington Hospital Center, Drug-eluting Stent (DES)
Official title: P-REWARDS (Promus - Registry Experience at the Washington Hospital Center, DES)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with at least one Promus, everolimus-eluting, Stent at the Washington Hospital Center.

Brief summary: Single-center registry of patients treated with at least one Promus, everolimus-eluting, Stent, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

Detailed description: Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES). The everolimus eluting stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. While registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Promus® Stent for at least 1 year post initial stent implantation.

Eligibility criteria: Inclusion Criteria:

* Patients, male or female, \>18 years of age
* Patients who received at least one Promus drug-eluting stent at the Washington Hospital Center

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Evaluation of Major Adverse Cardiac Events (MACE) post Promus Stent implantation
timeFrame: Follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Research Institute/Cardiovascular Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03835195: Comprehensive Care in Type 1 Diabetes and Associated Outcomes
Official title: Comprehensive Care in Type 1 Diabetes and Associated Outcomes: AIDDA: a Quasiexperimental Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Quasi-experimental, retrospective, before and after study, with a control group, to evaluate the effect of an intervention based on disease management, on metabolic control and hospitalizations, in a group of patients with type Diabetes 1, attended in a Provider Institution of Health Services of the city of Medellin - Colombia.

Detailed description: Evaluate the effect of an intervention based on the management of the disease, on metabolic control and the number of hospitalizations related to diabetes, in a group of patients with Type 1 Diabetes attended in a specialized Health Services Provider Institution in the city of Medellin - Colombia.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with type 1 diabetes.
* Patients affiliated to the Entity Administrator of Health Benefits Plans (EPS Sura)
* Patients with age greater than or equal to 15 years, who had been referred to the institution at the discretion of the treating physician, for poor metabolic control and had to enter a hemoglobin glycated (HbA1C) ≥ 7.0%.

Exclusion Criteria:

* Patients who at the time of recruitment were treated with continuous insulin infusion device (insulin pump) and patients with gestational diabetes were excluded.

Primary outcomes:
measure: Differences in HbA1C value after the intervention
timeFrame: 4-9 months
Secondary outcomes:
measure: Proportion of patients diagnosed with dyslipidemia after the intervention
timeFrame: 4-9 months
measure: Proportion of patients with hypoglycaemia after the intervention
timeFrame: 4-9 months
measure: Number of hospitalizations associated with diabetes, after the intervention
timeFrame: 4-9 months
measure: Proportion of patients diagnosed with hypertension after the intervention
timeFrame: 4-9 months
measure: Difference in the body mass index after the intervention
timeFrame: 4-9 months
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Clínica Integral de Diabetes
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: John Jairo Zuleta Tobón, MD, Msc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06436495: Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects
Official title: Validation of Methodologies: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Comprehensive Evaluation of Scalp Dandruff in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dandruff
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to validate methods for assessing scalp hair dandruff by comparing three evaluation techniques: the Adherent Scalp Flaking Score (ASFS), Phototrichogram, and 60-second hair combing.

These assessments will be conducted before and after hair wash interventions on adult human subjects to evaluate adherent and non-adherent scalp flakes. By comparing the results of these evaluations, the study aims to determine the consistency and reliability of each method in assessing the presence and severity of dandruff. Establishing correlation between these assessment techniques is essential for validating their usefulness in evaluating the effectiveness of hair care products and treatments in reducing scalp dandruff. This research aims to improve the accuracy and reliability of dandruff evaluation methods, benefiting both dermatological research and clinical practice in managing this prevalent condition.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 55 years (both inclusive).
* Good general health as determined from recent medical history.
* No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.

Exclusion Criteria:

* Non-willing subjects and subjects with a history of allergies or specific allergic reactions upon using dermatological/cosmetic products will not be included.

Primary outcomes:
measure: Adherent Scalp Flaking Score
timeFrame: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
measure: Scalp Condition using Phototrichogram
timeFrame: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
Secondary outcomes:
measure: Non-adherent scalp flakes evaluation
timeFrame: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
Other outcomes:
Locations:
city: Gandhinagar
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
References:
Clinical trial NCT01700595: Preexpanded Perforator Flaps in Children
Official title: Preexpanded Perforator Flaps in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contractures
Scars
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 7
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Contractures and broad scars of the axilla, anterior chest wall and neck have detrimental effects on functional, physical and psychological development of children. Perforator flaps have already been shown to be reliable options for the reconstruction of contractures but there have been no reports demonstrating the value of preexpanded perforator flaps of dorsolateral trunk region in treatment of extensive contractures and scars of pediatric patients. The purpose of this study is to demonstrate these techniques by a case series formed of pediatric patients with broad scars and contractures of anterior chest wall, axilla, neck and breasts. Seven pediatric patients (mean age, 11,6 years) who were treated by preexpanded perforator flaps are presented. By this means, clinical experience on intercostal artery perforator (ICAP) flap, thoracodorsal artery perforator (TDAP) flap, circumflex scapular artery perforator (CSAP) flap and lumbar artery perforator flap was shared. Flaps as large as 20,5x10,5 cm in size could be successfully transferred in pediatric patients. Broad scar tissues were resurfaced with broad flaps carrying similar characteristics with the uninjured anterior chest wall and neck skin in six of our patients. In one patient with partial necrosis, full thickness skin graft was used for the residual defect. The mean duration of postoperative (after flap transfer) follow-ups was 17,2 months. The preexpanded TDAP, ICAP and CSAP flaps are revealed to be useful reconstructive options for the treatment of scars and contractures of anterior chest wall, axilla, neck and breast in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* pediatric age group
* broad scars and contractures

Exclusion Criteria:

* age over 18 years
* minimal scars and skin defects that could be treated by minor interventions

Primary outcomes:
measure: Range of motion of the particular joint
timeFrame: at least three months after flap tarnsfer
Secondary outcomes:
measure: Replaced tissue dimensions
timeFrame: at least three months after the operation
Other outcomes:
measure: Developement of related anatomic structures
timeFrame: at least a year after flap transfer
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
Study officials:
References:
citation: Hocaoglu E, Aydin H. Preexpanded perforator flaps of the dorsolateral trunk in pediatric patients. Plast Reconstr Surg. 2013 May;131(5):1077-1086. doi: 10.1097/PRS.0b013e3182865dd7.
Clinical trial NCT04512495: Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?
Official title: Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma
Keywords: Leiomyosarcoma
Dedifferentiated liposarcoma
Myxoid liposarcoma
Synovialosarcoma
Osteosarcoma
Ewing's sarcoma
Cancer cell/macrophage hybrid cells
Hybrid cells
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood.

The study will be conducted on a population of patients with sarcoma and treated in the context of routine care.

For each included patient, blood samples will be collected during baseline visit and after the initiation therapy.

At the end of the 2nd blood collection, the patient will have completed his participation in the study.


Eligibility criteria: Inclusion Criteria:

1. Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.
2. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
3. Age ≥ 18 years old.
4. Localized or metastatic disease or recurrent disease.
5. Patient who has not yet initiated specific treatment for sarcoma.
6. Patient affiliated to a Social Health Insurance in France.
7. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria:

1. Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.
2. Associated pathology(s) that may prevent the proper conduct of the procedure under consideration.
3. Pregnant or breastfeeding woman.
4. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
5. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Primary outcomes:
measure: Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
timeFrame: 6 months after the end of inclusions
Secondary outcomes:
measure: Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.
timeFrame: 6 months after the end of inclusions
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
Study officials:
References: