louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01998984: Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Official title: Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2013-12-03
Enrollment: 266
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: This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel


Eligibility criteria: Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities

Exclusion Criteria:

* Location of the treatment area (trunk (except chest) or extremities)

  * within 5 cm of an incompletely healed wound,
  * within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
* Prior treatment with ingenol mebutate within the selected treatment area
* Lesions in the treatment area that have:

  * atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous horns) and/or,
  * recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)

Primary outcomes:
measure: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs)
timeFrame: At Week 8
Secondary outcomes:
measure: Percentage of Reduction in Actinic Keratosis (AK) Lesion Count From Baseline (Day 1) (Multiple Imputation)
timeFrame: At Week 8
measure: Percentage of Participants With Partial Clearance of AKs
timeFrame: At Week 8
Other outcomes:
Locations:
city: Smithtown
country: United States
facility: Long Island Skin Cancer and Dermatologic Surgery
state: New York
Study officials:
affiliation: Lond Island Skin Cancer and Dermatologic Surgery
name: Daniel M Siegel, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01824784: TopQ Cut-Off Determination Study
Official title: TopQ Cut-off Determination Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Normal Eyes
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sujects that have no known ocular pathologies

Brief summary: To determine optimal cut-off value for TopQ cut-off.


Eligibility criteria: Inclusion Criteria:

* No known ocular pathologies

Exclusion Criteria:

* Any known ocular pathologies

Primary outcomes:
measure: Retinal Thickness
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Medical Systems, Inc.
state: New Jersey
Study officials:
affiliation: Director of Clinical Marketing
name: Michael Sinai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06109584: Verification of the Correct Insertion of a Central Venous Catheter
Official title: Verification of the Correct Insertion of a Supradiaphragmatic Central Venous Catheter by a Single Echocardiographic Plane
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Catheter Related Complication
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria.
Primary purpose: DIAGNOSTIC

Brief summary: The investigators propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age in whom a decision is made to place a supradiaphragmatic central venous catheter.
* Patients who agree to participate in the study

Exclusion Criteria:

* Patients with devices that may interfere with the ultrasound images.
* Patients with poor ultrasound window
* Patients with superior vena cava syndrome

Primary outcomes:
measure: To determine the incidence of malposition of central venous catheter
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Paula Gil Esteller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05662384: Small Bowel Obstruction. A Prospective Multicener Study
Official title: A Multicenter Prospective Study on Small Bowel Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Bowel Obstruction
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: North Estonian Medical Center
First posted: 2022-12-22
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized with mechanical small bowel obstruction

Brief summary: To get an overview of patients hospitalized with mechanical small bowel obstruction and the evaluate the use of contrast media as part of conservative management. To analyze how many patients were operated on and in how many cases conservative measures helped.

Detailed description: This is a multicenter prospective study conducted at two regional hospitals of Estonia: Tartu University Hospital and North Estonian Medical Center. The data of the patients' hospitalized for SBO between May 2021 and April 2022 were collectedafter patients gave their informed consent to be enrolled in the study.

Eligible patients were adults aged 18 years or older with mechanical small bowel obstruction. Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study.

Characteristics of abdominal pain (absent/intermittent/permanent), presence of nausea/vomiting, absence of flatus, results of blood tests (white blood cell count (WBC), C-reactive protein (CRP), lactate level (Lac), estimated glomerular filtration rate (eGFR)), radiology imaging techniques used, previous abdominal/pelvic surgeries, previous episodes of bowel obstruction. It was documented whether immediate surgical treatment was implemented, or whether conservative management was initiated. In the case of conservative treatment, it was recorded whether contrast media (CM) was or was not used. In the case of surgical treatment, the type of surgery (adhesiolysis/ bowel resection/ other) was recorded.

Eligibility criteria: Inclusion Criteria:

* aged 18 years or older with mechanical small bowel obstruction who signed an informed consent form

Exclusion Criteria:

* Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study

Primary outcomes:
measure: Resolution on SBO
timeFrame: Hospitalization period (approximately 5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
Study officials:
affiliation: University of Tartu
name: Liis Jaanimäe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02829684: Register of Patients With Prader-Willi Syndrome
Official title: Implementation of a National Register of Children and Adults Presenting Prader-Willi Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prader-Willi Syndrome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 500
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: Patients will be included by the paediatric endocrinologists or the endocrinologists for adults of each region based on their own recruitment

Brief summary: Prader-Willi Syndrome (PWS) is a rare syndrome with a prevalence of 15 to 20 000 at birth. PWS represents a large fraction of mental retardation syndromes due to a genetic cause and the most frequent cause of genetic obesity. The majority of the patients are seen by paediatricians. This syndrome is responsible for severe physical, psychological and social impairments.

The diversity and the severity of the manifestations of this disease explain the requirement of multidisciplinary care which deserve specific evaluation. Today the follow-up and management of a great proportion of these patients are greatly insufficient if not absent.

Teams strongly lack information on the natural history of this severe disease and on the factors involved in its evolution and the outcome of these patients throughout life. The present project is to implement a register in the whole country for children and adult patients


Eligibility criteria: Inclusion Criteria:

* all subjects with a Prader-Willi Syndrome

Exclusion Criteria:

-

Primary outcomes:
measure: collect data about patients
timeFrame: Baseline
Secondary outcomes:
measure: collect data about patients
timeFrame: During 10 years at least
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Children
Study officials:
affiliation: University Hospital, Toulouse
name: Tauber Maité, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pacoricona Alfaro DL, Lemoine P, Ehlinger V, Molinas C, Diene G, Valette M, Pinto G, Coupaye M, Poitou-Bernert C, Thuilleaux D, Arnaud C, Tauber M. Causes of death in Prader-Willi syndrome: lessons from 11 years' experience of a national reference center. Orphanet J Rare Dis. 2019 Nov 4;14(1):238. doi: 10.1186/s13023-019-1214-2.
Clinical trial NCT00594984: Phase I/II Combination With Irinotecan- Erbitux
Official title: A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs Placebo in Combination With Erbitux and Irinotecan K-Ras Wildtype Subjects With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Colorectal Cancer (MCRC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 38
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: Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)

Part 2: To compare median duration of progression free survival (PFS)


Eligibility criteria: Inclusion Criteria:

* Biopsy proven MCRC
* Prior irinotecan allowed
* Prior Erbitux allowed

Exclusion Criteria:

* No prior brivanib
* No prior combination of irinotecan with Erbitux
* No secondary malignancies
* No anti-coagulation therapy
* No prior history of blood clots requiring anti-coagulation

Primary outcomes:
measure: Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial
timeFrame: PK C1D1-C2-D3, biomarker throughout the study
measure: Safety and tolerability of interventions will be collected
timeFrame: throughout the study on Part II
Secondary outcomes:
measure: Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects
timeFrame: throughout the study on Part II
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Usc/Norris Comprehensive Cancer Center Hospital
state: California
city: Los Angeles
country: United States
facility: Usc/Norris Comprehensive Cancer Center
state: California
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Odense C
country: Denmark
facility: Local Institution
city: Meldola Fc
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06654284: Patient-Reported Quality of Life in Patients with an Implantable-Cardioverter Defibrillator - a Longitudinal Observational Study
Official title: Patient-Reported Quality of Life in Patients with an Implantable-Cardioverter Defibrillator - a Longitudinal Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Implantable Cardioverter Defibrillator (ICD)
Keywords: quality of life
Implantable Cardioverter Defibrillator (ICD)
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 400
Sex: MALE
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 any type of implantable cardioverter-defibrillator implanted and followed at UZ Leuven.

Brief summary: Patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (ICD), which has repeatedly shown improved survival. However, living with an ICD may pose several challenges and affect quality of life (QoL). This prospective longitudinal observational cohort studies will provide detailed insights in the change of patient-reported QoL after ICD impalntation. The aim is to study the change in time of the QoL perspective of patients who have an ICD, including physical and emotional health; ICD acceptance; concerns of ICD patients with regard to physical and sexual activity.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age
* Patients either scheduled for a new ICD implantation or scheduled for an elective generator change
* Willing and able to provide signed written informed consent.

Exclusion Criteria:

* Patients with a mental disability

Primary outcomes:
measure: General QoL assessed using the Short Form Health Survey (SF-12)
timeFrame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
Secondary outcomes:
measure: - Cardiac-specific QoL assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
measure: Florida Shock Acceptance score (FSAS)
timeFrame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
measure: ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS)
timeFrame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
measure: Steinke Sexual Concerns Inventory
timeFrame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
measure: "Concept of a Good Death" questionnaire
timeFrame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06940284: Food Intake of Hospitalized Elderly and Its Influence on Muscular and Clinical Outcomes
Official title: Food Intake of Hospitalized Elderly and Its Influence on Muscular and Clinical Outcomes: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrophy, Muscular
Undernutrition
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older individuals hospitalized

Brief summary: The objectives of the present study are: 1) to characterize the energy-protein intake of the elderly during hospitalization; 2) to verify the influence of energy-protein intake during hospitalization on muscular (i.e., cross-sectional area of the rectus femoris and vastus lateralis muscles, muscle strength, functionality and level of independence) and clinical (i.e., length of hospital stay, hospital readmission and mortality) at the time of hospital discharge, 2 and 6 months after hospital discharge and; 3) to verify whether energy-protein intake during hospitalization is a significant predictor of loss of function and muscle mass, length of hospital stay, hospital readmission rate and mortality.


Eligibility criteria: Inclusion Criteria:

* both sex;
* 65 years and older;
* hospital stay less than 48 hours;

Exclusion Criteria:

* cancer in the last 5 years;
* delirium;
* cognitive deficit that impossibility the patient to read and sign the informed consent form;
* neurological disease;
* neurodegenerative muscular disease;
* patients receive nutrition via enteral and parenteral routes.

Primary outcomes:
measure: Vastus Lateralis Muscle Cross-sectional Area
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
Secondary outcomes:
measure: Handgrip strength
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Muscle function
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Functional independence
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Length of hospital stay
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Mortality
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Hospital readmission post-medical discharge
timeFrame: 1- and 2- months post-medical discharge
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Hamilton Roschel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02148484: Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
Official title: Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PTSD
Keywords: PTSD
Cognitive Behavioral Treatment
Child Sexual Abuse
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Posttraumatic stress disorder (PTSD) is the most common disorder among childhood sexual abuse survivors and is associated with substantial psychosocial and medical problems, but evidence-based treatment for PTSD in adolescents is lacking. This study aims to examine the efficacy and effectiveness of prolonged exposure therapy for adolescents with client-centered therapy.


Eligibility criteria: Inclusion Criteria: female gender, age 13-18, and a primary DSM-IV-TR diagnosis of chronic or subthreshold PTSD related to sexual assault

Exclusion Criteria: current suicidal ideation with intent, uncontrolled bipolar disorder, schizophrenia, other thought disorders, or conduct disorder, the presence of a pervasive developmental disorder, initiation of treatment with psychotropic medication within the previous 12 weeks, and current inpatient psychiatric treatment

Primary outcomes:
measure: Change from baseline on PTSD symptoms utilizing the Child PTSD Symptom Scale-Interview (CPSS-I)
timeFrame: Baseline, mid-treatment, post-treatment, 3-, 6-, and 12-month follow-ups
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Edna B Foa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang C, Kaczkurkin AN, McLean CP, Foa EB. Emotion regulation is associated with PTSD and depression among female adolescent survivors of childhood sexual abuse. Psychol Trauma. 2018 May;10(3):319-326. doi: 10.1037/tra0000306. Epub 2017 Jul 6.
citation: Kaczkurkin AN, Asnaani A, Zhong J, Foa EB. The Moderating Effect of State Anger on Treatment Outcome in Female Adolescents With PTSD. J Trauma Stress. 2016 Aug;29(4):325-31. doi: 10.1002/jts.22116. Epub 2016 Jul 26.
citation: Foa EB, McLean CP, Capaldi S, Rosenfield D. Prolonged exposure vs supportive counseling for sexual abuse-related PTSD in adolescent girls: a randomized clinical trial. JAMA. 2013 Dec 25;310(24):2650-7. doi: 10.1001/jama.2013.282829.