louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01723631: Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
Official title: Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
TRAP
TRAP-Myéline
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2012-11-08
Enrollment: 189
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,


Eligibility criteria: Inclusion Criteria:

* These criteria depend on the subgroup belongs to the patient.
* Signed consent
* Membership of a social security system

Exclusion Criteria:

* Whatever the patient group or control:
* Processing immunosuppressive.
* Processing by a monoclonal antibody.
* Previous treatment with an immunosuppressant for a significant period of time (more than 6 months of oral treatment, more than 6 cycles of cyclophosphamide over 3 cures mitoxantrone).
* Carcinomatous pathology known evolving.
* People under guardianship.
* Pregnant women.
* Patients not motivated to study. Known patients with anemia (hemoglobin \<10g/100ml)

Primary outcomes:
measure: Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis
timeFrame: 2 years
Secondary outcomes:
measure: Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Bron
country: France
facility: Hopital neurologigue Pierre Wertheimer
city: Clermont Ferrand
country: France
facility: University Hospital of clermont Ferrand
city: Lille
country: France
facility: University Hospital of Lille
city: Marseille
country: France
facility: University Hospital of Marseille
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nantes
country: France
facility: University Hospital of Nantes
city: Nice
country: France
facility: University Hospital of Nice
city: Rennes
country: France
facility: University Hospital of Rennes
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
References:
Clinical trial NCT00367731: NOW Thai HAART Study
Official title: Neurological Outcomes With in THAI National HAART Program.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
AIDS
Neurological Complications
Keywords: HIV
AIDS
Neurological complications
HAART
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Rajavithi Biomolecular Research Center
First posted: 2006-08-23
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: After Initiation of HAART in peoples who living with HIV/AIDS in Thailand by the year 2000, rapidly expanded HAART access of national project has been promoted in 2004. Free ARVs (For CD4\<200cell/cu.mm. or in symptomatic HIV with CD4\<250 cell/cu.mm. )and CD4 monitoring has been available. The first-line regimen is d4T+3TC+NVP in mainly the first time (Naive) patients. CD4 response ), rate of opportunistic infection, and neurological outcomes were measured. Rate of ARV change, adverse events,treatment failure, TB co-infection rate, percent changing to EFV-based regimen or PI-based regimen were recorded.

Any Adverse Events including, Sever rash, Severe Hepatitis, Lipid abnormalities, Severe Anemia and Other, common AEs will be analysed.


Eligibility criteria: Inclusion Criteria:

* HIV/AIDS patients.
* Age \>15 years.
* informed consent

Exclusion Criteria:

* Not informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Lumpang
country: Thailand
facility: Lumpang Hospital
city: Ubonratchathani
country: Thailand
facility: Sappasithiprasong Hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Subsai Kongsaengdao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004831: Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythropoietic Protoporphyria
Keywords: erythropoietic protoporphyria
inborn errors of metabolism
porphyria
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: St. Luke's-Roosevelt Hospital Center
First posted: 2000-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study.

Patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally twice daily, 2 capsules with breakfast and 2 with lunch. Group 1 receives cysteine hydrochloride in drug ingestion period 1 followed by placebo in period 2. Group 2 receives placebo in period 1 followed by cysteine hydrochloride in period 2. Both groups ingest placebo for 1 week between the periods. Each drug ingestion period lasts 8 weeks.

Follow up phone calls are made at the end of months 1 and 3. All patients schedule follow up visits at the end of each drug ingestion period.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Documented erythropoietic protoporphyria Determination of elevated protoporphyrin within the past year Experiencing photosensitivity --Prior/Concurrent Therapy-- No concurrent use of betacarotene --Patient Characteristics-- Other: Not pregnant or nursing Fertile female patients must use effective contraception while on study and for 3 weeks thereafter

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Micheline M Mathews-Roth
role: STUDY_CHAIR
References:
Clinical trial NCT04461431: Clinical Study of Posterolateral Structure of Knee Joint Under Arthroscopy
Official title: Clinical Study of Anatomical Reconstruction Technique of Posterolateral Structure of Knee Joint Under Arthroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: the Posterolateral Structure of the Knee Joint
Arthroscopy
Anatomical Reconstruction
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To study the clinical effect of anatomical reconstruction of the posterolateral structure of the knee joint under arthroscopy.

Methods: The patients who were admitted to hospital for the treatment of posterolateral structural injuries of the knee joint, including those with other ligament injuries (combined with anterior and posterior cruciate ligament injuries and medial collateral ligament injuries) were subjected to arthroscopic reconstruction of the posterolateral structures. Carry out preoperative and postoperative evaluations, and conduct preoperative and postoperative comparative studies to clarify the clinical effect of the procedure.

Expected results: The anatomical reconstruction technique of the posterolateral structure of the knee joint under arthroscopy may effectively restore the stability and motor function of the knee joint.

Expected conclusion: Arthroscopic anatomical reconstruction of the posterolateral structure of the knee is an effective minimally invasive technique.


Eligibility criteria: Inclusion Criteria:

* Age \<70 years old
* Those without avulsion of the affected biceps femoris tendon or iliac tibial bundle
* Those without avulsion fracture of the fibular stop of the lateral collateral ligament

Exclusion Criteria:

* none

Primary outcomes:
measure: KT2000
timeFrame: 1 year after operation
measure: Lysholm
timeFrame: 1 year after operation
measure: Tegner
timeFrame: 1 year after operation
measure: IKDC
timeFrame: 1 year after operation
Secondary outcomes:
measure: MRI
timeFrame: 1 year after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
state: Beijing
Study officials:
References:
Clinical trial NCT05670431: The Effect of Smile Designs on Aesthetic Perception
Official title: The Effect of Smile Designs Using the Digital Smile Design Program on Aesthetic Perception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dentistry
Perception
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4th and 5th-grade students of a dentistry faculty: 4th and 5th-grade students at the university where the researcher works (Trakya University, Faculty of Dentistry)

Dentists and specialist dentists: Dentists and specialist dentists working in health institutions in the country where the researcher is located (Republic of Türkiye)

Laypeople: People who came to the dental faculty for treatment, relatives and friends of the researcher.

Brief summary: The goal of this observational study is to examine the effect of designs using different aesthetic dental proportions made with the digital smile design program on the aesthetic perception of individuals of different ages, gender, and educational status.

The main questions it aims to answer are:

1. The golden ratio is the most aesthetic ratio known and accepted in dentofacial structures.
2. There is no significant difference between the aesthetic perception of dental students, dentists, specialist dentists and laypeople.

Participants will answer:

* The first 5 questions related that demographic data such as age, gender, and educational status.
* The smile designs of a woman and a man, prepared according to 8 different principles, will be evaluated by the participants according to the Likert scale.

Researchers will compare the 4th and 5th-grade students of a dentistry faculty, dentists, specialist dentists and laypeople to see the effect of smile design on facial aesthetic perception.


Eligibility criteria: Inclusion Criteria:

* Anyone who can answer the survey online

Exclusion Criteria:

* individuals under the age of 18

Primary outcomes:
measure: Likert scale
timeFrame: 1 day (single measurement)
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Trakya University
state: Edirne
Study officials:
References:
Clinical trial NCT00578331: Safety Study of Olopatadine Nasal Spray
Official title: Safety Study of Olopatadine Nasal Spray
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Keywords: rhinitis
perennial allergic rhinitis
allergic rhinitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 890
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older

Exclusion Criteria:

* Age 11 years and younger

Primary outcomes:
measure: Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire
timeFrame: day 30
Secondary outcomes:
measure: Average Number of Days of Rescue Medication Taken
timeFrame: Month 1 through Month 12
Other outcomes:
Locations:
city: Waco
country: United States
facility: Waco
state: Texas
Study officials:
affiliation: Alcon Research
name: Margaret Drake
role: STUDY_DIRECTOR
References:
Clinical trial NCT05527431: High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma
Official title: High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blunt Injury of Thorax
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 120
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: to compare high flow nasal cannula against noninvasive ventilation in patients with non-sever blunt chest trauma in improvement of oxygenation, need for intubation and mechanical ventilation within 28 days


Eligibility criteria: Inclusion Criteria:

* Age ≥18 y,
* Willing and able to provide written informed consent prior to performing study procedures,
* currently hospitalized and requiring medical care for non-sever blunt chest trauma (abbreviated injury severity scale ≤ 2) SpO2 90% or less while breathing 10 L/min.

Exclusion Criteria:

* Contraindications of noninvasive ventilation (face trauma or surgery, airway obstruction, upper gastrointestinal tract bleeding, disturbed level of consciousness), -smoker
* intubation for any cause other than respiratory cause

Primary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: 3 successive days
Secondary outcomes:
measure: Discomfort score
timeFrame: 3 successive days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT05718973: A Short, Animated Storytelling Video to Boost Psychological Capital
Official title: Efficacy of a Short, Animated Storytelling Video to Boost Psychological Capital in the Post-pandemic Era: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Capital
Keywords: psychological capital
education entertainment intervention
short, animated storytelling
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Heidelberg University
First posted: 2023-02-08
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 4-armed, parallel, randomized controlled trial, conducted purely online
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effect of a short, animated storytelling intervention video on positive psychological capital intervention on immediate and medium-term psychological capital and related constructs, gratitude and happiness. We will also measure voluntary engagement with the content of the short, animated storytelling intervention video on positive psychological capital.

In this 4-armed, parallel, randomized controlled trial, 10,000 adult, US participants will be randomly assigned to (1) a short, animated storytelling intervention video on positive psychological capital followed by the psychological capital , gratitude and happiness surveys (2) the surveys only, (3) an attention placebo control video followed by the before mentioned surveys, and (4) an arm that is exposed to neither the video nor the surveys. Two weeks later, participants in all four arms will complete all of the surveys.

The primary outcome is psychological capital (immediate and medium-term). Secondary outcomes are gratitude and happiness (immediate and medium-term) as well as voluntary engagement with the short, animated storytelling video content.


Eligibility criteria: Inclusion Criteria:

* Registration with the Prolific platform

Exclusion Criteria:

* none

Primary outcomes:
measure: Immediate effect of the short, animated storytelling intervention video on positive psychological capital
timeFrame: immediately after watching the video
Secondary outcomes:
measure: Medium-term effect of the short, animated storytelling intervention video on psychological capital
timeFrame: 2 weeks
measure: Immediate effect of the short, animated storytellingintervention video on gratitude and happiness
timeFrame: immediately after watching the video
measure: Medium-term effect of exposure to psychological capital and related psychological scales on these same outcomes
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Heidelberg University
name: Till Bärnighausen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06045273: The Elders' Resilience Curriculum
Official title: The Elders' Resilience Curriculum: Toward Building Empirical Evidence Around a Culturally-Grounded, Strengths-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Keywords: American Indian
Alaska Native
Suicide prevention
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-09-21
Enrollment: 72
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The overall goal of this research is to better understand if and how the Elders' Resilience Curriculum (ERC), a culturally grounded, school-based upstream suicide prevention program taught by White Mountain Apache Tribe (WMAT) Elders to youth, promotes connectedness, cultural strengths, and reasons for living among American Indian youth.

Detailed description: The overall goal of this research is to better understand if and how the Elders' Resilience Curriculum (ERC), a culturally grounded, school-based upstream suicide prevention program taught by White Mountain Apache Tribe (WMAT) Elders to youth, promotes connectedness, cultural strengths, and reasons for living among American Indian youth. Prior to this trial, the investigators collaborated with WMAT research partners to gather qualitative data to identify key protective factors and core components of the ERC. After identifying key protective factors and core components of the ERC, the investigators developed a culturally adapted assessment battery and theoretical model to assess the ERC. This study works with White Mountain Apache tribal community partners to collaboratively pilot test a rigorous evaluation of the ERC.

Eligibility criteria: Inclusion Criteria:

* Ages 9-14 years
* Enrolled in a school where the Elders' Resilience Curriculum is delivered
* Participating in the Elders' Resilience Curriculum Program

Exclusion Criteria:

* Parent/Guardian objection to youth participation

Primary outcomes:
measure: Change in Reasons for Life as Assessed by the Reasons for Life Scale
timeFrame: Baseline, 26 weeks
measure: Change in Cultural Connectedness as Assessed by the Cultural Connectedness Scale - Short Form
timeFrame: Baseline, 26 weeks
Secondary outcomes:
measure: Change in Awareness of Connectedness as Assessed by the Awareness of Connectedness Scale
timeFrame: Baseline, 26 weeks
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: CIH Whiteriver Office
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Victoria O'Keefe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01102673: Single Dose Study of PF-04991532 in Healthy Subjects
Official title: A Phase 1 Placebo-Controlled Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Food Effect of Single Escalating Oral Doses of PF-04991532 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Keywords: phase 1
safety and tolerability
PK
T2DM
type 2 diabetes mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK) and preliminary food effect of PF-04991532 following single escalating oral doses in healthy adult subjects.

Detailed description: Safety/Tolerability and PK

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Self-reported history of hypoglycemia, or fasting laboratory glucose value \</=80 mg/dL at screening or Day 0 of Period 1, confirmed by a single repeat if deemed necessary.

Primary outcomes:
measure: Safety and Tolerability Endpoints: physical exams, AE monitoring, 12-lead ECGs, continuous cardiac monitoring, vital sign and clinical safety laboratory (including frequent glucose assessments via glucometer) measurements.
timeFrame: 1 month
measure: PK Endpoints: AUC(0-inf), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit.
timeFrame: 1 month
Secondary outcomes:
measure: none-see my comment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: