louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00881374: Dermacyd Infantile (Lactic Acid)- Compatibility.
Official title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermic Irritability, Dermic Sensitivity) of Dermacyd Infantile (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.


Eligibility criteria: Inclusion criteria:

* Photo type Skin I,II, III e IV
* Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.

Exclusion criteria:

* Lactation or gestation
* Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Previous atopy
* History of sensitivity or irritation for topic products
* Active cutaneous diseases which can interfere in the study results
* Use of new drugs and/ or cosmetics during the study
* Cutaneous reactivity
* Previous participation in studies, which had used the product
* Volunteers who have immunodeficiency congenital or acquired
* Relevant clinical history or present evidence of alcohol abuse or others drugs
* Non tolerance to some component of the study product.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: During 6 weeks (i.e. treatment period)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT00644774: A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications
Official title: A Comparative, Multi-Center, Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: pediatric taste test
antibiotic taste test
cefdinir
azithromycin
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 157
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.

Detailed description: The Primary Purpose for the study is "Other". Per ClinicalTrias.gov, more information regarding the primary purpose is described here; this study is a pediatric taste test.

Eligibility criteria: Inclusion Criteria:

* Female or male child age 4 through 8 years in good general health.
* Minimum weight of 16.3 kg (36 lb).
* Willing to comply with appropriate instructions provided to complete the study.
* Written informed consent from parent/legal guardian.

Exclusion Criteria:

* Current medical condition, that in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.).
* History of allergic reaction to cefdinir, azithromycin, prescription (e.g. penicillins or cephalosporins) and/or OTC medications, and/or food products.
* History of significant medical condition (e.g., GI disorders, hematological or bleeding disorders, renal or hepatic diseases).
* Use of any oral medication, vitamins or herbal supplements within 6 hours prior to tasting.
* Temperature \> than 99.2°F. Participation in a clinical or marketing research study within the past 3 months.
* Sibling of another subject on the study, or living in the same household as another subject that has participated in a clinical or marketing research study within the past 3 months.
* Family member or close friend employed by an advertising agency, market research company, and/or a company that processes or manufacturers medical or health care products.

Primary outcomes:
measure: Taste and smell acceptance and preference
timeFrame: 2 hours
Secondary outcomes:
measure: Adverse events assessment
timeFrame: 72 hours with follow-up to a satisfactory conclusion
measure: Concomitant Medications
timeFrame: 72 hours
measure: Vital signs
timeFrame: 2 hours
measure: Any clinically abnormal observations
timeFrame: 2 hours with follow-up to a satisfactory conclusion
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: St. Petersburg
country: United States
state: Florida
city: Miamiville
country: United States
state: Ohio
Study officials:
References:
Clinical trial NCT00187174: Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors
Official title: Phase I Trial of RAD001C (Everolimus) in Pediatric Patients With Recurrent Refractory Solid Tumors or Brain Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Brain Tumors
Rhabdomyosarcoma
Sarcoma, Soft Tissue
Keywords: Brain tumors
Soft Tissue Sarcomas
Refractory solid tumors
Recurrent or Refractory Rhabdomyosarcomatous Soft Tissue and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-09-16
Enrollment: 41
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with recurrent or refractory solid tumors or brain tumors that are unresponsive to conventional therapy, or with no known effective therapy, will be treated. Experiments in the laboratory have shown the experimental drug RAD001C (RAD001, Everolimus) can prevent cells from multiplying. RAD001 is now being tested in diseases such as cancer, in which excessive cell multiplication needs to be stopped. The drug has been tested in adult cancer patients and has been well tolerated by subjects in these studies. It is experimental and, therefore, available in clinical trials.

Detailed description: Although a Phase II portion of this study was planned, it was never initiated.

Eligibility criteria: Inclusion Criteria:

* Adequate performance status
* Adequate bone marrow, kidney, heart, and liver function

Exclusion Criteria:

* Must not be receiving concomitant anti-cancer treatment
* Must not be pregnant

Primary outcomes:
measure: To find the highest dose of RAD001 that can be given to children with refractory or relapsing solid tumors, leukemias, or brain tumors without causing severe side effects
timeFrame: Within 30 days per subject
Secondary outcomes:
measure: To find out if there are changes in the body's blood cells and tumor cells after treatment with RAD001
timeFrame: Within 30 days per subject
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Wayne L Furman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02298374: Evaluation of Homecare Reablement, the Trondheim Model
Official title: Evaluation of Homecare Reablement, the Trondheim Model
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mobility Limitation
Asthenia
Keywords: Rehabilitation
Evaluation studies
Home care services
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Trondheim Kommune
name: St. Olavs Hospital
First posted: 2014-11-24
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim is to evaluate a model of home-based rehabilitation. The intervention targets elder persons who receive homecare services, but still are relatively independent in most activities of daily living. The model focuses on early identification of decline in function and intervention in the home environment through close cooperation between the participant, homecare services and therapists.


Eligibility criteria: Inclusion Criteria:

* receive homecare services
* live within the catchment area

Exclusion Criteria:

* In-patient length of stay (IPLOS) score \> 2.0
* severe dementia

Primary outcomes:
measure: Change in Activity level (measured by body-worn sensors)
timeFrame: 1 years
Secondary outcomes:
measure: Change in Short Physical performance battery score
timeFrame: 1 year
measure: Change in received hours with homecare services
timeFrame: 1 year
measure: Qualys (EQ- 5D)
timeFrame: 1 year
measure: Change in IPLOS score
timeFrame: one year
measure: Change in cognitive function (Subscore of the Iplos score)
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jorunn L Helbostad, phd prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02910674: Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report
Official title: Dario Blood Glucose Monitoring System - Android Devices User Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: LabStyle Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 102
Sex: ALL
Minimum age (years): 13
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.

Detailed description: The objectives for this study are to evaluate the blood glucose level results obtained from the subject's fingertip using the Dario Blood Glucose Monitoring System paired with a reference device from one of three Android smart mobile device families as compared to the results from the Yellow Springs Instrument 2300 STAT Plus. The usability of the Dario Blood Glucose Monitoring System when paired with a reference device from one of three Android smart mobile device families and used by laypersons is also evaluated.

Eligibility criteria: Inclusion Criteria:

* Subject has Type 1 or Type II diabetes
* Subject speaks and reads English proficiently
* Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study)

Exclusion Criteria:

* Subject has medical training or works in the field of blood glucose monitoring systems.
* Subject is critically ill.
* Subject has an impairment that prevents him/her from following the study procedures.
* Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
* Hematocrit levels outside the range of 20%-60%.

Primary outcomes:
measure: Accuracy of Glucose Concentrations (%)
timeFrame: 1 Day
measure: Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS"
timeFrame: 1 Day
measure: Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"
timeFrame: 1 Day
measure: Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?"
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
Study officials:
References:
Clinical trial NCT00004274: Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome
Official title: Controlled Study of Estrogen Effects on Cognitive and Social Function in Girls With Turner's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Turner's Syndrome
Keywords: Turner's syndrome
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Jefferson Medical College of Thomas Jefferson University
First posted: 1999-10-19
Enrollment: 260
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce estrogen. Giving estrogen is standard treatment for girls who have Turner's syndrome. Estrogen may be effective treatment for mental and social functioning problems experienced by girls with Turner's syndrome.

PURPOSE: Clinical trial to study the effectiveness of long term estrogen therapy on mental and social functioning in girls who have Turner's syndrome.

Detailed description: PROTOCOL OUTLINE: Participants are evaluated for cognitive and social function at entry and 4 years following entry. Assessments include the Wechsler Intelligence Scale for Children-Revised, a child behavior checklist, the Children's Self-Concept Scale, and visual-spatial, visual-motor, attention, memory, language, and facial recognition tasks.

Patients (and parents) undergo X-chromosome analysis; brain magnetic imaging is optional.

Controls are matched using school selection and telephone interviews.

A study duration of 12 years is estimated.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Girls aged 8 and 12 years with Turner's syndrome-compatible karyotype
* Age-matched girls without Turner's syndrome entered as controls
* Concurrent registration on Thomas Jefferson University growth study required of subjects with Turner's syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Medical College of Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Jefferson Medical College of Thomas Jefferson University
name: Judith Levine Ross
role: STUDY_CHAIR
References:
Clinical trial NCT02181374: The Diagnosis Value of Serum Marker in Stroke Associated With Nonvalvular Atrial Fibrillation.
Official title: The Diagnosis Value of Serum Marker in Stroke Associated With Nonvalvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: atrial fibrillation
NT-proBNP
Cardioembolic Stroke
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Tang-Du Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Shaanxi Provincial People's Hospital
First posted: 2014-07-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 ≤ Age ≤ 85; meet the clinical diagnostic criteria for acute ischemic stroke; onset within 24 hours at the same time more than one hour; it was diagnosed with experiential doctor.

Brief summary: The purpose of this study is to evaluate the diagnostic value of serum NT - proBNP in stroke associated with nonvalvular atrial fibrilltion.

Detailed description: All included in the cases in 7 days of blood samples, the detection of serum NT - proBNP.Through the single factor analysis to determine the serum NT - proBNP central source sex stroke prediction values.

Eligibility criteria: Inclusion Criteria:

* 18 ≤ Age ≤ 85;
* Meet the clinical diagnostic criteria for acute ischemic stroke;
* onset within 7 days;

Exclusion Criteria:

* Severe systemic disease (chronic inflammation, infection, blood system diseases, cancer, kidney failure, liver failure,heart failure);
* Nearly a month history of myocardial infarction;
* pregnant;
* Serious neurological disease that the diagnosis is unclear;

Primary outcomes:
measure: The diagnostic value of serum NT - proBNP in stroke associated with nonvalvular atrial fibrilltion
timeFrame: 34 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Department of Neurology, Xijing Hospital
state: Shaanxi
Study officials:
affiliation: The Department of Neurology, Xijing Hospital
name: Wen Jiang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06775574: Prognostic Significance of the Lung Immune Prognostic Index (LIPI) in Postoperative Clear Cell Renal Cell Carcinoma: a Multicenter Retrospective Cohort Study
Official title: Prognostic Significance of the Lung Immune Prognostic Index (LIPI) in Postoperative Clear Cell Renal Cell Carcinoma: a Multicenter Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ccRCC
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 704
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: This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy.

Brief summary: This retrospective study included 704 patients with ccRCC who underwent radical or partial nephrectomy. Patients were stratified into the LIPI good group and the intermediate/poor (int./poor) group based on dNLR (≥ 3) and LDH (≥ 245 U/L) levels. Propensity score matching (PSM) was used to adjust for baseline differences and minimize selection bias. Kaplan-Meier survival curves and Cox regression models were employed to evaluate the impact of LIPI and other clinical factors on recurrence-free survival (RFS) and overall survival (OS).


Eligibility criteria: Inclusion Criteria:

1. Pathologically diagnosed with ccRCC;
2. Underwent radical or partial nephrectomy.

Exclusion Criteria:

1. presence of concurrent malignancies;
2. missing data or failure to follow-up

Primary outcomes:
measure: overall survival (OS)
timeFrame: 5 years
measure: recurrence-free survival (RFS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT03301974: A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
Official title: A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pterygium
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. The investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.

Detailed description: Design: Prospective randomized comparative interventional clinical study Setting: Assiut university hospital \& El-Mabarah hospital for health insurance Methods: The study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).

Eligibility criteria: Inclusion Criteria:

1. Patients complaining of primary Progressive nasal pterygium.
2. Patients with pterygium threatening the visual axis.

Exclusion Criteria:

1. Double head pterygium.
2. Pseudopterygium
3. Recurrent pterygium
4. Patients with history of any bleeding abnormalities
5. Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.

Primary outcomes:
measure: Recurrence Rate
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Graft stability
timeFrame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
measure: Postoperative inflammation
timeFrame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
measure: Postoperative discomfort
timeFrame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
measure: Overall patient satisfaction
timeFrame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
measure: Complications
timeFrame: 1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
Other outcomes:
Locations:
Study officials:
References: