louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04210960: Correlation of Serum Lactate and Activity of Multiple Sclerosis
Official title: Correlation of Serum Lactate and Activity of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis, serum lactate and MRS
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 80 Egyptian subjects (50 multiple sclerosis patients (patients group = group I) and 30 normal healthy control (control group = group II)

Brief summary: Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS

Detailed description: Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS and magentic resonanace imaging , magentic resonanace spectroscopy

Eligibility criteria: Inclusion Criteria:

-Patients with multiple sclerosis (RRMS,PPMS and SPMS)

Exclusion Criteria:

-Patients with any other medical conditions that may affect the serum lactate level

Primary outcomes:
measure: Biochemical testing
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Assistant Prof of Neurology
name: Esmael M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esmael A, Talaat M, Egila H, Eltoukhy K. Mitochondrial dysfunction and serum lactate as a biomarker for the progression and disability in MS and its correlation with the radiological findings. Neurol Res. 2021 Jul;43(7):582-590. doi: 10.1080/01616412.2021.1893567. Epub 2021 Mar 4.
Clinical trial NCT00255060: Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
Official title: Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: United States Department of Defense
First posted: 2005-11-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with high risk of breast cancer

Brief summary: To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.

Detailed description: General Purpose: The purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality.

The following are our specific goals in this endeavor;

1. To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography
2. To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings
3. To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a \>10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology.

Eligibility criteria: Inclusion Criteria:Subjects must be female, between the ages of 25 and 65, or ten years younger than the youngest breast cancer diagnosed in the family, or have no mutation identified but have a greater than 10% risk of developing breast cancer in ten years (based on the Claus Model).

May have had previous breast or ovarian cancer, but must be at least one year out from treatment of a Stage 1 or early 2 cancer.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: James M Ford
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04807660: Bacteriological Evaluation of Children With Otorrhea
Official title: Bacteriological Evaluation of Spontaneous Otorrhea in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Otorrhea
Keywords: otorrrhea
children
spontaneous perforation of the tympanic membrane
ambulatory
streptococcus pneumoniae
heamophilus influenzae
moraxella catarrhalis
streptococcus pyogenes
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all children from 3 months to 15 years old with otorrhea

Brief summary: After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). The aim of this study was to describe the bacteriological causes of SPTM several years after PCV13 implementation, in 2010.

Detailed description: Since October 2015, children with spontaneous perforation of the tympanic membrane (SPTM) are prospectively enrolled by 41 pediatricians who are part of a research and teaching network (ACTIV, Association Clinique et Thérapeutique Infantile du Val de Marne \[Clinical and Therapeutic Association of Val de Marne\]) throughout France. For some patients, otorrhea is the first manifestation of AOM; for others, otorrhea occurred after AOM treatment failure or recurrence. Failure (non-responsive AOM) is defined as otorrhea appearing despite at least 48 hr of antibiotics or recurring less than 4 days after the end of antibiotic treatment. Recurrence is defined by the appearance of otorrhea 4 to 30 days after the end of antibiotic treatment for AOM.

Middle ear fluid (MEF) is obtained by sampling spontaneous discharge according to clinical practice guidelines. MEF specimens are obtained with cotton-tipped wire swabs, immediately placed in transport medium (Copan Venturi Transystem®, Brescia, Italy), and transported within 48 hr to one of the two centralized microbiology laboratories (Robert Debré Hospital or National Centre for Pneumococci at European Georges Pompidou Hospital, Paris, France).

Eligibility criteria: Inclusion Criteria:

* children from 3 months to 15 years old
* with otorrhea
* signed parents consent

Exclusion Criteria:

* children under 3 months
* children \> 15 years old

Primary outcomes:
measure: Bacteria identification
timeFrame: at inclusion
Secondary outcomes:
measure: Describe the serotypes of S. pneumoniae
timeFrame: at inclusion
measure: Describe the resistance of heamophilus influenzae
timeFrame: at inclusion
Other outcomes:
Locations:
city: Créteil
country: France
facility: ACTIV
Study officials:
affiliation: Association Clinique et Thérapeutique Infantile du Val de Marne
name: Robert Cohen
role: STUDY_DIRECTOR
References:
Clinical trial NCT03425760: A Cross-sectional Study of COPD and Symptom Variability in MEA Countries
Official title: A Cross-sectional Study of COPD and Symptom Variability in MEA Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 3254
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: Stable GOLD C or D COPD patient under maintenance treatment, over 45 years

Brief summary: This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities.

It will also explore the current practice in management of stable GOLD C and D COPD patients.

Detailed description: 1. Primary objective: To assess perception of daily and weekly variability of symptoms in stable GOLD C and D COPD patients and their impact on daily life activities
2. Secondary objectives:

   * To describe the current treatment practice for the management of GOLD C and D COPD in MEA countries and their adherence to the GOLD 2015 guidelines
   * To compare patients' perception of symptoms variability and their impact on activities between Gold categories C and D
   * To identify demographic, behavioral and clinical factors associated with symptoms variability.

Eligibility criteria: Inclusion Criteria:

* Patients eligible for inclusion have to fulfill all of the following criteria:

  1. Stable GOLD C or D COPD patient under maintenance treatment, over 45 years, who provided signed informed consent;
  2. COPD diagnosis documented by spirometry performed in the past 12 months with an FEV1/FVC \< 0.7 and an FEV1 \< 50% predicted.

Exclusion Criteria:

Patients are not eligible for inclusion if they meet one of the following criteria:

1. Patient with an ongoing COPD exacerbation\*;
2. Patient who has experienced an exacerbation\* in the previous 3 months;
3. History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
4. Inability to understand the study related questions;
5. Mentally disabled patient or unable to read and write;
6. Pregnant.
7. Current participation in a clinical trial;

Primary outcomes:
measure: Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients
timeFrame: 1 Year
measure: Impact of symptom variability on daily life activities of Chronic obstructive pulmonary disease(COPD) Patients
timeFrame: 1 Year
Secondary outcomes:
measure: Current treatment practice for the management of COPD in Middle East Africa countries and their adherence to The Global Initiative for Chronic Obstructive Lung Disease(GOLD 2015) guidelines
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00568360: Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer
Official title: Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 8
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: All patients with newly diagnosed head and neck cancer as well as those being seen for routine follow up with no evidence of current disease and healthy volunteers are eligible for this study.

Brief summary: Endoscopy is a standard part of the evaluation of patients with head and neck cancer used for determining the extent of tumor involvement. However, not all areas involved by tumor are apparent visually. Preliminary results indicate that compared with normal tissues, tumors have abnormal levels of capillary oxygenation. The purpose of this study is to determine the ability of non-pulsatile visible light tissue oxygen monitoring to differentiate normal and tumor tissue based on capillary oxygenation during endoscopy Should this be possible, this method could be used to mark tumor extent and invasion, even when that invasion is up to 5mm blow the tissue surface.


Eligibility criteria: Inclusion Criteria:All patients with newly diagnosed head and neck cancer as well as those being seen for routine follow up with no evidence of current disease and healthy volunteers are eligible for this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Peter Maxim PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05320094: A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
Official title: An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Mavacamten
Sorbitol
Activated Charcoal
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Body mass index between 18 and 30 kg/m\^2, inclusive, at the Screening Visit
* Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments

Exclusion Criteria:

* Current or recent (within 3 months of study intervention administration) gastrointestinal disease
* History of sorbitol or fructose intolerance or inability to tolerate activated charcoal
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
timeFrame: Up to 2 months
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
timeFrame: Up to 2 months
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 1 month
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 3 months
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 3 months
measure: Number of participants with vital sign abnormalities exceeding predefined thresholds
timeFrame: Up to 3 months
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 3 Months
measure: Number of participants with physical exam abnormalities
timeFrame: Up to 3 months
measure: Number of participants with clinical laboratory evaluation abnormalities
timeFrame: Up to 3 months
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 1 month
measure: Apparent terminal plasma half-life (T-HALF)
timeFrame: Up to 2 months
measure: Concentration at 24 hours (C24)
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Local Institution - 0001
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06712394: Knee Osteoarthritis and IPACK
Official title: Interspace Between the Popliteal Artery and Capsule of the Posterior Knee-
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis, Knee
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 50-90 who underwent IPACK block treatment due to Knee OA

Brief summary: Interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) block involves ultrasound-guided local anesthetic infiltration of the space between the popliteal artery and the posterior knee joint capsule.

The purpose of the study; To investigate the effectiveness of this block applied to knee osteoarthritis in clinical practice.

In this study, patients who underwent IPACK block by the practitioner; Demographic data, medications used, block success, block characteristics and block-related complications will be recorded observationally. Before and after the block procedure, patients' pain was measured with the Numeric Rating Scale (NRS) at 1st and 3rd months, their disability levels were measured with The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and Short Form-12 (Short Form). Quality of life will be measured with the -SF-12) survey.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from grade 3 and 4 knee osteoarthritis

Exclusion Criteria:

* Patients who have had previous knee surgery
* Patients who have had any knee injection in the last 3 months
* Malignancy
* Inflammatory disease
* Infectious disease (local or general)

Primary outcomes:
measure: Pain assessment
timeFrame: 1st and 3rd month after the procedure
measure: Functional status
timeFrame: 1st and 3rd month after the procedure
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 1st and 3rd month after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: sakarya training and research hospital, pain clinic
name: Rıdvan Isık
role: STUDY_CHAIR
References:
Clinical trial NCT00875394: Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
Official title: A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy


Eligibility criteria: Inclusion Criteria:

* Patient Has Type 2 Diabetes Mellitus
* Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
* Patient Is Currently On Metformin Therapy (1500 Mg/Day)
* Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With \>2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
* Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
* Patient Has An A1c of 6.5 % - 11.0%

Exclusion Criteria:

* Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24
timeFrame: Baseline and 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002794: Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
Official title: Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Retinoblastoma
Keywords: intraocular retinoblastoma
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-26
Enrollment: 25
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma.

Detailed description: OBJECTIVES: I. Estimate the objective response rate in infants and children with retinoblastoma when treated with carboplatin (CBDCA) and vincristine (VCR) every 3 weeks for 24 weeks. II. Assess the success of this regimen in delaying radiotherapy and eliminating the need for surgery by estimating the cumulative incidence function of treatment failure. III. Estimate the cumulative incidence of failure of this regimen as measured by subsequent treatment with radiotherapy or surgery.

OUTLINE: All patients receive carboplatin and vincristine every 3 weeks for a maximum of 8 courses. Patients with disease progression after at least 2 courses are removed from study and considered for alternative therapy. Patients are followed every 6 weeks for 1 year, every 2 months for 1 year, every 3-4 months for 3 years, and yearly for 12 years.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 4.5 years.

Eligibility criteria: DISEASE CHARACTERISTICS: Newly diagnosed retinoblastoma Bilateral or multifocal unilateral disease in children under age 10 Unilateral, multifocal tumors less than 5 dd in children under age 2 No metastatic disease Disease evidenced by ophthalmoscopic/imaging exam, ultrasound, CT, or MRI Fundus drawings and photographs required

PATIENT CHARACTERISTICS: Age: 10 and under Performance status: Not specified Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee, Memphis Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: Saint Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Carlos Rodriguez-Galindo, MD
role: STUDY_CHAIR
References: