louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01791608: Zinc Sulphate vs. Zinc Amino Acid Chelate
Official title: Effect of Zinc Sulphate and Zinc Amino Acid Chelate in Prevention Acute Diarrhea and Acute Respiratory Infection, Medellín 2012
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Acute Respiratory Infection
Keywords: Child, Preschool
Dietary Zinc
Zinc sulfate
zinc-glycine chelate
Lead sponsor: CES University
Sponsor class: OTHER
Collaborators: name: Nutreva S.A.S.
name: Foundation Child Care - FAN
First posted: 2013-02-15
Enrollment: 360
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years.

Among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to infections. Zinc deficiency has been shown to favor the development of infections and has been considered a real public health problem.

Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that has shown evidence of being better absorbed and tolerated.

We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in the prevention of acute diarrheal disease and acute respiratory infection.


Eligibility criteria: Inclusion Criteria:

Children who

* Belong to institute FAN in Medellín
* Attend full time to institute FAN (eight hours)
* Have 2 to 5 years

Exclusion Criteria:

Children who

* Children at the began of the study are with acute diarrheal disease and acute respiratory infection.
* Recurrent pneumonia, cystic fibrosis, gastrointestinal malformations, persistent diarrhea of any cause, inflammatory bowel disease.
* Failure to attend the educational institution for more than 10 days
* No consumption of zinc supplementation for more than 10 days, because of insistence to the school

Primary outcomes:
measure: Incidence acute diarrheal disease and acute respiratory infection
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Adverse reaction
timeFrame: Fortnightly. During 4 months of intervention
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: CES University
state: Antioquia
Study officials:
affiliation: CES University
name: Liliana LM Montoya, Master
role: STUDY_DIRECTOR
References:
citation: Sanchez J, Villada OA, Rojas ML, Montoya L, Diaz A, Vargas C, Chica J, Herrera AA. [Effect of zinc amino acid chelate and zinc sulfate in the incidence of respiratory infection and diarrhea among preschool children in child daycare centers]. Biomedica. 2014 Jan-Mar;34(1):79-91. doi: 10.1590/S0120-41572014000100011. Spanish.
Clinical trial NCT02550808: Metabolic Changes in Patients With Chronic Cardiopulmonary Disease
Official title: Metabolic and Histological Changes in Skeletal Muscle and Fat Tissue in Patients With Chronic Cardiopulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Malignancy
Chronic Kidney Disease
Lead sponsor: General and Teaching Hospital Celje
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
name: General Hospital Murska Sobota
name: Maastricht University
First posted: 2015-09-16
Enrollment: 400
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: Patients with chronic disease (Heart failure, COPD, malignancy, CKD) and healthy controls

Brief summary: This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic cardiopulmonary disease. The investigators will also investigate metabolic disorders like glucose metabolism, presence of metabolic syndrome, body composition and histological changes in skeletal muscle and body fat. Finally, patients will be followed for clinical endpoints.


Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic disease (Heart failure, COPD, malignancy, CKD) or no diagnosis (controls)

Exclusion Criteria:

* refuse to participate

Primary outcomes:
measure: Insulin resistance (HOMA-IR)
timeFrame: Baseline
Secondary outcomes:
measure: Muscle strength (Handgrip test)
timeFrame: Baseline
measure: Change in exercise capacity (6 minute walk test)
timeFrame: baseline and after 5 weeks
measure: Neurohormonal activation (NT-proBNP concentration)
timeFrame: Baseline
measure: Change in apoptosis in skeletal muscle (number of apoptotic cells per square mm)
timeFrame: Baseline and after 5 weeks
measure: Change in insulin resistance (HOMA-IR)
timeFrame: Baseline and after 5 weeks
Other outcomes:
Locations:
city: Celje
country: Slovenia
facility: General Hospital Celje
Study officials:
References:
Clinical trial NCT00851708: Impact of N-Acetylcysteine on Oxidative Stress and Renal Function in Deceased Kidney Transplant Recipients
Official title: Oxidative Stress and Postoperatory Renal Function in Deceased Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deceased Kidney Transplantation
Keywords: kidney
deceased kidney transplant
oxidative stress
renal function measurements
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2009-02-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this interventional, prospective, randomized clinical trial is to evaluate the impact of the antioxidant N-acetylcysteine on oxidative stress in the first seven postoperative days and on renal function in the first three postoperative months in deceased kidney transplantation.


Eligibility criteria: Inclusion Criteria:

* First transplant
* Deceased kidney transplant

Exclusion Criteria:

* postoperative recovery at critical care unit
* illicit drug addiction
* psychiatric disorders

Primary outcomes:
measure: Tiobarbituric acid reactive species measures
timeFrame: First seven postoperative days
Secondary outcomes:
measure: Serum creatinine
timeFrame: 7, 15, 30, 60, 90 postoperative day
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Clinics Hospital, University of Sao Paulo, Medical School
Study officials:
References:
Clinical trial NCT01137708: CP-690,550 And Oral Contraception Drug-Drug Interaction Study
Official title: A Phase 1, Randomized, Open Label, 2-Way Crossover Study To Assess The Effect Of Multiple Dose CP-690,550 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids In Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: drug interactions
CYP3A
oral contraceptive
anti-rheumatic agents
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to assess whether co-administration of CP-690,550 and oral contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis

Exclusion Criteria:

* Any medical reason which would contraindicate the administration of oral contraceptives
* Clinically significant infections within the past 3 months or history of febrile illness within 5 days
* Positive screening test for Hepatitis B surface antigen, anti Hepatitis C antibody, or human immunodeficiency virus
* Pregnant or nursing women, and women of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception

Primary outcomes:
measure: AUCinf of ethinyloestradiol (EE) and levonorgestrel (LN)
timeFrame: 12 days
Secondary outcomes:
measure: AUClast, Cmax, Tmax, and t½ of ethinyloestradiol (EE) and levonorgestrel (LN)
timeFrame: 12 days
measure: Number of adverse events and number of participants with adverse events
timeFrame: 12 days
measure: Changes in complete blood count and serum chemistry profile
timeFrame: 12 days
measure: Changes in vital signs
timeFrame: 12 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02861508: Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department
Official title: Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Dyspnea
Syncope
Hypotension
Keywords: Ultrasonography
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the proposed research is to examine whether incorporating point-of-care ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure \<100 or shock index \[heart rate divided by systolic blood pressure\] \>1)

Exclusion Criteria:

* \<18 years old
* Prisoner or ward of the state
* Trauma
* High acuity requiring treatment in resuscitation room
* Obvious cause of symptoms (e.g. acute GI bleed causing hypotension)
* Any form of "do not resuscitate" (DNR) order
* Roomed in hall of emergency department (location not amenable to ultrasound protocol)

Primary outcomes:
measure: Time to appropriate intervention
timeFrame: Within 30 days of presentation
Secondary outcomes:
measure: Diagnostic accuracy
timeFrame: Within 30 days of presentation
measure: Diagnostic certainty
timeFrame: Within 2 days of presentation
measure: Time to disposition
timeFrame: Within 2 days of presentation
measure: Total length of stay
timeFrame: Within 30 days of presentation
measure: 30-day in-hospital mortality
timeFrame: Within 30 days of presentation
measure: Duration of POCUS
timeFrame: Within 2 days of presentation
Other outcomes:
measure: Return visits with missed diagnosis
timeFrame: Within 30 days of presentation
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Christopher Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03326908: Description of the Interdigitation Retinal Area by SD-OCT: An Exploratory Study
Official title: Description of the Interdigitation Retinal Area by SD-OCT (Spectral Domain Optical Coherence Tomography): An Exploratory Study (ODIGIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tomography, Optical Coherence
Retina
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Improvement of retinal medical imaging opens new perspectives for exploring the retinal structures. Optical coherence spectral domain (SD-OCT), which has been widely used in the last ten years, is certainly the most advanced device. In the analysis of patients without retinal disease using SD-OCT, granulations in the interdigitation area were observed. These granulations have never been described with this device. They could correspond either to the degradation products of the external segments of the photoreceptors or to melanosomes. A descriptive study of these granulations at different examination times and in different lighting situations would allow us to obtain essential information for a better understanding of this area. Based on the results, larger studies could explore this area more finely in retinal pathologies involving dysfunctions of photoreceptors or of the pigmentary epithelium.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older
* Consent to participate

Exclusion Criteria:

* Retinal abnormalities

Primary outcomes:
measure: Variation of the number of hyperreflective granulations in the interdigitation area according to time and enlightenment
timeFrame: 1 hour after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
References:
Clinical trial NCT00971308: Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus
Official title: Open Label, Multiple-Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of BMS-824393 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.


Eligibility criteria: Inclusion Criteria:

* Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1
* HCV RNA viral load of ≤10\*5\* IU/mL (100,000 IU/mL)
* Body Mass Index (BMI) of 18 to 35 kg/m², inclusive

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection
* Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study

Primary outcomes:
measure: Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects
timeFrame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
Secondary outcomes:
measure: To assess the change in HCV RNA over time during three days of dosing with BMS- 824393 and during the follow-up period in chronically genotype subtype 1a and 1b HCV infected subjects
timeFrame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
measure: To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b)
timeFrame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
measure: To assess the safety and tolerability of multiple oral doses of BMS-824393
timeFrame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Cypress
country: United States
facility: West Coast Clinical Trials, Llc
state: California
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Baltimore
country: United States
facility: Parexel International - Baltimore Epcu
state: Maryland
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01967108: Post Extubation Chest Physiotherapy in ICU
Official title: The Effect of Post Extubation Chest Physiotherapy on Respiratory Complications and Weaning Failure in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning From Mechanical Ventilation
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 65
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: The purpose of this study is to examine the efficacy of chest physiotheray treatment in preventing pulmonary complications and weaning faliure, in extubated critically ill patients.


Eligibility criteria: Inclusion Criteria:ICU patients, over 18 years' old, mechanical ventilated over 24 hours, candidates for extubation -

Exclusion Criteria: Mental conditions, retardation, dementia, pregnancy, re-intubated patients

-

Primary outcomes:
measure: re-intubation
timeFrame: 48 hours
Secondary outcomes:
measure: oxygen saturation decrease
timeFrame: 48 hours
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Intensive Care Unit, Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Enbar Foox, B.PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06212908: Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer
Official title: Integrating Periodontal Therapy and Biofilm Management Into Breast Cancer Patients' Care: Periodontal, Hematological and Salivary Parameters Assessment Before and During Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Gingivitis
Periodontal
Keywords: Breast cancer
Gingivitis
Periodontal therapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Daniela Bazan Palioto
First posted: 2024-01-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Objective: To evaluate the impact of chemotherapy on periodontal conditions, hematology, and salivary flow in patients with breast cancer and gingivitis, after basic periodontal therapy (BPT).

Methods: They were divided into patients with breast cancer and gingivitis (BC/G =20); and patients without cancer with gingivitis (G=20). Clinical parameters \[Plaque Index (PI), bleeding on probing (BOP), Probing Depth (PS), Clinical Attachment Level (CAL)\], hematological parameters (complete blood count), and salivary flow were evaluated at baseline, 6, 12 and 24 weeks.

Detailed description: Objective: To evaluate the impact of chemotherapy on periodontal conditions, hematology, and salivary flow in patients with breast cancer and gingivitis, after basic periodontal therapy (BPT).

Methods: They were divided into patients with breast cancer and gingivitis (BC/G =20); and patients without cancer with gingivitis (G=20). Clinical parameters \[Plaque Index (PI), bleeding on probing (BOP), Probing Depth (PS), Clinical Attachment Level (CAL)\], hematological parameters (complete blood count), and salivary flow were evaluated at baseline, 6, 12 and 24 weeks.

Eligibility criteria: - All patients were diagnosed with localized gingivitis (G) The inclusion criteria were: At least 15 teeth; no loss of attachment and probing depth ≤ 3mm; bleeding on probing ≥ 10% of sites, no radiographic bone loss.

Exclusion Criteria:

1) systemic diseases (e.g. diabetes, cardiovascular diseases) or autoimmune diseases in addition to cancer; 2) patients with periodontitis; 3) use of any medication that could interfere with periodontal aspects; 4) smokers; 5) Pregnant or lactating patients.

Primary outcomes:
measure: Periodontal conditions
timeFrame: before and after post treatment (baseline, 6 weeks, 12 and 24 weeks)
Secondary outcomes:
measure: Salivary Flow
timeFrame: before and after post treatment (baseline, 6 weeks, 12 and 24 weeks)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06596408: Evaluation of Retinal Vascular Density in High Myopia Without Pathological Myopic Maculopathy Using OCTA .
Official title: Evaluation of Retinal Vascular Density in High Myopia Without Pathological Myopic Maculopathy Using OCTA .
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Myopia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Study aiming to evaluate Macular Vascular Density in High Myopes without pathological myopic maculopathy in outpatient clinic in Sohag teaching hospital using OCTA .

Detailed description: Study Design : This is a cross sectional observational study , of about 50 patients attending ophthalmology outpatient clinic at Sohag Teaching Hospital .

Inclusion criteria :

All myopic patients with axial high myopia (-6 spherical refractive error or more) attending the ophthalmology outpatient clinic .

Exclusion criteria :

The exclusion criteria will include :

* History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
* Previous intraocular surgery or ocular injury .
* Any patient with pathological myopic maculopathy (epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy ) .

Eligibility criteria: Inclusion Criteria wil include :

* All myopic patients with axial high myopia (-6 spherical refractive error or more) of different age groups .

Exclusion Criteria will include :

* -History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
* Previous intraocular surgery or ocular injury .
* Any patient with pathological myopic maculopathy as epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy .

Primary outcomes:
measure: Outcome of evaluation of vascular density in high myopes
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: Adham Salah Mohammed, lecturer
role: STUDY_CHAIR
References: