louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02087709: Effect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome
Official title: Effect of Hypocaloric Diet on Biomarkers of Metabolic Profile, Insulin Resistance and Body Composition in Women With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Insulin Resistance
Adipokines
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State University
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2014-03-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of a hypocaloric diet on biomarkers associated with insulin resistance, metabolic profile and body composition in women with Metabolic Syndrome.


Eligibility criteria: Inclusion Criteria:

* BMI of 30-34.9 kg/m2, diagnostic of metabolic syndrome based on National Cholesterol Education Panel ATPIII (2002)

Exclusion Criteria:

* Diabetes mellitus, non-treated thyroid disease, treatment with lipid-lowering drugs and glucocorticoids or weight loss treatment within the previous 3 months.

Primary outcomes:
measure: Weight
timeFrame: Change from baseline at 3rd month
Secondary outcomes:
measure: Insulin resistance markers
timeFrame: Change from baseline at 3rd month
Other outcomes:
measure: Adipokines
timeFrame: Change from baseline at 3rd month
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
state: RJ
Study officials:
References:
Clinical trial NCT01465009: Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold
Official title: Double-blind, Randomized, Placebo-controlled, Single Dose, Parallel Group Study Evaluating Efficacy and Safety of 1000 mg Acetylsalicylic Acid and 1000 mg Paracetamol in Adult Patients With Sore Throat Associated With a Common Cold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Common Cold
Pharyngitis
Tonsillitis
Keywords: Sore Throat
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 508
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 determine the efficacy and safety of 1000 mg Aspirin (study medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of sore throat associated with a common cold. The study is designed to develop a treatment method against sore throat associated with a common cold which will have more advantages for patients than the methods that are currently available.


Eligibility criteria: Inclusion Criteria:

* Male and female patients
* Onset of common cold within the past 5 days
* Current sore throat
* Confirmed presence of a tonsillo-pharyngitis

Exclusion Criteria:

* Hypersensitivity to acetylsalicylic acid, salicylates, paracetamol, or any other NSAID
* Pregnant or lactating women
* History or acute state of peptic ulceration or gastrointestinal bleeding
* History of bleeding tendency
* History of asthma
* Inability to breathe through the nose or a history of chronic mouth breathing
* Other exclusion criteria may apply

Primary outcomes:
measure: Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol
timeFrame: For 6 hours after drug intake
Secondary outcomes:
measure: Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo
timeFrame: For 6 hours after drug intake
measure: Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol
timeFrame: For 6 hours after drug intake
measure: Total pain relief of Acetylsalicylic Acid in comparison to Placebo
timeFrame: For 6 hours after drug intake
measure: Evaluation of Upper Respiratory Tract Infection symtoms
timeFrame: 2 hours after drug intake
measure: Adverse Event collection
timeFrame: Up to 17 days after Screening
Other outcomes:
Locations:
city: Reading
country: United Kingdom
state: Berkshire
city: Manchester
country: United Kingdom
state: Greater Manchester
city: Chorley
country: United Kingdom
state: Lancashire
city: Wigan
country: United Kingdom
state: Lancashire
city: Liverpool
country: United Kingdom
state: Merseyside
city: Liverpool
country: United Kingdom
state: Merseyside
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Birmingham
country: United Kingdom
state: West Midlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01315509: Dental Status of Patients With Severe Mental Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
PTSD
Depression
Keywords: Severe mental illness
Dental measures
Resistant depression
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: THE SEVERE MENTAL ILL IN THE PSYCHIATRIC POPULATION OF THE HADASSAH MEDICAL ORGINIZATION -PSYCHIATRIC OUTPATIENT CLINIC

Brief summary: The investigators aim to assess the dental status of psychiatric patients suffering from severe mental illness (schizophrenia, bipolar disorder, ptsd, resistant depression).

Detailed description: PATIENTS WILL BE ASSESSED USING THE

1. DMFT (Decayed/Missing/Filled teeth)

AN EPIDEMILOGICAL ASSESSMENT TOOL THAT ASSESSES:

1. THE NUMBER OF TEETH WITH CURRENT DECAY
2. THE NUMBER OF TEETH MISSING
3. THE NUMBER OF TEATH TREATED IN THE PAST (FILLED)

2. CPI - Community Periodontal Index AN ASSESSMENT OF THE GUMS

3. OHIP-Oral Health Impact Profile A SELF-RATING FORM TO ASSESS THE SOCIAL AND FUNCTIONAL AFECTS OF THIER DENTAL STATUS

Eligibility criteria: Inclusion Criteria:

* All psychiatric patients suffering from schizophrenia, bipolar disorder, PTSD or resistant depression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Israel
country: Israel
facility: Rena Cooper-Kazaz
Study officials:
References:
citation: Matevosyan NR. Oral health of adults with serious mental illnesses: a review. Community Ment Health J. 2010 Dec;46(6):553-62. doi: 10.1007/s10597-009-9280-x. Epub 2009 Dec 29.
Clinical trial NCT02919709: Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells
Official title: Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 or more.
2. Patients diagnosed with a thoracic or abdominal aortic aneurysm with no indication for surgical treatment (diameters \> 30 mm but \< 50 mm).
3. Patients accepting to sign a specific informed consent.

Exclusion Criteria:

1. Unstable coronary artery disease.
2. Congenital heart disease.
3. Any evolving infectious syndrome or viral infection (HIV, HBV or HCV).
4. Any chronic inflammatory or autoimmune disease.
5. Prior administration of G-CSF; EPO; GM-CSF.
6. Liver failure.
7. Prior oncologic disease or ongoing cancer with a life expectancy \< 1 year.
8. Dementia.
9. Pregnancy.
10. Patients aged \< 18.

Primary outcomes:
measure: progenitor cells CD34+ blood levels
timeFrame: At diagnosis of aneurysm
measure: progenitor cells CD34+ blood levels
timeFrame: 6 month after disgnosis
measure: progenitor cells CD34+ blood levels
timeFrame: 12 month after diagnosis
measure: progenitor cells CD34+ blood levels
timeFrame: 18 month after diagnosis
measure: progenitor cells CD34+ blood levels
timeFrame: 24 month after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU de Besançon
Study officials:
References:
Clinical trial NCT03204409: ZIKAlliance Natural History Study
Official title: Longitudinal Clinical and Virological Study Among Symptomatic Patients With Zika Virus Infection in the City of Sao Paulo, Brazil
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Zika Virus
Zika Virus Infection
Keywords: CHIKV
DENGUE
Chikungunya
DENV
Lead sponsor: University of Heidelberg Medical Center
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2017-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General Population

Brief summary: Study to enroll up to 1000 adult patients (\>18 years) presenting with febrile or rash illness of short duration (\<72h) in designated clinics in the State of Sao Paulo, Brazil.

Detailed description: * Study to enroll up to 1000 adult patients (\>18 years) presenting with febrile or rash illness of short duration (\<72h) in designated clinics in the State of Sao Paulo, Brazil.
* Following enrolment (day 0), patients will be followed up at days 2-3, 7, 14, 21, 30, 90, 180 and 360 with clinical and biological procedures (blood and urine samples).
* For patients with proven ZIKA Virus (ZIKV) infection, follow-up samples will include blood, saliva, urine and genital samples.
* For non-ZIKV infected patients, follow-up samples will include serological monitoring at days 14, 30, 180 and 360, and for men, possible assessment of genital fluids at day 180.
* All patients will be evaluated for impact on disability up to one year. Household adult contacts of ZIKV patients will be invited for ZIKV evaluation including collection of blood and urine samples.

Eligibility criteria: Inclusion Criteria:

* Rash or Fever illness
* within 72 hours of symptom onset

Exclusion Criteria:

* presence of symptoms or complications indicative of a bacterial infection

Primary outcomes:
measure: ZIKA Virus Infection
timeFrame: up to one year
measure: DENGUE Virus Infection
timeFrame: up to one year
measure: Chikungunya Virus Infection
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University Hospital Heidelberg
name: Thomas Jänisch
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avelino-Silva VI, Mayaud P, Tami A, Miranda MC, Rosenberger KD, Alexander N, Nacul L, Segurado A, Pohl M, Bethencourt S, Villar LA, Viana IFT, Rabello R, Soria C, Salgado SP, Gotuzzo E, Guzman MG, Martinez PA, Lopez-Gatell H, Hegewisch-Taylor J, Borja-Aburto VH, Gonzalez C, Netto EM, Saba Villarroel PM, Hoen B, Brasil P, Marques ETA, Rockx B, Koopmans M, de Lamballerie X, Jaenisch T; ZIKAlliance Clinical Study Group. Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium. BMC Infect Dis. 2019 Dec 26;19(1):1081. doi: 10.1186/s12879-019-4685-9.
Clinical trial NCT03680209: Training Procedural Simulation of Nurses in Reducing Complications Related to Arteriovenous Fistula Puncture
Official title: Interest of Training in Procedural Simulation of Nurses in Reducing Complications Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nurse's Role
Simulation
Arteriovenous Fistula
Keywords: Task trainning
Procedural simulation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 1280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who come to dialysis

Brief summary: Interest of training in procedural simulation of nurses in the reduction of complications related to arteriovenous fistula puncture in hemodialysis patients

Detailed description: Primary objective :

To compare the number of complications related to arteriovenous fistula (AVF)puncture before and after a complete simulation training program, on a fistula arm of procedural simulation (conceptualization of the approach + puncture + palpation + identification + use of ultrasound)

Secondary objective (s):

Compare other adverse events related to AVF puncture during a hemodialysis session

Eligibility criteria: Inclusion Criteria:

* Patients whose nurse is trained in hemodialysis receiving a FAV puncture in the hemodialysis unit of the nephrology department, dialysis, transplantation

Exclusion Criteria:

* Patients with AVF puncture in the emergency / withdrawal area of the nephrology department, dialysis, transplantation

Primary outcomes:
measure: Complications related to arteriovenous fistula puncture (AVF)
timeFrame: 25 days
Secondary outcomes:
measure: Adverse events related to AVF puncture during a hemodialysis session
timeFrame: 25 days
measure: Adverse events related to AVF puncture during a hemodialysis session
timeFrame: 25 days
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Erwan Guillouët
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01741909: Reducing Cost of Azythromycin by Transferring From IV to Oral Therapy
Official title: Can the Cost of Azythromycin in be Reduced in Hospitalized Patients With Community Acquired Pneumonia by Quick Transfer From Intravenous to Oral Therapy?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pneumonia
Keywords: azythromycin
community acquired pneumonia
intravenous
oral
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intravenous Azythromycin therapy is considerably more expensive than oral therapy. The investigators believe that intravenous therapy is prolonged more that necessary and that oral therapy can be used much earlier in the course of the disease. The investigators plan to check if that statement is true and intervene in order to shorten the intravenous therapy.

Detailed description: The study will be performed in two stages. First a retrospective review of medical files of 50 patients hospitalized in the Haemek Medical Center with severe community acquired pneumonia, treated with azythromycin. The files will be reviewed for the criteria clinical improvement, and for azythromycin therapy, oral or intravenous.

The results of this review will help us define the appropriate behavioral intervention in order to cause doctors to transfer from IV to PO therapy at the earliest appropriate time. An intervention such as posters, pharmacy overseeing etc will be introduced. 3 months after the intervention, an additional 50 files of pneumonia patients treated with azythromycin will be reviewed in order to check the efficacy of the intervention.

The Review board and the NIH will be updated about the intervention, as soon as the investigators have decided what intervention is appropriate

Eligibility criteria: Inclusion Criteria:

* All patients hospitalized with community acquired pneumonia treated by azythromycin

Exclusion Criteria:

* Age under 18

Primary outcomes:
measure: length of intravenous azythromycin treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: haemek medical center
name: Lee H Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03404609: Rapid Non-Invasive Brain Stimulation for OCD (oTMS)
Official title: Rapid Non-Invasive Brain Stimulation for OCD (oTMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OCD
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand how cortical stimulation affects Obsessive-Compulsive Disorder (OCD) symptoms.

Detailed description: Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to understand how cortical stimulation affects Obsessive-Compulsive Disorder

Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Primary diagnosis of OCD
* Sufficient severity of OCD symptoms
* Capacity to provide informed consent

Exclusion Criteria:

* Psychiatric or medical conditions or medications that make participation unsafe
* Pregnant or nursing females
* Previous exposure to TMS or ECT
* History of any implanted device or psychosurgery
* Presence of metallic device or dental braces

Primary outcomes:
measure: Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
timeFrame: Baseline and up to two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Carolyn Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Nolan Williams, MD
role: STUDY_DIRECTOR
References:
citation: Williams NR, Sudheimer KD, Cole EJ, Varias AD, Goldstein-Piekarski AN, Stetz P, Lombardi A, Filippou-Frye M, van Roessel P, Anderson K, McCarthy EA, Wright B, Sandhu T, Menon S, Jo B, Koran L, Williams LM, Rodriguez CI. Accelerated neuromodulation therapy for Obsessive-Compulsive Disorder. Brain Stimul. 2021 Mar-Apr;14(2):435-437. doi: 10.1016/j.brs.2021.02.013. Epub 2021 Feb 23. No abstract available.
Clinical trial NCT00815009: Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
Official title: Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Keywords: NAFLD
NASH
Lead sponsor: San Antonio Military Medical Center
Sponsor class: FED
First posted: 2008-12-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet will have a greater effect on slowing disease progression and reversing hepatic steatosis and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to a regular healthy diet alone.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 yrs
* DEERS eligible (DoD beneficiary)
* All participants must plan to be in the area for at least nine months
* Liver biopsy confirmed NAFLD/NASH (NAS Score evaluating steatosis, lobular inflammation and hepatocyte ballooning) within the past 6 months

Exclusion Criteria:

* Alcohol consumption \> 20 g/d or history of alcohol abuse
* Hepatitis A, B, C
* Chronic liver disease of any other etiology
* Fatty acid oxidation disorder (Inborn errors of metabolism)
* Insulin therapy regime for treatment of diabetes
* Pregnancy

Primary outcomes:
measure: NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
timeFrame: 6 months
Secondary outcomes:
measure: Insulin resistance (IR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: San Antonio Military Medical Center
name: Renee E Cole, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05666609: Fistula-in-ano in Infants and Children
Official title: Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trail on the Duration of Non-cutting Seton Placement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fistula in Ano
Lead sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: duration of placed seton 4 weeks Group B: duration of placed seton 12 weeks
Primary purpose: TREATMENT

Brief summary: In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.

Detailed description: In this prospective, randomized trail, patients are treated in case of fistula-in-ano with non-cutting seton placement. They are then randomized 1:1 in either Group A (duration of placed seton for 4 weeks) or Group B (duration of placed seton for 12 weeks). Patients are participating after informed consent is obtained.

Eligibility criteria: Inclusion Criteria:

* any patient with FIA and treatment with non-cutting seton placement in our institution
* regardless of underlying diagnoses
* age 0-18 years

Exclusion Criteria:

* none

Primary outcomes:
measure: Recurrent fistula in ano
timeFrame: 6 months after initial surgery
measure: Recurrent perianal abscess
timeFrame: 6 months after initial surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
state: Bavaria
Study officials:
affiliation: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Sonja Diez, MD
role: PRINCIPAL_INVESTIGATOR
References: