louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00722345: Exercise Consultation in Obese Youth
Official title: Can Exercise Consultation Increase Activity Levels and Improve Metabolic Markers in Obese Adolescents? A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Physical activity
Adolescents
Exercise counseling intervention
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2008-07-25
Enrollment: 33
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise consultation, an intervention approach based on the transtheoretical model has been successful in promoting physical activity (PA) among adults. It is unknown whether this approach would be efficacious with youth. The purpose of this pilot study was to assess whether exercise consultation would increase PA levels and improve anthropometric measures and metabolic markers in obese adolescents.


Eligibility criteria: Inclusion Criteria:

* Adolescents
* BMI greater than or equal to the 95th percentile for age (2000 CDC growth charts)

Exclusion Criteria:

* Pregnancy
* Underlying medical condition, physical or cognitive disability that will impair individual's ability to participate in physical activity

Primary outcomes:
measure: Physical activity counts per minute (accelerometer data)
timeFrame: At baseline and at 3 months
Secondary outcomes:
measure: Stage of change
timeFrame: At baseline and at 3 months
measure: Lipids
timeFrame: At baseline and at 3 months
measure: Glucose
timeFrame: At baseline and at 3 months
measure: Insulin
timeFrame: At baseline and at 3 months
measure: Blood pressure
timeFrame: At baseline and at 3 months
measure: Anthropometric mesures (height, weight, waist circumference, hip circumference)
timeFrame: At baseline and at 3 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier Universitaire Ste-Justine
state: Quebec
Study officials:
affiliation: Ste-Justine Hospital/McGill University
name: Melanie Henderson, MD MSc FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Ste-Justine Hospital/University of Montreal
name: Celine Huot, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Denis Daneman, MB BCh FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Janet Hux, MD SM
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Anthony Hanley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Concordia University, Montreal
name: Jennifer McGrath, PhD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ste-Justine Hospital/University of Montreal
name: Marie Lambert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Gillian L Booth, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02834845: Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension
Official title: Comparison of Effects of Sevoflurane and Desflurane on Cerebral Oxygenation During Controlled Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oxygen Saturation
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. On this account, the investigators aim to investigate the effects of different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation during controlled hypotension using near infrared spectroscopy.


Eligibility criteria: Inclusion Criteria:

* Patients in American Society of Anesthesiology (ASA) classification I and II
* Patients undergoing elective septoplasty operation

Exclusion Criteria:

* Patients in ASA classification III and higher
* Emergency surgery
* Patients in New York Heart Association classification III-IV
* Patients with known allergy to drugs used in the study

Primary outcomes:
measure: Cerebral oxygen saturation as measured by Near Infrared Spectroscopy
timeFrame: Duration of surgery
Secondary outcomes:
measure: Total remifentanil consumption as measured in micrograms
timeFrame: Duration of surgery
measure: The effect of anesthetics on hemodynamic variables
timeFrame: Duration of surgery
measure: The effect of anesthetics on hemodynamic variables
timeFrame: Duration of surgery
measure: The effect of anesthetics on hemodynamic variables
timeFrame: Duration of surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University Hospital
Study officials:
affiliation: Fellow
name: Ülkü C Köksoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05596045: Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients
Official title: A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 Tablets in Mild or Moderate COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: SARS CoV 2 Infection
Keywords: ASC10
RdRp
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2022-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase Ib, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, efficacy and pharmacokinetics of ASC10 tablets in mild or moderate COVID-19 subjects.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥18 years at screening;
2. Those females who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose;
3. If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug;
4. Has a documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤5 days prior to randomization.

Exclusion Criteria:

1. Females who are pregnant, planning to become pregnant, or breastfeeding;
2. Has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from COVID-19;
3. Has hypersensitivity or other contraindication to any of the components of the study interventions;
4. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.

Primary outcomes:
measure: Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses
timeFrame: From Day 0 to Study Completion, up to 32 days
measure: PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h
timeFrame: From Day 1 to Day 6
Secondary outcomes:
measure: Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms
timeFrame: From Day 1 to Study Completion, up to 32 days
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Hialeah
country: United States
facility: Aga Clinical Trials
state: Florida
Study officials:
References:
Clinical trial NCT00734045: Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples
Official title: Prospective Evaluation of the StatusFirst™ CHF NT-proBNP Device in Human Whole Blood and Plasma Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure (CHF)
Keywords: Congestive Heart Failure (CHF)
NT-proBNP
Lead sponsor: Nanogen, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 450
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients to be recruited for the study should either:

* have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR
* be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.

Brief summary: The primary objective of the study is to establish the correlation between NT-proBNP measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in EDTA and Li-Hep anticoagulant tubes and measured by the StatusFirst™ CHF NT-proBNP device in conjunction with the DXpressTM Reader in a laboratory setting.


Eligibility criteria: Inclusion Criteria:

* Have clinically confirmed heart failure (NYHA class I-IV) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, OR
* Be non-CHF controls greater than 45 years of age with no history of heart failure or cardiovascular disease.

Exclusion Criteria:

* Be 45 years of age or younger

Primary outcomes:
measure: StatusFirst CHF NT-proBNP test result
timeFrame: At presentation to study site (no follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: US Department of Veteran's Affairs
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California San Francisco and San Francisco General Hospital
name: Alan Wu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California San Diego; Veteran's Affairs
name: Alan Maisel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610545: Atorvastatin in Perioperative Vascular Surgery - Pilot Study
Official title: Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vascular Surgery
Keywords: ATORVASTATIN
VASCULAR SURGERY
CARDIOVASCULAR OUTCOMES
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in comparative standard doses in the perioperative period of major vascular surgery.

Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs


Eligibility criteria: Inclusion Criteria:

* Vascular surgery (abdominal aortic aneurysm , carotid endarterectomy , limbs revascularization)

Exclusion Criteria:

* Pregnant or lactating women
* Patient with sensitivity to atorvastatin
* Patient has elevations in certain laboratory values (CK, AST, ALT)
* Known history of active hepatic disease or known hepatic insufficiency
* Patients participating in another clinical trial
* Prior statin therapy to include: \>10 mg of atorvastatin (Lipitor) or \>20 mg of other HMG-CoA Reductase Inhibitors (statins) or use rosuvastatin
* Serious infectious disease after surgery
* Known history of cancer

Primary outcomes:
measure: mortality ; myocardial infarction ; stroke
timeFrame: within 90 days after surgery
Secondary outcomes:
measure: Change and percent change from baseline to the surgery of treatment for LDL-C, HDL-C, TC, and TG for subjects
timeFrame: within 24h before surgery
measure: Change and percent change from baseline to the surgery of treatment for hs-CRP
timeFrame: within 24h before surgery
measure: Safety of atorvastatin through laboratory assessment
timeFrame: within 24h before surgery
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Clinics Hospital - State University Campinas
state: São Paulo
Study officials:
affiliation: STATE UNIVERSITY CAMPINAS
name: OTAVIO COELHO, PhD
role: STUDY_DIRECTOR
affiliation: STATE UNIVERSITY CAMPINAS
name: RAITANY C ALMEIDA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02724345: Postoperative Adjuvant TACE Treatment in CK18 Positive Patients
Official title: The Effect of Postoperative Adjuvant TACE Treatment in CK18 Positive Patients of Hepatocellular Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Adjuvant TACE
Hepatocellular Carcinoma.
Keywords: Cell keratin 18
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 320 patients with HCC

Brief summary: To evaluate and analyse the clinical effect and application value of postoperative adjuvant TACE treatment in patients with different expression levels of CK18 using randomized controlled study and provide evidence for the necessity of postoperative adjuvant TACE.


Eligibility criteria: Inclusion Criteria:

1. Via clinical diagnosis and confirm it is primary liver cancer
2. Pathological evidence of HCC
3. Estimate tumor can gain treatment of curing operation
4. No evidence for extrahepatic metestasis
5. liver function ：Child-Pugh A/B

Exclusion Criteria:

1. reject to attend；
2. impossible to come to our hospital for physical examination regularly.
3. cancer epitome、seed focus、lymph node or distant metastasis
4. Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Time to recurrence
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05871645: Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study
Official title: Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Accreta
Keywords: JSICA technique
Placenta Accreta
Uterine Preservation
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 323
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to present the Jakarta Surgical Uterine Conservation (JSICA) technique and its perioperative outcomes in Placenta Accreta Spectrum patients. Participants are all patients undergoing standard hysterectomy or the Jakarta Surgical Uterine Conservation (JSICA) technique. Researchers will compare both groups to see if there are any differences in the perioperative outcomes.

Detailed description: This study uses data from Cipto Mangunkusumo General Hospital's Placenta Accreta Case Register. This register includes all patients with a confirmed placenta accreta spectrum diagnosis. Data collected includes demographic characteristics, risk factors, surgery characteristics, and perioperative outcomes. In this study, researchers would like to evaluate the perioperative outcomes of the JSICA technique in comparison to a standard hysterectomy.

Eligibility criteria: Inclusion Criteria for JSICA:

1. Focal accreta invasion ( \< 50% anterior wall)
2. Anterior invasion
3. No parametrial or bladder invasion
4. Residual tissue or healthy myometrium min 3 cm above the OUI or cervix
5. Good uterine contraction post-repair (with or without compression sutures)
6. Hemodynamically stable

Exclusion Criteria:

-

Primary outcomes:
measure: Intraoperative bleeding
timeFrame: Perioperative
measure: Operation duration
timeFrame: Perioperative
measure: Number of Patients Admitted to ICU
timeFrame: 24 hours
measure: Rate of Intraoperative complications
timeFrame: Intraoperative
Secondary outcomes:
measure: Intraoperative Bleeding in JSICA compared to hysterectomy
timeFrame: Perioperative
measure: Operation duration in JSICA compared to hysterectomy
timeFrame: Perioperative
measure: Number of Patients Admitted to ICU in JSICA compared to hysterectomy
timeFrame: 24 hours
measure: Rate of Intraoperative complications in JSICA compared to hysterectomy
timeFrame: Perioperative
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT01627145: Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug
Official title: Post-treatment Normallized Urodynamic Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Correlations With Voiding Diary, King's Health Questionnaire, and Overactive Bladder Sympto
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: overactive bladder syndrome
derusor overactivity
urodynamic studies
bladder oversensitivity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug and Its Conelations With Voiding Diary, King's Health Quentionaire, Overactive Bladder Sympton Scores and Patient Perception of Bladder Condition.


Eligibility criteria: Inclusion Criteria:

* female patients within 18 years old to 99 years old with overactive bladder syndrome

Exclusion Criteria:

* unwilling or unable to perform testing procedure

Primary outcomes:
measure: The percentage of normalized urodynamic pattern after treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: The percentage of recurrence rates after treatment during follow-up and further to analyze the risk factors of recurrence
timeFrame: 48 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: No 8, Chung-Shan South Road,
Study officials:
References:
Clinical trial NCT02002845: A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures
Official title: A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System
Keywords: Tongue base resection, partial glossectomy
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System

Brief summary: A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.

Detailed description: Primary Effectiveness Endpoint:

• Ability to complete procedure without a need for conversion to a non-robotic approach

Safety Endpoint:

Assessment of adverse events through post-operative follow-up including but not limited to:

• Bleeding

▪ Mortality

Additional endpoints evaluated may include:

* Procedure times
* Length of hospital stay
* Volume of tissue resected
* Use of tissue sealants

Eligibility criteria: Inclusion Criteria:

* The specific surgical procedure involved a lingual tonsillectomy, tongue base resection, or a partial glossectomy procedure.
* Subject was ≥18 years of age at the time of procedure

Exclusion Criteria:

* Subject underwent a benign non-tumor TORS procedure that did not involve either a lingual tonsillectomy, tongue base resection or partial glossectomy.
* Subject underwent a TORS procedure for oropharyngeal cancer

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: intra-operative
measure: Primary Safety endpoint
timeFrame: up to 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Middlesex Hospital
state: Connecticut
city: Ypsilanti
country: United States
facility: St. Jose Mercey Health System
state: Michigan
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Intutive Surgical
name: Shilpa Mehendale, MS
role: STUDY_DIRECTOR
References: