louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02350621: Cervical Foraminal Stenosis and Radiculopathy - ACDF Versus Minimal Invasive Posterior Cervical Foraminotomy.
Official title: Cervical Foraminal Stenosis and Radiculopathy - Anterior Cervical Discectomy and Fusion (ACDF) Versus Minimal Invasive Posterior Cervical Foraminotomy miPCF).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiculopathy
Keywords: cervical foraminal stenosis minimal invasive foraminotomy
Lead sponsor: Stockholm Spine Center AB
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive posterior cervical foraminiotomy.

80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications, health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively (foraminotomy group).


Eligibility criteria: Inclusion Criteria:

* Cervical radiculopathy on 1 or 2 levels correlated on MRI and CT Arm pain more than 30 (VAS). Duration more than 3 months.

Exclusion Criteria:

* Myelopathy. Soft disc hernia. Previous neck surgery. Tumors, infection, WAD, trauma, generalized pain syndrome.

Primary outcomes:
measure: Neck Disability Index
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stockholm Spine Center
name: Tycho Tullberg, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01982721: Evaluation of an Acceleration-Based Prosthetic Knee Locking Mechanism for Reducing the Risk of Falling in Transfemoral Amputees
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transfemoral Amputees
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Dr. Sigal Portnoy
First posted: 2013-11-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The investigators hypothesize that a new automatic prosthetic knee locking mechanism will improve gait characteristics during an induced controlled trip and reduce fear of falling.


Eligibility criteria: Inclusion Criteria:

* transfemoral amputees
* Independent ambulation with a prosthesis
* Full cognitive and cooperative ability to follow simple instructions
* No orthopaedic or neurologic impairments present, that are unrelated to the amputation at the time of the trial

Exclusion Criteria:

* Cognitive disorders preventing the subject from understanding the trial protocol, signing a consent form or following the researcher's instructions
* Orthopaedic or neurologic impairment, un-related to the amputation
* Pregnant woman
* Weight exceeding 100 kg

Primary outcomes:
measure: 3D angles of the ankle, knee, hip and pelvis
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT00997321: Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)
Official title: Propofol Versus Ketamine for Procedural Sedation During Painful Procedures in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Keywords: ketamine
propofol
procedural sedation
moderate procedural sedation in the ED
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 100
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: This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.


Eligibility criteria: Inclusion Criteria:

* patients who require moderate procedural sedation with propofol in the ED

Exclusion Criteria:

* age \> 17 years
* pregnant
* intoxicated
* cannot give informed consent
* allergy to ketamine or propofol
* patient will require deep procedural sedation
* ASA physical status score \> 2

Primary outcomes:
measure: Respiratory Depression (Sub-clinical and Clinical Signs)
timeFrame: From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)
Secondary outcomes:
measure: Time to Return of Baseline Mental Status
timeFrame: from start of procedure until the return of baseline mental status up to 120 minutes
measure: Patient Reported Pain or Recall of the Procedure
timeFrame: single measurement immediately after patient returns to baseline mental status after sedation procedure
measure: Depth of Sedation
timeFrame: single measurement during sedation procedure
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: James R Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miner JR, Gray RO, Bahr J, Patel R, McGill JW. Randomized clinical trial of propofol versus ketamine for procedural sedation in the emergency department. Acad Emerg Med. 2010 Jun;17(6):604-11. doi: 10.1111/j.1553-2712.2010.00776.x.
Clinical trial NCT06004921: A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers
Official title: A Phase 1, Double-Blinded, Randomised, Placebo-Controlled, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of AB801
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: AB801
Healthy volunteer
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.


Eligibility criteria: Key Inclusion Criteria:

* Healthy as determined by medical evaluation by study physician
* Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)\^2 as measured at screening
* Weight ≥ 50 kg at screening
* Must agree to adhere to the protocol defined contraception requirements

Key Exclusion Criteria:

* Do not have suitable veins for multiple venepunctures/cannulation as assessed by the study physician
* Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula (QTcF) ≥ 450 msec for males and \> 470 millisecond (msec) for females at screening and pre-dose
* Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the study physician
* Received any study medicine in a clinical research study within the last 90 days
* Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid reducing agents and including CYP3A inhibitor and/or inducers

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 30 days
measure: Area Under the Plasma Drug Concentration-Time Curve (AUC)
timeFrame: Predose, Up to 120 hours postdose
measure: Maximum Concentration (Cmax) in Plasma
timeFrame: Predose, Up to 120 hours postdose
measure: Time to Maximum Concentration (Tmax) in Plasma
timeFrame: Predose, Up to 120 hours postdose
measure: Half-Life Time (t1/2)
timeFrame: Predose, Up to 120 hours postdose
Secondary outcomes:
measure: Change from Baseline in Holter Electrocardiogram Monitoring Scale
timeFrame: Predose up to 25 hours postdose
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences - Nottingham
Study officials:
affiliation: Arcus Biosciences
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02385721: Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan)
Official title: A Prospective, Observational, Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan) During 1 Year Among 20 and Older Diagnosed With Essential Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Keywords: Hypertension
Fimasartan
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-03-11
Enrollment: 601
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypertension Patients

Brief summary: Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.

Detailed description: This study is designed to evaluate the incidence and characteristics (profile, relationship to the study drug, severity, and outcome) of adverse events (AEs) observed during 1-year treatment with Kanarb tablet® (fimasartan)

Eligibility criteria: Inclusion Criteria:

1. Patients with essential hypertension
2. Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or newly
3. Male and female adults aged 20 years or older
4. Voluntarily provided a written consent to participate in the study

Exclusion Criteria:

1. Patients with hypersensitivity to this drug or the ingredients of this drug
2. Pregnant or breast-feeding women
3. Patients on renal dialysis
4. Patients with moderate to severe hepatic impairment
5. Patients with biliary atresia
6. Genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
7. Patients considered inappropriate for taking Kanarb tablet® (fimasartan) by investigator
8. Clinically significant abnormal liver function (AST, ALT ≥2 x upper limit of normal (ULN); TB ≥1.5 ULN)

Primary outcomes:
measure: Number of Participants Experiencing AEs or ADRs
timeFrame: up to 12 months
Secondary outcomes:
measure: Treatment Persistence Rate of Fimasartan
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yoon Jun Kim
Study officials:
affiliation: Boryung Pharmaceutical Co., Ltd
name: Myung Sook Hong
role: STUDY_DIRECTOR
References:
citation: Oh GC, Joo KW, Kim MA, Choi DJ, Kim YJ, Lee HY. Long-Term Safety of a Novel Angiotensin Receptor Blocker, Fimasartan, According to the Absence or Presence of Underlying Liver Disease in Korean Hypertensive Patients: A Prospective, 12-Month, Observational Study. Drug Des Devel Ther. 2020 Apr 3;14:1341-1349. doi: 10.2147/DDDT.S233174. eCollection 2020.
Clinical trial NCT01714921: Protecta Smart Analysis Register
Official title: ProSA Protecta Smart Analysis Register
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With an Indication for an ICD Implantation According to the Guidelines
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic GmbH Germany
First posted: 2012-10-26
Enrollment: 504
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: Patients that satisfy the inclusion criteria and signed the informed consent

Brief summary: ProSA is a prospective, non-randomized, multicenter, observational study investigating the utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a Protecta™, Protecta™ XT or any equivalent following product.


Eligibility criteria: Inclusion Criteria:

* patients implanted with an Implantable Cardioverter Defibrillator (ICD) with the smart shock algorithm (Protecta™, Protecta™ XT or any equivalent following product)
* written informed consent

Exclusion Criteria:

* patients with life expectancy less than 24 months
* patients younger than 18 years
* pregnant or breast feeding women

Primary outcomes:
measure: Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.
timeFrame: 24 months
Secondary outcomes:
measure: Number of Patients With All Smart Shock Algorithms Are Programmed on
timeFrame: 90 days or 180 days
measure: Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology
timeFrame: 24 months
measure: Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.
timeFrame: 24 months
measure: Number of Patients That Developed AT/AF
timeFrame: 24 months
measure: Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.
timeFrame: At the first Follow-Up ≥ 90 days post-implant
measure: Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms
timeFrame: through study completion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06398821: G3P-01 in Volunteers With Elevated Galectin-3
Official title: A Dose Ranging Target Engagement Study of a Food-Grade Pectic Food Supplement (G3P-01) in Volunteers With Elevated Levels of Galectin-3 - the Galaxy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Galectin 3
Healthy Aging
Keywords: Galectin 3
Lead sponsor: General Practitioners Research Institute
Sponsor class: NETWORK
Collaborators: name: G3 Pharmaceuticals
First posted: 2024-05-03
Enrollment: 48
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: G3P-01 is an investigational pectin extracted, enriched and purified from commercial squash puree intended for human consumption. Pectins are an important constituent of fruits and vegetables, and health benefits are attributed to its intake. Some of the health benefits of pectins are attributed to inhibition of galectin-3. This study investigates if 30-days of G3P-01 intake in individuals with elevated galectin-3 induces biomarker changes that can be attributed to target engagement. Participants will be randomized into four groups (placebo, 100mg, 250mg and 1000mg G3P-01).


Eligibility criteria: Inclusion Criteria:

* Invited through cohort study.
* Plasma galectin-3 level of 16 ng/mL or higher
* Male and female subjects ≥45 and ≤75 years of age
* Females will be non-pregnant, non-lactating, and have no intent to become pregnant during the study period.
* Able to participate in the study in the opinion of the Investigator.
* Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
* An Independent Ethics Committee or in Dutch Medisch- Ethische Toetsingscommissie (METC) -approved informed consent is signed and dated prior to any study-related activities.

Exclusion Criteria:

* Existing clinically significant concurrent medical condition which in the opinion of the Investigator may interfere with the study.
* Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening.
* Participation in a clinical trial of an investigational drug within 30 days prior to Screening, or is currently participating in another trial of an investigational drug, supplement or device.

Primary outcomes:
measure: To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (≥ 16.0ng/mL)
timeFrame: 4 months
measure: To evaluate tolerability of G3P-01
timeFrame: 4 months
measure: To evaluate tolerability of G3P-01
timeFrame: 4 months
measure: To evaluate tolerability of G3P-01
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: General Practitioners Research Institute
Study officials:
affiliation: General Practitioners Research Institute
name: J WH Kocks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03020121: Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
Official title: Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Cervical Neoplasm
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 28
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media diluted in HPV diluent to adjudicated histology results from biopsy.


Eligibility criteria: Inclusion Criteria:

* Females who are greater than or equal to 21 years of age,
* Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology result,
* Females who provide informed consent

Exclusion Criteria:

* Known pregnant
* Prior complete or partial hysterectomy involving removal of cervix
* Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
* Colposcopy clinic referral patients

Primary outcomes:
measure: Sensitivity
timeFrame: 18 months
measure: Specificity
timeFrame: 18 months
measure: PositivePredictive Value
timeFrame: 18 months
measure: Negative Predictive Value
timeFrame: 18 Months
measure: Likelyhood ratio
timeFrame: 18 months
measure: Absolute Risk
timeFrame: 18 Months
measure: Relative Risk
timeFrame: 18 Months
measure: Positive Percent Agreement
timeFrame: 18 Months
measure: Negative PercentAgreement
timeFrame: 18 months
measure: Non reportable rate
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Denver
country: United States
facility: American Pathology Partners Inc.
state: Colorado
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Sidney & Lois Eskenazi Hospital
state: Indiana
city: Omaha
country: United States
facility: Transgenomics
state: Nebraska
city: Albuquerque
country: United States
facility: Southwest Womens Health
state: New Mexico
city: Albuquerque
country: United States
facility: Tricore Reference Lab
state: New Mexico
city: Irvington
country: United States
facility: Research Pathology Associates, LLC
state: New York
city: Charlotte
country: United States
facility: Research Pathology Associates
state: North Carolina
city: San Antonio
country: United States
facility: Center for Disease Detection
state: Texas
city: Outremont
country: Canada
facility: BioVision
state: Quebec
Study officials:
References:
Clinical trial NCT06742021: Application of DCE-MRI Based on 4D FreeBreathing in Predicting the Efficacy of Immune and Targeted Therapy in Lung Cancer
Official title: Application of DCE-MRI Based on 4D FreeBreathing in Predicting the Efficacy of Immune and Targeted Therapy in Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to address the challenge of predicting the efficacy of targeted and immunotherapy in lung cancer patients. By utilizing two DCE-MRI images-one before treatment and one after one treatment cycle-along with the patients' clinical and pathological information, we aim to achieve accurate prediction of the therapeutic efficacy of targeted and immunotherapy in lung cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Tumor size greater than 2 cm
2. Age between 18 and 75 years

Exclusion Criteria:

1. Presence of MRI contraindications (e.g., metal implants, pacemaker implantation, etc.)
2. Allergy to gadolinium contrast agents
3. Lesions difficult to delineate on images due to conditions such as atelectasis or diffuse lesions

Primary outcomes:
measure: Tumor treatment response evaluation
timeFrame: within one week before treatment and two weeks after treatment completion
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
affiliation: Ethics Committee of Yunnan Provincial Cancer Hospital
name: Lianhua Ye
role: STUDY_DIRECTOR
References:
Clinical trial NCT04779021: Caracterisation of COVID-19 Patients Hospitalized in Infectious Disease Department
Official title: Caracterisation of SARS-Cov2 Infected Patients Hospitalized in Infectious Disease Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
SARS-CoV Infection
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 1300
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: Patients hospitalized for SARS-COV2 infection

Brief summary: The main objective of this cohort is to characterize COVID-19 patients hospitalized in infectious disease department. The collection of clinical and biological data from start of hospitalization to long-term follow up will contribute to a better description of the patient care, to the identification of predisposition to complication related to the disease, and to the evaluation of the impact of different therapeutical strategies.


Eligibility criteria: Inclusion Criteria:

* Age \> or = to 18
* Patients hospitalised for SARS-CoV-2 infection confirmed by RT PCRand/or CT scan and/or serology

Exclusion Criteria:

* Patients for whom SARS-CoV-2 infection has not been confirmed

Primary outcomes:
measure: Clinical characteristics
timeFrame: 34 months
measure: Biological characteristics
timeFrame: 34 months
measure: Radiological characteristics
timeFrame: 34 months
Secondary outcomes:
measure: Number of patient hospitalised for Covid-19
timeFrame: 34 months
measure: Overall Inpatient Mortality
timeFrame: 34 months
measure: Requirement for mechanical ventilation
timeFrame: 34 months
measure: ICU Length of Stay (LOS)
timeFrame: 34 months
measure: Evolution of patient general state during hospitalisation
timeFrame: 34 months
measure: Biological tests
timeFrame: 34 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE - Infectiologie
city: Nice
country: France
facility: CHU de NICE - Urgences
Study officials:
References: