louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03015142: Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
Official title: Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Diseases
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 21
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients \> 16 years.

Brief summary: There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries). The objective of the study was to investigate the accuracy of screw placement during spine surgery.


Eligibility criteria: Inclusion Criteria:

* Subject undergoing a spine surgery with pedicle screw placement
* Subject 16 years of age or older
* Subject able to give informed consent

Exclusion Criteria:

* Subject participating in a potentially confounding device or drug trial during the course of the study.
* Subject meeting an exclusion criteria according to national law (e.g. pregnant woman, breast feeding woman)

Primary outcomes:
measure: Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software
timeFrame: During surgery, mean 6.71 hours
Secondary outcomes:
measure: Procedure Time
timeFrame: During surgery, mean 6.71 hours
measure: Time to Insert Pedicle Screw
timeFrame: Intraoperative, mean 5.18 hours
measure: Length of Hospitalization
timeFrame: From start of the interventional procedure until hospital discharge, approximately 5.3 days
measure: System Usability Score (SUS Score)
timeFrame: End of all surgeries
measure: Patient Radiation Dose
timeFrame: During surgery, mean 6.71 hours
measure: Patient Radiation Dose
timeFrame: During surgery, mean 6.71 hours
measure: Radiation Dose (Effective Dose) Received by Operator
timeFrame: During surgery, mean 6.71 hours
measure: Procedure Related Complications
timeFrame: During surgery, mean 6.71 hours
measure: Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event
timeFrame: From start of enrollment until hospital discharge, approximately 51 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Adrian Elmi-Terander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01118442: Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics
Official title: Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Keywords: Aortic Stenosis
Coronary Flow
Wave Intensity Analysis
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing transcutaneous aortic valve insertion who meet study criteria

Brief summary: Narrowing of the main valve which controls blood leaving the heart leads to a marked increase in death. To overcome this narrowing the heart muscle thickens abnormally and contracts more vigorously. However, in doing so, blood flow patterns to the heart muscle change through mechanisms which are incompletely understood. New technology allows such heart valve blockages to be fixed using balloons and metal stents inserted through tubes placed in arteries in the leg. Using sensors placed in these tubes it is possible to make detailed measurements of coronary flow and pressure, and apply new mathematical techniques to allow a better understanding of the detrimental effects that aortic stenosis has on coronary flow, before and after valve surgery.


Eligibility criteria: Inclusion Criteria:

* Severe Aortic Stenosis undergoing TAVI
* Normal coronary arteries
* Normal left ventricular function
* No other valvular pathology

Exclusion Criteria:

* Unable to consent
* Left ventricular impairment
* Left ventricular regional wall motion abnormality
* Other valve abnormality

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College NHS Trust
Study officials:
affiliation: Imperial College London
name: Justin E Davies, MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davies JE, Sen S, Broyd C, Hadjiloizou N, Baksi J, Francis DP, Foale RA, Parker KH, Hughes AD, Chukwuemeka A, Casula R, Malik IS, Mikhail GW, Mayet J. Arterial pulse wave dynamics after percutaneous aortic valve replacement: fall in coronary diastolic suction with increasing heart rate as a basis for angina symptoms in aortic stenosis. Circulation. 2011 Oct 4;124(14):1565-72. doi: 10.1161/CIRCULATIONAHA.110.011916. Epub 2011 Sep 12.
Clinical trial NCT01902342: A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir
Official title: A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Pharmacokinetic Characteristics of Oseltamivir in Healthy Korean Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers.


Eligibility criteria: Inclusion Criteria:

Healthy subjects:

1. Agreement with written informed consent
2. Adult healthy male or female subject age 20 to 45

Exclusion Criteria:

1. Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
2. Medication with any drug which may affect the pharmacokinetics of oseltamivir within 14 days
3. Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
4. Subject with known for hypersensitivity reactions to oseltamivir
5. Subject who perform contraception during study periods
6. Female woman who are pregnant or are breast feeding
7. An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: Oseltamivir pharmacokinetic parameters
timeFrame: Up to 0 to 48 h post dose
measure: Oseltamivir carboxylate pharmacokinetic parameters
timeFrame: Up to 0 to 48 h post dose
Secondary outcomes:
measure: Other oseltamivir pharmacokinetic parameters
timeFrame: Up to 0 to 48 h post dose
measure: Other oseltamivir carboxylate pharmacokinetic parameters
timeFrame: Up to 0 to 48 h post dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital
name: Kyoung Soo Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh J, Lee S, Lee H, Cho JY, Yoon SH, Jang IJ, Yu KS, Lim KS. The novel carboxylesterase 1 variant c.662A>G may decrease the bioactivation of oseltamivir in humans. PLoS One. 2017 Apr 24;12(4):e0176320. doi: 10.1371/journal.pone.0176320. eCollection 2017.
Clinical trial NCT03364842: Furosemide and Coarctation Surgery Lung Complications
Official title: Furosemide: Would it Help to Improve the Lungs During Aortic Coarctation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: in our study the investigators give furosemide during surgery for repair of aortic coarctation via lateral thoracotomy and evaluated lung complications in comparison to control group


Eligibility criteria: Inclusion Criteria:

* coarctation of aorta

Exclusion Criteria:

* heart failure, bleeding diathesis, associated cardiac congenital anomalies

Primary outcomes:
measure: lung ultrasonography scale > 24
timeFrame: a 1 year study
Secondary outcomes:
measure: Pao2/ Fio2 ratio
timeFrame: a 1 year study
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT03826342: Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
Official title: Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infection
Alcohol Use Complicating the Puerperium
Alcohol Use Complicating Pregnancy, Unspecified Trimester
Drug Use
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-02-01
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a computer-delivered screening and brief intervention (SBI) that simultaneously targets sexually transmitted infection (STI) risk and alcohol/drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.


Eligibility criteria: Inclusion Criteria:

* At least one unprotected vaginal (or anal) sex occasion in the past 30 days
* Having more than one male sex partner in the last 6 months and/or having uncertainty about current partner's monogamy.
* Pregnant
* Current alcohol/drug use risk.

Exclusion Criteria:

* Unable to understand English

Primary outcomes:
measure: Unprotected Sexual Occasions (USOs)
timeFrame: Up to 6 months
measure: Alcohol Use Measured by Timeline Follow-Back (TLFB)
timeFrame: Up to 6 months
measure: Cannabis Use Measured by Timeline Follow-Back (TLFB)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Sexually Transmitted Infections (STIs)
timeFrame: Baseline to 6 weeks postpartum (up to 11 months)
measure: Unprotected Sexual Occasions (USOs) Postpartum
timeFrame: 6 weeks postpartum (up to 11 months)
measure: Birth Weight of Baby
timeFrame: 6 weeks postpartum (up to 11 months)
measure: Baby Head Circumference
timeFrame: 6 weeks postpartum (up to 11 months)
measure: Baby Birth Length
timeFrame: 6 weeks postpartum (up to 11 months)
measure: Heavy Episodic Drinking
timeFrame: 6 weeks postpartum (up to 11 months)
measure: Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM)
timeFrame: 6 weeks post-partum (up to 11 months)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: West Ann Arbor Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Golfo Tzilos Wernette
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tzilos Wernette G, Countryman K, Mmeje O, Ngo QM, Zlotnick C. Adapting to the Pandemic: Protocol of a Web-Based Perinatal Health Study to Improve Maternal and Infant Outcomes. JMIR Res Protoc. 2021 Sep 10;10(9):e30367. doi: 10.2196/30367.
Clinical trial NCT04230642: Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
Official title: Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Tumor
Lead sponsor: Quantum Surgical
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.

Detailed description: The device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of needle, as well as in verification of needle position during CT guided percutaneous ablation procedures.

After validation of the correct positioning of the needle, the tumor ablation procedure is conducted with a device routinely used by the investigator. The Acquisition of a post-interventional CT-guided image is realized to evaluate adverse events occurrence.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old,
* Patient for whom an ablation procedure under CT guidance in liver organ has been prescribed and consensually agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
* Patient not taking platelet antiaggregant or having stopped taking it for 5 days and not taking anticoagulant (thrombocytes ≥ 50 000/mm3, TP \> 50%),
* Patient who agrees to participate in the evaluation and who has signed the inform consent,
* Patient covered by social security system.

Exclusion Criteria:

* Patient unable to undergo general anesthesia,
* Patient unable to tolerate CT contrast agent
* Patient already participating in another clinical study
* Pregnant or breast-feeding woman.

Primary outcomes:
measure: Evaluation of the safety related to the procedure
timeFrame: During the procedure
measure: Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached
timeFrame: During the procedure
Secondary outcomes:
measure: Evaluation of the accuracy of the device
timeFrame: Through study completion, an average of 1 month
measure: Evaluation of the needle readjustments of the device
timeFrame: During the procedure
measure: Evaluation of the safety not related to the procedure
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Chu Montpellier
city: Villejuif
country: France
facility: Gustave Roussy Institut
Study officials:
affiliation: Head of radiology department
name: Boris Guiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05327842: Evaluation of a Flexible Videoscope Training Simulator
Official title: Evaluation of a Flexible Videoscope Training Simulator: a Randomized, Controlled, Simulation Teaching Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Airway
Keywords: intubation
flexible bronchoscope
difficult airway
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 43
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: Flexible bronchoscope or videoscope plays important roles in managing difficult airway. But this technique is time-consuming and very difficult to learn for novices. The investigators design a simple training simulator to help them master this technique.

Detailed description: In this study, residents without operational experience will be recruited. The training effect of the new simulator will be evaluated by comparison with traditional simulation teaching. Participants will receive training with the new simulator or traditional method for 1hour, and then they perform intubation with flexible videoscope in a simulated difficult airway model. The insertion time and success rate will be recorded. Last, they will complete the questionnaire.

Eligibility criteria: Inclusion Criteria:

* Resident or Medical student
* Willing to participate to the study
* Consent to evaluate the measured data

Exclusion Criteria:

* experienced anesthetists

Primary outcomes:
measure: insertion time
timeFrame: 1 hour
Secondary outcomes:
measure: success rate
timeFrame: 1 hour
Other outcomes:
measure: Questionnaire
timeFrame: 1 hour
Locations:
city: Wuhan
country: China
facility: Department of Anesthesiology, Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wenlong Yao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03220542: The Effect of Broccoli Sprout Extract and Probiotics for Eradication of Helicobacter Pylori
Official title: The Effect of Broccoli Sprout Extract and Probiotics on Proton Pump Inhibitor-based Triple Therapy for Eradication of Helicobacter Pylori: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori
Probiotics
Sulforaphane
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In Korea, the first-line therapy to treat Helicobacter pylori (Hp) consists of a proton pump inhibitor (PPI) and two antibiotics for one week. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. In vitro study, we previously reported that a broccoli sprout extract containing sulforaphane may prevent lipid peroxidation in the gastric mucosa and play a cytoprotective role in Hp-induced gastritis. Also, several studies suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events. But, their effect for eradication of Hp is not yet conclusive. The aims of this prospective study is to investigate the efficacy of a broccoli sprout extract containing sulforaphane and probiotics for eradication of Hp, compared with standard triple therapy.


Eligibility criteria: Inclusion Criteria:

* Helicobacter pylori infected patients
* Patients with active or healing gastric/duodenal ulcers

Exclusion Criteria:

* prior Hp eradication therapy
* previous gastric resection
* previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics within 4 weeks of the study
* Patients who were pregnant or lactating

Primary outcomes:
measure: Helicobacter pylori eradication
timeFrame: 5 weeks after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
References:
Clinical trial NCT05729542: Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Official title: Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically with Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Injuries
Syndesmotic Injuries
Ankle Fractures
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.


Eligibility criteria: Inclusion Criteria:

* Ankle fracture with associated syndesmotic injury requiring surgery
* Age 18 years or older
* Ability to understand the content of the patient information/informed consent form

Exclusion Criteria:

* Any not medically managed severe systemic disease
* Patient preference for specific implant
* Refusal of randomization
* Pregnant patients
* Prisoners
* Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain score
timeFrame: 1 year
measure: Foot and Ankle Disability Index
timeFrame: 1 year
measure: Olerud-Molander Ankle Score
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with medical or surgical complications
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References: