louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01619202: Comparing Driving Performance Among Trained and Untrained Drivers Using a Driving Simulator
Official title: Comparison of Driving Performance Among Trained and Untrained Novice Drivers: Validation of a Multidimensional Simulated Driving Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention Harmful Effects
Accidents, Traffic
Accident Prevention
Keywords: accident prevention
Adolescent
examination, automobile driver
Driving simulator
Young drivers
Driving education
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
name: National Institute of Nursing Research (NINR)
name: University of Pennsylvania
First posted: 2012-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine differences in driving performance on a simulated driving assessment between novice teen drivers who receive the Risk Anticipation-Perception Training (RAPT) program and novice teen drivers who do not receive the training program.

Detailed description: Motor vehicle crashes remain the number one cause of death among teens in the United States. Teen drivers (ages 16 to 19) are four times more likely to be involved in fatal crashes than adult drivers (ages 25 to 69). Driving simulators are a safer alternative to on-road assessments that are often affordable and can provide experimental control for research. Though driving simulators have advantages for evaluating driving performance in teens, there are gaps in the literature on the validity of a multidimensional outcome of driving performance in a simulator. To further examine the validity of a multidimensional measure of driving performance in a simulator, we compare simulated driving performance among teens who are trained hazard anticipation-perception training and those who are not.

Eligibility criteria: Inclusion Criteria:

* Holds a valid driver's license for less than or equal to 180 days
* 16 - 18 years of age

Exclusion Criteria:

* Self-reports claustrophobia, migraine headaches, and/or motion sickness
* Females who are pregnant
* Previously participated in another CHOP driving simulator study
* Non-English Speaking

Primary outcomes:
measure: Simulated driving performance measured by the number of errors made or the lack thereof, during a series of simulated drives.
timeFrame: at least 1 week after training or enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Flaura K Winston, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04202302: Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome
Official title: The Impact of Vaginal Profile During Ovarian Stimulation on the IVF/ICSI Outcome: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginal Flora Imbalance
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is from the infertility patients of reproductive center of Sun Yat-sen Memorial Hospital.

Brief summary: Vaginal flora is closely related to female reproductive health. Previous studies have suggested that the composition of the vaginal flora is related to the pregnancy outcomes, and abnormalities in the vaginal flora lead to a decrease in the success rate of IVF. During the IVF treatment, the hormone level changes far exceed the physiological level. What changes will happen to the vaginal flora? Does IVF treatment itself affect the vaginal flora and affect outcomes? This study used prospective cohort study to show the changes in vaginal flora during conventional IVF treatment, providing more evidence for revealing the relationship between vaginal flora and infertility treatment outcomes.


Eligibility criteria: Inclusion Criteria:

* 20-40 years old
* BMI\<30kg/m2
* First IVF/ICSI cycle (GnRH agonist or antagonist protocol)
* no vaginitis after recruitment
* completion of oocyte retrieval

Exclusion Criteria

* history of RSA
* history of endometriosis
* Immune diseases such as SLE, etc., and the use of immunosuppressive agents, glucocorticoids, etc.
* obvious hydrosalpinx(\>2cm in diameter by ultrasound)

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 12.2019-03.2020
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Reproductive center of Sun Yat-sen memorial hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT03605602: A Real World Study Based on NGS (TRUMPRWS)
Official title: TRUMPRWS: A Non-interventional Study on Genetic Variants and Its Clinical Relevance in Chinese Patients With Advanced NSCLC (TRUMPRWS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 2700
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: Histologically or cytologically confirmed NSCLC

Brief summary: This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner.

Detailed description: This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner.

The eligible patients will be recruited after NGS analysis for tumor tissue and the inform-consent is obtained. The study required information will be collected (every 3 months).

Eligibility criteria: Inclusion Criteria:

1. Patients must be ≥20 years of age.
2. Provision of fully informed consent prior to any study specific procedures.
3. Histologically or cytologically confirmed, unresectable stage IIIB or stage IV NSCLC.
4. Genetic variants of tumor tissue detected by NGS.

Exclusion Criteria:

None.

Primary outcomes:
measure: Clinical relevance between genomic profiling and overall survival
timeFrame: [ Time Frame: From registration onto that step until death, or censored at the date of last contact, assessed up to 3 years]
Secondary outcomes:
measure: The characteristics of genomic variation and dynamic changes during different anti-tumor treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology
state: Guangdong
Study officials:
affiliation: Guangdong Association of Clinical Trials (GACT)
name: Yi-Long Wu, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01892202: A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis
Official title: Efficacy of C.E.R.A for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV , Not on Dialysis , Treated According to Routine Clinical Practice
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-04
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This multicenter observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18 to 65 years of age inclusive
* Patients with chronic kidney disease Stage III-IV not on dialysis
* Hb \< 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels)
* Adequate iron status as judged by the treating physician

Exclusion Criteria:

* Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
* Significant acute or chronic bleeding
* Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
* Active malignant disease during the last five years (except non-melanoma skin cancer)
* Uncontrolled or symptomatic secondary hyperparathyroidism
* Epileptic seizure during the last 6 months
* Poorly controlled hypertension (sitting blood pressure \> 170/100 mmHG)
* Myocardial infarction or stroke, or severe or unstable CAD
* Severe liver disease during the previous 6 months
* Congestive heart failure NYHA Class III-IV
* Diagnosis or suspicion of pure red cell aplasia (PRCA)
* Planned elective surgery during the study period (except cataract surgery and vascular access surgery)
* Transfusion of red blood cells during the previous 2 months
* Pregnant women
* Any contra-indications to Mircera

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02677402: Effects of Various Modalities Water Immersion on Veins
Official title: Effects of Thermo Neutral Water Immersion, Cold-water Immersion and Contrast Water Therapy on Lower Limb Veins Calibres
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrotherapy
Keywords: femoral vein
saphenous vein
hydrostatic pressure
temperature
recovery
Lead sponsor: University of Franche-Comté
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Objectives In this study the investigators examined the changes in common femoral vein (CFV) and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT).

Design Ten professional handball players visited the laboratory on three occasions. At each visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air (baseline) and then 16-minutes lower limbs TNI (\~35°C), CWI (\~12°C) or CWT (2:2minutes (\~12°C to \~35°C) ratio), selected randomly.

Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the end of 16 min immersion.


Eligibility criteria: Inclusion Criteria:

* Free healthy voluntary

Exclusion Criteria:

* hypersensitivity to cold

Primary outcomes:
measure: change in common femoral vein cross-section (mm2) during three immersion modalities immersion
timeFrame: Change from Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements
measure: change in great saphenous vein antero posterior diameter (mm) during three immersion modalities immersion
timeFrame: Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Beliard
Study officials:
affiliation: University of Franche-Comte
name: Samuel Beliard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02279602: Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study
Official title: Rollover for Study OX4218s, A P2 Study to Investigate Safety and Activity of Fosbretabulin Tromethamine in the Treatment of Well-Differentiated, Low-to-Intermediate-Grade Unresectable, Recurrent or Metastatic PNET or GI-NET With Elevated Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumors
Keywords: Pancreatic
Gastrointestional
Lead sponsor: Mateon Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 7
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: Subjects achieving a clinical response in study OX4218s with a biomarker reduction or symptom response are eligible to enroll in this rollover study to continue once every three weeks fosbretabulin infusions for up to one year.

Detailed description: Subjects enrolled in the PNET/GI-NET study OX4218s received weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks. Subjects achieving a clinical response with a biomarker reduction or symptom response based on investigator assessment are eligible to enroll in this rollover study (protocol OX4219s). Subjects will receive fosbretabulin every three weeks for a maximum of approximately one year or until disease progression, unacceptable toxicity, consent withdrawal, protocol-noncompliance, or the investigator feels that it is no longer in the subject's best interest to continue therapy.

Eligibility criteria: Inclusion Criteria:

* Subject has been treated in the OXiGENE-sponsored Phase 2 study OX4218s

Exclusion Criteria:

* Subject has not received fosbretabulin treatment in the study OX4218s

Primary outcomes:
measure: Change in biomarkers from baseline
timeFrame: 48 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Lexington
country: United States
facility: Markey Cancer Center, Clinical Research Office
state: Kentucky
city: Bronx
country: United States
facility: Montefiore
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Milwaukee
country: United States
facility: Froedtert Hospital, Medicial College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT02704702: A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Fimasartan
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2016-03-10
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

Detailed description: This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.

Eligibility criteria: Inclusion Criteria:

1. Caucasian male 19-55 years of age.
2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
3. Medically healthy with no clinically significant medical history.
4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
4. Plasma donation within 7 days prior to the first dose of study drug.
5. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).

Primary outcomes:
measure: Area Under the Concentration-time Curve
timeFrame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
measure: Maximum Observed Concentration
timeFrame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
measure: Time to Reach Maximum Observed Plasma Concentration
timeFrame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Celelion, Inc.
name: Laura Sterling, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05112302: A Study to Evaluate Virtual Reality As Adjunct to Anesthesia During Orthopedic Surgery
Official title: Use of Virtual Reality As an Adjunct for Anesthesia During Orthopedic Procedures Under Regional or Central Neuraxial Nerve Block. a Pilot and Feasibility Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Knee Arthropathy
Hip Injuries
Keywords: virtual reality
knee arthroplasty
hip arthroplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 50
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: Adult patients undergoing elective orthopedic surgery

Brief summary: The purpose of this study is to obtain feedback from patients and orthopedic surgeons who agree to use virtual reality (VR ) as an adjunct to standard of care in orthopedic cases under regional or central neuraxial nerve block. This will serve as a preliminary study for future trials to compare outcomes between VR and standard of care vs standard of care only.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Patients scheduled for orthopedic procedure under regional or central neuraxial nerve block (anterior primary hip arthroplasty or primary knee arthroplasty).
* Subject willing to participate and able to provide informed consent.

Exclusion Criteria:

* Age \< 18 years old.
* History of motion sickness or blindness.
* Unable to consent due to cognitive difficulty.
* Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software.

Sensitivity to flashing light or motion.

* Recent stroke.
* Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open wound, sores, or skin rash on face).

Primary outcomes:
measure: Impact of virtual reality on anxiety level
timeFrame: Up to 2 hours
Secondary outcomes:
measure: Impact of virtual reality on pharmacological therapy doses
timeFrame: Up to 2 hours
measure: Impact of virtual reality on patient's perioperative temperature
timeFrame: Up to 3 hours
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Klaus Torp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04654702: Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.
Official title: A Multi-center, Prospective, Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap in Patients With Asthma and Perennial Allergic Rhinitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perennial Allergic Rhinitis
Asthma
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2020-12-04
Enrollment: 2671
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3,000 patients

Brief summary: Investigator examines the past prescription patterns and the reasons for the change of prescription to Monterizine capsules for Perennial Allergic Rhinitis patients with Asthma who will be taking Monterizine capsules to treat allergic rhinitis.

After being given Monterizine capsules, Investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).

Detailed description: A Multi-center, Prospective, Observational Study

Eligibility criteria: Inclusion Criteria:

1. Male or female aged ≥ 15 years
2. Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis
3. Patients who provided a signed written informed consent form

Exclusion Criteria:

1. Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives
2. Patients with renal failure(CLCR,10ml/min) and hemodialysis patients
3. A female who is pregnant, may be pregnant, or is lactating
4. Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption

Primary outcomes:
measure: The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline
timeFrame: 3 Month
Secondary outcomes:
measure: The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline
timeFrame: 6Month
measure: The change in the therapeutic satisfaction at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline
timeFrame: 3Month,6Month
measure: The change in the quality of life at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline
timeFrame: 3Month,6Month
measure: The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline
timeFrame: 3Month,6Month
measure: Occurrence and frequency of adverse events
timeFrame: 6Month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 59 institutions including Chung-Ang University Hospital
Study officials:
affiliation: 59 institutions including Chung-Ang University Hospital
name: Byoung-Whui Choi
role: PRINCIPAL_INVESTIGATOR
References: