louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03184675: The Effects of Functional Action-Observation Training on Gait Ability in Patients With Chronic Stroke
Official title: Main Researcher for the Effects of Functional Action-observation Training on Gait Ability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to examine the effects of functional action observation training on gait ability in chronic stroke patients.


Eligibility criteria: Inclusion Criteria:

1. diagnosis with stroke through computed tomography or magnetic resonance imaging, more than six months ago.
2. determination not to have cognitive disability, based on the score(\>24 point) of mini mental state examination-Korea version.
3. determination not to have visual abnormalities including the unilateral neglect through the motor-free visual perception test(MVPT)
4. ability to independently gait longer than 10m in the room and to keep standing up without help.

Exclusion Criteria:

1. surgery in the last three months
2. participating any other research

Primary outcomes:
measure: temporal gait variables
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00496275: Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC
Official title: A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
ZACTIMA
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed non small cell lung cancer (stage IIIB-IV)
* Life expectancy greater than 12 weeks
* At least 1 measurable lesion greater than 10mm in smallest diameter.

Exclusion Criteria:

* Prior treatment with anticancer agent
* Brain metastases
* Major surgery within last 4 weeks

Primary outcomes:
measure: Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin
Secondary outcomes:
measure: Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered
timeFrame: Predetermined timepoints after dose administration
measure: Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT02801175: Effect of Left Atrial Ablation on Left Atrial Appendage Emptying Flow Velocity
Official title: Differential Effect of Radiofrequency and Cryoballoon Ablation on Left Atrial Appendage Emptying Flow Velocity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: G.Gennimatas General Hospital
First posted: 2016-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ablation-naive patients with paroxysmal AFib

Brief summary: Consecutive patients with paroxysmal AFib scheduled to undergo pulmonary vein isolation either with radiofrequency (RF) or cryoballoon will be included. Left atrial appendage emptying flow velocity (LAA-EFV) will be measured with transesophageal echocardiography (TEE) immediately before and following left atrial ablation (1 month post). The change in LAA-EFV will be compared between the two groups (RF versus Cryo).


Eligibility criteria: Inclusion Criteria:

Paroxysmal atrial fibrillation, no absolute contraindication for anticoagulation

Exclusion Criteria:

Previous cardiac surgery Previous left atrial ablation History of cerebrovascular event Presence of LAA thrombus Inability to provide informed consent

Primary outcomes:
measure: LAA-EFV
timeFrame: 1 month
Secondary outcomes:
measure: LAA-EFV
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Dept. of Cardiology, Univ of Athens Med Sch
Study officials:
References:
Clinical trial NCT03941275: SelectSecure 3830 Lead Imaging
Official title: SelectSecure 3830 Lead Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of both genders, 18 years of age and older that are currently implanted with at least one SelectSecure 3830 lead, regardless of device type and who meet all inclusion and no exclusion criteria are eligible for the study.

Brief summary: This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model.


Eligibility criteria: Inclusion Criteria:

* Patients who are at least 18 years of age
* Patient has a pacing, ICD or CRT system incorporating at least one SelectSecure 3830 lead in the right atrium or right ventricle
* Patients able and willing to attend imaging session
* Patients able and willing to give informed consent
* Pacing capture threshold and pacing impedance of the lead are within normal range at the time of enrollment
* Patient must be able to accomplish arm flexion and adduction past 90 degrees

Exclusion Criteria:

* Subjects who require a legally authorized representative to obtain consent
* Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)
* Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
* Subjects that were implanted with a pacing, ICD, CRT device and/or cardiac leads less than three months ago

Primary outcomes:
measure: Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.
timeFrame: approximately 30 minutes
Secondary outcomes:
measure: Acquire accelerometer-based motion data
timeFrame: approximately 30 minutes
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Silver Spring
country: United States
facility: Associates in Cardiology PA
state: Maryland
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
Study officials:
References:
Clinical trial NCT04697875: Hemodynamic Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension
Official title: Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: hypoxia
exercise
hemodynamics
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To study hemodynamic effects of acute normobaric hypoxia during exercise in patients with pulmonary hypertension in a single-center randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zürich altitude on ambient air
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* patients who take nitrates
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Primary outcomes:
measure: mean pulmonary artery pressure (mPAP) / cardiac output (CO)
timeFrame: 2 hours
Secondary outcomes:
measure: Differences in pulmonary arterial pressure
timeFrame: 2 hours
measure: Differences in cardiac output
timeFrame: 2 hours
measure: Pulmonary vascular resistance
timeFrame: 2 hours
measure: Differences in pulmonary artery wedge pressure
timeFrame: 2 hours
measure: Differences in right atrial pressure
timeFrame: 2 hours
measure: Differences in mixed venous oxygen saturation
timeFrame: 2 hours
measure: Differences in heart rate
timeFrame: 2 hours
measure: Differences in blood pressure
timeFrame: 2 hours
measure: Differences in oxygen saturation
timeFrame: 2 hours
measure: Differences in arterial blood gases
timeFrame: 2 hours
measure: Differences in mixed venous blood gases
timeFrame: 2 hours
measure: Differences in cerebral tissue oxygenation
timeFrame: 2 hours
measure: Differences in muscle tissue oxygenation
timeFrame: 2 hours
measure: Differences in symptoms (Borg dyspnoea)
timeFrame: 2 hours
measure: Differences in symptoms (Borg leg effort)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: UniversityHospital Zurich, Department of Pulmonology
Study officials:
affiliation: UniversityHospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02825875: Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer
Official title: Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2016-07-07
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adenocarcinoma of the prostate

Brief summary: In this study we aim to more precisely define the clinical utility of PSMA imaging across a range of clinical indications in men with prostate cancer. To accomplish this, we will make the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation oncologists at Johns Hopkins and survey physicians as to the indication for ordering the PET/CT and if a change in management occurred as the result of new information gained from the scan. We believe these data will prove critical for planning future studies aimed at evaluating the efficacy of this test for improving patient outcomes.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Willingness to signed informed consent
3. Histologically confirmed adenocarcinoma of the prostate
4. PSA measurement ≤60 days prior to study enrollment
5. Completed radiographic evaluation with whole-body bone scan (99mTc-MDP or Na18F) and cross-sectional imaging (CT or MRI) of the abdomen and pelvis ≤60 days prior to study enrollment

Exclusion Criteria:

1. Administered a radioisotope within 5 physical half-lives prior to study enrollment
2. History of other malignancy diagnosed within the last 5 years (exceptions: low grade urothelial carcinoma of the bladder, squamous cell carcinoma or basal cell carcinoma of the skin).

Primary outcomes:
measure: Physician responses to a questionnaire
timeFrame: less than 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Professor of Oncology
name: Michael Gorin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234375: Use of Gadolinium in CT Pulmonary Angiography
Official title: Efficacy of Gadolinium Contrast in CT Pulmonary Angiography in Patients With Allergy to Iodine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism
Contrast
Computed tomography
Gadolinium
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who have a contraindication to iodine based contrast. These patients normally get investigated with studies such as ultrasound and nuclear medicine studies but the fastest and preferred investigation is CT with contrast to look for filling defects in the pulmonary arteries. The investigators will assess whether gadolinium, which is currently used with MRI can be used with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium contrast on CT.

Detailed description: Contrast enhancement with Gadolinium will be evaluated to assess its efficacy for diagnosis and exclusion of pulmonary embolism in a patient who previously would not have been investigated with CTPA due to an underlying allergy to contrast or other contraindication. If this proves beneficial, it will allow such patients to be investigated successfully with CTPA

Eligibility criteria: Inclusion Criteria:

* Patients suspected of having a Pulmonary embolus
* Allergy to Iodine based intravenous contrast

Exclusion Criteria:

* Renal impairment
* Less than 20 years of age
* Non-English speaking
* Pregnancy
* Allergy to Gadolinium

Primary outcomes:
measure: Diagnosis of Pulmonary Embolism
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04501575: Feasibility of RCT on the Efficacy of the Osteopathic Consultation in Computer Users
Official title: A Feasibility Study of a Randomized Controlled Trial to Assess the Efficacy of the Osteopathic Consultation on Neck-shoulder Pain in Computer Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trapezius Muscle Strain
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 30
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: TREATMENT

Brief summary: This study investigates the feasibility of conducting a large scale Randomized Controlled Trial (RCT) to analyze the efficacy of the osteopathic consultation in reducing the intensity of pain and changing electromyographic activity in the musculature of the neck-shoulder region for the computer user's population.


Eligibility criteria: Inclusion Criteria:

* Uses computer for over five hours daily, for over one year
* Reports non-specific pain over the neck-shoulder region

Exclusion Criteria:

* No neurologic signs or symptoms
* No known pathology that could mask the reported pain
* No knowledge or experience with osteopathy

Primary outcomes:
measure: Differences in electrical activity during typing task using surface electromyography
timeFrame: baseline and after 2-4 days of the treatment
measure: Differences in Pressure-pain Threshold (PPT)
timeFrame: baseline and after 2-4 days of the treatment
measure: Difference in the self-reported intensity of pain using the numerical rating scale (NRS)
timeFrame: baseline, after 2-4 days of the treatment and after 1 week of the treatment
Secondary outcomes:
measure: Satisfaction Level with the experience
timeFrame: 1 week after data collection for all participants.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Labiomep
Study officials:
affiliation: Professor
name: José Torres da Costa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santiago RJ, Esteves JE, Baptista JS, Magalhaes A, Costa JT. Results of a feasibility randomised controlled trial of osteopathy on neck-shoulder pain in computer users. Complement Ther Clin Pract. 2022 Feb;46:101507. doi: 10.1016/j.ctcp.2021.101507. Epub 2021 Nov 3.
Clinical trial NCT06797375: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants
Official title: Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RLYB116 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Hematologic Diseases
Autoimmune Diseases
Keywords: complement-mediated diseases
Lead sponsor: Rallybio
Sponsor class: INDUSTRY
First posted: 2025-01-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RLYB116 (with an improved impurity profile) following repeated administration of RLYB116 in healthy participants.


Eligibility criteria: Inclusion Criteria:

1. Male and female participants, 18 to 55 years of age.
2. Able to provide written informed consent.
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2.
4. Must have been vaccinated against N. meningitidis and S. pneumoniae with approved vaccine according to product label. All participants considered eligible for enrollment will be vaccinated or willing to receive vaccination according to the following:

   1. Vaccination with Meningococcal Group A, C, W135, and Y conjugate vaccine (Menveo® or an acceptable alternative) + Pneumococcal Polysaccharide Vaccine (Pneumovax® 23 or an acceptable alternative) at least 28 days prior to receiving the first dose of RLYB116.
   2. Vaccination with Meningococcal Group B (Bexsero®) at least 14 days prior to receiving the first dose of RLYB116.

Exclusion Criteria:

1. Participants that smoke more than 10 cigarettes per week
2. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus.
3. Pregnant or nursing
4. Donation or loss of greater than 400 mL of blood within 56 days of study enrollment
5. History of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to N. meningitidis or S. pneumoniae vaccines.

Primary outcomes:
measure: Number of participants with treatment related adverse events as defined by CTCAE 5.0.
timeFrame: From baseline to Day 1, 2, 3, 4, 5, 8, 9, 15, 16, 22, 23, 29, 30, 32, 33, 36, 43, 57, 71, 99
Secondary outcomes:
measure: Inhibition of complement activation measured by free/total C5 concentrations and hemolytic activity
timeFrame: Day 1, 2, 8, 15, 29, 20, 32, 33, 43, 57, 71, 99
measure: Anti-RLYB116 antibodies measured in serum
timeFrame: Day 1, 29, 99
measure: Exposure to RLYB116 as measured in serum
timeFrame: Day 1, 2, 3, 4, 5, 8, 15, 29, 53, 57, 71, 99
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00015275: Pathophysiological Subtyping of Abnormalities in Cocaine Dependence - 9
Official title: Pathophysiological Subtyping of Abnormalities in Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: New York MDRU
First posted: 2001-04-18
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to define pathophysiological subtypes of abnormalities in subjects with cocaine dependence.

Detailed description: The objective of this study is to define subgroups of patients with differential treatment outcome on the basis of differential baseline electrophysiological clusters.

Eligibility criteria: Inclusion Criteria:

Cocaine dependence. Seeking residential treatment.

Primary outcomes:
measure: Identification of homogenous subgroups within total population of cocaine dependent adults
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York MDRU
state: New York
Study officials:
affiliation: New York MDRU
name: John Rotrosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: