louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00504426: Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Official title: Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain Due to Osteoporosis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 101
Sex: FEMALE
Minimum age (years): 46
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Patients who fulfill all of the following items

  * Patients with primary osteoporosis
  * Patients who have existing 1-4 vertebral fractures
  * Patients with back pain persisting for one week or more
  * Postmenopausal women between 46 and less than 80 years of age

Primary outcomes:
measure: Pain (Subjective Symptom)
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Improvement Rate of Pain (Doctor's Judgment)
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Hokkaido Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
Study officials:
affiliation: Division of New Product Evaluation and Development
name: Katsuhisa Saito
role: STUDY_DIRECTOR
References:
Clinical trial NCT02983526: Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Osteoarthritis of Hip Nos
Secondary Osteoarthritis of Hip
Keywords: short stem
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden. The patients were randomized to either CFP or Corail stem, both groups received Delta cup from Lima. Randomisation was done using envelopes. Patients could only participate with one hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.

Detailed description: The concept of femoral neck preserving hip replacement is intended for the young and active patients. By preserving proximal bone load, the transmission to the proximal femur is supposed to improve and future revision surgery would be facilitated. The hypothesis is that a more conservative resection of the femoral neck could lead to better clinical outcomes compared to a conventional stem. The clinical outcomes and the fixation of a short femoral stem were therefore compared with a stem of standard length. 83 patients were included in our randomized controlled trial where patients either received a Collum Femoris Preserving (CFP) stem or a Corail hip stem. Clinical outcomes are being assessed, plain radiographs are studied and the early migration is being measured using radiostereometric analysis. All of the patients have gone through 1 year follow-up. The 2 years results will be available at the end of 2017.

Eligibility criteria: Inclusion Criteria:

* primary osteoarthritis of hip
* secondary osteoarthritis due to hip dysplasia or Perthes under condition that the collum anatomy is well preserved and largely unaffected by the primary disease
* avascular necrosis of femoral head
* anatomy suitable for both designs according to preoperative planning

Exclusion Criteria:

* previous treatment with cortisone
* generalized joint disease

Primary outcomes:
measure: Oxford Hip Score
timeFrame: Preoperatively to 2 years
measure: Radiostereometric analysis
timeFrame: Preoperatively to 2 years
Secondary outcomes:
measure: Patient satisfaction (VAS), Pain (VAS)
timeFrame: Preoperatively to 2 years
measure: Harris hip score
timeFrame: Preoperatively to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Sahlgrenska University Hospital
name: Johan Kärrholm, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06710626: Control of Assistive Devices Via Brain-Computer Interface Technology
Official title: CONVOY: An Early Feasibility Study of Neural Control of Assistive Devices Via Brain-Computer Interface Technology
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tetraplegia/Tetraparesis
Amyotrophic Lateral Sclerosis (ALS)
Quadriplegia
Spinal Cord Injury (SCI)
Spinal Cord Injury Cervical
Keywords: brain computer interface
robotic arm
assistive device
Neuralink N1 Implant
Neuralink
N1 Implant
ALS
Spinal cord injury
Quadriplegia
tetraplegia
Robot
external device control
neuroprosthetics
Lead sponsor: Neuralink Corp
Sponsor class: INDUSTRY
First posted: 2024-11-29
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS).
Primary purpose: OTHER

Brief summary: The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.


Eligibility criteria: Inclusion Criteria:

* Continued enrollment in the PRIME Study.
* Implanted with the N1 Implant.

Exclusion Criteria:

* Explantation or deactivation of the N1 Implant.
* Insufficient N1 Implant BCI performance demonstrated.
* Lack of a suitable physical space to perform research sessions.
* Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.

Primary outcomes:
measure: Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant.
timeFrame: 3-months following first use of the assistive device
Secondary outcomes:
measure: Rate of Device-Related Adverse Events (AE)
timeFrame: Up to 72 months after enrollment
measure: Assessment of Quality of Life Using the Psychosocial Impact of Assistive Devices Scale (PIADS)
timeFrame: From enrollment, every 3 months, up to 72 months
measure: Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score
timeFrame: From enrollment, every 3 months, up to 72 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
Study officials:
References:
Clinical trial NCT03252626: Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke
Official title: Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ischemic stroke has a variety of treatments and currently drug therapy is one of the main treatments.A number of clinical studies have proved that alprostadil (PGE1) has pharmacological effects of significant dilation of blood vessels, inhibition of plate aggregation, anti-atherosclerosis and increased cerebral blood flow.Evaluate the 90-days efficacy by comparing two groups of patients'(one with alprostadil,another with placebo) mRS.


Eligibility criteria: Inclusion Criteria:

1. ischemic stroke diagnosed by CT or MRI
2. Age: 18-75 years
3. Pre-stroke mRS score is 0-1
4. within 72 hours symptoms onset
5. 4 ≤ NIHSS \<20
6. Patient is willing to participate voluntarily and to sign a written patient informed consent

Exclusion Criteria:

1. intracranial tumors, encephalitis or lesions diagnosed by CT or MRI
2. patients with thrombolytic therapy
3. low platelet , blood system diseases or other bleeding tendency
4. suspected subarachnoid hemorrhage or aortic dissection coma
5. atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate \<50 beats / min
6. ALT or AST continued to rise more than 3 times the upper limit of normal creatinine clearance rate\<30ml/min
7. Dementia and mental illness
8. Patient who is participating in other trials or has been participated in other trials in recent 3 months

Primary outcomes:
measure: Modified Rankin Scale at Day 90
timeFrame: day 90
Secondary outcomes:
measure: Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
timeFrame: day 30, day 90
measure: Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
timeFrame: day 30, day 90
measure: Barthel Index score
timeFrame: day 30, day 90
measure: EQ-5D scale
timeFrame: day 30, day 90
measure: Documentation of adverse events (AEs)
timeFrame: day 30, day 90
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01703026: Contrast Enhanced EUS in the Evaluation of Pancreatic Cancer and Pancreatic Masses
Official title: Contrast Enhanced EUS Using Definity in the Evaluation of Pancreatic Cancer and Pancreatic Masses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 50 subjects will be enrolled. The study population will be drawn from patients referred for EUS evaluation on basis of suspected pancreatic cancer. These patients could be either from clinics or from the hospital wards.

Brief summary: Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to detect pancreatic cancer at an earlier stage, to improve current method of T staging and assessment of surgical resectability and also to distinguish between benign and malignant pancreatic masses. All these will translate into better clinical outcome, and also avoid unnecessary surgery in situations of unresectable cancers.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients over a 1-year period referred for EUS examination due to suspected pancreatic lesions will be enrolled.
* Age 21 years and above.
* Ability to provide informed consent

Exclusion Criteria:

Patients with clinical conditions that preclude the use of DEFINITY™ will be excluded. These conditions are:

* Right-to-left, bi-directional, or transient right-to-left cardiac shunts;
* Worsening or clinically unstable congestive heart failure;
* Acute myocardial infarction or acute coronary syndromes;
* Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval;
* Respiratory failure;
* Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature;
* Hypersensitivity to DEFINITY™ or its components.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References:
citation: Bilimoria KY, Bentrem DJ, Ko CY, Ritchey J, Stewart AK, Winchester DP, Talamonti MS. Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database. Cancer. 2007 Aug 15;110(4):738-44. doi: 10.1002/cncr.22852.
citation: Ang TL. Endoscopic ultrasound: moving from diagnostics to therapeutics. J Dig Dis. 2008 Aug;9(3):117-28. doi: 10.1111/j.1751-2980.2008.00333.x.
citation: Snady H, Cooperman A, Siegel J. Endoscopic ultrasonography compared with computed tomography with ERCP in patients with obstructive jaundice or small peri-pancreatic mass. Gastrointest Endosc. 1992 Jan-Feb;38(1):27-34. doi: 10.1016/s0016-5107(92)70326-5.
Clinical trial NCT05701865: Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention
Official title: Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention for Sexual Violence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Intoxication
Lead sponsor: Georgia State University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this experimental study is to examine the effect of alcohol, gender, and bystander attitudes on bystander barriers and sexual violence intervention among young adult men and women (age 21-20). The main questions it aims to answer are:

* Does alcohol intoxication and gender influence bystander barriers and sexual violence intervention?
* Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among men, compared to women?
* Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among those with higher, compared to lower, prosocial bystander attitudes?

Participants will be randomly assigned to one of two beverage conditions (alcohol or control beverage) and those assigned to alcohol will complete the study on either the ascending or descending alcohol limb. Participants will project themselves into a heat-of-the moment, risky sexual violence scenario that will assess bystander barriers and behavioral intentions. Researchers will compare those assigned to the alcohol and control beverage condition and men/women to see if this impacts bystander barriers and sexual violence intervention.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 21 and 30
* Report that on at least 3 days in the past year they have consumed an alcohol quantity on a single occasion that was equal or greater to the dose administered in the lab

Exclusion Criteria:

* Currently seeking treatment or in recovery for an alcohol or substance use disorder
* A medical condition or medication use in which alcohol consumption is medically contraindicated
* Pregnant, nursing, or has engaged in sexual intercourse without effective contraception in the past two weeks
* If the participant is less than six feet tall and weighs over 250 pounds or is over six feet tall and weighs over 300 pounds

Primary outcomes:
measure: Articulated Thoughts of Barriers to Bystander Intervention
timeFrame: 35 minutes to 2.5 hours post-drinking
measure: Articulated Thoughts of Intentions to Intervene as a Bystander
timeFrame: 35 minutes to 2.5 hours post-drinking
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Ruschelle M Leone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870765: Safety Study of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.
Official title: Prospective Randomised Study on the Safety of Non-invasive Ventilation Versus High-flow Oxygen in Patients With Hypoxemic Respiratory Failure Undergoing Fiberoptic Bronchoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 40
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: Bronchoscopy with broncho-alveolar lavage is a diagnostic tool in patients with pneumonia. Especially patients with acute or chronic pulmonary diseases are at risk of respiratory failure during or after bronchoscopy. It is known that in these cases bronchoscopy can be performed safely using non-invasive ventilation. It seems probable that high-flow oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of respiratory failure during fiberoptic bronchoscopy while improving patient comfort. In this prospective randomised study the safety of high-flow oxygen is compared with non-invasive ventilation in patients with hypoxemic respiratory failure undergoing fiberoptic bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* patients treated in an intensive care unit
* indication for bronchoscopy and broncho-alveolar lavage
* presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) and/or hypercapnic respiratory failure

Exclusion Criteria:

* patients already on invasive ventilation
* indication for intubation
* blocked nasopharynx
* contraindications for non-invasive ventilation or high-flow oxygen

Primary outcomes:
measure: Mean decrease in the saturation of oxygen (SpO2) during bronchoscopy.
timeFrame: during fiberoptic bronchoscopy
Secondary outcomes:
measure: Changes in blood gases after the completion of fiberoptic bronchoscopy.
timeFrame: 1 hour after the completion of bronchoscopy
Other outcomes:
measure: Requirement of intubation after the completion of bronchoscopy.
timeFrame: 8 hours after the completion of bronchoscopy
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine
Study officials:
References:
citation: Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.
Clinical trial NCT01990365: The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures
Official title: The Influence of Vertebral Mobility on Low Back Pain in Patients With Acute Osteoporotic Vertebral Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporotic Vertebral Fracture
Keywords: Vertebral fracture, low back pain, gips, mobility
Lead sponsor: Tomidahama Hospital
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 300
Sex: ALL
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Osteoporotic patients with acute vertbral fracture

Brief summary: Many patients with acute osteoporotic vertebral fracture (acute OVFs) admitted because of low back pain. But there are only part of patients with acute OVFs, because some patients do not have low back pain although OVFs occurred.

Detailed description: Many patients of acute OVFs present with low back pain. While there are also many patients without low back pain even if acute OVFs occurred. The mechanism of low back pain after acute OVFs is well unknown. We set up a hypothesis that low back pain results from vertebral body mobility, which refers to a change of vertebral height or configuration with changes in body positioning. The main objective of this study is to reveal the relationship between vertebral body mobility and low back pain.

Eligibility criteria: Inclusion Criteria:

* Patients with acute osteoporosis fractures

Exclusion Criteria:

* Patients without acute osteoporosis fractures (metastasis, infection, deformity,etc)

Primary outcomes:
measure: Relationship between dynamic mobility of acute vertebral fracture body and low back pain
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yokkaichi
country: Japan
facility: Tomidahama Hospital
state: Mie
Study officials:
References:
Clinical trial NCT01661465: Routine Clinical Screening for Substance Use Disorders in the Emergency Room Setting
Official title: Routine Clinical Screening for Substance Use Disorders in the Emergency Room Setting
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Substance Use
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 9212
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to University Hospital Emergency Department

Brief summary: To ensure consistent documentation of alcohol and substance use, the emergency medicine is initiating a new standard of care for substance use screening: the use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed in triage. This questionnaire will allow emergency medicine patients presenting to the emergency room. This study will also review medical records after one year of the index emergency room visit to establish rates or re-presentation and hospitalization correlated with different substance use.

Detailed description: Screening for alcohol use and substances of abuse in the emergency and trauma settings is critical for both effective current treatment of the presenting clinical issue and prevention of future incidents. Identification, engagement and treatment of substance use disorders decreased trauma and emergency department visits and medical comorbidities (Bertholet et al., 2005; Kaner et al., 2007). To ensure consistent documentation of alcohol and substance use, the emergency medicine is initiating a new standard of care for substance use screening: the use of a brief self-evaluation questionnaire on alcohol, tobacco and illicit substance use to be completed in triage. This questionnaire will allow emergency medicine patients presenting to the emergency room. This research study will perform a chart review on all self-evaluation questionnaires on alcohol, tobacco and substance use to determine the prevalence of use of specific substances in this patient population and associated demographic predictors and medical comorbidities. This study will also review medical records after one year of the index emergency room visit to establish rates or re-presentation and hospitalization correlated with different substance use.

Eligibility criteria: Inclusion Criteria:

* Able to complete a questionnaire

Exclusion Criteria:

* Younger than 19 Unable or unwilling to complete a self-assessment form written in English Prisoners

Primary outcomes:
measure: Percent of subjects with re-presentation of drug or alcohol abuse 1 year after initial presentation to Emergency Department
timeFrame: baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
Study officials:
References: