louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03202433: Reduce Stress Associated With Needle Aspiration, in Voluntary and Replacement Blood Donors
Official title: Use of Virtual Reality in Blood Donors, an Innovative Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Keywords: Virtual Reality
Stress Reduction
Needle Aspiration
Blood Donors
Intervention
Lead sponsor: Center for Blood and Tissues IV and V Region, Chile
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation of two groups (Study and Control)
Primary purpose: TREATMENT

Brief summary: Reduce stress associated with needle aspiration, in voluntary and replacement blood donors.

This study has not been completed.

Detailed description: The purpose of the study is to investigate the effectiveness of Virtual Reality (as a form of distraction) to reduce the stress associated with extraction needle puncture in the volunteer blood donors and reposition of Fixed Collection of the Valparaiso Blood Center, Of the Valparaíso San Antonio Health Service.

Eligibility criteria: Inclusion Criteria:

* Able to understand and / or visualize the numerical scale of pain
* Spanish spoken
* Greater than 50 Kilograms of weight
* Blood hemoglobin: Greater than 12.5 g% in women and greater than 13.5 g% in men
* Have been accepted as a blood donor.

Exclusion Criteria:

* Unable to understand and / or visualize the numerical scale of pain
* Does not speak Spanish
* Less than 50 Kilograms
* Blood hemoglobin: Less than 12.5 g% in women and less than 13.5 g% in men.
* Have been rejected as a blood donor.

Primary outcomes:
measure: Numerical scale of pain (EN)
timeFrame: Once finalized the donation that should last a maximum of 15 minutes.
Secondary outcomes:
measure: Heart rate. Measurement with automatic equipment
timeFrame: Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes
measure: Blood pressure. Measurement with automatic equipment
timeFrame: Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes
Other outcomes:
Locations:
city: Valparaiso
country: Chile
facility: Blood and Tissue Center
Study officials:
affiliation: Medical College of Chile
name: Pedro Meneses
role: STUDY_DIRECTOR
References:
citation: Riva G, Raspelli S, Pallavicini F, Grassi A, Algeri D, Wiederhold BK, Gaggioli A. Interreality in the management of psychological stress: a clinical scenario. Stud Health Technol Inform. 2010;154:20-5.
citation: Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
Clinical trial NCT00750633: A Phase III Study of an Otic Formulation in Acute Otitis Externa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Externa
Keywords: swimmer's ear
ear drops
ear infection
ear pain
ear inflammation
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 990
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin
* A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks
* Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
* Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
* Known or suspected ear infection of fungal or mycobacterial origin
* Prior otologic surgery within 6 months of study entry
* Seborrheic dermatitis or other skin conditions of the external auditory canal
* Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis
* Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator
* Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study \[e.g., cleft palate (including repairs), Downs Syndrome, and cranial facial reconstruction\]
* Any current known or suspected infection (other than AOE) requiring systemic antimicrobial therapy
* Use of prohibited medications or inadequate washout of any medication listed in protocol
* Concomitant use of topical or oral analgesics (i.e., NSAIDs and aspirin products) which may have anti inflammatory effects. Patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. Use of acetaminophen ("Tylenol") is permitted during the trial
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Clinical Cure
timeFrame: Day 3
measure: Clinical Cure
timeFrame: Day 12
Secondary outcomes:
measure: Microbiological Success
timeFrame: Day 12
Other outcomes:
Locations:
Study officials:
affiliation: 1-888-451-3937
name: Contact Alcon Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02426333: Optimizing Abiraterone Therapy
Official title: Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker - Drug Exposure - as a Predictor for Drug Response in Patients With mCRPC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration Resistant Prostate Cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2015-04-24
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated

Brief summary: The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
* Age ≥18 years
* Feasible to collect blood samples from
* Life expectancy of \> 6 months
* Measurable disease
* Able and willing to give written informed consent prior to screening and enrollment

Exclusion Criteria:

* other anticancer therapies
* potent CYP3A4 inducers
* herbal medicine that could interfere with abiraterone exposure

Primary outcomes:
measure: abiraterone AUC
timeFrame: 6 months
Secondary outcomes:
measure: biomarkers: relation between biomarkers and treatment response
timeFrame: 6 months
measure: biomarker reduction
timeFrame: 6 months
Other outcomes:
Locations:
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
Study officials:
affiliation: Radboud University Medical Center
name: Nielka van Erp, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Jack Schalken, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02653833: The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy
Official title: Skeletal Muscle Blood Flow in Becker Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Muscular Dystrophy
Keywords: Becker
Muscular Dystrophy
Skeletal Muscle
blood flow
Ultrasound
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This pilot study tests the hypothesis that the medication nitric oxide extract from beetroot juice improves blood flow to the skeletal muscle during exercise. The investigators will use cutting edge technology with contrast enhanced ultrasound to visualize the microvascular blood supply to the forearm. Animal studies have shown reversal of muscle damage with improved delivery of blood to the exercising muscle. This research aims to understand the mechanism of action of this medication in a way it has never been studied before. The results may help benefit individuals with muscular Dystrophy in the future.

Detailed description: The subjects are asked to perform a graded hand-grip exercise while blood flow to the skeletal muscle is visualized by contrast enhanced ultrasound.

This is done at baseline and after taking the study agent.

Eligibility criteria: Inclusion Criteria:

* Healthy man, aged 18 to 45 years, currently taking no medication. OR
* Clinical diagnosis of Becker Muscular Dystrophy (BMD), aged 18 to 45 years, and currently taking no medication.

Exclusion Criteria:

* Hypertension, diabetes, heart failure, liver disease
* ECG evidence of prolonged QT interval

Primary outcomes:
measure: Change in Skeletal Muscle Blood Flow
timeFrame: At baseline and within one hours after taking beetroot juice or Tadalafil
Secondary outcomes:
measure: Change in Measured Functional Sympatholysis
timeFrame: At baseline, and within an hour after taking beetroot juice or Tadalafil
measure: Change in Measured Flow Mediated Dilation (FMD)
timeFrame: At baseline, and within an hour after taking beetroot juice or Tadalafil
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ronald G Victor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00255333: INNO-105 in Patients With Solid Tumors
Official title: A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Weekly Intravenous INNO-105 in Adult Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tumors
Lead sponsor: Innovive Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-11-18
Enrollment: 24
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: The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Have a histologically or cytologically confirmed diagnosis of a solid malignancy (patients may have either measurable or nonmeasurable disease).
2. Be ≥18 years old.
3. Not eligible for effective therapy likely to provide clinical benefit.
4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
5. Acceptable pretreatment clinical laboratory results.
6. Life expectancy of greater than 12 weeks.

Exclusion Criteria:

1. Have received previous treatment with INNO-105.
2. Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
3. Are pregnant or lactating.
4. Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
5. Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.
6. Have not recovered from acute toxicity of all previous therapy prior to enrollment.
7. Have symptomatic or untreated central nervous system (CNS) metastases.
8. Have a susceptibility to hypotension, bradycardia, and/or hypopnea, such as patients with known coronary heart disease, arrhythmias, cerebral vascular disease, and chronic obstructive airways disease (CO2-retaining).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
affiliation: Mary Crowley Medical Research Center
name: Casey Cunningham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland Greenebaum Cancer Center
name: Edward Sausville, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01413633: A Novel Technique For Gall Bladder Fundus Retraction In Single Incision Laparoscopic Cholecystectomy
Official title: A Novel Technique For Gall Bladder Fundus Retraction In Single Incision Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Diseases
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators describe a novel technique for GB fundus retraction.

Detailed description: few methods are available for gall bladder (GB) retraction in SILC to replace the usage of ancillary ports imitating retraction from conventional technique, e.g. trans-parietal stitches mini-loop retractor , a Kirschner wire . This technical note describes a novel way to retract the gall bladder fundus.

Eligibility criteria: Inclusion Criteria:

* all cases underwent single incision cholecystectomy

Exclusion Criteria:

* none

Primary outcomes:
measure: operative time
timeFrame: about 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: DRAMADAN ELLITHY, M
role: STUDY_CHAIR
References:
Clinical trial NCT06222333: Breathing Exercise for Rib Fracture
Official title: Can Breathing Exercise Reduce Pulmonary Complications in Rib Fractures: Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rib Fractures
Spirometry
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Respiratory physiotherapy is routinely performed after thoracic surgery operations to increase lung expansion and prevent pulmonary complications such as atelectasis and pneumonia. It is a controversial issue whether respiratory physiotherapy reduces pulmonary complications in rib fractures. In our study, patients with rib fractures will be divided into two groups. In the control group, standard treatment consisting of routine analgesic treatments will be applied. In the other group, respiratory physiotherapy will be applied with triflu for 8 hours a day. At the end of the study, pulmonary complications in both groups will be compared.

Detailed description: Patients between the ages of 18 and 100 who will apply to our hospital due to rib fractures between April 2024 and April 2025 will be evaluated. Patients who meet the inclusion criteria will be included in the study. Patients will be divided into two groups using randomization blocks. Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen. In the other group of patients, in addition to conservative treatment, triflow breathing exercise will be applied for 8 hours a day. Respiratory function test pain scores and pulmonary complications of patients in the two groups will be compared statistically.

Eligibility criteria: Inclusion Criteria:

* Isolated thoracic injury within 24 hours
* Age between 18-100

Exclusion Criteria:

* Pneumothorax and hemothorax requiring intervention at admission
* Injury severity index \>16
* COPD, Atshma
* Extrathoracic trauma

Primary outcomes:
measure: FEV1, FVC, FEV1/FVC results on day 7
timeFrame: 7 days
Secondary outcomes:
measure: Number of Participants with Pneumonia
timeFrame: 7 days
measure: FEV1, FVC, FEV1/FVC results on day 2
timeFrame: 2 days
Other outcomes:
Locations:
city: Kastamonu
country: Turkey
facility: Kastamonu University
Study officials:
References:
Clinical trial NCT01200433: The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Neurosurgery
Keywords: dexmedetomidine
propofol
cerebral blood flow
brain oxygenation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.


Eligibility criteria: Inclusion Criteria:

* ASA I-III.
* Scheduled for DBS.

Exclusion Criteria:

* History of dystonia.
* Severe heart failure with ejection fraction less than 30%.
* History of obstructive sleep apnea.
* History of renal failure with creatinine level \> 2 mg/dl.
* Allergies to α-2 agonists and propofol.
* Current use of α-2 agonist medications such as clonidine.

Primary outcomes:
measure: Cerebral Blood Flow
timeFrame: For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.
measure: Brain Oxygen
timeFrame: during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods
Secondary outcomes:
measure: Cerebral Blood Flow
timeFrame: after procedure, in post anesthesia care unit (PACU)
measure: Alertness/Sedation
timeFrame: at the first peak during DBS surgery
measure: Pulsatility Index
timeFrame: at the first peak during DBS surgery
measure: Cerebral Perfusion Pressure
timeFrame: at the first peak during DBS surgery
measure: Number of Hypertensive Episodes
timeFrame: During DBS surgery
measure: Number of Apneic Episodes.
timeFrame: during DBS surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ehab Farag, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farag E, Kot M, Podolyak A, Argalious M, Deogaonkar M, Mascha EJ, Xu Z, Katzan I, Ebrahim Z. The relative effects of dexmedetomidine and propofol on cerebral blood flow velocity and regional brain oxygenation: A randomised noninferiority trial. Eur J Anaesthesiol. 2017 Nov;34(11):732-739. doi: 10.1097/EJA.0000000000000662.
Clinical trial NCT05595733: Can NAVA Mode Reduce Mechanical Ventilation Day in Patients With COPD ?
Official title: Can Neurally Adjusted Ventilatory Assist Mode Reduce Mechanical Ventilation Day in Patients With Chronic Obstructive Pulmonary Disease ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Lung Diseases
Keywords: Neurally Adjusted Ventilatory Assist
ventilator-free days
patient-ventilator synchrony
diaphragm atrophy
Chronic Obstructive Pulmonary Disease
Lead sponsor: Fu Jen Catholic University Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background： Neurally Adjusted Ventilatory Assist (NAVA) mode is a new mode of ventilator, using electronic potential of diaphragm to adjust tidal volume. At the same time, this mode can trigger and cycle-off inspiratory time by high sensitivity of electronic potential of diaphragm, increase patient-ventilator synchrony, reduce sedative drug, improve oxygenation, shorten mechanical ventilation day and reduce the rate of diaphragm atrophy. It can improve survival rate and hospital day of patients. Both the animal and human experiment have the effect of lung and diaphragm protection Effect： The results of this trial are expected to obtain electronic potential of diaphragm in patients with obstructive pulmonary disease. Reviewing the current literature, few related literatures have such data presentation. This trial hopes to evaluate whether the use of NAVA can reduce mechanical ventilation day by analyzing electronic potential of diaphragm in patients with obstructive pulmonary disease.

Investigators expect that participants with obstructive pulmonary disease using NAVA mode will have significantly less mechanical ventilation day than using conventional mode


Eligibility criteria: Inclusion Criteria:

1. Obstructive pulmonary diseases include chronic obstructive pulmonary disease (COPD), asthma (Asthma), cystic fibrosis (cystic fibrosis), bronchiectasis (bronchiectasis), bronchiolitis or other diseases that cause airway stenosis, etc.
2. Other patients with obstructive pulmonary disease assessed by the clinical team
3. Consent signed by the principal or legal representative
4. Age \> 20 years old and \< 99 years old

Exclusion Criteria:

1. Those who cannot place a nasogastric tube due to medical conditions
2. Pregnant women
3. Those who have received gas cutting
4. Patients with phrenic nerve palsy
5. Neuromuscular disease
6. Intubation due to cardiac arrest

Primary outcomes:
measure: ventilator-free days(VFDs)
timeFrame: up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Fu Jen Catholic University Hospital All Rights Reserved
Study officials:
References: