louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05690919: Examining the Experiences of Brain Injury Patients in Medical Trials
Official title: A Study Analyzing Brain Injury Patients Experience Patterns in Medical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Brain Injuries
Keywords: Brain Injuries
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Brain injury patients who are actively considering enrolling in an intensive clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Historically, participation in clinical trials has been skewed towards certain groups. However, research on the factors that influence participation, both positive and negative, is limited.

Brain injury clinical trial patients help us identify these factors by sharing trial experiences during the course of the interventional medical study.

This study will include a diverse group of participants to gather a wide range of information on clinical trial experiences. The collected data will then be used to benefit future brain injury patients who are considering participating in a medical study.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with brain injury
* Patient is 18 years old
* Patient has self-identified as planning to enroll in an interventional clinical trial

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Patient is pregnant
* Inability to perform regular electronic reporting

Primary outcomes:
measure: Number of patients who decide to enroll in a brain injury clinical trial.
timeFrame: 3 months
measure: Rate of patients who remain in brain injury clinical trial to trial completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Maas AI, Roozenbeek B, Manley GT. Clinical trials in traumatic brain injury: past experience and current developments. Neurotherapeutics. 2010 Jan;7(1):115-26. doi: 10.1016/j.nurt.2009.10.022.
citation: Wat R, Mammi M, Paredes J, Haines J, Alasmari M, Liew A, Lu VM, Arnaout O, Smith TR, Gormley WB, Aglio LS, Mekary RA, Zaidi H. The Effectiveness of Antiepileptic Medications as Prophylaxis of Early Seizure in Patients with Traumatic Brain Injury Compared with Placebo or No Treatment: A Systematic Review and Meta-Analysis. World Neurosurg. 2019 Feb;122:433-440. doi: 10.1016/j.wneu.2018.11.076. Epub 2018 Nov 20.
citation: Kjeldsen SS, Brodal L, Brunner I. Activity and rest in patients with severe acquired brain injury: an observational study. Disabil Rehabil. 2022 Jun;44(12):2744-2751. doi: 10.1080/09638288.2020.1844317. Epub 2020 Nov 8.
Clinical trial NCT03920319: Bupropion and Cigarette-Related Cues in Smokers
Official title: Effect of Bupropion Treatment on Brain Activation Induced by Cigarette-Related Cues in Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Smoking, Tobacco
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, before-after controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: Randomized, double-blind, before-after controlled trial to assess changes in regional brain activation in response to cigarette-related cues from before to after treatment with bupropion (vs placebo).


Eligibility criteria: Inclusion Criteria:

* Treatment-seeking cigarette smoker
* Meet DSM-IV criteria for nicotine dependence
* Negative result on urine test for drug use during screening

Exclusion Criteria:

* History of any Axis I psychiatric diagnosis other than nicotine dependence
* Medical conditions that might affect brain function
* Current use of medications that could alter brain function
* Pregnancy
* Current illicit drug use other than occasional use of marijuana

Primary outcomes:
measure: Craving ratings
timeFrame: 8 weeks
Secondary outcomes:
measure: Exhaled carbon monoxide (CO)
timeFrame: 8 weeks
measure: Cigarettes per day
timeFrame: 8 weeks
measure: Fagerström Test for Nicotine Dependence (FTND)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01326819: Comparison of Normal Readings and Repeatability Across Skin Colors
Official title: Comparison Study of Three Regional Oxygen Saturation (rSO2) Systems Across a Wide Range of Skin Colors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Near Infrared Spectroscopy
Keywords: Near infrared spectroscopy
Skin pigmentation
Regional oxygen saturation
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2011-03-31
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* of any race or ethnicity
* greater than eighteen years of age
* weighs greater than or equal to 40 kilograms
* is not currently admitted to the hospital
* is not known to be pregnant
* understands English
* is willing and able to provide informed consent and comply with study procedures

Exclusion Criteria:

* is less than eighteen years of age
* weighs less than 40 kilograms
* if known to be pregnant
* is a current patient in the hospital
* does not understand English
* has known anemia
* is unwilling and able to provide informed consent and comply with study procedures

Primary outcomes:
measure: The mean and standard deviation of readings with all four regional oxygen saturation devices.
timeFrame: Data analysis will be performed when 240 subjects have been enrolled (7 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Univeristy of Minnesota
name: Kumar Belani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06243419: Veın Imagıng Devıce And Vırtual Realıty
Official title: The Effect Of Vein Imaging Device And Virtual Reality On Catheter Intervention Success, Procedure Related Outcomes During Peripheral Intravenous Catheterization in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Emotional Distress
Fear
Anxiety State
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to evaluate the effect of a vein imaging device and virtual reality distraction on the success of peripheral intravenous catheter (PIC) placement, intervention duration, emotional appearance, pain, fear, and anxiety related to PIC intervention in children aged 4-10 years in a pediatric emergency unit.

Detailed description: The children were divided into four groups: control group, vein imaging group, virtual reality group, and vein imaging and virtual reality group. The duration of the intervention and the number of PIC interventions performed on each patient were recorded. The children were assessed before and after the procedure using the Emotional Appearance Scale for Children. After the procedure, the Child Fear Scale and Child Anxiety Scale-State were used to evaluate the most painful moment experienced by the child during the procedure using the Wong-Baker FACES (WB-FACES) and Color Analog Scale.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 4-10
* The child agrees to voluntarily participate in the study.
* Parents agree to voluntarily participate in the study
* Obtaining consent from the child and parent

Exclusion Criteria:

* Need for urgent resuscitation
* Having a fever (\>37.5C) and severe dehydration
* The fact that the patient had taken analgesics before the PIC intervention.

Primary outcomes:
measure: Pain assesed by Wong-Baker FACES
timeFrame: immediately after the vascular access (on average 2-3 minutes later)
measure: Anxiety assesed by Children Anxiety Meter-State
timeFrame: immediately after the vascular access (on average 2-3 minutes later)
measure: Fear assesed by Child Fear Scale
timeFrame: immediately after the vascular access (on average 2-3 minutes later)
measure: the success of peripheral intravenous catheter (PIC) placement
timeFrame: at PIC insertion
measure: Emotional Appearance by Emotional Appearance Scale for Children
timeFrame: before the PIC insertion and immediately after the PIC insertion (on average 2-3 minutes later)]
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Gülçin Özalp Gerçeker, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06316219: The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Endometrial Preparation
Official title: The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometrial Polyp
Endometrial Diseases
Keywords: Hysteroscopy
Endometrial preparation
Lead sponsor: University of Palermo
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2024-03-18
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Nomegestrol Acetate/Estradiol, in rapid preparation of endometrium for hysteroscopic polypectomy.


Eligibility criteria: Inclusion Criteria:

* Patients with endometrial polyps.

Exclusion Criteria:

* Patients with other endometrial pathologies.

Primary outcomes:
measure: Quality of endometrial preparation
timeFrame: 14th day of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Andrea Etrusco
city: Rome
country: Italy
facility: Marco Monti
Study officials:
References:
Clinical trial NCT03672019: A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage
Official title: Health-Related Quality of Life in Patients Undergoing Percutaneous Biliary Drainage For Malignant Biliary Obstruction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Malignant Biliary Obstruction
Keywords: Percutaneous Biliary Drainage
Quality of life
18-366
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 118
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: Potential research subjects will be identified in the interventional radiology clinic or while admitted based on a request for a biliary drainage procedure from their primary oncologist or surgeon at MSK.

Brief summary: The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure. The study will also help us learn whether having a drainage catheter or a stent placed during the procedure makes a difference in the participant's quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients with known malignancy presenting for treatment of biliary obstruction
* Undergoing initial Interventional Radiology PBD procedure
* Fluent in English to enable instrument completion
* At least18 years of age
* Must be physically and mentally capable of completing instruments
* Must be able to comprehend and execute informed consent

Exclusion Criteria:

* Patients will be excluded if:

  * Indication for drainage is acute, symptomatic cholangitis requiring an emergent procedure
  * Previous PBD procedure
  * Presence of an indwelling biliary stent
* Medical or psychiatric condition that, in the judgment of the consenting professional, prevents appropriate comprehension and execution of either the informed consent or the study instruments

Primary outcomes:
measure: change in the FACT-Hep scores
timeFrame: baseline to week 4 post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Piera Cote Robson, MSN, CNS, NP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00458419: Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
Official title: Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: dyspnea; leg discomfort; exercise duration
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2007-04-10
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Endorphins are naturally occurring narcotic substances that are released when individuals perform exercise. The hypothesis of the study is that endorphins reduce the severity of breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). The initial five visits include familiarization and validation of a computerized system for patients to report dyspnea and leg discomfort continuously during exercise testing.

At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5 minutes prior to exercise in a double-blinded design. The primary outcome is the slope of oxygen consumption - dyspnea.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Ability to exercise
* Ability to computer mouse to provide ratings
* \> 10 pack-years smoking
* Baseline dyspnea index \< 9

Exclusion Criteria:

* Clinically significant comorbidities

Primary outcomes:
measure: Slope of oxygen consumption - dyspnea during treadmill exercise.
timeFrame: throughout exercise
Secondary outcomes:
measure: Exercise duration
timeFrame: 10-14 minutes
measure: Peak ratings of breathlessness
timeFrame: at end of exercsie - 10-15 minutes
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Doanld A Mahler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahler DA, Murray JA, Waterman LA, Ward J, Kraemer WJ, Zhang X, Baird JC. Endogenous opioids modify dyspnoea during treadmill exercise in patients with COPD. Eur Respir J. 2009 Apr;33(4):771-7. doi: 10.1183/09031936.00145208. Epub 2009 Feb 12.
Clinical trial NCT03584919: Comparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans
Official title: Comparison of Doxycycline and Cefuroxime Axetil in Patients With Erythema Migrans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema Chronicum Migrans
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 509
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).


Eligibility criteria: Inclusion Criteria:

* typical solitary erythema migrans as defined by the United States Centers for Disease Control and Prevention. In addition, patients with skin lesion \<5 cm in diameter were also included if they recalled a recent tick bite at the site of the skin lesion, had a symptom-free interval between the bite and the onset of the lesion, and reported an expanding skin lesion prior to diagnosis.

Exclusion Criteria:

* Lyme disease previously
* pregnancy or lactation
* immunocompromised
* serious adverse reaction to a beta-lactam or tetracycline drug in the past
* received an antibiotic with known anti-borrelial activity within 10 days
* multiple erythema migrans lesions
* presence of an extracutaneous manifestation of Lyme disease

Primary outcomes:
measure: Change from Baseline in Objective Manifestations and Subjective New or Increased Symptoms (NOIS) in Patients Treated for Erythema Migrans With Doxycycline or Cefuroxime Axetil for 15 Days
timeFrame: One year follow-up (follow-up time points at 14 days, 2 months, 6 months, and 12 months after enrolment)
Secondary outcomes:
measure: Number of Patients (at 12 Months After Treatment With Doxycycline or Cefuroxime Axetil for 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.
timeFrame: 12 months after treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.
Clinical trial NCT06049719: Reliabılıty,Validity Of The Turkish Version Of The NIH-Minimal Dataset
Official title: Translation, Cross-cultural Adaptation and Validation of the Turkish Version of NIH Task Force's Recommended Multidimensional Minimal Dataset for Research on Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: validity
reliability
low back apain
translation
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 18 years of age with chronic low back pain.

Brief summary: This study, we performed the Turkish version validity and reliability of the NIH Task Force's Recommended Multidimensional Minimal Dataset

Detailed description: Low back pain is defined as the pain that can occur in the region between the lower border of the scapula and the hip, sometimes spreading to the lower extremities, which causes activity limitation and is one of the most common health problems in the society. Appropriate use of assessment questionnaires is one of the most important steps in the evaluation of the functional level of the patient and in deciding on an effective treatment protocol. The purpose of our study is to determine the Turkish version, validity and reliability of NIH Task Force's Recommended Multidimensional Minimal Dataset. 200 patients with chronic low back pain were included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire.

Eligibility criteria: Inclusion Criteria:

* Having a low back pain Literate

Exclusion Criteria:

* pregnant,
* canser
* trauma

Primary outcomes:
measure: Roland Morris disability questionnaire
timeFrame: 10 minute
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 10 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
city: Ankara
country: Turkey
facility: Gokhan MARAS
city: Ankara
country: Turkey
facility: Gökhan maraş
Study officials:
affiliation: Gazi University
name: Seyit Citaker, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT02032719: Improved Self Management in Uncontrolled Systolic Hypertension
Official title: Investigating Improved Self Management in Uncontrolled Systolic Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Systolic Hypertension
Keywords: Hypertension, Systolic, Uncontrolled
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 65
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who receive smartphone-assisted health coaching will have a significantly lower 24 hour ambulatory blood pressure mean than patients who receive just health coaching

Detailed description: Primary Outcome Measure: Mean 24 hour ambulatory blood pressure

Secondary Outcome Measures: Profile of Mood States-SF Vigor Scale; Satisfaction with Life Scale; Positive and Negative Affect Schedule; Hospital Anxiety and Depression Scale; SF - 12

Eligibility criteria: Inclusion Criteria:

* 25 - 70 years old;
* mean daytime systolic BP\> 130 mm. Hg.

Exclusion Criteria:

* Severe or end-stage organ disease (liver, kidney, heart, lung) or history of diabetic ketoacidosis, or any other illness with expected survival less than 1 year;
* severe cognitive impairment;
* diagnosed psychiatric illness or disability;
* clinical significant cardiac arrhythmia;
* symptomatic orthostatic hypertension;
* pregnancy;
* not fluent in english.

Primary outcomes:
measure: 24 hour ambulatory blood pressure mean
timeFrame: 6 months follow up from baseline
Secondary outcomes:
measure: Quality of life self report measures
timeFrame: Baseline and 6 months followup
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
Study officials:
References: