louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00073359: Effects of Therapist Behavior on the Treatment of Depressed Adolescents
Official title: Engagement and Alliance in CBT for Depressed Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depression
Depressive Disorder
Dysthymic Disorder
Keywords: Adolescent
Lead sponsor: University of Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify and evaluate therapist behaviors that affect how well and how long adolescent patients stay in treatment for depression.

Detailed description: Early patient drop out, sporadic attendance, and minimal participation have hindered the development and administration of effective treatments for adolescent depression. Adolescents who do not receive adequate exposure to active treatment are unlikely to benefit from experimentally supported treatments. Certain therapist behaviors may influence the attendance, drop-out, and overall participation of adolescents with depression. This study will evaluate the effect of engagement interventions and alliance on attendance, participation, completion, and outcome in depressed adolescents.

Participants in this study will have 12 weekly sessions of cognitive behavioral therapy (CBT) at a school-based health clinic. Audio recordings from the completed CBT sessions will be replayed and evaluated to identify therapist engagement interventions, therapy alliance, and treatment participation.

Eligibility criteria: Inclusion Criteria:

* Major depression or dysthymic disorder
* Referred by school

Exclusion Criteria:

* Comorbid psychosis, bipolar disorder, or mental retardation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Public Schools Health Clinics
state: Colorado
Study officials:
References:
Clinical trial NCT02083159: C1q/TNF-related Proteins in Non-Alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NAFLD
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects who visited for a routine health check-up at the Health Promotion Center of Korea University Guro Hospital were enrolled using predefined inclusion and exclusion criteria.

Brief summary: Non-alcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the liver, which is one of the most common forms of chronic liver disease in developed countries. In western countries, the prevalence of NAFLD in the general population is estimated to be 20-30%; in obese populations, this increases to 57.5-74%. But, it hasn't been clearly elucidated yet regarding the underlying disease pathophysiology and treatmet strategy.

Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. To date, 15 CTRP family members have been found that might play major roles in glucose metabolism and inflammation.

The investigators tried to clarify the relationship between CTRP family and NAFLD in Korean men and women.


Eligibility criteria: Inclusion Criteria:

* 20\<age\<80
* apparently healthy subjects

Exclusion Criteria:

* a history of CVD
* diabetes
* stage 2 hypertension
* malignancy
* severe renal or hepatic disease

Primary outcomes:
measure: serum concentration of CTRP-1, 3, or 9 in the subjects with/without NAFLD
timeFrame: at enrollment
Secondary outcomes:
measure: The relationships of serum CTRPs/adiponectin levels with cardiometabolic risk profiles
timeFrame: at enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Univ. Guro Hospital
Study officials:
References:
Clinical trial NCT00263159: Pharmaceutical Care for Asthma Control Improvement (PHARMACI)-Study
Official title: Pharmaceutical Care for Asthma Control Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2005-12-07
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients.

Detailed description: The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients. Patients will be randomly allocated to the control group (= no input from pharmacist) or intervention group (= with pharmaceutical care at baseline and follow-up visits over 6 months).

Eligibility criteria: Inclusion Criteria:

* Patients with persistent asthma
* Asthma treatment for at least 12 months
* Regular visitors of the participating community pharmacy

Exclusion Criteria:

* Severe co-morbidity
* \> 10 pack-years smoking history
* Asthma Control Test score \< 15 or =25

Primary outcomes:
measure: The difference between study groups in the change of asthma control from baseline and follow-up visits
timeFrame: after 1, 3 and 6 months
Secondary outcomes:
measure: Peak flow
timeFrame: after 3 and 6 months
measure: Knowledge of asthma and treatment
timeFrame: after 6 months
measure: Asthma quality of life questionnaire (AQLQ)
timeFrame: after 6 months
measure: Therapy adherence
measure: Inhalation techniques
timeFrame: after 6 months
measure: Smoking
timeFrame: after 6 months
measure: Asthma exacerbations
timeFrame: after 6 months
measure: General Practitioner (GP) visits, emergency room visits and hospitalisations
measure: Working days lost and school days lost
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Guy Brusselle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00959959: ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer
Official title: ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: CRPC
HRPC
TOK-001
ARMOR
ARMOR1
ESL
Galeterone
Lead sponsor: LTN PHARMACEUTICALS, INC.
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Confirmed cancer of the prostate
* Progressing disease in spite of androgen ablation therapy
* Able to swallow multiple capsules

Exclusion Criteria:

* Participation in another clinical trial \< 4 weeks prior to enrollment
* Metastatic disease with one or more of the following:

  * Liver involvement
  * Bone pain associated with confirmed evidence of metastases
  * Non-hepatic visceral involvement
* The following medications:

  * Prior treatment with MDV3100, abiraterone, Provenge or TAK700
  * Prior treatment with ketoconazole
  * Prior treatment with chemotherapy
  * Prior radiation therapy completed ≤ 4 weeks prior to enrollment
* The following medical conditions:

  * Active angina pectoris
  * History of Hepatitis B or Hepatitis C
  * Known HIV infection
  * Ongoing hypertension

Note: There are additional inclusion and exclusion criteria. The clinical site center will determine if you are eligible. If you are not eligible for the trial, site staff will detail the reasons to you.

Primary outcomes:
measure: Phase 1: Incidence of adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy Measures
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada & US Oncology Research
state: Nevada
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Greenville
country: United States
facility: Greenville Hospital System University Medical Center
state: South Carolina
city: Seattle
country: United States
facility: University of Washington/Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: University of Washington
name: R. B. Montgomery, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: M. E. Taplin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000259: Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11
Official title: Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: sevoflurane
nitrous oxide
subjective effects
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Pain intensity
timeFrame: 30 min of inhalation
measure: Psychomotor performance
timeFrame: Baseline, 5 min of inhalation; 5, 30, 60 minutes recovery
measure: Cognitive performance
timeFrame: Baseline, every 5 min during inhalation, 5, 30, & 60 min during recovery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anesthesiology. 1997 (in press).
Clinical trial NCT02088359: Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm Infants
Keywords: cycled light, near darkness, growth
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 150
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infant (\<32 gestational weeks) were enrolled in this study.

Brief summary: Infants are exposed to either continuous bright light continuous near darkness or unstructured combination of the two. The investigators primary objective is to determine the effectiveness cycled light and near darkness on growth in preterm infants.


Eligibility criteria: Inclusion Criteria:

* \<32 gestational weeks preterm infants

Exclusion Criteria:

* Major congenital anomaly
* Small for gestation age
* Grade III-IV intracranial hemorrhage

Primary outcomes:
measure: Effectiveness on growth
timeFrame: 3-12 months
Secondary outcomes:
measure: Feeding
timeFrame: 0-1 month
measure: Ventilation support
timeFrame: 0-1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
References:
Clinical trial NCT02852759: A Cold Physical Treatment to Manage Insulin Resistance
Official title: A Cold Physical Treatment to Manage Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Hyperglycemia
Hyperinsulinemia
Diabetes
Obesity
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2016-08-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insulin resistant volunteers will choose to undergo an 8-week cold treatment, 2 hours per day, to selective regions of the body enriched with brown fat including neck, supraclavicular and interscapular regions) in combination with electroacupuncture (EA). Their insulin sensitivity and glucose and lipid homeostasis will be measured. The brown fat activation will be assessed by positron emission tomography and computed tomography (PET/CT)-scans and/or serum marker measurements.


Eligibility criteria: Inclusion Criteria:

* BMI: 20-30
* Insulin resistant

Exclusion Criteria:

* uncontrolled hypertension
* insulin dependent diabetics
* heart diseases
* hyperthyroidism
* secondary obesity
* surgical operation within treatment or planned in two months
* pregnancy
* anemia
* liver or kidney failure
* cancer

Primary outcomes:
measure: Change of Glucose Tolerance measured by OGTT
timeFrame: 0, 8 week, 2 hours for each measurement
Secondary outcomes:
measure: Change of serum insulin levels
timeFrame: 0, 8 week
measure: Change of Body weight
timeFrame: 0, 8 week
measure: Change of 2-deoxy-2-[fluorine-18]fluoro- D-glucose (FDG) uptake by PET/CT-scans
timeFrame: 0 and 8 week, 2 hours for each measurement
measure: Change of glucose infusion rate by hyperinsulinemic euglycemic clamp
timeFrame: 0 and 8 week, 5 hours for each measurement
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
Study officials:
affiliation: Columbia University
name: Li Qiang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03224559: Applying Neuromodulation to Accelerate Training Effects
Official title: Applying Neuromodulation to Accelerate Training Effects
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cognition
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers, 18-65 years old

Brief summary: This study seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills.

Detailed description: This study uses noninvasive electrical stimulation delivered through seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills.

Eligibility criteria: Inclusion Criteria:

People may participate in the experiment if they have normal or corrected vision, are in good health, and are at least 18 years old.

Exclusion Criteria:

People will be screened and excluded from participation if they are currently ill or if they report any history of seizures, if they lack the capacity to consent or appear to lack capacity to consent, if they have participated in previous thinking skills training or brain stimulation, or if they are currently taking certain substances/medications that might change thinking skills.

Primary outcomes:
measure: Change in Working memory
timeFrame: Baseline through 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Angus W MacDonald, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Joshua E Mervis, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00705159: Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Official title: Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conjunctivitis
Keywords: Blepharokeratoconjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 137
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.


Eligibility criteria: Inclusion Criteria:

* children 0-6 years of age.
* clinical diagnosis of blepharoconjunctivitis
* Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
* Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

* Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
* Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
* Subjects who are monocular.
* Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
* Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.

Primary outcomes:
measure: Change From Baseline in the Total Blepharoconjunctivitis Grade.
timeFrame: Baseline to 15 days
Secondary outcomes:
measure: Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
timeFrame: Baseline to Day 3
measure: Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
timeFrame: Baseline to Day 7
Other outcomes:
Locations:
city: Erie
country: United States
facility: Pediatric Ophthalmology of Erie
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05892159: Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis
Official title: Heart Rate Variability Biofeedback in the Treatment of Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective interventional study exploring the modifiability of physiological metrics, namely Heart Rate Variability (HRV), using a 5-week standardized HRV biofeedback intervention in subjects with symptomatic ulcerative colitis. Participants will be followed for 17 weeks. The goal is the understand if modifying these markers can impact ulcerative colitis related symptoms.


Eligibility criteria: Inclusion Criteria:

* Adult subjects (18-65 years old)
* Ulcerative colitis with a symptomatic flare (SCCAI ≥3) and without inflammation (FC\<250µg/ml)

Exclusion Criteria:

* Individuals who take medications known to alter heart rate variability
* Individuals with pacemakers or other implantable devices

Primary outcomes:
measure: Irritable Bowel Syndrome Symptom Severity Scale Score
timeFrame: at end of Week 5
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Robert Hirten
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03168659: CardioFocus HeartLight Post-Approval Study
Official title: Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.

Detailed description: This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
* failure of at least one anti-arrhythmic drug
* others

Exclusion Criteria:

* overall good health as established by multiple criteria

Primary outcomes:
measure: The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period
timeFrame: Day 91 through 12 months
Secondary outcomes:
Other outcomes:
measure: Chronic Effectiveness
timeFrame: 36 months
measure: Chronic Safety
timeFrame: 36 months
measure: Effect of Operator Experience on primary effectiveness endpoint
timeFrame: 36 months
measure: Effect of Operator Experience on primary safety endpoint
timeFrame: 36 months
measure: Safety Outcomes by Gender
timeFrame: 12 months and 36 months
measure: Neurological Events
timeFrame: 36 months
Locations:
city: Tucson
country: United States
facility: University of Arizona Sarver HeartCenter
state: Arizona
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
Study officials:
References: