louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02400983: Real Life Automatic Atrial Capture Device Control
Official title: Registry on Automatic Algorhitm on Atrial Capture: REAL ACap Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinus Bradycardia
Sinus Node Disease
Atrio-ventricular Block
Heart Failure
Keywords: ACAP, Automatic Algorithm
Lead sponsor: Maria Vittoria Hospital
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 318
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients had undergone first implantation or device replacement with a device (PM, ICD, CRT-P, CRT-D) endowed with ACAP Confirm ® algorithm features between May 2011 and March 2012

Brief summary: The main objective of this study is to verify the effectiveness of the new ACAP ® Confirm algorithm in the automatic management of atrial capture.


Eligibility criteria: Inclusion Criteria:

* Patients had undergone first implantation or device replacement with a Medical device (PM, ICD, CRT-P, CRT-D) endowed with ACAP Confirm ® algorithm features between May 2011 and March 2012

Exclusion Criteria:

* Atrial fibrillation

Primary outcomes:
measure: The main objective of this study is to verify the effectiveness of the new ACAP Confirm ® algorithm in management of atrial capture in both new implants and patients undergoing device replacements with different manufactures atrial leads.
timeFrame: 6 Months
Secondary outcomes:
measure: Relationship with pulse width
timeFrame: 6 Months
measure: Clinical equivalence of automatic and manual thresholds tests results.
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Maria Vittoria Hospital
name: Massimo Giammaria
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02621983: Aerobic Exercise for Cognition in Schizophrenia
Official title: Aerobic Exercise for Cognition in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Exercise
Cognition
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Emory University
First posted: 2015-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the ability of aerobic exercise (AE) to improve cognition in people with schizophrenia. Participants will be randomly assigned to one of two interventions: (1) aerobic exercise class (stationary bicycle, or "spin" class) for up to 45 minutes three times per week for 12 weeks, or (2) balance and stretching class for up to 45 minutes three times per week for 12 weeks.

Detailed description: Schizophrenia (SCZ) is a severe, chronic, and disabling psychotic illness that affects approximately 87,000 Veterans. Previous studies have reported improved short-term memory with AE, but there in a lack of information on cognitive effects of AE in SCZ. The investigators want to determine if twelve weeks of AE training improves cognitive function in Veterans with SCZ.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* maintained on stable doses of outpatient psychiatric medications for at least 30 days
* compliant with outpatient follow-up
* have a stable place to live
* access to transportation to the hospital
* doing less than 20 minutes per week of regular physical activity in the past month

Exclusion Criteria:

* Bipolar disorder;
* active substance dependence within the prior 30 days
* more than 2 psychiatric admissions within the prior six months
* known HIV infection or AIDS
* history of traumatic brain injury
* current seizure disorder
* Alzheimer's disease or other dementia
* clinical history of mild cognitive impairment
* Parkinson's disease
* other current clinically significant neurological disease
* unstable medical condition that would be expected to interfere with fitness training
* significant hearing or visual impairment

Primary outcomes:
measure: Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Functional Ability
timeFrame: Baseline, 12 weeks
measure: Change in MCCB Scores
timeFrame: Baseline, 20 weeks
measure: Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA)
timeFrame: Baseline, 20 weeks
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Erica J. Duncan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01628783: Sequence Towards Remission in Depression
Official title: Sequence Towards Remission in Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depression
Keywords: Depression
emotional processing
fMRI
autobiographic memory
moderator of treatment response
mediator of treatment response
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Academy of Finland
First posted: 2012-06-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators use clinical, biological and imaging markers to develop predictive markers for remission from depression. The investigators compare individuals who have received placebo to individuals who have received 10 mg of escitalopram for one week. In this double-blind, randomized study the investigators a) compare the groups to observe the short-term effects of escitalopram and b) study the predictive value of these observations with respect to remission. Measures include, but are not restricted to, limbic emotional reactivity as assessed by fMRI, emotional processing, emotional memory, autobiographical memory.


Eligibility criteria: Inclusion Criteria:

* Major depressive disorder with current major depressive episode according to a SCID-I/P interview
* Montgomery-Åsberg depression rating score 15-30
* Age 18-60

Exclusion Criteria:

* Borderline, schizoid or schizotypal personality, bipolar or any psychotic disorder
* Primary diagnosis is anxiety disorder: 300.00, .01, .02, .21, .22, .29, .23, .3, 309.81, 308.3, 293.89
* Significant current suicidal ideation, or history of a suicide attempt
* Lifetime substance dependence; Last-year substance abuse; Last month over 24/16 standard doses of alcohol/week; Lifetime use of illicit substances \> x5; Any illicit substance use in last month
* Depressive disorder due to medical condition or chemical substance
* Antidepressant medication use in last 4 months
* Severe, unstable somatic illness
* Use of antipsychotics, mood stabilizers, systemic corticosteroids, β-blockers or daytime benzodiazepines (a small dose of ≤10mg zolpidem once daily is permissible)

Primary outcomes:
measure: Montgomery-Åsberg rating scale
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Psychiatry Centre
Study officials:
affiliation: University of Helsinki
name: Erkki Isometsä, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Helsinki
name: Jesper Ekelund, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03221283: The Application of Music Therapy in Female Amphetamine Use Disorder
Official title: The Intervention of Group Therapy: Music in Mood Problems of Female Amphetamine Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amphetamine Addiction
Keywords: Music therapy
Depression
Emotion
Motivation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The group music therapy will be used to treat female amphetamine-type stimulant (ATS) addiction

Detailed description: Amphetamine addicts are often accompanied by severe emotional problems and are difficult to control and regulate negative emotions by themselves.And the emotional problems are high risk factors of addicts relapse. Music therapy as the intervention is in order to improve amphetamine addicts' emotional status and the ability of emotion regulation. Self-rating Depression Scale(SDS), Self-rating Anxiety scale(SAS) will be used to investigate the emotion of participants. These methods will also be used to evaluate the efficacy of the intervention.

Eligibility criteria: Inclusion Criteria:

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorder
* Junior high school degree or above
* Normal vision and hearing
* Have emotional problem

Exclusion Criteria:

* Other substance abuse or dependence in recent a years (except nicotine)
* Mental impairment, Intelligence Quotient (IQ) \< 70
* Mental disorders
* Physical disease

Primary outcomes:
measure: Change from Baseline Depression status assessed by Self-rating Depression Scale (SDS) at 4 months.
timeFrame: Baseline, 2 months,4 months, and 7months
Secondary outcomes:
measure: Anxiety status assessed by Self-rating Anxiety Scale (SAS)
timeFrame: Baseline, 2 months,4 months, and 7months
measure: Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS)
timeFrame: Baseline, 2 months,4 months, and 7months
measure: Empathy ability assessed by Interpersonal Reactivity Index-C(IRI-C)
timeFrame: Baseline, 2 months,4 months, and 7months
measure: Motivation for treatment assessed by Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES)
timeFrame: Baseline, 2 months,4 months, and 7months
measure: Change from Baseline emotional status assessed by emotional STROOP paradigm
timeFrame: Baseline, 2 months,4 months, and 7months
measure: Sleep status assessed by Pittsburgh Sleep Quality Index(PSQI)
timeFrame: Baseline, 2 months,4 months, and 7months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Women's Compulsory Isolation Detoxification Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhao min, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02936583: Sun Protection Factor Assay (SPF Assay 207/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT02558283: A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults
Official title: A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Fold
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-09-23
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.


Eligibility criteria: Inclusion Criteria:

* Presence of nasolabial folds
* Agree to refrain from treatment with other anti-wrinkle/volumizers below the eye for the duration of the study

Exclusion Criteria:

* Ever received semi-permanent fillers or permanent facial implants below the eyes, or plans to receive these treatments during the study
* Undergone temporary dermal filler treatment (eg, hyaluronic acid or collagen) below the eyes within 12 months, or plans to undergo these treatments during the study
* Undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures in the face or neck within 6 months, or plans to undergo these treatments during the study

Primary outcomes:
measure: Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS)
timeFrame: Month 6
Secondary outcomes:
measure: Subject's Assessment of Procedural Pain on an 11-Point Scale
timeFrame: Day 1
measure: Investigator's Assessment of Each NLF on the 5-Point Global Aesthetic Improvement Scale (GAIS)
timeFrame: Month 6
measure: Subject's Assessment of Each NLF on the 5-Point GAIS
timeFrame: Month 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Guangzhou
country: China
facility: General Hospital of Guangzhou Military Command of PLA
city: Guangzhou
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Shanghai
country: China
facility: Shanghai 9th Hospital
Study officials:
affiliation: Allergan
name: Yi Jia
role: STUDY_DIRECTOR
References:
Clinical trial NCT02365883: Transrectal Photoacoustic Imaging of the Prostate
Official title: Transrectal Photoacoustic Imaging of the Prostate
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Transrectal Imaging
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English-speaking men at the Palo Alto Veterans Hospital between the ages of 18 and 80 years with clinically localized prostate cancer who desire prostatectomy.

Brief summary: The purpose of this study is to image human prostate tissue using a new transrectal photoacoustic imaging probe and correlate this with ultrasound and MRI imaging performed once the specimen has been surgically removed. We hope to see what we can visualize with our device as this has never been done before. Eventually, we hope to use a similar device to image the prostate in men being seen by their doctor for prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with clinically-localized prostate cancer
* Participant desires prostatectomy
* Male
* Patient receiving treatment at Palo Alto Veterans Administration (VA) Hospital
* Age 18 to 80 years old
* English-speaking

Exclusion Criteria:

* Cannot tolerate a surgical prostatectomy due to medical comorbidities
* Cannot give informed consent

Primary outcomes:
measure: Quality of images obtained
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Cancer Institute
state: California
Study officials:
affiliation: Stanford University
name: Sanjiv S. Gambhir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04500483: Indirect Calorimetry in Patients at Risk of Malnutrition
Official title: Measurement of Resting Energy Expenditure in Burn or Critically Ill Patients at Risk of Malnutrition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Burns
Critical Illness
Indirect Calorimetry
Resting Energy Expenditure
Nutrition Disorders
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 100
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: the study population is divided into two groups: burn patients with minor burn exclusively treated in an outpatient setting, and ICU survivors who were discharged fro ICU after a stay of at least 7 days

Brief summary: Burn patients treated in an outpatient clinic and ICU survivors are at risk of malnutrition. There are no clear guidelines determining the energy target in those two populations. The aim of this observation study is to measure the resting energy expenditure of those patients, using indirect calorimetry.


Eligibility criteria: Inclusion Criteria:

* minor burn treated in an outpatient setting
* ICU survivor, who was discharged from ICU after a stay of at least 7 days

Exclusion Criteria:

* oxygen supply
* chest drainage
* not french speaking
* confusion, coma
* cognitive disorder
* patient refusal

Primary outcomes:
measure: resting energy expenditure
timeFrame: during the 7 days following injury in burn patients or following ICU discharge in ICU survivors
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Liège
Study officials:
References:
Clinical trial NCT00772083: Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors
Official title: Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Colorectal Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Healthier Wisconsin Partnership Program
name: Versiti
name: National Anemia Action Council
First posted: 2008-10-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Blood donors are a precious community resource. Each month at Blood Center of Wisconsin (BCW), 200 men and 600 women over age 50 are turned away ("deferred") because of anemia. In those over 50, anemia may signal serious underlying disease such as colorectal cancer (CRC). CRC is the #3 cause of cancer death in Wisconsin with more than 1,000 deaths in 2006. Yet with proper testing CRC outcomes can be improved by early diagnosis. This project will focus on a population of deferred older blood donors to develop and test educational materials that will motivate donors to seek medical attention for their anemia, so that the underlying cause is diagnosed and treated. This project has the potential to lead to better CRC outcomes in Wisconsin blood donors.


Eligibility criteria: Inclusion Criteria:

* adult blood donors who have been "deferred" (not allowed to donate) due to low blood count, specifically all male donors found to have hematocrit \< 38% and to all female donors over 50 years old found to have hematocrit \< 36%

Exclusion Criteria:

* deferred donors who have previously donated more than 3 times in the past year, as their anemia is more likely due to frequent donation
* women less than 50 years old

Primary outcomes:
measure: self-reported seeking of medical care for diagnosis of anemia found at time of blood donation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: BloodCenter of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Kenneth G Schellhase, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Versiti
name: Alan Mast, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03030183: Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab
Official title: A Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have an Inadequate Response to Eculizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Keywords: PNH
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-01-24
Enrollment: 3
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: The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to eculizumab. Patients will be treated with RA101495 for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PNH by flow cytometry
* Inadequate response to eculizumab defined as having received eculizumab for at least 6 months plus a documented LDH level ≥ 1.5 x the upper limit of normal (ULN) and/or the presence of a known C5 mutation conferring resistance to eculizumab

Exclusion Criteria:

* History of meningococcal disease
* Current systemic infection or suspicion of active bacterial infection

Primary outcomes:
measure: Change-from-baseline in Serum Lactate Dehydrogenase (LDH) Levels.
timeFrame: Through Week 12 of the study
Secondary outcomes:
measure: Change-from-baseline Bilirubin Values
timeFrame: Through week 12
measure: Change-from-baseline Total Hemoglobin Values
timeFrame: Through week 12
measure: Change-from-baseline Free Hemoglobin Values
timeFrame: Through week 12
measure: Change-from-baseline Haptoglobin Values
timeFrame: Through week 12
measure: Change-from-baseline Reticulocyte Values
timeFrame: Through week 12
measure: Change-from-baseline Hemoglobinuria Values
timeFrame: Through week 12
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Investigative Site
state: California
city: Los Angeles
country: United States
facility: Investigative Site
state: California
city: Chicago
country: United States
facility: Investigative Site
state: Illinois
city: Manhasset
country: United States
facility: Investigative Site
state: New York
city: Durham
country: United States
facility: Investigative Site
state: North Carolina
city: Dallas
country: United States
facility: Investigative Site
state: Texas
Study officials:
affiliation: St James' Institute of Oncology
name: Dr. Anita Hill
role: STUDY_CHAIR
References: