louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00769249: Positive Changes in Quality of Life of Older Cancer Patients and Their Caregivers
Official title: Correlates of Post-Traumatic Growth in Cancer Patients and Their Partners
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: RATIONALE: Gathering information about the positive changes in quality of life of older patients with cancer and their care givers may help doctors learn more about the disease and plan better treatment.

PURPOSE: This research study is looking at positive changes in the quality of life of older cancer patients and their caregivers.

Detailed description: OBJECTIVES:

Primary

* To use prior data from an existing registry (Quality of Life Survey Registry for Persons With Cancer and Family Caregivers protocol CASE-8Z05) and to expand upon these data by adding measures that capture the particularly salient concepts of the patient/caregiver dyadic relationship and posttraumatic growth.
* To identify rates and psychosocial correlates of posttraumatic growth among older adult cancer patient/spouse or partner dyads.

OUTLINE: Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Patient must meet the following criteria:

  * Confirmed cancer of any type
  * Currently receiving medical care at the Ireland Cancer Center at University Hospitals of Cleveland
  * Must have enrolled and participated in CASE-8Z05
* Identified available family caregiver of a patient diagnosed with stage III or IV cancer

PATIENT CHARACTERISTICS:

* Patients must meet the following criteria:

  * ECOG performance status 0-3
  * Cognitively competent to be interviewed
  * Able to speak and comprehend English
* Caregivers must be able to speak and comprehend English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Rate of posttraumatic growth
timeFrame: after diagnosis of cancer
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: T.J. McCallum, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01185249: Congestive Heart Failure Weight Study
Official title: Time of Day and Accurate Weights for Patients With Congestive Heart Failure (CHF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: CHF
congestive heart failure
Lead sponsor: Central DuPage Hospital
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Early morning weights to monitor CHF patient's fluid status is common practice but there is a lack of evidence that this is the best practice. The purpose of this study is to determine if there is a difference in net weight gain or loss for hospitalized patients with CHF who are weighed in the evening instead of early morning.

Detailed description: This is a quasi-experimental pilot study with prospective cohort design. Study subjects will be weighed in the early morning and then again in the evening for a minimum of three days. Analysis will be accomplished on data by analysis within-subjects data utilizing the paired t test. Other data to be collected includes dates of hospitalization, demographics, dose and timing of medications, lab results and documentation of comorbid conditions.

Eligibility criteria: Inclusion Criteria:

* 18-85 years old
* Admitted to hospital with a primary diagnosis of heart failure or fluid overload
* Ambulatory with a medical order to be out of bed
* Able to stand on a scale
* Have no problems with balance

Exclusion Criteria:

* Patients with a primary diagnosis other than heart failure or fluid overload
* Patients diagnosed with renal failure
* Non-English speaking
* Unable to follow directions or consent due to cognitive impairment
* Medical order for bed rest
* Involved in another study

Primary outcomes:
measure: The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients
timeFrame: Mean differences in the morning (5am) weights compared for three consecutive days. Day 1, Day 2, Day 3. Mean difference in the morning (5am) and evening (8pm) weights for three consecutive days. Day 1, Day 2, Day 3.
Secondary outcomes:
Other outcomes:
Locations:
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
Study officials:
affiliation: Central DuPage Hospital
name: Alice M Siehoff, DNP, RN-BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02201849: A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Alkermes
ALKS 8700
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.

Detailed description: This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the sponsorship of the trial was transferred to Biogen along with responsibility for subsequent updates to the record.

Eligibility criteria: Inclusion Criteria:

* Has a body-mass Index (BMI) \>/=18.0 and \</=32.0 kg/m2
* Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration
* Additional criteria may apply

Exclusion Criteria:

* Is currently pregnant or breastfeeding
* Has a lifetime history of menopausal hot flashes
* Has a clinically significant medical condition
* Has had a clinically significant illness in the 30 days prior to first study drug administration
* Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration
* Has had any vaccinations in the 4 weeks prior to inpatient admission
* Has a lifetime history of diabetes
* Additional criteria may apply

Primary outcomes:
measure: Safety and tolerability will be measured by incidence of adverse events
timeFrame: up to 27 days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 27 days
measure: Time to attain Cmax (Tmax)
timeFrame: Up to 27 days
measure: Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)
timeFrame: Up to 27 days
measure: Area under the concentration-time curve from time 0 to infinity (AUCinf)
timeFrame: Up to 27 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05557149: Virtual Reality Exposure and Respiratory Relaxation-Based Coping With Cocaine Craving in Cocaine Users
Official title: Development and Evaluation of a Virtual Reality Application for Eliciting Craving and Its Physiological Arousal in Cocaine Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality Exposure Therapy
Cocaine Use Disorder
Keywords: Virtual Reality
Cocaine Craving
Cue Exposure Therapy
Lead sponsor: Laboratoire de Psychologie des Cognitions
Sponsor class: OTHER
Collaborators: name: ICube Laboratory - Team IGG
name: Ithaque Association
name: University Hospitals of Strasbourg
name: University Hospital, Strasbourg, France
name: The French National Cancer Institute
name: The French Institute for Public Health Research
First posted: 2022-09-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Our study main objective is to test whether virtual reality exposure could elicit cocaine craving and its physiological arousal in cocaine users. Investigators aim to compare self-reported cocaine craving, self-efficacy to cope with craving and emotional states levels in 11 voluntary and adults cocaine users in 3 consecutive 10-mins conditions: Neutral VR (virtual reality exposure to neutral stimuli), Cocaine VR (virtual reality exposure to cocaine use-related stimuli) and Relaxation (respiratory relaxation).


Eligibility criteria: Inclusion Criteria:

- Cocaine use within the past 28 days

Exclusion Criteria:

* Actual manic or hypomanic episode (MINI, Lecrubier and al., 1998)
* Actual psychotic episode (MINI, Lecrubier and al., 1998)
* Actual high suicidal risk (MINI, Lecrubier and al., 1998)
* Being involved in incarceration procedure
* Medical risk for safety while physiological arousal (e.g. cardiac disease)
* Disability for performing virtual reality task (e.g. blindness or deafness)
* Significant motion sickness symptoms (SSQ pre-post total score ≥ 15, Bimberg et al., 2020)

Primary outcomes:
measure: Cocaine Craving Intensity
timeFrame: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Secondary outcomes:
measure: Self-Efficacy to Cope with Cocaine Craving without Using
timeFrame: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
measure: Negative Emotional States
timeFrame: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
measure: Positive Emotional States
timeFrame: Immediatly after Neutral VR, Cocaine VR and Relaxation (10 mins between each measure)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire de Psychologie des Cognitions (Strasbourg University)
state: Bas-Rhin
Study officials:
affiliation: Laboratoire de Psychologie des Cognitions (Strasbourg University)
name: Thomas Lehoux, Ph.D. Candidate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02187549: Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Hyaluronic Acid
Osteoarthritis
Knee
Hyaluronan
Viscoelastic
Hydrogel
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 332
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* Symptomatic osteoarthritis of the knee.

Exclusion Criteria:

* No disorders which could interfere with study required assessments.

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score
timeFrame: 26 weeks
Secondary outcomes:
measure: Patient Global Assessment
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Brimingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Carmichael
country: United States
facility: Med Center
state: California
city: El Cajon
country: United States
facility: Triwest Research Associates
state: California
city: Thousand Oaks
country: United States
facility: Westlake Medical
state: California
city: Englewood
country: United States
facility: Colorado Orthopedic Consultants
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical
state: Connecticut
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts
state: Florida
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group
state: Michigan
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Egg Harbor Township
country: United States
facility: Fabio Orozco
state: New Jersey
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research
state: Ohio
city: Altoona
country: United States
facility: Blair Orphopedics
state: Pennsylvania
city: Houston
country: United States
facility: West Houston Clinical Research
state: Texas
Study officials:
References:
Clinical trial NCT03917849: Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy
Official title: Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellar Tendinitis
Jumper's Knee
Lead sponsor: Universidad Nacional de Córdoba
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to investigate the efficacy of Inertial Flywheel Resistance program vs Heavy slow resistance in patients with chronic patellar tendinopathy.

The investigators hypothesize that Inertial Flywheel Resistance program will yield a more positive clinical outcome and function in patients with patellar tendinopathy compared to heavy slow resistance group.

Detailed description: Randomized controlled intervention study

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of patellar tendinopathy
* Symptoms \> 3 months
* Pain localized to the inferior pole of the patella
* Victorian Institute of Sport Assessment (VISA) score less than 80 points
* Palpation tenderness of the patellar tendon
* Abnormal tendon (hypoechoic) confirmed by ultrasonography.

Exclusion Criteria:

* Previous knee surgery
* Confounding diagnosis to the knee joint
* Previous corticosteroids injections
* Arthritis or diabetes

Primary outcomes:
measure: Victorian Institute of Sports Assessment (VISA-P questionnaire)
timeFrame: 0 - 12 weeks
Secondary outcomes:
measure: Patient-Specific Functional Scale
timeFrame: 0 - 12 weeks
measure: Patient Global Impression of Change
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Adherence self-report questionnaire
timeFrame: 12 weeks
measure: Single-leg decline squat (SLDS) test
timeFrame: 0 - 12 weeks
measure: Knee extension machine test
timeFrame: 0 - 12 weeks
measure: Jump test
timeFrame: 0 - 12 weeks
Other outcomes:
Locations:
city: Córdoba
country: Argentina
facility: Universidad Nacional de Cordoba
state: C
city: Cordoba
country: Argentina
facility: Universidad Nacional de Cordoba
Study officials:
affiliation: Departments of Biomedical Physics - University of Cordoba Argentina
name: Vilma Campana, Dr
role: STUDY_DIRECTOR
References:
citation: Ruffino D, Malliaras P, Marchegiani S, Campana V. Inertial flywheel vs heavy slow resistance training among athletes with patellar tendinopathy: A randomised trial. Phys Ther Sport. 2021 Nov;52:30-37. doi: 10.1016/j.ptsp.2021.08.002. Epub 2021 Aug 4.
Clinical trial NCT02554149: Radiological Measurement of Femoral Stem Version Using Lateral Decubitus Method: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty
Total Hip Replacement
Keywords: total hip
stem version
replacement
hip
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent THR between October 2015 and December 2015

Brief summary: The purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability.

Detailed description: Version of the femoral stem is an important factor influencing the risk of dislocation after total hip replacement (THR) as well as the position of the acetabular component. However, there is no radiological method of measuring stem anteversion described in the literature. Investigators propose a radiological method to measure stem version and have assessed its reliability and validity. In 40 patients who underwent THR, a hip radiograph and CT scan were taken to measure stem anteversion.

Eligibility criteria: Inclusion Criteria:

* Investigators recruited 40 consecutive patients who underwent THR between October 2015 and December 2015

Exclusion Criteria:

* patients who could not extend the hip because of a residual flexion contracture.
* who had a flexion contracture of the knee or who could not flex the hip to 90° even after THR were excluded because participants could not adopt the posture required for the particular radiographs and CT scans.

Primary outcomes:
measure: stem anteversion of the hip radiograph(decubitus lateral view)
timeFrame: postoperative 4days
measure: stem anteversion of the CT scan
timeFrame: postoperative 4days
Secondary outcomes:
measure: The correlation between stem anteversion of the decubitus lateral view and stem version of the CT scan
timeFrame: postoperative 4days
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul national University Bundang Hospital
state: Gyeounggi-do
Study officials:
affiliation: Director, Head of Orthopaedics, Seoul National university Bundang Hospital
name: Kyung-Hoi Koo, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592149: Survey of Prevalence of Loss of Appetite in Subject With Health Disorders
Official title: Survey of Prevalence of Loss of Appetite in Subject With Health Disorders.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appetite
Keywords: Appetite
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 16629
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with various health related disoder

Brief summary: The study is an epidemiological survey to find out the incidence of loss of appetite in Indian patients suffering from various health disorders. This survey will be conducted to obtain information on appetite from a total of 17500 subjects This study does not intend to study the effect of any drugs. The primary source of information will be the subjects themselves. The study will be conducted at 275 - 350 centres spread across India.This is a single visit study.The physician will conduct routine clinical, physical and general examination.


Eligibility criteria: Inclusion Criteria:

* Men and Non-pregnant women ≥ 18 years of age recuperating from healthcare disorders like:Malaria fever, Typhoid or enteric fever
* Hepatitis
* Acute infections including respiratory, urinary tract infections etc treated with antibiotic
* Tuberculosis
* Patient discharged from hospital after general surgical procedures like acute appendectomy, etc.
* Any other condition

Exclusion Criteria:

* Patients unwilling to provide informed consent \& comply with the study procedure
* Patient using drugs which affect appetite like Cyproheptadine etc.

Primary outcomes:
measure: Percentage of patients with loss of appetite
timeFrame: 1 Day
Secondary outcomes:
measure: Percentage of patients with fatigue
timeFrame: 1 Day
measure: Distribution of fatigue among the patients with respect to disease
timeFrame: 1 Day
measure: Percentage of patients with moderate to very severe Fatigue.
timeFrame: 1 Day
Other outcomes:
Locations:
city: Many Locations
country: India
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03187249: Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression
Official title: Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Anxiety
Depression
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 500
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anxiety and depression have negative effect on outcomes of chronic obstructive pulmonary disease (COPD). Intervention strategy including behavioral-cognitive therapy and pulmonary rehabilitation are promising in improving life quality, disease symptom and outcomes. But there's not standard algorithm in China so far. The study aims to compare the effectiveness of these interventions and develop an intervention algorithm of anxiety and depression in COPD.


Eligibility criteria: Inclusion Criteria:

* Stable COPD patients with mild or moderate anxiety and depression

Exclusion Criteria:

* Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months
* Patients with tumor history during past 5 years
* Patients with COPD exacerbations during past 4 weeks
* Participants in clinical trials
* Patients in pregnancy or breastfeeding
* Patients unable to complete questionaire independently
* Patients older than 80 years old
* Patients receiving long-term domiciliary oxygen therapy

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: moderate and severe COPD exacerbations
timeFrame: 3 years
measure: modified British medical research council score
timeFrame: 3 years
measure: COPD assessment test score
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: