louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03419442: Multi-academic Center Study of Xofigo Patients
Official title: A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients With Metastatic Castration-Resistant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer, Castration Resistant
Keywords: Prostate cancer
Bone metastases
Xofigo
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be comprised of patients with CRPC and bone metastasis who have received at least one dose of radium-223 at one of the participating cancer centers. The participating centers are 4 tertiary care cancer centers (Dana Farber Cancer Institute, Tulane Cancer Center, Memorial Sloan Kettering Cancer Center and Beth Israel Deaconess Medical Center)

Brief summary: The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide.

The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.


Eligibility criteria: Inclusion Criteria:

* Received at least one dose of radium-223 after mCRPC diagnosis
* Received at least one prescription or dose of chemotherapy for treatment of mCRPC

Exclusion Criteria:

- No documented visceral metastasis at initiation of radium-223

Primary outcomes:
measure: Overall survival
timeFrame: Up to 30 months
measure: Time to symtomatic skeletal event(SSE)
timeFrame: Up to 30 months
measure: Reasons for treatment discontinuation
timeFrame: Up to 30 months
Secondary outcomes:
measure: Laboratory-based outcomes collected by questionnaire
timeFrame: Up to 30 months
measure: Treatments received
timeFrame: Up to 30 months
measure: Number of hospitalizations
timeFrame: Up to 30 months
measure: PSA PFS
timeFrame: Up to 30 months
measure: Non-laboratory based clinically relevant safety outcomes
timeFrame: Up to 30 months
measure: hospital length of stay
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer US
state: New Jersey
Study officials:
References:
Clinical trial NCT01044342: A Healthy Volunteer Study to Evaluate Reversibility of Induced Impairment of Cognition
Official title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Four-period Cross-over Study to Evaluate the Scopolamine Cognition Model in Healthy Male Subjects Using AZD1446 and Donepezil Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognition
Keywords: Healthy Volunteers
EEG
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-01-07
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if cognitive impairment induced by scopolamine is reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by electroencephalogram (EEG) measures.


Eligibility criteria: Inclusion Criteria:

* BMI 18-30
* Non-smoker for at least 4 weeks

Exclusion Criteria:

* Any clinically relevant acute or chronic disease
* Hypersensitivity to scopolamine
* History of substance abuse

Primary outcomes:
measure: qEEG assessed through the absolutes alpha-power of the two occipital leads
timeFrame: In each treatment period (1, 2, 3, 4) the measure will be taken on Day 1 prior to dosing of AZD1446 or placebo and1h, 2h, 3h, 6h, and 24 hour after dosing of AZD1446 or placebo
Secondary outcomes:
measure: qEEGs/ERPs assessed by mismatch negativity and p300
timeFrame: In each treatment period (1, 2, 3, 4) the measure will be taken on Day 1 prior to dosing of AZD1446 or placebo and1h, 2h, 3h, 6h, and 24 hour after dosing of AZD1446 or placebo
Other outcomes:
Locations:
city: Rouffach
country: France
facility: Research Site
Study officials:
References:
Clinical trial NCT04389242: Online Cognitive Behavioral Intervention Program for Hong Kong University Students
Official title: An Evidence-based Program Evaluation of the Effectiveness of Internet-based Cognitive Behavioral Preventive Intervention in Reducing Psychological Distress for Chinese University Students in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Stockholm University
name: Research Grants Council, Hong Kong
First posted: 2020-05-15
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Online Cognitive Behavioral Therapy
Primary purpose: TREATMENT

Brief summary: Brief summary:

The objective of this study is to develop an internet-based cognitive behavioral intervention program (including an online platform and a smartphone application) for Chinese university students in Hong Kong, and examine its effectiveness in reducing psychological distress, anxiety/depression symptoms, and improving emotions and automatic thoughts. The 3-month maintenance effect will also be tested.

Detailed description: Previous research has provided evidence for the effectiveness of internet-based cognitive behavioral intervention in improving mental health, but most studies were done in Western countries. This study is intended to design a culturally appropriate online program especially for Chinese university students in Hong Kong. The program will include 8 weekly sessions and one face-to-face session and one telephone follow-up with a with certified CBT therapist. The effects on psychological distress, anxiety/depression, emotions, and automatic thoughts will be tested.

Eligibility criteria: Inclusion Criteria:

* Chinese nationality
* Has mild to moderate level of psychological distress
* Receive no face-to-face counselling since program commencement

Exclusion Criteria:

* Has low/high level of psychological distress
* Has one or more psychosis
* Has suicidal risk in the past 3 months

Primary outcomes:
measure: General Health Questionnaire-12 (GHQ-12)
timeFrame: 3 months
Secondary outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 3 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: 3 months
measure: Chinese Automatic Thoughts Questionnaire (CATQ)
timeFrame: 3 months
measure: Chinese Affect Scale (CAS)
timeFrame: 3 months
measure: Electronic Learning Satisfaction Scale (ELSS) (administered at post-test only))
timeFrame: 2 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Jiayan Pan
Study officials:
affiliation: Hong Kong Baptist University
name: Jiayan Pan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02080442: Balance Training for Chronic Obstructive Pulmonary Disease (COPD)
Official title: Balance Training for COPD in Pulmonary Rehabilitation (PR): An Effectiveness Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Balance
Pulmonary Rehabilitation
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
Collaborators: name: Ontario Lung Association
First posted: 2014-03-06
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD enrolled in PR

Brief summary: The study will involve direct knowledge translation of a laboratory-based study of balance training for patients with COPD, first to the investigators PR program and then, after disseminating the results, this approach could be used to impact on clinical practice in any PR program.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Self-report of decline in balance or fall in the last 5 years or a recent near fall
* Smoking history greater than 10 pack years
* Are able to provide written informed consent.

Exclusion Criteria:

* An inability to communicate because of language skills, hearing or cognitive impairment
* Evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced Parkinson's disease, amputation).

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: at 6 weeks
measure: Timed Up and Go (TUG):
timeFrame: at 6 weeks
Secondary outcomes:
measure: The Balance Evaluation Systems Test (BESTest)
timeFrame: at 6 weeks
measure: Activity-specific Balance Confidence (ABC) Scale
timeFrame: at 6 weeks
Other outcomes:
measure: Balance training progression: the training prescription and progression will be recorded
timeFrame: at 6 weeks
measure: Therapists' and the participants' satisfaction
timeFrame: at 6 weeks
measure: Safety: any adverse events associated with balance training will be recorded
timeFrame: at 6 weeks
measure: Applicability and adherence
timeFrame: at 6 weeks
measure: The Six-Minute Walk Test (6MWT)
timeFrame: at 6 weeks
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Center
state: Ontario
Study officials:
References:
citation: Harrison SL, Beauchamp MK, Sibley K, Araujo T, Romano J, Goldstein RS, Brooks D. Minimizing the evidence-practice gap - a prospective cohort study incorporating balance training into pulmonary rehabilitation for individuals with chronic obstructive pulmonary disease. BMC Pulm Med. 2015 Jul 23;15:73. doi: 10.1186/s12890-015-0067-2.
Clinical trial NCT00186342: Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies
Official title: Allogeneic Sibling and Unrelated Donor Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Busulfan, Etoposide and Cyclophosphamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Disease
Myelodysplastic Syndromes
Leukemia, Myeloid, Chronic
Myeloproliferative Disorders
Blood and Marrow Transplant (BMT)
Myelodysplastic Syndromes (MDS)
Leukemia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 51
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).

Detailed description: To learn whether a new preparative regimen to prepare patients for bone marrow transplantation is useful in patients above 50 years of age and whether it is useful in patients with myelodysplastic syndromes.

Eligibility criteria: Inclusion Criteria:1) Patients aged 51-60 with acute non-lymphocytic leukemia in first or subsequent remission and acute lymphocytic leukemia in first remission with high risk features which include elevated white blood cell count at presentation, cytogenetic abnormalities, extramedullary leukemia, ALL in greater than first remission and patients with chronic myelogenous leukemia at any stage who have a histocompatible sibling donor.

2) Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.

3) Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.

4) Patients with secondary myelodysplasia following cytotoxic chemotherapy. Exclusion Criteria:- Organ dysfunction

Primary outcomes:
measure: tolerability
measure: efficacy of therapy
Secondary outcomes:
measure: compare efficacy of this treatment to historical controls
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Robert S Negrin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02954042: Pelvital Stress Urinary Incontinence Training Device: P-SUIT
Official title: Pelvital Stress Urinary Incontinence Training Device: P-SUIT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence
Keywords: Incontinence
Lead sponsor: Pelvital USA, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to compare the clinical benefits of using the Pelvital product, in comparison to a sham procedure as a noninvasive treatment for female incontinence

Detailed description: 120 subjects with SUI will be recruited into a randomized, double-blind, sham-controlled crossover trial. Subjects will be allocated in a 1:1 ratio (60 per arm) to either the control arm (PFMT) or the treatment arm (PFMT in conjunction with the Pelvital therapy). Subjects will conduct their respective therapy five minutes a day over the course of six weeks. At weeks two, four and six, the subjects will conduct bi-weekly check-ups. After six weeks, all patients in the control arm will have the option to cross over into the treatment arm if no improvement in symptoms has been shown.

Eligibility criteria: Inclusion Criteria:

1. Female gender,
2. Ages 18-75,
3. Clinical diagnosis of stress urinary incontinence,
4. Ability to contract the pelvic floor muscles,
5. Able to document incontinence and voiding in a diary,
6. Provision of written informed consent form,
7. Minimum of 10 grams increase at initial 24-hour pad weight test

Exclusion Criteria:

1. Diagnosed mixed or urge urinary incontinence,
2. Impaired cognitive function or neurologic conditions
3. Physical limitations that impede the patient's ability to participate (e.g., ability to stand),
4. Acute infections or hematuria,
5. Pregnant or actively trying to conceive,
6. History of pelvic irradiation,
7. Concurrent medications with α-adrenergic antagonists or diuretics
8. Pelvic organ prolapse stage III or IV,
9. Severe urethral sphincter weakness and/or defect,
10. Suspected urethral and/or vesical fistula

Primary outcomes:
measure: Improvement in severity of involuntary urine loss
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: incontinence episode frequency
timeFrame: Baseline, 6 weeks
measure: health-related quality of life
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Maple Grove
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Maplewood
country: United States
facility: Metro OBGYN
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Minnesota
name: Nissrine Nakib, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000442: Naltrexone for Relapse Prevention
Official title: Etiology and Treatment of Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 1999-11-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol dependence.
* Abstinent from alcohol for a period of at least 3 days prior to beginning of study.
* Able to read English and complete study evaluations.
* Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.

Exclusion Criteria:

* Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis.
* Prior history of opioid dependence.
* Regular use of psychoactive drugs including anxiolytics and antidepressants.
* Prior treatment with naltrexone.
* Current use of disulfiram.
* Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania).
* Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease.
* Abstinent longer than 28 days prior to randomization.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Department of Psychiatry, University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02617342: Robot-Mediated Intervention for Children With Autism Spectrum Disorders
Official title: Robot-Mediated Social Skills Intervention for Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Intervention
Autism Spectrum Disorder
Social Skills
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Aetna, Inc.
First posted: 2015-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to examine the impact of an interactive, social robotics program in helping children with autism spectrum disorders (ASD) understand emotions and how to better recognize emotions while interacting with others. Eligible families will be randomized to either the robot intervention (n=20) or a no intervention (TAU; n=20) condition for 8-14 weeks. Assessments will occur at pre- and post-intervention as well as weekly for both conditions.


Eligibility criteria: Inclusion Criteria:

* Child participants must be between the ages of 4 years, 0 months and 8 years, 11 months.
* Children must meet criteria for ASD or autism on the Autism Diagnostic Observation Schedule (ADOS-2; Lord et al., 2012) plus receive a clinical judgment of pervasive developmental disorder not otherwise specified (PDD-NOS) or autism by the study team.
* Children must possess sufficient expressive language skills to qualify for at least an ADOS-2 Module 2.
* Caregivers must agree to participate in the study and commit to having their child participating in the intervention to which they are randomized for approximately three months.
* Caregivers must agree to bring their child in for pre-testing and post-testing.
* Family must speak English at least 50% in the home.

Exclusion Criteria:

* Child IQ \<70 (per Stanford Binet short form).
* History of head injury, seizure disorder, severe aggression or self-injurious behavior.
* Vision impairment after correction.
* Cannot be living in foster care.

Primary outcomes:
measure: Change in baseline emotions accurately identified on the Transporters Quiz
timeFrame: 14 weeks into treatment (at completion of intervention)
Secondary outcomes:
measure: Change in baseline Social Responsiveness Scale Score
timeFrame: 14 weeks into treatment (at completion of intervention)
measure: Number of prompt-free intervals during the treatment sessions
timeFrame: Weekly throughout intervention schedule (8-14 weeks)
measure: Change in baseline parent report of child's emotion recognition
timeFrame: 14 weeks into treatment (at completion of intervention)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Rebecca Landa, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: