louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01639196: Brief Online Intervention for Chronic Pain
Official title: The Expressive Writing Paradigm: A Study of Therapeutic Effectiveness for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Psychological adjustment
Writing
Brief intervention
Online
Internet interventions
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 93
Sex: ALL
Minimum age (years): 18
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 explore the effects of writing about chronic pain on mental and physical health. The effectiveness of two different types of brief online writing interventions will be explored in individuals with chronic pain.

Detailed description: Chronic pain is highly prevalent and costly, but often not treated effectively. Psychological interventions are needed as part of chronic pain treatment since the pain affects many aspects of an individual's life. In particular, brief psychological interventions that are easily accessible (i.e., online) could benefit many people with chronic pain. Writing interventions have been used in recent years to understand difficult experiences. Writing interventions have been found to help individuals explore distressing thoughts and feelings, such as those that are associated with pain.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with chronic pain or a chronic pain condition or discussed pain management strategies (e.g., pain medication) with a doctor
* Experience pain on most days of the month for at least six months
* Able to read and write in English

Exclusion Criteria:

* Chronic pain directly caused by a terminal condition (e.g., stage 4 cancer)

Primary outcomes:
measure: Change from Baseline in Self-Compassion Scale
timeFrame: Change from Baseline in Self-Compassion Scale at 4 weeks
measure: Change from Baseline in Pain Self-Efficacy Scale
timeFrame: Change from Baseline in Pain Self-Efficacy Scale at 4 weeks
Secondary outcomes:
measure: Change from Baseline in Pain Severity
timeFrame: Change from Baseline in Pain Severity at 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland, College Park
name: Mary Ann Hoffman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01968096: The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury(SCI)
Keywords: Reflex
Post activation
Spinal cord injury
Pre-synaptic inhibition
Machine driven passive strech
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.

Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.

The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.


Eligibility criteria: Stage 1 subjects: Spinal cord injury subject

Inclusion Criteria:

* Clinical diagnosis of spinal cord injury \< 2 years

Stage 2 subjects: Incomplete spinal cord injury subject

Inclusion Criteria:

* Clinical diagnosis of incomplete spinal cord injury
* ASIA classification:B, C, or D

Stage 3 subjects: Spinal cord injury subjects with high muscle tone

Inclusion Criteria:

* Clinical diagnosis of spinal cord injury.
* ASIA classification: A, B, C, or D

Primary outcomes:
measure: Clinical muscle tone tests & Peripheral nerve Stimulation machine
timeFrame: Participants will be followed for the duration of invention, an expected average of 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References:
Clinical trial NCT01028196: Observational Study to Evaluate Bipolar Disorder Symptoms in Patients Presented With Schizophrenia or Depression
Official title: Epidemiological Observational Non-interventional Study to Research the Prevalence of Bipolar Criteria of Hospital In-patients With Schizophrenia and Patients With Recurrent Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizoaffective Disorder
Recurrent Depression
Keywords: schizophrenia
schizoaffective disorder
recurrent depression
Bipolar disorders
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having current diagnosis of schizophrenia/ schizoaffective disorder (in-patients) and patients having current diagnosis of recurrent depression (both in-patients and out-patients) will be included into this study.

Brief summary: This study is aimed to evaluate the bipolar disorder symptoms in patients presented with schizophrenia, schizoaffective disorder or recurrent depression.

Bipolar disorder is a group of mood disorders characterised by elevated or irritable mood episodes in patient's lifetime history accompanied by some additional symptoms. In this study modern bipolar disorders screening/assessment instruments will be used to explore the prevalence of bipolarity symptoms in patients who never been diagnosed with bipolar disorders. The results of this study could be useful for more accurate assessment of bipolar disorders prevalence in psychiatric patient population, could help to improve the diagnostics of bipolar disorders and management of bipolar patients.


Eligibility criteria: Inclusion Criteria:

* signed patient informed consent
* In-patients with the diagnosis of schizophrenia with episodic course or schizoaffective disorder, OR in-patients and out-patients with the diagnosis of recurrent depression.
* The duration of the disease is 3 years and longer and two or more episodes of the disease in the patients history.

Exclusion Criteria:

* Current diagnosis of Bipolar Disorder
* Severe and unspecified forms of schizophrenia (schizophrenia with continuous course, hebephrenic schizophrenia, catatonic schizophrenia, undifferentiated schizophrenia, unspecified schizophrenia) and organic affective disorder or intoxication induced affective disorder.
* Any other concomitant conditions which, in the judgment of investigator, will not allow the patient to complete the study procedures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chita
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Mental Disorders Moscow Research Institute of Psychiatry
name: Sergey N. Mosolov, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01033396: The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
Official title: A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragweed Pollen In An Environmental Exposure Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis Environmental exposure unit
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects 18-60 years allergic to ragweed pollen.
* Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit.

Exclusion Criteria:

* Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764.
* Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.

Primary outcomes:
measure: Congestion scores
timeFrame: 6 hours
measure: Other allergic rhinitis symptoms
timeFrame: 6 hours
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 6 hours
measure: Blood pressure/pulse rate
timeFrame: 6 hours
measure: Adverse event reporting
timeFrame: 2 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: North ML, Walker TJ, Steacy LM, Hobsbawn BG, Allan RJ, Hackman F, Sun X, Day AG, Ellis AK. Add-on histamine receptor-3 antagonist for allergic rhinitis: a double blind randomized crossover trial using the environmental exposure unit. Allergy Asthma Clin Immunol. 2014 Jul 3;10(1):33. doi: 10.1186/1710-1492-10-33. eCollection 2014.
Clinical trial NCT03690596: Smoking Relapse Prevention Via Just-in-Time-Adaptive Interventions
Official title: Personalized Smoking Relapse Prevention Delivered in Real-Time Via Just-in-Time-Adaptive Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Meharry Medical College
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Medical University of South Carolina
First posted: 2018-10-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A small-scale randomized controlled trial (RCT) will pilot test a personalized JITAI designed to guide delivery of fast acting nicotine replacement therapy (NRT; lozenge) in real-time, to prevent smoking relapse. Specifically, a smartphone application (app), will integrate pre-quit smoking data with objective location data captured via global positioning system (GPS) to establish relapse risk (hotspot) algorithms. During a quit attempt, the GPS-enabled app (QuitBuddy) will detect proximity to hotspots and deliver NRT prompts, all of which will occur automatically and prior to exposure. Thus, QuitBuddy will optimize NRT use to prevent cue-provoked cravings known to undermine sustained abstinence, thereby repurposing this evidence-based cessation medication to promote relapse prevention. QuitBuddy will be tested against standard care (NRT with brief instructions). Two versions of QuitBuddy will be tested, which will differ only in how hotspot algorithms are derived: retrospectively from locations recalled at the onset of a quit attempt (QuitBuddy-Recall) or based on real-time EMA completed pre-quit (QuitBuddy).


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* daily cigarette smoker of \> 9 cigarettes/day for past year
* CO breath monitor detects \> 10ppm
* literate in English
* willing to make a quit attempt in the next week with nicotine replacement therapy
* no plans to travel outside of a 100-mile radius of Charleston during the study

Exclusion Criteria:

* FDA contraindications for use of NRT:

  1. Pregnant
  2. Breastfeeding or planning to become pregnant
  3. Recent (past 3 months) cardiovascular trauma: MI, stroke
* current use (past 30 days) of alternative tobacco products or smoking cessation medications

Primary outcomes:
measure: Abstinence from cigarettes
timeFrame: 12 Weeks
Secondary outcomes:
measure: Abstinence from cigarettes
timeFrame: 4 weeks
measure: Abstinence from cigarettes
timeFrame: 1 week
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
Study officials:
affiliation: Meharry Medical College
name: Bryan W Heckman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01000896: Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel
Official title: A Phase I, Open-Label, Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD0530 in Combination With Carboplatin and Paclitaxel Chemotherapy in Japanese Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cancer
Non Small Cell Lung Cancer
Epithelial Ovarian Cancer
Keywords: Phase I
cancer
solid tumors
advanced solid malignancies
NSCLC
epithelial ovarian cancer
dose escalation
combination treatment
src inhibitor
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Japanese patients with non small cell lung cancer or epithelial ovarian cancer
* Must be suitable for treatment with carboplatin and paclitaxel
* Relatively good overall health other than cancer

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells).
* Poor liver or kidney function.
* Patients unable to discontinue drugs known to be potent inhibitors or inducers of CYP3A4 within 2 weeks prior to registration

Primary outcomes:
measure: Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, general examination, HRCT, SpO2, ECG
timeFrame: Laboratory assessment prior to chemotherapy administration in all treatment cycles and on days 2, 8 and 15 in cycle 1. General exam, SpO2 and ECG prior to chemotherapy administration in all treatment cycles. HRCT scans performed days 21, 42, 70-98.
Secondary outcomes:
measure: Assessment of the pharmacokinetics of AZD0530 (Cssmax, Cssmin, tmax, AUCss0-24, CL/F), its N-desmethyl metabolite M594347 (Cssmax, Cssmin, tmax, AUCss0-24), and carboplatin / paclitaxel (Cmax, AUC, AUC0-t, t1/2, CL and Vss)
timeFrame: Schedule of PK assessment1. AZD0530/N-desmethyl metabolite M594347Cycle1-day21 -Cycle2-day2; 11point2. carboplatinCycle1-day1 ~ day2; 8 pointCycle2-day1 ~ day2; 8 point3. paclitaxelCycle1-day1 ~day2; 9 pointCycle2-day1 ~ day2; 9 point
Other outcomes:
Locations:
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Mary Stuart
role: STUDY_DIRECTOR
affiliation: National Hospital Organisation Kyushu Cancer Centre
name: Takashi Seto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Hospital Organisation Shikoku Cancer Centre
name: Naoyuki Nogami, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01357096: Development and Efficacy Evaluation of Integrated Chronic Care and Health Promotion Model for Patients With Coronary Artery Disease in Taiwan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Stable Angina
Keywords: intervention
CABG or PTCA
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 400
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The hypothesis of this project is to examine whether the integrated health care program as the intervention group can reduce the recurrence and mortality of coronary artery-related diseases than the traditional one as the comparison group.


Eligibility criteria: Inclusion Criteria:

* patients who suffered from acute myocardial infarction or stable angina with intervention (CABG or PTCA)

Exclusion Criteria:

1. Age \> 85 yrs old.
2. Worse short-term prognosis (e.g.cancer, congestive heart failure NYHA IV)
3. Any systemic disease which will limit the exercise program (e.g. bed-ridden stroke)
4. Unable to participate in the trial due to any logic reasons

Primary outcomes:
measure: Death, non-fatal MI, non-fatal stroke, recurrent angina, emergency room (ER) visit due to any CV-related diseases or readmission due to any CV-related diseases confirmed by the physicians.
timeFrame: one year
Secondary outcomes:
measure: BP, lipid, glucose, EBM drugs and self-care efficacy
timeFrame: one year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References:
Clinical trial NCT00278096: Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly
Official title: Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability
Occupational Therapy
Keywords: disability
occupational therapy
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
First posted: 2006-01-18
Enrollment: 400
Sex: ALL
Minimum age (years): 85
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly.

Detailed description: Community-dwelling elderly, and particularly the oldest old, are generally viewed as highly susceptible to the 'inverse care law'. That is, those in greatest need for preventive assessment and surveillance have the highest potential benefit but are most likely to be missed. Hence, active case-finding and close follow-up might be an important strategy for maintaining the health, independence, and well-being of very elderly people who are at a particularly high risk.

In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly. Subjects in the intervention group will be visited by an occupational therapist who provides training and education about assistive devices that are already present and will give recommendations and information about procedures, possibilities, and costs of assistive devices and community-based services. Control subjects will not be visited by an occupational therapist.

The primary outcome measure of the trial will be the score on the Groningen Activity Restriction Scale (GARS). Secondary outcome measures will be well-being and feelings of loneliness.

Eligibility criteria: Inclusion Criteria:

* age 85 years
* living independently
* MMSE score \> 18 points

Exclusion Criteria:

* none

Primary outcomes:
measure: Score on the Groningen Activity Restriction Scale (GARS)
Secondary outcomes:
measure: Well-being and feelings of loneliness.
Other outcomes:
Locations:
Study officials:
affiliation: Leiden University Medical Center
name: Anton JM de Craen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00746096: Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
Official title: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 115
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
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 combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.


Eligibility criteria: Inclusion Criteria:

* primary dysmenorrhea

Exclusion Criteria:

* severe hepatopathy
* pregnant woman

Primary outcomes:
measure: Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)
timeFrame: 16weeks
Secondary outcomes:
measure: Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)
timeFrame: 16weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nissay Hospital,Osaka,Japan
name: Naoki Terakawa, M.D.,Ph.D.
role: STUDY_DIRECTOR
References:
citation: Harada T, Momoeda M, Terakawa N, Taketani Y, Hoshiai H. Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2011 May;95(6):1928-31. doi: 10.1016/j.fertnstert.2011.02.045. Epub 2011 Mar 21.