louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03742765: Incentivizing Planning & Output in Exercising
Official title: Incentivizing Planning & Output in Exercising
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Exercise
Incentives
Planning
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test whether incentivizing pre-workout activities (i.e., planning workouts) is more effective than incentivizing actual workouts. This study has two conditions: planning condition (with incentives for planning) vs. output (with incentives for working out). The focus of the incentives will be reinforced by three text messages per week and weekly emails.

Detailed description: Gym members register online to participate in a 28-day workout program. Upon registration, participants are assigned to one of two conditions (a condition that incentivizes planning or a condition that incentivizes workouts). Upon registration, participants are prompted to create a workout schedule and are given tips about how to create a workout habit. Over the 28-day intervention period, participants receive text message reminders prior to their scheduled workouts and emails reminding them of their schedules. In both conditions, participants receive points every day that they go to the gym, which can be redeemed for a gift card after the intervention period. In the planning condition, participants can receive bonus points for responding to each of three text messages each week asking about their plans for going to the gym. In the output condition, participants receive bonus points for their first three workouts each week.

Eligibility criteria: Inclusion Criteria:

* Has 24 Hour Fitness gym membership

Exclusion Criteria:

-

Primary outcomes:
measure: Gym visits per week
timeFrame: During the 28-day intervention period
measure: Gym visits per week
timeFrame: During the 4-weeks post-intervention
measure: Gym visits per week
timeFrame: During the 10-weeks post-intervention
measure: Whether or not a participant visits the gym in a given week
timeFrame: During the 28-day intervention period
measure: Whether or not a participant visits the gym in a given week
timeFrame: During the 4-weeks post intervention
measure: Whether or not a participant visits the gym in a given week
timeFrame: During the 10-weeks post intervention
Secondary outcomes:
measure: Gym visits per week
timeFrame: During the 52-weeks post-intervention
measure: Whether or not a participant visits the gym in a given week
timeFrame: During the 52-weeks post-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01621165: Prazosin as an Antimanic Agent in Severe Mania or Mixed States
Official title: Prazosin as an Antimanic Agent in Severe Mania or Mixed Episodes: a Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bipolar, Mania
Bipolar, Mixed State
Keywords: treatment of bipolar, mania
double-blind, placebo-controlled study
drug intervention
add-on study
prazosin
alpha-1 adrenergic antagonist
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 0
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: Mania has been considered to be, in part, a hyperadrenergic state. One focus of treatment of mania involves directly targeting this hyperexcitable state by reducing arousal with antiadrenergic agents. This can be achieved by decreasing norepinephrine release by stimulating presynaptic inhibitory receptors. Prazosin, FDA approved for the treatment of high blood pressure works in part by blocking postsynaptic alpha-adrenergic receptors. Prazosin has been found to be clinically useful for the treatment of Post Traumatic Stress Disorder. It is reasonable, therefore, to anticipate that prazosin might be helpful in the treatment of mania.


Eligibility criteria: Inclusion Criteria:

* Age 18-60
* Primary diagnosis of bipolar disorder with severe mania or mixed episode
* YMRS score of \> 20
* Documented medical evaluation without acute or serious medical illness
* Negative pregnancy test
* Healthy functioning liver

Exclusion Criteria:

* Lack of capacity to provide informed consent
* Involuntary commitment
* Low blood pressure
* History of adverse reaction or allergy to prazosin or other quinazolines
* Informed consent not given or retracted during study
* History of narcolepsy
* Unstable or acute medical illness

Primary outcomes:
measure: Young Mania Rating Scale (YMRS)
timeFrame: 10 days
Secondary outcomes:
measure: Mania Acute Changes Scale (MACS)
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Mclean Hospital
name: Elizabeth S Liebson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01375465: The 001-DIOR Multicenter Registry
Official title: The 001-DIOR Multicenter Registry (A Novel Percutaneous Coronary Intervention With the New Paclitaxel-eluting Balloon DIOR in Ostial Bifurcated Lesions)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Eurocor GmbH
Sponsor class: INDUSTRY
First posted: 2011-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary intervention (PCI) to assess the clinical success, efficacy and safety of the Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat the stenotic site branch.


Eligibility criteria: Inclusion Criteria:

* De novo bifurcated lesions 001 of Medina classification, with significant stenosis only in the ostium of the side branch and a reference vessel diameter is bigger or equal 2.0mm; the DIOR balloon will be used to the treat the side branch.
* The patient has clinical evidence of myocardial ischemia (stable or unstable angina, acute and non acute myocardial infarction, silent ischemia: ECG, exercise test, etz...)
* As the maximal length of the DIORTM balloon is 30 mm, all eligible lesions should be no longer than 25 mm to ensure an adequate drug elution in the treated segment, avoiding the phenomenon of "geographical miss" .
* Target lesion(s) stenosis is more or equal 50% by visual estimation.

Exclusion Criteria:

* Cardiogenic shock
* Any serious disease that might limit patient survival to less than one year
* Inability to perform clinical follow-up for a period of 1 year
* Left main bifurcation lesions: ostial left circumflex or ostial left anterior descending artery stenosis.
* Lesion length \> 25 mm
* Target vessel reference diameter \< 2mm
* Stenosis \< 50% of the reference luminal diameter
* Severe angiographic calcification at the level of the target lesion

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 6 months
Secondary outcomes:
measure: target vessel revascularization (TVR) rate, either symptom or ischemia-driven
timeFrame: 6 months
measure: Segment treated thrombosis (STT), according to ARC definitions
timeFrame: 6 months
measure: Late Lumen Loss
timeFrame: 6 months
measure: Binary restenosis rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital Trías i Pujol
Study officials:
affiliation: Hospital Sant Pau, Barcelona
name: Antonio Serra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Sant Pau, Barcelona
name: Beatriz Vaquerizo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00761865: Lateral Ankle Sprain Study
Official title: Lateral Ankle Sprain Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lateral Ankle Sprain
Keywords: Lateral Ankle Sprin
Air Cast Stirrup Brace
High Tide Fracture Boot
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-09-30
Enrollment: 34
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 compare the short term treatment outcome measures of the standard of care air cell stirrup brace to that of a high tide fracture boot in patients with lateral ankle sprains.

Detailed description: 100 patients with Grade II-III lateral ankle sprains requiring crutches will be invited to participate. Patients will randomly be assigned to be treated with either the Air Cast Stirrup Brace (n=50) or the High Tide Fracture Boot (n=50). All patients will be given instructions to use the fracture boot or air cell brace at all times of ambulatory activity until follow-up and to use NSAIDS as needed. At their 2 week post-sprain follow-up the following outcomes measures will be assessed: Modified Karlsson score (disease specific survey) Pain VAS Patient satisfaction with treatment VAS SMFA (general health measure) Ability to walk without crutches

Eligibility criteria: Inclusion Criteria:

* Age 18 \& Over
* Lateral Ankle Sprain (Grade II or III) presenting within 48 hours of initial injury without prior treatment

Exclusion Criteria:

* Patients less than 18 years old
* Those not able to give consent
* Women who are pregnant or are expecting to become pregnant
* \> 48 hrs from injury at time of presentation
* Prior treatment for injury
* Fracture at time of current ankle injury or previous ankle fracture
* Deltoid ligament injuries
* Other orthopaedic injuries at time of presentation
* Intoxication
* Workman's Compensation injury
* Mental Illness
* Dementia

Primary outcomes:
measure: Modified Karlsson Score
timeFrame: 2 weeks post-sprain
Secondary outcomes:
measure: Patient Satisfaction (Measured on a Visual Analog Scale)
timeFrame: 2 weeks post-sprain
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Benedict DiGiovanni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01344265: The Correlation Between B-type Natriuretic Peptide (BNP) and Global End Diastolic Volume
Official title: The Correlation Between BNP and Global End Diastolic Volume
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: B-type natriuretic peptide
global end diastolic volume
Lead sponsor: Jinhua Central Hospital
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill patients who required hemodynamic monitoring using PiCCO

Brief summary: The investigators hypothesized that the serum B-type Natriuretic Peptide (BNP) level may be correlated with global end diastolic volume (GEDV) as measured by transpulmonary thermodilution technique (PiCCO). The rationale is that some animal studies have proven that BNP is released from ventricular myocardium in response to physical expansion. Such physical expansion can be measured by GEDV. If the hypothesis can be confirmed with our study, the serum level BNP can be used to monitor volume status of critically ill patient, instead of the invasive monitoring system.


Eligibility criteria: Inclusion Criteria:

* critically ill patients who required hemodynamic monitoring using PiCCO

Exclusion Criteria:

* patients with renal dysfunction
* those older than 80 years
* pregnant women

Primary outcomes:
measure: global end diastolic volume
timeFrame: within 12 h after measurement of BNP
Secondary outcomes:
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Jinhua central hospital
state: Zhejiang
Study officials:
affiliation: Jinhua Central Hospital
name: Zhongheng Zhang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03555565: Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"
Official title: Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 1026
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 with type 2 diabetes mellitus for whom combination therapy with alogliptin and metformin hydrochloride is appropriate in the opinion of a physician as the routine medical care.

Brief summary: The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.

Detailed description: The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more).

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600.

This multi-center observational trial will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

* Participants should meet one or more of the following:

  1. Have renal impairment (mild)
  2. Have hepatic impairment (mild or moderate)
  3. Elderly (aged 65 years or more)

Exclusion Criteria:

* Participants with any contraindication for study drug.

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Events
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, up to final assessment point (up to Month 12)
measure: Change From Baseline in Fasting Blood Glucose
timeFrame: Baseline, up to final assessment point (up to Month 12)
measure: Change From Baseline in Fasting Insulin Level
timeFrame: Baseline, up to final assessment point (up to Month 12)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00097565: An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma
Official title: The National Lymphocare Study: An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Non Hodgkin
Keywords: Follicular Non-Hodgkin's Lymphoma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-25
Enrollment: 2740
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: Patients with follicular NHL will be recruited from participating managed care organizations, community physicians or practices, and academic centers throughout the United States.

Brief summary: This is a prospective, observational, longitudinal, multicenter study of patients with newly diagnosed follicular Non Hodgkin's Lymphoma (NHL) designed to delineate differences in clinical outcome by comparing the effectiveness and safety of common treatment regimens.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form (unless the Institutional Review Board \[IRB\] has granted a waiver of consent)
* Signed Authorization for the Use and Disclosure of Health Information document
* Age ≥18 years
* Histologic documentation of follicular NHL, according to Revised European-American Lymphoma (REAL) classification system, as assessed by the local pathologist and treating physician
* Initial diagnosis of follicular B-cell NHL within 6 months prior to enrollment
* Availability of cancer-specific historical data points in the patient's medical records

Exclusion Criteria:

* Other indolent or histologic NHL subtypes
* Diagnosis of lymphoma \> 6 months prior to enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Cinical Trials
role: STUDY_DIRECTOR
References:
citation: Nastoupil LJ, Sinha R, Byrtek M, Ziemiecki R, Zhou X, Taylor M, Friedberg JW, Link BK, Cerhan JR, Dawson K, Flowers CR. Outcomes following watchful waiting for stage II-IV follicular lymphoma patients in the modern era. Br J Haematol. 2016 Mar;172(5):724-34. doi: 10.1111/bjh.13895. Epub 2016 Jan 5.
citation: Wagner-Johnston ND, Link BK, Byrtek M, Dawson KL, Hainsworth J, Flowers CR, Friedberg JW, Bartlett NL. Outcomes of transformed follicular lymphoma in the modern era: a report from the National LymphoCare Study (NLCS). Blood. 2015 Aug 13;126(7):851-7. doi: 10.1182/blood-2015-01-621375. Epub 2015 Jun 23.
Clinical trial NCT03260465: Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup
Official title: A Randomized Controlled Trial With the seleXys PC Cup and RM Pressfit Vitamys Cup in Combination With the Optimys Short Stem
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Joint
Arthritis, Degenerative
Keywords: total hip replacement
roentgen stereophotogrammetric analysis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 53
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomised single-center study with 2 treatment arms.
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in combination with the optimys short stem. Wear rate and migration is assessed with roentgen stereophotogrammetric analysis (RSA) measurements.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic arthritis who are candidates for a primary total hip arthroplasty with an uncemented femoral stem as determined jointly by the surgeon and the patient.
* Patients suitable for an uncemented acetabular component in combination with a 36mm femoral head (seleXys PC cup: 52mm, 54mm or 56mm; RM Pressfit vitamys: 52mm, 54mm or 56mm)
* Patients between the ages of 50 and 75 inclusive
* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria:

* Patients that require an acetabular cup size which cannot be used in combination with a 36mm femoral head
* Patients that offer no guarantee for regular follow-up controls
* Patients that have a revision surgery
* Patients that have a fracture of the femoral neck or a bone tumour in the area of the femur or pelvis
* Patients that had a previous osteotomy of the femur or pelvis
* Pregnant women or those seeking to become pregnant
* Patients with a history of active infection

Primary outcomes:
measure: Wear Rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Klinik für Orthopädie und Traumatologie, University Hospital Basel
state: BL
Study officials:
affiliation: Klinik für Orthopädie und Traumatologie, Universitätsspital Basel
name: Karl Stoffel, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03675165: Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience
Official title: Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Prevention
Psychology
Self-Management
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine how the 'Best Possible Self' (BPS) intervention influences diabetes symptomatology over a four week period by assessing stress and resilience as mediatory effects. Half of the participants will receive the BPS straight away while the other half will be put on a waiting list and will act as the control group.

Detailed description: The BPS is a "positive" psychology intervention; i.e. it facilitates positive emotion in order to achieve psychological, behavioural, and even physiological changes. The present team's previous research has demonstrated that the BPS is effective at reducing certain diabetes symptoms, though the exact mechanisms by which it does so are unclear. According to the Stress Buffering Model of Physical Activity, psychological stress is the catalyst that triggers behavioural and physiological responses critical to health while positive emotions can improve health by helping people to cope. The Broaden and Build Theory of Positive Emotions, meanwhile, suggests that this is because positive emotions allow people to build resilience.

In this study, the aim is to examine whether stress and resilience in particular mediate the relationship between intervention and diabetes symptoms. Research around stress and resilience has shown these factors to be important not only in the physical health of people with diabetes but for also decreasing illness symptomatology in non-clinical samples more generally.

Eligibility criteria: Inclusion Criteria:

* Non-clinical sample
* 18+
* Access to the internet

Exclusion Criteria:

* Severe mental illness (such as schizophrenia or bipolar depression)

Primary outcomes:
measure: Diabetes Symptomatology (assessed using the Diabetes Symptoms Checklist - Revised)
timeFrame: Four Weeks
Secondary outcomes:
Other outcomes:
measure: Self-Reported Stress (assessed using the Perceived Stress Scale)
timeFrame: Four weeks
measure: Self-Reported Resilience (assessed using the Six-Item Brief Resilience Scale)
timeFrame: Four Weeks
measure: Diabetes Risk (calculated using the Canadian Diabetes Risk Questionnaire)
timeFrame: Four Weeks
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
state: Merseyside
Study officials:
affiliation: Liverpool John Moores University
name: Kanayo F Umeh
role: STUDY_DIRECTOR
References: