louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02665611: Remote Monitoring and Support for Patients With Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence
Official title: The Effect of Remote Monitoring and Support for Patients Suffering From Schizophrenia, Schizoaffective or Bipolar Disorder on Adherence to Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
First posted: 2016-01-28
Enrollment: 300
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: Moma call center will provide unique service -Remote monitoring and support for mental health patients .The aim of this reserch is reducing hospitalization and improve adherence, by reaching out and there for monitoring very closely .

Detailed description: "Moma" call center is a result of collaboration between Maccabi Health Services and The Gertner Institute of Epidemiology and Health Policy Research. The call center provides remote continuous monitoring and support for patients with chronic illnesses, and has been found useful for improvement in treatment adherence and other clinical measures in patients with diabetes and CHF.

The current project focuses on patients diagnosed with schizophrenia, schizoaffective disorder and bipolar disorder. Patients that suffer from these disorders are prone to low adherence and are at risk for discontinuation of treatment and frequent relapses.

The advantages of the "Moma" call-center include high availability, reaching out, collaboration between treatment centers and agents, and continuous remote monitoring. We hypothesize that these factors will enable improvement of support provided to these patients, early detection of their needs, connection with community care agents, monitoring of treatment adherence, and remote interventions targeted towards prevention of relapse.

Eligibility criteria: Inclusion Criteria:

Men \& women,

1. age 18-60 ,
2. "Maccabi Health service" patients with diagnosis of: schizophrenia, Schizo - effective or Bipolar Dis.
3. Must have 30 days or more of hospitalization (during 3 years). Treated with psychiatric medication.
4. Living independently or with a help of a caregiver.
5. Is able to provide written informed consent.

Exclusion Criteria:

1. Violent, or suicidal.
2. Drug\\ Alcohol, addiction,
3. End stage Disease (Cancer, ESRF act.)
4. Non - in depended and without Care giver/legal guardian

Primary outcomes:
measure: number of days of hospitalization
timeFrame: through study competion ,an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Asaf B Caspi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01894711: Real World Efficiency of Trastuzumab in Early Breast Cancer
Official title: Real-world Use and (Cost)-Effectiveness of Adjuvant Trastuzumab in Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 2684
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.

That is, no distant metastasis at the time of the primary diagnosis

Brief summary: AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands.

RESEARCH QUESTIONS / OBJECTIVES

1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
2. Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands?

To address the research questions (objectives), the following outcome measures will be determined:

CLINICAL OUTCOME MEASURES

1. Actual trastuzumab administration as opposed to planned trastuzumab administration
2. Selection criteria for chemotherapy and trastuzumab in daily practice
3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac
4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab

   ECONOMIC OUTCOME MEASURES
5. Volumes and costs of diagnostic tests and therapies including those for (distant) relapse
6. Cost-effectiveness of trastuzumab in clinical trials versus in real world


Eligibility criteria: Inclusion Criteria:

* All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.

Exclusion Criteria:

* Distant metastasis at the time of the primary diagnosis

Primary outcomes:
measure: Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor
timeFrame: events, within an average of 5-year between diagnosis and last follow up
Secondary outcomes:
measure: Number of patients treated with trastuzumab who develop (cardio)toxicity?
timeFrame: temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up
Other outcomes:
measure: Cost-effectiveness os trastuzumab in adjuvant breast cancer patients
timeFrame: volume and cost, within an average of 5-year between diagnosis and last follow up
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Vivianne CG Tjan-Heijnen, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05064111: Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy
Official title: Improved Detection and Localization Accuracy of Early Aggressive Prostate Adenocarcinoma Using Novel MR-directed Ultrasound-guided (MRdUSg) Prostate Biopsy Technique
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 100
Sex: MALE
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: Adult male patients undergoing diagnostic work up for suspected or recurrent prostate cancer as standard of care.

Brief summary: The purpose of this study is to utilize this technology in the early detection and staging of pathologic states within prostate cancer patients using the information obtained on mpMRI and serum biomarkers from the patient's blood (if collected). Ultimately, investigators hope to improve the diagnostic accuracy and treatment selection process for these patients. Applying the fusion software which adds mpMRI to ultrasound images in real time, to an otherwise clinically standard but non-targeted ultrasound-guided prostate biopsy procedure will help with accurate and early diagnosis of prostate cancer.


Eligibility criteria: Inclusion Criteria:

1. Able to give informed consent
2. Male - age \> 18
3. mpMRI within the previous 6 months (PIRADS 3,4,5, all stages of PCa)
4. Scheduled for TRUS biopsy for prostate lesion or mass

Exclusion Criteria:

1. Age under 18 years of age.
2. Female
3. Pre-existing blood dyscrasias
4. Inability to perform TRUS due to anal sphincter closure/surgery
5. Patients needing general anesthesia
6. Patients allergic to lidocaine
7. Patients allergic or unable to take antibiotics

Primary outcomes:
measure: Evaluate investigational fusion software.
timeFrame: Through study completion, planned 5 year duration.
Secondary outcomes:
measure: Assess accuracy of mpMRI.
timeFrame: Through study completion, planned 5 year duration.
measure: Assess sensitivity of software.
timeFrame: Through study completion, planned 5 year duration.
measure: Correlation of imaging with biomarkers.
timeFrame: Through study completion, planned 5 year duration.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Hina Arif-Tiwari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01125111: The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer
Official title: The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 69
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who visit Severance Hospital for rectal cancer

Brief summary: The clinical study of making the evidence with application of Da vinci-Robot assisted low anterior resection in rectal cancer


Eligibility criteria: Inclusion Criteria:

* 75 \> age \> 20
* Rectal cancer
* Non-distance metastasis
* Agree with this study

Exclusion Criteria:

* Benign prostate hyperplasia
* Previous history of urinary bladder or prostate gland operation
* Severe erectile dysfunction
* Defined as patients whose erectile scores were less than 10 in a preoperative questionnaire of the International Index of Erectile Function (IIEF)

Primary outcomes:
measure: The difference in 1 month between two surgical methods in terms of Bladder function.
timeFrame: 1 month
Secondary outcomes:
measure: The difference in 3 months between two surgical methods in tems of Sexual function.
timeFrame: 3 months
measure: The serial change of Bladder and sexual function according to times, in each operation method.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
name: Nam Kyu Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02543411: Use of Lidocaine in Endoscopic Submucosal Dissection
Official title: Effect of Intravenous Lidocaine During Endoscopic Submucosal Dissection for Gastric Neoplasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Neoplasm
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection.

The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.


Eligibility criteria: Inclusion Criteria:

1. Endoscopic submucosal dissection for the treatments of early gastric neoplasm

Exclusion Criteria:

1. Allergy to lidocaine
2. Chronic pain
3. Chronic abuse of opioid or NSAID
4. Atrioventricular conductance block
5. Liver dysfunction
6. Renal dysfunction

Primary outcomes:
measure: Fentanyl consumption during sedation
timeFrame: During sedation, an expected average of 40 minutes
Secondary outcomes:
measure: Pain intensity measured by numerical rating scale
timeFrame: 30 min, 6 hr, and 24 hr after procedure
measure: Incidence of nausea and vomiting
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02595411: Reliability of the Melbourne Assessment
Official title: Reliability of the Melbourne Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Stroke
Traumatic Brain Injury
Meningomyelocele
Central Nervous System Diseases
Keywords: Children
Rehabilitation
Upper Limb
Assessments
Outcome Measures
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with central motor disorders and impaired upper limb function

Brief summary: The aim of the study is to investigate the reliability of the Melbourne Assessment.

Detailed description: Children with central motor disorders will be tested twice within one week with the Melbourne Assessment. The assessments will be video scored. At a later time point, different raters will rate the same video for inter-rater reliability, the same rater will score the same video for intra-rater reliability, and the same rater will score the repeated assessment videos for test-retest reliability.

Eligibility criteria: Inclusion Criteria:

* central motor disorders
* ambulant or stationary patients of the Rehabilitation Center Affoltern am Albis
* ability to understand test instructions
* ability to sit upright for 25 minutes
* minimal activity in the assessed upper limb

Exclusion Criteria:

* severe visual and/or auditory problems
* acute lesion in the to assessed upper limb
* lack of compliance

Primary outcomes:
measure: Melbourne Assessment 2
timeFrame: 2 assessments within 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Affoltern am Albis
country: Switzerland
facility: University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
Study officials:
affiliation: University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
name: Hubertus van Hedel, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04966611: Anlotinib for Esophageal Cancer (AFEC)
Official title: A Real World Study on the Effect of Single or Combined Treatment of Anlotinib on Survival and Prognosis of Advanced Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Lead sponsor: Anyang Tumor Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced esophageal cancer

Brief summary: The purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced esophageal cancer in the real world, and to summarize the treatment experience of a wide range of people.


Eligibility criteria: Inclusion Criteria:

1. Age: ≥ 18 years old, male or female;
2. Patients with esophageal cancer were diagnosed;
3. Patients assessed by doctors to benefit from single or combined treatment of arotinib;
4. Patients volunteered to join the project.

Exclusion Criteria:

None

Primary outcomes:
measure: OS
timeFrame: From date of admission until the date of death from any cause, assessed up to 24 months
Secondary outcomes:
measure: PFS
timeFrame: From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Other outcomes:
Locations:
city: Anyang
country: China
facility: Anyang Cancer Hospital
Study officials:
References:
Clinical trial NCT03861611: A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
Official title: A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Back Pain Without Radiation
Low Back Pain
Keywords: ketorolac
diclofenac
ibuprofen
low back pain
back pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac

Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris Disability Questionnaire (RMQ)

Detailed description: More than 2.5 million patients present to US emergency departments (ED) annually with low back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit. Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit for acute LBP, this clinical trial proposes to determine whether there is a difference in efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.

Eligibility criteria: Inclusion Criteria:

* Men or women age 18-64.
* Present to ED primary for management of Low Back Pain (LBP)
* Functionally impairing back pain: A baseline score of greater than 5 on the Roland-Morris Disability Questionnaire
* Musculoskeletal etiology of low back.
* Non-radicular pain.
* Pain duration \<2 weeks (336 hours).
* Non-traumatic LBP
* Participant is to be discharged home.

Exclusion Criteria:

* Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.
* Not available for follow-up
* Pregnant
* Chronic pain syndrome
* Allergic to or intolerant of investigational medications
* Contra-indications to investigational medications

Primary outcomes:
measure: Change From Baseline to Day 5 in Functional Impairment
timeFrame: Baseline to 5 days
Secondary outcomes:
measure: Worst LBP 2 Days After ED Visit
timeFrame: 2 days after Emergency department visit
measure: Frequency of LBP 2 Days After ED Visit
timeFrame: 2 days after Emergency department visit
measure: How Often Participants Used Assigned Medication
timeFrame: 24 hours to 5 days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Eddie Irizarry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01886911: Games & Well-Being Study
Official title: Neural Correlates of Video Game Based Training to Foster Mindfulness and Prosocial Skills in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attentional Processing
Adolescent Behavior
Keywords: prosocial behavior
prosocial
attention training
attention
empathy
emotion recognition
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 192
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This project is focused on the neural and behavioral correlates of two different videos games that will be used as training tools. The two video games, developed by the Games Learning Society research group at the University of Wisconsin-Madison (UW) and the Wisconsin Institute for Discovery, are tailored to train mindfulness, particularly the regulation of attention; and prosocial behavior, especially sensitivity to others, in adolescents. This study will evaluate the hypothesis that systematic playing of mindfulness and prosocial games will change brain function in specific attentional, social and emotional circuits in potentially beneficial ways, and will impact performance on cognitive tasks of attention, and on measures of social cue perception and the propensity to share and behave altruistically. The investigators will employ behavioral and functional MRI-based neuroimaging measures to evaluate the investigators hypothesis.


Eligibility criteria: Inclusion Criteria:

* Fluent English speaker
* Enrolled in 7th or 8th grade

Exclusion Criteria:

* Currently on psychotropic medications

Primary outcomes:
measure: Change from baseline in behavioral measures
timeFrame: baseline and up to 3 weeks
measure: Change from baseline in fMRI
timeFrame: baseline and up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Richard Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patsenko EG, Adluru N, Birn RM, Stodola DE, Kral TRA, Farajian R, Flook L, Burghy CA, Steinkuehler C, Davidson RJ. Mindfulness video game improves connectivity of the fronto-parietal attentional network in adolescents: A multi-modal imaging study. Sci Rep. 2019 Dec 10;9(1):18667. doi: 10.1038/s41598-019-53393-x.
Clinical trial NCT02621411: Observational Study of Preoperative Screen for Substance Abuse
Official title: Preoperative Screen for Substance Abuse in Trauma Patients Undergoing Emergency Operation: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Screen for Substance Abuse in in Patients Undergoing Emergency Operation
Keywords: Substance abuse
Emergency operation
Preoperative screen
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 1031
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The trauma patients undergoing emergency operation

Brief summary: Substance abuse is a growing problem world wide, and treatment of substance abusers in the perioperative period, especially for emergency operation is challenging. The objectives of this study are to determine the proportions of substance abusers in the trauma patients undergoing emergency operation by preoperative screen, observe the differences of consumption of anesthetics and other medications during perioperative period between substance abusers and non-abusers, as well as postoperative complications, and explore an optimal scheme for substance abusers.


Eligibility criteria: Inclusion Criteria:

* Patients aged 16\~70 years；
* Informed consent signed

Exclusion Criteria:

* Aged\<16 years or \>70 years；
* Refuse to sign consent;
* Other conditions that may preclude the patients from the study, such as language barrier, psychiatric disorders, unable to attend research center for follow up.
* Patients who enrolled to another research study or are taking experimental medication in last 3 months prior to this study.
* Not suitable for the study, after assessment by the investigators.

Primary outcomes:
measure: Proportion of substance abuser in all the emergency operation patients
timeFrame: 1 year
Secondary outcomes:
measure: Perioperative consumption of medications
timeFrame: 1 day
measure: Incidence and severity of postoperative complications
timeFrame: 30 days
Other outcomes:
measure: Proportion of HIV, HCV, syphilis positive in substance abusers and non-abusers.
timeFrame: 1 day
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ren Liao, M.D.
role: STUDY_DIRECTOR
References: