louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00281749: Telephone Call From Acute Care Physicians to Long Term Care Physicians: Impact on Transitional Care of Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Parkinson Disease
Dysphagia
Keywords: ALZHEIMER'S D-SE
PARKINSON'S D-SE
FRAILTY
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2006-01-25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A telephone call from a physician taking care of a patient in the hospital to a physician in the long term care setting at the time of discharge can improve transitional care for elderly patients. We believe direct communication between physicians can reduce re-hospitalizations, medication errors, morbidity and mortality. No studies have been done that involve physician-to-physician sign-outs after hospital discharge to the nursing home. In our study, we would like to address the breakdown in the transfer of information to the nursing home setting.


Eligibility criteria: Inclusion Criteria:

* patients transitioning from the Acute Care for The Elderly (ACE) Unit patients at Maimonides Medical Center to Metropolitan Jewish Geriatric Center (MJGC).

Exclusion Criteria:

* AGE BELOW 65

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonide Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: SERGEY I GENKIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01274949: The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i
Official title: The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy Severe ED Patients Not Responding to Oral Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: LI-ESWT
Erectile Dysfunction
Radical Prostatectomy
Non PDE5 inhibitor responders
Shock wave
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Medispec
First posted: 2011-01-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.

Detailed description: We included severe ED patients that underwent radical prostatectomy at least one year previously and failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy. Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. This study further emphasises the need to study specific populations with unique etiologies causing ED.

Eligibility criteria: Inclusion Criteria:

* Post Radical prostatectomy
* ED of more than 6 months
* Rigidity score ≤ 2 during PDE5i therapy
* Stable heterosexual relationship for more than 3 months
* Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .

Exclusion Criteria:

* Prior surgery or radiotherapy in pelvic region
* Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Cardiovascular conditions that prevent sexual activity

Primary outcomes:
measure: IIEF-ED Domain score
timeFrame: 17 weeks after first visit
Secondary outcomes:
measure: Rigidity scale
timeFrame: 17 weeks after first visit
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: neuro-urology unit, Rambam Medical Center
Study officials:
affiliation: Rambam Medical Investigator
name: Ilan Gruenwald, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04411849: Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in Appalachia
Official title: A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening Among Women in Appalachia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Carcinoma
Human Papillomavirus Infection
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-02
Enrollment: 802
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.

Detailed description: PRIMARY OBJECTIVES:

Determine the effectiveness of the intervention in increasing cervical cancer screening.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation.

GROUP II: Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

Eligibility criteria: Inclusion Criteria:

* Not within recommended cervical cancer screening guidelines for women in this age range (i.e., no Papanicolaou \[Pap\] test in last 3 years or no Pap test plus clinic-based HPV test in last 5 years)
* Resident of an Appalachian county
* Not currently pregnant
* Intact cervix
* No history of invasive cervical cancer
* Seen in a participating clinic/health system in last 2 years (i.e., active patient)
* Have a working telephone

Primary outcomes:
measure: Effectiveness of Human Papillomavirus (HPV) Intervention
timeFrame: Up to 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky/Markey Cancer Center
state: Kentucky
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Paul Reiter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02421549: Remote Interrogation in Rural Emergency Departments
Official title: Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Heart Disease
Cardiovascular Disease
Heart Failure
Arrhythmias, Cardiac
Keywords: Remote Monitoring
Remote Care
Cardiac Resynchronization Therapy
Pacemaker
Implantable Cardioverter Defibrillator
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The purpose of the study is to determine if utilization of remote monitoring technology in a rural emergency department may improve patient care.

Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in the remote monitoring group comprised of patients with SJM devices compatible with the unpaired transmitter and 100 patients will be in the usual medical care group comprised of patients with SJM devices that are not compatible with the unpaired transmitter or that have a competitor's device.


Eligibility criteria: Inclusion Criteria:

1. Presents to Emergency Department with an implanted pacemaker or defibrillator.
2. Are 18 years of age or older.
3. Are willing and able to provide informed consent for study participation.
4. Are willing and able to complete a 30-60 day follow up phone call.

Exclusion Criteria:

1. Are unwilling to provide written informed consent.

Primary outcomes:
measure: Time to Clinical Specialist Treatment Decision
timeFrame: 1 day
Secondary outcomes:
measure: Health Care Utilization Rate
timeFrame: Within 30 days of initial ED visit
Other outcomes:
measure: Time to Device Interrogation
timeFrame: 1 day
Locations:
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
Study officials:
affiliation: New Mexico Heart Institute, PA
name: Ross Downey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03426449: Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure
Official title: Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fissure
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence.

Detailed description: The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence. We hypothesized that performing internal sphincterotomy in a point midway between the standard lateral position and the posterior midline position would confer better healing and relief of symptoms with less incidence of fecal incontinence while avoiding the development of keyhole deformity.

Eligibility criteria: Inclusion Criteria:

* Adult patients of both genders with chronic posterior anal fissure were included to the study.

Exclusion Criteria:

* Patients with anterior or lateral anal fissure,
* patients with previous anal surgery,
* patients with concomitant anorectal pathology,
* patients with secondary anal fissure due to Crohn's disease or other specific etiology,
* patients with any degree of fecal incontinence,
* patients with active anorectal sepsis.

Primary outcomes:
measure: Duration of healing
timeFrame: 6-8 weeks after surgery
Secondary outcomes:
measure: Anal pain
timeFrame: 1-6 weeks after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alawady M, Emile SH, Abdelnaby M, Elbanna H, Farid M. Posterolateral versus lateral internal anal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. Int J Colorectal Dis. 2018 Oct;33(10):1461-1467. doi: 10.1007/s00384-018-3087-6. Epub 2018 May 19.
Clinical trial NCT02088749: Comparison of Weight Management Programs Delivered in Large Versus Small Groups
Official title: Comparison of Weight Management Programs Delivered in Large Versus Small Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
weight loss
treatment
lifestyle
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the 6- and 12-month weight changes associated with lifestyle interventions delivered in a large group or small groups of participants. It is hypothesized that participants receiving treatment in a small group will have greater weight loss than those assigned to a larger group.


Eligibility criteria: Inclusion Criteria:

* at least 21 years-old
* body mass index (BMI) between 30-45

Exclusion Criteria:

* have lost \>4.5 kg in past six months
* have medical condition(s) likely to affect ability to participate in physical activity
* planning to relocate from the area in next 12 months
* unable or unwilling to attend weekly group sessions
* unwilling to accept random assignment

Primary outcomes:
measure: change in body weight from baseline to months 6 and 12
timeFrame: baseline, month 6, month 12
Secondary outcomes:
measure: treatment attendance
timeFrame: 12 months
measure: treatment adherence
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: University of Alabama at Birmingham
name: Gareth Dutton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01932749: The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression
Official title: The Comparison of Effectiveness of Bilateral rTMS Versus Unilateral TMS in Patients With Bipolar Depression: a Study Randomized and Single Blind
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: University of Tehran
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of repetitive TMS in reduction of depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety symptoms and quality of life will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test). QEEG apply before and after rTMS in all subjects.


Eligibility criteria: Inclusion Criteria:

1. Outpatients male and female with the range of 18-65 years of age
2. The diagnosis of Bipolar disorder according to DSM-IV-TR
3. Completion of consent form
4. Being under supervision of a psychiatrist,
5. Having BDI\>14
6. Being able to adhere to treatment schedule,
7. Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks .

Exclusion Criteria:

1. The history of rTMS treatment for any reason
2. Intracranial implant and other ferromagnetic materials close to the head
3. Cardiac pacemaker
4. Drug pumps
5. The risk of seizure with any reasons
6. High intracranial pressure
7. The history of epilepsy or seizure in the first relatives
8. Any metal in head
9. Pregnancy
10. Breastfeeding
11. High risk of suicide 12 Having personality disorder in axis II

Primary outcomes:
measure: Change in depression severity.Depression will be assessed using the Beck depression inventory
timeFrame: Baseline to four weeks
Secondary outcomes:
measure: Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory.
timeFrame: Test Day 1, 10 & 20
measure: Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF)
timeFrame: Test Day 1, 10& 20
measure: Change in QEEG and low resolution brain electromagnetic tomography (LORETA)
timeFrame: Before treatment, immediately after treatment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Atieh neuroscience center
Study officials:
References:
Clinical trial NCT00723749: Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
Official title: Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Data From a Real Life Scenario.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-Related Disorders
Opiate Dependence
Drug Abuse
Keywords: Suboxone
Subutex
Buprenorphine
Naloxone
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 384
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Opioid-dependent patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.

Brief summary: The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.

Detailed description: Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned and indicated.

Eligibility criteria: Inclusion Criteria:

* Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.

Exclusion Criteria:

* In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.

Primary outcomes:
measure: Retention Rate After 12 Months of Treatment With Suboxone
timeFrame: 12 months
Secondary outcomes:
measure: Dosage of SUBOXONE®
timeFrame: Day 1 and Final Assessment (month 12 or time of dropout)
measure: Take Home Prescriptions of SUBOXONE®
timeFrame: Day 1 and Final Assessment (month 12 or time of dropout)
measure: Drug Craving (Subjective Effects of Therapy)
timeFrame: Baseline and Final Assessment (month 12 or time of dropout)
Other outcomes:
Locations:
Study officials:
affiliation: Praxiszentrum im Tal (pit), Munich (Germany)
name: Markus Backmund, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05869149: Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial
Official title: Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Eating Index
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: George Washington University
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-05-22
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Working with independently owned restaurants, a common source of calorie-rich, nutrient-poor foods in predominantly minority, low-income urban neighborhoods, has the potential to improve dietary quality, and contribute to cancer prevention. This study uses systems science approaches to improve access to healthier foods in independently owned restaurants by: 1) testing the effects of a novel intervention called FRESH (Focus on Restaurant Engagement to Strengthen Health) on dietary quality, health indicators and other outcomes in African American and Latin communities, and 2) developing a system dynamics model to allow stakeholders to virtually test FRESH strategies in their own communities. The resulting restaurant intervention simulation model offers potential cost savings from avoided trial-and-error testing, and will support community-based cancer prevention.


Eligibility criteria: Inclusion Criteria:

* Adult (18-75 years)
* Regular restaurant customer (e.g., visits the specified restaurant at least 1x/week)
* Live in a household of at least 2 persons (criterion intended to provide a more stable sample, and to reduce loss to follow-up)
* Current resident of study neighborhood

Exclusion Criteria:

* Anticipate moving out of Baltimore or District of Columbia metropolitan area in the next 18 months
* Pregnant (due to changes in diet, weight and body composition)

Primary outcomes:
measure: Change in Customer Dietary Quality
timeFrame: 1 hour, 24 months apart
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Joel Gittlesohn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02935049: Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique
Official title: Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Adenoma
Intramucinous Adenocarcinoma
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 120
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 colorectal adenoma or intramucinous adenocarcinoma

Brief summary: For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection)


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years,
* Patient with colorectal adenoma or intramucinous adenocarcinoma

Exclusion Criteria:

* Contraindication surgery

Primary outcomes:
measure: Relapse rate
timeFrame: From surgery to 1 year
Secondary outcomes:
measure: Complications rate
timeFrame: From surgery to 6 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: GENRE
Study officials:
affiliation: Institut Paoli-Calmettes
name: RATONE Jean Philippe, MD
role: PRINCIPAL_INVESTIGATOR
References: