louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01171950: CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
Official title: CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Keywords: Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Corporation
First posted: 2010-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.


Eligibility criteria: Inclusion Criteria:

1. Age 5 years to 16 years, inclusive
2. Inability to wean from cardiopulmonary bypass (CPB)

Exclusion Criteria:

1. Body weight \< 20 kg
2. Severe aortic insufficiency
3. Unrestricted intra-cardiac communications (i.e. large VSD)
4. Pulmonary vascular resistance index (PVRI) \> 10 IU
5. Presence of DIC
6. On hemodialysis (excluding hemofiltration)
7. Contraindications to systemic anticoagulation
8. Active systemic infection unresponsive to antibiotics
9. Unresolved malignancy
10. On other investigational VAS

Primary outcomes:
measure: Survival
timeFrame: 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant
Secondary outcomes:
measure: Evaluation of end-organ function
timeFrame: 30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant
Other outcomes:
Locations:
Study officials:
affiliation: Thoratec Corporation/Abbott
name: Pooja Chatterjee
role: STUDY_DIRECTOR
References:
Clinical trial NCT06326450: Traditional In-Person Vs. Remote AR Clinical Simulation
Official title: Traditional In-Person Vs. Remote AR Clinical Simulation: A Non-Inferiority, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a non-inferiority, international, controlled trial that aims to evaluate the progression of physicians and residents through an Advanced Cardiac Life Support (ACLS) clinical simulated scenario. The study's primary objective is to compare the performance outcomes between two groups: participants in the traditional in-person simulation and those immersed in the Augmented Reality (AR) scenario


Eligibility criteria: Inclusion Criteria:

* Brazilian resident

Exclusion Criteria:

* a history of severe motion sickness
* currently have nausea
* a history of seizures
* wear corrective glasses.

Primary outcomes:
measure: Progression through the ACLS clinical simulation demonstrated by NTS and TS
timeFrame: immediately after simulation
Secondary outcomes:
measure: Demonstration of NTS during ACLS scenario
timeFrame: immediately after simulation
measure: Evaluation of the AR system's usability
timeFrame: immediately after simulation
measure: Exploration of perceptions, attitudes, and opinions of the AR simulation participants
timeFrame: immediately after simulation
measure: Evaluation of the AR system's ergonomics
timeFrame: immediately after simulation
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Parkard Children's Hospital
state: California
Study officials:
References:
Clinical trial NCT04931550: Clinical Study of Impact of Different Pacing Site in Patients
Official title: Clinical Study of Impact of Different Pacing Site in Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bradyarrhythmias
Heart Failure
Pacemaker
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: According to the current reports and the researcher's pacing implantation status, with an enrollment rate of 90% and a loss of follow-up rate of 10%, it is estimated that 600 cases were screened, 540 cases were selected, and about 500 cases were effective.

Brief summary: At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients. With the rapid development of technology, different sites can be chosen to pace, such as right atrial appendage, the atrial septum and the right atrial wall in the atrium, His bundle, left bundle branch area, right ventricular apex, outflow tract, and left ventricular pacing via coronary vein in the ventricle. There are few studies comparing the long-term efficacy and safety of different pacing sites in daily practice. This study aims to observe the efficacy and safety of cardiac pacing at different sites in short and long term, and to compare the advantages and disadvantages of pacing at different sites.


Eligibility criteria: Inclusion Criteria:

* Patients who received pacemaker implantation in the Second Hospital of Zhejiang Medical University by Pan Xiaohong and other surgeons.
* Patients who have the ability to understand the test and can cooperate with investigators.

Exclusion Criteria:

* Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors.

Primary outcomes:
measure: Composite of Cardiovascular death, myocardial infarction, and stroke events
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
References:
Clinical trial NCT03188250: Chama Cha MamaToto: a Pilot Study of Peer Support Groups in Kenya
Official title: Increasing Pregnancy Health Services Uptake Through Integrated Peer Support Groups in Kenya: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Group, Peer
Lead sponsor: Moi University
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: University of Toronto
First posted: 2017-06-15
Enrollment: 515
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Preventing maternal and newborn deaths remain high on the global agenda. To address this, the Academic Model Providing Access to Healthcare (AMPATH), in partnership with the Government of Kenya, launched Chama cha MamaToto, a community-led peer-support model that groups women together in pregnancy and infancy. Central to the chama approach is the integration of health, social and financial literacy education with a savings/loans program.

Detailed description: To evaluate the feasibility of chamas, we analysed group attendance rates, GISE participation, membership retention, and continuation of the groups beyond the one year. To evaluate the effect of chamas, the investigators compared data from a prospective cohort of women in chamas with a group of controls who did not belong to a chama, matched for age, parity, and location of prenatal care. To evaluate the acceptability of chamas, FGDs were carried out with chama and non-chama participants, health providers and community health workers.

Eligibility criteria: Inclusion Criteria:

* Pregnant women in communities where chamas were taking place
* Any woman attending chama

Exclusion Criteria:

-

Primary outcomes:
measure: Facility delivery
timeFrame: 22 months
Secondary outcomes:
measure: 4 ANC visits
timeFrame: 22 months
measure: CHV homevisit
timeFrame: 22 months
measure: Exclusive breastfeeding
timeFrame: 22 months
Other outcomes:
Locations:
Study officials:
affiliation: Moi University
name: Astrid Christoffersen-Deb, MDCM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maldonado LY, Songok JJ, Snelgrove JW, Ochieng CB, Chelagat S, Ikemeri JE, Okwanyi MA, Cole DC, Ruhl LJ, Christoffersen-Deb A. Promoting positive maternal, newborn, and child health behaviors through a group-based health education and microfinance program: a prospective matched cohort study in western Kenya. BMC Pregnancy Childbirth. 2020 May 12;20(1):288. doi: 10.1186/s12884-020-02978-w.
Clinical trial NCT00277550: The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia
Official title: A Randomized, Double-blind, Placebo-controlled Evaluation of the Effects of Tegaserod (6 mg b.i.d) on Whole Gut Transit Time in Patients With Chronic Idiopathic Constipation and Dyspepsia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Constipation and Dyspepsia
Keywords: Constipation, Tegaserod, Dyspepsia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2006-01-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia


Eligibility criteria: Inclusion Criteria:

* Females aged 18 to 64 years of age
* Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:

  1. Less than 3 bowel movements per week
  2. Hard or lumpy stools
  3. Straining during bowel movements
  4. Feeling of incomplete evacuation
* Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating

Exclusion Criteria:

* Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives
* Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians
* Patients with constipation secondary to medication use as determined by the study physician
* Patients with clinically significant abnormal TSH levels at screening
* Patients that have heartburn or abdominal pain as their predominant GI symptom
* Evidence of cathartic colon or a history of laxative abuse

  * Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
Secondary outcomes:
measure: To evaluate the PD effects of tegaserod on upper & lower GI transit
measure: To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Nicholas Talley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Michael Crowell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02063750: Strengthening Exercises for Fibromyalgia
Official title: Effectiveness of Strengthening Exercises Using the Swiss Ball for Patients With Fibromyalgia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Muscle strength exercises
Pain
Quality of life
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in patients with fibromyalgia (FM).

Material and Method: Sixty FM patients were randomized into two groups: an intervention group (IG), in which patients performed muscle strength exercises using the Swiss ball, and a stretching group (SG), in which patients performed stretching exercises. All patients participated in 40-minute training sessions three times per week for 12 weeks. The IG performed the following eight strengthening exercises using a Swiss ball: lateral rise, simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row, reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1 repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The assessor was blind to patient allocation.


Eligibility criteria: Inclusion Criteria:

* female with fibromyalgia according to the classification criteria of the American College of Rheumatology;
* aged between 20 and 65 years old.

Exclusion Criteria:

* uncontrolled hypertension;
* decompensated cardiac disease;
* history of syncope or exercise-induced arrhythmias and decompensated diabetes;
* severe psychiatric illness;
* history of regular exercise at least twice a week for the last 6 months;
* any other condition that could prevent the patient from performing physical exercises.

Primary outcomes:
measure: Changes in Pain - VAS
timeFrame: Basline, after 6 and 12 weeks
Secondary outcomes:
measure: Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire
timeFrame: Baseline, after 6 and 12 weeks
measure: Changes in muscle strength using the maximum repetition (1 RM)
timeFrame: Baseline, after 6 and 12 weeks
measure: Changes in consumption of analgesics
timeFrame: After 6 and 12 weeks from baseline
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
References:
Clinical trial NCT02975050: Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
Official title: Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Volunteer Validation Study
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: This study has the following objective:

• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.

The μ-Cor validation will be demonstrated at two body locations:

1. Side location (below left armpit) for study arm 1, and
2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

Detailed description: This study has the following objective:

• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.

The μ-Cor validation will be demonstrated at two body locations:

1. Side location (below left armpit) for study arm 1, and
2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 21 years of age or older.
* Subject is willing and able to sign the Informed Consent Form.
* Subject is healthy, able and willing to complete all the preparation steps and study procedures.

Exclusion Criteria

* Female subject with a known pregnancy or unsure about pregnancy status.
* Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
* Subjects with skin breakdown in areas where device placement is required.
* Subjects with chronic lung disease or asthma.
* Subjects with a history of cardiovascular diseases.
* Subjects who are diabetic.
* Subjects living with kidney failure or dialysis.
* Subjects with a history of liver failure.
* Subjects with any known malignancy (i.e. cancer patients).
* Subjects with implanted devices in the thoracic region

Primary outcomes:
measure: Respiratory rate
timeFrame: Immediately
measure: Posture
timeFrame: Immediately
measure: Activity
timeFrame: Immediately
measure: Heart Rate
timeFrame: Immediately
measure: ECG
timeFrame: Immediately
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05087550: Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
Official title: Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant
Keywords: Organ Procurement and Transplant Network (OPTN)
Liver Allocation Policy
Lead sponsor: Methodist Health System
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2021-10-21
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Data from patients who underwent liver transplantation between February 4th, 2019 - February 4th, 2020, and February 5th, 2020 - February 5th, 2021 will be included in the study.

Brief summary: Organ procurement organizations (OPO) have increased organ recovery efficiency and yield and have also reduced organ acquisition charges. The new liver allocation policy came into effect in February 2020 and aims to increase access to organs for waitlist candidates with the greatest severity of illness. The urgent change was driven by the perception that patients were dying because of arbitrary boundaries and inequitable access. Critics of the new policy have highlighted the potential cost implications particularly at an OPO level. A study of five OPOs throughout the United States highlighted an increase in costs ranging from 43% - 206% despite the same volume of livers transplanted. The main reason for the cost appears to lie in organ handling and transport. This mirrors the findings of Puri and colleagues who acknowledged changes to lung transplantation at Barnes Jewish Hospital in the pre- and post-policy eras and reported a substantial decline in local donors. The new lung system has also resulted in a higher organ discard rate and ultimately higher costs. Such data has generated meaningful discussions regarding optimizing organ allocation polices, however, data from individual transplant centers is lacking in the literature. Changes at a transplant center level relating to recipient costs are likely impacted by the new policy, which could be related to patient travel, accommodation, work up etc.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Underwent liver transplantation at MDMC between February 4th 2019 - February 4th 2020 and February 5th 2020 - February 5th 2021

Exclusion Criteria:

* Below 18 years of age
* Did not undergo liver transplantation

Primary outcomes:
measure: Liver transplant volume
timeFrame: 02/04/2019 - 02/05/2021
measure: Cost
timeFrame: 02/04/2019 - 02/05/2021
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Alejandro Mejia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01348750: Healing Touch & Guided Imagery for Posttraumatic Stress Disorder Symptoms
Official title: Healing Touch and Guided Imagery Intervention in Post-deployment Military Personnel With Posttraumatic Stress Disorder Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD
Healing Touch
Guided Imagery
Military
Complementary Medicine
Lead sponsor: Scripps Center for Integrative Medicine
Sponsor class: OTHER
Collaborators: name: Marine Corps Base Camp Pendleton
First posted: 2011-05-05
Enrollment: 123
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: This is a randomized controlled 2 year trial at Camp Pendleton, CA to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery, HT+GI) reduces Posttraumatic Stress Disorder (PTSD) symptoms as compared to treatment as usual (TAU) in returning combat-exposed active duty military with significant PTSD symptoms. Secondary aims will evaluate the effect of HT and GI on measures of depression, hostility, and general health status in this population.

Detailed description: The study enrolled 123 active duty subjects from the Marine Corps Base Camp Pendleton in Southern California with at least one or more symptoms of PTSD .

Eligibility criteria: Inclusion Criteria:

1. Female or male subjects 18 years or older
2. Post-deployment from a combat zone
3. Identified by post-deployment health re-assessment to have PTSD symptoms
4. Referred by Camp Pendleton
5. Subjects who are willing to sign a consent
6. Subjects who are willing to participate for the length of the study

Exclusions:

1. Female subjects who are now pregnant or nursing
2. Subjects who are receiving healing touch or using guided imagery from other sources
3. Subjects who have any major health condition that may interfere with participating in this study

Primary outcomes:
measure: 17-item PTSD Checklist (Military)is used to determine the effect of the intervention
timeFrame: After 6 treatments of healing touch and guided imagery
Secondary outcomes:
measure: Depression (Beck Depression Inventory)
timeFrame: After 6 treatments of healing touch and guided imagery
measure: Quality of Life (SF36)
timeFrame: After 6 treatments of healing touch and guided imagery
measure: Hostility (Cook-Medley Hostility Inventory)
timeFrame: After 6 treatments of healing touch and guided
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Center for Integrative Medicine
state: California
Study officials:
affiliation: Scripps Center for Integrative Medicine
name: Erminia M Guarneri, MD
role: PRINCIPAL_INVESTIGATOR
References: