louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01035489: Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum
Official title: Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure
Keywords: Pacemaker treatment in heart failure
Cardiac resynchronization therapy
DDD pacemakers
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we prospectively randomized the right ventricular lead placement to find evidence of differences in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements of reverse remodelling and dyssynchrony.


Eligibility criteria: Inclusion Criteria:

* CRT:

  * LVEF \< 35%
  * LVEDD \> 5.5 cm
  * NYHA 3-4
  * QRS \> 120 ms
  * Optimal medical treatment
  * Both CRT-pacemakers (CRT-P) and CRT combined with ICD (CRT-D)

Exclusion Criteria:

* Not fulfilling inclusion criteria or not written consensus

Primary outcomes:
measure: Echocardiographic reverse remodelling and dyssynchrony
timeFrame: 3, 6, 12, 18 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Faerestrand S
name: Svein Faerestrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. The impact of left ventricular lead position on left ventricular reverse remodelling and improvement in mechanical dyssynchrony in cardiac resynchronization therapy. Eur Heart J Cardiovasc Imaging. 2012 Dec;13(12):991-1000. doi: 10.1093/ehjci/jes114. Epub 2012 Jun 7.
citation: Kristiansen HM, Hovstad T, Vollan G, Keilegavlen H, Faerestrand S. Clinical implication of right ventricular to left ventricular interlead sensed electrical delay in cardiac resynchronization therapy. Europace. 2012 Jul;14(7):986-93. doi: 10.1093/europace/eur429. Epub 2012 Feb 2.
citation: Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. A randomized study of haemodynamic effects and left ventricular dyssynchrony in right ventricular apical vs. high posterior septal pacing in cardiac resynchronization therapy. Eur J Heart Fail. 2012 May;14(5):506-16. doi: 10.1093/eurjhf/hfr162. Epub 2012 Jan 26.
Clinical trial NCT01772589: Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration
Official title: Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration. A Randomized Controlled Study With Radiostereometric Analysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There have been considerable efforts to control rising health care costs. One of the more recent developments is the practice of reprocessing single use medical devices. This practice has been shown to provide considerable savings for health care payers. Medical devices have been reprocessed in a number of different medical fields including Orthopaedic Surgery. One of the devices that has been reprocessed are the Precision Saw Blades from Stryker Inc. These saw blades are used during Total Knee Arthroplasty (TKA) surgery. The reprocessed Precision saw blades are Health Canada approved and are available at Capital Health.

Beyond the benefits to the environment and cost savings, the investigators do not know if the reprocessed saw blades work better, work worse or the same as non reprocessed saw blades. This study is designed to determine if the reprocessed saw blades used during a TKA work as well as a new saw blade.


Eligibility criteria: Inclusion Criteria:

1. Symptomatic osteoarthritis of the knee indicating surgical intervention
2. Between the ages of 21 and 80 inclusive
3. Ability to give informed consent

Exclusion Criteria:

1. Significant co-morbidity affecting ability to ambulate
2. Flexion contracture greater than 15°
3. Extension lag greater than 10°
4. Tibial subluxation greater than 10 mm on standing AP radiograph
5. Prior arthroplasty, patellectomy or osteotomy with the affected knee
6. Lateral or medial collateral ligament instability (\> 10° varus/valgus)
7. Leg length discrepancy greater than 10 mm
8. Bone quality precluding uncemented fixation
9. Pregnancy
10. Active or prior infection
11. Morbid Obesity (BMI \> 40)
12. Medical condition precluding major surgery
13. Severe osteoporosis or osteopenia
14. Neuromuscular impairment

Primary outcomes:
measure: Implant migration
timeFrame: 2 years
Secondary outcomes:
measure: Economics
timeFrame: 1 year
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
Study officials:
affiliation: Capital Health, Canada
name: Glen Richardson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03085589: MOWI Amulet Mobile Health Technology Validation
Official title: Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development & Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: elderly
telemedicine
obesity
rural health
health promotion
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-03-21
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants screened and recruited primarily in local primary care setting (Department of Community and Family Medicine at Dartmouth Hitchcock Medical Center), as well as through other marketing channels such as posters and radio advertising. Community leaders and clinicians recruited by invitation from the principal investigator.

Brief summary: This study aims to adapt a mobile health device (Amulet) for use in older adults. It is the second in a series of four research studies whose overarching goal is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity who may or may not live in a rural area.


Eligibility criteria: Inclusion Criteria:

* Age 18-64; and Age≥65 years
* Body Mass Index (BMI) ≥ 30kg/m\^2 for those aged≥65 years
* Waist circumference ≥88cm in females or ≥102cm in male for those aged≥65 years

Exclusion Criteria for those aged ≥65 years:

* Severe mental or life-threatening illness
* Dementia
* Substance use
* History of bariatric surgery
* Suicidal ideation
* Unable to perform measures
* Reside in nursing home

Primary outcomes:
measure: Step Count Reliability
timeFrame: All outcomes of this Aim will take approximately 3 hours
measure: Strength Reliability
timeFrame: All outcomes of this Aim will take approximately 3 hours
measure: Sit-to-Stand Reliability
timeFrame: All outcomes of this Aim will take approximately 3 hours
measure: Activity Reliability
timeFrame: All outcomes of this Aim will take approximately 3 hours
Secondary outcomes:
measure: Satisfaction of Amulet
timeFrame: All outcomes of this Aim will take approximately 3 hours
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center / Dartmouth Medical School
name: John A Batsis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00714389: Uroflow Measurements in Healthy Volunteers
Official title: Uroflow Measurements in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Urogynecology
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urogynecology clinic

Brief summary: The goal of this study to determine normal values for certain urinary measurements in order to better understand voiding dysfunction in women.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers/employees
* Normal voiding function.
* Willing to participate.

Exclusion Criteria:

* Subjects currently receiving treatment for any lower urinary tract condition or having any voiding difficulty.

Primary outcomes:
measure: Voided Volume
timeFrame: March 2008
measure: Maximal Flow Rate
timeFrame: March 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Urogynecology and Reconstructive Pelvic Surgery Center
state: New York
Study officials:
affiliation: University of Rochester
name: Gunhilde Buchsbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00411489: Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
Official title: Use of a New Endosurgical Operating System for Endoscopic Stoma and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: USGI Medical
Sponsor class: INDUSTRY
First posted: 2006-12-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of the gastric pouch and/or stoma. A second surgical procedure to reduce the size of the pouch and/or stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure. This study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass.


Eligibility criteria: Inclusion Criteria:

* 18 yrs of age or older and \< 65 yrs of age
* At least 2 yrs post-Roux-En-Y gastric bypass surgery
* Initially achieved at least 50% weight loss
* At enrollment, has regain at least 15% of weight loss
* BMI 40 or greater or 35 or greater with one or more co-morbidities
* Stoma diameter at least 20 mm
* Completes successful nutritional screening
* Is a candidate for a surgical revision procedure
* Is a reasonable risk to undergo general anesthesia
* Completes successful cardiopulmonary evaluation
* ASA Classification of less than or equal to III
* Able to provide written consent
* Able to return for protocol-specified evaluations

Exclusion Criteria:

* Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments
* Previous bariatric revision procedure
* Has another causal factor for weight regain other than stoma or pouch dilatation
* Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program

Primary outcomes:
measure: weight loss
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia-Presbyterian Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Clinic
state: Oregon
Study officials:
affiliation: Oregon Clinic
name: Lee L Swanstrom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06785389: Influence of Preoperative Fear on Pain and Postoperative Outcomes
Official title: Influence of Preoperative Fear on Pain and Postoperative Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fear
Pain Management
Anxiety
Complications of Surgical Procedures or Medical Care
Keywords: preoperative fear
postoperative pain
postoperative outcomes
preoperative anxiety
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 103
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: All patients undergoing scheduled surgery with general anesthesia requiring hospital admission during the study period.

Brief summary: Fear of anesthesia plays a crucial role in the perioperative setting and can negatively affect recovery. The main objective is to assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery, as well as to relate preoperative anxiety to postoperative analgesic assessment in this population.

This is a prospective observational study including all patients scheduled for surger between January 20 and May 30, 2025

Detailed description: Fear is a response that arises in the face of immediate threats, such as medical procedures, while anxiety is related to uncertainty about treatment and prognosis. These factors can negatively affect recovery. Assessing anxiety levels using specific tools may be essential to predict clinical outcomes and facilitate patient recovery after surgery.

This prospective observational study will assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery. It will also relate preoperative anxiety to postoperative analgesic assessment in this population.

Disease or disorder under study: Fear of anesthesia and postoperative pain control using two preoperative questionnaires. Patients will be followed up until discharge to assess postoperative pain and postoperative outcomes. 103 patients scheduled for surgery between January 20 and May 30, 2025 will be included.

Eligibility criteria: Inclusion Criteria:

* All patients older than 18 years old scheduled for surgery with admission during the study period will be included.
* Verbal and written informed consent.

Exclusion Criteria:

* Minors
* Cognitive impairment
* Patients not being able to understand and respond to preoperative questionnaires
* Patients not being able to respond to postoperative pain assessment
* Patients not giving informed consent.

Primary outcomes:
measure: Postoperative pain using Nummerical Rating Scale
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00234689: Efficacy of Naltrexone Treatment as Augmentation to SSRI in OCD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-10-07
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Assessing the efficacy of Naltrexone as augmentation to SSRI in patients with OCD


Eligibility criteria: Inclusion Criteria:

* Diagnosis of OCD
* Treatment with SSRI for at least 10 weeks with no response

Exclusion Criteria:

* Suffering from any medical condition
* treatment with opiates
* chronic use of drugs
* Hepatitis or other liver related diseases
* Incapability to sign an informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Tel Aviv University
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: Revital Amiaz, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04061889: Clinical Epidemiology Cohort Study for Patient Living With HIV
Official title: Clinical Epidemiology Cohort Study for Patient Living With HIV
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1 Infection
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 infected adult

Brief summary: This is a retrospective observational cohort study for the patient living with HIV aiming to understand more in disease progress, resistant mutation, comorbidity, and common coinfection.


Eligibility criteria: Inclusion Criteria:

* Patient living with HIV receiving follow-up in Kaohsiung VGH

Exclusion Criteria:

* not applicable

Primary outcomes:
measure: Hazard ratio of cohort epidemiology characteristics in treatment failure, renal failure and hepatitis D coinfection
timeFrame: on average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veteran General Hospital
state: Kaohsiung City
Study officials:
affiliation: Kaohsiung Veteran General Hospital
name: Hung Chin Tsai, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02202889: Improving Bone Health in Adolescence Through Targeted Behavioral Intervention
Official title: Improving Bone Health in Adolescence Through Targeted Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Development
Dietary Adequacy
Keywords: Adolescents
Bone mass
Calcium
Perceived milk intolerance
lactose maldigestion
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: University of Hawaii
name: Arizona State University
name: University of California, Davis
name: University of Nevada, Las Vegas
name: Ohio State University
name: Southern Illinois University
First posted: 2014-07-29
Enrollment: 848
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: School based educational intervention to educate on bone health among Hispanic, Asian or non-Hispanic white girls between 10-13 years with end points of knowledge gained, calcium intake and bone density in . The hypothesis was that the educational program would increase knowledge, improve dairy food and calcium consumption and enhance bone health in this population. A secondary hypothesis was that lactose maldigestion would be an impediment to improved dairy food consumption.

Detailed description: A targeted behavioral intervention to improve calcium intake and bone mass was conducted at middle schools in 6 states. The primary outcomes of bone mass and dietary calcium were assessed among Asian, Hispanic, or non-Hispanic white girls between 10 -13 y. Lactose maldigestion (LM) was determined by a breath hydrogen test (BHT). Perceived milk intolerance (PMI) and calcium intake were assessed by questionnaires and bone mineral content (BMC) was determined by dual energy X-ray absorptiometry (DXA). Data from 473 girls were used in a multiple linear regression to examine the impact of the intervention while accounting for PMI and LM and adjusting for covariates.

Eligibility criteria: Inclusion Criteria:

Middle schools within one-hour driving time of one of the designated DXA measurement sites were eligible to participate in ACT if their student population had a higher proportion of Asian or Hispanic students than the respective state's average. - Girls recruited for evaluation measures were limited to those being at least 75% Asian, Hispanic or non-Hispanic White based on the race/ethnicity of their biological parents.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Bone Mineral Content
timeFrame: 18 months
measure: Dietary Calcium
timeFrame: 18 months
Secondary outcomes:
measure: Lactose maldigestion
timeFrame: Baseline
Other outcomes:
measure: Perceived lactose intolerance
timeFrame: Baseline
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Dennis Savaiano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hawaii
name: Carol Boushey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01693289: Study to Compare Between Combimed Metformin-letrozole and Ovarian Drilling in Pcos With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome
Official title: Phase 1 Study of Efficacy of Combined Metformin-letrozole in Comparison With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Focus of Study
Keywords: Metformin
letrozole
ovarian drilling
clomiphene resistance
polycystic ovary.
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2012-09-26
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study compare the hormonal-metabolic and reproductive outcome between combined metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic syndrome


Eligibility criteria: Inclusion Criteria:

* polycystic ovary syndrome
* infertility
* clomiphene citrate resistance

Exclusion Criteria:

* women with other causes of infertility as male factor or tubal factor, those with endocrine disorders as thyroid dysfunction and hyperprolactinemia women who received hormonal treatment or ovulation induction drugs 3 months prior to the study
* pregnancy during follow up

Primary outcomes:
measure: hormonal and metabolic changes
timeFrame: 6 months
Secondary outcomes:
measure: reproductive outcome
timeFrame: 6months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
References: