louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00223340: The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care
Official title: Diabetes and Cardiovascular Risks in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: patient activation
primary care
diabetes
cardiovascular risk
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The purpose of this pilot study is to collect preliminary information about the best way to implement an intervention to reduce the risks of heart disease and stroke.

Detailed description: This study has two types of interventions. The clinics and patients are randomly assigned to either a control or intervention group. All clinics have both control and intervention patients. In the clinic intervention, we help doctors monitor patient information about the risk factors of heart disease and stroke. In the patient intervention, we contact patients by phone to discuss these risk factors before their doctor visits.

Eligibility criteria: Inclusion Criteria:

* Patient must be diagnosed with diabetes for at least 12 months.
* Patient must be with current physician for at least 12 months.
* Study staff must be able to reach patient by telephone.

Exclusion Criteria:

* Pregnant women are excluded.

Primary outcomes:
measure: Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke
Secondary outcomes:
measure: Patient Outcome Measures: Hemoglobin A1c (HbA1c), lipids (low-density lipoprotein [LDL] non-high-density lipoprotein [HDL] triglycerides), blood pressure
measure: Patient assessed health status, diabetes self-care activities and knowledge of cardiovascular (CV) risk factors
measure: Physician Outcome Measures: Physician knowledge, attitude and readiness to change practice; Physician-level measure of patient-centeredness of encounter and interpersonal communication
measure: Assessment of Chronic Illness Care (ACIC) Surveys
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio (Texas)
state: Texas
Study officials:
affiliation: Univ. of Texas Health Science Center at San Antonio
name: Michael L Parchman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04079140: Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion
Official title: Benefits of Self-administered Vaginal Dinoprostone Administration 12 Hours Prior to Intrauterine Device Insertion in Adolescent and Young Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IUD Insertion Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

Detailed description: Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria: Inclusion Criteria:

* nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device

Exclusion Criteria:

* pregnancy and contraindication or allergy to dinoprostone or contraindication to IUD insertion, chronic pelvic pain,pelvic inflammatory disease,analgesic intake 24 hours prior to IUD insertion.

Primary outcomes:
measure: The difference in pain scores during intrauterine device insertion
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of medicine Cairo university
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219440: A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
Official title: A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.

Detailed description: A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial

1. ACTOS plus a standard diet
2. ACTOS plus a portion-controlled diet
3. Metformin plus a standard diet. The end-point of the trial is the change in body fat content from baseline to the end of the trial

Eligibility criteria: Inclusion Criteria:

* Men and women age 35 to 75 who have type 2 diabetes mellitus

Exclusion Criteria:

* Individuals with co-existing other diseases

Primary outcomes:
measure: glucose
timeFrame: 4 months
Secondary outcomes:
measure: Change in lipids
timeFrame: 4 months
measure: blood pressure
timeFrame: 4 months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Center
state: Louisiana
Study officials:
affiliation: Pennington Center
name: George A Bray, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin CK, Gupta AK, Smith SR, Greenway FL, Han H, Bray GA. Effect of pioglitazone on energy intake and ghrelin in diabetic patients. Diabetes Care. 2010 Apr;33(4):742-4. doi: 10.2337/dc09-1600. Epub 2010 Jan 12.
citation: Gupta AK, Smith SR, Greenway FL, Bray GA. Pioglitazone treatment in type 2 diabetes mellitus when combined with portion control diet modifies the metabolic syndrome. Diabetes Obes Metab. 2009 Apr;11(4):330-7. doi: 10.1111/j.1463-1326.2008.00965.x.
Clinical trial NCT03947840: Physical Activity and Its Impact on Colon Cancer Surgery
Official title: Physical Activity and Its Impact on Colon Cancer Surgery: Clinical and Histological Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Physical Activity
Keywords: Colon cancer
Physical activity
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Västerbotten County Council, Sweden
First posted: 2019-05-13
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are going to surgery due to colon cancer.

Brief summary: This is a prospective clinical study that studies how the physical activity level before operation of colon cancer affects the outcome of complication and histology.

The hypothesis is that patients who are more physical active have less postoperative complications and different histological immunological response around the tumor.

The investigators are testing the patients before the surgery with physical tests for fitness, strength and physical activity level. Questionnaires are also filled by the patients for pain, anxiety, depression and motivation for life style changes. Their body mass is analyzed with a DEXA (Dual-energy X-ray absorptiometry scan).

For one years the investigators are monitoring their activity and follow up for physical tests, DEXA and questionnaires is at 6 and 12 months.

The histology is analyzed after surgery to se if there is a different immunological response around the tumor.


Eligibility criteria: Inclusion Criteria:

* 18 years.
* Colon cancer which is going to surgery

Exclusion Criteria:

* Not able to do physical tests
* Severe disease that makes a risk to do tests.
* Not able to make informed consent due to psychic disease or dementia

Primary outcomes:
measure: Number of postoperative complications
timeFrame: 1 year
measure: Rate of immunological response
timeFrame: 1 year
Secondary outcomes:
measure: Rate of recovery in physical activity
timeFrame: 1 year
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Region Vasterbotten, centre of surgery
state: Vasterbotten
Study officials:
affiliation: Umeå Universitet
name: Karin Strigård
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04799340: Computer-based Training of Face Recollection to Improve Face Recognition in Developmental Prosopagnosia
Official title: Characterizing and Remediating Recollection-specific Face Recognition Deficits in Developmental Prosopagnosia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Prosopagnosia
Lead sponsor: Boston VA Research Institute, Inc.
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effectiveness of a cognitive training intervention targeting face recollection, repetition lag training, at improving face recognition in Developmental Prosopagnosia.


Eligibility criteria: Inclusion Criteria:

Developmental prosopagnosic participants will be included if they are...

* aged 18-90,
* have lifelong histories of face recognition difficulties that impact their everyday life (i.e., not associated with some event such as a stroke, seizure, etc)
* score significantly below the mean on the famous faces test and Cambridge Face Memory Test

Exclusion Criteria:

Participants will be excluded from the study if they...

* have a history of a significant neurological disorder including hydrocephalus, stroke, moderate to severe traumatic brain injury (TBI), severe neuromuscular diseases, or severe hypoxia due to cardiac arrest.
* have impairments that interfere with cognitive performance, such as uncorrected hearing or vision, lack of English proficiency, musculoskeletal or other issues
* have psychiatric disorders, such as schizophrenia, major depressive disorder, bipolar disorder, chronic intractable obsessive-compulsive disorder, or agoraphobia.
* We will exclude individuals who are currently dependent on alcohol or other substances, as this may negatively impact cognitive performance.
* We will exclude participants who currently are, or within the last 6 months, participating in a behavioral or pharmacological intervention.
* Patients with a history of mild TBI or simple concussion will not be excluded as long as it was \> 6 months ago and as long as they have not had repeated concussions (\>5)
* We will include individuals with a diagnosis of ADHD as long as their medication has been consistent for the past 6 months.

Primary outcomes:
measure: Cambridge Face Memory Test
timeFrame: 15 minutes
measure: Face Recollection
timeFrame: 15 minutes
measure: Face Perception
timeFrame: 30 minutes
Secondary outcomes:
measure: Self-reported face recognition
timeFrame: 5 minutes
measure: Face-name learning task
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System, 150 S. Huntington Ave.
state: Massachusetts
Study officials:
References:
Clinical trial NCT04203940: Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair
Official title: Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 40
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: Because it avoids direct nerve irritation or entrapment, mesh fixation with tissue adhesive glue seems an optimal option to reduce postoperative pain. Indeed, preliminary results published with different glues all showed promising results with reduced postoperative pain.

This randomized controlled study aimed to compare mesh fixation using N-butyl 2-cyanoacrylate with classical suture fixation in Lichtenstein hernia repair in terms of chronic groin pain, postoperative complications, operative time and recurrence.


Eligibility criteria: Inclusion Criteria:

* Patients of both genders aging between 18-65 years with primary unilateral uncomplicated inguinal hernia were included.

Exclusion Criteria:

* Patients with bilateral or sliding inguinal hernia.
* incarcerated or strangulated hernia
* recurrent inguinal hernia
* femoral hernia
* patients unwilling to participate in the trial.

Primary outcomes:
measure: Pain score at 12 months after surgery
timeFrame: 12 months after hernia repair
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00978640: Sirtuin Mediated Effects of 36 Hour Fast and 1 Hour Exercise
Official title: Sirtuin Mediated Effects of 36 h Fast and 1 h Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Sirt1 activity
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hypothesis: during fasting and exercise will there be an activation of sirtuins (Sirt1).

Primarily the investigators will investigate Sirt1 activity in muscle- and fat-biopsies after fasting for 36 hours and after 1 hour of ergometer-cycling at 50 Vo2max.

In addition to this the investigators will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.


Eligibility criteria: Inclusion Criteria:

* healthy men
* Body mass index (BMI) 20-26
* age 18-45 years

Exclusion Criteria:

* any kind of disease
* any use of medicine

Primary outcomes:
measure: Sirt1 activity
timeFrame: 60 min
Secondary outcomes:
measure: secondary will we investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.
timeFrame: 4 h
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: mikkel Holm Vendelbo
state: Jylland
Study officials:
References:
Clinical trial NCT02919540: Effect of "Kangaroo Mother Care" on Premature Infants Physiological Outcomes
Official title: Effect of "Kangaroo Mother Care Approach" on Premature Infants' Physiological Outcomes in Jordan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Neonate
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project aims at testing the effect of applying the KMC on the premature infants' physiological outcomes. The findings of this project are expected to contribute to the discipline of preterm infants' care by providing evidence of the benefits, barriers, and facilities of providing the KMC in our Jordanian NICUs.

Detailed description: Premature infants are often unable physiologically to adapt well to the stressful environment of the NICU. These neonates are commonly at risk for the development of short and long term outcomes ranging from mild developmental delay to severe disability. The Kangaroo mother care approach (KMC) is developed to minimize the effect of prematurity and the NICU environmental stressors on premature infants. This project aims at assessing the neonatal nurses' knowledge and attitudes of the application of the KMC approach in the neonatal intensive care unit (NICU), testing the effect of applying the KMC on the premature infants' physiological outcomes, and exploring the mothers' lived experiences of providing KMC for their premature infants. The findings of this project are expected to contribute to the discipline of preterm infants' care by providing evidence of the benefits, barriers, and facilities of providing the KMC in our Jordanian NICUs.

Eligibility criteria: Inclusion Criteria:

* all stable preterm or low birth weight infants (stable infants are those who are able to breath unassisted and have no major health problems (WHO, 2003)), weighing more than 1800gm, who are admitted to the NICUs at the time of study and whose mothers consent to participate and willing to practice the KMC with her infant

Exclusion Criteria:

* high risk preterm or low birth weight infants.

Primary outcomes:
measure: Breastfeeding outcome
timeFrame: 4-6 months
Secondary outcomes:
measure: Body temperature
timeFrame: 4-6 months
measure: Heart rate (beat per minute)
timeFrame: 4-6 months
measure: Respiratory activity (breath per minute)
timeFrame: 4-6 months
Other outcomes:
Locations:
Study officials:
affiliation: Jordan University of Science and Technology
name: khulood K. Shattnawi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01723540: A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy
Official title: A Comparison of Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy Versus Laparoscopic Cholecystectomy; a Randomised Two-center Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2012-11-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery.


Eligibility criteria: Inclusion Criteria:- Uncomplicted symptomatic cholelithiasis cholecystitis confirmed by ultrasoud

* ASA physical status 1-3
* Body mass index 18-30
* AGE 18 - 75 years

Exclusion Criteria:

* Pregnancy or lactating
* common bile-duct stones
* acute cholecystitis
* previous upper abdominal operation
* Chirrosis
* Renal disease
* Pancreatitis
* ASA 4-5
* Participation of any other clinical trial within 30 days before the start of the screening period
* History of uncontrolled cardiovascular, epileptic disorder, psychosis.

Primary outcomes:
measure: Early recovery
timeFrame: One month
Secondary outcomes:
measure: Peroperative outcome
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
References:
Clinical trial NCT02822040: An Evaluation of Root Length Measurements Using Intraoral Scan and Panoramic Radiographs
Official title: An Evaluation of Root Length Measurements Using Intraoral Scan and Panoramic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Root Resorption
Keywords: Root Resorption
Panoramic Radiograph
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 21
Sex: ALL
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone orthodontic treatment, and associated tooth movement, and have initial records directly before the initiation of treatment.

Brief summary: This study will attempt to validate a method of estimating root length on panoramic radiograph by crown measurement on intraoral digital scans.

Detailed description: Intraoral digital scans will be taken on patients who have completed orthodontic treatment, and measurements will be made on the crown dimensions. These dimensions will then be applied onto the same teeth as seen on panoramic radiographs and a mathematical relationship will be determined for root length. Changes in root length will be measured from initial records to treatment complete panoramic radiographs and these estimates will be compared to actual root length changes as measured in CBCT (Cone Beam Computed Tomography) records.

Eligibility criteria: Inclusion Criteria:

* Subject has initial records including CBCT scan and panoramic radiograph that are clear. Subject must have no restorations or significant loss in tooth structure in target teeth or teeth adjacent to target.

Exclusion Criteria:

* Subjects who have records that are not clear, and who are missing target teeth.

Primary outcomes:
measure: Change in root length in mm
timeFrame: Root length will be measured at the initiation of orthodontic treatment and at an average of 24 months later.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University
name: Rodrigo Viecilli, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: