louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01145391: Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial
Official title: Health Promotion Outreach To Overcome Clinical Inertia In The Treatment Of Patients With Poorly-Controlled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
blood pressure
primary care
patient centered medical home
health information technology
clinical inertia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2010-06-16
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this project is to use health information technology and team-based care in novel ways to support the establishment of a Patient-Centered Medical Home model of care aimed at improving the diagnosis and management of hypertension. Compared with patients who receive usual care, patients who receive intervention will have a lower average systolic blood pressure 9 months after randomization.


Eligibility criteria: Inclusion Criteria:

* Adult men and women age 18-79
* At least 2 Blood Pressure readings from separate days on record
* Average of last 3 Blood Pressure readings (or last 2 if only 2 available) with (Systolic Blood Pressure ≥140 or Diastolic Blood Pressure ≥90) and (last Systolic Blood Pressure ≥135 or last Diastolic Blood Pressure ≥85), recorded by any University of Colorado Hospital clinic within the last 18 months
* No clinic visit in the past month
* At least one Primary Care Physician visit in the past 18 months
* First Primary Care Physician visit at least 6 months in the past

Exclusion Criteria:

* Serious comorbidities, including active cancer diagnosis, hospice care, nursing home residence
* Diagnosis of diabetes (these patients are enrolled in a separate study that also targets Blood Pressure control)
* End-stage renal disease / hemodialysis
* Primary Care Physician appointment pending
* Patient instructed to monitor Blood Pressure at home / documentation of white coat hypertension
* Blood Pressure managed by specialist or outside provider

Primary outcomes:
measure: Blood Pressure
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: Clinical Inertia
timeFrame: Baseline, 9 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amy Huebschmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huebschmann AG, Mizrahi T, Soenksen A, Beaty BL, Denberg TD. Reducing clinical inertia in hypertension treatment: a pragmatic randomized controlled trial. J Clin Hypertens (Greenwich). 2012 May;14(5):322-9. doi: 10.1111/j.1751-7176.2012.00607.x. Epub 2012 Mar 16.
Clinical trial NCT06431191: Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture
Official title: Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture in Small to Medium Size Rotator Cuff Tear
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Full Rotator Cuff Tear
Microfracture Procedure
Double Raw Repair
Lateral Raw Repair
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized controlled study of rotator cuff repair with lateral raw or double raw combined with microfracture procedure. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and, 3 months, 6 months, 12 months and 24 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of double raw or only lateral raw repair combined with microfracture on the treatment of rotator cuff. In order to figure out whether medial raw anchor necessary during tendon repair combined with microfracture in small to medium size rotator cuff tear.


Eligibility criteria: Inclusion Criteria:

* Arthroscopy confirmed small to medium full rotator cuff tear
* Unilateral rotator cuff injury
* Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients
* Young and middle-aged patients aged 20 to 60

Exclusion Criteria:

* Previous shoulder surgery (incision or arthroscopy)
* Combined with diseases of other parts of the same limb
* Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on
* Bilateral onset
* Unable or unwilling to receive clinical follow-up

Primary outcomes:
measure: rotator cuff re-tear rate
timeFrame: 6, 12, 24 months postoperatively
Secondary outcomes:
measure: VAS (Visual Analogue Scale)
timeFrame: 1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively
measure: ASES(American Shoulder and Elbow Surgeons'Form)
timeFrame: 3,6,12,24 months postoperatively
measure: Constant score
timeFrame: 3,6,12,24 months postoperatively
measure: UCLA (University LosAngeles scoring system)
timeFrame: 3,6,12,24 months postoperatively
measure: SST (simple shoulder test)
timeFrame: 3,6,12,24 months postoperatively
measure: front extension, external rotation and internal rotation strength of shoulder
timeFrame: 6,12,24 months postoperatively
measure: surgical time
timeFrame: immediately after the surgery
measure: Hospitalization expenses
timeFrame: immediately after the patient discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01284491: A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
Official title: A Prospective, Randomized, Controlled Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Macromastia
Keywords: Breast reduction
PlasmaBlade
Electrosurgery
PEAK Surgical
Medtronic Advanced Energy
Medtronic
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged scars formed following incision with a standard scalpel.

Detailed description: Subjects attended one of two evaluation dates scheduled on January 21, 2011 and February 23, 2011. During this visit, subjects gave informed consent and were instructed on evaluating their breast reduction scars using the Patient Scar Assessment Scale. Following subjects' self-evaluation, each subject was evaluated by three evaluators using the Observer Scar Assessment Scale.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 70
2. Physically healthy, stable weight
3. Non-smokers, or prior smokers who stopped smoking at least two weeks prior to surgery.
4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
5. Subject must be willing and able to comply with specified follow-up evaluations.
6. Subjects who have participated in the PEAK PlasmaBlade bilateral breast reduction study.

Exclusion Criteria:

1. Age younger than 18 or greater than 70 years old
2. Anticoagulation therapy which cannot be discontinued
3. Smoking (continuous; any substance)
4. Infection (local or systemic)
5. Cognitive impairment or mental illness
6. Severe cardiopulmonary deficiencies
7. Known coagulopathy
8. Immunocompromised
9. Prior history of breast cancer
10. Kidney disease (any type)
11. Currently taking any medication known to affect healing
12. Subjects who did not participated in the PEAK PlasmaBlade bilateral breast reduction study
13. Unable to follow instructions or complete follow-up

Primary outcomes:
measure: Scar Quality
timeFrame: 0-18 months following breast reduction surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Gupta Plastic Surgery
state: California
Study officials:
affiliation: Gupta Plastic Surgery
name: Abhay Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402791: Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples
Official title: Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 60
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: Couples for whom the women have been surgically treated for deep endometriosis at the Nîmes University Hospital

Brief summary: The primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners.


Eligibility criteria: Inclusion Criteria:

* The patient (and her partner) must have given his/her informed and signed consent
* The patient (and her partner) must be insured or beneficiary of a health insurance plan
* Couples for whom the woman has formerly undergone surgical treatment for endometriosis, and for the partner agrees to respond to questionnaires for this study

Exclusion Criteria:

* The patient (or her partner) is participating in another study
* The patient (or her partner) is in an exclusion period determined by a previous study
* The patient (or her partner) is under judicial protection, under tutorship or curatorship
* The patient (or her partner) refuses to sign the consent
* It is impossible to correctly inform the patient (or her partner)
* The patient is pregnant
* The patient is breastfeeding
* The patient was surgically treated for endometriosis, but was single.

Primary outcomes:
measure: Score for the SFQ questionnaire
timeFrame: Day 1
measure: Score for the IIEF questionnaire
timeFrame: Day 1
Secondary outcomes:
measure: Scores for each sub-domain of the SFQ questionnaire
timeFrame: Day 1
measure: Scores for each sub-domain of the IIEF questionnaire
timeFrame: Day 1
measure: Sexual treatment request (yes/no)
timeFrame: Day 1
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Stéphane Droupy, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01181791: Effects of Lactobacillus Reuteri in Premature Infants
Official title: Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Infant Disease
Keywords: probiotics
premature infants
feeding tolerance
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica de Chile
First posted: 2010-08-13
Enrollment: 65
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Administration of probiotic Lactobacillus Reuteri
Primary purpose: PREVENTION

Brief summary: This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.

The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.

Detailed description: The primary outcome "days to achieve full feeds" will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live

Eligibility criteria: Inclusion Criteria:

* Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days

Exclusion Criteria:

* Chromosomal anomalies.
* Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
* Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
* Parental refusal
* Prior enrollment into a conflicting clinical trial

Primary outcomes:
measure: Time to reach full feeds
timeFrame: First 40 days after birth
Secondary outcomes:
measure: Intestinal colonization
timeFrame: 0-6 months after birth
measure: Intestinal immunological response
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Sotero del Rio
city: Santiago
country: Chile
facility: Pontifica Universidad Catolica
Study officials:
affiliation: University of Miami
name: Teresa del Moral, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Clinical trial NCT01790191: Comparison of Effect of Repeated Exposure, Flavor-Flavor and Flavor-Nutrient Learning on Vegetable Acceptance in Infants
Official title: Comparison of the Effect of Repeated Exposure, Flavor-Flavor Learning and Flavor-Nutrient Learning on Vegetable Acceptance in Weaning Age Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development of Eating Behavior
Keywords: Children
Eating behaviour
Intake
Liking
Conditioned liking
Flavour
Nutrient
Vegetable
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2013-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims at comparing learning mechanisms to increase vegetable acceptance in infants at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and flavor-nutrient learning (FNL); measuring the stability of the learning effect; and examining the impact of infants' feeding history on vegetable acceptance.


Eligibility criteria: Inclusion Criteria:

* Healthy infants, aged between 4 and 8 months old, not yet introduced to complementary foods

Exclusion Criteria:

* Infants with food allergies, with chronic health problem, or born before 36 weeks of gestational age

Primary outcomes:
measure: Food intake
timeFrame: Participants will be followed for an average duration of 8 months
Secondary outcomes:
measure: Food Liking
timeFrame: Participants will be followed for an average duration of 8 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre des Sciences du Goût et de l'Alimentation
Study officials:
affiliation: Centre des Sciences du Goût et de l'Alimentation INRA
name: Sophie Nicklaus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01320891: Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators
Official title: Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Large Bowel Cancer
Keywords: general anaesthesia for major abdominal surgery
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: B. Braun Melsungen AG
First posted: 2011-03-23
Enrollment: 40
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: Aim of the study is to ascertain whether a different strategy of fluids administration can be responsible of differences in terms of acid/base disorders (Stewart approach), pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated either with not-balanced solutions (Normal Saline) or balanced solutions


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of large bowel cancer
* Age \> 18 years old

Exclusion Criteria:

Emergency surgery for bowel punch or intestinal occlusion

* Massive bleeding
* Therapy with corticosteroid or nonsteroid antiinflammatory substances
* Renal insufficiency (serum creatinine \> 200 micromol /l)
* Cardiac insufficiency (NYHA III-IV)
* Altered liver function (ALT \> 40 U/l AST \>40 U/l)
* Preoperative anaemia ( Hb \< 10 g/dl )
* Allergy to hydrossietilic starches
* Patient rejection to share the study

Primary outcomes:
measure: acid/base disorder
timeFrame: T0: anaesthesia induction (control value) T1: end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery
Secondary outcomes:
measure: pro/antiinflammatory cytokine
timeFrame: T0: anaesthesia induction (control value) T1:end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: S.Anna Universitary Hospital
Study officials:
affiliation: Ferrara Univesity
name: Carlo A Volta, Professor
role: STUDY_CHAIR
References:
citation: Volta CA, Trentini A, Farabegoli L, Manfrinato MC, Alvisi V, Dallocchio F, Marangoni E, Alvisi R, Bellini T. Effects of two different strategies of fluid administration on inflammatory mediators, plasma electrolytes and acid/base disorders in patients undergoing major abdominal surgery: a randomized double blind study. J Inflamm (Lond). 2013 Sep 24;10(1):29. doi: 10.1186/1476-9255-10-29.
Clinical trial NCT04992091: Effects of Constructive Debriefing on Procedural Skills and Satisfaction of Nursing Students in Low Fidelity Context. A Randomized Controlled Trial.
Official title: Constructive Debriefing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Skill. Learning
Keywords: Debriefing, Procedural skills, Satisfaction, Reflection, Critical thinking
Lead sponsor: Shifa Tameer-e-Millat University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Purposes: This study was set out to measure the effectiveness of constructive debriefing on procedural skills and satisfaction of nursing students in the low-fidelity context in comparison to traditional debriefing.

Method: The randomized controlled (Parallel double blinded) trial design was used.

Participant: Out of 51 approached, 34 students were selected from the list of participants by a data collector using simple random sampling technique. Following, block randomization was applied using Microsoft Excel to create two equivalent (n=17) groups i.e. experimental and non-experimental.

Setting: The study was conducted in private college of nursing Islamabad Pakistan Intervention: The experimental group received constructive debriefing and non-experimental group received the traditional debriefing. The data were collected using suctioning, sterile dressing skills checklist, and debriefing reflection subscale of Satisfaction with Simulation Experience Scale.


Eligibility criteria: Inclusion Criteria:

- Students who were enrolled in the Adult Health Nursing (AHN) course were included in the study

Exclusion Criteria:

* Studentsnts who were repeating the course and were absent for two or more days during skills demonstration and signing off were excluded

Primary outcomes:
measure: learning scores
timeFrame: 8months
Secondary outcomes:
measure: satisfaction level
timeFrame: 8months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Bushra
state: Punjab
Study officials:
References:
Clinical trial NCT01992991: Transcranial Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage
Official title: Transcranial Direct Current Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Disorders
Keywords: transcranial stimulation
Intracranial hemorrhage
Home training
Occupational Therapy
Jebsen Taylor Hand Function Test
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of transcranial stimulation for upper limb training of patients with sequelae from an intracranial hemorrhage.

Patients receive five days of upper limb occupational therapy training in combination with real or sham stimulation. Patients complete the Jebsen Taylor Hand Function Test before, after and 7 days later. The intervention takes place at patients' home address.

Detailed description: Aim: To investigate the effect of anodal transcranial direct current stimulation (tDCS) for upper limb training of individuals with sequelae from intracranial hemorrhage.

Design: Triple-blinded randomised controlled trial Study population: Patients with intracranial hemorrhage (ICH) of non-traumatic aetiology. Between 6 months and five years from injury.

Intervention:

Group 1 receive five days of upper limb occupational therapy in combination with anodal stimulation Group 2 receive five days of upper limb occupational therapy in combination with sham stimulation The intervention takes place at patients' home address. Assessment tool: Patients complete the Jebsen Taylor Hand Function Test at baseline, post-intervention and at 7 days follow-up.

Eligibility criteria: Inclusion Criteria:

* Intracranial hemorrhage
* Injury between 6 months and 5 years

Exclusion Criteria:

* Traumatic brain injury
* Other neurological disorders
* Epilepsy
* Metal implants in the head

Primary outcomes:
measure: Change in Jebsen Taylor Hand Function Test
timeFrame: Change from baseline until 7 days follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation and Research Centre
state: Jutland
Study officials:
affiliation: Hammel Neurorehabilitation and Research Centre
name: Henning Andersen, MD, PhD
role: STUDY_DIRECTOR
References: