louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04543656: Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence
Official title: Personalized Blood Pressure Care for Prehypertensive Patients Using IoMTs and Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-hypertension
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this RCT, up to 100 adults classified as pre-hypertensive will be randomized to either an artificial intelligence (AI) based lifestyle intervention group or an active control group with a 1 to 1 ratio. Both groups will receive an identical activity tracker (Samsung Galaxy Watch) and BP monitor (Omron Evolv). The AI intervention group will receive automated and personalized lifestyle recommendations based on their lifestyle (e.g. sleep, exercise and diet) and blood pressure (BP) data, involving an automated analytics engine using statistics and machine learning. The active control group will not receive these lifestyle recommendations. The investigators aim to assess objectively the effectiveness of the AI-based personalized lifestyle recommendations on the patients BP.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* SBP between 130 mmHg to 139 mmHg or/and DBP between 80 to 89 mmHg in a research office
* speaking and reading English
* having an iPhone 8 or newer or an Android x or newer

Exclusion Criteria:

* currently taking antihypertensive medication
* self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)
* current participation in a lifestyle modification program or research study
* self-report of being currently pregnant

Primary outcomes:
measure: Average change in systolic blood pressure (SBP) in experimental vs. control group
timeFrame: Initial 2 week data collection, weekly lifestyle recommendations, 6 months total
measure: Average change in diastolic blood pressure (DBP) in experimental vs. control group
timeFrame: Initial 2 week data collection, weekly lifestyle recommendations, 6 months total
Secondary outcomes:
measure: Number of patients in experimental group that followed lifestyle recommendations
timeFrame: Initial 2 week data collection, weekly lifestyle recommendations, 6 months total
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
Clinical trial NCT00013156: Cost-Effectiveness of Lung Volume Reduction Surgery
Official title: Cost-Effectiveness of Lung Volume Reduction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Emphysema
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 92
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.

Detailed description: Background:

Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.

Objectives:

Evaluate cost-effectiveness of LVRS compared to current therapy for COPD.

Methods:

This is a case control study in which veterans undergoing LVRS at VA Puget Sound Health Care System (VAPSHCS) are compared to patients with a similar severity of disease at Boise VAMC who are not undergoing LVRS. Changes in health related quality of life are being evaluated using three instruments: the SF-36, the St. George�s Respiratory Questionnaire, and the Quality of Well-Being Scale, the latter to calculate utility associated with different health states. Costs will be determined using utilization data on outpatient visits, medications, oxygen use, inpatient days, radiology tests, laboratory tests, and emergency room visits are being collected for the twelve months before and after surgery. Costs will be calculated according to VA and community standards.

Status:

Complete.

Eligibility criteria: Inclusion Criteria:

Severe COPD as defined by FEV1 of 20-30% predicted; marked hyperinflation with a residual volume of \>165% predicted; 6-min walk greater than 600 ft; abstinence from cigarette smoking for 3-mths; absence of co-morbid illnesses that would significantly increase surgical risk, such as severe coronary artery disease

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Hugh F Huizenga, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Stephan D. Fihn, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huizenga HF, Ramsey SD, Albert RK. Estimated growth of lung volume reduction surgery among Medicare enrollees: 1994 to 1996. Chest. 1998 Dec;114(6):1583-7. doi: 10.1378/chest.114.6.1583.
Clinical trial NCT04824456: Neurosensory Assesment After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT
Official title: Evaluation of Neurosensory Disturbance After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.
Primary purpose: SCREENING

Brief summary: The bilateral sagittal split Ramus osteotomy (BSSRO) was introduced by Trauner and Obwegeser. Since then, many modifications of this procedure have been reported, leading to a less difficult and more predictable procedure for correcting mandibular anomalies. persistent post-operative neurosensory disturbances of the inferior alveolar nerve are still one of the major complications of this operation. The incidence has decreased over the years due to improved techniques and the use of different instruments. However, most recent series still report postoperative persistent hypesthesia of the inferior alveolar nerve in more than 10% of the patients up to 48%.

There are no reports on the influence of other surgical variables on the persisting post-operative hypesthesia. Several methods have been reported for evaluating neurosensory disturbances of the inferior alveolar nerve. One of the simplest methods reported is tactile evaluation based on subjective sensation reported by the patients. Many authors have used this method in their evaluation of post-operative hypesthesia.


Eligibility criteria: IInclusion criteria:

1. Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.
2. Adults \>18 years.
3. Systemically healthy.

Exclusion criteria:

1. Patients not indicated for orthognathic surgery.
2. Severe systemic disease.
3. Have a medical condition associated with systemic neuropathy (e.g. diabetes)
4. Patients whom cannot tolerate follow up intervals. (affect accuracy of study results)
5. Are unwilling to sign informed consent.

Primary outcomes:
measure: neurosensory disturbance of the inferior alveolar nerve.
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of bad split
timeFrame: 1 year
measure: post operative edema ,
timeFrame: 1 year
measure: post operative pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT03462056: Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
Official title: Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2018-03-12
Enrollment: 16
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with cystic fibrosis require increased caloric intake to maintain appropriate growth, an important determinant of long-term outcomes. This study seeks to determine the feasibility of using a novel therapeutic food to promote weight gain and growth in children with cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Cystic Fibrosis diagnosed by sweat test or genetic testing.
* Exocrine Pancreatic Insufficiency and receiving pancreatic enzyme replacement therapy
* BMI or weight for age of less than the 50th percentile

Exclusion Criteria:

* Cystic fibrosis related diabetes mellitus
* Cystic fibrosis related liver disease.
* Anaphylactic or other allergy to peanut, cow's milk, oat flour or other RUTF ingredients.
* Patients who are status-post lung or liver transplantation
* Currently receiving enteral supplemental nutrition through gastrostomy or nasogastric tube.

Primary outcomes:
measure: BMI Z-score
timeFrame: 3 months
Secondary outcomes:
measure: Weight Z-score
timeFrame: 3 months
measure: Body Composition
timeFrame: 3 months
measure: Body Composition
timeFrame: 3 months
measure: Pulmonary Function
timeFrame: 3 months
measure: Compliance of taking supplemental food
timeFrame: 3 months
measure: Quality of Life
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan T Pitman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Mark J Manary, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00494156: Anticoagulation in Blunt Cerebrovascular Injuries
Official title: Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Carotid Artery Injury
Vertebral Artery Injury
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2007-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Originally thought to be a rare occurrence, BCVI are now diagnosed in approximately 1% of blunt trauma patients. Initially BCVI were thought to have unavoidable devastating neurologic outcomes. But early reports suggested anticoagulation might decrease these events. If untreated, carotid artery injuries (CAI) have a stoke rate up to 50% depending on injury grade, with increasing stroke rates correlating with increasing grades of injury. Current studies report early treatment with antithrombotics - either heparin or anti-platelet agents - in patients with BCVI markedly reduces stroke rates and resultant neurologic morbidity. As reports of bleeding complications have altered heparin protocols in these patients, the use of antiplatelet agents is attractive. Although heparin has been has been proposed as the gold standard treatment due to its initial empiric use, no comparative studies of antithrombotic agents has been performed.

In sum, Grade I-III blunt carotid and vertebral arterial injuries (BCVI) have the potential for stroke, and should be treated. Heparin has not been shown to clearly improve healing rates compared with antiplatelet therapy. The purpose of this study is to determine whether systemic anticoagulation alters the course of Grade I-III BCVI compared with antiplatelet therapy. The investigators study hypothesis is that Grade I-III BCVI will heal or progress to pseudoaneurysm formation, independent of systemic antithrombotic regimen, and that the combination of aspirin and clopidogrel is equally efficacious in preventing neurologic symptoms compared to systemic heparin associated with Grade I-III BCVI.


Eligibility criteria: Inclusion Criteria:

* Patients greater than 18 years old with documented grade I-III blunt cerebrovascular injuries.

Exclusion Criteria:

* Pregnancy
* Nasal polyps
* Previous gastrointestinal bleeding secondary to antiplatelet medications
* Contraindication to systemic anticoagulation.

Primary outcomes:
measure: Neurologic sequelae
timeFrame: during hospital visit
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health Medical Center
name: Clay Cothren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05123456: Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL
Official title: Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ACL
Anterior Curciate Ligament
Anterolateral Ligament
Knee Injuries
ALL
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
name: Private Hospital Jean Mermoz
First posted: 2021-11-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent an isolated Anterior Cruciate Ligament (ACL) reconstruction or a combined ACL and anterolateral ligament reconstruction (Extra Articular Plasty) between January 1, 2011 and March 31, 2012.
* Patients affiliated or beneficiaries of a social security scheme
* Patients who have given their express consent.

Exclusion Criteria:

* Patients with pediatric ACL reconstruction technique
* Patients with a complex associated gesture such as osteotomy or ligamentoplasty other than extra articular plastic surgery.
* Contraindication to a radio control (pregnancy)
* Patient's refusal to participate in the study
* Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.

Primary outcomes:
measure: Assessment of the prevalence of femoro-tibial osteoarthritis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital privé Jean Mermoz
Study officials:
References:
Clinical trial NCT06900556: Dry Cupping for Recovery From Muscle Damage
Official title: Effect of Post-exercise Dry Cupping Therapy on Muscle Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Damage
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study compares the effect of dry cupping to placebo cupping after muscle-damaging exercise on recovery of muscle strength, muscle swelling, and muscle soreness.

Detailed description: Dry cupping is a technique where cups are placed on the skin and a suction device is used to remove air from the cups. This study aims to investigate whether dry cupping therapy can enhance muscle recovery following exercise by measuring muscle soreness, swelling, and strength in the biceps. Six sets of biceps curls (emphasizing concentric and eccentric overload) will be performed on each arm, followed by dry cupping with suction applied to one arm (experimental) and dry cupping without suction (placebo) applied to the opposite arm. Experimental and placebo arms for each participant will be randomized. Before exercise and immediately, 24 hours, 48 hours, and 72 hours after exercise, muscle strength, muscle swelling (ultrasound), and muscle soreness (visual analog scale) will be assessed.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 18-35 years old
* Experienced with upper arm resistance training for at least 3 months

Exclusion Criteria:

* Conditions that might make exercise dangerous (determined by "yes" answers to the "Get Active Questionnaire")
* Open wounds, scars, eczema, or other skin sensitivities on the biceps area

Primary outcomes:
measure: Biceps isometric strength measured by dynamometry (Nm)
timeFrame: Change over 72 hours
Secondary outcomes:
measure: Biceps swelling (muscle thickness) measured with ultrasound (cm)
timeFrame: Change over 24 hours
measure: Biceps muscle soreness measured with a visual analog scale from 0 (no soreness) to 10 (maximal soreness)
timeFrame: Change over 72 hours
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: College of Kinesiology, University of Saskatchewan
state: Saskatchewan
Study officials:
References:
Clinical trial NCT02464956: Production of iPSC Derived RPE Cells for Transplantation in AMD
Official title: Feasibility of Production of Induced Pluripotent Stem Cell Derived Retinal Pigment Epithelial Cells Fulfilling Regulatory Requirements for Human Transplantation in Dry Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration (AMD)
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2015-06-08
Enrollment: 3
Sex: ALL
Minimum age (years): 50
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: Patients affected by Age Related Macular Degeneration (AMD)

Brief summary: No treatments exist for Age-related Macular Degeneration (AMD) when there is cell loss such as in late wet AMD or dry AMD. The differentiation of RPE cells from patient derived iPSC will offer valuable source of tissue for transplantation in these forms of AMD and may form basis for a future treatment option in terms of cell transplantation.

Detailed description: It has been shown that adult human skin cells or human blood cells can be reprogrammed to become stem cells. This type of stem cell is called an induced Pluripotent Stem Cell (iPSC).It has been shown specifically that this type of stem cell can be produced from adult human skin cells or blood cells can in turn be converted into Retinal Pigment Epithelial (RPE) cells. These RPE cells are a very important cell type in the human retina that are abnormal and ultimately lost in Age-related Macular Degeneration (AMD). Although it has been shown to be possible to make RPE cells from adult human skin, it has not been done to a level to fulfil regulatory requirements for human transplantation in AMD.

This is a feasibility study involving 10 patients. The efficiency of creating an iPSC-Derived RPE cells from a patient's own skin or blood will be examined. A sample size of 10 patients will allow us to potentially consolidate the safety and efficacy of this method in order to create these cells within the context of a future transplantation trial.

Eligibility criteria: Inclusion Criteria:

* Subjects over the age of 18 years
* Subjects with the ability to give informed consent
* Subjects with known AMD (both wet and dry)

Exclusion Criteria:

* Unable to give informed consent
* Subjects unable to give blood sample for medical reasons
* Subjects with coagulopathies
* Subjects who are known to be at risk of keloid scarring

Primary outcomes:
measure: Successful production of a Retinal Epithelial (RPE) layer that fulfils Regulatory Regulation for transplantation. This will be confirmed with standard laboratory characterisation of RPE and completed toxicity and safety studies on the cell layer.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: