louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04177524: Distracted Driving App Study for Teens and Parents/Caregivers
Official title: An Informatics Approach to Preventing Distracted Driving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distracted Driving
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Minnesota HealthSolutions
First posted: 2019-11-26
Enrollment: 134
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will utilize a crossover design with randomized assignment to three study arms to allow for comparison of app modes within drivers as each driver will act as their own control. The three app modes are: Background Mode (app runs in background and participants do not lock/unlock the phone), Manual Mode (participants manually unlock the phone), and Auto-Detect Mode (participants are automatically locked out of their phone if their phone camera detects them to be a driver or are automatically allowed to use their phone if the camera detects them to be a passenger).
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine if a new smartphone application helps to decrease distracted driving, and to learn about parent and teen perspectives about the application

Detailed description: This 3-group randomized controlled trial aims to (1) evaluate the frequency of smartphone use among young drivers and their parents/caregivers while driving; and (2) determine if the LifeSaver mobile app reduces the rate of smartphone use while driving. Eligible participants will be licensed teenage drivers between the ages of 16 and 18 years, and a parent/caregiver. The app will be downloaded and installed on both parent/caregivers' and teens' phones to monitor phone use while in a vehicle for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Licensed teen drivers 16 years to 18 years and one parent/caregiver
* Teen and parent/caregiver are both Android smartphone users
* Teen and parent/caregiver both drive a minimum of 2 days per week

Exclusion Criteria:

* Non-fluency in written or spoken English

Primary outcomes:
measure: Change in frequency of smartphone use while driving
timeFrame: Week 2, 4, 6, and post-intervention at Week 8
Secondary outcomes:
measure: Change in frequency of self-reported smartphone use while driving
timeFrame: Weeks 2, 4, 6, and Post-Intervention at Week 8
measure: Participant acceptability of the smartphone App: survey
timeFrame: Post-Intervention at Week 8
measure: Participant usability of the smartphone app: survey
timeFrame: Post-Intervention at Week 8
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia Roberts Center for Pediatric Research
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Allison Curry, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota HealthSolutions
name: Sara Seifert, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01656824: Tissue Study of Bv8/PK-2 Inhibition in Human Cancer
Official title: Study of Human Primary Cancer Tissue Implanted in Mice Lacking Bv8/PH-2 in Their Bone Marrow-derived Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Bv8/PK-2
MDSC Myeloid Derived Suppressor Cells
BMDC Bone Marrow Derived Cells
Angiogenesis
Pancreatic Cancer
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with pancreatic cancer and are candidates for whipple's procedure

Brief summary: Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice and transform their bone marrow cells into non-Bv8 producing cells. than we will implant primary human tumor tissue (taken from surgical specimens after informed consent)in those mice and follow-up on the mice.

Detailed description: 1-10 grams of human cancer tissue will be taken from surgical specimen without interference to the pathological data gathering process. those tissues will be implanted in nude mice that will either be treated with anti-Bv8 antibodies or will be transplanted with bone marrow in which Bv8 expression is silenced.

Eligibility criteria: Inclusion Criteria:

* ages 18-85 years
* Pathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma undergoing surgical pancreaticoduodenectomy

Exclusion Criteria:

* refuse to take part
* preoperative chemotherapy

Primary outcomes:
measure: Tumor growth in xenograft model
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Erez Hasnis, MD;PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Erez Hasnis, MD; PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03992924: Physiology & Optical Coherence in STEMI
Official title: A Prospective Evaluation of Clinical Impact of Physiology & Optical Coherence Tomography Guided PCI in STEMI Patients Without Undergoing Primary PCI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 300
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: The objective of this study is to prospectively evaluate the outcomes of different treatment pathways using a Physiology \& Imaging guided PCI in patients with STMEI.

A multi-centre study that will prospectively enrol consecutive STEMI patients who don't receive primary PCI within 48 hours after symptom onset because of different reasons.

STEMI patients with culprit lesion stenosis between 0%-90% will be included in this study and randomized to angiography-guided, FFR-guided or OCT guided PCI groups.


Eligibility criteria: Inclusion Criteria:

- Age ≥18 years STEMI for 7-30 days Have not undergone PCI because: Stabilization in a non-PCI hospital followed by transfer to a tertiary hospital for further evaluation;Previous emergent angio without ballooning or stenting;Previous emergent Thrombus Aspiration without ballooning or stenting;Pharmacoinvasive therapy Stenosis between 0%-90% TIMI flow grad 3

Exclusion Criteria:

- Left main disease or bypass disease Intolerance to a study drug, metal alloys, or contrast media Life expectancy less than one year Previous PCI or CABG history Cardiogenic shock or LVEF\<35% Severe renal or hepatic dysfunction, hemodynamic instability \>90% stenosis in culprit lesion TIMI flow ≤ grade 2 Planned surgery within 6 months after index procedure Clinical indications of inability to tolerate DAPT for 12 months Inability to provide written informed consent Participation in another trial before reaching the primary endpoint

Primary outcomes:
measure: One-year target lesion failure (TLF)
timeFrame: 12 month
Secondary outcomes:
measure: Incidence of Major Adverse Cardiovascular Events (MACE)
timeFrame: 12 month
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
References:
Clinical trial NCT01881724: Impact of Sleep Education Program on Glycemic Control in Hong Kong Chinese Type 2 Diabetic Patients
Official title: Impact of Sleep Education Program on Glycemic Control in Hong Kong Chinese Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 264
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: This is a randomized controlled trial with 12 month sleep education as intervention, followed by a 12 month observational period, to study whether sleep education would improve glycemic control and cardiometabolic profile of sleep deprived type 2 diabetic patients and evaluate the neurohormonal changes associated with sleep education.

Detailed description: Patients will be identified from the Diabetes Mellitus and Endocrine Centre of Prince of Wales Hospital and Yao Chung Kit Diabetes Assessment Centre, The Chinese University of Hong Kong. All participants will have diabetes complications screening and comphrensive evaluations for glycemic control and cardiometabolic risk factors.Eligible subjects will be randomized to 2 groups (usual or conventional care versus intervention with sleep education program) for 12 months.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-65 years
2. Type 2 diabetes mellitus
3. Chinese ethnicity
4. Able and willing to give informed written consent
5. Sleep deprived, defined as subjective sleeping time \<6 hours per day

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. Known history of psychiatric disorders (e.g. depression, anxiety, dementia)
3. Sleep disorders secondary to another medical condition (e.g. obstructive sleep apnoea (OSA), circadian rhythm sleep disorder)
4. Concomitant chronic medical condition that was likely to be the cause of sleep problem (e.g. benign prostatic hypertrophy, chronic pain)
5. Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep.
6. Any condition, as judged by the investigators, as ineligible to participate in this study

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: 12 months
Secondary outcomes:
measure: fasting plasma glucose
timeFrame: 12 months
measure: insulin resistance
timeFrame: 12 months
measure: body weight
timeFrame: 12 months
measure: blood pressure
timeFrame: 12 months
measure: lipid profile
timeFrame: 12 months
measure: sleep duration
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Alice PS Kong, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06839924: Effect of Motor Cognitive Interference on Cognition and Quality of Life on Patients with Multiple Sclerosis
Official title: Effect of Motor Cognitive Interference on Cognition and Quality of Life on Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, MS
Keywords: Multiple Sclerosis
MS
Cognition
Cognitive Motor Interference
quality of life
Qol
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 44
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Is there an effect of Cognitive Motor Interference on Cognition and quality of life on Multiple Sclerosis patients.

Detailed description: we will assess the effectiveness of Cognitive Motor interference on Cognition and quality of life on Multiple Sclerosis patients

Eligibility criteria: Inclusion Criteria:

1. M S patients complain of Mild Cognitive impairment according to Modified Mini Mental State (MMSE).
2. Patients with remission and relapse, primary and secondary progression types of MS.
3. Age between 25 and 45 years.
4. Patients from both gender.

Exclusion Criteria:

1. patients have visual disorders
2. patients have auditory disturbance
3. Non educational patients.
4. Patients with psychiatric disorders.
5. Patients with mod to severe cognitive impairment according to MMSE

Primary outcomes:
measure: Cognition (working memory and divided attention)
timeFrame: baseline assessment and after 12 sessions of Cognitive motor interference 3 sessions per weak for 4 weaks
Secondary outcomes:
measure: A health-related quality of life
timeFrame: Baseline assessment and after 12 sessions of Cognitive motor interference 3 sessions per weak for 4 weaks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
References:
Clinical trial NCT02018224: Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
Official title: Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Achilles tendon rupture, operative treatment, elongation, long-term follow up.
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 55
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: The intention is to compare 60 patients with Achilles tendon rupture, who where randomized in 1998-2001 preoperatively to receive end-to-end suturation by the Krackow locking loop technique either without augmentation or with one central down-turned gastrocnemius fascia flap (Silfverskjöld). Postoperative care was identical for both groups; A brace allowed free active plantar flexion of the ankle postoperatively, whereas dorsiflexion was restricted to neutral for the first three weeks. Weight bearing was limited for six weeks. To compare these treatments, we use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. Mean follow-up time is 14 years.

Hypothesis; Augmentation with a down-turned gastrocnemius fascia flap does not provide better result than would end-to-end suture repair with use of the Krackow locking loop surgical technique in long-term follow up.


Eligibility criteria: Inclusion Criteria:

* Total achilles tendon rupture diagnose.

Exclusion Criteria:

* more than 7 days old rupture, local corticosteroids injection in around the achilles tendon, rupture was open/ there where skin problems over achilles tendon area, patient lived abroad, if the main author was unavailable, or patient refused to participate.

Primary outcomes:
measure: Subjective results in conservative and operative treatment of Achilles tendon rupture.
timeFrame: 14 years
measure: Objective results in operative treatment of Achilles tendon rupture.
timeFrame: 14 years
Secondary outcomes:
measure: Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture
timeFrame: 14 years
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
References:
Clinical trial NCT04358224: The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment
Official title: The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Eczema
Lead sponsor: Bernstein Clinical Research Center
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis

Detailed description: The study consists of 9 visits. Duplimab will used in the treatment of adult onset atopic dermatitis. Qualified subjects will receive 5 dupilumab open-label injections. Skin biopsies/ skin strips will be obtained at the beginning and the end of treatment. TARC and IgE levels will be obtained at the beginning and end of treatment. Subjects will complete daily diaries assessing atopic dermatitis symptoms. Patient reported out comes will be completed at each visit

Eligibility criteria: Inclusion Criteria:

* history of adult onset atopic dermatitis

Exclusion Criteria:

-

Primary outcomes:
measure: The primary objective of this study is to correlate cutaneous transcriptomes with before and after Dupilumab treatment outcomes in patients who meet the clinical diagnostic criteria for adult onset AD.
timeFrame: after 6 months
Secondary outcomes:
measure: To investigate possible influence of Dupilumab on serologic protein biomarkers in patients with adult onset AD
timeFrame: after 6 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
Study officials:
affiliation: Bernstein Clinial Research Center
name: Jonathan Bernstein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01558596: Remote Ischemic Preconditioning Prior to Vascular Surgery
Official title: Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Arterial Disease
Vascular Surgery
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-03-20
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators have previously shown that elective vascular surgery is a high-risk operation with an anticipated risk of either death or heart attack of 15%. This study is testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior to the operation is safe, feasible and reduces the incidence of an adverse, perioperative cardiac complication.

Detailed description: The proposed investigation has a single blind, randomized design and plans to enroll 180-205 patients who are scheduled to have major, elective vascular surgery for occlusive carotid disease, expanding abdominal aortic aneurysm (AAA), occlusive lower extremity disease and/or critical limb ischemia at the Minneapolis VA Health Care Center. 24 hours prior to the patient's scheduled vascular operation, RIPC therapy will be applied to one of the participant's upper arms to cause forearm ischemia. Clinically collected, pre-operative troponins, creatine kinase MBs (CK-MBs), EKGs along with troponins, CK-MBs and EKGs collected on day 1, 2, 3 and day 7 (if still hospitalized) will be utilized to evaluate the occurrence of perioperative, adverse cardiac events.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective major vascular surgery at the Minneapolis VA Medical Center for abdominal aortic aneurysm, carotid disease or limb ischemia.
* Age \> 18.
* Provides informed consent.

Exclusion Criteria:

* Hypertensive crisis
* Peripheral arterial disease of the upper extremities
* Arteriovenous (AV) fistula
* Acute Coronary Syndrome (ACS) in the last 6 months
* Severe valvular heart disease
* Pregnant women
* Unable to provide consent

Primary outcomes:
measure: Troponin I Elevation Above the Upper Reference Limit (URL)
timeFrame: Within 3 days of the vascular operation
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Santiago A Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia S, Rector TS, Zakharova M, Herrmann RR, Adabag S, Bertog S, Sandoval Y, Santilli S, Brilakis ES, McFalls EO. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916.
Clinical trial NCT01379196: Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
Official title: Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Graves Ophthalmopathy
Keywords: Graves Orbitopathy
Macrolide antibiotics
Inflammation
Clinical Activity Score
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of Azithromycin (a macrolide class antibiotic), given three times weekly, for patients with active moderate-severe, non sight-threatening, Graves Orbitopathy.

Indices for follow-up will include:

* Clinical activity score
* Anti-TSH receptor antibody levels
* Thickening of extraocular muscles per ultrasound
* Quality of life score for Graves Orbitopathy patients

Detailed description: Graves Orbitopathy (GO) is an autoimmune inflammatory disorder causing visual morbidity, cosmetic morbidity and interference with quality of life. The disease has an inflammatory stage and a non-inflammatory, fibrotic stage.

Treatment of inflammatory stage moderate-severe GO includes steroids, as recommended by the EUGOGO consortium. However, the length of treatment needed and the risk of steroid side-effects may lead to multiple undesired treatment induced morbidity.

Antibiotics of the macrolide group posses known immune-modulatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of macrolide antibiotics for delaying graft rejection following lung transplants.

We propose to test the effect of this class of antibiotics for non-sight threatening, moderate-severe, inflammatory GO.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Graves Orbitopathy
* Clinical activity score higher than 2
* Must be able to swallow tablets

Exclusion Criteria:

* sight-threatening Graves Orbitopathy
* Diplopia in primary gaze
* Macrolide allergy or intolerance

Primary outcomes:
measure: Change in clinical activity score between baseline and after three months
timeFrame: Three months
Secondary outcomes:
measure: Measurement of extraocular muscle thickening
timeFrame: 3 months
measure: ANTI TSH Receptor antibody levels
timeFrame: 0, 3 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel
name: Hadas Kalish, MD
role: PRINCIPAL_INVESTIGATOR
References: