louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00670943: Effect of Abrupt Plavix® Discontinuation on Platelet Function
Official title: Effect of Abrupt Plavix® Discontinuation on Platelet Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Clopidogrel discontinuation
Platelet aggregation
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Hopital du Sacre-Coeur de Montreal
First posted: 2008-05-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stable coronary artery disease

Brief summary: The well established importance of regular administration of antiplatelet drugs stands on firm grounds, as large meta-analyses have shown these therapies to significantly reduce the risk of death. Plavix® (clopidogrel) is widely used following coronary angioplasty, to reduce the risk of periprocedural thrombotic complications, for up to one year. As the current recommendations suggest clopidogrel use for no longer than one year, the drug is normally discontinued within that period. In the limited state of knowledge on antiplatelet drug withdrawal, an early sound of alarm has risen from early thromboembolic complications reported after the interruption of antiplatelet treatment used in prevention of ischemic vascular disease. Although little information is available, discontinuation of thienopyridines has been associated with increased thromboembolic complications, mainly acute stent thrombosis. These complications may signal a platelet sensitization effect to aggregating stimuli by antiplatelet drugs taken chronically.

The current study aims to evaluate the impact of clopidogrel discontinuation on platelet function, in order to shed light on underlying mechanisms leading to increased risk of acute thrombo-occlusive events.


Eligibility criteria: Inclusion Criteria:

* Group 1: Patients suffering from stable CAD scheduled to discontinue clopidogrel therapy at least one month after stent implantation
* Group 2: Stable clopidogrel-naïve CAD patients
* Patients willing to participate in the study and to sign the informed consent form

Exclusion Criteria:

* Acute coronary syndrome or revascularization in the last 3 months prior to enrolment
* Concurrent ingestion of nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective anti-inflammatory drugs), ticlopidine, dipyridamole, warfarin or acenocoumarol
* Major surgical procedure within 1 month before enrolment
* Platelet count outside the 100 000 to 450 000/μL range
* Hematocrit \< 25% or haemoglobin \< 100 g/L
* Patient undergoing dialysis for chronic renal failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
Study officials:
affiliation: Hopital du Sacre-Coeur de Montreal
name: Jean G Diodati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753843: Brief Delay in Cord Clamping and Neurobehaviour in Preterms
Official title: A Randomised Controlled Trial to Evaluate the Role of Brief Delay in Cord Clamping in Preterm Neonates (34-36weeks) on Short Term Neurodevelopmental Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Preterm Birth
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2012-12-20
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: RESEARCH HYPOTHESIS Brief delay(\>30 sec to \<60 sec ) in cord clamping as compared to early cord clamping (\< 20 sec) leads to a better short term neurobehavioural outcome in preterm (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants (n.a.p.i.) at 37 weeks of post conceptional age

Detailed description: Delayed cord clamping (DCC) : Well described phenomenon in term infants .

* The optimal timing of clamping of umbilical cord in preterm infants : A subject of debate.
* Even a brief delay in cord clamping leads to an additional transfer of iron amounting to 40-50 mg/kg which may prevent iron deficiency.¹
* This low cost intervention can have significant public health importance in resource constrained settings.
* The effect of this intervention on neurobehaviour of preterm neonates has not been assessed.
* This aspect has been identified by WHO and Cochrane as a potentially researchable area

Eligibility criteria: Inclusion Criteria:

* All preterm deliveries -infants born at 34 weeks 0 days to 36 weeks +6 days gestational age as estimated by last menstrual period or early ultrasound scan.
* Infants delivered vaginally or by caesarean section in cephalic presentation
* Singleton pregnancy
* Parental consent

Exclusion Criteria:

* Fetus with gross congenital anomaly
* Fetus with hydrops
* Rh negative pregnancy

Primary outcomes:
measure: short term neurobehavioral outcome
timeFrame: at 37 weeks post conceptional age
Secondary outcomes:
measure: measuring cord hematocrit
timeFrame: at birth
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Lady Hardinge Medical College
state: Delhi
Study officials:
affiliation: Lady Hardinge Medical College
name: Vikram Datta, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05562843: Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004
Official title: Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD ILD
Lead sponsor: H-CYTE
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Conventional treatment for chronic lung disease typically involves inhaled bronchodilators, steroids, oxygen therapy, antifibrotic medications, lung reduction surgery and lung transplantation for the management of symptoms, although none of these modalities (aside from surgery/transplant) thwarts long-term progression of the disease.. With transplantation the availability of donor lungs is scarce and the longterm need for anti-rejection medication and monitoring can be overwhelming. Recent advances in the field of regenerative medicine in lung disease have demonstrated that autologous cellular therapy may reduce inflammation and aid in the maintenance and repair of damaged lung tissue

Brief summary: For this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using proprietary Emcyte™ equipment/centrifugation, and then returned to the patient same day via the peripheral circulation. As circulation occurs, the concentrated cells enter the right heart and are then disseminated into the lungs, becoming trapped in the lung's microcirculation. Here, the cells are believed to produce multiple bioactive factors such as cytokines and anti-inflammatory mediators. Several growth factors are released by activated platelets becoming honing cells for healing within the tissue. The exact long-term mechanism of action of PRP-PC in the lungs remains under investigation. Safety studies have proven that autologous treatment is incredibly safe, largely because of the minimal cell manipulation and the autologous nature of the cells. Prior observational studies in this are have shown strong safety profiles as well as strong efficacy in both COPD and ILD.

Detailed description: Study Objective(s) Primary

* To determine if pulmonary function improves following ceullar therapy Secondary
* To determine if participants' perceived quality of life related to breathing improves following cellular therapy To evaluate the safety of autologous PRP-PC administration for chronic lung disease

Eligibility criteria: Inclusion Criteria:

1. Subjects age 18 and older
2. Diagnosis of COPD or an interstitial lung disease

Exclusion Criteria:

Pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-

Primary outcomes:
measure: Pulmonary Lung Function
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life subjective
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Centers for Respiratory Health
state: Florida
Study officials:
References:
Clinical trial NCT06173843: Occupational Exposures Among Firefighters
Official title: Effect of Occupational Exposures on Cancer Pathophysiology Among Firefighters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Cancer
Occupational exposure
Lead sponsor: Vincere Cancer Center
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Actively working or retired firefighters of any adult age, any gender and any demographic group are eligible, with no limitations regarding general health status other than those specified in the protocol Eligibility Criteria.

Brief summary: This study aims to understand the effect of occupational exposures, including PFAS exposures, among firefighters.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older; any gender
* Currently (or previously) employed as a firefighter, full-time or part-time, participating in Vincere's First Responder Cancer Screening Program
* Willing to provide a blood, urine, and/or tissue sample
* Able to provide informed consent to participate in the study

(A small group of non-firefighters will be enrolled to act as a comparison group)

Primary outcomes:
measure: Exposures associated with elevated PFAS
timeFrame: 5 years
Secondary outcomes:
measure: Cancer rates
timeFrame: 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Vincere Cancer Center
state: Arizona
Study officials:
References:
Clinical trial NCT05707143: Effects of Home Based Stabilization and Kegel Exercises on Postnatal Females
Official title: Comparative Effects of Home Based Stabilization and Kegel Exercises on Low Back Pain, Disability and Quality of Life in Postnatal Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: disability
low back pain
females
quality of life
stabilization exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of home based stabilization exercises and kegel exercises on low back pain, disability and quality of life in postnatal females.


Eligibility criteria: Inclusion Criteria:

* Cesarean delivery.
* Multi gravida females.
* Postpartum low back pain last for 1 year

Exclusion Criteria:

* Low back pain before pregnancy.
* Urogenital infections.
* History of pelvic floor or lumber surgery.
* Malignancy.
* Pelvic or lumber fractures

Primary outcomes:
measure: Visual analogue scale
timeFrame: 6th week
measure: Short form 36
timeFrame: 6th week
measure: Oswestry disability index
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: gynecological department of Services hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hina Gul, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khorasani F, Ghaderi F, Bastani P, Sarbakhsh P, Berghmans B. The Effects of home-based stabilization exercises focusing on the pelvic floor on postnatal stress urinary incontinence and low back pain: a randomized controlled trial. Int Urogynecol J. 2020 Nov;31(11):2301-2307. doi: 10.1007/s00192-020-04284-7. Epub 2020 Apr 10.
citation: Urme NA, Alam F, Jahan N. Effectiveness of Specific Lumbar Stabilization Exercise for LBP among Postpartum Women: A Quasi-Experimental Study. Journal of Advanced Academic Research. 2021;8(1):79-95
citation: Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.
citation: Unsgaard-Tondel M, Vasseljen O, Woodhouse A, Morkved S. Exercises for Women with Persistent Pelvic and Low Back Pain after Pregnancy. Glob J Health Sci. 2016 Sep 1;8(9):54311. doi: 10.5539/gjhs.v8n9p107.
citation: Tseng PC, Puthussery S, Pappas Y, Gau ML. A systematic review of randomised controlled trials on the effectiveness of exercise programs on Lumbo Pelvic Pain among postnatal women. BMC Pregnancy Childbirth. 2015 Nov 26;15:316. doi: 10.1186/s12884-015-0736-4.
Clinical trial NCT02411643: Molecular Effects of Topical Calcipotriene on Morphea
Official title: Molecular Effects of Topical Calcipotriene on Morphea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Morphea
Localized Scleroderma
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be obtained and used for a control. This is an initial study to look at the molecular effects of topical calcipotriene on human morphea-involved skin. This study will look at the differences between affected and unaffected skin. This study also will look at clinical outcomes in morphea patients and determine if there are any clinical predictors for improvement with the medication.


Eligibility criteria: Inclusion Criteria:

* Subjects with clinically-diagnosed or biopsy proven plaque-type, guttate, linear, segmental, and generalized morphea that are receiving calcipotriene 0.005% ointment as part of their standard of care treatment will be included.
* Subjects are allowed to have previously been on any therapy as long as they have been off systemic treatment, topical therapy or phototherapy for 4 weeks prior to baseline.
* Age ≥ 18 years.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Subjects with the diagnosis of morphea profundus, eosinophilic fasciitis, and atrophoderma will be excluded.
* Subjects who are receiving oral or topical immunosuppression therapy or phototherapy within 4 weeks prior to entering the study.
* Subjects may not be receiving any investigational agents.
* Subjects must not be pregnant or nursing.
* Patients allergic to lidocaine or epinephrine or who have a history of impaired wound healing or for any reason are unable to undergo a skin biopsy.

Primary outcomes:
measure: Change of Gene Expression From Skin Biopsy
timeFrame: day 0 and 3 months
Secondary outcomes:
measure: Quality of Life
timeFrame: day 0 and 3 months
measure: Modified Localized Scleroderma Skin Score
timeFrame: day 0 and 3 months
measure: Change of Appearance of Skin Biopsy
timeFrame: day 0 and 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
References:
Clinical trial NCT02831543: Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Functional Dyspepsia
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2016-07-13
Enrollment: 354
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in functional dyspepsia patients.


Eligibility criteria: Inclusion Criteria:

1. Male and female aged 19 years or older
2. Patient with functional dyspepsia met the ROME III criteria or symptom assessment form

Exclusion Criteria:

1. Patient with peptic ulcer or gastroesophageal reflux disease
2. Patients with previous gastrointestinal surgery
3. Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
4. Patients with history of gastrointestinal cancer
5. Patients with pancreatic disease (pancreatitis, pancreatic cancer, etc), biliary disease, inflammatory bowel disease, acute gastritis.
6. Patients with Zollinger-Ellison syndrome
7. Patients with irritable bowel syndrome
8. Pregnant or lactating women
9. Patients with hepatic abnormality
10. Patients with renal dysfunction or chronic kidney disease
11. Patients who are judged by the investigators to be unsuitable to participate in the clinical trial.

Primary outcomes:
measure: The responder ratio of GOS(Global Overall Symptom)
timeFrame: at the 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Seong Nam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyung-gi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04968743: Phase-dependent Evaluation of Motor Cortex Excitability With TMS in Stroke
Official title: Phase-dependent Evaluation of Motor Cortex Excitability With TMS in Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on motor cortex excitability in individuals who have suffered stroke and to study the influence of the phase of the oscillatory rhythm (mu frequency) on motor excitability in stroke individuals.

Detailed description: Neurological disorders, including stroke, are associated with impaired movement leading to significant negative effects on quality of life. Transcranial magnetic stimulation (TMS) is increasingly being explored as a rehabilitation strategy to enhance plasticity in motor regions.

However, it is not yet fully understood how TMS acts on motor circuits and what optimal stimulation parameters are. TMS is a noninvasive neuromodulation method which enables in vivo perturbation of neural activity in humans through the application of electromagnetic fields to the brain. TMS has an established safety profile and has been explored extensively in clinical trials for a range of neurological and psychiatric disorders. Particularly, in potential positive effects of TMS have been identified for stroke rehabilitation. However, significant variability in treatment outcomes across patients has been found, making it necessary to improve current stimulation protocols and to investigate basic mechanism of action . The investigators plan to study the effects of TMS to the motor cortex in individuals who suffered stroke for movement rehabilitation. The investigators plan to measure motor evoked potentials (MEPs) at different phases of the motor mu-rhythm measured with EEG. Mu rhythms are related to healthy movement execution. By this, the investigators characterize phase-dependent cortical excitability differences in stroke.

Eligibility criteria: Inclusion Criteria:

* Suffering from chronic stroke, resulting in self-reported motor deficits (stroke occurring more than 6 months before study enrollment)
* Confident level of English language

Exclusion Criteria:

* Metal or electric implant in the head, neck, or chest area
* Upper extremity botulinum toxin treatment in the last 6 months
* Pregnancy or breastfeeding
* Prior occurrence of unprovoked seizure

Primary outcomes:
measure: Motor evoked potentials (MEPs)
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Department of Biomedical Engineering
name: Alexander Opitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02617043: Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
Official title: Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
hypofractionated whole breast irradiation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.


Eligibility criteria: Inclusion Criteria:

* Female
* 18-60 years old
* Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
* Pathologically confirmed invasive breast cancer
* A pathological T1-2N0M0 tumor
* Tumor bed is labeled with Titanium clips
* Negative surgical margins
* Written informed consent.

Exclusion Criteria:

* KPS\<70
* Treated with neoadjuvant chemotherapy
* Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm)
* With severe comorbidity
* Previous breast cancer or other malignant tumor history
* Previous radiotherapy for breast or thorax
* Medical contraindication for radiotherapy
* Pregnant or nursing

Primary outcomes:
measure: Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0
timeFrame: 2 year
Secondary outcomes:
measure: acute radiation-induced toxicity assessed by CTCAE v4.0
timeFrame: during radiotherapy; 3months; 6 months
measure: local-regional recurrence
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Overall survival Over survival
timeFrame: 5 years
measure: Late complications
timeFrame: 1,2,3,4,5years
measure: cosmetic effect measured by Harvard 4 scale evaluation system
timeFrame: 2,3,4,5years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xiaoli Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: