louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01051297: Obstructive Sleep Apnea and Venous Thromboembolism
Official title: Patients With Obstructive Sleep Apnea (OSA), Independent of Obesity, Are at Increased Risk of Venous Thromboembolic Events (VTE)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstructive Sleep Apnea
Venous Thrombosis
Pulmonary Embolism
Venous Thromboembolism
Keywords: Obstructive sleep apnea
venous thrombosis
pulmonary embolism
venous thromboembolism
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (\>=18 years) with sleep study , OSA or VTE

Brief summary: There is a clear link between obstructive sleep apnea (OSA) and cardiovascular disease. However, there has been no clear link between OSA and venous thromboembolism (VTE). The objective of this study is to evaluate such a link.

Detailed description: Design:

1. retrospective chart review of all patients with VTE over 10 year period
2. retrospective chart review of all patients with OSA over 10 year period
3. prospective 1 year follow up of all patients diagnosed with new VTE
4. prospective 1 year follow up of all patients undergoing sleep study

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>= 18 years) with sleep study, OSA or VTE

Exclusion Criteria:

* Below 18 years of age

Primary outcomes:
measure: incidence of VTE for the OSA cohort
timeFrame: 12 months
measure: incidence of OSA for the VTE cohort
timeFrame: 12 months
Secondary outcomes:
measure: death
timeFrame: 12 month
measure: bleeding
timeFrame: 12 months
measure: composite outcome of death, VTE , or bleeding
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri-Columbia
name: OUSAMA DABBAGH, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Columbia
name: JAMES P BOSANQUET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosanquet JP, Bade BC, Zia MF, Karo A, Hassan O, Hess BT, Dabbagh O. Patients with venous thromboembolism appear to have higher prevalence of obstructive sleep apnea than the general population. Clin Appl Thromb Hemost. 2011 Nov-Dec;17(6):E119-24. doi: 10.1177/1076029610389023. Epub 2010 Dec 15.
Clinical trial NCT02994797: Ultrasound Elastography of Salivary Glands
Official title: Elastometry of the Salivary Glands in Sicca Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: sjögren Disease
Keywords: salivary glands
ultrasonography
elastometry
elastography
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 78
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: NON_PROBABILITY_SAMPLE
Study population: male or female

more than 18 years old

consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome

Brief summary: Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS.


Eligibility criteria: Inclusion Criteria:

* Male or female
* More than 18 years old
* Consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome
* Consent agreement

Exclusion Criteria:

* No consent agreement
* No sicca symptoms

Primary outcomes:
measure: salivary glands elastometry
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
References:
Clinical trial NCT06751797: Balance Confidence and Kinesiophobia in Parkinson's Disease
Official title: Balance Confidence, Kinesiophobia, and Associated Factors in Parkinson's Disease: A Controlled Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson disease and healthy controls

Brief summary: 31 patients aged 50-80 years diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stages 1-3) and 31 healthy volunteers. At the start of the study, sociodemographic data for all participants will be recorded. To assess the mental and functional status of Parkinson's disease patients, the Mini-Mental State Examination (MMSE) and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used. Balance confidence levels will be assessed using the Activities-specific Balance Confidence Scale-6 (ABC-6), overall balance using the Berg Balance Scale (BBS), fear of falling using the Falls Efficacy Scale (FES), and kinesiophobia levels using the Tampa Scale of Kinesiophobia (TSK).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Idiopathic Parkinson's Disease by a neurology specialist.
* Modified Hoehn-Yahr Staging Scale classification between stages 1-3.
* Mini-Mental State Examination (MMSE) score of 24 or higher.
* Age between 50-80 years.
* Volunteered to participate in the study.

Exclusion Criteria:

* Use of medications, apart from routine Parkinson's disease treatments, that could affect balance or muscle strength.
* Presence of neurological or musculoskeletal conditions other than Parkinson's disease.
* Refusal to participate in the study.
* Presence of psychiatric disorders.
* Presence of cognitive impairments.

Primary outcomes:
measure: Balance Confidence (ABC-6 Scale)
timeFrame: Baseline
Secondary outcomes:
measure: Balance Level (Berg Balance Scale)
timeFrame: Baseline
measure: Fear of Falling (Falls Efficacy Scale)
timeFrame: Baseline
measure: Kinesiophobia (Tampa Scale of Kinesiophobia)
timeFrame: Baseline
measure: Mental Status (MMSE)
timeFrame: Baseline
measure: Functional status (MDS-UPDRS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
Study officials:
References:
Clinical trial NCT06337097: STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
Official title: STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immune Checkpoint Therapy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects.

Detailed description: Primary Objectives:

* Myocarditis CTCAE version 5.0 grade ≥ 3
* Ventricular tachycardia (≥ 30 seconds)
* Advanced atrioventricular block
* Incident heart failure event
* Cardiovascular mortality
* Non-fatal sudden cardiac arrest
* Acute coronary syndrome
* Pericarditis
* Pericardial tamponade

Secondary Objectives:

* Time from symptom onset to diagnosis of major adverse cardiovascular events
* Time from symptom onset to diagnosis of myocarditis
* Initial hospitalization duration for the adverse cardiovascular event from primary endpoint
* Peak biomarker levels including troponin T, troponin I, creatine kinase, and creatine kinase myocardial band
* Percentage of patients with negative workup for myocarditis
* Percentage of patients requiring major cardiac testing including echocardiograms, cardiac magnetic resonance imaging, and/or invasive heart catheterization
* Duration of interruption and/or discontinuation of immune checkpoint inhibitor therapy
* Cancer progression free survival
* Time to next cancer therapy

Eligibility criteria: Inclusion Criteria:

* Male or female patient ≥18 years old
* Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic
* Willingness to provide informed consent

Exclusion Criteria:

* Troponin T not available at screening or prior to randomization
* Inability to comply with planned study procedures
* Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment
* Any medical condition that could interfere with, or for which the treatment might interfere with the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the participant by participating in the study
* Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.

Primary outcomes:
measure: Safety and adverse events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Nicolas Palaskas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03687697: Comparison of Global, G-TL, & Cornell Media
Official title: A Randomized Controlled Trial Comparing Global Medium With G-TL, Cornell Single and Sequential Steps Media by the Time-Lapse System.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infertility
Keywords: IVF
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 0
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: OTHER

Brief summary: This is a prospective, randomized clinical trial to compare the Global commercial single step media to 1) G-TL (Vitrolife), 2) Weill Cornell's single step and sequential steps media, which all support human embryo development in the laboratory using the Vitrolife Time-Lapse system. The main goal of the study is to identify the best culture medium for optimal embryo development.

Detailed description: Culture media are used to culture embryos in order to support their development in the laboratory. New media are being introduced to the market. Clinical studies have shown that the use of the single-step Global medium for culture of human embryos from the zygote stage to the blastocyst stage has resulted in better in-vitro development than a variety of sequential media system.

Global is a FDA approved commercial single-step medium for all embryo culture from Day 0 to the blastocyst stage.

G-TL (Time-Lapse) is a FDA approved commercial single-step medium from Vitrolife. It was developed to be used with time-lapse devices as a continuous embryo culture medium from Day 0 to Day 5/6.

C3 is Cornell's in house made single-step buffered medium for embryo culture from oocyte fertilization to blastocyst stage used as standard of care.

C1/C2 is Cornell's in house made buffered sequential medium otherwise known as multi step medium, use to culture embryos for development. It is formulated to meet the embryos requirements at two specific stages of development but require removal of the dish from the incubator to physically exchange the culture media surrounding the embryos. This medium will be the control.

Eligibility criteria: Inclusion Criteria:

* 40 years of age or younger (maternal)
* 65 years of age or younger (paternal)
* 10 or more oocytes
* Fresh or frozen oocytes (including donor)
* Fresh or frozen (including donor) sperm can be used
* ICSI only
* Frozen embryos from this study can be included in the outcome portion of this study.
* PGD and/or PGS patients included

Exclusion Criteria:

* Patients with less than 10 oocytes
* Co-culture patients

Primary outcomes:
measure: Embryo development
timeFrame: Day 5
Secondary outcomes:
measure: Implantation rate
timeFrame: 4 weeks
measure: Pregnancy rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Reproductive Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nikica Zaninovic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02079597: The Role of Ninjurin-1 During Systemic Inflammation
Official title: Prospective Study to Analyze Ninjurin-1 and Its Soluble Part During Systemic Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ninj1 Expression
SIRS
Keywords: SIRS
Ninj1
Sepsis
Healthy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SIRS patients: Intensive care unit

Brief summary: * With the underlying study the investigators address the question if Ninjurin-1 (Ninj1) expression is altered in patients with systemic inflammatory response syndrome (SIRS) in comparison to healthy volunteers.
* The adhesion molecule Ninj1 is induced following nerve injury where it contributes to nerve generation. Besides it is described to facilitate leukocyte migration especially in the nervous system.
* The investigators hypothesize that Ninj1 expression is increased in SIRS patients, which will fortify its impact during inflammation and the transferability from bench to bedside.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* cardiac surgery patients

Exclusion Criteria:

* included in an interventional study
* Preoperative Infection (e.g. Endocarditis)

Primary outcomes:
measure: Ninj1 expression on blood leukocytes
timeFrame: one day post surgery
Secondary outcomes:
measure: grade of systemic inflammation
timeFrame: one day post surgery
Other outcomes:
measure: Soluble Ninj1 concentration/expression rates
timeFrame: one day post surgery
Locations:
city: Frankfurt
country: Germany
facility: Department of Anesthesiology, University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Department of Anesthesiology, University Hospital Frankfurt
name: Patrick Meybohm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00891397: Pregabalin Versus Placebo as an Add on for Complex Regional Pain Syndrome (CPRS) of the Upper Limb Managed by Stellate Ganglion Block (The PREGA Study)
Official title: Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Complex Regional Pain Syndromes
Keywords: CPRS
stellate ganglion block
pregabalin
pain
Type I
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Hamilton Health Sciences Corporation
First posted: 2009-05-01
Enrollment: 14
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 purpose of this study is to assess the efficacy of pregabalin in patients with complex regional pain syndrome Type I and to determine whether it provides clinically significant pain relief and whether it improves functioning of the upper limb.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with CRPS Type I as per the IASP (International Association for the Study of Pain) criteria which states presence of an initiating noxious event, or cause for immobilization
* Evidence at some point of swelling, color change, hot/cold/sweaty sensation and no other condition which can account for the pain and dysfunction of the upper limb
* Men or women between ages 18-65 year old
* Women should not be pregnant or breast feeding
* No change in treatment for 4 weeks prior to recruitment
* Pain scores of 4/10 on a verbal analogue scale

Exclusion Criteria:

* Patients with a neurologic disorder unrelated to CRPS
* Patients who are already on pregabalin
* Patients with renal impairment whose creatinine clearance is less than 60 ml/min
* Patients with congestive heart failure who are also diabetic and taking thiazolidinedione medication like rivoglitazone
* Unstable psychiatric history
* Patients with another problem with equal or worse pain
* Unstable medical condition

Primary outcomes:
measure: Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly.
timeFrame: Three months
Secondary outcomes:
measure: Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form.
timeFrame: Three months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Norman Buckley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freynhagen R, Strojek K, Griesing T, Whalen E, Balkenohl M. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain. 2005 Jun;115(3):254-263. doi: 10.1016/j.pain.2005.02.032. Epub 2005 Apr 18.
Clinical trial NCT03847597: Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment
Official title: Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Limb Ischemia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 50
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: Patients with chronic limb ischemia that are scheduled for transfemoral amputation

Brief summary: The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting).

However, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. Furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment.

There is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.


Eligibility criteria: Inclusion criteria:

* Age \> 18 years old
* Men and women
* Patient with chronic limb ischemia that is scheduled for transfemoral amputation in the University Hospital of Strasbourg
* Patient giving his -non-opposition to the explantation and use of the femoro-popliteal arterial segment

Exclusion criteria:

* Refusal to give his consent
* Impossibility to give clear information to the patient
* Pregnant and breastfeeding women
* Patient under administrative protection

Primary outcomes:
measure: Descriptive analysis of the arterial structure in micro-CT.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Nabil CHAKFE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05915897: Whole Blood Biospecimen Collection for Subjects With Chronic Granulomatous Disease (CGD)
Official title: Whole Blood Biospecimen Collection for Subjects With Chronic Granulomatous Disease (CGD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Granulomatous Disease
Lead sponsor: Sanguine Biosciences
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants have been diagnosed with Chronic Granulomatous Disease (CGD)

Brief summary: The primary study objective is to collect biospecimen samples (e.g., blood) from participants diagnosed with Chronic Granulomatous Disease (CGD). The biospecimens will be used to create a biorepository that can be used to identify disease associated biomarkers and potential targets with immune and multi-omics profiling. The disease sample collection and analysis will be the foundation for an extensive network of biospecimen access and linked datasets for future translational research.


Eligibility criteria: Inclusion Criteria:

* The participant is willing and able to provide written informed consent
* The participant is willing and able to provide appropriate photo identification
* Participants aged 18 to 85
* Participants have been diagnosed with Chronic Granulomatous Disease (CGD)
* Subjects who have a confirmed p47phox CGD mutation or Subjects who have a confirmed X-linked CGD mutation

Exclusion Criteria:

* Participants who are pregnant or are nursing
* Participants with a known history of HIV, hepatitis, or other infectious diseases
* Participants who have taken an investigational product in the last 30 days
* Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months

Primary outcomes:
measure: Participants have been diagnosed with Chronic Granulomatous Disease (CGD)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Sanguine BioSciences, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT02762097: Clinical Pregnancy Rate After Removal of Unsuspected Polyps
Official title: Clinical Pregnancy Rate in Women With Unexplained Infertility After Removal of Unsuspected Intrauterine Pathology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Infertility
Keywords: polyps
saline sonography
infertility
Lead sponsor: Karachi Medical and Dental College
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polyps are fleshy outgrowths of the inner lining of the womb which may hinder implantation of embryo and lead to subfertility.This study evaluates whether removal of endometrial polyps in womb affects chances of pregnancy in women in whom no other causes of subfertility can be found. Half of the women would have these polyps removed after their consent and the other half who would not consent would not undergo any such intervention


Eligibility criteria: Inclusion Criteria:

* Normal semen analysis
* 24 months of unprotected sexual intercourse
* NORMAL TVS
* Normal hysterosalpingogram
* Evidence of spontaneous ovulation
* No history of Pelvic inflammatory disease
* Polyps on saline sonography

Exclusion Criteria:

* History of taking hormones
* Thyroid disorder
* prior hysteroscopy treatment
* intermenstrual blood loss.

Primary outcomes:
measure: Clinical pregnancy rate:
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: