louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02240654: Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe
Official title: Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 36573
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New users of dabigatran etexilate in each database

Brief summary: This is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first captured prescription of dabigatran etexilate in each database. The study will be conducted using Cegedim Strategic Database (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink (CPRD, UK).

Detailed description: Study Design:

Eligibility criteria: Inclusion criteria:

1. Have at least 1 year of enrolment in the electronic database.
2. Have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.

Primary outcomes:
measure: Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.
timeFrame: Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: 1160.144.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Cainzos-Achirica M, Varas-Lorenzo C, Pottegard A, Asmar J, Plana E, Rasmussen L, Bizouard G, Forns J, Hellfritzsch M, Zint K, Perez-Gutthann S, Pladevall-Vila M. Methodological challenges when evaluating potential off-label prescribing of drugs using electronic health care databases: A case study of dabigatran etexilate in Europe. Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):713-723. doi: 10.1002/pds.4416. Epub 2018 Mar 23.
Clinical trial NCT06368154: Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity
Official title: Prospective Cohort Study of Exosomal microRNAs as Biomarkers for Diagnosis and Therapeutic Efficacy Evaluation of Metabolic Bone Diseases in Premature Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Exosomes
Newborn
Bone Diseases, Metabolic
Lead sponsor: Hunan Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-16
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gestational age \< 37 weeks, corrected gestational age \< 44 weeks, there was no history of surgery, blood transfusion, congenital malformation and inherited metabolic diseases.

Brief summary: Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs.


Eligibility criteria: Inclusion Criteria:

* The gestational age was 37+0-41+6 weeks and the age was less than 28 days

Exclusion Criteria:

* There was no blood transfusion, no operation, no congenital malformation, no inherited metabolic diseases, no history of intravenous nutrition, and no intestinal diseases

Primary outcomes:
measure: exosomes
timeFrame: 6 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT02251054: Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder
Official title: Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Multimedia
Behavioral Therapy
Lead sponsor: Miami VA Healthcare System
Sponsor class: FED
Collaborators: name: Pfizer
First posted: 2014-09-26
Enrollment: 47
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study compares the efficacy of embedding avatars into an online self-management program that teaches OAB behavioral therapy on OAB-related quality of life, symptoms, self-efficacy, and adherence versus the same program without avatars


Eligibility criteria: Inclusion Criteria:

* age 55 or older
* women living in the community
* who could read and speak English
* urgency (≥3 episodes/24 hrs.) ± urge urinary incontinence
* urinary frequency (≥8 times/24 hrs.)
* nocturia (awakening ≥2 times at night)

Exclusion Criteria:

* hematuria
* abdominal pain
* fever
* cognitive impairment (Mini-Cog \< 3)
* positive screen for depression (PHQ2 \> 3)
* hearing issues
* uncorrected visual difficulties

Primary outcomes:
measure: Overactive bladder- health related quality of life (OAB HRQOL)
timeFrame: Baseline and at one, six, and 12 weeks
Secondary outcomes:
measure: Perception of Bladder Condition (PPBC)
timeFrame: Baseline and at one, six, and 12 weeks
measure: Overactive bladder symptoms
timeFrame: 12 weeks duration
measure: Geriatric Self-Efficacy Index for Urinary Incontinence (GSEI)
timeFrame: Baseline and at one, six, and 12 weeks
measure: Adherence to Pelvic Floor Muscle Exercises (PFMEs)
timeFrame: Baseline and at one, six, and 12 weeks
measure: Avatar Recognition
timeFrame: At 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
Study officials:
affiliation: Miami VAHS
name: Allen D Andrade, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrade AD, Anam R, Karanam C, Downey P, Ruiz JG. An overactive bladder online self-management program with embedded avatars: a randomized controlled trial of efficacy. Urology. 2015 Mar;85(3):561-7. doi: 10.1016/j.urology.2014.11.017. Epub 2015 Jan 10.
Clinical trial NCT01118754: Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Official title: Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dry Eye
Keywords: Santen
Dry
Eye
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 132
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 purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of dry eye defined by protocol
* 18 years or older, and sign written informed consent
* negative pregnancy test and utilizing reliable contraceptive throughout study

Exclusion Criteria:

* use of any topical ocular medications
* any ocular surgery within 90 days of study
* laser refractive surgery within one year of study
* ocular, lid disease/abnormalities that may interfere with the study
* corneal transplants
* uncontrolled systemic conditions
* females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
* participated in another drug trial within 30 days prior to study

Primary outcomes:
measure: Total fluorescein corneal staining
timeFrame: 8 weeks
measure: Ocular Symptom Severity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Inglewood
country: United States
state: California
city: Torrance
country: United States
state: California
city: Bloomfield
country: United States
state: Connecticut
city: Indianapolis
country: United States
state: Indiana
city: New Albany
country: United States
state: Indiana
city: Gretna
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: San Antonio
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT02201654: Stylet vs No Stylet During EBUS TBNA
Official title: Stylet Versus no Stylet in Endobronchial Ultrasound Transbronchial Aspiration (EBUS-TBNA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This research study compares two ways to biopsy lymph nodes in the chest using endobronchial ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted through the mouth into the large airways of the chest, allowing us to see (via ultrasound) and biopsy the lymph nodes in the chest.

The purpose of this research study is to determine if the EBUS-TBNA procedure can be made simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an inner stylet that runs through the middle of the needle. Because many other biopsy needles (such as the needles used in breast biopsy and different types of lung biopsy needles) do not use an inner stylet, the investigators do not think the use of a stylet is necessary. If this step can be safely eliminated without decreasing the effectiveness of the procedure, this could shorten the procedure (saving time). This study is deigned to formally test the hypothesis that a stylet is not necessary in EBUS-TBNA.


Eligibility criteria: Inclusion Criteria:

* All patients \>18 years old and capable of informed consent refereed for EBUS-TBNA at our institution.

Exclusion Criteria:

* Standard contraindications to EBUS (coagulopathy, anti-platlet/anti-coagulant use, clinical instability)
* Pregnant women

Primary outcomes:
measure: Diagnostic agreement (percentage of samples that have the same diagnosis)
timeFrame: At time of biopsy
Secondary outcomes:
measure: Pneumothorax rate (percentage of procedures that result in a pneumothorax)
timeFrame: 1 week post-procedure
measure: Bleeding rate (% of procedures that have significant bleeding)
timeFrame: 1 week post-procedure
measure: Hospital Admission (% of procedures that result in unanticipated admission to the hospital)
timeFrame: 1 week post-procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
References:
Clinical trial NCT01781754: Changes in Mitochondrial Uncoupling Protein 2 (UCP2) Messenger RNA(mRNA) in Type 2 Diabetes (T2DM) Patients
Official title: Changes in UCP2 mRNA in T2DM Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Keywords: Glycemic control
Metabolic control
Oxidative stress
Diabetes
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Un balanced diabetic patients

Brief summary: Many patients with Diabetes find difficulties in achieving glycemic control. Hemoglobin A1c(HgBA1c) is used as a marker for glycemic control. UCP2 is affected by high glucose levels, high free fatty acids and high oxidative stress.

The investigators intend to learn about the changes in UCP2 along the process of reaching glycemic control.


Eligibility criteria: Inclusion Criteria:

* Un balanced diabetic patients.

Exclusion Criteria:

* No current infection.

Primary outcomes:
measure: Levels of gene expression for UCP2 (RQ)
timeFrame: 6 months
Secondary outcomes:
measure: Improved metabolic state
timeFrame: 6 months
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
citation: Dmitriev AD, Factor MI, Segal OL, Pavlova EV, Massino YS, Smirnova MB, Yakovleva DA, Dmitriev DA, Kizim EA, Kolyaskina GI, Brusov OS. Western blot analysis of human and rat serotonin transporter in platelets and brain using site-specific antibodies: evidence that transporter undergoes endoproteolytic cleavage. Clin Chim Acta. 2005 Jun;356(1-2):76-94. doi: 10.1016/j.cccn.2004.12.019. Epub 2005 Mar 17.
citation: Rudofsky G Jr, Schroedter A, Schlotterer A, Voron'ko OE, Schlimme M, Tafel J, Isermann BH, Humpert PM, Morcos M, Bierhaus A, Nawroth PP, Hamann A. Functional polymorphisms of UCP2 and UCP3 are associated with a reduced prevalence of diabetic neuropathy in patients with type 1 diabetes. Diabetes Care. 2006 Jan;29(1):89-94. doi: 10.2337/diacare.29.01.06.dc05-0757.
citation: Dulloo AG, Samec S. Uncoupling proteins: their roles in adaptive thermogenesis and substrate metabolism reconsidered. Br J Nutr. 2001 Aug;86(2):123-39. doi: 10.1079/bjn2001412.
citation: Schrauwen P, Hesselink M. UCP2 and UCP3 in muscle controlling body metabolism. J Exp Biol. 2002 Aug;205(Pt 15):2275-85. doi: 10.1242/jeb.205.15.2275.
citation: Rendel M. Advances in diabetes for the millennium: nutritional therapy of type 2 diabetes. MedGenMed. 2004 Sep 1;6(3 Suppl):10.
citation: Krauss S, Zhang CY, Lowell BB. The mitochondrial uncoupling-protein homologues. Nat Rev Mol Cell Biol. 2005 Mar;6(3):248-61. doi: 10.1038/nrm1592.
citation: Borecky J, Vercesi AE. Plant uncoupling mitochondrial protein and alternative oxidase: energy metabolism and stress. Biosci Rep. 2005 Jun-Aug;25(3-4):271-86. doi: 10.1007/s10540-005-2889-2.
Clinical trial NCT01879254: Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD).
Official title: Long-term Follow-up in Patients With Deep Brain Stimulation (DBS) for Severe Treatment Refractory Obsessive Compulsive Disorder (OCD).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive Compulsive Disorder (OCD)
Keywords: obsessive compulsive disorder (OCD)
deep brain stimulation (DBS)
psychosurgery
long-term follow-up
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have received DBS for OCD will be included in this study.

Brief summary: For this human research, 17 treatment-refractory OCD patients who already received DBS implants for treatment refractory OCD between June 1998 and October 2007 will be included. New patients that complete the protocol on "refining the target for DBS in OCD" will be included in this follow-up study as well. They will be psychiatrically evaluated on regular bases: at least twice yearly in the years two to five after surgery, at least once a year for the years thereafter. The duration of this protocol is indefinite, but spans at least 10 years. The main aim of this study is to investigate the long-term effect of DBS in OCD patients.


Eligibility criteria: Inclusion Criteria:

* Patients who have received DBS implantation for the treatment of OCD

Exclusion Criteria:

-

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT06450054: Effects of Aerobic Training in Diabetic vs Non-Diabetic Post-Stroke Patients
Official title: Effects of Aerobic Training in Diabetic vs Non-Diabetic Post-Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to investigate the effects of aerobic training in post-stroke patients, both diabetic and non-diabetic, in terms of their metabolic response to exercise and psychosocial well-being. It is crucial to understand the metabolic changes that occur due to stroke and diabetes, including glucose and lipid profiles.

Detailed description: The study will explore how aerobic training can influence insulin sensitivity and lipid metabolism differently in diabetic and non-diabetic patients, which may affect overall recovery outcomes. It is also essential to assess psychosocial well-being, including depression and satisfaction with life. Aerobic exercise has been shown to improve mood and enhance overall quality of life in post-stroke patients. By assessing these variables comprehensively, tailored rehabilitation strategies can be developed to optimise metabolic and psychosocial outcomes in diabetic and non-diabetic post-stroke populations, ultimately improving overall well-being and quality of life.

Eligibility criteria: Inclusion Criteria:

* Male and female post-stroke patients will be inactive or insufficiently active.
* The Patient's age ranged from 18 to 74. They will have a balanced sitting position or can ambulate.
* The stroke will not last less than six months and not more than two years.
* Exercises will be performed at a vigorous intensity greater than 60% of the individual's maximum cardiorespiratory capacity.
* Patients with adequate cognitive abilities (Mini-Mental Scale \>24) to understand and obey instructions

Exclusion Criteria:

* Unconscious patients or communication problems that could prevent them from completing the tests used in the study.
* Those with bilateral or previous hemiplegia and sensory aphasia
* Comorbid neurological diseases (multiple sclerosis, Parkinson's disease, spinal cord injury, traumatic brain injury, brain tumour, etc.
* Those with any contraindications for the maximum exercise test
* Cardiovascular or pulmonary conditions (unsettled angina, current myocardial infarction during the last three months, congestive heart failure, severe heart valve dysfunction)
* Musculoskeletal problems such as extreme arthritis and fracture

Primary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: IMC Physical Therapy Hospital (Neuro-Rehab Department) DHA
Study officials:
References:
Clinical trial NCT01359254: Cord Blood Transplantation for Patients With Cancer
Official title: Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hematological Disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.

Detailed description: Primary Objective

- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease

Secondary Objectives

* To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
* To describe the incidence and severity of acute and chronic GVHD.

Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory acute leukemia (myeloid or lymphoid)
* Acute leukemia in first remission at high-risk for recurrence
* Chronic myelogenous leukemia in accelerated phase or blast-crisis
* Chronic myelogenous leukemia in chronic phase
* Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
* Chronic lymphocytic leukemia, relapsed or with poor prognostic features
* Multiple myeloma
* Myelodysplastic syndrome
* Chronic myeloproliferative disease
* Hemoglobinopathies
* Aplastic anemia

Exclusion Criteria:

* Zubrod performance status \> 2
* Life expectancy is severely limited by concomitant illness
* Patients with severely decreased LVEF or impaired pulmonary function tests
* Estimated Creatinine Clearance \<50 ml/min
* Serum bilirubin\> 2.0 mg/dl or SGPT \>3 x upper limit of normal
* Evidence of chronic active hepatitis or cirrhosis
* HIV-positive
* Patient is pregnant
* Patient or guardian not able to sign informed consent

Primary outcomes:
measure: Cord Blood Engraftment by Day 100
timeFrame: 100 days
Secondary outcomes:
measure: Survival at Day 100
timeFrame: 100 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Andrew Artz, MD
role: PRINCIPAL_INVESTIGATOR
References: