louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04597138: Deep Venous Thrombus Characteristics and Venous Dynamics With Subsequent Thrombus Resolution and Post-thrombotic Syndrome
Official title: The Relationship Between Deep Venous Thrombus Characteristics and Venous Dynamics With Subsequent Thrombus Resolution and Post-thrombotic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Keywords: Thrombus Resolution
Post-Thrombotic Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute, proximal DVT initiating anticoagulation

Brief summary: The goal of this study is to examine in vivo thrombosis characteristics with ultrasound shear wave elastography (SWE) and determine the relationship with thrombus resolution and postthrombotic syndrome (PTS) in patients with acute proximal Deep Vein Thrombosis (DVT).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute, proximal (popliteal and above) DVT with or without Pulmonary Embolism within 72 hours
* ≥18 Years Old

Exclusion Criteria

* prior episode of DVT
* contraindication to standard therapeutic anticoagulation

Primary outcomes:
measure: Thrombus Resolution
timeFrame: 3 Months after diagnosis of DVT.
Secondary outcomes:
measure: Post-thrombotic syndrome
timeFrame: 6 months after diagnosis of DVT
measure: Vein Specific Quality of Life
timeFrame: 6 months after diagnosis of DVT
Other outcomes:
measure: Post-thrombotic syndrome
timeFrame: 3 and 12 months after diagnosis of DVT
measure: Vein Specific Quality of Life
timeFrame: 3 and 12 months after diagnosis of DVT
measure: Thrombus Resolution
timeFrame: 3 Months after diagnosis of DVT.
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Damon Houghton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01510938: Probiotics in Respiratory Tract Infections in Children
Official title: Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Respiratory Tract
Keywords: Children
Respiratory Tract Infections
Prevention
Lead sponsor: Lviv National Medical University
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 242
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children


Eligibility criteria: Inclusion Criteria:

* Age 3-12 yrs
* At least one episode of respiratory tract infection in the previous epidemiological season
* Direct telephone access available
* Informed consent signed

Exclusion Criteria:

* Vaccination against the influenza
* Chronic adeno-tonsillar pathology
* Recurrent otitis
* Sinusitis
* Respiratory allergy
* Acute or chronic intestinal disease with diarrhea and/or malabsorption syndrome
* Lactose intolerance
* Functional or organic constipation
* Down syndrome
* Congenital or acquired heart disease
* Cerebral palsy
* Any chronic hepatic, renal, metabolic, or immune system disease

Primary outcomes:
measure: Incidence of respiratory tract infection episodes in a child
timeFrame: 1 month
Secondary outcomes:
measure: Duration of respiratory tract infection
timeFrame: 21 days
measure: Severity of respiratory tract infection
timeFrame: 21 days
measure: Complications of respiratory tract infections
timeFrame: 21 days
measure: Antibiotic prescriptions
timeFrame: 21 days
measure: Hospitalization rate
timeFrame: 21 days
measure: Number of unscheduled doctor visits
timeFrame: 21 days
measure: Number of days daycare/school missed
timeFrame: 21 days
measure: Number of workdays missed by parents
timeFrame: 21 days
measure: Time to resolution of individual CARIFS item
timeFrame: 21
measure: 25% and 50% decrease in the CARIFS score
timeFrame: 21day
measure: Percent and duration of the use of over-the-counter medications
timeFrame: 21day
Other outcomes:
Locations:
city: Lviv
country: Ukraine
facility: Lviv City Children Hospital
Study officials:
affiliation: Lviv National Medical University
name: Sergei V Gerasimov, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123238: Positioning of Surgical Patients With Sleep Apnea
Official title: Non-Supine Positioning in Treatment of Surgical Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to evaluate the effect of non-supine positioning in the treatment of surgical patients with obstructive sleep apnea. The hypothesis is that non-supine positioning will result in a decrease in acute hypoxic events, defined as the number of apneas/hypopneas per hour of sleep.

Detailed description: This is a prospective, randomized controlled trial that will comprise of two stages. Stage 1 is a pilot study of 30 patients at high risk or diagnosed with obstructive sleep apnea who are scheduled for routine surgery. These patients will be randomized 1:1:1 to standard of care (0 degree bed angle), 30 degree bed angle, or 60 degree bed angle. Acute hypoxic events will be analyzed pre and post-op in the randomly assigned bed position. PACU nurses will also be surveyed for patient-favored non-supine positioning (30 vs. 60 degrees). Stage 2 will be a larger, powered trial to evaluate the efficacy of just one bed angle (30 or 60 degrees) based on the Stage 1 results.

Eligibility criteria: Inclusion Criteria:

* Minimum 1 night postoperative hospital stay
* More than 18 and less than 80 years old
* Identified as high risk of OSA (SACS \> 15) or a history of OSA without CPAP treatment

Exclusion Criteria:

* Unwilling or unable to give informed consent
* Undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery
* Currently undergoing treatment for sleep apnea including CPAP
* Requiring prolonged postoperative ventilation
* NYHA functional class III and IV
* Valvular heart disease, dilated cardiomyopathy, implanted cardiac pacemaker, or unstable angina
* Myocardial infarction or cardiac surgery within 3 months
* Chronic obstructive pulmonary disease, or asthma
* Presence of tracheostomy, facial, neck, or chest wall abnormalities
* Abdominal aortic aneurysm surgery, chemotherapy, or immunosuppressive therapy within 3 months
* Visiting preoperative clinic less than 3 days before surgery
* Requiring postoperative nasogastric tube

Primary outcomes:
measure: Acute Hypoxic Index (AHI)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: Aryeh Shander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04619238: Reliability of KHQ and ICIQ-SF in Assessing Urinary Incontinence Effects in Polish Women
Official title: Reliability of The King's Health Questionnaire and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form in Assessing Urinary Incontinence Effects in Polish Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Overactive Bladder
Stress Urinary Incontinence
Urge Incontinence
Keywords: king's health questionnaire
the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women age 18-82 years who declared symptoms of urinary incontinence

Brief summary: The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.

Detailed description: Purpose The King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form are widely used in clinical practice. The aim of this study was to assess the psychometric properties of KHQ and ICIQ-SF in polish women.

Methods One hundred fifty-five women with urinary incontinence (UI) aged between 19-82 years underwent urodynamic investigation and completed both KHQ and ICIQ-SF. To evaluate the factor structure and construct the validity of the KHQ and ICIQ, Principal Component Analysis (PCA) using VARIMAX rotation was conducted for all questionnaire items. PCA results were also confirmed by Spearman's correlations between KHQ and ICIQ items. Moreover, the internal consistency of the KHQ and ICIQ was estimated by way of Cronbach's alpha coefficient (α). Statistical analysis was performed using STATISTICA version 13.1 software (StatSoft, Poland), as well as open source R software (version 3.4.4).

Eligibility criteria: Inclusion Criteria:

* informed consent
* patients with symptoms of urinary incontinence
* age 18-82 years

Exclusion Criteria:

* lack of consent
* inability to understand the study protocol

Primary outcomes:
measure: psychometric properties of KHQ in polish women with urinary incontinence
timeFrame: 2017-2018
measure: psychometric properties of ICIQ-SF in polish women with urinary incontinence
timeFrame: 2017-2018
Secondary outcomes:
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Katarzyna Skorupska
Study officials:
affiliation: Medical University of Lublin
name: Tomasz Rechberger, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01973738: Comparison Between Raloxifene and Bazedoxifene
Official title: Comparison of the Clinical Efficacy and Safety Between Raloxifene and Bazedoxifene in Postmenopausal Women.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Selective Estrogen Receptor Modulator
Keywords: raloxifene
bazedoxifene
bone mineral density
bone turnover markers
bone quality
Lead sponsor: Tomidahama Hospital
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 300
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Osteoporosis patients using SERM more for five years.

Brief summary: Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.

Detailed description: Selective estrogen receptor modulator (SERM) is an important option for postmenopausal osteoporosis. There are two SERM approved in Japan for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. One is raloxifene (RLX), and the other is bazedoxifene (BZA). There are few reports concerning to the clinical efficacy and safety data. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.

The main objective of this study is to reveal the effects of RLX and BZA on bone mineral density, bone turnover markers, and bone quality markers.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women

Exclusion Criteria:

* Patients who could not use SERM

Primary outcomes:
measure: Effects of raloxifene vs. bazedoxifene on bone mineral density, bone turnover markers and bone quality markers in postmenopausal osteoporosis.
timeFrame: Up to 72 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yokkaichi
country: Japan
facility: Tomidahama Hospital
state: Mie
Study officials:
References:
Clinical trial NCT04846738: Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors in Brain Damaged Patients Admitted to Intensive Care Unit
Official title: Comparative Interest of Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors at 12 Months in Brain Damaged Patients (Stroke or Head Trauma) Admitted to Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Damage
Keywords: Brain injury
Transcranial Doppler
Quantitative Pupillometry,
neurological prognosis
modified Rankin Score (mRS)
Glasgow Outcome Scale Extended (GOS-E)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All brain damaged patients (stroke or head trauma), admitted to Intensive Care Unit since December 1, 2020

Brief summary: Transcranial Doppler is performed daily in Intensive Care Unit in brain damaged patients. For a few years now, the measurement of the photomotor reflex by quantitative Pupillometry has been routinely performed in Intensive Care Units. The objective of this work is to see if Transcranial Doppler recorded parameters and Pupillary parameters are correlated to the neurological prognosis evaluated at 9 months by the Modified Rankin Score (mRS) and the Glasgow Outcome Scale Extended (GOS-E).


Eligibility criteria: Inclusion Criteria:

* All brain damaged patients (stroke or head trauma)
* Admitted to Intensive Care Unit since December 1, 2020

Exclusion Criteria:

* Refusal by the patient or his/her legal representative.
* Benefiting from legal protection

Primary outcomes:
measure: Modified Rankin Score (mRS) (0-5)
timeFrame: Year: 1
measure: Glasgow Outcome Scale Extended (GOS-E) (1-8)
timeFrame: Year: 1
Secondary outcomes:
measure: Mean Systolic Velocity (VMS)
timeFrame: At inclusion
measure: Intra-Cranial Pressure (ICP)
timeFrame: At inclusion
measure: Pulsatility Index (PI)
timeFrame: At inclusion
measure: Tele-Diastolic Velocity (TDV)
timeFrame: At inclusion
measure: Basic pupil diameter
timeFrame: At inclusion
measure: Percentage of variation of the pupil diameter
timeFrame: At inclusion
measure: Latent and slope of the standard photomotor reflex
timeFrame: At inclusion
measure: Tissue Partial Oxygen Pressure (PtiO2)
timeFrame: At inclusion
measure: Bispectral Index (BIS)
timeFrame: At inclusion
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: At inclusion
measure: Heart rate
timeFrame: At inclusion
measure: Blood pressure
timeFrame: At inclusion
measure: Natremia (mmol/l)
timeFrame: At inclusion
measure: Glycemia (mmol/l)
timeFrame: At inclusion
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David CHARIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002338: Different Surgical Techniques for Pterygium Surgery
Official title: Epidemiological Profile and Comparison Between Different Surgical Techniques for Pterygium Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pterygium
Keywords: pterygium surgery
refractive changes
surgical technique
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who were underwent pterygium surgery

Brief summary: A study to research the post-operative results according to the chosen surgical technique and evaluate the refractive changes before and after the excision of pterygium.

Detailed description: To analyze the epidemiological profile of patients who were operated of pterygium in Eyes Institute of Goiânia, analyze the post-operative results according to the chosen surgical technique and evaluate the refractive changes before and after the excision of pterygium.

Eligibility criteria: Inclusion Criteria:

* Patients who were underwent the pterygium surgery during the period between from February 2013 to August 2013

Exclusion Criteria:

* Patients with mature cataract

Primary outcomes:
measure: Refractive pre-operative
timeFrame: 8 weeks
Secondary outcomes:
measure: Refractive post-operative
timeFrame: 8 weeks
Other outcomes:
measure: Comparison between different surgical techniques for pterygium surgery
timeFrame: 6 weeks
Locations:
city: Goiania
country: Brazil
facility: Instituto de Olhos de Goiania
state: Goias
Study officials:
affiliation: Instituto de Olhos de Goiania
name: Adriana R Almeida, MS-V
role: STUDY_CHAIR
affiliation: Instituto de Olhos de Goiania
name: Larissa S Stival, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02366338: PRescriptiOn PattERns Of Oral Anticoagulants
Official title: PRescriptiOn PattERns Of Oral Anticoagulants in Non-valvular Atrial Fibrillation: A Single Center Experience From Turkey (PROPER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 148
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: Non-valvular AF patients

Brief summary: Atrial fibrillation is the major cause of acute ischemic stroke. The risk of stroke was shown to decline by oral anticoagulant therapy. The investigators intended to evaluate appropriate use of anticoagulants in non-valvular AF patients.

Detailed description: Atrial fibrillation, the most common sustained arrhythmia, is the major cause of acute ischemic stroke. The prognosis of ischemic stroke associated with atrial fibrillation (AF) tends to have a worse prognosis for recovery compared with other ischemic stroke subtypes. The risk of stroke was shown to decline to 68% by oral anticoagulant (OAC) therapy.The investigators have evaluated appropriate use of anticoagulants in non-valvular AF patients. Appropriate use of oral anticoagulants was assessed by Medication Appropriateness Index (MAI). The MAI consists of 10 criteias namely, indication, choice, dosage, modalities and practicability of administration, drug-drug interactions, drug-disease interactions, duplication, duration, and cost-effectiveness. The tenth criteria was not evaluated because of limited data regarding cost-effectiveness of the drugs.

Eligibility criteria: Inclusion Criteria:

* Non valbular AF \>18 years

Exclusion Criteria:

* Not currently receiving anticoagulant

Primary outcomes:
measure: Number of Patients With at Least One Inappropriate MAI Criterion
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Ozcan Basaran
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03862638: Yoga Therapy for Chronic Tension-Type Headache
Official title: Yoga Therapy for Chronic Tension-Type Headache: An Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tension-Type Headache
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Yog-Kulam
name: Department of Zoology, University of Rajasthan, India
First posted: 2019-03-05
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic tension headache represents a considerable social burden in terms of both costs to the health services and also the costs of lost productivity. Episodic tension-type headache can be treated with rest and analgesics, while chronic tension-type headache demands a more fundamental treatment.

Effectiveness of yoga therapy in the management of chronic tension type headache is limited. In this study, yoga therapy was used to explore its effect on chronic tension-type headache.


Eligibility criteria: Inclusion Criteria:

* Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta);
* Aged 18-55 years;
* Having the ability of understanding and completing the headache dairy;
* Provide written informed consent.

Exclusion Criteria:

* No headache during the pervious 3 months;
* Taking any prophylactic medication during the previous one month;
* Secondary headache or any systematic cause
* Having serious conditions of the heart, liver, kidney or other organs;
* In pregnancy or lactation, or planning to be pregnant in 6 months;
* Drug and Substance abuse
* Diagnosed psychiatric condition
* Taking any other complementary and alternative medicines
* Practicing yoga of any kind in last three months

Primary outcomes:
measure: The number of days with headache
timeFrame: Change from baseline to 12-week of intervention
Secondary outcomes:
measure: The medication intake
timeFrame: Change from baseline to 12 week of intervention
measure: Intensity of Pan
timeFrame: Change from baseline to12 week of intervention
measure: Duration of Pain
timeFrame: Change from baseline to12 week of intervention
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Research Institue
state: Rajasthan
Study officials:
affiliation: Yog-Kulam
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deaprtment of Zoology, University of Rajasthan
name: PJ John, PhD
role: STUDY_DIRECTOR
affiliation: SMS Medical College and Hospital
name: Chandra M Sharma, DM
role: STUDY_CHAIR
References: