louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00117546: Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia
Official title: Cardiovascular Performance and Autonomic Reactivity in Formerly Preeclamptic Women With a Contracted Plasma Volume (CAPACITY Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preeclampsia
Keywords: CAPACITY trial
preeclampsia
plasma volume
sympathetic activity
hypertension
cardiovascular system
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-07-07
Enrollment: 35
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: A history of preeclampsia is associated with a low plasma volume and higher sympathetic activity. Methyldopa will suppress sympathetic activity to normal values. In this study, the researchers will test that effect on the total cardiovascular balance.

Detailed description: This is a randomized double-blind placebo controlled cross-over study in formerly preeclamptic women with a contracted plasma volume. The researchers will test the effect of methyldopa on the cardiovascular balance and orthostatic tolerance in women with a history of preeclampsia and healthy controls.

Eligibility criteria: Inclusion Criteria:

* Primiparous
* History of preeclampsia
* Low plasma volume

Exclusion Criteria:

* Thrombophilia
* Hypertension
* Auto-immune disorder
* Insulin dependent diabetes mellitus

Primary outcomes:
measure: normalized plasma volume
timeFrame: 1 month
Secondary outcomes:
measure: increased orthostatic tolerance
timeFrame: 1 month
measure: normalized cardiovascular balance
timeFrame: 1 month
measure: venous capacitance
timeFrame: 1 month
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
Study officials:
affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre
name: Ineke Krabbendam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00270946: Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
Official title: A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Venous Stasis Ulcer
Keywords: Venous leg ulcer
OrCel
Compression therapy
Lead sponsor: Ortec International
Sponsor class: INDUSTRY
First posted: 2005-12-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy.

Patients were treated for 12 weeks. Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound.


Eligibility criteria: Inclusion Criteria:

* Any race, between 18 and 85 years of age
* Male or female
* Chronic venous insufficiency
* Ulcer size between 2 and 20 sq cm, inclusive
* Ulcer present for at least one month
* ABI \>0.7

Exclusion Criteria:

* Decrease in wound size \>35% during Screening Phase
* Infection at the ulcer site
* Uncontrolled diabetes mellitus
* Previous treatment with excluded medications

Primary outcomes:
measure: Investigator assessment of wound healing
Secondary outcomes:
measure: Planimetric assessment of wound healing
measure: Photographic assessment of wound healing
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Terry Treadwell, MD
state: Alabama
Study officials:
References:
Clinical trial NCT00172146: Influences of Cane Use on Voluntary Forward Stepping Movement and Associated Attentional Demands in Hemiplegic Patients
Official title: Influences of Cane Use on Voluntary Forward Stepping Movement and Associated Attentional Demands in Hemiplegic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Hemiplegia
Regular cane
Volitional stepping
Dynamic equilibrium
Attention
Dual task
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-15
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The purpose of this study was to examine the influence of cane use on the movement, kinetics, and associated attentional demands of performing a voluntary forward stepping movement in patients with stroke and age-matched healthy adults.


Eligibility criteria: Inclusion Criteria:

Healthy subjects

* Age ang Sex are correspond with the stroke subjects(between 30 and 75 years old)
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital

Stroke subjects

* between 30 and 75 years old
* stroke confirmed by ICD-10-CM (including I60, I61, I62, I63, I67, and I63.9)
* first stroke with single side hemiplegia and received acute treatment at NTUH
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
* able to stand independently for 10 minutes and to forward step without ankle-foot orthosis
* Mini-Mental State Examination (MMSE) score at least 24

Excursion criteria:

Healthy subjects

* having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those would influence the belance or motor ability

Stroke subjects

* having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
* having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal or cardiovascular disorders, or disorders from systematic diseases those will influence standing ability other than stroke
* having hemi-neglect or hemi-anopia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
state: Province of China
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Fang Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155246: Efficacy of Pentoxifylline on Chronic Kidney Disease
Official title: Phase 4 Study of the Efficacy of Pentoxifylline in Patients With Chronic Kidney Disease Receiving Angiotensin Receptor Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: CKD, pentoxifylline
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study whether pentoxifylline has additive renoprotective effect in patients taking ARB

Detailed description: In patients with CKD and serum creatinine 1.3\~6.0 md/gl, having taken losartan 100 mg/day for at least 3 months, with stable renal function, will be recruited to a randomized open-label trial. Patients taking pentoxifylline or not will be compared for their spot urinary proteinuria, estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups in a 2-year study. Add-on pentoxifylline in control group in the same dose as in treat group will be performed to observe the renoprotective effect if any protective potential is demonstrated in the end of maintenance 12 months.

Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease with serum creatinine 1.3\~6.0 mg/dl

Exclusion Criteria:

* History of allergy to pentoxifylline
* Females are nursing or pregnant
* Obstructive uropathy
* Unable to stop chronic immunosuppressive therapy, NSAID
* Congestive heart failure (New York Heart Association functional class III or IV)
* Unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, within the past 6 months prior to signing the informed consent form
* Cerebral hemorrhage within the past 6 months prior to signing the informed consent form
* Retinal hemorrhage within the past 6 months prior to signing the informed consent form
* Known or suspected secondary hypertension (e.g., primary aldosteronism, renovascular hypertension, pheochromocytoma)
* Severe uncontrolled hypertension with SBP \> 220 mmHg and/or DBP \> 115 mmHg
* Hepatic dysfunction as defined by the following laboratory parameters: ALT or AST \> 2 times the upper limit of the normal range
* Biliary obstructive disorders (e.g. cholestasis)
* Active malignancy

Primary outcomes:
measure: spot urinary proteinuria between groups
Secondary outcomes:
measure: estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hosptial
name: Tun-Jun Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03140046: Visual Outcomes of Topography Guided Photorefractive Keratectomy (PRK) for Treatment of Patients With Irregular Cornea
Official title: Visual Outcomes of Topography Guided Photorefractive Keratectomy (PRK) for Treatment of Patients With Irregular Cornea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irregular Astigmatism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Irregular astigmatism is one of the most serious and frequent complications of corneal refractive surgery and one of the worst sequelae of other forms of corneal surgery . It is also considered as one of common, serious complications of corneal injuries .

Spectacle correction is usually not useful in the correction of corneal irregular astigmatism. Contact lenses represent a good alternative, but their adaptation and stability are limited by the irregular corneal surface and patient discomfort.

In recent years, advancements in laser technology have offered better tools for dealing with irregular astigmatism with finding new surgical methods to improve corneal regularity for the correction of irregular astigmatism.

Topography-linked excimer laser is a potentially effective technique in the treatment of irregular astigmatism after keratoplasty . In fact, customized ablation was shown to be an effective means of treatment of irregular astigmatism due to different etiologies Such as corneal Injuries , scar , or postoperative.

Some of the theoretical advantages of topography-driven photorefractive keratectomy (PRK) are a better astigmatic correction, the possibility of correcting irregular astigmatism, and a smaller ablation volume compared with standard treatments, resulting in better visual performance.

Aim of the work To evaluate the efficacy, safety, and predictability of topography-guided photorefractive keratectomy (PRK) to improve refractive status of patient with irregular Cornea.


Eligibility criteria: Inclusion Criteria:

* Patients with irregular corneal astigmatism caused by:

  * Trauma.
  * Non - Central Corneal Scars.
  * Previous corneal surgery.
* With No other abnormalities in the eye.
* Patient is willing to enter the study and sign a consent.

Exclusion Criteria:

* Patients with central corneal scars.
* Patients with central haze interfering with visual acuity.
* Patients with ectasia at corneal graft margins.
* Patients with irregular astigmatism caused by corneal ectasia or keratoconus.
* Patients had refractive surgery with ablations leaving a residual corneal thickness less than 250 μm.

Primary outcomes:
measure: Visual Acuity
timeFrame: follow up after 1 day, 1 week, 1 month and 3 months
Secondary outcomes:
measure: Refractive State
timeFrame: follow up after 1 day, 1 week, 1 month and 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT00660946: Comparison of Point of Care to Lab INR in Dialysis Patients on Warfarin
Official title: Correlation of Point of Care INR to Laboratory INR in Hemodialysis Patients Taking Warfarin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation in Dialysis Patients
Keywords: anticoagulation in dialysis patients
chronic anticoagulation
warfarin
hemodialysis
INR
Point of Care
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dialysis patients who undergo INR testing in the management their chronic warfarin therapy.

Brief summary: To determine whether point of care (POC) International Normalized Ratio (INR) test results correlate with plasma INR measures in hemodialysis patients.

Detailed description: 37 chronic hemodialysis patients being anticoagulated with warfarin require INR monitoring routinely.

Eligibility criteria: Inclusion Criteria:

* Chronic dialysis patients on chronic warfarin anticoagulation.

Exclusion Criteria:

* On warfarin for less than 1 month.

Primary outcomes:
measure: To determine whether Point of Care INR testing would be suitable in the management of dialysis patients on chronic warfarin therapy
timeFrame: Not an intervention study, but observational in this cohort
Secondary outcomes:
measure: Determine whether Point of Care INR devices maintain test accuracy in dialysis patients who are temporarily anemic (HCT <32%) according to their CBC
timeFrame: Not an intervention study, but observational in the cohort (statistics completed 1.5 yrs)
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic Rochester, Mn USA
name: Robert W. Hoel, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoel RW, Albright RC, Beyer LK, Santrach PJ, Magtibay DL, Everson SL, McBane RD. Correlation of point-of-care International Normalized Ratio to laboratory International Normalized Ratio in hemodialysis patients taking warfarin. Clin J Am Soc Nephrol. 2009 Jan;4(1):99-104. doi: 10.2215/CJN.03360708. Epub 2008 Nov 5.
Clinical trial NCT06184646: Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women
Official title: Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Disease, Metabolic
Keywords: Osteopenia
Prune
Functional food
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.

Detailed description: Two hundred randomly assigned to one of two treatment groups: 1) 30 g prunes and 2) control (0 g prunes). Both groups received 500 mg calcium and 400 IU Vitamin D as a daily supplement. Blood samples are collected at baseline, 12 and 24 months to assess biomarkers of bone turnover. Physical activity recall and food records are obtained at baseline, 12 and 24 months to examine physical activity and dietary confounders as potential covariates. Dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) will be completed at baseline, 12 and 24 months to examine bone mineral density and structure.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal
* BMD t-score is between 0.5 and 2 SD below the mean
* Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study

Exclusion Criteria:

* Women whose BMD t-score at any site falls below 2.5 SD of the mean
* Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
* Subjects who smoke cigarettes or vape
* Regular consumption of dried plum or prune juice

Primary outcomes:
measure: Changes from baseline in bone mineral density at 12 and 24 months
timeFrame: Baseline, 12 months, and 24 months
Secondary outcomes:
measure: Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months
timeFrame: Baseline, 12 months, and 24 months
measure: Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months
timeFrame: Baseline, 12 months, and 24 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Shirin Hooshmand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04087746: Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema (DME)
Official title: Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic macular edema (DME) is a sign of diabetic retinopathy that affects central vision. It is also a leading cause of visual decline in younger patients, especially in developing countries like our Arab community. Intra-vitrreal injection of anti-vascular endothelial growth factor (AVEGF) in management of DME had significant improvement in the final logMAR Un-corrected Distant Visual Acuity ( UCDVA) and logMAR Best Corrected Distant Visual Acuity (BCDVA), as well as reduction in the central retinal thickness from baseline measurement.

Detailed description: The investigators randomly assigned four hundreds eyes of diabetic patients with central diabetic macular edema for intra-vitreal injection of AVEGF group I (200 patients eyes) received aflibercept 2.0 mg and group II (200 patients eyes) received ranibizumab 0.3 mg. Injection was at 4 weeks interval according to the used protocol. The primary outcome was measuring the mean change in visual acuity as functional outcome and the secondary outcomes were the mean change in central macular thickness, as anatomical outcome rather than safety and efficacy of those two anti-VEGF drugs.

Eligibility criteria: Inclusion Criteria:

* Patients with type 1 or 2 diabetes mellitus with central DME clinically as well as documented by optical coherence tomography (OCT) imaging
* The age of the patients at least 20 years old
* Patients not receiving AVEGF injection, at least for one year
* The BCDVA letter score of at least one eye (range, 0 to 115, with higher scores indicating better visual acuity of 90 (Snellen = 20/32) to 40 (Snellen = 20/320) and central DME .

Exclusion Criteria:

* Patients with cataract
* Glaucoma patient
* Previous AVEGF injection in less than one year
* Patients not attending all of the scheduled follow up visits

Primary outcomes:
measure: measuring the main change in visual acuity
timeFrame: 2 years
Secondary outcomes:
measure: the main change in central macular thickness
timeFrame: 2 years
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
affiliation: Minia University
name: Shaaban AM Elwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03120546: Cervical Spine Motion During Tracheal Intubation: Video Laryngoscope vs Rigid Video Stylet
Official title: A Randomized Comparison of Cervical Spine Motion During Tracheal Intubation Using Video Laryngoscope or Rigid Video Stylet in Patients With Simulated Cervical Immobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: cervical spine motion
video laryngoscope
rigid video stylet
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: In this study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.

Detailed description: In patients with an unstable cervical spine, neck extension during tracheal intubation may result in harmful events such as spinal cord injury. Thus, it is important to minimize cervical spine motion in these patients. In this randomized crossover study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years undergoing elective endovascular cerebral aneurysm coiling to general anesthesia in a neuroangiography suite

Exclusion Criteria:

* Patients with upper airway abnormalities such as inflammation, abscesses, tumors, polyps, and trauma
* Patients with a medical history of gastroesophageal reflux disease and previous airway surgery, at high risk for aspiration, coagulation disorders, or a Hunt Hess grade of 3-5

Primary outcomes:
measure: maximum cervical spine motion
timeFrame: during tracheal intubation
Secondary outcomes:
measure: intubation time
timeFrame: during tracheal intubation
measure: number of intubation trial
timeFrame: during tracheal intubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Tae Kyong Kim, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: