louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04005612: Effect of Vitamin d and Omega 3 on Osteocalcin
Official title: Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Plasma Osteocalcin Levels : a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D Deficiency
plama osteocalcin
omega-3 fatty acids
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels

Detailed description: The data about effect of vitamin D3 (VD3) and omega-3 fatty acids(omega-3FA) on plasma levels of osteocalcin (OCN) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the OCN levels.

This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on PLASMA OCN levels in females and males with vitamin D deficiency (VDD).

This randomized, controlled clinical trial was designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks,separately and with each other, on the plasma levels of OCN and 25-hydroxy vitamin D (25OHD).

This study was conducted during winter in 86 healthy Jordanian females and males with VDD with a mean age of (40± 10) years.

Fasting serum levels for 25OHD,OCN, PTH (parathyroid hormone),calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial .

Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of vitamin D deficiency (VD \< 30 ng / ml).

Exclusion Criteria:

* People who previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation.
* People with bone disorders also excluded.

Primary outcomes:
measure: vitamin d3 levels
timeFrame: 8 weeks
measure: osteocalcin levels
timeFrame: 8 weeks
Secondary outcomes:
measure: PTH
timeFrame: 8 weeks
measure: calcium
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Applied Science University
Study officials:
affiliation: Applied Science Private University
name: Mahmoud S Abu-Samak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
Clinical trial NCT03588312: Long Term Results in Hypoplastic Aortic Arch Repair in Neonates Using a Glutaraldehyde Treated Autologous Pericardial Patch
Official title: Retrospective Analysis of Results in Children Treated by an Autologous Pericardial Patch to Repair a Hypoplastic Aortic Arch Associated to Other Congenital Heart Defects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Hypoplasia of Aortic Arch
Keywords: Aortic arch hypoplasia
Glutaraldehyde treated autologous pericardium
Single stage repair
Congenital heart defects
Newborns
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 80
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newborns treated in Hopital Universitaire Des Enfants - Reine Fabiola (Brussels, Belgium) for a hypoplastic aortic arch and other congenital heart defects.

Brief summary: Hypoplastic aortic arch is a congenital heart defect that is prejudicial for the growth of newborns. It is often associated to other heart defects. Different surgical techniques exist to address this defect, but the literature is very poor with regards to the use of an autologous pericardial patch. Most use extensive dissection techniques or synthetic patches. Here investigators report institution's original approach using the newborns own pericardium for what investigators believe to be an optimal correction of the hypoplasia., with preserved growth potential.

Detailed description: Retrospective analysis of an already well codified surgical intervention carried out in HUDERF under extra-corporeal circulation

Eligibility criteria: Inclusion Criteria:

* Newborns with a hypoplastic aortic arch undergoing a first intervention

Exclusion Criteria:

* none

Primary outcomes:
measure: Overall survival
timeFrame: 30 days post surgery
Secondary outcomes:
measure: Freedom from re-intervention
timeFrame: Up to 18 years post initial surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire Des Enfants Reine Fabiola
Study officials:
References:
Clinical trial NCT03808012: Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
Official title: Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive after inguinal hernia are scarce and so far do not offer conclusive results. Aim of the study is to analyse reaction time and foot transfer time (together brake response time) and brake force in a brake simulator before and after scheduled inguinal hernia surgery (Liechtenstein procedure).


Eligibility criteria: Inclusion Criteria:

* scheduled surgery for inguinal hernia of the right groin with Lichtenstein procedure
* valid driving license
* male and female

Exclusion Criteria:

* lacking driving license
* pregnancy
* neuromuscular disorder (e.g. myopathy, muscular dystrophy)
* central neurological disorders/diseases (e.g. apoplexia, psychiatric diseases)

Primary outcomes:
measure: Braking performance 1
timeFrame: measurements will be: preoperatively, 2 days postoperatively
measure: Braking performance 2
timeFrame: measurements will be: preoperatively, 8 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of Orthopaedics
Study officials:
affiliation: University Hospital Tuebingen
name: Ulf K Hofmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06240312: Optic Nerve Head Strain as Biomarker for Glaucoma
Official title: Optic Nerve Head Strain as Biomarker for Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2024-02-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will test the hypothesis that images of the optic nerve head taken a 2 different eye pressures will yield strain estimates that are predictive of the course of glaucoma.

Detailed description: Existing glaucoma patients and suitable control adults will be imaged with an FDA-approved optical coherence tomography instrument. Those who are imaged at 2 different eye pressures will generate biomechanical strain estimates. These will be compared to visual field and retinal nerve fiber layer measurements over time. The investigators expect that baseline strain and their changes over time will be associated with progression rate of glaucoma damage, providing a biomarker for susceptibility.

Eligibility criteria: Inclusion Criteria:

* Existing glaucoma patients of Johns Hopkins

Exclusion Criteria:

* Inability to perform imaging
* illiterate
* hearing impaired
* non-English speakers

Primary outcomes:
measure: Optic nerve head mechanical strain compared to visual field change over time
timeFrame: Approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Harry Quigley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02121912: Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
Official title: Pilairo Q In-lab Market Research - Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2014-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and pressure data, and complete questionnaires regarding satisfaction and ease of use at the end of the night. It is hypothesised that the Pilairo Q mask will be superior to other standard masks for CPAP therapy in terms of ease of use, satisfaction and overall titration experience.

Detailed description: Participants will be recruited from patients who visit the sleep lab for CPAP titration. Only eligible participants, that provide written informed consent, will be enrolled into the investigation

Only those participants whom are previously diagnosed with an AHI \>5 can be approached and enrolled into the study.

Once the consent form has been signed, participants will be randomly assigned to receive either Pilairo or any other standard care nasal/nasal pillows mask for their CPAP titration. A randomisation log will be provided by FPH.

The titration session will take place as per the lab's routine practice.

Throughout the night the Sleep Technician will record in the CRF the absolute leak value for the mask every 10 minutes.

At the end of the session the Sleep Technician will complete a questionnaire in relation to the titration experience for that participant/mask. The data will be collected in the CRF that FPH staff will provide to the site.

Eligibility criteria: Inclusion Criteria:

* AHI equal or greater than 15 from the diagnostic night.
* Equal or greater than 18 years of age

Exclusion Criteria:

* Inability to give informed consent.
* History of intolerance to CPAP.
* Anatomical or physiological conditions making CPAP therapy appropriate (for example a deviated septum)

Primary outcomes:
measure: Subjective Questionnaire of Mask Experience
timeFrame: 1 night in the lab
Secondary outcomes:
measure: Mask Leak
timeFrame: Every 10min, for up to 8 hours
measure: Sleep Technicians Recommendation to Use Mask
timeFrame: 1 night in the lab
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Evangelisches Krankenhaus Herne
Study officials:
affiliation: Evangelisches Krankenhaus Herne
name: Martina Neddermann, Dr.med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01425112: Comparison of Subconjuctival Versus Topical Bevacizumab as Adjunct Therapy to Trabeculectomy
Official title: Clinical Trial Comparing Subconjunctival and Topical Bevacizumab as Adjuncts to Trabeculectomy in Improving Outcomes for Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications of Treatment
Progression
Keywords: trabeculectomy
bevacizumab
anti-VEGF
Efficacy
Lead sponsor: Sudhalkar Eye Hospital
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 180
Sex: ALL
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bevacizumab is an anti vascular endothelial growth factor(anti-VEGF) substance that is known to reduce neovascularization and fibrovascular proliferation in inflammatory conditions, including post-operative inflammation. It has shown efficacy in numerous ocular conditions(off-label), that includes Age related macular degeneration, proliferative diabetic retinopathy, neovascular glaucoma and corneal neovascularization. It is being explored as an option for preventing recurrence of pterygium and as an adjunct to improving outcomes of trabeculectomy. There is a debate as to the mode and duration of bevacizumab administration for trabeculectomy. This study aims to compare a single subconjunctival dose of bevacizumab with topical therapy over one month in terms of outcomes of trabeculectomy surgery, non-progression of field loss and stable intraocular pressure(IOP) control.


Eligibility criteria: Inclusion Criteria:

* Primary Open Angle Glaucoma
* Progression
* Failure to reach target IOP
* Non compliant

Exclusion Criteria:

* Resurgery
* Systemic contraindication to bevacizumab
* All other forms of glaucoma

Primary outcomes:
measure: Intraocular pressure control
timeFrame: For 2 years
Secondary outcomes:
measure: Progression
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00716612: Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications)
Official title: Effect of Coenzyme Q 10 Supplementation on Myalgia Induced by HMG-CoA Reductase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Statin Induced Myalgia
Keywords: Coenzyme Q 10
Statin
Myalgia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
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 determine whether Coenzyme Q 10 supplementation will decrease the rate of Muscle Pain in patients with previous statin related Muscle Pain.


Eligibility criteria: Inclusion Criteria:

* Patients treated for hyperlipidemia with a HMG-CoA reductase inhibitor (i.e. pravastatin, simvastatin rosuvastatin or atorvastatin) and reporting myopathic symptoms

Exclusion Criteria:

* Patients with other identifiable cause of myopathy. Patients with clinical evidence of hepatic, renal, or endocrine disease; coagulopathy; or other serious medical conditions will be excluded.

Primary outcomes:
measure: 1. The number of patients who tolerate statin at the initial dose. 2. The number of patients remaining on statin therapy. 3. Change in myalgia score.
timeFrame: 4, 8, and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
Study officials:
affiliation: Hadassah-Hebrew University Hospital
name: David Rott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02816112: Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia
Official title: A Multi-Centre Study to Compare Granulocyte-colony Stimulating Factors to Antibiotics for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induced Febrile Neutropenia REaCT-TC2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Early Stage Breast Cancer
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 458
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. TC chemotherapy can cause febrile neutropenia (FN) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment efficacy. To reduce the risk of chemotherapy-induced FN,TC is administered with either one of two highly effective standard treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte colony-stimulating factor (G-CSF). However, there are considerable cost differences between these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment while oral ciprofloxacin costs about $100.

The investigators have therefore been performing a feasibility study to explore whether the "integrated consent model" involving oral consent is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the investigators are therefore now performing a definitive study comparing G-CSF with ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically important endpoints of hospitalizations and febrile neutropenia rates.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary breast cancer
* Planned TC chemotherapy
* ≥19 years of age
* Able to provide verbal consent

Exclusion Criteria:

* Contraindication to either Ciprofloxacin or G-CSF

Primary outcomes:
measure: Febrile neutropenia
timeFrame: 2 years
measure: Treatment-related hospitalization
timeFrame: 2 years
Secondary outcomes:
measure: Chemotherapy dose reduction
timeFrame: 2 years
measure: Chemotherapy dose delay
timeFrame: 2 years
measure: Chemotherapy discontinuation
timeFrame: 2 years
measure: Microbiologic infections
timeFrame: 2 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Mark Clemons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03563612: Differential Lung Ventilation vs. CPAP
Official title: Differential Lung Ventilation vs. CPAP During One Lung Ventilation for Video Assisted Lung Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: One Lung Ventilation
Continuous Positive Airway Pressure
Differential Lung Ventilation
Keywords: one lung ventilation
continuous positive airway pressure
differential lung ventilation
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective randomized controlled crossover study
Primary purpose: TREATMENT

Brief summary: In this study we compared the efficacy of continuous positive airway pressure (CPAP) to differential lung ventilation, in terms of patient's oxygenation, during video assisted thoracoscopic lung resection.

Detailed description: Background: One Lung Ventilation (OLV) is the technique used during lung resection surgery in order to facilitate optimal surgical conditions. OLV may result in hypoxemia due to the shunt created. Several techniques are used to overcome the hypoxemia, one of which is continuous positive airway pressure (CPAP) to the non-dependent lung. Another technique is ventilating the non-dependent lung with a minimal volume, thus creating differential lung ventilation (DLV). In this study we compared the efficacy of CPAP to DLV during video assisted thoracoscopic lung resection.

Patients and Method: This is a prospective study of 30 adult patients undergoing elective video assisted thoracoscopic lung lobectomy. Each patient was ventilated in four modes: two lung ventilation, OLV, OLV+CPAP and OLV+DLV. Fifteen patients were ventilated with CPAP first and DLV next, and the other 15 were ventilated with DLV first and then CPAP. Five minutes separated each mode, during which the non-dependent lung was open to room air. We measured the patient's arterial blood gas during each mode of ventilation. The surgeons, who were blinded to the ventilation technique, were asked to assess the surgical conditions at each stage.

Eligibility criteria: Inclusion Criteria:

1. Adult patients diagnised with lung cancer
2. Scheduled to have thoracoscopic lung lobectomy -

Exclusion Criteria:

1. Pregnancy
2. ASA\>=4
3. Difficult intubation -

Primary outcomes:
measure: arterial blood oxygenation
timeFrame: intraoperative
Secondary outcomes:
measure: interference with surgical field exposure
timeFrame: intraoperative
measure: airway pressure in the dependent lung during one lung ventilation
timeFrame: intraoperative
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
citation: Kremer R, Aboud W, Haberfeld O, Armali M, Barak M. Differential lung ventilation for increased oxygenation during one lung ventilation for video assisted lung surgery. J Cardiothorac Surg. 2019 May 6;14(1):89. doi: 10.1186/s13019-019-0910-2.
Clinical trial NCT03221712: The Registry Study to Compare the Cardiopulmonary Exercise Test Parameters Before and After Cardiac Rehabilitation in Patients With Chronic Total Occlusion of the Coronary Arteries
Official title: The Registry Study to Compare the Cardiopulmonary Exercise Test Parameters Before and After Cardiac Rehabilitation in Patients With Chronic Total Occlusion of the Coronary Arteries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Total Occlusion of Coronary Artery
Keywords: cardiopulmonary exercise test
chronic total occlusion
cardiac rehabilitation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 5000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.

Brief summary: The aim of this study is to find strategy for treatment through comparing the cardiopulmonary exercise test parameters before and after cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.


Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Chronic total occlusion of coronary artery disease
* Cardiac rehabilitation

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Death
timeFrame: 5 year
measure: Myocardial infarction
timeFrame: 5 year
measure: Repeat revascularization
timeFrame: 5 year
Secondary outcomes:
measure: Maximum rate of oxygen consumption
timeFrame: 5 year
measure: Respiratory exchange ratio
timeFrame: 5 year
measure: Maximal heart rate
timeFrame: 5 year
measure: Physical activity_METs
timeFrame: 5 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: