louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05507840: Photobiomodulation for Dry Age Related Macula Degeneration
Official title: Photobiomodulation for Dry Age Related Macula Degeneration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Photobiomodulation
Age-Related Macular Degeneration
Keywords: choroidal neovascular membrane
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 121
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate the effect of photobiomodulation treatment on the risk of developing late age related macula degeneration (AMD) in the study eye in patients with wet AMD in the fellow eye.


Eligibility criteria: Inclusion Criteria:

* patients with dry AMD in the study eye and wet AMD in the control eye

Exclusion Criteria:

* Geographic atrophy of the central macular region at enrolment
* Previous/ active wet AMD in the study eye
* A history of epilepsy
* Retinal diseases apart from AMD
* Significant media opacities
* Cataracts worse than grade 2 (LOCS III classification)
* Change in AREDS 2 supplements (vitamins) 1 month before the study and during the study trial was allowed.
* Ongoing systemic medications that are photosensitizing (e.g. tetracyclins)
* Systemic medications during the last 6 months that can cause deposits in the macular region (hydroxychloroquine, amiodarone)
* Unable to give informed consent
* Unable to cooperate with the treatment and follow-up

Primary outcomes:
measure: Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01044940: Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children
Official title: Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colloid Osmotic Pressure
Keywords: Colloid Osmotic pressure in interstitial fluid
Colloid Osmotic pressure in plasma
Protein fractions in interstitial fluid
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asphyxiated babyes Children with heart defects who need surgery Newborn who need blood transfusion

Brief summary: The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and plasma in healthy children under two years, in asphyxiated babies and in children undergoing heart surgery.


Eligibility criteria: Inclusion Criteria:

* Newborn

Exclusion Criteria:

* Syndromes

Primary outcomes:
measure: Colloid osmotic pressure
timeFrame: 6, 12, 24, 48, 72 hours post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University hospital
Study officials:
affiliation: Haukeland University Hospital
name: Hans Joergen T Guthe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guthe HJT, Nedrebo T, Damas JK, Wiig H, Berg A. Transcapillary fluid flux and inflammatory response during neonatal therapeutic hypothermia: an open, longitudinal, observational study. BMC Pediatr. 2018 Feb 23;18(1):82. doi: 10.1186/s12887-018-1020-3.
Clinical trial NCT01936740: Comparison of Two Phacoemulsification-methods: HF EasyTip 2.2mm vs. HF EasyTip 2.8mm
Official title: Comparison of Two Phacoemulsification-methods: HF EasyTip 2.2mm vs. HF EasyTip 2.8mm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: Efficacy and Safety
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.


Eligibility criteria: Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution
* LOCS 2-5

Exclusion Criteria:

* previous intraocular surgery or ocular trauma
* previous corneal pathology
* previous endothelial cell count \<1200
* glaucoma
* uveitis
* PEX
* diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
* intraocular complication like posterior capsular
* postoperative comlpications (e.g. postoperative uveitis)

Primary outcomes:
measure: phacoemulsification time
timeFrame: intraoperative
measure: effective phacoemulsification time
timeFrame: intraoperative
measure: fluid volume
timeFrame: intraoperative
Secondary outcomes:
measure: postoperative corneal oedema
timeFrame: 1 day, 1 week, 6 months
measure: postoperative endotheial cell loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology and Optometry of the Medical University Vienna
Study officials:
References:
Clinical trial NCT03972540: Effect of Mindful Eating on Weight Management in Breast Cancer Survivors
Official title: Effect of a Mindful Eating Intervention on Weight Management in Overweight and Obese Postmenopausal Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: Obesity
Mindful eating
Postmenopausal breast cancer survivors
Weight management
Cardiovascular health
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 13
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors.

Detailed description: Being overweight is associated with increased risk for chronic disease and premature death in breast cancer survivors. This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors. The one-group pre-posttest study design included eight weekly group-based mindful eating sessions on strategies to intentionally and attentively consume food. Anthropometrics, blood pressure, mindfulness, nutritional intake, and physical activity were collected at baseline and 12-weeks follow-up. Data on feasibility and acceptability were collected at study completion.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal female
* Breast cancer survivor (in remission)
* Completed cancer treatment at the time of study enrollment
* Body Mass Index (BMI) equal or greater than 25 kg/m²

Exclusion Criteria:

* None.

Primary outcomes:
measure: Body Mass Index
timeFrame: Change measured between weeks 1 and 12
measure: Blood Pressure
timeFrame: Change measured between weeks 1 and 12
measure: Waste and Hip Circumference
timeFrame: Change measured between weeks 1 and 12
measure: Body Fat Percentage
timeFrame: Change measured between weeks 1 and 12
measure: Feasibility of Conducting the Intervention
timeFrame: Measured at week 12
measure: Acceptability of the Intervention
timeFrame: Measured at week 12
Secondary outcomes:
measure: Mindful Eating Measures
timeFrame: Change measured between weeks 1 and 12
Other outcomes:
measure: Nutritional Intake
timeFrame: Change measured between weeks 1 and 12
measure: Physical Activity
timeFrame: Change measured between weeks 1 and 12
Locations:
Study officials:
References:
Clinical trial NCT06212440: Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients After Neoadjuvant Chemotherapy
Official title: Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy : Expanded Access Clinical Study in 3 Arms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sentinel Lymph Node Biopsy
Neoadjuvant Therapy
Breast Neoplasm
Keywords: breast cancer
sentinel node biopsy
neoadjuvant chemotherapy
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2024-01-18
Enrollment: 348
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label, prospective, single-institution, 3-arms expended randomized study
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).

Detailed description: After NAC, the sentinel lymph node (SLN) identification rate is lower, and it has a higher false-negative rate than that in early-stage breast cancer. As appropriate SLN surgery directly affects the treatment and prognosis of patients undergoing NAC, evaluation to identify SLN using various methods is necessary.

This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).

Eligibility criteria: Inclusion Criteria:

* The patient with locally advanced breast cancer who achieved neoadjuvant chemotherapy
* Confirmed operability with imaging study after neoadjuvant chemotherapy
* Age over 20 years old
* ECOG Performance status : 0-2
* The patient with written informed consent form

Exclusion Criteria:

* The patient with previous ipsilateral breast cancer history
* The patinet with previous ipsilateral axillary surgical procedure (e.g. excisional or incisional biopsy, axillary dissection)
* The patient without neoadjuvant chemotherapy
* Inoperable imaging study after neoadjuvant chemotherapy
* Inflammatory breast cancer
* Pregnant patient

Primary outcomes:
measure: Identification rate of sentinel lymph node
timeFrame: during operation
Secondary outcomes:
measure: Comparison of operation time for sentinel lymph node biopsy
timeFrame: during operation
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: National cancer center
state: Gyeonggi
Study officials:
affiliation: National Cancer Center, Korea
name: Seeyoun Lee, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01893840: Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg
Official title: Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periferal Arterial Occlusive Disease, PAOD
Lead sponsor: Otivio AS
Sponsor class: INDUSTRY
Collaborators: name: European Union
name: The Research Council of Norway
First posted: 2013-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A study to assess the effect of negative pulsating pressure therapy on patients with impaired blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase the blood flow to the leg in these patients.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent
* Age 30-90 years
* Affected foot/shoe sise less than 46 (approximate foot length less than 29.5 cm)
* Patients with Peripheral Arterial Occlusive Disease (PAOD) grade 2,3 or 4, i.e.:

  1. Clinically verified grade 2, i.e. Intermittent Claudication:

     * Ancle-Brachial Index (ABI)less than 0.9 or
     * Toe brachial Index (TBI) less than 0.7 or
     * Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
  2. Clinically verified grade 3, i.e. Critical Limb Ischemia (CLI):

     * ABI less than 0.4 or
     * Toe pressure less than 30 mmHg
     * Rest pain since at least 2 weeks or
     * Use of analgesics for rest pain for at least 2 weeks or
     * Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
  3. Clinically verified grade 4, i.e. CLI:

     * Ischemic ulcers or gangrene/tissue loss
     * ABI less than 0.4
     * Toe pressure less than 30 mmHg
     * Rest pain since at least 2 weeks or
     * Use of analgesics for rest pain for at least 2 weeks or
     * Ultrasound and/or CT/MR angiography suggesting stenosis(es)and/or occlusion(s)

Exclusion Criteria:

* Grade 1 PAOD
* Incapable of consenting voluntarily
* Fewer higher than 39 degrees Centigrade
* Severe Chronic Obstructive Pulmonary Disease (COPD)
* Severe heart disease such as unstable angina, severe heart failure and severe valve failure
* Severe Polyneurophathy
* Verified Osteomyelitis other than in the Phanlanx
* Currently treated for cancer and With a life expectancy of less than 2 years

Primary outcomes:
measure: % of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF)
timeFrame: up to 1 hour
Secondary outcomes:
measure: Patient comfort measured by asking the patient a fixed set of questions
timeFrame: up to 1 hour
Other outcomes:
measure: Fitting time
timeFrame: up to 1 hour
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: Principal Investigator
name: Jarlis Wesche, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05813340: Vascularized Inter-positional Periosteal Connective-tissue Flap Versus Collagen Membrane in Guided Bone Regeneration
Official title: Vascularized Inter-positional Periosteal Connective-tissue Flap Versus Collagen Membrane in Guided Bone Regeneration in Horizontal Ridge Augmentation in Aesthetic Zone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Horizontal Ridge Deficiency
Keywords: VIPCTF
GBR
Horizontal ridge augmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study compares 2 techniques in guided bone regeneration for horizontal ridge augmentation in aesthetic zone

Detailed description: Guided bone regeneration is a technique for ridge augmentation using membranes The membrane of GBR is an essential component of treatment as it has some important characteristics manageability, space-making ability, and adequate mechanical, physical properties, and biocompatibility Collagen membranes are the most commonly used and can inhibit soft tissue growth in bone defects and achieve better wound healing and bone regeneration.

on the other hand, a Vascularized inter-positional periosteal connective tissue flap is a flap that has been used as a substitute for the collagen membrane with promising results. Vascularized inter-positional periosteal connective tissue flap (VIPCTF) may have many advantages over traditional collagen membranes such as; high vascularity, decreased cost (as it may substitute membrane), providing an increase in soft tissue thickness, and reusability.

So Evaluation of effect of vascularized interpositional periosteal connective tissue flap on horizontal ridge augmentation grafting of the anterior maxilla in comaprison with the collagen membranes

Eligibility criteria: Inclusion Criteria:

* Patients with a horizontal defect in anterior and premolar areas of the maxilla (aesthetic zone).

Exclusion Criteria:

* poor oral hygiene
* radiation therapy of head and neck cancer
* intraoral soft and hard tissue lesions
* Heavy smoking
* Bone pathology

Primary outcomes:
measure: Amount of bone width gain (horizontal augmentation)
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of bone formation in the bone biopsy
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry Cairo university
Study officials:
affiliation: Cairo University
name: Esraa Ismail, Maters
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khajehahmadi, S., & Rahpeyma, A. (2014). Vascularized interpositional periosteal connective tissue flap in implant dentistry. Journal of Dental Implants, 4(1), 29. https://doi.org/10.4103/0974-6781.130952
Clinical trial NCT00315640: Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
Official title: A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eye Diseases
Keywords: Elevated IOP due to intravitreal triamcinolone therapy
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-04-19
Enrollment: 70
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 the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.


Eligibility criteria: Inclusion Criteria:

* Either gender
* 18 years of age or older
* IOP elevation caused by steroid usage
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Under 18 years of age
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Mean change in IOP at Week 4 from Baseline
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Jacksonville
state: Florida
city: Miami
country: United States
facility: Miami
state: Florida
city: Detroit
country: United States
facility: Detroit
state: Michigan
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
facility: Houston
state: Texas
city: San Paulo
country: Brazil
facility: San Paulo
city: Budapest
country: Hungary
facility: Budapest
city: Padova
country: Italy
facility: Padova
city: Amsterdam
country: Netherlands
facility: Amsterdam
city: Bayamon
country: Puerto Rico
facility: Bayamon
city: Barcelona
country: Spain
facility: Barcelona
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne
Study officials:
affiliation: Alcon Research
name: Theresa Landry
role: STUDY_DIRECTOR
References:
Clinical trial NCT03872167: Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.
Official title: Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode in Patients With NIV Criteria.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemic Respiratory Failure
Hypercapnic Respiratory Failure
Keywords: NIV
hypoxemia
hypercapnia
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the polysomnographic performance of an automatic ventilatory mode compared with the gold standard (manual polysomnographic titration) to adjust chronic non-invasive ventilation by means of a randomized cross-over study.

Detailed description: Prospective randomized crossover study in 26 patients with chronic non-invasive ventilation (NIV) criteria, comparing the NIV titration with polysomnography vs an automatic mode of ventilation. It will be compared with clinical parameters of ventilation, blood analysis and inflammation reactants as well as evaluating the patient's comfort after each mode.

Eligibility criteria: Inclusion Criteria: chronic respiratory failure

* Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% \>10%)

Exclusion Criteria:

* Under 18 years old.
* Presence of severe uncontrolled cardiac comorbidity.
* Impossibility to achieve adaptation to therapy in the training session.

Primary outcomes:
measure: Partial pressure of carbon dioxide (PaCO2)
timeFrame: two weeks
measure: Partial pressure of oxygen (PaO2)
timeFrame: two weeks
Secondary outcomes:
measure: Oxygen saving time below 90% (CT90%)
timeFrame: one month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona.
Study officials:
affiliation: Hospital Clinic
name: CRISTINA EMBID LOPEZ, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic
name: MONICA C MATUTE VILLACIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00676767: Resistant Starch on Glycemic Response in Older Adults
Official title: Resistant Starch Type 4 on the Glycemic Response in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: Aging
Diabetes
Diet
Fiber
Lead sponsor: Kansas State University
Sponsor class: OTHER
Collaborators: name: MGP Ingredients, Inc.
First posted: 2008-05-13
Enrollment: 9
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults.

Detailed description: To measure the blood glucose response, we collected blood samples before eating and 15, 30, 45, 60, 90 and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy (not diagnosed with disease)
* Over 60 years of age

Exclusion Criteria:

* Diagnosed with diabetes or other metabolic disorder
* Allergies to wheat
* Non-smokers

Primary outcomes:
measure: Glycemic Response
timeFrame: 2-hours
Secondary outcomes:
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Human Metabolism Laboratory
state: Kansas
Study officials:
affiliation: Kansas State University
name: Mark D Haub, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: