louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02379208: Evaluation of Rate of Progression With Perimetry in Newly Diagnosed Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Keywords: Visual Field Tests
Ocular Hypertension
Glaucoma, Open-Angle
Quality of Life
Glaucoma progression
Early glaucoma
Frequency Doubling Technology (FDT)
RareBit
Octopus 900 perimetry
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2015-03-04
Enrollment: 60
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: Patients referred to Turku University Central Hospital for suspected or newly diagnosed open angle glaucoma

Brief summary: The purpose of this study is to evaluate rate of progression in newly diagnosed open angle glaucoma with different types of perimetry. Would it be possible to find the rapidly progressing individuals sooner by doing perimetry more often? Is there a difference between different types of perimetry in early glaucoma? What would be the optimal timing of perimetry in newly diagnosed glaucoma? In addition the quality of life in glaucoma patients will be evaluated with two types of questionnaires in three different time points. The enrolled patients will receive appropriate treatment according to glaucoma management guidelines.


Eligibility criteria: Inclusion Criteria:

* Recently diagnosed open angle glaucoma

Exclusion Criteria:

* Significant visual impairment due to another disease (e.g. diabetic retinopathy or maculopathy, cataract, visual field defect after stroke)
* Inability to perform perimetry reliably

Primary outcomes:
measure: Change in mean defect in Octopus perimetry
timeFrame: Baseline, 2, 4, 8, 12, 16, 20, 22, 24 months
Secondary outcomes:
measure: Change in VF-7- instrument score
timeFrame: 2, 12, 24 months
measure: Change in 15D-instrument score
timeFrame: 2, 12, 24 months
measure: Differences in visual field defects between Octopus, frequency doubling technology, RareBit-perimeters
timeFrame: 2, 12, 24 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Central Hospital
Study officials:
affiliation: University of Turku
name: Eija Vesti, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02572908: Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
Official title: Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Wheat Sensitivity
Keywords: wheat, IBS, gluten, ATI
Lead sponsor: Oy Karl Fazer Ab
Sponsor class: INDUSTRY
First posted: 2015-10-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

* IBS \& subjective sensitivity to wheat

Exclusion Criteria:

* celiac disease, pregnancy, lactation, IBD, major GI operations

Primary outcomes:
measure: Subjective symptoms using visual analog scale (VAS) daily
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Aava Medical Centre
Study officials:
References:
Clinical trial NCT03255408: Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia
Official title: Role of Cerebral Blood Flow on Ventilatory Stability During Sleep in Normoxia and Intermittent Hypoxia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Obstructive Sleep Apnea of Adult
Hypoxia, Brain
Sleep Apnea
Sleep Disorder
Stroke
Blood Pressure
Endothelial Dysfunction
Oxidative Stress
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A prospective double blind, placebo-controlled, randomized cross-over trial to evaluate the effect of lowering cerebral blood flow on the ventilatory chemoreflexes (acute hypoxic and hypercapnic ventilatory responses).

Detailed description: The investigators will explore the relationship between changes in Cerebral Blood Flow (CBF) and ventilatory chemoreflexes i.e. Acute Ventilatory Response to Hypoxia (AHVR) and Acute Hypercapnic Ventilatory Response (HCVR) before, during and after sleep under normoxic conditions and sleep accompanied by isocapnic Intermittent Hypoxia (IH) among healthy human study participants.

A pharmacological intervention will be utilized to manipulate the CBF in a randomized order. The study participants will also be randomly assigned the order to sleep either under normoxia or IH exposure. The experiments will be separated from one another with an interval of sufficient drug and IH exposure washout period. The venous blood samples and urinary samples will be collected for the vascular biomarkers.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* 18 - 45 years of age
* Living in Calgary for the past one year
* Have no medical condition or should not be taking any blood pressure medications.
* The participant should not be lactose intolerant

Exclusion Criteria:

* Cerebrovascular, cardio-respiratory, renal and metabolic diseases
* Bleeding disorders and upper gastrointestinal diseases e.g. peptic ulcer disease
* Pregnancy, obese and sleep-disordered breathing
* Drug allergies to non-steroidal anti-inflammatories
* Currently smoking

Primary outcomes:
measure: Changes in cerebral blood flow and ventilatory chemoreflexes
timeFrame: ~18 months (from the starting time of recruiting study participants)
measure: Cerebral blood flow responses and ventilatory chemoreflexes during sleep
timeFrame: ~18 months (from the starting time of recruiting study participants)
Secondary outcomes:
measure: Changes in reactive oxygen species and vascular biomarkers
timeFrame: ~24 months (from the starting time of recruiting study participants)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03098108: Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer
Official title: Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer: Prospective Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Previously Irradiated Recurrent Rectal Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: CCPT arm
Primary purpose: TREATMENT

Brief summary: The investigators conduct this study to evaluate the efficacy and adverse effect of salvage concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously irradiated recurrent rectal cancer.

Detailed description: The obtaining of local control in previously irradiated recurrent rectal cancer is crucial for survival prolongation as well as quality of life of patients. But, it is not easy to get with surgery and/or conventional radiotherapy (RT) because of the limitation of RT dose. Proton therapy has unique advantage showing superior dose distribution focusing tumor escaping surrounding normal tissues using "Bragg-peak".

Eligibility criteria: Inclusion Criteria:

* previously diagnosed as rectal cancer and received curative intent treatment
* diagnosed as recurrent rectal cancer either pathology or radiologic exam
* discussed at tumor board and recommend proton therapy
* previous history of pelvic area radiotherapy
* Eastern Cooperative Oncology Group performance status of 0 to 2
* informed consent to present study
* consent to contraception for 6 months during and after study participation
* maintained bone marrow function ( absolute neutrophil count ≥ 1,2 \* 109/L, platelet count ≥ 100 \* 109/L)
* maintained renal, hepatic function creatinine clearance ≥ 50 mL/minute total bilirubin ≥ 2.2 mg/dl alkaline phosphatase ≥ 192 U/L

Exclusion Criteria:

* Pregnant and/or breastfeeding woman
* Less than 12 weeks of expected survival
* Uncontrolled active co-morbidity

Primary outcomes:
measure: local control rate at 3-year
timeFrame: 3-year after CCPT
Secondary outcomes:
measure: adverse events
timeFrame: 3 months after CCPT
measure: objective response rate
timeFrame: 1 and 3 months after CCPT
measure: time to local tumor progression
timeFrame: 3-year after CCPT
measure: progression free survival
timeFrame: 3-year after CCPT
measure: Core Quality of life (QOL-C) assessment
timeFrame: Baseline, at last week of CCPT, 1 and 3 months after CCPT
measure: Colonrectum Quality of life (QOL-CR) assessment
timeFrame: Baseline, at last week of CCPT, 1 and 3 months after CCPT
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03892408: High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial
Official title: High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foreign Bodies
Tumor
Stenosis Trachea
Bronchus Tumour
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective Randomized, open label Trial
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.


Eligibility criteria: Inclusion Criteria:

* 1. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
* 2. Patients aged 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion Criteria:

* 1. Patients with dementia or cognitive impairment
* 2. pregnant women
* 3. Patients undergoing extracorporeal membrane oxygenation (ECMO)
* 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
* 5. Patients with current maxillofacial trauma or basal skull fracture
* 6. Patients who had previously undergone rigid bronchoscopy / surgery
* 7. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

Primary outcomes:
measure: the lowest oxygen saturation
timeFrame: apnea period during the rigidbroscopic procedure/surgery
Secondary outcomes:
measure: Hypoxia occurs the first time
timeFrame: intraoperative (The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea)
measure: End-tidal carbon dioxide partial pressure
timeFrame: Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea)
measure: Arterial oxygen / carbon dioxide partial pressure
timeFrame: shortly before start of apnea (within 30 seconds)
measure: Arterial oxygen / carbon dioxide partial pressure
timeFrame: shortly after end of apnea (within 30 seconds)
measure: hypoxemia related surgical interruptions
timeFrame: 4) hypoxemia related surgical interruptions during apneic period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00947908: Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy
Official title: Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hymenoptera Venom Allergy
Keywords: Hymenoptera venom allergy
Dendritic cells (DC)
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Dendritic cells (DC) play a key role in the pathogenesis of allergic diseases. The regulation of blood dendritic cells in patients with hymenoptera venom allergy before and during immune therapy is unknown.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed hymenoptera venom allergy
* No previous treatments for hymenoptera venom allergy

Exclusion Criteria:

* Treatment with immunosuppressive agents
* Any malignant disease
* Infections within 1 week prior to the initiation of the treatment

Primary outcomes:
measure: Number of myeloid DC and plasmacytoid DC in peripheral blood
timeFrame: Directly before, 1 hour after, and 12 months after initiation of immune therapy
Secondary outcomes:
measure: Surface molecule expression on myeloid DC and plasmacytoid DC
timeFrame: Directly before, 1 hour after, and 12 months after initiation of immune therapy
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock
state: mecklenburg-Vorpommern
Study officials:
References:
citation: Bratke K, Lommatzsch M, Julius P, Kuepper M, Kleine HD, Luttmann W, Christian Virchow J. Dendritic cell subsets in human bronchoalveolar lavage fluid after segmental allergen challenge. Thorax. 2007 Feb;62(2):168-75. doi: 10.1136/thx.2006.067793. Epub 2006 Aug 23.
citation: Dreschler K, Bratke K, Petermann S, Bier A, Thamm P, Kuepper M, Virchow JC, Lommatzsch M. Impact of immunotherapy on blood dendritic cells in patients with Hymenoptera venom allergy. J Allergy Clin Immunol. 2011 Feb;127(2):487-494.e1-3. doi: 10.1016/j.jaci.2010.12.003.
Clinical trial NCT03672708: Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia
Official title: Cresyl Violet as a New Contrast Agent in Confocal Laser Endomicroscopy for in Vivo Diagnosis of Gastric Intestinal Metaplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Intestinal Metaplasia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye


Eligibility criteria: Inclusion Criteria:

* patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above
* patients with H. pylori infection, or known GIM or atrophic gastritis

Exclusion Criteria:

* patients with a history of GI surgery
* advanced gastric carcinoma or any other malignancy in the GI tract
* acute upper GI bleeding
* patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function
* patients refused to provide informed consent

Primary outcomes:
measure: feasibility of CV for identifying GIM
timeFrame: 1 month
measure: feasibility of CV for identifying GIM
timeFrame: 1 month
measure: newly pCLE criteria with CV application for GIM
timeFrame: 1 month
measure: newly pCLE criteria with CV application for GIM
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology,Qilu Hospital,shandong University
name: Yanqing Li, PhD,MD
role: STUDY_DIRECTOR
affiliation: Department of Gastroenterology,Qilu Hospital,shandong University
name: Zhen Li, PhD,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01454908: Oxford Partial Knee Kinematics Gait Analysis Study
Official title: Investigation of Unicompartmental Knee Arthroplasty and Functional, Daily Activities: A Quantitative Assessment of Gait, Sit-to-Stand, and Stair Climbing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medial Knee Compartment Arthritis
Keywords: partial knee arthroplasty
Lead sponsor: The CORE Institute
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the effect on gait of unicompartmental knee arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.


Eligibility criteria: Inclusion Criteria:

* Patients with medial knee compartment arthritis

Exclusion Criteria:

* Patients with diagnoses other than osteoarthritis (i.e., rheumatoid arthritis, psoriatic arthritis, etc.)
* Patients with significant diseases of other joints of the lower extremity
* Patients with a diagnosed disorder with gait disturbance (e.g. lower extremity weakness, prior lower extremity arthrodesis, diagnosed movement disorders, etc.).

Primary outcomes:
measure: Knee Society Score (KSS)
timeFrame: up to 1 month pre-operatively and at 1 year post operatively
Secondary outcomes:
measure: Range of Motion (ROM)
timeFrame: up to 1 month pre-operatively and at 1 year post operatively
Other outcomes:
Locations:
city: Sun City West
country: United States
facility: SHRI-CORE Orthopedic Research Lab
state: Arizona
Study officials:
References:
Clinical trial NCT04222608: The BRAvAdO Registry
Official title: BRAzilian Registry of Acute Coronary Syndrome in Oncologic Patients - The BRAvAdO Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ACS - Acute Coronary Syndrome
Oncology
Keywords: Cardio-Oncology
Interventional Cardiology
Cancer
Oncology
Acute Coronary Syndrome
Myocardial Infarction
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Instituto do Cancer do Estado de São Paulo
name: Beneficência Portuguesa de São Paulo
name: Instituto de Cardiologia do Rio Grande do Sul
name: InCor Heart Institute
First posted: 2020-01-10
Enrollment: 600
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: Cancer patients with Acute Coronary Syndrome (ACS)

Brief summary: The BRAVADO Registry pretends to identify stratification, diagnosis, total atherosclerotic burden and treatment approaches in oncologic patients with Acute Coronary Syndrome (ACS) and identify strategies to improve health care quality


Eligibility criteria: Inclusion Criteria:

* Definitive cancer diagnosis - biopsy
* Acute Coronary Syndrome - requiring urgent invasive risk stratification

Exclusion Criteria:

* KPS \< 60 , ECOG \>/ 3
* Life expectancy less 24hs
* End of Life Care
* Lack of consistent record data

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 30 days
measure: Total Atherosclerotic burden and lesion complexity on angiography
timeFrame: 30 days
measure: Incidence of Major Bleeding
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Carlos M Campos
Study officials:
References:
Clinical trial NCT02246608: Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
Official title: Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Wound Abdominal Wall
Wound Non Healing
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
First posted: 2014-09-23
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT.

Detailed description: In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be randomized to receive either:

1. Oasis® matrix, applied to the wound, along with standard of care including NPWT OR
2. Standard foam, applied to the wound prior to activation of NPWT, which is standard care.

Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation canister will be collected for specimen analysis.

The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth factors and interleukins in fluid evacuated from the wound.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-89 who exhibit stage III or IV trunk pressure wounds with no signs of infection.
* HbA1C \< 8 (if patient is diabetic)
* Adequate nutrition including albumin above 2.0 and prealbumin above 15.

Exclusion Criteria:

* Wounds that cannot have a NPWT device properly applied due to location (too close to anus), diarrhea, periwound skin issues.
* Patients with Infected wounds.

Primary outcomes:
measure: Closure Rate of Non-healing Wounds
timeFrame: 12 weeks
Secondary outcomes:
measure: Growth Factors
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
Study officials:
affiliation: Kettering Health Network
name: Richard Simman, MD
role: PRINCIPAL_INVESTIGATOR
References: