louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02710292: Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population
Official title: Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-03-16
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.


Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent form;
* Habitual current daily disposable soft contact lenses wearer;
* Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
* Lenses within the power range specified in the protocol;
* Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
* Acceptable lens fit with both study contact lenses;
* Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Currently wearing DT1 or TE sphere lenses;
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
* Eye injury or surgery within 12 weeks immediately prior to enrollment;
* History of herpetic keratitis, ocular surgery or irregular cornea;
* Prior refractive surgery;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Participation in any clinical trial within 30 days of the enrollment visit;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear
timeFrame: Day 10, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Contact Alcon Japan, Ltd. for Trial Locations
Study officials:
affiliation: Alcon Japan, Ltd.
name: Clinical Manager, Clinical Development
role: STUDY_DIRECTOR
References:
Clinical trial NCT04218292: Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan
Official title: Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma Injury
Bleeding
Lead sponsor: KA Medical, LLC
Sponsor class: INDUSTRY
Collaborators: name: Merit Medical Systems, Inc.
First posted: 2020-01-06
Enrollment: 40
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 requiring routine standard of care for peripheral embolization. Some of the patients will be liver cancer patients undergoing palliative treatment with SIRT who have a life expectancy that may be less than 12 months. Other patients may be treated for trauma or bleeding.

Brief summary: This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.


Eligibility criteria: Inclusion Criteria:

* Subject is scheduled for arterial embolization in the peripheral vasculature.
* Subject is greater than 18 years of age

Exclusion Criteria:

* Subject is unable to give informed consent
* Subject is pregnant or breastfeeding
* Subject has allergy to nickel
* Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.

Primary outcomes:
measure: Rate of serious device-related and procedure-related adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Rate of successful delivery of the device
timeFrame: 1 day
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: University Hospital Magdeburg
Study officials:
affiliation: University Hospital Magdeburg, Germany
name: Maciej Pech, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397292: Registry for Patients Undergoing Pulmonary Procedures
Official title: Registry Examining Retrospective and Prospective Data for Patients Undergoing Pulmonary Procedures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Procedures
Keywords: Bronchoscopy
Interventional Pulmonary
Pleuroscopy
Tracheostomy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 220
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: ONLY ADULT PATIENTS (\>18 YEARS OLD) that have a planned PULMONARY PROCEDURE will be potential participants. This will also include a special group, prisoners.

Brief summary: The purpose of this research study is to examine the safety, tolerability, and effectiveness of currently available pulmonary procedures when used to diagnose or treat different diseases.

This study will collect information that may influence the outcome of the procedure and identify factors that may affect the procedures yield or safety. The information will be entered into a registry or data storage.

Detailed description: This is a retrospective and prospective data registry of all pulmonary diagnostic and therapeutic interventional pulmonary procedures at a single academic center. All pulmonary procedures upon completion will be entered into a database by the participating investigator performing the procedure. For both diagnostic and therapeutic cases, the data will require additional input 1-4 weeks after the procedure in order to place the diagnosis and follow-up data. Retrospective data will only be collected for patients that had their procedures prior to approval of this registry.

Study data will be collected and managed using REDCap (Research Electronic Data Capture) electronic data (CTSA Awared - Award Number UL1RR031990) capture tools hosted at Virginia Commonwealth University. REDCap is a secure, web-based application designed to support data capture for research studies.

The prison population will also be included in the registry in order to examine the effects of pulmonary procedures on a special population.

Eligibility criteria: Inclusion Criteria:

* ADULT PATIENTS (\>18 YEARS OLD) that have a planned PULMONARY PROCEDURE

Exclusion Criteria:

* ALL KNOWN PREGNANT PATIENTS WILL BE EXCLUDED FROM THIS REGISTRY.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Hans J Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02095392: Effects of Soluble Phosphate in Humans
Official title: The Effect of Soluble Phosphate in Combination With Different Calcium Doses on Calcium and Phosphorus Metabolism in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: soluble phosphate
phosphorus metabolism
calcium metabolism
bone metabolism
human study
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study was conducted to investigate the effect of soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. The main aim of the study is to investigate the influence of a soluble phosphate supplementation on the fasting blood phosphate concentration and the dependency of an additional calcium intake.


Eligibility criteria: Inclusion Criteria:

* age between 18-60 years
* physical health

Exclusion Criteria:

* postmenopausal women
* kidney diseases
* diabetes mellitus
* metabolic diseases
* osteoporosis
* intake of dietary supplements
* pregnancy and lactation

Primary outcomes:
measure: Fasting phosphate concentration in blood
timeFrame: 8 weeks
Secondary outcomes:
measure: Calcium and phosphorus metabolism
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology
state: Thuringia
Study officials:
affiliation: Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology
name: Michael Glei, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trautvetter U, Camarinha-Silva A, Jahreis G, Lorkowski S, Glei M. High phosphorus intake and gut-related parameters - results of a randomized placebo-controlled human intervention study. Nutr J. 2018 Feb 16;17(1):23. doi: 10.1186/s12937-018-0331-4.
citation: Trautvetter U, Jahreis G, Kiehntopf M, Glei M. Consequences of a high phosphorus intake on mineral metabolism and bone remodeling in dependence of calcium intake in healthy subjects - a randomized placebo-controlled human intervention study. Nutr J. 2016 Jan 19;15:7. doi: 10.1186/s12937-016-0125-5.
Clinical trial NCT01216592: Airway Inflammation, Symptoms and Lung Function in COPD
Official title: Correlations Between Airway Inflammation, Symptoms and Lung Functions in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Airway inflammation
Symptoms
Lung function
Correlation
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2010-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Moderate to severe COPD patients (according to GOLD guidelines) will be enrolled in the study

Brief summary: Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high prevalence worldwide and with relevant impact on patient-related quality of life, morbidity and mortality. There is evidence that airway inflammation correlates with the severity of the disease and that airway inflammation is further enhanced during exacerbation. However, it is unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by changes in airway inflammation.

Detailed description: Patients will undergo a visit every 7 days during one month (5 visits in total). At each visit airway inflammation (exhaled NO, sputum inflammatory cell count) and lung function will be performed. At home patients will be asked to fill a daily diary for symptom assessment.

Eligibility criteria: Inclusion Criteria:

* Post-bronchodilator FEV1/FVC ratio \< 70%
* Post-bronchodilator FEV1 \< 80%
* Smokers or ex-smoker with pack/years \> 15

Exclusion Criteria:

* Atopy
* Asthma
* Concomitant lung diseases (e.g. lung cancer)
* Acute infections of the respiratory tree in the previous 2 months including COPD exacerbation.

Primary outcomes:
measure: Correlation between changes in airway inflammation and symptom score
timeFrame: 1 month,
Secondary outcomes:
measure: Correlation between changes in airway inflammation and lung function
timeFrame: 1 month
measure: Correlations between airway inflammation and symptom scores
timeFrame: 1 month
measure: Correlations between airway inflammation and lung function
timeFrame: 1 month
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara
Study officials:
affiliation: Università degli Studi di Ferrara
name: Alberto Papi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Contoli M, Baraldo S, Conti V, Gnesini G, Marku B, Casolari P, Scrigner P, Morelli P, Saetta M, Spanevello A, Papi A. Airway inflammatory profile is correlated with symptoms in stable COPD: A longitudinal proof-of-concept cohort study. Respirology. 2020 Jan;25(1):80-88. doi: 10.1111/resp.13607. Epub 2019 Jun 28.
Clinical trial NCT06863389: Comparison of Chen's U-suture Technique with Duct-to-Mucosa Anastomosis and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy
Official title: Comparison of Chen's U-suture Technique with Duct-to-Mucosa Anastomosis and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreaticoduodenectomy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 5788
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent open pancreaticoduodenectomy during the period from January 1, 2014 to December 31, 2019 at 21 hospitals in China were restrospectively recruited. All patients underwent standard open pancreaticoduodenectomy with Child reconstruction which were performed by senior hepato-pancreato-biliary surgeons who performed over 200 pancreaticoduodenectomy per year. According to different PJ, patients were divided into three groups: Chen's, IG, DTM.

Brief summary: Data of patients treated with pancreaticoduodenectomy in 21 hospitals from January 2014 to December 2019 were retrospectively collected and classified to Chen's group, duct-to-mucosa group and invagination group according to different pancreaticojejunostomy. Propensity score matching analysis was performed to balance the baseline differences among three groups. The surgical outcomes were compared. Independent risk factors for postoperative pancreatic fistula were confirmed by logistic regression analysis, and subgroup analysis was also conducted.


Eligibility criteria: Inclusion Criteria:

* open pancreaticoduodenectomy
* Chen's U-suture technique or invagination or duct-to-mucosa anastomosis

Exclusion Criteria:

* missing data

Primary outcomes:
measure: postoperative pancreatic fistula
timeFrame: postoperative 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00176189: Clinical Performance of Extended All-Ceramic Fixed Partial Dentures Based on Zircon-Oxide Ceramics.
Official title: Clinical Performance of Extended All-Ceramic Fixed Partial Dentures Based on Zircon-Oxide Ceramics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss, Teeth Replaced Using All Ceramic FPDs
Keywords: FPD, all-ceramic
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fixed-partial dentures fabricated of zircon-oxide ceramics were introduced in dentistry some time ago. However, the survival rate of all-ceramic extended (up to 47mm) fixed-partial dentures is unknown.

The hypothesis was that long FDPs fabricated of zirkon-oxide withstand masticatory forces in the posterior and anterior regio of the jaw.

Detailed description: 30 patients with at least 2 missing posterior or anterior teeth will be included in the study. All patients will receive all-ceramic fixed partial dentures.

Eligibility criteria: Inclusion Criteria:

* All patients older 18 years
* At least two missing posterior teeth
* Tooth wear\<3

Exclusion Criteria:

* Bruxism
* Mental disorders
* Pregnancy
* Tooth mobility\>1

Primary outcomes:
measure: Survival rate of the FPDs
Secondary outcomes:
measure: Esthetical and functional performance of the FPDs
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
affiliation: Department of prosthodontics, University of Heidelberg
name: Peter Rammelsberg, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02193789: Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration
Official title: The Effect of Newly Designed Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration in Benign Stricture of Gastroduodenal Anastomosis: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroduodenal Anastomosis
Keywords: Anastomosis site structure
Stent insertion
Stent migration
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis site stricture is very severe complication. It can improve by temporary through the scope covered metallic stent. It is very effective procedure about the stricture. But stent migration is very severe complication. Herein the investigators suggest newly method to prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent stent migration. But it is difficult to remove stent after resolved stricture. So the investigators add the suture between hemoclip and stent. And the investigators cut the suture when stent removal.


Eligibility criteria: Inclusion Criteria:

* subtotal gastrectomy with Billroth-I or Billroth-II anastomosis
* symptom of gastric outlet obstruction
* anastomosis site stricture after surgery

Exclusion Criteria:

* patients of the impossible stent insertion due to other complication
* foreigner
* no agree a concent

Primary outcomes:
measure: Improvement of symptom (Resolving anastomosis site stricture)
timeFrame: Up to 1 month
Secondary outcomes:
measure: Complications associated with the procedure
timeFrame: Up to 1 month (time of stent removal)
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university hospital
state: Gyeong-gi do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Sun Gyo Lim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Ki Seong Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Joon Koo Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04276389: OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery
Official title: OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery After Lesion Preparation With Scoring Balloon - A Prospective Multicenter Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.


Eligibility criteria: Inclusion Criteria:

1. 18 to 85 years old
2. Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, or silent ischemia.
3. Reference vessel diameter \>2.5 mm, and \<4.0 mm.
4. Lesion length of \<22 mm
5. Written informed consent

Exclusion Criteria:

1. Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction
2. Cardiogenic shock (systolic arterial pressure \<90mmHg), congestive heart failure (NYHA or Killip≥3)
3. Chronic kidney disease (eGFR \<30 ml/min)
4. Lesion length \>22 mm, or vessel diameters of \<2.5 mm or \>4.0 mm
5. Stents covering a major side branch (\>2 mm)
6. Left main lesion
7. Graft lesion
8. Aortic-coronary ostial lesion
9. In-stent restenotic lesion
10. Chronic total occlusion
11. Severe calcified lesions.
12. Visible angiographic thrombus
13. Severe comorbidities: eg. malignancy (life expectancy \<2 years)

Primary outcomes:
measure: Late lumen loss
timeFrame: 9 months
Secondary outcomes:
measure: Rate of binary restenosis
timeFrame: 9 months
measure: Target lesion failure
timeFrame: 9 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References: