louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01480557: Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
Official title: Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
phacoemulsification
liquefaction
torsional ip
endothelial cell count
central corneal edema
central corneal sensitivity
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 75
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Objective of this study is the comparative assessment of the impact of torsional and liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal sensitivity (CCS) in a sample of cataract patients.

Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale \[10\]. By means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) Torsional group (TG) and b) Liquefaction group (LG).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

* Endothelial cell count less than 1900,
* glaucoma,
* IOP-lowering medications,
* former incisional surgery,
* former diagnosis of corneal disease,
* diabetes or autoimmune diseases

Primary outcomes:
measure: Endothelial cell count (ECC)
timeFrame: 1 month postoperatively
Secondary outcomes:
measure: Uncorrected visual acuity (UVA)
timeFrame: 1 month postoperatively
measure: Central corneal thickness (CCT)
timeFrame: 1 month postoperatively
measure: Central Corneal Sensitivity (CCS)
timeFrame: 1 month postoperatively
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labiris G, Gatzioufas Z, Giarmoukakis A, Sideroudi H, Kozobolis VP. Liquefaction versus torsional IP: a comparative study on endothelial cells, corneal edema and corneal sensitivity. Ophthalmic Res. 2013;49(1):37-42. doi: 10.1159/000342974. Epub 2012 Oct 23.
Clinical trial NCT00151957: Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials
Official title: A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Noven Pharmaceuticals, Inc.
First posted: 2005-09-09
Enrollment: 450
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Detailed description: Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Eligibility criteria: Inclusion Criteria:

* Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
* Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.

Exclusion Criteria:

* Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
* Female subject is pregnant or lactating

Primary outcomes:
measure: Treatment emergent adverse events over 12 months.
timeFrame: Weekly
Secondary outcomes:
measure: ADHD-RS-IV scores
timeFrame: Weekly
measure: Parent Global Assessment
timeFrame: Weekly
measure: Clinical Global Impressions Scale
timeFrame: Weekly
measure: Child's Sleep Habits Questionnaire
timeFrame: Weekly
Other outcomes:
Locations:
Study officials:
References:
citation: Findling RL, Wigal SB, Bukstein OG, Boellner SW, Abikoff HB, Turnbow JM, Civil R. Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials. Clin Ther. 2009 Aug;31(8):1844-55. doi: 10.1016/j.clinthera.2009.08.002.
Clinical trial NCT04860648: Lung Ultrasound Guided Prevention of Postoperative Pulmonary Complications in Moderate to High Risk Patients
Official title: The Second Affiliated Hospital of Zhejiang University, School of Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Respiratory Complication
Keywords: lung ultrasound, postoperative pulmonary complications
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative pulmonary complications (PPCs) occur in many patients, especially those with high risks, and are associated with increased hospital length of stay, morbidity and costs of care. According to European Perioperative Clinical Outcome definitions, major pulmonary complications include atelectasis, respiratory infection, pleural effusion, and pneumothorax. Because identifying patients at high risk for PPCs may allow earlier treatment, predictive scores ( the Assess Respiratory Risk in Surgical Patients in Catalonia score \[ARISCAT\]) have been developed.Lung ultrasound (LUS) is more accurate than chest X-ray in diagnosing pulmonary complications, and lung ultrasound performed in the postanesthesia care unit may identify patients at higher risk for pulmonary complications. So we aimed to study if lung ultrasound can guide the prevention of PPCs in moderate to high risk patients.

Detailed description: patients recruited are randomized into the two groups: LUS group and Control group. Patients in LUS group received ultrasound examination and guided the treatment according to the ultrasound results, while the control group did not receive ultrasound examination, just the same as the routine clinical practice. This study aims to explore whether ultrasound-guided clinical treatment can reduce the incidence of postoperative pulmonary complications in moderate to highrisk patients. Before operation, informed consent was signed according to the inclusion criteria, and the incidence of pulmonary complications within 5 days after operation (or before discharge) was recorded after operation.

Eligibility criteria: Inclusion Criteria:

* Age≥18 Estimated ARISCAT score ≥26分

Exclusion Criteria:

* transferred to ward or ICU directly day surgery (patients won't stay in hospital longer than 24 hours after surgery actual ARISCAT score \< 26分 the technical incompatibility of the acoustic window patients refused pregnant

Primary outcomes:
measure: the incidence of postoperative pulmonary complications
timeFrame: within 5 days after operation or before discharge, whichever came first
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Min Yan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05651048: The Role of BEMER and Kinesiotape in Increasing the Effectiveness of Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery
Official title: The Role of BEMER and Kinesiotape in Increasing the Effectiveness of Physiotherapy and
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Post Operative
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The literature indicates that postoperative pulmonary complications are seen when pain is not treated effectively after videothoracoscopy surgery (VATS). After surgery, physiotherapy and rehabilitation approaches are applied to prevent complications. Bio-Electro-Magnetic-Energy-Regulation (BEMER) therapy uses low-frequency electromagnetic energy to regulate vasomotion in capillaries and increase microcirculation. BEMER therapy can be applied together with physiotherapy and rehabilitation. The aim of this study is to investigate the effectiveness of BEMER application, which is added to the physiotherapy and rehabilitation program applied after videothoracoscopy surgery.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for the study were to have undergone VATS lobectomy and to be aged between 18 and 75 years.

Exclusion Criteria:

* Presence of pacemaker, severe cardiac failure, severe arrhythmia
* Those with cooperative disorders
* Presence of neurological or orthopedic problems affecting the extremities
* Those with severe psychiatric disorders
* Failure to perform the operation according to the result of intraoperative tumor staging
* Patients who go out of the standard Analgesia protocol
* Patients who were taken back from the service to the intensive care unit

Primary outcomes:
measure: Change From Baseline in Pain Scores
timeFrame: Postoperative 4th day
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Istanbul University - Cerrahpasa
Study officials:
References:
Clinical trial NCT01930448: Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1
Official title: Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastric Bypass Surgery
Gastric Banding
Type 2 Diabetes
Keywords: Bariatric
Gastric Bypass
Gastric Banding,
Type 2 Diabetes
Incretins
GLP-1
GIP
Insulin secretion
insulin sensitivity
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: severly obese patients with type 2 diabetes undergoing gastric bypass or gastric banding

Brief summary: Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.

Detailed description: All participants will be tested before and then after 10 and 20-30% weight loss after either GBP or AGB surgery. Subjects will undergo an oral glucose tolerance test (OGTT) an isoglycemic intravenous glucose test (IVGT) to assess the incretin effect, a measure of insulin sensitivity by an intravenous insulin sensitivity test (IVGTT) and body composition measurements.

Eligibility criteria: Inclusion Criteria:

* obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery

Primary outcomes:
measure: Change in Incretin Effect
timeFrame: Before surgery, 1, 12, and 24 months post
Secondary outcomes:
measure: Change in Body Composition
timeFrame: Before surgery, 12, and 24 months post
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital-New York Obesity Nutrition Research Center
state: New York
Study officials:
affiliation: New York Obesity Nutrition Research Center
name: Blandine Laferrere, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06190548: Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection
Official title: Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection: a Single-centre Cohort Study With Multiplex Analyses in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Bacterial
Keywords: Klebsiella pneumoniae
hypervirulent
clinical outcome
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CRKP infection

Brief summary: The goal of this observational study is to learn about the risk factors of mortality for CRKP infected patients, and to compare the clinical outcomes between hvCRKP infection and cCRKP infection. The main question it aims to answer is • Whether hypervirulence would add value to cCRKP infection and cause worse outcomes? Participants data will be collected through medical records.

Detailed description: We conducted an observational cohort study comprising three-year (2019-2022) data in a Chinese university hospital. We performed genome sequencing for CRKP strains, compared adult patients infected by hvCRKP with those by non-hypervirulent "classical" CRKP (cCRKP), and used propensity score matching (PSM) for imbalanced baseline characteristics. We defined 30-day all-cause and attributed mortalities and 30-day ranking outcomes (death, no response/progress, remission) as primary outcomes and post-infection stay and survival as secondary outcomes. We constructed mortality-predicting models and performed subgroup analyses for CRKP of the dominant sequence or capsular type or with varied virulence profiles and for patients with bloodstream or lower respiratory tract infections.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18-year-old) with CRKP infections were included.

Exclusion Criteria:

* younger than 18 years old; clinical samples were identified to contain CRKP but were sentenced to be colonization

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
measure: The number of participants with status
timeFrame: 30 days
Secondary outcomes:
measure: length of stay (LOS) in the hospital
timeFrame: 30 days
measure: post-infection survival
timeFrame: 30 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Center of infectious diseases
role: STUDY_DIRECTOR
References:
Clinical trial NCT03858348: A Retrospective rEal-life daTa Study to Assess the exaceRbations and Lung functIon in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination
Official title: A Retrospective rEal-life daTa Study to Assess the Incidence of exaceRbations and Change in Lung functIon Forced Expiratory Volume (FEV1) in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Fixed Dose Combination (FDC) Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
COPD Exacerbation
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) combination is commonly prescribed to treat COPD; we will perform a retrospective analysis on the effect of adding a long-acting muscarinic receptor antagonist (LAMA) to ICS/LABA combination in COPD.

Detailed description: According to the current guidelines for the treatment of COPD, it is recommended to use combination therapies with different or complementary mechanisms of action . Data suggest that open triple therapy incorporating LAMA with ICS / LABA combination products administered through different delivery devices may be beneficial for improving pulmonary function in patients with COPD. However, there is little evidence of the effect of triple therapy on pulmonary function and the incidence of exacerbations in COPD patients.

Eligibility criteria: Inclusion

* Patients with COPD who started treatment with a fixed combination of fluticasone / salmeterol via the Elpenhaler® device after 01/01/2012 and were treated continuously for at least 1 year during the recording period.
* Patients for whom spirometric data are available per monitoring year during recording.
* Patients for whom exacerbation data are available per monitoring year during recording.

Exclusion

•Patients with asthma

Primary outcomes:
measure: FEV1
timeFrame: 36 months
measure: Exacerbations
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papanikolaou Hospital of Thessaloniki
Study officials:
References:
Clinical trial NCT04556448: RCT Comparing Invisalign and Traditional Orthodontic Treatment
Official title: A Randomized Controlled Trial Comparing the Effectiveness of Invisalign and Traditional Orthodontic Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 78
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized RCT
Primary purpose: TREATMENT

Brief summary: Comparison of orthodontic patients treated with aligners and traditional (clear braces)

Detailed description: Patients were selected based on being adults and having mild Class I malocclusion. They were randomly allocated into either the aligner group and the traditiona (clear braces group).. The aligner group was treated with invisalign, with up to two adjustments at the end of treatment. The traditional group had clear braces placed on their teeth. The outcome variables including the following: 1) pain and discomfort related to treatment, 2) posttreatment occlusal status, and 3) postretention occlusal status.

Eligibility criteria: Inclusion Criteria:

1. Class I molar and canine relationships
2. Non-extraction treatments
3. Mandibular crowding of 4 mm or less
4. No missing tooth (from second to second molar)

Exclusion Criteria:

1. Anterior or posterior crossbites
2. Anterior or lateral open bites
3. Maxillary overjet exceeding 3mm
4. Impacted tooth

Primary outcomes:
measure: Occlusal changes
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A&M Baylor College of Dentisry
state: Texas
Study officials:
affiliation: TAMU Health Science Center
name: Peter Buschang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06223048: A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma
Official title: A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Keywords: POAG
Lead sponsor: Amydis Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2, randomized, parallel arm, open-label, masked endpoint study
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG).

Detailed description: This open-label, masked endpoint assessment study will evaluate safety, tolerability, plasma pharmacokinetics (PK) and biological activity of intravenous (IV) doses of AMDX-2011P in participants with POAG. Assessments of retinal images will be conducted by centrally masked assessors.

Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging, and blood collection and PK.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of primary open angle glaucoma in both eyes
2. Able to fixate
3. Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam

Exclusion Criteria:

1. Participants unable to read or write
2. Ocular media is not sufficiently clear to obtain acceptable quality images
3. Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)

Primary outcomes:
measure: AMDX-2011P Adverse Events Profile
timeFrame: 8 days
Secondary outcomes:
measure: Concentration of AMDX-2011P
timeFrame: 2 hours
measure: Pharmacokinetic Analysis of AMDX-2011P
timeFrame: 2 hours
measure: Biological Activity
timeFrame: 1 day
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
affiliation: Amydis Inc.
name: David Bingaman
role: STUDY_DIRECTOR
References: