louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01833117: Efficacy and Safety Study of FID 119515A
Official title: A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
Tear film
Tear break-up time
Ocular surface
Eye drops
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-04-16
Enrollment: 75
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 was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.

Detailed description: Subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.

Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent.
* Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
* At least a 3 month documented history of dry eye in both eyes.
* TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Any evidence of ocular infection or inflammation within 30 days prior to Screening.
* Any ocular surgery.
* Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
* Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy.
* Use of topical ocular prescription or non-prescription medications within 30 days of Screening.
* Participation in any other clinical trial within 30 days prior to Screening.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes
timeFrame: Baseline, 60 minutes
Secondary outcomes:
measure: Area Under Curve (AUC) of TBUT From 0 to 60 Minutes
timeFrame: 0 to 60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Lisa Lindsey, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05124834: System Accuracy of the Blood Glucose Monitor for Personal Use JT100
Official title: Evaluierung Der Systemgenauigkeit Des JT100 Blood Glucose Monitoring Systems Der Firma Tyson Bioresearch Inc. gemäß DIN EN ISO 15197:2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
Collaborators: name: Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
First posted: 2021-11-18
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

Detailed description: This study assesses the system accuracy the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines

Eligibility criteria: Inclusion Criteria:

* Male or female patients with clinical indication for blood glucose testing
* Signed form of consent
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

* Pregnancy or lactation
* Severe acute disease (at study physician's discretion)
* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
* Current constitution that does not allow participating in the study (e.g. hematocrit out of
* the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
* Being unable to give informed consent
* Age younger than 18 years
* Legally incompetent

Primary outcomes:
measure: Analysis of system accuracy based on DIN EN ISO 15197
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Eckhard Salzsieder, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00178334: Screening for Urinary Incontinence by Primary Care Providers
Official title: Screening for Urinary Incontinence by Primary Care Providers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-09-15
Enrollment: 554
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care providers

Brief summary: The purpose of this study is to:

* Assess the rate of screening for urinary incontinence (UI) in women by their primary care providers
* Identify the type of screening used by primary care providers
* Identify barriers to screening for UI
* Identify differences in screening rates between specialties
* Assess whether primary care providers view UI as a serious medical problem
* Assess the comfort level of primary care providers in the diagnosis and treatment of UI
* Identify primary care providers' preferred mode of learning more about UI

Detailed description: UI is a very common condition whose prevalence can be expected to increase dramatically in the coming decades. Treatment options are available to improve women's health and quality of life. However, inadequate communication between physicians and patients leads to decreased diagnosis and treatment. Past studies evaluating the use of screening by primary care providers, who act as gatekeepers in our healthcare system, clearly demonstrate that improvements must be made in the screening system. We propose a survey of local primary care providers to quantify screening rates for UI and identify barriers to successful screening. The information collected in this survey will allow us to identify methods such as targeted education opportunities and patient literature or questionnaires that will assist providers and their patients in initiating discussion and evaluation of UI.

Eligibility criteria: Inclusion Criteria:

* All primary care providers in the Greater Rochester metropolitan area, including: Primary care Medical Doctors (MD), Doctors of Osteopathy (DO), Primary care Nurse Practitioners (NP), and Physician Assistants (PA)

Exclusion Criteria:

* Physicians in the Greater Rochester metropolitan area who are not primary care providers

Primary outcomes:
measure: Questionnaire
timeFrame: Response to mailing
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Gunhilde Buchsbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06558734: Pediatric Fiberglass Crown in Primary Teeth
Official title: Evaluation of the Clinical Success of Pediatric Fiberglass Crowns in Primary Teeth Using Different Luting Cements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Dental Plaque
Keywords: Fiberglass crown
Glass-ionomer cement
Resin-modified glass-ionomer cement
Primary molar teeth
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical trial aims to evaluate the clinical success of fiberglass crowns applied to primary teeth and to assess the impact of two different luting cements on the success of the fiberglass crowns. The main questions to answer are:

* Will fiberglass crowns demonstrate sufficient clinical success to serve as a viable alternative to existing pediatric crowns?
* Will there be any differences in the clinical success and mechanical properties of fiberglass crowns based on the type of luting cement used?

Thirty-eight children (60 teeth), between 5 and 9 years old (7.03±1.14), enrolled for the study. The researchers evaluated the clinical success of fiberglass crowns bonded with two different types of luting cement (1: FujiOne; 2: FujiCEM 2) based on retention, anatomical integrity, effect on periodontal health and parental satisfaction.

Participants will:

-Visit the clinic 1st, 3rd, 6th, 12th months after cementatiton.


Eligibility criteria: Inclusion Criteria:

For participants:

* absence of any systemic disease
* absence of any periodontal disease
* no unilateral chewing habit
* a Frankl scale score of three-four

For teeth:

* no percussion or palpation sensitivity
* no malocclusion
* no pathological mobility
* no pulpal treatment due to caries or other reasons
* had sound cervical margins
* not hypoplastic or hypocalcified
* had opposing functioning teeth
* had physiological root resorption not exceeding one-third of the root length
* had deep dentin caries with two or more surface that do not contain pulp involvement

Exclusion Criteria:

* did not attend their follow-up appointments

Primary outcomes:
measure: Crown success
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Secondary outcomes:
measure: Plaque Index
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
measure: Gingival Index
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Other outcomes:
measure: Parental Satisfaction with fiberglass crown restorations
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Zulfikar Zahit Ciftci, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03692234: Homoarginine Supplementation in Patients After Stroke
Official title: Homoarginine in Stroke (HiS) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deficiency; Diet
Keywords: homoarginine
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double-blind placebo controlled
Primary purpose: BASIC_SCIENCE

Brief summary: This study represents a follow-up of the previous study "Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects" (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* ischemic stroke (CT or MRI), high-risk transient ischemic attack (ABCD2-score \>= 4) or acute central retinal artery occlusion
* serum homoarginine \</= 2.1 umol/L
* signed informed consent

Exclusion Criteria:

* no acute stroke
* serum homoarginine \> 2.1 umol/L
* heart failure (NYHA \> 1)
* chronic kidney disease (GFR \<60 mL/min)
* not competent
* pregnancy, lactation
* no or withdrawn signed informed consent

Primary outcomes:
measure: Homoarginine serum concentration
timeFrame: six month
Secondary outcomes:
measure: Intima-media thickness
timeFrame: six month
measure: National Institute of Health Stroke Scale
timeFrame: six month
measure: Modified Ranking Scale
timeFrame: six month
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg
Study officials:
References:
citation: Atzler D, Schonhoff M, Cordts K, Ortland I, Hoppe J, Hummel FC, Gerloff C, Jaehde U, Jagodzinski A, Boger RH, Choe CU, Schwedhelm E. Oral supplementation with L-homoarginine in young volunteers. Br J Clin Pharmacol. 2016 Dec;82(6):1477-1485. doi: 10.1111/bcp.13068. Epub 2016 Sep 20.
Clinical trial NCT04766034: Impact of Behavioral Economic Strategies on Low-Income Older Adults' Food Choices in Online Retail Settings
Official title: Impact of Behavioral Economic Strategies on Low-Income Older Adults' Food Choices in Online Retail Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-02-23
Enrollment: 7710
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The specific aims of this proposal are to 1) develop the components of a behavioral economics strategy (i.e., healthy bundle defaults) to influence diet behaviors; 2) characterize the online grocery shopping behaviors and attitudes of low-income adults nationally; and 3) examine the extent to which "healthy bundles defaults" and other behavioral economic strategies increase fruit and vegetable purchases among low-income adults in an online randomized controlled experiment.


Eligibility criteria: Inclusion Criteria:

* aged 18-99 years
* ability to read and speak English
* have ever received SNAP benefits
* live with fewer than 5 people
* access to a personal computer, laptop, tablet, or mobile phone.

Exclusion Criteria:

* aged \<18 years or \>99 years
* lack the ability to read and speak English
* have never received SNAP benefits
* live with 5 or more people
* do not have access to a personal computer, laptop, tablet, or mobile phone

Primary outcomes:
measure: Real Dollars Spent on Fruit and Vegetables Per Basket
timeFrame: Day 1
Secondary outcomes:
measure: Real Dollars Spent on Eligible Fruits Only
timeFrame: Day 1
measure: Real Dollars Spent on Eligible Vegetables Only
timeFrame: Day 1
measure: Real Dollars Spent on Eligible Fresh Fruits and Vegetables
timeFrame: Day 1
measure: Real Dollars Spent on Eligible Frozen Fruits and Vegetables
timeFrame: Day 1
measure: Real Dollars Spent on Eligible Canned Fruits and Vegetables
timeFrame: Day 1
measure: Total Calories From Fruits and Vegetables Per Basket
timeFrame: Day 1
measure: Number of Participants Who Purchased Fruits and/or Vegetables
timeFrame: Day 1
measure: Number of Participants Who Kept Healthy Bundle Default Shopping Cart Items in Basket at Purchase
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Pasquale Rummo, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03900234: Prevalence of Chronic Venous Disease in General Population
Official title: Cross-Sectional Population Based Study on Prevalence and Risk Factors for Chronic Venous Disease in General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Venous Insufficiency
Keywords: chronic venous disease
prevalence
risk factors
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 783
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the residents of 10 years and more living in the same settlement, willing to participate will be included

Brief summary: This study is designed to find prevalence and risk factors for chronic venous disease (CVD) in the general population. All the resident, who live in a single rural settlement will be invited to participate.

Detailed description: The study has cross-sectional design. All the residents aged 10 and more, living in the single rural settlement located in Central Russia will be invited to participate in the study.

Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Possible factors that may influence CVD development will be registered.

Signs and symptoms of CVD will be registered. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.

Eligibility criteria: Inclusion Criteria:

* residents living in the rural settlement where study will be conducted
* both female and male
* age 10 years and more
* agree to participate
* signed infromed consent

Exclusion Criteria:

* age 9 years and less
* not signed informed consent

Primary outcomes:
measure: Presence of chronic venous disease
timeFrame: up to Sept. 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
Study officials:
affiliation: Russian National Research Medical University
name: Igor Zolotukhin, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zolotukhin IA, Seliverstov EI, Shevtsov YN, Avakiants IP, Tatarintsev AM, Kirienko AI. Risk factors for venous symptoms in Russian patients with chronic venous disease. Curr Med Res Opin. 2019 Sep;35(9):1583-1587. doi: 10.1080/03007995.2019.1605050. Epub 2019 May 13.
Clinical trial NCT03362034: Chairside Time and Accuracy of Indirect Bonding of Orthodontic Attachments Using Double Versus Single Transfer Tray
Official title: Chairside Time and Accuracy of Indirect Bonding of Orthodontic Attachments Using Double Versus Single Transfer Tray: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: compare the chairside time and the accuracy of transferring attachments between single and double sheets vacuum tray techniques during indirect bonding of orthodontic attachments using superimposition on computer software


Eligibility criteria: Inclusion Criteria:

1. Patient with maxillary full set of teeth and undergoing fixed orthodontic treatment.
2. Good oral hygiene.
3. Mild to moderate crowding.

Exclusion Criteria:

1. Patients with partially erupted teeth in the maxillary arch.
2. Signs of caries, large restorations or abnormalities of crown morphology.
3. The need of banding.
4. Bad oral hygiene measures.

Primary outcomes:
measure: Chairside time of brackets bonding
timeFrame: an average of 30 minutes
Secondary outcomes:
measure: Accuracy of orthodontic attachments transfer
timeFrame: one day after bonding
measure: Accuracy of orthodontic attachments transfer
timeFrame: one day after bonding
Other outcomes:
measure: immediate Bond failure
timeFrame: immediately after bonding
Locations:
Study officials:
References:
Clinical trial NCT04001634: Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC
Official title: Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 285
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Brief summary: To explore the real world situation of trastuzumab and lapatinib combined chemotherapy in China, and to explore the relationship between progression free survival and treatment.


Eligibility criteria: Inclusion Criteria:

* 1. woman, age \> 18 years old 2. Diagnosed with HER2 +Metastatic Breast Cancer 3. Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy for at least one cycle, starting from 2013.09.01-2019.07.31 4. Available medical history

Exclusion Criteria:

* 1. Incomplete medical history

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
measure: OS
timeFrame: 6 weeks
measure: ORR
timeFrame: 6 weeks
Secondary outcomes:
measure: Treatment Pattern
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Biyun Wang, MD
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Gong C, Lu Q, Zhou Z, Luo T, Li W, Li G, Ge R, Xu F, Wang B. Real-World Data of Triplet Combination of Trastuzumab, Lapatinib, and Chemotherapy in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study. Front Oncol. 2020 Mar 3;10:271. doi: 10.3389/fonc.2020.00271. eCollection 2020.
Clinical trial NCT05408234: Modified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients
Official title: Modified Foot Exercise to Improve Peripheral Perfussion and Sensitivity on Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: foot exercise, Diabetes Mellitus type 2
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study was conducted in the control and treatment groups where the control group will get the treatment of doing modified leg exercises for one week. The control group did not get the modified leg exercise. Both groups received standard therapy for type 2 diabetes.
Primary purpose: TREATMENT

Brief summary: Subject will be trained to do regular foot exercise during their visit to the clinic. We will evaluate foot sensitivity and peripheral perfussion after

Detailed description: Use an 8-10 MHz Doppler probe with a gel smeared over the sensor. Place the Doppler probe on the pulse area at a 45-60° angle to the skin surface.

Move the probe to find the most precise and robust arterial pulse before inflating the cuff.

The cuff is inflated about 20 mm Hg above the point where the arterial Doppler sound disappears.

Then slowly deflate until the Doppler sound reappears and records this value. The blood pressure at which the arterial pulse reappears is the systolic pressure for that blood vessel.

If the flow is still detected at the maximum inflation rate (300 mmHg), the cuff should be deflated immediately to avoid pain.

Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus Type 2

Exclusion Criteria:

* Chronic Heart Failure
* Chronic Kidney Diseae

Primary outcomes:
measure: Fasting Blood Glucose
timeFrame: Cange Fasting Blood Glucose in 1 weeks
measure: Monofilament test
timeFrame: Cange monofilament test in 1 weeks
measure: Ankle Brachial Index
timeFrame: Cange Ankle Brachial Index in 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Surakarta
country: Indonesia
facility: RS UNS (Universitas Sebelas Maret Hospital)
state: Central Java
Study officials:
affiliation: Universitas Sebelas Maret
name: Nurhasan Agung Prabowo, MD
role: PRINCIPAL_INVESTIGATOR
References: