louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02013791: Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
Official title: A Phase 2, Multi-center, Vehicle- and Sham-controlled, Randomized Study of RESTASIS® X in Patients With Moderate to Severe Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 55
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: This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe dry eye disease in both eyes
* Best-corrected visual acuity (BCVA) of 20/100 or better in each eye

Exclusion Criteria:

* Use of any cyclosporine preparations within 3 months
* Use of topical medications, other than artificial tears, in the eyes within 1 month
* Use of contact lenses in either eye within 1 month
* Stage 2 only: Participation in Stage 1 of this study

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: First dose of study drug to up to 24 Weeks
Secondary outcomes:
Other outcomes:
measure: Change From Baseline in Corneal Staining Score Using a 6-Point Scale
timeFrame: Baseline (Day 1) to Week 12
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: Irvine
country: United States
facility: Lakeside Vision Center
state: California
city: Newport Beach
country: United States
facility: Steve Yoelin MD Medical Asscociates
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University - Wilmer Eye Institute
state: Maryland
city: Kenosha
country: United States
facility: Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: Allergan
name: Eleonora Safyan
role: STUDY_DIRECTOR
References:
Clinical trial NCT01376791: Assess the Effect of Treating Periodontal Disease on Cardiovascular Function in Young Adults
Official title: Oral Flora, Periodontitis, and Vascular Dysfunction in Young Native Americans.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Disease
Atherosclerosis
Keywords: Periodontal disease
Atherosclerosis
Oral Pathogens
Native Americans
Inflammatory cytokines
Microbial metagenomics
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
name: University of California, San Diego
First posted: 2011-06-20
Enrollment: 92
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises 200 Native Americans seeking health care at the Indian Health Council.

Brief summary: We propose to examine a population of Native Americans who have had little or no dental care, and to determine if periodontal disease is associated with early signs of vascular dysfunction or systemic inflammation. We then propose to treat the periodontitis and re-evaluate vascular function. We will determine if gingivitis or mild/moderate periodontitis is associated with detectable vascular dysfunction. Microbial metagenomics will be correlated with vascular function.


Eligibility criteria: Inclusion Criteria:

* American Indian/Alaskan Natives seeking health care at the Indian Health Council, Inc.
* Males and females aged 21-40 years.

Exclusion criteria:

* Recent (within 6 months) periodontal treatment
* History of high blood pressure or existing heart disease
* Xerostomia
* Currently receiving treatment for cancer
* Currently taking anti-inflammatory medications (except H2 blockers, statins, or medications that can affect periodontal status
* Immunosuppressed due to medication or HIV infection, or presence of active infection such as hepatitis or tuberculosis
* Fewer than 20 teeth in functional dentition, excluding third molars, or other gross oral pathology

Primary outcomes:
measure: Determination of bacterial populations in periodontal samples before and after standard periodontal treatment, stratified by severity of gum disease, using microbial metagenomics analysis.
timeFrame: Time of enrollment and at 6 week follow up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Valley Center
country: United States
facility: Indian Health Council
state: California
Study officials:
affiliation: San Diego State University
name: Roberta A Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03173391: Long-term Efficacy and Safety of HMS5552 in T2DM Subjects
Official title: A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 With Additional 28-week Open-label Treatment to Evaluate the Safety of HMS5552 Alone in T2DM Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: GKA
T2DM
HMS5552
monotherapy
Lead sponsor: Hua Medicine Limited
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2017-06-01
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety and population PK of HMS5552 as monotherapy in adult type 2 diabetic subjects, there will be 2 groups in the first 24 weeks, one group will receive HMS5552 , while the other group will receive placebo ; after 24 weeks, all subjects will receive HMS5552 for 28 weeks.

Detailed description: This study is a phase III study in subjects with T2DM. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects. The eligible subjects are randomly assigned to HMS5552 75mg BID group or placebo BID group with ratio 2:1 to receive a 24-week double-blind treatment. Then all subjects receive 28-week open-label treatment of HMS5552 75mg BID . After 52-week treatment, all investigational drugs should be discontinued, followed by 1 week for safety evaluation.

Eligibility criteria: Inclusion Criteria:

1. Male or female, aged 18\~75 years old
2. naive T2DM 3.7.5% ≤ HbA1c ≤ 11.0% at screening 4.18.5 kg/m2 \< BMI \< 35.0 kg/m2 at screening;

Exclusion Criteria:

1. T1DM
2. Fasting C-peptide \<1.0 ng/ml (0.33 nmol/L) at screening
3. Medical history of severe hypoglycemia, diabetic ketoacidosis, diabetes lactic acidosis or hyperosmotic nonketotic diabetic coma, severe cardio-cerebrovascular,unstable or rapidly progressive kidney disease, active liver diseases,diagnosed mental disease,etc

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: 24 weeks
Secondary outcomes:
measure: The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline
timeFrame: 24 weeks
measure: The change of fasting plasma glucose (FPG) from baseline
timeFrame: 24 weeks
measure: The proportion of subjects with HbA1c < 7.0%
timeFrame: 24 weeks
measure: Incidence of Treatment-Emergent Adverse Events over time
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Hua Medicine Limited
state: Shanghai
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Dalong Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04279691: Prolactin Hormone in Rheumatoid Arthritis Patients With Periodontitis
Official title: Synovial and Gingival Crevicular Fluid Levels of Prolactin Hormone in Rheumatoid Arthritis Patients With Periodontitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Periodontitis
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian patients with active rheumatoid arthritis and periodontitis.

Brief summary: In this study we will assess the presence of prolactin hormone in the gingival crevicular fluid , and synovial fluid of patient with rheumatoid arthritis and periodontitis


Eligibility criteria: Inclusion Criteria:

* for first group patients with active rheumatoid arthritis with periodontitis.
* second group , patients with periodontitis and otherwise systemically healthy
* third group, systemically and periodontallly healthy subjects

Exclusion Criteria:

* smokers,
* pregnant or lactating females
* patients taking medications the affects levels of prolactin hormone.
* no periodontal treatment in the past six months

Primary outcomes:
measure: prolactin hormone levels in the tested media
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00955591: Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men
Official title: Comparison of Flocked vs. Dacron Swab for Anal Cytology, Correspondence With High Resolution Anoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Cancer
Nonneoplastic Condition
Precancerous Condition
Keywords: human papilloma virus infection
anal cancer
HIV infection
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-08-10
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human papillomavirus. It is not yet known which type of swab is more effective in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.

PURPOSE: This clinical trial is comparing two types of swabs in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.

Detailed description: OBJECTIVES:

* To determine whether the anal cytology screening outcome derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens in men who have sex with men.
* To determine whether the number and type-specific identification for human papillomavirus derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens.

OUTLINE: Dry sterile Dacron swabs and flocked nylon swabs are used to collect intra-anal cytology specimens for anal Pap testing and human papillomavirus typing. Participants undergo a digital rectal examination and high-resolution anoscopy. If lesions are identified, an anal biopsy is performed for histological examination.

Eligibility criteria: Inclusion Criteria:

* HIV-infected or -uninfected adult men who have sex with men
* Concurrent enrollment in the Multicenter AIDS Cohort Study required

Exclusion Criteria:

* history of anal perforation or other medical contraindications

Primary outcomes:
measure: Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab
timeFrame: a day
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Dorothy Wiley, Ph.D. RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiley DJ, Hsu H, Bolan R, Voskanian A, Elashoff D, Young S, Dayrit R, Barman P, DeAzambuja K, Masongsong EV, Martinez-Maza O, Detels R. Comparison of 2 anal cytology protocols to predict high-grade anal intraepithelial neoplasia. J Low Genit Tract Dis. 2013 Oct;17(4):414-24. doi: 10.1097/LGT.0b013e318281d36e.
Clinical trial NCT05965791: Median Nerve Function During Phalen's Test
Official title: Electrophysiological Assessment of the Median Nerve During the Phalen's Test for Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women aged 18-45 recruited from the local community.

Brief summary: This study will use electromyography and nerve conduction studies to evaluate median nerve function during the Phalen's wrist flexion test in different wrist positions.

Detailed description: The Phalen's test is commonly used to assess carpal tunnel syndrome. However, it is unclear which wrist position during this test best isolates median nerve function. This study will measure thenar muscle activation and median nerve conduction in 30 healthy participants performing the Phalen's test. Different wrist flexion angles will be evaluated to determine which position optimally targets the median nerve. Results may enhance utilization of the Phalen's test in clinical practice and research.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18-45 years
* No history of hand/wrist disorders

Exclusion Criteria:

* Contraindications to EMG or NCV
* Neurological or muscular disorders

Primary outcomes:
measure: Thenar Muscle Activation
timeFrame: Baseline
measure: Median Nerve Conduction Velocity during Phalen's Test
timeFrame: Baseline
measure: Median Nerve Distal Latency during Phalen's Test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References:
Clinical trial NCT03286491: Clinical Decision Support System to Define 30 Day Adverse Clinical Events for Emergency Department Acute Coronary Syndromes
Official title: Development of Clinical Decision Support System to Define 30 Day Adverse Clinical Events (Non Fatal Myocardial Infarction, Cardiac Related Death or Coronary Intervention) for Patients Presenting to Emergency Department With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Clinical Decision Support System
Keywords: acute coronary syndrome, risk classification, 30 day adverse event, clinical decision support system
Lead sponsor: Turkish Ministry of Health Izmir Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2017-09-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to emergency deparmtent with acute chest pain consistent with acute coronary syndrome will be included for analysis.

Brief summary: Acute coronary syndromes are among main complains for patients presenting to emergency department. Risk classification systems are used to classify patients to appropriate risks and help physicians manage diagnosis strategies and treatments. Purpose of this study is to develop a clinical decision support system for patients presenting to emergency department with the help of statistical machine learning.

Detailed description: Acute coronary syndromes are among main complains for patients presenting to emergency department and create a burden to emergency departments and hospitals. Risk classification systems were developed and used to classify patients to appropriate risk groups. According to risk classification, different diagnosis and treatment modalities can be used and help physicians manage diagnosis strategies and treatments. Purpose of this study is to develop a clinical decision support system for patients presenting to emergency department with the help of statistical machine learning.

Eligibility criteria: Inclusion Criteria:

* Presenting to emergency department with acute chest pain consistent with acute coronary syndrome

Exclusion Criteria:

* Patients with less than 18 years old
* Patients presenting with ST-segment elevation myocardial infarction
* Patients presenting with other causes of acute chest pain (pneumothorax, pulmonary -embolism, aortic dissection
* Decline to participate in study

Primary outcomes:
measure: Non fatal myocardial infarction, cardiac related death or coronary intervention in 30 days
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bozyaka Training and Research Hospital
Study officials:
References:
Clinical trial NCT05267691: Pathological Characteristics of Basal Cell Carcinoma
Official title: Basal Cell Carcinomas on Sun-protected Versus Sun-exposed Body Sites: a Clinicopathological Descriptive Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatological Tumors
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Visiting dermatology or surgery clinics in the tertiary hospital

Brief summary: A hospital based cross-sectional study was conducted from 2017 to February 2021. Clinical history, examination and histopathological variants were collected from medical files and pathology reports. Confirmation of pathology was done in all the patients visiting skin and plastic surgery department with suspected lesions.

Detailed description: Some cases may be tested for immunohistochemistry on the tissue block

Eligibility criteria: Inclusion Criteria:

* Excised lesion
* Confirmed basal cell carcinoma pathologically

Exclusion Criteria:

* Incision biopsy
* Incomplete follow up

Primary outcomes:
measure: Healing
timeFrame: 1 day
Secondary outcomes:
measure: Recurrence
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abdulkarim Hasan
Study officials:
affiliation: Al-Azhar University
name: Abdulkarim Hasan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04166591: Study 1 Replication and Extension of Prior Work
Official title: Learning New Words From Overhearing in Children With ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Emerson College
First posted: 2019-11-18
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children).

Specific Aim 1 (Experiment 1): Subaim 1a: Identify child characteristics associated with learning from overhearing. In a prior study, the investigators found that 13 children with ASD were able to learn the meanings of novel words that they heard used in a conversation involving two adults. In the current study, the investigators aim to study a larger sample to identify what child characteristics are associated with good learning in an overhearing situation as compared to a situation in which the child is directly taught the new word. Subaim 1b: Assess retention and generalization of words learned from overhearing. The investigators will re-test children on their knowledge of the word meanings after a 10-minute delay to see if they both retain the word meanings and can generalize the new words to new situations.


Eligibility criteria: Inclusion Criteria:

* children with or without a diagnosis of ASD between 18 to 71 months of age

Exclusion Criteria:

* native language is not English
* born premature (\< 36 weeks)
* has uncorrected hearing or vision impairments
* has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD)
* has a history of photosensitive epileptic seizures

Primary outcomes:
measure: Number of Children Who Select the Target Object as Measured by Gaze Preference.
timeFrame: immediately after viewing 3-minute interaction
measure: Number of Children Who Select the Target Object as Measured by Gaze Preference.
timeFrame: 5 minutes after viewing interaction
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Emerson College
state: Massachusetts
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References: