louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01942226: Investigation on Medical Management of Dry Eye Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndrome
Keywords: Dry eye syndrome
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Sun-Huei Tseng Eye Institute
name: Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University, Tainan, Taiwan
name: Allergan Pharmaceuticals Taiwan Co., Ltd.
First posted: 2013-09-13
Enrollment: 466
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from a primary care clinic or a tertiary referral center

Brief summary: Dry eye is a common complaint in patients encountered by ophthalmologists, which may result from the inflammatory response and can occur in the absence of systemic disease. However, the management of dry eye syndrome in real setting warrants assessment but remains lacking in Taiwan. We conducted an perspective observational study to evaluate the medical management of dry eye patients.


Eligibility criteria: Inclusion Criteria:

* Have given a written informed consent
* Clinical diagnosis of dry eye syndrome
* Have at least one Schirmer's test positive result (less than 10mm/5min) in at least one eye within one year

Exclusion Criteria:

* Pregnancy
* Cognitive or psychiatric deficit that precludes informed consent
* Cognitive or psychiatric deficit that precludes ability to perform requirements of the investigation

Primary outcomes:
measure: Artificial tears utilization patterns
timeFrame: within 1 month before recruitment
Secondary outcomes:
measure: Changes of dry eye symptoms, evaluated by clinicians
timeFrame: Baseline
measure: Changes of dry eye symptoms, evaluated by patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Sun-Huei Tseng Eye Institute
city: Taipei
country: Taiwan
facility: Department of Ophthalmology, National Taiwan University Hospital
Study officials:
affiliation: Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University
name: Yea-Huei Kao Yang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeh PT, Chien HC, Ng K, Tseng SH, Chen WL, Hou YC, Wang IJ, Chu HS, Kao Yang YH, Hu FR. Concordance between patient and clinician assessment of dry eye severity and treatment response in Taiwan. Cornea. 2015 May;34(5):500-5. doi: 10.1097/ICO.0000000000000409.
Clinical trial NCT04966026: Clinical Characteristics and Outcome of Patients With COPD With Pneumonia
Official title: Study on the Clinical Characteristics and Outcome of Patients With COPD Combined With Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Chronic Obstructive Pulmonary Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 143
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD combined with pneumonia admitted to Peking University Third Hospital from March 1, 2017 to February 28, 2018

Brief summary: To identify the clinical characteristics of patients with chronic obstructive pulmonary disease (COPD) combined with community-acquired pneumonia (CAP) and the factors influencing clinical transition.

Detailed description: To identify the clinical characteristics of patients with chronic obstructive pulmonary disease (COPD) combined with community-acquired pneumonia (CAP) and the factors influencing clinical transition.Compared to other chronic airway diseases, COPD patients can often have CAP in combination, but there is a lack of comparative studies between COPD patients with CAP and non-COPD patients with CAP.

Eligibility criteria: Inclusion Criteria:

1. CAP meets the diagnostic criteria published in 2016 Chinese CAP diagnosis and treatment guidelines; CPOPD and AECOPD meet the diagnostic criteria published in Chinese 2013 COPD diagnosis and treatment guidelines;
2. Age ≧ 40years.

Exclusion Criteria:

1. age \<40years;
2. pregnancy;
3. positive for human immunodeficiency virus (HIV) antibodies;
4. suspected or confirmed tuberculosis or fungal infection of the lung.

Primary outcomes:
measure: mortality rate
timeFrame: Day 28 from hospitalization
Secondary outcomes:
measure: Number of days in hospital
timeFrame: through study completion, an average of 1 year
measure: number of days in ICU
timeFrame: through study completion, an average of 1 year
measure: number of days on mechanical ventilation
timeFrame: through study completion, an average of 1 year
measure: cause of using antimicrobial drugs
timeFrame: through study completion, an average of 1 year
measure: hospital fees
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University 3rd Hospital
name: Yongchang Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184626: Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.
Official title: Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 97
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Body mass index equal to or lesser than 35.0 kg/m2
* Currently treated with oral hypoglycaemic drug

Exclusion Criteria:

* Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
* Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results

Primary outcomes:
measure: HbA1c
timeFrame: Measured at end of treatment (26 weeks)
Secondary outcomes:
measure: safety variables
measure: other glycemic variables
measure: Fasting plasma glucose value
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06175026: Encouraging Healthy and Sustainable Dietary Substitutions
Official title: Encouraging Healthy and Sustainable Dietary Substitutions: A Randomized Experiment With Emerging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Keywords: health
environment
sustainability
food choices
dietary substitutions
diet
emerging adults
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-12-18
Enrollment: 1753
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to examine emerging adults' responses to dietary substitution messages about health, the environment, or both health and the environment.

Detailed description: This online study will examine emerging adults' responses to dietary substitution messages about 4 different topics. Participants will be randomized to 1 of 4 topic arms: 1) Control (neutral topic, not related to health or the environment); 2) Health topic; 3) Environment topic; 4) Health and Environment topic. Participants will view messages about each of 4 dietary substitutions: replacing red meat with chicken or vegetarian options; replacing dairy milk with non-dairy milk; replacing juice with whole fruit; and replacing sugar-sweetened beverages with water. For each dietary substitution, participants will view 2 messages about their assigned topic, with the 2 messages shown in random order. Participants will rate each message on perceived message effectiveness (primary outcome).

Eligibility criteria: Inclusion Criteria:

* Age between 18-25 years
* Reside in the United States
* Ability to complete a survey in English

Exclusion Criteria:

* Older than 25 years; younger than 18 years
* Reside outside of the United States
* Unable to complete a survey in English

Primary outcomes:
measure: Perceived Message Effectiveness
timeFrame: Survey questions administered after participant viewed each message; overall survey took up to 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford School of Medicine
state: California
Study officials:
affiliation: Assistant Professor
name: Anna Grummon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05241626: AS-OCT of the Cornea in Thyroid Diseases
Official title: Anterior Segment Optical Coherence Tomography Study of the Tear Film and Cornea in Thyroid Eye Diseases.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Eye Disease
Keywords: Cornea- Tear film- AS-OCT
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were divided into 3 groups. Group 1 included 70 eyes of 35 patients of thyroid inactive disease, group 2 included 70 eyes of 35 patients of thyroid active disease, and group 3 included 70 eyes of 35 healthy controls

Brief summary: use the anterior segment optical coherence tomography (AS-OCT) to evaluate the tear meniscus parameters, total corneal thickness (CT), and epithelial thickness in active and inactive thyroid eye diseases (TED) patients and compare them with age-matched controls.

Detailed description: A prospective case-control clinical study. The study subjects were divided into 3 groups, group 1 of inactive thyroid patients, group 2 of active thyroid patients, and group 3 of healthy controls. The AS-OCT was used to measure lower tear meniscus parameters (tear meniscus height (TMH), tear meniscus depth (TMD), and tear meniscus area (TMA)), total CT and epithelial thickness

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were patients with thyroid disorders with age between 20 to 60 years with no ocular manifestations

Exclusion Criteria:

* being younger than 20 or older than 60, presence of systemic diseases as diabetes mellitus (DM) and autoimmune diseases as rheumatoid arthritis (RA) that may cause dry eye, previous ocular surgery, use of contact lenses, smokers, pregnant women, and breastfeeding women.

Primary outcomes:
measure: Tear Meniscus Height
timeFrame: through study completion, an average of 6 months
measure: Tear Meniscus Depth (TMD):
timeFrame: through study completion, an average of 6 months
measure: Tear Meniscus Area (TMA)
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia Faculty of medicine
city: Minya
country: Egypt
facility: Minia University hospital
Study officials:
affiliation: Minia faculty of medicine
name: mohamed Mahmoud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04332926: Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)
Official title: Effects of E-Cigarette Nicotine Content in Smokers (Nicotine Flux Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Keywords: Electronic Cigarette
Nicotine Flux
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-04-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.


Eligibility criteria: Inclusion Criteria:

* healthy (determined by self-report)
* between the ages of 18-55
* willing to provide informed consent
* able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
* Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Primary outcomes:
measure: Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT)
timeFrame: The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session.
measure: Breakpoint of Drug Purchase Task (DPT)
timeFrame: Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($).
measure: Effort for Product Puffs With Progressive Ratio Task (PRT)
timeFrame: The PRT is completed once per study session, at 85 minutes into the session.
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Center for the Study of Tobacco Products
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Caroline O Cobb, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Andrew Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06883526: Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma
Official title: A Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lymphoma
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: PART 1:

1. To explore the safety of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.
2. To determine the recommended Phase II dosing regimen for relapsed or refractory lymphoma.

PART 2:

To evaluate the efficacy of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.


Eligibility criteria: Inclusion Criteria:

* Fully understand this study and voluntarily sign the ICF；
* Age ≥18 at ICF signing, regardless of gender；
* Histologically confirmed relapsed or refractory lymphoma.

Exclusion Criteria:

* Lymphoma with known CNS involvement；
* Severe cardiovascular/cerebrovascular diseases.
* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Immunogenicity
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT01366326: Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects
Official title: A Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.


Eligibility criteria: Inclusion Criteria:

1. Body weight ≥40 kg (88 lb)
2. In good health with no clinically significant abnormal findings on the physical examination, medical history or the screening 12-lead ECG
3. Non-smoker
4. Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone).

Exclusion Criteria:

1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
2. History of clinically significant allergies
3. Positive urine screen for drugs
4. History of positive blood screen for human immunodeficiency virus (HIV), hepatitis B virus (Hep B), or hepatitis C virus (HCV)
5. Prior exposure, allergy or known hypersensitivity to methylnaltrexone
6. Diagnosis of alcohol or substance dependence within the past 12 months.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of MNTX and its Metabolites
timeFrame: 7 days
Secondary outcomes:
measure: Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites
timeFrame: 7 Days
measure: Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites.
timeFrame: 7 Days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06351826: Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department
Official title: Effectiveness of ELLASI Intervention Towards Response Time, Deterioration, and Metabolic Status of Polytrauma Patients in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polytrauma
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to test the effectiveness of ELLASI intervention in response time, deterioration score, and metabolic status of polytrauma patients in the emergency department. The main questions it aims to answer are:

1. Is the response time of polytrauma patients who receive ELLASI in the intervention group faster than the control group?
2. Is the deterioration score of polytrauma patients who receive ELLASI in the intervention group better than the control group?
3. Is the metabolic status of polytrauma patients who receive ELLASI in the intervention group better than the control group?

Polytrauma patients in the intervention group will receive ELLASI, a structured intervention consisting of the six following:

1. Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway,
2. Patient positioning and giving oxygen, head-up,
3. Stabilisation, including IV insertion, applying pressure and bandage, place monitor, and haemodynamic monitoring
4. Assessment: re-assessment of pain and other main complaints
5. Make sure informed consents are documented
6. Inform patient and family for further intervention

Polytrauma patients in the control group will receive the usual/standard intervention.

Response time, early warning score, and arterial blood gas of polytrauma patients from both groups will be obtained and documented before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* Polytrauma patients
* Have not received medical treatment before

Exclusion Criteria:

* Canceled registration
* Polytrauma patients who are unwilling to participate in the study

Primary outcomes:
measure: Response time
timeFrame: Immediately before and after the intervention
measure: Deterioration score
timeFrame: Immediately before the intervention start and 3 hours after the intervention end
measure: Acidic Level (pH)
timeFrame: Immediately before the intervention start and 3 hours after the intervention end
measure: Base Excess (BE)
timeFrame: Immediately before the intervention start and 3 hours after the intervention end
measure: Bicarbonate level (HCO3)
timeFrame: Immediately before the intervention start and 3 hours after the intervention end
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSCM
state: Jawa Barat
Study officials:
References: