louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02312375: Effects of Fimasartan on Insulin Secretion in Type 2 Diabetic Patients
Official title: Effects of Fimasartan on Insulin Secretion, and Interaction With DPP4 Inhibitors in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the effect of ARB in improving insulin secretion in patients with type 2 diabetes. The investigators also aimed to evaluate if there are potential synergisms between ARB and DPP4 inhibitors in improving insulin secretion and urinary albumin secretion in diabetic patients.

Detailed description: Angiotensin II has been reported to insulin secretion in beta cells. Angiotensin II indirectly improves insulin secretion in beta cells via vasoconstriction and reduced islet blood flow. Chronic exposure to high glucose or high fat increases expression of AT1R (angiotensin type 1 receptor), leading to reactive oxidative stresses, inflammation, and apoptosis in beta cells, finally decreased insulin formation and secretion. Some studies showed the beneficial effect of blocking AT1R on insulin secretion and beta cell proliferation in animal models using angiotensin receptor blocker (ARB). Furthermore, 26 weeks of valsartan treatment improved insulin secretion in humans with impaired glucose regulation.

Eligibility criteria: Inclusion Criteria:

* Aged 20\~80 years
* Type 2 diabetic patients diagnosed more than 6 months ago
* HbA1c ≤8.5% at screening
* No change of OAD within the 3 months before screening
* SBP \<140 mmHg and DBP \<90 mmHg with anti-hypertensive drug at screening
* SBP ≥140 mmHg or DBP ≥80 mmHg without anti-hypertensive drug at screening

Exclusion Criteria:

* Type 1 diabetic patients or active insulin treatment at screening
* Treatment with ARB or ACEi within 1 month prior to screening
* Uncontrolled hypertension with SBP \>170 mmHg or DBP \>100 mmHg
* Pregnancy or lactation
* Elevated liver enzyme (AST or ALT \> 3 times the UNL) or elevated serum Cr (≥1.5 mg/dL in men and 1.4 mg/dL in women)

Primary outcomes:
measure: Insulinogenic index
timeFrame: 16 week
Secondary outcomes:
measure: HOMA β-cell function
timeFrame: 16 week
measure: Insulin resistance
timeFrame: 16 week
measure: Urinary albumin creatinine ratio, urinary protein creatinine ratio
timeFrame: 16 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00601575: Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions
Official title: A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Participation in a clinicl trial within 30 days prior to study initiation.
* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Three period, Fourteen day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Research
state: Arkansas
Study officials:
affiliation: Arkansas Research
name: Jerry Herron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06493175: The Application of Large Language Model in Emergency Chest Pain Triage
Official title: The Application of Large Language Model in Emergency Chest Pain Triage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Pain
Keywords: large language model
Chest Pain
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Jinan Central Hospital
name: Qingdao Municipal Hospital
name: Tianjin Medical University General Hospital
name: The First Hospital of Hebei Medical University
First posted: 2024-07-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the accuracy and efficiency of large language model in emergency triage.

Detailed description: The study is to evaluate the value of large language model in emergency triage, their accuracy and efficiency were evaluated and compared with traditional triage. To explore whether the model can effectively reduce the workload of medical staff, while improving the speed and quality of triage. In addition, the ability of the model to predict serious medical events such as acute heart events and strokes was evaluated. It also included surveys of patients; acceptance and satisfaction with the use of the artificial intelligence-assisted triage system. Analyze the economic benefits of adopting this technology, including cost saving and optimal allocation of resources.

Eligibility criteria: Inclusion Criteria:

1. All patients with chest pain entered the emergency triage procedure.
2. patients aged 18 and above.

Exclusion Criteria:

1. Patients with severe cognitive impairment or inability to communicate.
2. There are patients who have been explicitly referred to specific departments (for example, some of the 120 transfer patients, who may go directly to the green channel) .
3. Patients with unstable vital signs .
4. Patients with potential medical problems.
5. Is participating in other clinical trials.
6. Failure to follow test procedures.
7. Those who refuse to sign the informed consent form.

Primary outcomes:
measure: The Diagnostic Accuracy Rate of MedGuide-V5
timeFrame: through study completion, an average of 10 months
Secondary outcomes:
measure: The Satisfaction of Medical Personnel
timeFrame: during evaluation
measure: Medical Personnel Treatment Plan Adjustment Rate
timeFrame: during evaluation
measure: Emergency Department Revisit Rate within 30 Days
timeFrame: during evaluation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yi-Da Tang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01831375: Cancer Prevention and Care Among Aged
Official title: Health Care Partners in Cancer Prevention and Care Among Aged
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 697
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research represents a pioneering effort to design a brief, cost effective and readily transportable program that will enable disadvantaged elders to become more effective participants in their health care.

The intervention is expected to result in trained elders becoming more knowledgeable health care partners. Trained patients will be prepared for appointments and will engage their primary care physicians in active dialogue regarding cancer prevention and screening.

Based on self-advocacy, these patients are expected to receive better preventive care and report greater satisfaction with care. Program participation can subsequently contribute to general health improvements and minimize health disparities.

Detailed description: In a randomized controlled trial (RCT) with 400 older adults, the investigators will assess the efficacy of the "Speak Up" intervention (N=200) relative to an attention control group "Connect" program (N=200), aimed at enhancing social and civic engagement. Participants will now obtain resource materials that include decision aids and diary logs to bring to visits with doctors. The investigators will implement "Speak Up" and "Connect" programs in two unique study populations: 1) participants in the ongoing NCI study and 2) older adults attending senior center programs sponsored by Area Agencies on Aging (AAAs). Participants will be assessed prior to the intervention and 2 month, and 12 months post intervention. The investigators will have an observation window of 12 months to determine whether and when the older adult obtained screening. The selection of a shorter follow-up time frame will help reduce attrition.

Eligibility criteria: Inclusion Criteria:

* Men and women
* Over the age of 65 from Area Agencies of Aging who are interested in participating

Exclusion Criteria:

* No exclusion

Primary outcomes:
measure: Perception of Physician Quality Scale
timeFrame: one year
Secondary outcomes:
measure: Cancer Screening Recommendations
timeFrame: one year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Eva Kahana, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01482975: Tailored Interventions to Prevent Substance Abuse
Official title: Tailored Interventions to Prevent Substance Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention Harmful Effects
Keywords: tobacco
alcohol
diet
exercise
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 4158
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The overarching objective of this research is to prevent substance use in early adolescents through the use of innovative interactive interventions tailored to each individual's particular risk profile for using cigarettes and alcohol. The specific aims are: (1) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents smoke-free compared to a comparison group; (2) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents from using alcohol compared to a comparison group; and (3) To replicate findings that the tailored diet and physical activity interventions will be effective in reducing these two high risk behaviors as part of the comparison condition.

Detailed description: Research across age groups (elementary, middle and high school), populations (U.S., U.K., and Israel), and substances (tobacco, alcohol and other drugs) has consistently identified four clusters of non-users who vary in their risks for substance use: (1) Most Protected from substance use; (2) High Risk to use substances; (3) Ambivalent about staying substance free; and (4) Risk Denial about substance use. These profiles have demonstrated both internal and external validity as well as good ability to predict future substance use and, therefore, provide an opportunity to develop a new approach to prevention. These profiles will be employed as the basis for designing two innovative computer-based interventions to prevent substance abuse by adolescents. The two new tailored interventions (smoking prevention and alcohol prevention) will be developed and tested in a school-based clinical trial. The comparison group will receive two previously developed and tested tailored health behavior interventions (diet and physical activity).

Eligibility criteria: Inclusion Criteria:

* 6th grade student in one of 20 participating Middle Schools in RI
* English speaking
* Student Assent

Exclusion Criteria:

* Parent refusal for child to participate

Primary outcomes:
measure: Smoking Prevention
timeFrame: 36 months
measure: Alcohol Use Prevention
timeFrame: 36 months
measure: Exercise
timeFrame: 36 months
measure: Diet
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
Study officials:
affiliation: Univeristy of Rhode Island
name: Wayne F Velicer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03644875: Study of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
Official title: A Prospective, Single Center, Non-comparative, 90-Day Follow-up, Postmarket Clinical Investigation of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Surgery
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2018-08-23
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: The study patients will be recruited by the investigator, among patients scheduled to receive a standard cataract surgery taking inclusion and exclusion criteria into account. The investigator may also offer participation in the study to potential candidates identified in their patient database.

Brief summary: This is a prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etacoat in patients undergoing cataract surgery.

The performance is evaluated by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.


Eligibility criteria: Inclusion Criteria:

* Patients indicated for cataract surgery via the anterior chamber
* A negative urine pregnany test at Visit 1 or 2
* Capability to understand information about the investigation, including patients' obligations, and willingness to take part, as evidenced by signed and dated informed consent.

Exclusion Criteria:

* Patient who are known to be hypersensitive to HPMC or other components of the device
* Patients with corneal scars or corneal dystrophies interfering with study measurements
* Abnormal intraocular pressure which would interfere with surgery and follow up (in opinion of the investigator)
* Any other condition that in the opinion of the investigator would interfere with the participation in this investigation
* Any person dependent on the investigator or employees of the investigation site institution or the Sponsor
* Current or previous (within 30 days of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study
* Patients whose participation in clinical trials is prohibited by the Austrian Medical Devices Act

Primary outcomes:
measure: Specular microscopy to measure the preservation of endothelium
timeFrame: 90 days post surgery compared to baseline
Secondary outcomes:
measure: Specular microscopy to measure the corneal thickness
timeFrame: post surgery, 1 day and 90 days post surgery compared to baseline
measure: Intraocular pressure measurement
timeFrame: post surgery, 1 day and 90 days post surgery compared to baseline
measure: Questionnaire to assess the satisfaction with the application
timeFrame: day 0
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
Study officials:
References:
Clinical trial NCT02513875: Prevention of Type 2 Diabetes With Vitamin D
Official title: Prevention of Type 2 Diabetes in Women With Prediabetes Using Vitamin D Supplementation and Lifestyle Intervention in North India (PREVENT-WIN Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, India
First posted: 2015-08-03
Enrollment: 121
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The work plan will have the following S\&T components. Component 1: Cross-sectional Study

Cross-sectional study will be of 1.5 years where 400 women from rural will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure.

Component 2: Prospective Study

This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women with vitamin D deficiency. The women will be recruited from cross-sectional study, out patient department and health camps and they will be followed up for 2 years. The women will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be compared.


Eligibility criteria: Inclusion Criteria:

* Healthy women aged 20-60 years.

Exclusion Criteria:

* Received Vitamin D or calcium supplementation in the previous six months.
* On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (e.g. metformin, thiazolidenediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors, and drugs used in transplantation
* Pregnancy and lactation at time of study
* Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
* Known case of HIV infection.
* Known case of diabetes mellitus and other endocrine disorders.

Primary outcomes:
measure: fasting glucose (mg/dL)
timeFrame: 2 years
Secondary outcomes:
measure: TC (mg/dL)
timeFrame: 2 years
Other outcomes:
Locations:
city: Delhi
country: India
facility: Fortis CDOC center of Excellence for Diabetes Obesity and Endocrinoogy, New Delhi, India
Study officials:
affiliation: Diabetes Foundation, India
name: Anoop Misra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02604875: The Circadian Rhythm of Copeptin
Official title: The Circadian Rhythm of Copeptin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circadian Rhythm
Copeptin Blood Levels
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy subjects

Brief summary: The circadian rhythm of copeptin will be examined in healthy subjects.

Detailed description: In 18 healthy volunteers the circadian rhythm of copeptin will be examined by withdrawing blood samples for copeptin levels every 30 minutes for 24 hours.

Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* acute illness
* chronic illness
* pregnancy
* Anemia defined as Hb \< 30g/l

Primary outcomes:
measure: measurement of copeptin values in mmol/l within 24 hours to assess the amount of release in a day curve.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mirjam Christ-Crain, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871775: Effects of Therapeutic Intervention Through Selective Functional Movement Assessment on Pain, Function, Balance and Gait in Patients With Chronic Nonspecific Neck Pain
Official title: Effects of Therapeutic Intervention Through Selective Functional Movement Assessment on Pain, Function, Balance and Gait in Patients With Chronic Nonspecific Neck Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Nonspecific Neck Pain
Keywords: exercise
neck pain
chronic pain
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to the order of the physical examination, the scope of the problem is narrowed down by excluding the parts of the body that do not have problems and adjusting the load related to stability. A list of problems can be created through an algorithmic approach that guesses which structures will have problems through active or passive movement. This provides an optional therapeutic intervention.


Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 18 and 65 who have experienced chronic neck pain for more than 12 weeks (Blanpied et al., 2017).
* Those with more than moderate pain (4/10 cm) on the visual analogue scale (VAS) (Paksaichol et al., 2012).
* Those with a neck disability index (NDI) of mild disability (5/50 score) or higher (Lluch et al., 2014).
* Those who consented to participate in this study.

Exclusion Criteria:

* Patients with severe pathology such as radiation pain due to intervertebral disc herniation or neurological signs consistent with tumor, whiplash injury, cervical vertebra fracture, or nerve root compression.

Primary outcomes:
measure: neck disability index
timeFrame: change from baseline neck disability index at 8weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin University
Study officials:
affiliation: Yongin University
name: Dajeong Kim, MSc
role: PRINCIPAL_INVESTIGATOR
References: