louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02096432: Suicide Prevention in Chinese Older Adults
Official title: Suicide Prevention in Chinese Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Institute of Mental Health (NIMH)
First posted: 2014-03-26
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project aims to develop and refine a suicide intervention protocol, and pilot test a culturally tailored randomized control trial to reduce suicidal thoughts among U.S. Chinese older adults. During the first phase of the study, the investigators plan to invite the community advisory board and key stakeholders to participate in the iterative design and refinement of the study protocol. During the second phase of the project and after the initial screening and based on a specific set of inclusion criteria, the investigators will invite U.S. Chinese older adult to participate in a pilot randomized control trial of a culturally adapted intervention to reduce the frequency and intensity of suicidal thoughts in Chinese older adults. During the third phase of the project, the investigators plan to invite pilot intervention participants as well as key stakeholders and health care professionals on the cultural acceptability of the pilot intervention. Through the achievement of these objectives, the investigators will set the foundation to fully test a culturally adapted in-home intervention, which may be particularly suitable for Chinese older adults with suicidal thoughts as it addresses cultural-specific barriers and integrates care management within existing community services agencies using non-mental health professionals, including community health workers.


Eligibility criteria: Inclusion Criteria:

1. Self-identified as Chinese
2. \>50 years of age
3. Suicidal thoughts within the last month as detected from the Item 9 in PHQ-9
4. No plans to move for 6 months
5. No significant cognitive impairment with Chinese Mini-Mental State Examination (C-MMSE) score \>20

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Outcome measure will be measured in 10 weeks' time
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chinese community
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: XinQi Dong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Melissa A. Simon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06503432: The Effects of Programmed Death-ligand 1 on Postoperative Pain for Lung Cancer Patients
Official title: The Effects of Programmed Death-ligand 1 on Postoperative Pain for Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Postoperative Pain
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients underwent video-assisted thoracoscopic surgery for malignant lung disease.

Brief summary: The concentration of plasma programmed death-ligand 1(PD-L1) for lung cancer patients before video-assisted thoracoscopic surgery is detected. According to the distribution of plasma concentration, patients are divided into high or low expression of PD-L1. Differences in acute and chronic postoperative pain are compared between two groups of patients. And effects of PD-L1 expresion on postoperative pain in lung cancer patients are explained.

Detailed description: Chronic pain after video-assisted thoracoscopic surgery (VATS) has been a major concern for lung cancer patients. The relationship between plasma programmed cell death ligand-1 (PD-L1) concentration and chronic pain in post-VATS is uncertain. This study aims to explore the effects of PD-L1 levels on chronic pain and provide proactive pain management regimen according to individual genetic differences.

The concentration of plasma PD-L1 for lung cancer patients before video-assisted thoracoscopic surgery is detected. According to the distribution of plasma concentration, patients are divided into high or low expression of PD-L1. Differences in acute and chronic postoperative pain are compared between two groups of patients. And effects of PD-L1 expresion on postoperative pain in lung cancer patients are explained.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists physical status I-IV (males and females).
2. 18-80 years of age.
3. Patients undergoing video-assisted thoracoscopic surgery for malignant lung disease.

Exclusion Criteria:

1. History of opioid abuse.
2. Known psychiatric disorders.
3. Unexpected conversion to thoracotomy or transferred to intensive care unit for further treatment.
4. Combined with other surgeries or sites.

Primary outcomes:
measure: the incidence of chronic pain after surgery
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xue Tian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00747032: To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 0
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 aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stable, symptomatic plaque psoriasis
* Good health with the exception of psoriasis
* % BSA and plaque elevation requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing or planning a pregnancy within the study participation period.
* Subjects who have any systemic or dermatological disorders with the exception of psoriasis

Primary outcomes:
measure: Reduction in plaque elevation score
timeFrame: 8 weeks
Secondary outcomes:
measure: Reduction in Investigator´s Global Evaluation, erythema and scaling scores
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Fougera Pharmaceuticals Inc.
name: Kathleen Ocasio
role: STUDY_CHAIR
References:
Clinical trial NCT00740532: Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients
Official title: Observational Study Assessing Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: EGFR, HER-2, HER-3, MET, KRAS
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2008-08-25
Enrollment: 11
Sex: FEMALE
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: Breast cancer patients treated with Herceptin-based therapy

Brief summary: Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.

Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.


Eligibility criteria: Inclusion Criteria:

* Hystological diagnosis of breast cancer
* Availability of tumor tissue
* Availability to assess the response to Trastuzumab according to RECIST criteria
* Availability of clinical data

Exclusion Criteria:

* Unavailability of tumor tissue
* Impossibility to assess the response to Trastuzumab according to RECIST criteria

Primary outcomes:
measure: Association of a specific biomarker with response to Herceptin-based therapy
timeFrame: Response after two months of treatment
Secondary outcomes:
measure: Association of a specific biomarker with time to progression survival and patient's characteristics
timeFrame: At the end of enrollment
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01497132: Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2
Official title: Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Glucose Intolerance
Vitamin D Deficiency
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-12-22
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.


Eligibility criteria: Inclusion Criteria:

* Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
* BMI ≤ 32 kg/m2.
* HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
* Fasting plasma glucose \< 9 mmol/l
* S-25-OH-vitamin D3 \< 75 nmol/l.

Exclusion Criteria:

* Treatment with any vitamin D preparation.
* Regular sun-bathing in solarium.
* Hypercalcemia at screening, defined as free s-calcium \> 1.35 mmol/l.
* Hyperphosphatemia at screening, defined as s-phosphate \> 1.5 mmol/l.
* Sarcoidosis or other granulomatous disease.
* Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
* Impaired hepatic function.
* Impaired renal function
* Cardiac disease defined as:

  * Unstable angina pectoris
  * Myocardial infarction within the last 6 months
  * Congestive heart failure NYHA class III and IV
* Cerebral stroke within the last 6 months.
* Anti-diabetic medication of any kind.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.

Primary outcomes:
measure: Beta cell function
timeFrame: 8 weeks
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 8 weeks
measure: Glucose tolerance
timeFrame: 8 weeks
measure: Hypercalcemia
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dpt of Endocrinology, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Henrik Wagner, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wagner H, Alvarsson M, Mannheimer B, Degerblad M, Ostenson CG. No Effect of High-Dose Vitamin D Treatment on beta-Cell Function, Insulin Sensitivity, or Glucose Homeostasis in Subjects With Abnormal Glucose Tolerance: A Randomized Clinical Trial. Diabetes Care. 2016 Mar;39(3):345-52. doi: 10.2337/dc15-1057. Epub 2016 Jan 19.
citation: Mannheimer B, Wagner H, Ostenson CG, Diczfalusy U. No impact of vitamin D on the CYP3A biomarker 4beta-hydroxycholesterol in patients with abnormal glucose regulation. PLoS One. 2015 Apr 2;10(4):e0121984. doi: 10.1371/journal.pone.0121984. eCollection 2015.
Clinical trial NCT01662232: Improvement of Endothelial Function by EGCG
Official title: The Role of EGCG in Different Application Forms on Flow-mediated Dilation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Green tea
EGCG
Cardiovascular diseases
Endothelial function
Flow-mediated dilation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired endothelial function (assessed as flow-mediated dilation) represents an early marker for later cardiovascular events. Epidemiological and experimental studies suggest that consumption of tea is associated with lower progression of atherosclerosis and reduced cardiovascular mortality.

Tea contains high amounts of polyphenols with important biological activities. The green tea catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound in vitro. However, little is known about its contribution to beneficial effects of tea in vivo.

In this crossover study the impact of a single dose of EGCG applied in different forms (green tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in cardiovascular protective effects of green tea in vivo. The outcomes will provide insights about the role of EGCG in different application forms to improvements of endothelial function in humans.


Eligibility criteria: Inclusion Criteria:

* Male healthy volunteers
* 20-50 years
* BMI \< 27 kg/m2
* Cholesterol \< 240 mg/dl

Exclusion Criteria:

* Diabetes mellitus
* Hypertension
* Conditions with impaired endothelial function
* Smoking
* Regular drug use
* Alcohol abuse
* Regular tea drinkers

Primary outcomes:
measure: Flow-mediated dilation of the arteria brachialis
timeFrame: 2 hours after ingestion
Secondary outcomes:
measure: Agonist-induced platelet aggregation in vitro
timeFrame: 2 hours after ingestion
measure: Determination of plasma tea polyphenol levels
timeFrame: 2 hours after ingestion
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin
Study officials:
affiliation: Department of Cardiology and Angiology, Campus Mitte, Charité University Medicine Berlin, Germany
name: Mario Lorenz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00493532: A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Official title: An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-06-28
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility criteria: Inclusion Criteria:

* post-menopausal women with osteoporosis;
* \<=80 years of age;
* naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for \>1 year.

Exclusion Criteria:

* metabolic bone disease other than post-menopausal osteoporosis;
* treatment with other drugs affecting bone metabolism within last 6 months;
* previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chai Yi
country: Taiwan
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00164632: No More Falls Injury Prevention Study
Official title: California No More Falls! Senior Injury Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 552
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized controlled multi-component fall prevention study for older adults. The study integrates fall prevention into an existing community-based public health program for older adults.

Detailed description: A randomized controlled multi-component fall prevention study for older adults. The study integrates fall prevention into an existing community-based public health program for older adults. The study will evaluate the effectiveness of a fall prevention intervention among 552 seniors attending Preventive Health Care for the Aging (PHCA) clinics in two counties: urban San Diego county and rural Humboldt county. The intervention includes four elements: education about fall risk factors, referrals to community exercise programs to increase strength and balance, medication review, and home modification to reduce home hazards. The goal of the intervention is to reduce incidence of falls requiring hospitalization by 10%. Results of the study, which are expected to be completed by October 2004, will help guide future efforts to develop multifaceted fall prevention programs.

Eligibility criteria: Inclusion Criteria: PHCA clients age 65+ -

Exclusion Criteria: Age \<65

-

Primary outcomes:
measure: Number of falls reported after 12 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: California Department of Health Services
name: Barb Alberson, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00951132: Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy
Official title: Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Depression
Keywords: Inflammation
Atherosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: AstraZeneca
First posted: 2009-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients.

Detailed description: Depression is associated with increased risk of cardiovascular disease, in which one possible mechanism is systemic inflammation. Further, patients at high risk of cardiovascular disease, rosuvastatin decreases the risk, especially among patients with increased inflammation. This is a proof-of-concept study to investigate whether the antiinflammatory effect of rosuvastatin is similar in depressive as in patients with cardiovascular disease.

Eligibility criteria: Inclusion Criteria:

* Persisting self-reported depressive symptoms \> 5 weeks
* Indications of aortic atherosclerosis on PET/CT

Exclusion Criteria:

* Clinical indication of statin use.
* Contraindication of statins, or of PET/CT and MRI.
* Established cardiovascular disease.
* Bipolar disorder og comorbid psychosis.

Primary outcomes:
measure: Mean SUV of large arteries
timeFrame: 3 months
Secondary outcomes:
measure: Peripheral endothelial function (pulse wave amplitude)
timeFrame: 3 months
measure: Circulatory proinflammatory markers
timeFrame: 3 months
measure: Heart rate variability
timeFrame: 3 months
measure: Depressive symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Lorenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Torbjorn Omland, PhD
role: PRINCIPAL_INVESTIGATOR
References: