louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00970294: Pilot Project of Health Promotion for People With Diabetes
Official title: Feasibility and Effectiveness of a Health Promotion Program on Aerobic Fitness and Glycemic Control for Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. The purpose of this study is to gather preliminary data to assess the feasibility of an intense, customized health promotion program in people with diabetes, and to evaluate outcome measures following participation to determine effect size for future studies. Subjects with type 2 diabetes will participate in a 10-week health promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic and strength training exercises with a schedule of progression, individual nutrition counseling, and diabetes health education sessions.


Eligibility criteria: Inclusion Criteria:

1. diabetes type II
2. age 40-70

Exclusion Criteria:

1. hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months
2. significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus
3. recent symptoms of chest discomfort
4. currently smoking or significant pulmonary pathology
5. serious musculoskeletal problems that would limit ability to exercise
6. current active involvement in a regular exercise program (\> 3 times per week)
7. open wounds on the weight bearing surface of the feet
8. not able to ambulate independently
9. stroke or other central nervous system pathology
10. stage 2 hypertension (resting blood pressure \> 160 systolic or \> 100 diastolic)

Primary outcomes:
measure: Recruitment, Retention, Adherence
timeFrame: 10 weeks
Secondary outcomes:
measure: Aerobic Fitness
timeFrame: Baseline and at 10 weeks (change score)
measure: Glycemic Control
timeFrame: Baseline and at 10 weeks (change score)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Patricia Kluding PhD
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Patricia Kluding, PhD
role: STUDY_DIRECTOR
References:
citation: Kluding PM, Singh R, Goetz J, Rucker J, Bracciano S, Curry N. Feasibility and effectiveness of a pilot health promotion program for adults with type 2 diabetes: lessons learned. Diabetes Educ. 2010 Jul-Aug;36(4):595-602. doi: 10.1177/0145721710370718. Epub 2010 Jun 8.
Clinical trial NCT05680194: Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients
Official title: Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Keywords: ≥65 Years Old
early breast cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients ≥65 Years Old with breast cancer who received operaion in Peking Union Medical College Hospital

Brief summary: The elderly patients over 65 years old with breast cancer have concomitant diseases, poor tolerance to conventional treatment, and the specific prognosis of breast cancer is relatively good. Previous studies on breast cancer have almost excluded elderly breast cancer patients, and conventional treatment schemes cannot meet the clinical diagnosis and treatment needs of elderly breast cancer patients. The establishment of a prognosis model for elderly breast cancer patients can provide personalized treatment programs. This is important for prolonging the survival time of patients and improving the quality of life. This project plans to observe the relationship between prognosis and pathological staging, molecular typing, and concomitant diseases of elderly breast cancer patients in combination with immune genes, and establish a prognosis model of elderly breast cancer and verify it. This project is expected to establish a new prognostic model for elderly breast cancer patients, accurately judge the prognosis of patients, and provide a new basis for hierarchical and personalized treatment of elderly breast cancer.


Eligibility criteria: Inclusion Criteria:

* female patients with breast cancer
* ≥65 Years Old
* patients with breast cancer received operation in Peking Union Medical College Hospital
* treatment regimen was made in Peking Union Medical College Hospital

Exclusion Criteria:

* patients with metastasis
* patietns with recurrence
* patients without pathological information

Primary outcomes:
measure: 5-y DFS
timeFrame: 5 year
measure: 5-y BCSS
timeFrame: 5 year
Secondary outcomes:
measure: 5-y OS
timeFrame: 5 year
measure: 10-y DFS
timeFrame: 10 year
measure: 10-y BCSS
timeFrame: 10 year
measure: 10-y OS
timeFrame: 10 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Ying Zhong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02567994: Tenelia Triple Combination Study
Official title: Efficacy and Safety of Teneligliptin Versus Sitagliptin as add-on Therapy to Metformin Plus Glimepiride in T2DM Patinets With Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 201
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After a screening, a 2-week, single-blind placebo run-in, 200 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Teneligliptin 20mg or sitagliptin 100mg to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Detailed description: Subjects will visit the centers on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.

Eligibility criteria: Inclusion Criteria:

1. Patients with Type 2 Diabetes Mellitus
2. Adults aged ≥ 19 years old
3. Patients with HbA1c 7%\~11% at Screening and Run-in visit

Exclusion Criteria:

-

Primary outcomes:
measure: Change of HbAlc from baseline at Week 24
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01479894: Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer
Official title: Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Genomic Health
First posted: 2011-11-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. As such, all eligible patients must have a stored tumor specimen which can be accessed for analysis.

Brief summary: This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the distribution of Recurrence Score® and gene groups of stage II colon cancer in African American (AA) and Caucasian individuals. Other covariant factors in the medical chart will be analyzed as well. Three institutions will contribute patients to this study with a total patient number goal of approximately 200 with approximately 100 being AA and approximately 100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be matched for every African American enrolled.


Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 years of age or older.
* Subjects must be AA or Caucasian.
* Subjects with pathologic stage II colon cancer; Irrespective of number of nodes examined.

Exclusion Criteria:

* Patients of races other than AA or Caucasian.
* No tumor block available from initial diagnosis.
* No tumor or very little tumor (\<5% tumor present) in block as assessed by examination of the H\&E slide by the Genomic Health, Inc (GHI) - designated pathologist.
* Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H\&E slide by the GHI-designated pathologist.
* Insufficient RNA (\<5 ng/μL or 300 ng) for RT-PCR (radiation therapy - pathologic complete response) analysis.
* Failure of assay to meet pre-specified quality control (QC) specifications.

Primary outcomes:
measure: Compare the prognosis of colon cancer patients compared to gene expression.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References:
Clinical trial NCT03688594: Non Invasive Prenatal Test of Rare Genetic Diseases: Application to Rare Intellectual Disabilities
Official title: Non Invasive Prenatal Test of Rare Genetic Diseases: Application to Rare Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Genetic Disorders in Pregnancy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate performances of a NIPT test based onto the study of the maternal blood to search known genetic mutations already detected in the family and potentially inherited by the fetus. This test will avoid an invasive prenatal diagnosis in those families with a known genetic risk.

The performance of this test will be evaluated in terms of sensitivity and specificity with an adapted statistic model.

Secondary objectives of the protocol are

* To adapt NIPT to small DNA quantity (5-50 ng)
* To adapt bioinformatics pipeline to low rate of mosaicism
* To develop a tool to quantify the fetal fraction
* To evaluate the robustness of the method

This test is based onto capture and high throw put sequencing adapted to cell free plasmatic DNA of pregnant women in order to detect point mutation present in her fetus. This approach has been previously described for others clinical applications such as liquid biopsy in cancers but not for NIPT analysis.


Eligibility criteria: Inclusion Criteria:

* Couple (father, mother) \> 18 ans
* Pregnant woman (\> 12-15 weeks of gestation) with a fetal sampling needed in standard care.
* informed consent obtained
* couple affiliated to the social insurance in France

Exclusion Criteria:

* DNA extraction failure
* Absence of informed consent
* Father or mother placed under judicial protection or under guardianship or tutorship

Primary outcomes:
measure: Detection yield of fetal paternally transmitted single nucleotid variations (SNV) in free cell maternal DNA Absence of non fetal paternally transmitted single nucleotid variations (SNV) in maternal free cell DNA (cfDNA)
timeFrame: Measurement will be performed at the end of the protocol (12 months)
Secondary outcomes:
measure: Comparison of SNV detection efficiency of several bioinformatics pipeline Robustness evaluation in function of - Fetal percent in cfDNA - Genomic region - Initial input of cfDNA
timeFrame: Measurement will be performed at the end of the protocol (12 months)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT02133794: Tomosynthesis Use in Detecting Subtle Occult Hip Fractures
Official title: Tomosynthesis Use in Detecting Subtle Occult Hip Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fracture
Keywords: Hip fracture
Tomosynthesis
X-ray
Emergency room
Lead sponsor: Medical Imaging Informatics Research Centre at McMaster
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this project is to determine if using tomosynthesis, in conjunction with x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes to the emergency room with symptoms of a hip fracture.


Eligibility criteria: Inclusion Criteria:

* Men and women aged \> 18 years who/se:
* Present at the ER with a possible hip fracture and
* Have a negative x-ray for a hip fracture
* Physician has a high clinical suspicion of a hip fracture
* Provide provision of informed consent

Exclusion Criteria:

* Hip prosthesis on the same side of the suspected hip fracture
* Other serious medical illness that is likely to interfere with study participation
* Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
* Pregnant or suspected pregnancy

Primary outcomes:
measure: Number of patients with hip fracture detected with tomosynthesis versus x-ray alone.
timeFrame: Participants will be followed up to 3 months post tomosynthesis exam.
Secondary outcomes:
measure: ER wait time
timeFrame: End of study
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT01232894: 12-week Open-label Evaluation of Efficacy and Safety of Indacaterol
Official title: A 12 Week, Multi-center, Randomized, Open Label Study, eValuating the Efficacy and Safety of Treatment Regimens That Include ONbrez (Indacaterol) in Patients With Moderate to Severe COPD (MOVE-ON Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: indacaterol
COPD
Long-acting beta2-agonist (LABA)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
* Post-bronchodilator forced expiratory volume in 1 second (FEV1) \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \<70%
* Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)

Exclusion Criteria:

* Patients with a history of asthma
* Patients who are currently being treated for COPD with tiotropium (Spiriva®)
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline on Clinical COPD Questionnaire (CCQ) Score
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Novartis Investigative Site
city: Ashkelon
country: Israel
facility: Novartis Investigative Site
city: Holon
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Kfar Saba
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01869894: A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Biliary Obstruction
Keywords: Malignant biliary obstruction
metal stent
patency
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction


Eligibility criteria: Inclusion Criteria:

* The patients who had malignant biliary obstruction

Exclusion Criteria:

* The patients who had resectable biliary malignancy
* The patients who had hilar obstruction
* The patients who had duodenal obstruction
* The patients who had other malignancy which is not related to biliary obstruction
* The patients who had uncontrolled infection
* The patients who had poor performance (ECOG =3 or 4)
* The patients who were not acquired informed consent
* The patients who had technically difficult structure for ERCP

Primary outcomes:
measure: Median patency duration
timeFrame: Approximately 6 months later since the date of stent insertion
Secondary outcomes:
measure: 6-months patency rate
timeFrame: Approximately 6 months later since the date of stent insertion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
References:
citation: Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, Nakai Y, Yamamoto N, Tada M, Yoshida H, Shiratori Y, Kawabe T, Omata M. A prospective randomised study of "covered" versus "uncovered" diamond stents for the management of distal malignant biliary obstruction. Gut. 2004 May;53(5):729-34. doi: 10.1136/gut.2003.018945.
citation: Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992 Dec 19-26;340(8834-8835):1488-92. doi: 10.1016/0140-6736(92)92752-2.
citation: Lee HJ, Chung MJ, Park JY, Park SW, Nam CM, Song SY, Bang S. A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction. Surg Endosc. 2017 Aug;31(8):3159-3167. doi: 10.1007/s00464-016-5341-8. Epub 2016 Nov 18.
Clinical trial NCT03687294: Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas
Official title: Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Neoplasm of Salivary Gland
Benign Neoplasm of Salivary Gland
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian population

Brief summary: in this resarch we will use ELISA Technique to estimate Human Transcriptional Activator(MYB) Expression .compare it by Immmunohistochemistry analysis of MYB Expression in the malignant and benign salivary gland tumor


Eligibility criteria: Inclusion Criteria: .

* Patients with clinically evident salivary gland tumors; malignant tumors will be recruited in group I
* Benign tumors will be recruited in group II.

Exclusion Criteria:

* Subjects taking any drugs inducing any changes that could affect the salivary glands.
* Pregnant females.
* Subjects having any allergies, infectious or autoimmune diseases.
* Subjects having any metabolic disorders that can be manifested with salivary gland swelling as diabetes mellitus.

Primary outcomes:
measure: Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
References: