louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02320331: Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Kula No Na Po'e Hawaii
name: Ke Ola Mamo
name: Hawai'i Maoli
name: Kokua Kalihi Valley
First posted: 2014-12-19
Enrollment: 335
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the OHA PILI 'Ohana Project is to disseminate and evaluate the effectiveness of a community-based intervention (PILI 'Ohana Intervention Program) aimed at eliminating obesity in Pacific Peoples across the four islands. Dissemination will involve implementation of the program in eight communities through partnerships with nine different community-based organizations serving those areas (four founding community partners and five new community partners). These organizations provide services to a large number of Pacific Peoples, including (but not limited to) Native Hawaiians, Samoans, Filipinos, and Chuukese.

The main aims are to: (1) train five additional community organizations and their staff to deliver the PILI 'Ohana Intervention Program, (2) to enroll 150 overweight/obese participants across 8 different communities and four different islands into the intervention program, and (3) to evaluate the effectiveness of the program in reducing weight/BMI by at least 3% of the participant's initial weight.

The PILI 'Ohana Intervention is a 9-month lifestyle intervention focusing on individual health behaviors in the context of family and community environments and in the socio-cultural context of Pacific Peoples. In order to increase the likelihood that an organization will implement the PLP, they will be able to adapt the intervention and participant assessments. The POP will provide guidance on adaption of the intervention and assessments at the training (CHS #21680). What is described below is the maximum amount of contact and assessment procedures that participants will undergo. Therefore, organizations may change the timing of the 14 lessons and refrain from using all the assessment procedures, but will still provide the 14 lessons and offer the same incentives to participants for assessments.


Eligibility criteria: Inclusion Criteria:

* BMI greater than or equal to 25
* Clients and/or residents of communities served by 9 partnering community organizations

Exclusion Criteria:

-

Primary outcomes:
measure: Weight loss
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Department of Native Hawaiian Health, University of Hawaii
state: Hawaii
Study officials:
References:
Clinical trial NCT06579131: Seating Posture and Its Relation to Pain
Official title: The Physiotherapeutic Perspective on
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Posture; Myositis
Sitting Position
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers from the healthy population

Brief summary: A study has been designed to evaluate pain levels experienced by subjects in relation to different sitting postures. The objective is to investigate how various ergonomic sitting positions affect pain intensity, by systematically assessing pain across a range of sitting postures to identify significant differences and correlations.

Detailed description: A study has been designed to evaluate the pain levels experienced by subjects in relation to different sitting postures. The primary objective of this research is to investigate how various ergonomic sitting positions impact the intensity of pain reported by individuals. This will involve systematically assessing pain levels across a range of sitting postures to determine any significant differences and correlations. The findings are expected to provide insights into the relationship between sitting posture and pain, potentially guiding recommendations for ergonomic improvements.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18 and 65, Not having undergone any surgery affecting spinal posture in the last two years

Exclusion Criteria:

* • Psikiyatrik hastalık tanısı olması ya da tedavi alıyor olması Omurganın duruşunun etkilenmesine sebep olabilecek nörolojik, romatizmal, ortopedik hastalık tanısı almış olmak

Primary outcomes:
measure: pain assessment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03243331: An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
Official title: An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Triple Negative Breast Cancer
Metastatic Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Study will enroll 3 patients to the cohort 1 dose level. If 0 of 3 patients experience a DLT, the study will proceed to cohort 2. If 1 patient experiences a DLT, 3 additional patients will be enrolled into cohort 1. If 1 of 6 patients experience a DLT, the study will proceed and 3 patients will be enrolled to the cohort 2 dose level. If 0 patients experience a DLT in cohort 2, the study will proceed to cohort 3. If 1 patient experiences a DLT at cohort 2, 3 additional patients will be enrolled into cohort 2. If the study proceeds to cohort 3, 3 patients will be enrolled at this dose level. If 0 patients experience a DLT, the study will enroll an additional 3 patients at the cohort 3 dose level to better define the safety profile. If 1 of 3 patients experiences a DLT at cohort 3, 3 additional patients will still be enrolled into cohort 3. If 1 of 6 patients experience a DLT, the study will complete.
Primary purpose: TREATMENT

Brief summary: Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer


Eligibility criteria: Inclusion Criteria:

* Metastatic Triple-negative Breast Cancer
* Willingness to undergo tumor biopsy
* Patients must have received at least 1 prior chemotherapy regimen for metastatic disease

Exclusion Criteria:

* Previous treatment with mTOR inhibitor
* Untreated brain metastases

Primary outcomes:
measure: Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0
timeFrame: through study completion i.e. up to 1 year
Secondary outcomes:
measure: Efficacy in all enrolled subjects
timeFrame: 18 weeks
measure: Overall response rate in all enrolled subjects
timeFrame: through study completion i.e. up to 1 year
measure: Progression free survival in all enrolled subjects
timeFrame: through study completion i.e. up to 1 year
measure: Pharmacodynamic determination of inhibition of PI3k signaling
timeFrame: Cycle 1 Day 15
measure: Pharmacodynamic determination modulation of Wnt pathway
timeFrame: Cycle 1 Day 15
measure: Pharmacodynamic determination modulation of Wnt pathway
timeFrame: Cycle 1 Day 15
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Kathy Miller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Milan Radovich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04530331: Job-Site Diet Education on Metabolic Syndrome
Official title: Work-Site Nutrition Education and Metabolic Syndrome Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Health Education
Workplace
Lead sponsor: Lotung Poh-Ai Hospital
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study conducted an 8-week workplace nutrition education intervention to examine the effects of the intervention on metabolic syndrome factors associated with employees. A historical intervention was designed to recruit adults with a body mass index level of \>22 and without any endocrine disorder from a community in Yilan, Taiwan. The intervention group was recruited between 2010 and 2012 and received an 8-week intervention, during which dietitians delivered a nutrition education session and a one-on-one dietary guidance session on a weekly basis. The age- and sex-matched control group (n = 34) was recruited between 2014 and 2015 to analyze the metabolic syndrome variables. The metabolic syndrome variables included blood pressure, blood sugar, serum lipid profile, and waist circumference.

Detailed description: Content of classes Week1 Things that you must know during the weight reduction study period Week2 Daily individual calorie requirement: what are the main food groups? Week3 How to record the daily diet after the weight reduction program Week4 Food serving size and replacement Week5 The principles of eating out Week6 Physical activity advice (delivered with health education flyers to the participants)

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* BMI of ≥ 22

Exclusion Criteria:

* History of critical illness
* Having been diagnosed with at least one endocrine disorder

Primary outcomes:
measure: BMI
timeFrame: After 8 week intervention
measure: Waist circumference
timeFrame: After 8 week intervention
measure: Systolic blood pressure
timeFrame: After 8 week intervention
measure: Diastolic blood pressure
timeFrame: After 8 week intervention
measure: Fasting blood sugar
timeFrame: After 8 week intervention
measure: Serum triglyceride
timeFrame: After 8 week intervention
measure: Serum high density lipoprotein cholesterol
timeFrame: After 8 week intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01143831: Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation
Official title: Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombosis
Keywords: Vitamin K
Thrombosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate factor levels of the pro coagulant factors II, VII, IX, X, and the anticoagulant factors protein C and S in healthy volunteers during the intake of elevated levels of vitamin K in order to investigate whether there is any evidence that high dose vitamin K intake increases plasma coagulation factor activity.

Detailed description: 1. Recruit 8 male healthy individuals with no prior history of arterial or venous thrombosis (2 each from each of the following age ranges: 20-34, 35-49, 50-64, \>65).
2. Visit 1: Measure baseline activity levels of Factor II, Factor VII, Factor IX, Factor X, and levels of D-Dimer, TAT complexes, protein C and S activities. Also measure thrombin generation potential. Collaboration with a research laboratory will be sought to also determine factor VIIa levels.
3. Visit 2: Measure activity of Factor II, Factor VII, Factor IX, Factor X, levels of D-Dimer, TAT complexes, protein C and S activities and thrombin generation potential at the end of the 2 week period.
4. Have each individual consume 20 mg of Vitamin K2 orally per day for two weeks.
5. Visit 3: Measure Factor II, Factor VII, Factor IX, Factor X, D-Dimer, TAT complexes, protein C and S activities and thrombin generation potential at the end of the 2 week period.
6. Total length of study is 4 weeks.
7. Analyze the data sets for changes in levels / activities due to Vitamin K supplementation.

Eligibility criteria: Inclusion Criteria:

* Healthy adult male

Exclusion Criteria:

* prior history of arterial or venous thrombosis

Primary outcomes:
measure: Change in levels and activities due to vitamin K supplementation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill Department of Medicine, Division of Hematology
name: Stephan Moll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06108531: Tumor Exosome Liquid Biopsy Strategy to Diagnose Pancreatic Cancer
Official title: Study on the Application of Tumor Exosome Liquid Biopsy in the Early Diagnosis of Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pancreatic
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases will be patients with newly diagnosed pancreatic cancer. Controls will be selected from patients with pancreatitis in the same hospital as the cases, matched by sex, race and age (1:1). A total of 400 patients with gallbladder cancer will be recruited.

Brief summary: This is an observational study of patients diagnosed with pancreatic cancer by pathology, with a control group of patients with pathology suggestive of benign pancreatic lesions and normal subjects, and the diagnostic ability of exosomes to identify patients with pancreatic cancer was assessed through the detection of exosomes in the peripheral blood.


Eligibility criteria: Inclusion Criteria:

Diagnosis of pancreatic cancer confirmed by imaging (case) Diagnosis of chronic pancreatitis confirmed by imaging (hospital control)

Exclusion Criteria:

The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases

Primary outcomes:
measure: Characterization of proteins in tumor exosomes from patients with pancreatic cancer
timeFrame: Up to 2 years from start of study
measure: The expression of protein A in the circulating exosomes from patients
timeFrame: Up to 2 years from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT06202131: Prospective Single-center Study About the Use of ctDNA in the Management of Patients With Tumors of the Gastrointestinal Tract
Official title: Prospective Single-center Study About the Use of ctDNA in the Management of Patients With Tumors of the Gastrointestinal Tract
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Colon Cancer
Biliary Tract Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years old with an histological diagnosis of gastrointestinal tract cancer.

Brief summary: This study will evaluate the use of ctDNA in the clinical management of patients with tumors of the gastrointestinal tract.

Detailed description: This is a a prospective observational single-center study; it is a spontaneous study, not sponsored by pharmaceutical companies, and does not involve the use of experimental drugs. The study involves a collection of data, carried out while protecting the anonymity and personal information of individual patients suffering from neoplasms of the gastrointestinal tract, the execution of peripheral blood samples and the collection of faecal material at pre-determined times -points. Circulating biomarkers (as ctDNA) will be evaluated in these samples, in order to optimize both the diagnostic and therapeutic processes of patients with tumors of the gastrointestinal tract.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* PS ECOG \<2;
* Histological diagnosis of gastrointestinal cancer: esophageal, gastric, intestinal, pancreatic, biliary tract neoplasms;
* Radiological evidence of resectable/locally advanced/metastatic disease on the date of signing the written informed consent;
* Adequate organ and function;
* Availability of tumor histological material.

Exclusion Criteria:

* No histological diagnosis of neoplasia of the gastrointestinal tract.
* No written informed consent.

Primary outcomes:
measure: mOS
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
state: Lazio
Study officials:
References:
Clinical trial NCT05146531: Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
Official title: Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
intubation
laryngoscopes
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Obesity is associated with difficult intubation rate of 30%, and this study was performed to compare the use of McCoy laryngoscope and C-MAC D-blade video laryngoscope for intubation in obese patients. A total 104 patients with body mass index (BMI) ≥ 35kg/m² scheduled for general anesthesia were randomly assigned to be intubated with McCoy laryngoscope or C-MAC D-blade video laryngoscope. The primary outcome was intubation time, and secondary outcomes were mask ventilation scale, intubation difficulty scale (IDS), percentage of glottis opening (POGO) score, and hemodynamic variables including mean arterial pressure, heart rate and saturation.


Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists physical status of I-II patients with BMI ≥ 35 kg/m² scheduled for general anesthesia

Exclusion Criteria:

* patients with tracheal diseases, sore throat, neck pain and loose tooth.

Primary outcomes:
measure: Intubation time
timeFrame: The patients were excluded in this study if intubation time was over 90 seconds.
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym university sacred heart hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04689620: Helium Neon Laser Versus Gallium Arsenide Laser
Official title: Helium Neon Laser Versus Gallium Arsenide Laser In Healing Of Venous Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There will be different effects for different laser wavelengths in treatment of venous ulcer.

Detailed description: The cost of treating venous ulcer can vary within wide limits and depends on the technology used. In the countries of the European community, the closure of one ulcer as an outpatient procedure costs 800-1500 euros, and supporting anti-relapse treatment makes 100-150 euros per month. In the United States, for closure of venous ulcer within 3 months, direct medical costs reach US$1500- 2000. Prolongation of the treatment for a longer time results in increased cost up to US$30 000 or more.

Poor efficiency of the known methods of treating patients with venous ulcer necessitates the search for new ways and modes of laser therapy (LT) based on a comprehensive approach. Application of physical therapy, primarily with the use of LLLT, capable of influencing various stages in the pathogenesis of the disease, allows a high therapeutic effect in many cases, while ensuring systemic response of the patient's body with the proper exposure procedure.

So, the current study will be conducted to compare the effect of different laser wavelengths on venous ulcers and provide an effective treatment method for patients with venous ulcers with low cost and in short duration.

Eligibility criteria: Inclusion Criteria:

* All patients approximately the same age (50-60).
* All patients had venous leg ulcers just above medial malleolus. The common cause of ulcers for all cases was venous insufficiency.
* All patients with conscious.

Exclusion Criteria:

* All patients had no diabetes or blood problems.
* any immunity disorder affect wound heaing.

Primary outcomes:
measure: wound surface area
timeFrame: two months
measure: number of bacteria in wound
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04859920: Living Conditions of Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma in the Côte d'Or Region
Official title: Living Conditions of Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma in the Côte d'Or Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large Cell Diffuse Lymphoma
Follicular Lymphoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diffuse large cell diffuse B lymphoma Follicular Lymphoma

Brief summary: The development of new diagnostic tools and targeted therapy have significantly improved the management of non-Hodgkin's malignant lymphomas and thus their long-term prognosis. However, in the study of improved patient management, survival is not the only measurable indicator and preservation of quality of life is an essential component. In addition, there is little existing data regarding the determinants of quality of life in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) in the general population in France.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with DLBCL or FL between January 1, 2010 and December 31, 2017,
* Alive as of January 1, 2021,
* Updated patient address.

Exclusion Criteria:

* Other forms of Hematologic Malignancies at diagnosis,
* Minors.
* Person subject to legal protection (curatorship, guardianship)
* Person subject to a judicial safeguard measure
* Pregnant, parturient or breastfeeding woman
* Adults incapable of giving consent

Primary outcomes:
measure: Generic Questionnaire SF-12
timeFrame: At inclusion
measure: Specific questionnaire QLQ-C30
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: