louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06384118: Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study
Official title: Construction and Preliminary Verification of interventionImpact of an IMB Theory-based Health Education Intervention on Hypoglycemic Coping in Patients With Type 2 Diabetes: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Hypoglycemia
Health Education
Keywords: type 2 diabetes mellitus
hypoglycemic
coping style
IMB theory
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: From August 2023 to January 2024, 100 patients with type 2 diabetes who met the inclusion and exclusion criteria were selected from the endocrinology department of The purpose of this study was to construct a hypoglycemia coping intervention program for type 2 diabetic patients based on the IMB theory and to investigate the feasibility, acceptability, and initial effects of the program.

Detailed description: In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on IMB theory given on top of regular diabetes health education) and a control group (regular diabetes health education), with a 4-week intervention period and a 8-week follow-up period, for a total of 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients who meet the 2018 ADA medical standards for Diabetes diagnosis and treatment, are diagnosed with T2DM and use insulin or sulfonylurea drugs;
* Duration of diabetes mellitus ≥1 year
* Age ≥18 years old;
* A history of hypoglycemia in the past 6 months;
* Type 2 diabetes patients with hypoglycemia coping style questionnaire inclination, avoidance, compromise;
* Good communication and language skills;
* Have a smartphone and can use it;
* Voluntary participation in this study.

Exclusion Criteria:

* Patients with type 1 diabetes;
* Patients with type 2 diabetes combined with serious complications;
* Patients who have recently or are participating in other similar studies.

Primary outcomes:
measure: The hypoglycemic coping style
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Secondary outcomes:
measure: hypoglycemic fear behavioral
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
measure: Hypoglycemia fear worry
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
measure: Level of health information access behavior
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
measure: Level of health beliefs
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
measure: Level of diabetes knowledge
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Ya ting Liu
state: 未选择
Study officials:
affiliation: Yangzhou University
name: Ya T Liu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254318: Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)
Official title: Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycoses
Leukemia
Keywords: hematological malignancy
fungal infection
leukemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2010-12-06
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants at high risk for IFI at medical institutions in Canada

Brief summary: This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.


Eligibility criteria: Inclusion Criteria:

* To be eligible for study inclusion, the participant must have:
* A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant

Exclusion Criteria:

* The participant is not eligible for study inclusion if:
* Their IFI is not related to hematological malignancies.

Primary outcomes:
measure: Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution
timeFrame: 365 days
Secondary outcomes:
measure: Percentage of Participants With a Specific Fungal Pathogen at a Single Institution
timeFrame: 365 days
measure: Percentage of Participants With Invasive Fungal Infections in Canada
timeFrame: 365 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06449118: Effectiveness of Mindfulness-based Stress Reduction Program
Official title: The Effect of Mindfulness Based-stress Reduction Program Applied to Parents With Physically Disabled Children on Stress and Quality of Life: A Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Keywords: Mindfulness Stress Reduction Program
physically disabled
parent
quality of life
stress
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Having a physically disabled child presents serious challenges for parents, not only in the practice of daily living, but also on a psychological and emotional level. In addition to meeting the constant and complex needs of their children, these parents must also maintain their own emotional balance and psychological well-being. In the long term, high stress levels can seriously compromise parents' mental health and reduce their overall quality of life. Therefore, the development of effective stress management strategies and psychological support mechanisms for parents is critical not only for individual well-being but also for the health of family relationships. Mindfulness practices, in this context, emerge as powerful tools with the potential to increase parents' ability to cope with stress and improve emotional well-being. Therefore, this study aims to determine the effect of the mindfulness stress reduction program applied to parents of physically disabled children on stress and quality of life.


Eligibility criteria: Inclusion Criteria:

* Being able to read and write
* Having a child diagnosed with a physical disability

Exclusion Criteria:

* Having more than one physically disabled child

Primary outcomes:
measure: Mindful Attention Awareness Scale
timeFrame: Two months
measure: Parent Stress Scale
timeFrame: Two months
measure: World Health Organization's Quality of Life (WHOQOL-BREF) Questionnaire
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04217018: MR Based Prediction of Molecular Pathology in Glioma Using Artificial Intelligence
Official title: MR Based Prediction of Molecular Biomarkers or Subgroups in Primary Glioma Using Deep Learning or Machine Learning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Keywords: molecular
radiomics
deep learning
machine learning
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2020-01-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed glioma that receive tumor resection

Brief summary: This registry aims to collect clinical, molecular and radiologic data including detailed clinical parameters, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and conventional/advanced/new MR sequences (T1, T1c, T2, FLAIR, ADC, DTI, PWI, etc) of patients with primary gliomas. By leveraging artificial intelligence, this registry will seek to construct and refine algorithms that able to predict molecular pathology or subgroups of gliomas.

Detailed description: Non-invasive and precise prediction for molecular biomarkers such as 1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations is challenging. With the development of artificial intelligence, much more potential lies in the preoperative conventional/advanced MR imaging (T1 weighted imaging, T2 weighted imaging, FLAIR, contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, and perfusion imaging) could be excavated to aid prediction of molecular pathology of gliomas. The creation of a registry for primary glioma with detailed molecular pathology, radiological data and with sufficient sample size for deep learning (\>1000) provide considerable opportunities for personalized prediction of molecular pathology with non-invasiveness and precision.

Eligibility criteria: Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of primary glioma
* Life expectancy of greater than 3 months
* Must receive tumor resection
* Signed informed consent

Exclusion Criteria:

* No gliomas
* No sufficient amount of tumor tissues for detection of molecular pathology
* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic devices
* Patients who are pregnant or breast feeding
* Patients who are suffered from severe systematic malfunctions

Primary outcomes:
measure: AUC of prediction performance
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT00487318: Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
Official title: A Randomized Controlled Trial of Adding Fluvastatin to Standard Medical Treatment (SMT) and a Pilot Trial of Rosuvastatin and Other Statins With SMT, for Patients Infected With Chronic Hepatitis C Who Are Naive to Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: fluvastatin
hepatitis C
chronic hepatitis C
not previously treated with pegylated interferon and ribavirin
Lead sponsor: Bader, Ted, M.D.
Sponsor class: INDIV
Collaborators: name: US Department of Veterans Affairs
First posted: 2007-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.


Eligibility criteria: Inclusion Criteria:

* Not previously treated.
* Off alcohol and marijuana for 6 months
* HCV RNA positive

Exclusion Criteria:

* HIV positive
* Advanced liver disease
* Advanced cardiopulmonary disease
* Chronic renal failure

Primary outcomes:
measure: Sustained Viral response
timeFrame: 72 weeks
Secondary outcomes:
measure: Viral load at 4, 12 and 24 weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Veterans Administration Medical Center
state: Oklahoma
Study officials:
affiliation: OUHSC and VAMC
name: Ted F Bader, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01457118: An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
Official title: An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Solid Tumor
Keywords: Open Label multicenter extension study advanced solid tumors
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-10-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102.

In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.


Eligibility criteria: Inclusion:

1. Received prior treatment with NKTR-102
2. Free of disease progression since receiving NKTR-102
3. Adequate bone marrow and organ function
4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102
5. Agree to use adequate contraception

Exclusion:

1. Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study
2. A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose \< 70 mg/m2 upon entry into this study
3. Pregnancy or lactation

Primary outcomes:
measure: Length of Exposure to NKTR-102
timeFrame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Secondary outcomes:
measure: Adverse Events
timeFrame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
measure: Disease Status
timeFrame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
measure: Efficacy of NKTR-102
timeFrame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Investigator Site - Los Angeles
state: California
city: San Francisco
country: United States
facility: Investigator Site - San Francisco
state: California
city: Whittier
country: United States
facility: Investigator Site - Whittier
state: California
city: Minneapolis
country: United States
facility: Investigator Site - Minneapolis
state: Minnesota
city: Cleveland
country: United States
facility: Investigator Site - Cleveland
state: Ohio
city: Bruxelles
country: Belgium
facility: Investigator Site - Bruxelles
city: Liege
country: Belgium
facility: Investigator Site - Liege
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05069818: Variance of HRD From Paired Ovarian Cancer
Official title: Variance of HRD From Primary to Recurrent in High-grade Serous Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
HRD
Platinum-sensitive Ovarian Cancer
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 50
Sex: FEMALE
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: Platinum-sensitive relapsed high-grade serous ovarian cancer patients undergoing secondary cytoreductive surgery

Brief summary: Homologous recombination deficiency (HRD) is an important biomarker of poly (ADP-ribose) polymerase inhibitor (PARPi) in patients with high-grade serous ovarian cancer (HGSOC). The stability of HRD in the recurrent HGSOC and its primary pair remains unknown.

Detailed description: This study intends to perform HRD testing of ovarian cancer in the recurrent HGSOC and its primary pair, furtherly correlate HRD status and clinical characteristics in the recurited population.

Eligibility criteria: Inclusion Criteria:

1. Subjects join the study voluntarily and sign informed consent;
2. Female subjects are older than 18 years;
3. ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
4. Life expectancy≥3 months;
5. Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous histology

Exclusion Criteria:

1. Personnel involved in the formulation or implementation of the research plan;
2. The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;

Primary outcomes:
measure: Loss of heterozygosity (LOH) score in the primary and recurrent ovarian cancer
timeFrame: Through study completion, an average of 1 year]
measure: Homologous recombination deficiency (HRD) status
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: From the beginning of the patient's onset, an average of 1 year
measure: Overall survival
timeFrame: From the beginning of the patient's onset, an average of 3 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Xiaoxiang Chen
state: Jiangsu
Study officials:
affiliation: Jiangsu Cancer Institute & Hospital
name: Xiaoxiang Chen Chen, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04951518: VAN Assessment Tool in the Treatment of Acute Ischemic Stroke
Official title: VAN - Training of Emergency Medical Services to Improve Stroke Outcomes in Northwest Arkansas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Lead sponsor: Washington Regional Medical Center
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone experiencing acute ischemic stroke symptoms

Brief summary: To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction

Detailed description: The investigators propose to perform a 6-month pilot study in Northwest Arkansas in collaboration of two EMS providers; Central EMS and AirEvac. These local providers operate in the WRMC catchment area and transport over 90% of patients with a suspected stroke to WRMC comprehensive stroke center. Thus no changes to their standard operations would be implemented. The aim of this pilot study would be to test the accuracy of VAN-screening in the area in patients treated at WRMC - thus only patients who are brought to WRMC as per current protocol would be included in the study.

The investigators would train Central EMS and AirEvac personnel to perform the V.A.N screen, over a 2-month period (estimated June-July 2020) in several sessions at the Central EMS training center at 800 S. School Ave. in Fayetteville. This training would be performed by study investigators, assisted by medical students, residents, and advanced practice nurses (APNs). The training would consist of a training video, hands-on instruction, and sample scenarios.The investigators would survey all training participants to gather feedback on the format, delivery, and understanding of the training material. The PowerPoint presentation planned for the training session, as well as the post-training quiz, are attached as Appendices to this application. The investigators would expect a rate of 80% correct answers in the post-training quiz. All questions and scenarios would be discussed with all trainees after the quiz, and re-takes would be allowed.

Eligibility criteria: Inclusion Criteria:

* Patients treated for stroke at WRMC who are transported to the hospital by Central EMS or AirEvac

Exclusion Criteria:

* Stroke patients who arrive directly to the hospital (without the use of EMS services)

Primary outcomes:
measure: Reliability of VAN Assessment Tool
timeFrame: 1 Year
Secondary outcomes:
measure: Eligibility for Thrombolysis
timeFrame: 1 Year
measure: Eligibility for Thrombectomy
timeFrame: 1 Year
measure: Door to Intervention Time
timeFrame: 1 Year
measure: Modified Rankin Score
timeFrame: 1 Year
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Washington Regional Medical Center
state: Arkansas
Study officials:
References:
Clinical trial NCT03591718: A Study to Test Different Doses of BI 456906 in Patients With Obesity
Official title: A Phase I, Blinded Within Dose Groups, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Titration Schemes of BI 456906 in Patients With Obesity and Overweight.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-07-19
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.


Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥ 18 years and \< 70 years of age at screening
* Body Mass Index (BMI) ≥ 27 kg/m2 and \<40 kg/m2 at screening
* A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening
* HbA1c \<6.5%
* Further inclusion criteria apply

Exclusion Criteria:

* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Supine blood pressure (BP) ≥160/100 mmHg at screening
* Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Further exclusion criteria apply

Primary outcomes:
measure: Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme
timeFrame: Up to 132 days
Secondary outcomes:
measure: AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)
timeFrame: Up to 168 hours
measure: Cmax (maximum measured concentration of the analyte in plasma) after first dose
timeFrame: Up to 132 days
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Profil Mainz GmbH & Co. KG
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
References: