louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06614075: Diet Quality and Diabetes Risk in Overweight and Obese Adults
Official title: The Relationship Between Sociodemographic Characteristics, Lifestyle, and Diet Quality With Diabetes Risk in Overweight and Obese Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obesity
Keywords: diabetes mellitus
obesity
diet
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 1840
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample in Ankara, Turkey

Brief summary: The goal of this observational study is to learn about the relationship between diabetes risk with sociodemographic characteristics, lifestyle and diet quality in overweight and obese individuals. The main question it aims to answer is:

Is there a relationship between diabetes risk and diet quality in overweight and obese individuals?

Participants who are overweight and obese will answer survey questions about sociodemographic characteristics and lifestyle behaviors. 24 hour dietary recalls will be taken to evaluate diet quality. FINDRISC questionnaire will be applied to assess diabetes risk.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥25 kg/m²

Exclusion Criteria:

* Diabetes mellitus
* Psychiatric disorders
* Pregnant and lactating

Primary outcomes:
measure: Finnish Diabetes Risk Score (FINDRISC)
timeFrame: Baseline
measure: Healthy eating index-2015 (HEI-2015)
timeFrame: Baseline
Secondary outcomes:
measure: Sociodemographic characteristics
timeFrame: Baseline
measure: Lifestyle habits
timeFrame: Baseline
measure: Body weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Waist circumference
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
state: Çubuk
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Rahime E Karakaya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05141175: Tailored to You (TTY) Pilot Study
Official title: The Duke Primary Care Tailored to You (TTY) Blood Pressure Control Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this research study is to use a test called impedance cardiography (ICG) to provide more information about how to improve the control of blood pressure. Participants will be given this test so investigators can get more information about what is going on inside the heart and blood vessels that is contributing to high blood pressure. ICG is a lot like an EKG (electrocardiogram) in that it uses electrodes and a computer to make a report. Participants will lie down on the exam table and two electrodes go on the right ankle and two electrodes go on the left wrist. The process takes about 5 minutes and is painless and not invasive.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of hypertension
* Most recent office systolic BP average measured using automated office BP (AOBP) is ≥140 mmHg systolic or ≥90 mmHg diastolic
* Currently prescribed at least one BP-lowering medication
* Under the care of a primary care clinician

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants Enrolled as Measured by Enrollment Logs
timeFrame: 1.5 months
measure: Number of Participants That Completed Study as Measured by Enrollment Logs
timeFrame: 1.5 months
Secondary outcomes:
measure: Change in Blood Pressure as Measured by Medical Record
timeFrame: Baseline, 4 months
measure: Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Primary Care
state: North Carolina
Study officials:
affiliation: Duke University
name: Anthony Viera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00864175: Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer
Official title: A Phase 1/2, Modified Dose Escalation, Open Label Trial to Determine the Therapeutic Effect and Safety of INCB007839 Combined With Trastuzumab in Patients With Previously Untreated HER2 Positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive
* Measurable disease as defined by the RECIST criteria
* Life expectancy greater than or equal to 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Received any anticancer medications in the 28 days prior to enrollment into this study
* Received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
* History of deep venous thrombosis within the last year
* Contraindication to low dose warfarin therapy
* Clinically significant cardiomyopathy
* Prior treatment with INCB007839 or trastuzumab or lapatinib

Primary outcomes:
measure: Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
timeFrame: Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.
Secondary outcomes:
measure: To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination
timeFrame: Monthly
Other outcomes:
Locations:
city: Visakhapatnam
country: India
state: Andhra Pradesh
city: New Delhi
country: India
state: Ansari Nagar
city: Mangalore
country: India
state: Attavar
city: Bangalore
country: India
state: Karnataka
city: Hyderabaad
country: India
state: Punjagutta
city: Bangalore
country: India
state: Ram Nagar
city: Delhi
country: India
state: Rohini
city: Delhi
country: India
state: Vasundhara Enclave
city: Bhopal
country: India
city: Kolkata
country: India
city: Nashik
country: India
city: Pune
country: India
Study officials:
affiliation: Incyte Corporation
name: Bijyoyesh Mookerjee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01338675: Targeted Busulfan, Fludarabine Conditioning Regimen for Hematopoietic Stem Cell Transplantation in Chronic Granulomatous Disease(CGD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Granulomatous Disease
Keywords: Chronic granulomatous disease
Hematopoietic Stem Cell Transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the investigators plan to use optimal busulfan dose through pharmacokinetic study in stem cell transplantation of CGD patients.

Detailed description: Chronic granulomatous disease is one of the rare congenital immunodeficiency which can be cured by hematopoietic stem cell transplantation. Previous myeloablative conditioning regimen has problems related to the severe toxicities, and non-myeloablative conditioning regimen has the risk of graft failure. Recently, reduced-intensity myeloablative conditioning regimen with busulfan and fludarabine was used usually in leukemia patients.

Busulfan is a highly toxic drug with narrow therapeutic window. In this study we plan to use optimal busulfan dose through pharmacokinetic study in stem cell transplantation of CGD patients.

Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed as CGD.
* Patients who need hematopoietic stem cell transplantation with busulfan based conditioning regimen.
* Age: No limit.
* Performance status: ECOG 0-2.
* Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.
* Heart: a shortening fraction \> 30% and ejection fraction \> 45%.
* Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal.
* Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
* Patients must lack any active viral infections or active fungal infection.
* Appropriate donor is available.
* Patients (or one of parents if patients age \< 20) should sign informed consent.

Primary outcomes:
measure: Engraftment rate
timeFrame: 1 month after transplantation
Secondary outcomes:
measure: Transplantation-related mortality and toxicities
timeFrame: 1, 3, 6 and 12 months after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Daehangno, Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Hyoung Jin Kang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05220475: A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent
Official title: A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent: Prospective Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Biliary Obstruction
Keywords: Fully Covered Self Expandable Metal Stent
Uncovered Self Expandable Metal Stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 108
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: Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

Detailed description: This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.

Eligibility criteria: Inclusion Criteria:

* Adults with 19 years of age or older
* Those who voluntarily consented to the trial and signed a written consent
* Inoperable malignant biliary obstruction

Exclusion Criteria:

* Previous surgical biliary drainage
* Patients continuosly requiring percutaneous transhepatic biliary drainage
* History of biliary drainage with metal stent
* Biliary obstruction located in hilum or intrahepatic duct
* Patients with life expectancy of 3 months or less
* On pregnancy
* Unable to underwent endoscopic procedures

Primary outcomes:
measure: Rate of patent stent
timeFrame: 1 year
Secondary outcomes:
measure: Stent obstruction
timeFrame: 1 year
measure: Stent migration
timeFrame: 1 year
measure: Re-intervention
timeFrame: 1 year
measure: Adverse event
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang Hyub Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06550375: Clinical Outcomes With Bilateral Implantation of Odyssey IOLs
Official title: Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients With Bilateral Implantation of Odyssey Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Mann Eye Institute
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2024-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible test subjects will be aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.

Brief summary: This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery. Subjects will be assessed at least 3 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS and OSDI questionnaires, as well as measurement of visual acuities at distance, intermediate, and near.


Eligibility criteria: Inclusion Criteria:

• Patients aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.

Exclusion Criteria:

* Significant ocular comorbidities (e.g., macular degeneration, glaucoma).
* \< 2 weeks post YAG capsulotomy.
* Best corrected distance visual acuity worse than 20/25.

Primary outcomes:
measure: Visual Acuity at Distance (6m) logMAR
timeFrame: 3 months postoperative
measure: Visual Acuity at Intermediate (66cm) logMAR
timeFrame: 3 months postoperative
measure: Visual Acuity at Near (40cm) logMAR
timeFrame: 3 months postoperative
measure: Visual Acuity at Near (33cm) logMAR
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Houston
country: United States
facility: Mann Eye Institute
state: Texas
Study officials:
affiliation: Mann Eye Institute
name: Phillip Brunson, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00821275: Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma
Official title: Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Leiomyoma
Keywords: Uterine Artery Embolization
Leiomyoma
myomectomy
hysterectomy
pregnancy
complication
ovarian function
quality of life
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-01-13
Enrollment: 900
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of symptomatic uterine leiomyoma

Exclusion Criteria:

* pregnancy
* iodine agent allergy
* patient refuse to take part in this trial
* tumour size is less than 3cm or beyond 10cm
* with endometriosis
* with malignant diseases
* with abnormal coagulation function which can't restore
* with acute inflammatory diseases or acute episode of chronic inflammatory diseases
* with severe heart, lung, liver and kidney, et al. organ diseases.

Primary outcomes:
measure: quality of life
timeFrame: 1,3,5,10 year.
measure: pregnant
timeFrame: 3 years
Secondary outcomes:
measure: tumor recurrence
timeFrame: 1,3,5,10 years
measure: complications
timeFrame: 3,6,12,24 months
measure: ovarian functions
timeFrame: 3,6,12 months, 2,3,5 and 10 years
measure: symptom relief
timeFrame: 3,6,12,24 months
measure: tumour volume
timeFrame: 3,6,12 18 24 months and 3,5,10 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Nanfang medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: the first Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Hong Shan, M.D., PHD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01949259: Rapid Learning for Lung Cancer
Official title: Rapid Learning in Practice: A Lung Cancer Survival Decision Support System in Routine Patient Care Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Retrospective
Lung cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Liverpool Cancer Therapy Centre
name: Macarthur Cancer Therapy Centre, Liverpool
name: Ingham Institute Hospital, Liverpool
name: NSW, Australia
First posted: 2013-09-24
Enrollment: 10000
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: Lung cancer patients

Brief summary: A retrospective, data mining project that re-uses routine patient care data for decision support systems.

Detailed description: By installing tools that extract clinical data from electronic health records and image data from the Picture Archiving and Communication System, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.

Eligibility criteria: Inclusion Criteria:

- Patients notes as suffering from lung cancer in at least one clinical data source.

Primary outcomes:
measure: Survival
timeFrame: From radiotherapy until death
Secondary outcomes:
measure: Local control
timeFrame: From start of treatment until death,
measure: Distant metastases
timeFrame: From treatment until end of study
measure: Dyspnea
timeFrame: From inclusion until end of study
measure: Dysphagia
timeFrame: From treatment until end of study
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
state: Limburg
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Andre Dekker, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05668559: Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders
Official title: The Effects of rTMS on Postoperative Cognitive Function in Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 280
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: To investigate the impact of rTMS on the incidence of perioperative neurocognitive disorders in patients after after cardiac surgerysurgery. To explore the underlying mechanisms behind the efficacy.

Detailed description: There is a relatively high incidence of perioperative neurocognitive disorders（PND） after surgeries, and the incidence is even higher in the geriatric population undergoing cardiac surgery. Nevertheless, there remains no effective medication or intervention been approved in PND. It has been shown that brain stimulation can improve cognitive function in mild cognitively impaired patients. However, the effects on cognitive function in PND remain uninvestigated.

Eligibility criteria: Inclusion Criteria:

* 1. Age 18 years or older.
* 2. ASA class I - III, patients undergoing elective cardiac surgery(coronary artery bypass grafting, aortic or mitral valve surgery).
* 3. Sign the informed consent.
* 4. Able to complete follow-up visits.

Exclusion Criteria:

* 1. A history of psychopathology and/or taking medication.
* 2. Previous history of neurological disease.
* 3. Severe organic diseases.
* 4. RTMS contraindications (such as a history of epileptic seizures, metal implants near the head).
* 5. Having delirium, assessed by CAM, before surgery.
* 6. Participating in other clinical studies at the time of screening.
* 7. Having a cardiopulmonary arrest and cardiopulmonary resuscitation.
* 8. Having short-term second operation.

Primary outcomes:
measure: The incidence of PND on the postoperative day 30
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Postoperative delirium incidence
timeFrame: Within 7 days after surgery
measure: Perioperative pain
timeFrame: Within 7 days after surgery
measure: Sleep quality
timeFrame: Within 30 days after surgery
measure: Depressive symptom
timeFrame: Within 7 days after surgery
measure: Activities of daily living（ADL）
timeFrame: Within 30 days after surgery
measure: Length of hospital stay
timeFrame: From the date of admission until discharged from hospital, up to 30 days
measure: Length of ICU stay
timeFrame: From the date of admission until discharged from ICU, up to 30 days
measure: EEG characteristics
timeFrame: Within 30 days after surgery
measure: Incidence of major adverse cardiac and cerebral events
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Anshi Wu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01725659: Innovative Modalities for Restoring Upper Limb Function Post Stroke
Official title: Innovative Modalities for Restoring Upper Limb Function Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Stroke
electric stimulation
robotics
motor learning
Lead sponsor: Malcom Randall VA Medical Center
Sponsor class: FED
First posted: 2012-11-14
Enrollment: 35
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: PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).


Eligibility criteria: Inclusion Criteria:

* \>1 year post stroke no acute, uncontrolled medical condition single stroke

Exclusion Criteria:

* pacemaker other neurological condition more than one stroke

Primary outcomes:
measure: Fugl Meyer
timeFrame: after 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes Cleveland Department of Veterans Affairs Medical Center
state: Ohio
Study officials:
References: