louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01668888: Progranulin and CTRP3 in Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 127
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects who visited for a routine health check-up at the Health Promotion Center of Korea University Guro Hospital were enrolled using predefined inclusion and exclusion criteria.

Brief summary: Inflammation has been known to be a pivotal pathogenic mechanism of obesity-related disorders such as type 2 diabetes, metabolic syndrome and atherosclerosis. Adipose tissue functions as a major endocrine organ by adipokine mediated modulation of a number of signaling cascades in target tissues, that has pro-inflammatory or anti-inflammatory activities. Progranulin and CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to clarify the clinical meaning of these two adipokines in the subjects with or without metabolic syndrome


Eligibility criteria: Inclusion Criteria:

* 20\<age\<80
* apparently healthy subjects

Exclusion Criteria:

* a history of CVD
* diabetes
* stage 2 hypertension
* malignancy
* severe renal or hepatic disease

Primary outcomes:
measure: Serum concentration of progranulin in the subjects with metabolic syndrome
timeFrame: 12week
measure: Serum concentration of CTRP3 in the subjects with metabolic syndrome
timeFrame: 12week
Secondary outcomes:
measure: The relationship of serum progranulin levels with cardiovascular risk factors
timeFrame: 12 week
measure: The relationship of serum CTRP3 levels with cardiovascular risk factors
timeFrame: 12 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
citation: Yoo HJ, Hwang SY, Hong HC, Choi HY, Yang SJ, Choi DS, Baik SH, Bluher M, Youn BS, Choi KM. Implication of progranulin and C1q/TNF-related protein-3 (CTRP3) on inflammation and atherosclerosis in subjects with or without metabolic syndrome. PLoS One. 2013;8(2):e55744. doi: 10.1371/journal.pone.0055744. Epub 2013 Feb 7.
Clinical trial NCT03608488: The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women
Official title: The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: balance
vitamin D
exercise
fall risk
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 110
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In recent years, skeletal and nonskeletal effects of vitamin D has been studied. One of the effects of it was balance and fall prevention. However, these studies were performed on older patients who had not vitamin D deficiency. This study aimed to evaluate the effect of vitamin D replacement therapy and exercise on balance in 50-70 years-old postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* 50-70 years-old postmenopausal women
* Vitamin D level\<10 ng/ml and Vitamin D level\>30 ng/ml
* Independant in daily life
* Able to do exercise
* Able to read and write in Turkish

Exclusion Criteria:

* Diabetes mellitus,
* Polyneuropathy,
* Spinal stenosis,
* History of fracture or lower extremity operation,
* Rheumatologic diseases,
* History of chemotherapy
* Cognitive impairment

Primary outcomes:
measure: Postural Stability Test (Biodex) Assessed at Baseline
timeFrame: Baseline
measure: Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks)
timeFrame: After treatment (8 weeks)
measure: Berg Balance Test Assessed at Baseline
timeFrame: Baseline
measure: Berg Balance Test Assessed After Treatment (8weeks)
timeFrame: After treatment (8 weeks)
Secondary outcomes:
measure: Fall Risk Assesment Performed at Baseline
timeFrame: Baseline
measure: Fall Risk Assesment Performed After Treatment (8 Weeks)
timeFrame: After treatment (8 weeks)
measure: Health Status Assessed at Baseline
timeFrame: Baseline
measure: Health Status Assessed After Treatment (8 Weeks)
timeFrame: After treatment (8 weeks)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdulhamid Han Training and Research Hospital
Study officials:
affiliation: Sultan Abdulhamid Han Training and Research Hospital
name: Tugba Ozsoy-Unubol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00870688: Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening
Official title: Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: valproate
epilepsy
compliance
sustained released minitablet
Orfiril long
Lead sponsor: Desitin Arzneimittel GmbH
Sponsor class: INDUSTRY
First posted: 2009-03-27
Enrollment: 82
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample outpatients

Brief summary: Valproate is the first line therapy in primary generalized seizures. The applied drug contains sodium valproate in sustained release minitablets. As a multiple unit dosage form these can be easily swallowed and taken independent from meals.

A simple dosage scheme like valproate sustained release minitablets once daily in the evening should improve the compliance and likely the seizure situation of the patients. The data of this non interventional trial were directly extracted from the physician's electronic patient database. The observational period was 7 weeks compared to a retrospective period 7 weeks before start of the study.


Eligibility criteria: Inclusion Criteria:

* age of 12 years and above
* epilepsy patients
* indication to initiation / conversion to valproate sustained release minitablets once daily

Exclusion Criteria:

* contraindication to valproate use
* no indication for conversion to valproate sustained release minitablets once daily

Primary outcomes:
measure: Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
timeFrame: 7 weeks
measure: Number of Seizures Within 7 Weeks
timeFrame: 7 weeks
Secondary outcomes:
measure: Data About Efficacy, Safety and Compliance
timeFrame: 7 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01592188: Cognitively-Based Compassion Training and Mindfulness Attention Training Program
Official title: Cognitively-Based Compassion Training and Mindfulness Attention Training for Elementary School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Behavioral Resilience
Biological Resilience
Keywords: meditation, inflammation, children, attention
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 53
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This project will explore the effect of Cognitively-Based Compassion Training or mindfulness training on behavior and saliva stress hormones in elementary school-age children.

Detailed description: This project will explore the effect of Cognitively-Based Compassion Training (CBCT) or mindfulness training (MT) on different aspects of behavior and stress-related biology in elementary school-age children. The program will consist of 12 weeks of CBCT or MT, and various social behavioral assessments will be conducted. Participants will also provide saliva in which concentrations of stress hormones including cortisol and the inflammatory biomarkers C-reactive protein will be measured.

Eligibility criteria: Inclusion Criteria:

* age 7-12
* enrollment at the Paideia School.

Exclusion Criteria:

* poor physical health
* enrollment at a school other than the Paideia school.

Primary outcomes:
measure: Interpersonal behaviors assessed using standardized protocols of social behavior, social cognition, and empathy.
timeFrame: 12 weeks
measure: Concentrations of stress system biomarkers in saliva
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Paideia School
state: Georgia
Study officials:
affiliation: Emory University
name: Philippe Rochat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Thaddeus Pace, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598788: Microsampling Approach for Monitoring of Kinase Inhibitor Targeted Therapies
Official title: Development of a Microsampling Approach for Personalized Monitoring of Kinase Inhibitor Targeted Therapies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Concentrations of Nine Anti-cancer Drugs : Axitinib, Olaparib, regorafénib, Cabozantinib, Niraparib, Talazoparib, Palbociclib, Abemaciclib, Tucatinib
Keywords: ORAL CHEMOTHERAPIES
AT HOME THERAPEUTIC DRUG MONITORING
MICROSAMPLING STRATEGY
CONCENTRATION EFFECT RELATIONSHIP
PERSONALIZED MEDICINE
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with one of the 9 drugs concerned by the study : axitinib, olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib

Brief summary: The MISTIK project aims at clinically validating the technique of oral anticancer drugs determination by volumetric absorptive micro-sampling and at comparing the results to measurements performed on venous samples.

Detailed description: The International recommendations for the validation of DBS-based methods will be applied (Capiau et al, TDM, 2019) by including 40 patients per molecule of interest. Nine drugs will be monitored : axitinib, olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib.

Two samples will be collected from each patient, one by venous sampling and the second at the same time (approximately) using a capillary blood sample derived from a finger prick.

Eligibility criteria: Inclusion Criteria:

* Patients treated with one of the 9 drugs concerned by the study : axitinib, olaparib, regorafénib, cabozantinib, niraparib, talazoparib, palbociclib, abemaciclib, tucatinib
* person who does not object to their participation in the research

Exclusion Criteria:

* Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty

Primary outcomes:
measure: Comparison of venous blood vs VAMS concentrations
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Eugène Marquis Unicancer
city: Rennes
country: France
facility: Rennes University Hospital
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
affiliation: Rennes University Hospital
name: VERDIER Marie-Clemence
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03819088: Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer
Official title: Effects on QOL When Zinc is Supplemented in Patients With Upper GI Cancer on Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Carcinoma
Liver and Intrahepatic Bile Duct Carcinoma
Unresectable Esophageal Carcinoma
Unresectable Pancreatic Carcinoma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2019-01-28
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized study examines how well zinc works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc deficiency.

Detailed description: PRIMARY OBJECTIVE:

I. Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.

SECONDARY OBJECTIVES:

I. Correlate hypoalbuminemia with serum zinc deficiency.

II. Correlate zinc deficiency with neutropenia.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive zinc orally (PO) thrice daily (TID) for months 1 and 2 only of the first 4 months on therapy.

GROUP II: Patients receive zinc orally (PO) TID for months 3 and 4 only of the first 4 months on therapy.

Eligibility criteria: Inclusion Criteria:

* Patients who present to adult medical oncology outpatient clinic with new diagnosis of non-resectable gastric, gastro-esophageal, pancreas or biliary cancer
* Patients plan to receive chemotherapy at an Emory Cancer Center
* No prior chemotherapy or radiation therapy for newly diagnosed gastric, gastro-esophageal, pancreas or biliary cancer
* Patients must sign informed consent

Exclusion Criteria:

* Zinc supplementation is not indicated for pregnant or lactating women therefore, this is an exclusion criteria and women of childbearing age will complete a pregnancy test

Primary outcomes:
measure: Quality of life scores
timeFrame: Up to 4 months after study start
Secondary outcomes:
measure: Serum zinc level
timeFrame: Up to 4 months after study start
measure: Serum albumin level
timeFrame: Up to 4 months after study start
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Olatunji B. Alese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00826488: A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses
Official title: A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fibrocystic Disease of Breast
Breast Cancer
Keywords: Breast Cancer
Mammography
Benign masses
Breast Lump
Breast Biopsy
Breast Mass
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 136
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.


Eligibility criteria: Inclusion Criteria:

* Female
* Any race or ethnicity
* At least 35 years old
* Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center

Exclusion Criteria:

* Unable or unwilling to undergo informed consent
* Subjects who have breast implants
* Subjects who are unable or unwilling to tolerate compression
* Subjects who are pregnant or who think they may be pregnant
* Subjects who are currently lactating
* Men
* Women less than 35 years old
* Women greater than 80 years old
* Subjects whose breasts are larger than the tomosynthesis detector

Primary outcomes:
measure: It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: JoAnne Knight Breast Center, Barnes Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dione Farria, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04539288: Serum Biomarkers Associated With Postpartum T2DM in Women With GDM
Official title: Pregnancy to Postpartum Transition of Serum Biomarkers in Women With Gestational Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Keywords: GDM
T2DM
NGT
lipids
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 3099
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: GDM Women.

Brief summary: Gestational diabetes mellitus (GDM) is commonly linked to the development of type 2 diabetes mellitus (T2DM). There is a need to characterize metabolic changes associated with GDM in order to find novel biomarkers for T2DM.

Detailed description: GDM, a common complication of pregnancy, affects 17.8% of pregnancies worldwide per year. Women with a history of GDM have an approximately 7-fold higher risk for developing T2DM in the future than women without GDM. However, data on the factors associated with the development of T2DM in women with GDM are not widely available.

Eligibility criteria: Inclusion Criteria:

* Women who were dignosed GDM.
* Women with singleton pregnancy.
* Give birth in the First Affiliated Hospital in Sun Yat-sen University.

Exclusion Criteria:

* Women who were diagnosed PGDM.
* Younger than 18 years old.
* Older than 45 years old.
* Multiple pregnancy.
* Diagnosed DM before.
* Complicationg other diseases, like hypertension, thyroid diseases, etc.
* Taking any drug affect glucose and lipid metabolism.

Primary outcomes:
measure: T2DM
timeFrame: 4-6 weeks.
Secondary outcomes:
measure: IGT
timeFrame: 4-6 weeks.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Dongyu Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03877588: Nutritional Status in Retroperitoneal Sarcoma.
Official title: Perioperative Nutritional and Hemodinamic Support in Retroperitoneal Sarcoma Patients. A Phase II Prospective Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retroperitoneal Sarcoma
Malnutrition
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective feasibility study of perioperative nutrition in patients affected by primary retroperitoneal sarcoma

Detailed description: Aim of our study was to investigate the feasibility of a prehabilitation policy to optimize protein energetic reserves in a group of patients affected by primary localized RPS, candidate to a multiple organ resection surgery, as well as the feasibility of a standardized nutritional postoperative caloric target and its adequacy.

Eligibility criteria: Inclusion Criteria:

- every patient with retroperitoneal sarcoma scheduled for surgery

Exclusion Criteria:

* chronic renal failure
* diabetes mellitus
* emergency surgery
* physical status classification system ASA\>3
* any contraindication to arterial catheter in Femoral artery for PICCO hemodynamic monitoring

Primary outcomes:
measure: Rate of Adherence to protocol
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Previtali P, Fiore M, Colombo J, Arendar I, Fumagalli L, Pizzocri M, Colombo C, Rampello NN, Mariani L, Gronchi A, Codazzi D. Malnutrition and Perioperative Nutritional Support in Retroperitoneal Sarcoma Patients: Results from a Prospective Study. Ann Surg Oncol. 2020 Jun;27(6):2025-2032. doi: 10.1245/s10434-019-08121-0. Epub 2019 Dec 17.
Clinical trial NCT03369288: Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up
Official title: Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vertebral Fracture
Cement Augmentation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective PET-MRI follow-up
Primary purpose: DIAGNOSTIC

Brief summary: 3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.


Eligibility criteria: Inclusion criteria

* Men and women aged 18 to 70 years
* Minimum 3-year follow-up
* Single-level vertebral kyphoplasty
* Index surgery at UniversitätsSpital Zürich
* MRI-scan during initial treatment
* Informed consent provided

Exclusion criteria

* Combined with other operative procedure on the spine (e.g. dorsal instrumentation)
* Intraoperative intradiscal cement leakage
* Previous history of spinal surgery except on the cervical spine
* Metastatic disease with skeletal involvement
* Known chronic diseases of the bone metabolism other than osteoporosis
* Documented pregnancy (see also 6.3)
* Presence of implants not suited for MRI (pacemaker, neuro-stimulators, pain pumps, insulin pumps, Cochlea implants, metallic foreign bodies like bullet fragments)

Primary outcomes:
measure: Tracer Uptake
timeFrame: at least 3 years after kyphoplasty
Secondary outcomes:
measure: Intravertebral Discs
timeFrame: at least 3 years after kyphoplasty
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Division of Trauma Surgery, University Hospital Zurich
Study officials:
References: