louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02088918: A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in Healthy Male Subjects


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 40
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypertension or hyportension

Primary outcomes:
measure: AUC last
timeFrame: 0-~24hrs
measure: Cmax
timeFrame: 0~24hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam University Hospital
Study officials:
References:
Clinical trial NCT01480518: Biomarkers in Tissue Samples From Patients With Ewing Sarcoma
Official title: Analysis of GGAA-Microsatellites in Ewing Sarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-11-29
Enrollment: 166
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ewing sarcoma.

Brief summary: RATIONALE: Studying samples of tissue in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with Ewing sarcoma.

Detailed description: OBJECTIVES:

* To describe the spectrum of GGAA-microsatellite polymorphisms at specific loci in genomic DNA prepared from Ewing sarcoma tumor specimens.
* To determine if there are differences in GGAA-microsatellite polymorphisms in genomic DNA prepared from Ewing sarcoma tumor specimens as compared to non-afflicted European and African normal genomic DNA.
* To determine if GGAA-microsatellite polymorphisms at specific loci in genomic DNA prepared from Ewing's sarcoma tumor specimens correlates with disease outcome in patients treated on COG protocol AEWS0031.
* To determine whether whole-genome amplification introduces alterations in GGAA-microsatellites as compared to non-amplified genomic DNA.

OUTLINE: Genomic PCR is used to amplify the microsatellites in the NR0B1 and GSTM4 promoters. In addition to determining microsatellite size, each microsatellite is sequenced following cloning into the pCR4 vector (Invitrogen) using standard topoisomerase cloning protocols.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Specimens from patients with Ewing sarcoma used for protocol COG-AEWS08B1

  * Obtained from patient samples taken from patients enrolled on COG-AEWS0031
  * Whole genome-amplified DNA will be used

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Event-free survival
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Stephen Lessnick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03408418: L-PRF in Alveolar Ridge Preservation
Official title: Tomographic and Histological Evaluation of Postextraction Sockets Treated With Leucocyte- and Platelet-rich Fibrin: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss, Alveolar
Keywords: Platelet-rich fibrin
Tooth Extraction
Alveolar Bone Grafting
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 48
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after dental extractions is still a matter of debate. The available literature suggests that L-PRF performs positive effect to improve alveolar preservation resulting in less bone resorption on extraction sockets. L-PRF is a second generation of platelet concentrate produced without biochemical blood manipulation. L-PRF is composed by three key parameters: first, the presence of platelets; second, the presence of leucocytes; third, the density and complex organization of the fibrin matrix architecture produced by a natural polymerization process. The theory is that this key parameters acts to produce a faster bone healing.


Eligibility criteria: Inclusion Criteria:

* (1) Health patients, American Society of Anesthesiologists (ASA) I or II
* (2) Patients who need to submit tooth extraction (pre-molar, canine and incisor teeth - uniradicular teeth or teeth with fused roots) which present ideal conditions to receive dental implants after 3 months.

Exclusion Criteria:

* Smoking
* Systemic diseases related with healing disorders
* Poor oral hygiene
* Pregnant or lactating patient
* Use of flap elevation for dental extraction

Primary outcomes:
measure: Width resorption 1mm
timeFrame: After 3 months
Secondary outcomes:
measure: Width resorption 3mm
timeFrame: After 3 months
measure: Width resorption 5mm
timeFrame: After 3 months
measure: Histological Analysis - fibrous tissue
timeFrame: After 3 months
measure: Histological Analysis - bone cells
timeFrame: After 3 months
measure: Histological Analysis - capillary vessels
timeFrame: After 3 months
measure: Histological Analysis - new bone formation
timeFrame: After 3 months
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Rio de Janeiro State University
Study officials:
affiliation: Rio de Janeiro State University
name: João Canellas, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canellas JVDS, da Costa RC, Breves RC, de Oliveira GP, Figueredo CMDS, Fischer RG, Thole AA, Medeiros PJD, Ritto FG. Tomographic and histomorphometric evaluation of socket healing after tooth extraction using leukocyte- and platelet-rich fibrin: A randomized, single-blind, controlled clinical trial. J Craniomaxillofac Surg. 2020 Jan;48(1):24-32. doi: 10.1016/j.jcms.2019.11.006. Epub 2019 Nov 29.
Clinical trial NCT05400018: Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
Official title: Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GIST
Gastrointestinal Stromal Tumors
Lead sponsor: Genetron Health
Sponsor class: INDUSTRY
Collaborators: name: Peking University Cancer Hospital & Institute
name: Harbin Medical University
name: Shanghai 10th People's Hospital
First posted: 2022-06-01
Enrollment: 1041
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital sample

Brief summary: The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.

Detailed description: This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron D842V PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.

Eligibility criteria: Inclusion Criteria:

1. Paraffin-embedded tissue samples from patients clinically diagnosed with gastrointestinal stromal tumor (GIST), and a small number of other cancers or benign lesions in the gastrointestinal site were included as interference samples.
2. The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.
3. The sample is a formalin-fixed paraffin-embedded gastrointestinal stromal tumor tissue sample, and each sample can provide 5 paraffin sections or 5 paraffin rolls with a thickness of at least 5 µm.
4. The content of tumor cells meets the requirements of assessment reagents and comparison methods.

Exclusion Criteria:

1. The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps.
2. Samples that cannot complete the entire testing process.
3. Patients with incomplete sample information.

Primary outcomes:
measure: Ct Value (Ct Values From PCR Reaction)
timeFrame: 3 months
Secondary outcomes:
measure: PPV
timeFrame: 3 months
measure: NPV
timeFrame: 3 months
measure: Consistency (the Overall Ratio of True Positive and True Negative)
timeFrame: 3 months
measure: Kappa coefficient
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
Study officials:
References:
Clinical trial NCT01896518: Novel Methods to Reduce Children's Secondhand Smoke Exposure II
Official title: Novel Methods to Reduce Children's Secondhand Smoke Exposure II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondhand Smoke
Keywords: second hand smoke exposure; children
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall aim of the current study is to determine if the use of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing children's secondhand smoke exposure.


Eligibility criteria: Inclusion Criteria:

In order to be included in the study, participants must:

1. be the primary caregiver(defined as a person who spends the most time with the child and spends a minimum of 4 hours per day in the presence of the child) of a child between the ages of 3-11 (if caregiver has more \> 1 child between 3-11 years, we will include the youngest),
2. smoke at least 10 cigarettes per day for the past year,
3. indicate that they smoke around their child or in the car or home at least one time per week\],
4. have no intention of quitting smoking in the next 12-weeks,
5. aged 18-65 years,
6. be fluent in English,
7. have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension),
8. not currently pregnant, planning to become pregnant, or breastfeeding,
9. do not use non-cigarette tobacco (cigars, chewing tobacco)
10. have no prior use of any potential reduced exposure product,
11. have no major psychiatric impairment, including psychosis, suicidality, and/or any current alcohol/drug abuse or dependence

Exclusion Criteria:

Does not meet all of the requirements of inclusion criteria

Primary outcomes:
measure: Change in Child Salivary Cotinine
timeFrame: 3, 6, and 12 weeks
Secondary outcomes:
measure: Change in Parent and Child Lung Function
timeFrame: 3, 6, 12 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: The Children's Hospital at OU Medical Center
state: Oklahoma
Study officials:
affiliation: OTRC, OU Children's Hospital Dept. of Pediatrics, OU Cancer Center
name: Theodore Wagener, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02023918: Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes
Official title: Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Metabolic Syndrome
Insulin Resistance
Keywords: Growth hormone antagonism
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco General Hospital
First posted: 2013-12-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.


Eligibility criteria: Inclusion Criteria:

* BMI between 18-35
* Homeostatic model assessment - insulin resistance (HOMA-IR) \>2.77
* Able to administer daily subcutaneous injections of pegvisomant

Exclusion Criteria:

* Pregnancy
* Breastfeeding in the last 6 months
* Liver function tests greater than 3x the upper limits of normal
* unstable diet over the last 3 months
* unstable weight over the last 6 months
* unstable lipid lowering regimen
* diabetes - type 1 or type 2
* History of major gastrointestinal surgery
* History of pancreatic, liver, biliary, or intestinal disease
* Fasting blood glucose \>126
* Fasting triglycerides\>500
* A1c\>6.5

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 28 days
Secondary outcomes:
measure: Lipolysis
timeFrame: 28 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ethan J Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Morris Schambelan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Kathleen Mulligan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00497718: The Effect of Chiropractic Manipulation on Spine-related Pain and Balance in Older Adults
Official title: The Effect of Chiropractic Manipulation on Spine-related Pain and Balance in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Equilibrium
Back Pain
Lead sponsor: Cleveland Chiropractic College
Sponsor class: OTHER
First posted: 2007-07-09
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effect of chiropractic manipulation on spine-related pain and balance in older adults.

Detailed description: Chronic pain and risk factors for falls in older adults are significant public health issues. In order to evaluate an appropriate role for chiropractic in managing these problems in the population, this pilot cohort study will take multiple measurements, both self-reported and functional, on a sample of older adults with chronic spine-related pain who are recruited from the local community and receive chiropractic care in the Cleveland Chiropractic College health center over a four-week period.

Eligibility criteria: Inclusion Criteria:

1. Aged 60 or older
2. spine-related pain of \>3 months duration (by self-report).

Exclusion Criteria:

1. Non-ambulatory
2. chiropractic care or physical therapy within the past month (by self report)
3. contraindications to manipulation, as determined by the clinician through physical exam and x-rays (if indicated)
4. absence of indications for CMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation
5. unable to understand English adequately to complete study forms.

Primary outcomes:
measure: Test various recruitment methodologies.
timeFrame: Through December 2008
measure: Describe baseline characteristics of enrolled patients.
timeFrame: Through December 2008
measure: Assess patient outcomes in terms of balance, neck or back pain, and dizziness
timeFrame: Through December 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Cleveland Chiropractic College Health Center
state: Missouri
Study officials:
affiliation: Cleveland Chiropractic College
name: Cheryl Hawk, D.C., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00614718: Failure of Chronically Implanted Defibrillator Leads -Incidence and Management
Official title: Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death, Sudden, Cardiac
Ventricular Fibrillation
Keywords: Implantable cardioverter defibrillator
lead failure
pace/sense lead
ICD complication
inappropriate therapy
Defibrillators
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 1317
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004

Brief summary: Comparison of two different approaches to address the problem of malfunctioning ICD-leads. These leads consist of two parts. One that is used for detection of arrhythmias(and pacing if required) (Pace/Sense) and a second part that is used to deliver therapy is needed (Shock-coil).

The two approaches compared are:

Replacement of the entire lead in case of any lead malfunction versus placement of an additional pace/sense-lead if the shock-coil of the exiting lead was still functional.

Detailed description: Therapy with an implantable cardioverter defibrillator (ICD) has become a standard treatment for an increasing number of patients suffering from different types of heart diseases which can lead to fatal arrhythmias. This therapy was established about 20 Years ago and malfunctioning electrodes of these devices have been, and still are a serious problem leading to inappropriate therapy (shocks)or missed live saving therapy.

In case of a malfunctioning electrode it is established clinical practice to either replace the entire ICD electrode (which is used for detecting the arrhythmias as well as delivering the shock) or just to implant an additional electrode for detection of the arrhythmia (and pacing if required) given that the "shock"-part of the existing electrode is still functional.

There is no longterm outcome data comparing these two strategies. We included 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004. Incidence of lead failure, type of lead used, approach and outcome were evaluated.

Eligibility criteria: Inclusion Criteria:

* Implantation of an ICD between 1993 and 2004

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to lead failure or lead failure recurrence
timeFrame: from inclution to death or end of follow up (Jan 2004)
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Berlin
country: Germany
facility: Benjamin Franklin, Division of Cardiology,
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital Basel, Dept. Cardiology
name: Christian Sticherling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06733818: Physical Function From the Perspective of Active Ageing
Official title: The Evaluation of the Levels of Physical Function in Older Adults From the Perspective of Active Ageing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Physical Functional Performance
Physical Activity
Active Ageing
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 455
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study was conducted with individuals aged 65 and over residing in the Isparta province of Turkey. The study population comprised voluntary individuals aged 65 years and over who scored 24 points or more on the Mini Mental State Examination (MMSE) and demonstrated an ability to comprehend the instructions provided.

Brief summary: The aim of this study is to evaluate physical function from the perspective of active aging as well as to determine the relationship between physical activity and physical performance in the context of active aging.

This cross-sectional study was conducted with the participation of 215 (47.3%) males and 230 (52.7%) females, with a mean age of 69.09±8.59 years. Functional assessment of physical performance (Alusti), Physical Activity Scale for Elderly (PASE), and University of Jyvaskyla Active Ageing Scale (UJACAS) were employed to assess physical function and active aging levels of the elderly.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 65 years and over who scored 24 points or more on the Mini Mental State Examination (MMSE) and demonstrated an ability to comprehend the instructions provided.

Exclusion Criteria:

* Individuals who were diagnosed with a neurological disorder, had undergone surgery within the past six months, had been diagnosed with cancer, lacked the capacity for verbal communication, or had severe vision impairment were excluded from the study

Primary outcomes:
measure: Active Ageing Scale
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University Faculty of Health Sciences Physiotherapy and Rehabilitation Department
state: Merkez
Study officials:
References: