louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06017518: An Observational Study of Local Relapse After High Grade Osteosarcoma
Official title: An Observational Study of Local Relapse After High Grade Osteosarcoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteosarcoma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who experienced local relapse as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases

Brief summary: multicenter retrospective and prospective study in patients with high-grade osteosarcoma

Detailed description: This is a multicenter retrospective and prospective study that will analyze all cases with of diagnosis of local relapse in high-grade osteosarcoma from 01 January 1980 and all new cases referring to each participant site.

Eligibility criteria: Inclusion Criteria:

* Patients who experienced LR as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases
* Adequate patient compliance to follow-up visits
* Written informed consent prior to any study-specific analysis and/or data collection
* No age limits

Exclusion Criteria:

* Cases of LR demonstrated after \> 3 months after metastatic disease
* Impossibility to ensure adequate compliance

Primary outcomes:
measure: post local relapse survival
timeFrame: 24 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
state: BO
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
References:
Clinical trial NCT01809418: keePAP Device for Treatment of Obstructive Sleep Apnea
Official title: Efficacy Study of the keePAP Device in Reducing the Number of Obstructive Breathing Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: keepMED Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the Apnea Hyperpnoea Index (AHI) or Respiratory Disturbance Index (RDI) and measures of oxygen saturation during sleep.

Detailed description: Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.

The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the AHI/RDI and measures of oxygen saturation during sleep.

Eligibility criteria: Inclusion Criteria:

* Age over between 18 and 80 years old;
* AHI/RDI \> 5

Exclusion Criteria:

* Uncontrolled or serious illness (angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure),
* Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment;
* History of severe nasal allergies or sinusitis or difficulty breathing through the nose;
* Persistent blockage of one or both nostrils;
* Any previous operation or trauma to the nose;
* Any nasal, facial or head abnormalities that would not allow adequate placement of the device.
* Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure.
* Female subjects of childbearing age were excluded if they were pregnant or intending to become pregnant.

Primary outcomes:
measure: AHI/RDI and oxygen saturation during sleep
timeFrame: one night
Secondary outcomes:
measure: Patient comfort
timeFrame: one night
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Asher Tal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.
Clinical trial NCT03017118: Turmeric for Patients With Basal Joint Arthritis
Official title: A Randomized Controlled Trial Using Turmeric for Patients With Basal Joint Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thumb Osteoarthritis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess whether the use of a commercially available nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients with basal joint arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric on basal joint arthritis.


Eligibility criteria: Inclusion Criteria:

* 40 years of age or older
* English fluency and literacy
* Seeking care for basal joint pain
* Tender over basal joint
* Positive distraction rotation test (rotation of the thumb metacarpal base while applying axial traction)
* Radiographic evidence of Eaton stage 1 and 2 only

Exclusion Criteria:

* Secondary gains (litigations or worker compensation) procedures that may interfere with patients' motivation for treatment
* Inability or unwillingness to participate in a trial study
* Rheumatoid Arthritis or other inflammatory disorder diagnoses
* Post-traumatic osteoarthritis
* Patients on Coumadin/Steroids/NSAIDs/Tylenol
* Diabetes Mellitus
* Pregnant or lactating women
* Basal joint arthritis of Eaton stage 3
* Patients seeking other treatment for their basal joint arthritis (splint, corticosteroid injection, surgery)

Primary outcomes:
measure: Change in baseline pain intensity
timeFrame: Enrollment, 6 weeks, and 3 months
measure: Change in baseline disability
timeFrame: Enrollment, 6 weeks, and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03530618: Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children
Official title: Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization, Central Venous
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 88
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.


Eligibility criteria: Inclusion Criteria:

* surgery under general anesthesia
* require central venous catheterization

Exclusion Criteria:

* central vein anomaly
* hematoma in central vein
* catheterization site infection

Primary outcomes:
measure: First successful central venous catheterization rate
timeFrame: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
Secondary outcomes:
measure: Time to first puncture of central vein
timeFrame: Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds
measure: Time to guide wire insertion
timeFrame: Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
measure: Total time to central venous catheterization
timeFrame: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
measure: Number of central vein puncture trial
timeFrame: up to 5 times, an expected average observation time of 30 seconds
measure: Number of guide wire insertion trial
timeFrame: up to 5 times, an expected average observation time of 90 seconds
measure: First successful central vein puncture rate
timeFrame: Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
measure: First successful guide wire insertion rate
timeFrame: Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim EH, Kang P, Song IS, Ji SH, Jang YE, Lee JH, Kim HS, Kim JT. Straight-tip guidewire versus J-tip guidewire for central venous catheterisation in neonates and small infants: A randomised controlled trial. Eur J Anaesthesiol. 2022 Aug 1;39(8):656-661. doi: 10.1097/EJA.0000000000001695. Epub 2022 Jul 7.
Clinical trial NCT01424618: A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs
Official title: A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implantation, Embryo
Keywords: Donor eggs
Donor oocytes
Pregnancy
Embryo Implantation
Infertility
IVF
Lead sponsor: Kelly, Maureen, M.D.
Sponsor class: INDIV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-08-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares two different methods to prepare the uterine lining of recipients for implantation in cycles using donor eggs. The study method requires less time than the standard method.

It is hypothesized that both methods would be suitable for use in egg donor cycles.

Detailed description: Currently a combination of medications is used to prepare the uterine lining of recipients for implantation in egg donor cycles. The protocol used most commonly is as follows: Initially the individual's own pituitary-ovarian system is suppressed using a GnRH agonist so there are not conflicting signals sent to the uterus. This is followed by hormonal medication identical to what is secreted by the ovaries to prepare the uterine lining for subsequent embryo transfer in donor egg cycles.This preparation typically takes a minimum of four weeks.

This study will compare a different medication, a GnRh antagonist (which is commonly used in IVF) to suppress an individual's system during the preparation of the uterine lining. This protocol would generally take only two weeks to prepare the uterine lining.

Eligibility criteria: Inclusion Criteria:

* recipients awaiting egg donation
* some ovarian function
* normal endometrial cavity

Exclusion Criteria:

* submucosal myoma
* myoma(s) greater than 4 centimeters
* endometrial polyp
* DES exposure
* documented recalcitrant thin endometrium ( \<7 mm)
* untreated vulvovaginitis
* active pelvic infection
* endometrial cancer or suspected/known hormonally sensitive cancers
* breast cancer
* thromboembolic disease
* cerebrovascular or coronary heart disease
* diabetes mellitus
* hepatic tumors or active liver disease
* severe hypertension
* headaches with neurologic disease
* cholestatic disease
* heavy smoking over age 35

Primary outcomes:
measure: endometrial thickness measured by ultrasound
timeFrame: 2-4 weeks
Secondary outcomes:
measure: endometrial biopsy
timeFrame: 3-6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Society Hill Reproductive Medicine
state: Pennsylvania
Study officials:
affiliation: Society Hill Reproductive Medicine
name: Maureen Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05052918: The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
Official title: The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre Diabetes
Exercise
Metformin
Atherosclerosis
Keywords: Prediabetes
exercise
metformin
atherosclerosis
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.

Detailed description: The researchers think that the application of guide-based exercise programs in prediabetes patients will decrease the carotid intima-media thickness.The aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.

Eligibility criteria: Inclusion Criteria:

* Leading a sedentary life
* Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
* Have the same weight for 6 months before participating in the study (±2.5 kg)
* Those diagnosed with prediabetes by oral glucose tolerance test and/or HbA1c measurement

Exclusion Criteria:

* Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
* Having cardiovascular disease
* Being diabetic
* Using metformin before participating in the study
* Receiving hormone replacement therapy
* Life expectancy less than 1 year
* HIV positivity
* Substance use
* Functional dependency
* Cognitive weakness
* Those who have other diseases that will affect the results of the study (respiratory diseases, muscle diseases, etc.)
* Those who use drugs or supplements that will affect the results of the study

Primary outcomes:
measure: Carotid ultrasound
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Sultan Abdülhamid Han Training and Research Hospital
state: İstanbul
Study officials:
affiliation: Sultan Abdülhamid Han Training and Research Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803218: Randomized Study to Compare the Bioavailability of Two Fluticasone Propionate 0.005% Topical Ointments
Official title: Bioequivalence of Two Fluticasone Propionate 0.005% Topical Ointments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Bioequivalence
Fluticasone Propionate
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Community Volunteers

Brief summary: The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.005% Ointments in healthy, female subjects.


Eligibility criteria: Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Weight within +/- 20% from normal for height and weight for body frame
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating

Primary outcomes:
measure: Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
timeFrame: Over the course of one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02601118: Micro-expression Reading Skill Training in Medical Students
Official title: Effects of Micro- and Subtle-expression Reading Skill Training in Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 82
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study was undertaken to investigate the effectiveness of the Micro Expression Training Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal communication skills of medical students.

Detailed description: Teaching and assessing communication skills is an important component of medical school curricula, and it is not easy for medical students to develop non-verbal communication skills without adequate training. This study was undertaken to investigate the effectiveness of the Micro Expression Training Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal communication skills of medical students.

Eligibility criteria: Inclusion Criteria:

* Year 1 and 2 medical students, PNUSOM

Exclusion Criteria:

* incomplete survey response

Primary outcomes:
measure: Expression Training Tool score
timeFrame: through study completion, 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03243318: Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients
Official title: Motor Evoked Potential in the Affected Upper Limb Predicts the Potential of Motor Recovery in Subacute Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Subacute
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2017-08-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subacute stroke patients

Brief summary: Stroke is the third common cause of adult disability in dveloped countries. Early identification of the potential for motor recovery is important to avoid 'learned disuse' and to initiate appropriate therapy with achievable goals. The current cohort study focuses on those patients with SAFE \<8 and using motor evoked potentials (MEPs) to improve on prognostication of upper limb motor recovery among subacute stroke patients in a local stroke population.


Eligibility criteria: Inclusion Criteria:

* First stroke with hemiparesis or hemiplegia with SAFE \<8

Exclusion Criteria:

* contra-indication to TMS or MRI, history of seizure, pregnancy and mentally unfit to understand the consent

Primary outcomes:
measure: Action Research Arm Test
timeFrame: Change of Baseline Action Research Arm Test at 12 weeks post-stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Rehabilitation, Kowloon Hospital
Study officials:
References:
Clinical trial NCT00214318: Beta-2 Polymorphisms and Beta Receptor Selectivity
Official title: The Effects of ß2 Polymorphisms on Beta Selectivity After ß-adrenergic Blockade in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 25
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: We hypothesize that b2 adrenergic polymorphisms affect b-receptor selectivity in patients with heart failure treated with either a b1-selective or a b-nonselective agent. b-2 polymorphisms may contribute to differing responses to drug treatment with beta-blockers in heart failure. Characterizing these polymorphisms may help explain the variability in the degree of "selectivity" of action of b-blockers at the b receptor, namely if their action is specific for the b-1 or b-2 receptor. Part A was conducted at the University of Utah, and all subjects completed study related activities. Part B (sub-study) consists of genotyping of blood samples collected in part A, which will be completed at the University of Wisconsin. Sub-study (samples and DNA isolation) or Part B entailed analyzing an extra 10 mL of blood that was taken for DNA isolation. Genotyping (i.e. determination of genetic makeup) of beta adrenergic polymorphisms utilized polymerase chain reaction followed by pyrosequencing.


Eligibility criteria: Inclusion Criteria:

* systolic dysfunction with ejection fraction ≤40%
* symptomatic heart failure class 2-3
* \>18 years of age
* optimal medical therapy of HF excluding the use of any beta-blockers within the previous 30 days of the study

Exclusion Criteria:

* active myocarditis
* hemodynamically significant valvular heart disease
* hypertrophic cardiomyopathy
* contra-indications to beta-blockers
* concomitant use of beta-agonists
* beta-antagonist or anti-arrhythmics
* unstable angina
* myocardial infarction or bypass surgery within 3 months
* significant renal insufficiency \[creatinine \>2.5 mg/dL\], liver disease, or anemia

Primary outcomes:
measure: The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: orly vardeny
role: PRINCIPAL_INVESTIGATOR
References: