louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00180908: Comparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children
Official title: SFOP-OS94: Multicentric Randomised Phase III Trial Comparing Efficacy of Preoperative High-Dose Methotrexate Plus Doxorubicin to Efficacy of High-Dose Methotrexate Plus Etoposide and Ifosfamide, in Children and Adolescents Osteosarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteosarcoma
Localised High Grade Osteosarcoma of the Limbs
Keywords: Osteosarcoma
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 226
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two preoperative chemotherapy regimens based on high-dose methotrexate courses given alternately either with doxorubicin or with etoposide-ifosfamide.


Eligibility criteria: Inclusion Criteria:

* non metastatic limb osteosarcoma,
* age less than 20 years,
* biopsy proven high-grade osteosarcoma,
* no previous treatment,
* no contraindication to chemotherapy
* no previous malignancy,
* Written informed consent.

Exclusion Criteria:

* juxta-cortical sarcoma and microcellular anaplastic sarcoma,
* previous anticancer treatment
* contraindication to chemotherapy
* previous malignancy,

Primary outcomes:
measure: Good histological response (5% or less viable cells) after preoperative chemotherapy
Secondary outcomes:
measure: Event-free survival,
measure: Overall survival,
measure: Toxicity.
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave-Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Chantal Kalifa, MD
role: STUDY_CHAIR
References:
citation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
citation: Le Deley MC, Guinebretiere JM, Gentet JC, Pacquement H, Pichon F, Marec-Berard P, Entz-Werle N, Schmitt C, Brugieres L, Vanel D, Dupouy N, Tabone MD, Kalifa C; Societe Francaise d'Oncologie Pediatrique (SFOP). SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients. Eur J Cancer. 2007 Mar;43(4):752-61. doi: 10.1016/j.ejca.2006.10.023. Epub 2007 Jan 30.
Clinical trial NCT00816608: The Effect of Maximum Body Weight in Lifetime on the Development of Type 2 Diabetes
Official title: Study of MAXimum Weight in Lifetime on Glucose Homeostasis (MAXWEL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Prediabetes
Keywords: diabetes
prediabetes
impaired fasting glucose (IFG)
impaired glucose tolerance (IGT)
body weight
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2009-01-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean with type 2 diabetes Korean with confirmed IFG or IGT Korean with NGT

Brief summary: Hypothesis : The maximum body weight in lifetime is associated with the onset of development of type 2 diabetes.

Detailed description: Obesity is well recognized risk factor for type 2 diabetes. Recent studies reported that weight change, especially severe weight gain was associated with an increased risk of type 2 diabetes. The aim of this study is to investigate whether the maximum body weight of lifetime is associated with the early onset of type 2 diabetes or an increased risk of type 2 diabetes in Korean.

Eligibility criteria: Inclusion Criteria:

* Korean with type 2 diabetes
* Korean with confirmed IFG or IGT
* Korean with NGT

Exclusion Criteria:

* Malignancy except thyroid cancer
* Active tuberculosis

Primary outcomes:
measure: The development of diabetes
timeFrame: Five years
Secondary outcomes:
measure: DM complication
timeFrame: 5 years
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Bundang-gu
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03325608: Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients
Official title: Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2017-10-30
Enrollment: 889
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dementia is a common problem for older patients presenting to emergency departments and for the family caregivers who often lack support, understanding, and skills to manage the problems related to the need for emergency department visits. The purpose of Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED-CPCIP, here on referred to as POISED) randomized controlled trial is to use previously established quality improvement methods of root cause analysis to uncover reasons for emergency department use and to focus on caregiver activation within a program of dementia care management.

The goals of this study are to reduce recurrent emergency department visits and improve caregiver symptoms of depression, anxiety and need for social support.


Eligibility criteria: Inclusion Criteria:

* Must be in the emergency department for care at the point of recruitment
* Must be English- or Spanish-speaking
* Must have a family member or friend who provides caregiving assistance
* Must have a plan to be discharged to home (ESI = 4 or 5)
* Must have score \<3 on the MiniCog or if using caregiver assessment by IQCODE must be \>3.4
* Must have capacity to consent or have a proxy.

Exclusion Criteria:

* Care recipient (CR) is a resident of a nursing home or other supportive facility
* CR scores \> 3 on the MiniCog or the caregiver assessment by IQCODE was \< 3.4
* Caregiver (CG) declines participation
* CR is not being discharged to home

Primary outcomes:
measure: Percentage of Participants With an Emergency Department (ED) Visit Within 6 Months After Enrollment
timeFrame: Up to Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Chodosh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chodosh J, Connor K, Fowler N, Gao S, Perkins A, Grudzen C, Messina F, Mangold M, Smilowitz J, Boustani M, Borson S. Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients: Protocol for a Multisite Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 20;11(10):e36607. doi: 10.2196/36607.
Clinical trial NCT00862108: Methylphenidate Treatment Response Study of Genetic Polymorphism in Attention Deficit Hyperactivity Disorder(ADHD)
Official title: Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Polymorphism, Single Nucleotide
SLC6A2 protein, human
ADRA2A protein, human
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2009-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether norepinephrine gene polymorphism affect to treatment response in ADHD


Eligibility criteria: Inclusion Criteria:

* diagnosis made by DSM-IV and K-SADS-PL
* IQ \> 71

Exclusion Criteria:

* genetic disorder
* history of acquired brain injury
* seizure disorder
* other neurologic disorder
* mental disorder, pervasive developmental disorder
* obsessive-Compulsive disorder
* communication disorder
* learning disorder

Primary outcomes:
measure: Clinical Global Impression Scale-Improvement
timeFrame: 8 weeks
Secondary outcomes:
measure: ADHD rating scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Soo-Churl Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00561808: In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF
Official title: In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Keywords: PCO/PCOD
IVM
Immature Oocytes
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-11-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retrieval of immature oocytes from women with polycystic ovaries, their in-vitro maturation, fertilization and embryo transfer can prevent hormonal treatment that can lead to ovarian hyperstimulation. In addition, it can decrease discomfort and side-effects of routine daily administration of hormones and it can be cost-effective. Thirty healthy women with Polycystic Ovarian Syndrome aged 20-35, with BMI 18-30 kg/msq will be included in the study. Their immature oocytes will be retrieved from small follicles without any hormonal treatment. The oocytes will be fertilized post in-vitro maturation. The developed embryros will be transferred to the patients as in a routine IVF cycle.


Eligibility criteria: Inclusion Criteria:

* Healthy women diagnosed with Polycystic Ovarian Syndrome with BMI 18-30 kg/sqm, aged 20-35

Exclusion Criteria:

* Every one else

Primary outcomes:
measure: Maturation rate of oocytes, their fertilization rate, cleavage rate and embryo quality.
timeFrame: one year
Secondary outcomes:
measure: Implantation rate and successful delivery.
timeFrame: one year
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: IVF Unit, Hillel Yaffe Medical Center
Study officials:
affiliation: IVF Unit, Hillel Yaffe Medical Center
name: Adrian Ellenbogen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05627908: The PseAn Study - Study Protocol
Official title: Detection of Post-traumatic Abdominal Pseudoaneurysms by CEUS and CT: A Prospective Comparative Global Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Trauma
Follow-up in Abdominal Trauma
Keywords: trauma
CT scan
CEUS
follow up
abdominal pseudoaneurism
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients (18 years old and above) with proven blunt or penetrating splenic and/or liver and/or renal trauma as shown by a CT scan and classified according to the American Injury Scale American Association for Surgery (AAST) Organ Injury Scale (OIS) will be included

Brief summary: The researchers aim to study the role of contrast ultrasound in detecting post-traumatic splenic, hepatic, and renal PAs compared with the gold standard of CT with intravenous contrast at different follow-up time points, and whether it can replace CT scan in the follow-up of solid organ injuries

Detailed description: Adult patients (18 years old and above) with proven blunt or penetrating splenic and/or liver and/or renal trauma as shown by a CT scan and classified according to the American Injury Scale American Association for Surgery (AAST) Organ Injury Scale (OIS) with OIS III and above will undergo a follow-up with both a CEUS and CT scan to detect post-traumatic parenchymal pseudoaneurysm within two to five days from injury. Follow-up over five days post-admission will be included if they were performed within the same hospitalization

Eligibility criteria: Inclusion Criteria:

* adult patients (18 years old and above) with proven blunt or penetrating splenic and/or liver and/or renal trauma as shown by a CT scan and classified according to the American Injury Scale American Association for Surgery (AAST) Organ Injury Scale (OIS) will be included

Exclusion Criteria:

* minor to 18 years old

Primary outcomes:
measure: Pseudoaneursim (PA)
timeFrame: up to 5 days post patients admission
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST GOM Niguarda
state: Italia
Study officials:
References:
Clinical trial NCT04247308: Multi Modal Stimulations in Pre-term Neonates
Official title: Multi-modal Stimulations on Neuromotor Responses Among the Hospitalised Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Infant, Premature, Diseases
Keywords: Preterm
Neonate
Multi-modal stimulation
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
Collaborators: name: Maharishi Markendeswar University (Deemed to be University)
First posted: 2020-01-30
Enrollment: 56
Sex: ALL
Minimum age (years): 2
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group pre-test post-test design
Primary purpose: TREATMENT

Brief summary: A total of 56 neonates with LBW will recruited by the convenience sampling to participate in this two group pre-test post-test, single blinded randomized clinical study. After the demographics, recruited NLBW will be randomly divided into two groups, group A and group B with block randomization. There will be four blocks, with the matrix design of 4X14 here 14 being rows. Each block contained 4 chits (2 chits for each group), totalling 56. The subjects will be allotted to the group based on the randomly chosen chit by their parents. Once the block will be allotted, next row block was opened. Thus, equal number of NLBW will be assigned to each group over time.

Group A will be receiving multimodal sensory and kinesthetic stimulation (MSKS) and Group B will be receiving regular lifesaving hospital care. Group A will receive the interventions for 2 weeks period, totalling 10 sessions. Each session will last for 30 minutes duration.


Eligibility criteria: Inclusion Criteria:

1. Infants born between 28 and 36 week of gestation
2. Birth weight ranging from 1000-2500 g.
3. Medically stable preterm infants

Exclusion Criteria:

1. Medically unstable preterm infants.
2. Infants with congenital anomalies, congenital infections and central nervous system injury

Primary outcomes:
measure: Infant Neurological International Battery
timeFrame: Change from baseline and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ambala
country: India
facility: Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU)
name: Vencita P Aranha, MPT, (PhD)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aranha VP, Chahal A, Bhardwaj AK. Neonatal aquatic physiotherapy in neonatal intensive care units: A scoping review. J Neonatal Perinatal Med. 2022;15(2):229-235. doi: 10.3233/NPM-210858.
citation: Aranha VP, Chahal A, Bhardwaj AK. Short-term effects of multimodal stimulation on neuromotor behaviour and neonatal pain among hospitalized preterm infants: A feasibility, non-blinded randomized controlled trial. J Neonatal Perinatal Med. 2023;16(2):325-337. doi: 10.3233/NPM-210889.
Clinical trial NCT03237208: Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic
Official title: Patients Undergoing Routine Transcutaneous Electrical Nerve Stimulation Treatment in Patients With Renal Colic Who Admitted to the Emergency Department: A Randomized Double Blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Colic
Keywords: Transcutaneous electrical nerve stimulation
emergency medicine
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 100
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: The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department.

Detailed description: Renal colic, an intensely painful condition, is a common presenting complaint to the emergency department. Parenteral opioids, nonsteroidal anti-inflammatory drugs and acetaminophen are commonly used to provide relief from renal colic. The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department.

Study Design and Setting: A prospective, randomized, double-blind, placebo controlled, single-center, clinical trial will be conducted in emergency department of a tertiary care university hospital.

Eligibility criteria: Inclusion Criteria:

1. Adult patients with renal colic admitted to emergency department.
2. Adult patients who were definitively diagnosed with acute renal colic due to urinary system stones using unenhanced computed abdominopelvic tomography

Exclusion Criteria:

1. Patients below 18 years of age
2. Patients with haemodynamic instability, with fever (temperature=38°C \[100.4°F\]), with evidence of peritoneal inflammation,
3. Patients using any analgesic within the previous 48 hours of emergency department presentation
4. Patients who declined to participate

Primary outcomes:
measure: Reduction of the intensity of pain
timeFrame: 0 minutes, 15 minutes and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application
Secondary outcomes:
measure: Adverse events
timeFrame: 30 minutes after
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adiyaman University Research Hospital
state: Central
Study officials:
affiliation: Adiyaman University of Medical Faculty
name: Umut Gulacti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simpson PM, Fouche PF, Thomas RE, Bendall JC. Transcutaneous electrical nerve stimulation for relieving acute pain in the prehospital setting: a systematic review and meta-analysis of randomized-controlled trials. Eur J Emerg Med. 2014 Feb;21(1):10-7. doi: 10.1097/MEJ.0b013e328363c9c1.
Clinical trial NCT03144908: Healthcare Decisions on Dietary and Environmental Allergen Exposure
Official title: Medical Provider Experience and Assessment on Healthcare Decisions Regarding Dietary and Environmental Allergen Exposure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dietary Allergy
Environmental Allergy
Lead sponsor: Data Collection Analysis Business Management
Sponsor class: OTHER
Collaborators: name: PAS Research Services
First posted: 2017-05-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only licensed providers, as per the inclusion criteria

Brief summary: Design of this study is to collect data and review Principal Investigators standard operating procedures on allergy testing and changes made to their specific SOP.

Detailed description: The purpose of this minimal risk observational study is to increase surveillance for dietary and environmental allergens exposure and to also determine targeted risk reducing and preventative strategies.

Eligibility criteria: Inclusion Criteria:

* Must be a medical practitioner Medical Doctor (MD) Doctor of Osteopathic (DO) Physician Assistant (PA) Advanced Practice Registered Nurse (APRN) Nurse Practioner (NP) Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history.

Exclusion Criteria:

* Government funded insurance data cannot be included in the study

Primary outcomes:
measure: Provider Structures and Processes
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Land O' Lakes
country: United States
facility: DCABM
state: Florida
Study officials:
References: