louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06021314: Brace Efficiency and Generalized Joint Hypermobility
Official title: Investigation of the Relationship Between Generalized Joint Hypermobility and Brace Efficiency in Adolescent Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis Idiopathic
Hypermobility, Joint
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Gulhane School of Medicine
First posted: 2023-09-01
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who were diagnosed with adolescent idiopathic scoliosis and planned to use a cheneau type scoliosis brace.

Brief summary: The goal of this observational study is to learn about effect of generalised joint hypermobility on the effectiveness of the brace in children with Adolesan Idiopatic Scoliosis and who use braces due to brace indication.

The main questions it aims to answer are:

* Does Generalized Joint Hypermobility have an effect on the amount of in-brace improvement achieved in children using braces?
* Does Generalized Joint Hypermobility have an effect on the change in the numerical variables related to scoliosis recorded in the out-brace measurement at the end of 6 months?


Eligibility criteria: Inclusion Criteria:

* Being under brace treatment due to the diagnosis of adolescent idiopathic scoliosis.
* Having a standing posterior-anterior radiograph before and during the brace use.
* Having a curve of 20 degree and above according to the Cobb angle.
* Confirmation of participation.

Exclusion Criteria:

• Having systemic diseases related to GJH (Ehlers-Danlos, Down, Marfan, Larsen).

Primary outcomes:
measure: Change of in-brace scoliosis angle
timeFrame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
measure: Generalised Joint Hypermobility
timeFrame: After participant being included in the study, latest at the 4th week of the brace use.
Secondary outcomes:
measure: Change of in-brace vertebral rotation
timeFrame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
measure: Change of in-brace spinal height
timeFrame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
measure: Change of in-brace global cronal balance
timeFrame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
measure: Change of in-brace apical translation
timeFrame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
measure: Brace compliance
timeFrame: in-brace condition at the 4th week of the brace use
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Senay Cerezci Duygu
state: Keçiören
Study officials:
References:
Clinical trial NCT05780255: Quality of Life 1y and 2 y After VV-ECMO for COVID-19
Official title: Quality of Life 1y and 2 y After VV-ECMO for COVID-19, Measured by the 36-item Short Form Health Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Extracorporeal Membrane Oxygenation Complication
Quality of Life
Death
Keywords: ECMO
COVID-19
quality of life
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with PCR-confirmed COVID-19 infection with ARDS who require veno-venous ECMO therapy.

Brief summary: This study aims to investigate the quality of life and the outcome after veno-venous extracoporeal membrane oxygenation (ECMO) support fir severe acute respiratory syndrome (ARDS) in COVID-19 patients.

Detailed description: The investigators follow our COVID-19 patients supported by ECMO, we make phone calls or real-life visits to pthe patients to score the quality of life, by using the SF-36. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality , social functioning , role emotional , and mental health.

The participants are contacted 3 months, 6months, 1year and 2 years after the ECMO support started for evaluation of the SF-36.

Eligibility criteria: Inclusion Criteria:

* Patients with PCR-confirmed COVID-19 infection AND
* Acute Respiratory Distress Syndrome who require veno-venous ECMO therapy.

Exclusion Criteria:

* None

Primary outcomes:
measure: in-hospital mortality
timeFrame: mortality during hospitalisation, up to two years
measure: Quality of life 1y after ECMO insertion
timeFrame: 1 year
measure: Quality of life 2y after ECMO insertion
timeFrame: 2 years
Secondary outcomes:
measure: Lung complications requiring surgical treatment
timeFrame: From the start of VV-ECMO support until weaning of VV-ECMO, up to two years
measure: Duration of mechanical ventilation
timeFrame: 2 years
measure: LOS ICU
timeFrame: from the day of intensive care unit admission until the day of transfer to the ward, up to two years
measure: LOS hospital
timeFrame: from the day of hospital admission until the day that the participant is transferred to home, up to two years
measure: death after hospital discharge
timeFrame: after discharge from the hospital upon 2 years after
measure: Incidence of acute kidney injury
timeFrame: from the day of hospital admission until the day that the participant is transferred to home, up to two years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent university hospital
Study officials:
affiliation: UZ Gent
name: Harlinde Peperstraete
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00142155: Correlation of FC Gamma RIIIA Receptor Response in Patients With Waldenstrom's Macroglobulinemia
Official title: Correlation of Fc Gamma RIIIA Receptor Expression and Response to Rituximab and Other Monoclonal Antibodies in Patients With Waldenstrom's Macroglobulinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waldenstrom's Macroglobulinemia
Keywords: monoclonal antibody
Fc gamma RIII receptor expression
rituximab
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to determine if the type of Fc gamma RIIIa receptor that a particular patient's immune cells possess influences how they respond to rituximab and other monoclonal antibodies.

Detailed description: * A medical data collection survey sheet will be filled out by the patient or doctor with medical information pertaining to how the patient responded to rituximab and other monoclonal antibodies for use in this study.
* Blood work will be performed to analyze the blood by molecular technology to find the kind of Fc gamna RIIIa receptor the patient possess and correlate these findings with the outcome of treatment with rituximab or other monoclonal antibodies.

Eligibility criteria: Inclusion Criteria:

* Patients treated with rituximab or other monoclonal antibodies for Waldenstrom's macroglobulinemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Steven Treon, MD, MA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00118755: A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
Official title: A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-07-12
Enrollment: 435
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: This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m\^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m\^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m\^2 po bid on Days 1-7, oxaliplatin 85 mg/m\^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* Metastatic or inoperable locally advanced colorectal cancer
* \>=1 measurable target lesion

Exclusion Criteria:

* Previous systemic therapy for advanced or metastatic disease
* Previous treatment with bevacizumab

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Time to disease progression or death (through follow-up phase)
Secondary outcomes:
measure: Overall Survival
timeFrame: Time to death (through follow-up phase): Approximate Median of 718 days
measure: Best Overall Clinical Response
timeFrame: Through follow-up phase: Approximate Median of 318 days
measure: Duration of Overall Clinical Response (CR or PR)
timeFrame: Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02882555: Effect of Muscular Exercise on Cough Reflex
Official title: Effect of Muscular Exercise on Cough Reflex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 77
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The hypothesis is that the cough reflex induced by capsaicin is inhibited during exercise. The purpose of this study is to determine if a short muscular exercise inhibits the cough reflex induced by capsaicin inhalation.

Detailed description: Cough is an important reflex of defense of airways. It is also one of the more frequent symptoms during respiratory diseases. Chronic cough can be a disabling condition, apparently idiopathic or associated to pathology such as asthma, sinusitis with posterior discharge or gastroesophageal reflux.

Factors susceptible to provoke or increase cough are well known, but inhibiting factors are much less known. Muscular exercise is thought to influence respiratory reflexes in a considerable and complicated way. For example, a bronchodilation is observed in healthy or asthmatic individuals, but recovery period frequently triggers asthma attacks. Effects of exercise on cough reflex are much less known.

This study aims to determine the influence of muscular exercise on cough reflex in children and healthy adults.

Highlighting the inhibition of cough reflex by exercise can have a significant effect on chronic cough patient care. There is actually no symptomatic treatment really effective without side effects.

Eligibility criteria: Inclusion Criteria:

* Obtaining of informed consent (or informed consent of parents or persons with parental authority)
* Affiliation to social security
* Negative answer to all 12 questions of medical questionnaire for child or to all 11 questions of medical questionnaire for adult
* Normal cardio-respiratory examination
* Normal electrocardiogram
* Without spirometry obstructive syndrome (FEV1 \> 70% of predicted value and FEV1/FVC \>70%)

Exclusion Criteria:

* Refusal or impossibility of obtaining informed consent of person or of persons with parental authority)

Primary outcomes:
measure: Number of cough efforts occurring within 15 sec of the C5 aerosol at baseline and during exercise
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Explorations fonctionnelles pédiatriques, Hôpital d'enfants, CHRU de Nancy, France
name: François MARCHAL, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01772355: Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orbial Mass Lesion
Keywords: orbit; tumor; core biopsy
Lead sponsor: The S.N. Fyodorov Eye Microsurgery State Institution
Sponsor class: OTHER_GOV
First posted: 2013-01-21
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Core needle biopsy of orbital mass lesions with a semiautomated needles is a safe procedure that provides a sufficient amount of tissue material for standard histological and immunohistochemical analysis and can be an alternative or supplement to fine needle aspiration biopsy


Eligibility criteria: Inclusion Criteria:

* unresectable mass lesions with diffuse involvement of the orbit or the tumors with infiltrative growth and indistinct borders which needed to have morphologic verification

Exclusion Criteria:

* An anti-coagulant therapy at the time of biopsy,
* bleeding diathesis,
* suspected hypervascular lesions,
* orbital roof destruction with a tumor,
* apical location of the tumor

Primary outcomes:
measure: true identification of an orbital tumor with a core needle biopsy
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: The S.Fyodorov Eye Microsurgery Federal State Institution
Study officials:
References:
citation: Yarovoy AA, Bulgakova ES, Shatskikh AV, Uzunyan DG, Kleyankina SS, Golubeva OV. CORE needle biopsy of orbital tumors. Graefes Arch Clin Exp Ophthalmol. 2013 Aug;251(8):2057-61. doi: 10.1007/s00417-013-2315-6. Epub 2013 Mar 21.
Clinical trial NCT00828555: Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting
Official title: Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Vaccine
Papillomavirus Infection
Pertussis
Keywords: HPV vaccine
Tdap vaccine
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2009-01-26
Enrollment: 3988
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population Groups:

Adults

Minors

Patients

Pregnant Women

Fetuses

Brief summary: PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable diseases.

SPECIFIC AIMS

1. Determine the feasibility of implementing a successful vaccination program for adolescent and adult women in Ob/Gyn offices by direct assessment of medical personnel \& office staff on their:

   * Attitudes towards vaccination of women against preventable diseases
   * Perceived barriers to implementing a program to vaccinate women in their offices
   * Ideas on how to overcome barriers to successful program implementation
   * Current vaccination practices and office-specific administrative processes
2. Design \& implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, \& pertussis
3. Determine the effectiveness of the vaccination program based on

   * Pre- and post-program vaccination rates
   * Program satisfaction amongst Ob/Gyn providers and office staff
   * Willingness to continue and possibly extend the program to additional vaccines
4. Quantify the level of support and resources needed to develop and implement the vaccination program


Eligibility criteria: Inclusion Criteria:

* 4-5 community Ob/Gyn practices

Primary outcomes:
measure: Implementation and measurement of a health services intervention in community or private Ob/Gyn practices to improve the delivery of standard clinical care to vaccinate women against human papillomavirus, influenza, & pertussis.
timeFrame: Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009.
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Westside OBGYN
state: North Carolina
city: Durham
country: United States
facility: DWHA
state: North Carolina
city: Raleigh
country: United States
facility: Atrium OBGYN
state: North Carolina
city: Raleigh
country: United States
facility: Blue Ridge OBGYN
state: North Carolina
Study officials:
affiliation: Duke University
name: Geeta Swamy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05547555: Invasive PGT-A Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
Official title: IVF Outcomes Based on Invasive PGT-A Embryo Selection Versus Non Invasive PGT-A Assisted
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Aneuploidy
Chromosome Abnormality
Keywords: IVF
PGT-A
NON- INVASIVE PGT-A
TIME LAPSE
EMBRYO SELECTION
Lead sponsor: Assisting Nature
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 40 years old or older who were divided in two groups according to the embryo selection criteria for embryotransfer: women in group A proceeded to embryo transfer after invasive PGT-A assisted embryo selection and women in group B proceeded to embryo transfer after non- invasive PGT-A assisted embryo selection.

Brief summary: This is a prospective randomised study of the evaluation of the clinical IVF results after invasive PGT-A embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women.

Detailed description: A randomized prospective study focusing on subfertile women undergoing IVF treatment followed by embryo transfer on the blastocyst stage.

Women assigned to group A proceed to embryo transfer, after invasive PGT-A embryo selection, while women of group B after non-invasive PGT-A assisted embryo selection.

IVF outcomes, regarding the success rate of the trasnfer and the time required to achieve conception is studied in both groups.

Eligibility criteria: Inclusion Criteria:

* Women who followed IVF treatment
* 40 years old or older
* Single embryo transfer
* blastocyst stage cultured embryos

Exclusion Criteria:

* women under the age of 40 years
* not blastocyst transfer (transfers performed at earlier embryo stage)
* double embryotransfer
* women who had embryotransfer according to morphological criteria women whose embryos were not time-lapse monitored

Primary outcomes:
measure: Embryotransfers to conceive
timeFrame: Up to the embryotransfer of the last enrolled patient (Dec 2023)
measure: Time interval to conceive
timeFrame: Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024)
measure: Cumulative Live Birth Rate
timeFrame: Up to 38 weeks after the embryo transfer
Secondary outcomes:
measure: Abortion rate
timeFrame: Up to 2nd trimester miscarriages
measure: DaC rate
timeFrame: during pregnancy according to Greek Law
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Assisting Nature
state: Thessaloniki
Study officials:
References:
Clinical trial NCT03147755: Prevalence, Risk Factors and Complications of Oropharyngeal Dysphagia in Stroke Patients
Official title: Prevalence, Risk Factors and Complications of Oropharyngeal Dysphagia in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorders
Keywords: stroke
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to hospital with clinical suspicion of stroke

Brief summary: Oropharyngeal dysphagia (OD) is a common morbidity after stroke that disrupts swallowing physiology. The investigators aimed at evaluating the prevalence of oropharyngeal dysphagia (OD) after stroke and analysing the risk factors and associated complications.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to hospital with confirmed stroke diagnosis; signed informed consent

Exclusion Criteria:

* previous diagnosis of OD; transient ischemic attack; and being transferred from another hospital.

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: