louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00162695: Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rhabdomyosarcoma
Malignant Soft Tissue
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial.

IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery.

The study was powered to detect 10% difference in 3 year OS.


Eligibility criteria: Inclusion Criteria:

* age \> 6 months and \< 18 years
* no distant metastases
* diagnosis within previous 8 weeks without prior treatment except surgery
* pathology available for central review
* written consent according to institutional requirement

Exclusion Criteria:

* stage III (node positive)
* stage I or II non alveolar orbital tumours
* patients with parameningeal disease aged \< 3 years

Primary outcomes:
measure: To explore survival advantage for an intensified chemotherapy strategy in a randomised trial
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Odile OBERLIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital of Bristols, UK
name: Michael STEVENS, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04265495: Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !?
Official title: Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !? a Prospective Randomized Controlled Comparative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IVF
Keywords: Dual trigger implantation,
HCG
OHSS
ANTAGONIST
Lead sponsor: Al Baraka Fertility Hospital
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients \<40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol, then at the time of triggering, we divided the patients to 3 groups by for triggering by a dual trigger, urinary HCG and recombinant HCG and then will check the outcome regarding the maturity and oocyte quality, implantation rate, clinical pregnancy rate as well as incidence of OHSS

Brief summary: a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome of ICSI- antagonist cycles

Detailed description: a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome (oocyte quality, fertilization rate, implantation rate, clinical pregnancy rate as well as the incidence of OHSS) in ICSI- antagonist cycles

Eligibility criteria: Inclusion Criteria:

* patients \<40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol

Exclusion Criteria:

* age: \> 40 years
* BMI \> 30 ,
* long agonist protocol
* were chromosomal and genetic disorders, abnormal ultrasonogram of the uterine cavity

Primary outcomes:
measure: clinical pregnancy rate,
timeFrame: 4 WEEKS
measure: implantation rate,
timeFrame: 2 WEEKS
measure: incidence of OHSS.
timeFrame: 1 WEEK
Secondary outcomes:
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: Al-BARAKA FERTILITY HOSPITAL
state: Adliya
Study officials:
References:
Clinical trial NCT02727595: Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hallux Valgus
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Cycla Orthopedics Ltd.
First posted: 2016-04-04
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate safety, tolerability and performance of the CyclaPlex implant, a button and suture type implant device and instruments for the correction of the first inter metatarsal angle in subjects suffering from Hallux Valgus deformity.


Eligibility criteria: Inclusion Criteria:

* Weight less than 100 kilos
* IMA greater than 12 degrees
* IMA less than 7 degrees

Exclusion Criteria:

* Diabetics
* Known osteoporosis
* Known allergy or hypersensitivity to metals
* Gout or any systemic inflammatory arthropathy

Primary outcomes:
measure: IMA Reduction
timeFrame: One year
Secondary outcomes:
measure: American Orthopedic Foot and Ankle Society (AOFAS) Score
timeFrame: One year
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Ori Hadash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04968795: Heartfulness Meditation and Corporate Burnout
Official title: Effect of Heartfulness Corporate Wellness Program on Burnout Inventory Measurements
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burnout
Meditation
Stress
Heartfulness
Lead sponsor: Resolution Blue Labs Inc
Sponsor class: INDUSTRY
Collaborators: name: Heartfulness Institute
First posted: 2021-07-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is reflective of the general population, who work in large corporations and have self-identified as having moderate to high levels of stress.

Brief summary: The purpose of this study is to evaluate the effect of a 4-week heart-based meditation practice wellness workshop on burnout and emotional wellness in corporate employees. Corporate employees can be defined as individuals who work in large institutions with greater than 300 employees.

The specific aim of this study is to assess changes in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment using the Maslach Burnout Index. We hypothesize that the meditation wellness practice will be associated with reduction in burnout for those who take part in the meditation program in comparison to the participants who did not meditate and participate in the wellness program.


Eligibility criteria: Inclusion Criteria:

* Adults above 18 years of age willing to participate in the study.

Exclusion Criteria:

* Individuals less than 18 years of age, active suicidal ideation, current or past diagnoses of serious psychotic disorders- schizophrenia, personality disorders and post-traumatic stress disorder.

Primary outcomes:
measure: Differences in Burnout Scores
timeFrame: Week 0 & Week 4
Secondary outcomes:
measure: Changes in in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment, using the Maslach Burnout Inventory.
timeFrame: Week 0 & Week 4
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Resolution Blue Labs Inc
state: Ontario
Study officials:
affiliation: Resolution Blue Labs Inc
name: Andy Kumar, MD/PhD Candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: Resolution Blue Labs Inc
name: Aravindhan Ravindhran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Resolution Blue Labs Inc
name: Arth Patel, MD Candidate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03863795: Online Survey in Studying Smoking Attitudes and Behaviors Among Current Smokers
Official title: Self-Affirmation in the Context of Stigma-Induced Identity Threat Among Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoker
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2019-03-05
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Smokers recruited through Amazon Mechanical Turk

Brief summary: This trial uses an online survey to study smoking attitudes and behaviors among current smokers. An online survey consisting of questions about general demographics, smoking history, smoking attitudes, smoking behaviors, smoking intentions, health and qualities of daily life may help researchers understand the differences in smoking attitudes and behaviors among current smokers.

Detailed description: PRIMARY OBJECTIVES:

I. To examine if self-affirmation attenuates the effects of cigarette smoking stigmatization on smoking risk perceptions, pro-smoking beliefs, and intentions to change smoking behavior.

OUTLINE:

Participants are recruited and pre-screened via an online crowdsourcing program called Amazon Mechanical Turk (MTurk). Participants then respond to a one-time research survey over 20 minutes on SurveyGizmo, an on-line survey software platform.

Eligibility criteria: Inclusion Criteria:

* United States (US) adult smokers.

Primary outcomes:
measure: Quit Intentions
timeFrame: At the time of survey response within approximately 20 minutes
measure: Intentions to Switch Completely to E-cigarettes
timeFrame: At the time of survey response within approximately 20 minutes
measure: Intentions to Seek Cessation Counseling
timeFrame: At the time of survey response within approximately 20 minutes
measure: Intentions to Reduce Smoking
timeFrame: At the time of survey response within approximately 20 minutes
measure: Self-exempting Beliefs
timeFrame: At the time of survey response within approximately 20 minutes.
measure: Positive Cognitions About Smoking
timeFrame: At the time of survey response within approximately 20 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: NCI Division of Cancer Control and Population Sciences
state: Maryland
Study officials:
affiliation: NCI Division of Cancer Control and Population Sciences
name: Annette Kaufman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorgen LJ, Ferrer RA, Klein WMP, Kaufman AR. Smoking self-concept moderates the effects of self-affirmation on smoking-related beliefs and behavioral intentions. Psychol Health. 2022 Aug;37(8):964-984. doi: 10.1080/08870446.2021.1912346. Epub 2021 Apr 19.
Clinical trial NCT01735695: Performance Evaluation Study for a New Meconium Detection Test
Official title: Performance Evaluation Study for a New Meconium Detection Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Meconium
concentration
level
Lead sponsor: Laniado Hospital
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 100
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: PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic fluid samples will be tested for meconium with a new assay. The results will be correlated with other laboratory tests.

Detailed description: Female volunteers will be recruited locally in a single medical center. After the occurrence of amniotic membranes rupture, amniotic fluid samples will be collected extracorporeally.

Meconium concentration levels will be measured by the new test. Other laboratory tests will be employed in order to determine the accuracy of the new test.

Eligibility criteria: Inclusion Criteria:

* Provide written or oral informed consent to participate in the study and agree to comply with study procedures.
* Pregnant.
* Intend to seek medical care during pregnancy.

Exclusion Criteria:

* Amniotic fluid samples are mixed with urine.

Primary outcomes:
measure: Meconium concentration in amniotic fluid
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Natania
country: Israel
facility: Laniado Hospital
Study officials:
affiliation: Laniado Medical Center
name: Brigita Wintrov, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01713595: Safety Study of Inhaled Saline in Acute Lung Injury
Official title: Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pulmonary Edema
Keywords: Acute Lung Injury
Mechanical Ventilation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).

Detailed description: Hypertonic Saline (HS) aerosols have proven efficacious mucolytics in patient with cystic fibrosis and are well tolerated in that population. Safety concerns in mechanically ventilated patients with ARDS center primarily on HS's effects on lung water distribution (intra vs. extra alveolar) and on airway reactivity. For that reason we plan a small feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects of a single 5ml dose of 7% Saline aerosol on blood gas tensions, hemodynamics and the static and dynamic properties of the relaxed respiratory system. This narrowly scoped study is to lay the foundation for a larger multicenter intervention trial.

Eligibility criteria: Inclusion Criteria:

* Study participants will include consenting adult patients (age \> 18), who had been intubated and mechanically ventilated for \<72 hours and meet international consensus criteria for ARDS.

Primary outcomes:
measure: Dynamic Compliance of the Respiratory System
timeFrame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
Secondary outcomes:
measure: Patient-Ventilator Interactions
timeFrame: 5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery
Other outcomes:
measure: Arterial Blood Gas Tension
timeFrame: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
Locations:
Study officials:
affiliation: Mayo Clinic
name: Richard A Oeckler, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06042881: Retrospective Cohort Study of the Physiotherapy in Critically Ill Covid Patients
Official title: Retrospective Cohort Study of the Physiotherapy Procedure in Critically Ill Patients Diagnosed With COVID-19 During the First Wave
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: physical therapy
covid
mechanical ventilation
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample size obtained will not be from any formal calculation, it will be a sample per convenience of inclusion of all patients admitted to the ICU with a diagnosis of COVID-19 During the study period, 189 subjects, with whom it is expected to achieve the objectives of the study.

Brief summary: Retrospective cohort study that will include patients from the ICU of the Hospital de la Santa Creu i Sant Pau in Barcelona during the period between March 11 and May 13, 2020. The cohorts are made up of two groups of patients admitted for severe COVID during the first wave, according to whether or not they received physiotherapy and the possible impact of physiotherapy on the days of mechanical ventilation in the two study groups will be studied.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with COVID-19 in critical condition
* Adults \>18 years
* Admission to the ICU from March 11 to May 13, 2020

Exclusion Criteria:

* Patients readmitted on 2 occasions during the study period, the second will be omitted income.

Primary outcomes:
measure: Days of mechanical ventilation
timeFrame: 2 months
Secondary outcomes:
measure: days of stay
timeFrame: 2 months
measure: Assess morbidity and mortality.
timeFrame: 2 months
measure: Assess the comorbidities of patients admitted for COVID-19 in critical condition
timeFrame: 2 months
measure: PNS lesion in prono position
timeFrame: 2 months
measure: Assess the comorbidities of patients admitted for COVID-19 in critical condition
timeFrame: 2 months
measure: Start of standing in critrically ill
timeFrame: 2 months
measure: Workload in physiotherapy
timeFrame: 2 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT05804981: Early Detection of Cognitive Decline
Official title: Using the PROMIS Cognition Item Bank for Early Detection of Cognitive Decline in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
name: Northwestern University
First posted: 2023-04-07
Enrollment: 8723
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: a new questionnaire is integrated into the annual wellness visit. the questionnaire screens patients for cognitive decline
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial is to evaluate the impact of a brief cognitive screener on provider behavior in patients completing an annual wellness visit (AWV). The main question\[s\] it aims to answer are:

* do appropriate referrals increase for patients using the new screener?
* do appropriate diagnostic orders increase for patients using the new screener? Participants will respond to 4 questions about their cognitive abilities as part of a larger AWV protocol.

Researchers will compare provider behavior for patients completing AWVs before and after implementation of the new screener to see if referral, diagnostic and prescribing behaviors differ.

Detailed description: In the course of this two-year project, the RAND team and partners (University of Pittsburgh Medical Center \[UPMC\] and Northwestern University \[NU\]) will conduct secondary data analysis to establish the validity of scores from the PCF item bank; use the resulting data to derive meaningful scoring criteria and interpretation guidance, and determine the best short form item set from the PCF item bank to use for standardized cognitive impairment screening during the Medicare Annual Wellness Visit (AWV); use qualitative methods to refine workflow for administering the screener in primary care; work with UPMC to integrate the resultant brief self-reported PROMIS cognition screener (PRO-CIS) into their workflows; and evaluate the effect of implementing brief standardized PRO-CIS with interpretive guidance on primary care providers' behaviors.

Eligibility criteria: Inclusion Criteria:

* has AWV within study period

Exclusion Criteria:

* provider uses non-digital AWV form

Primary outcomes:
measure: specialist referrals
timeFrame: within one month post AWV
measure: diagnostic orders
timeFrame: within one month post AWV
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
Study officials:
affiliation: RAND
name: Maria Edelen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03207581: Effect of Coaching on Mid-Career Physician Well-Being, Job Satisfaction, and Fulfillment
Official title: RCT: Effect of Coaching on Mid-Career Physician Well-Being, Job Satisfaction, and Fulfillment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 87
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study will assess the effect of individualized professional coaching for mid-career family medicine and general internal medicine physicians on burnout, job satisfaction, and professional fulfillment.


Eligibility criteria: Inclusion Criteria

1. General internal medicine and family physicians
2. In practice for 5-30 years

Exclusion Criteria:

1. physicians who specialize in areas other than general internal medicine and family medicine
2. physicians who have been in practice less than 5 years or more than 30 years

Primary outcomes:
measure: Change in Maslach Burnout Inventory score
timeFrame: 6 month
measure: Change in Physician Job Satisfaction Scale score
timeFrame: 6 month
measure: change in Empowerment at Work Scale score
timeFrame: 6 month
measure: change in Utrecht Work Engagement score
timeFrame: 6 months
Secondary outcomes:
measure: Change in Maslach Burnout Inventory score
timeFrame: 12 month
measure: Change in Physician Job Satisfaction Scale score
timeFrame: 12 months
measure: change in Empowerment at Work Scale score
timeFrame: 12 months
measure: change in Utrecht Work Engagement score
timeFrame: 12 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Liselotte N Dyrbye
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dyrbye LN, Shanafelt TD, Gill PR, Satele DV, West CP. Effect of a Professional Coaching Intervention on the Well-being and Distress of Physicians: A Pilot Randomized Clinical Trial. JAMA Intern Med. 2019 Oct 1;179(10):1406-1414. doi: 10.1001/jamainternmed.2019.2425.