louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02191930: Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
Official title: Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine

1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy
2. Progression-free survival (PFS) 3 years after registration


Eligibility criteria: Inclusion Criteria (B-CAP):

* classical Hodgkin Lymphoma
* Age 60 years or older
* ECOG performance status ≤ 2 or ≤ 3 if due to HL
* CIRS-G score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and throat)
* Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
* written informed consent

Exclusion Criteria (B-CAP):

* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
* Prior chemotherapy or radiation for HL except prephase
* Peripheral neuropathy greater than CTC Grade 1

Inclusion Criteria (BV only):

* classical Hodgkin Lymphoma
* Age 60 years or older
* stage IA to IVB
* CIRS-G score of ≥ 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat)
* Patients not eligible to curative poly-chemotherapy at the investigators judgment
* written informed consent

Exclusion Criteria (BV only):

* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
* Prior chemotherapy or radiation for HL except prephase as outlined in the protocol
* Peripheral neuropathy greater than CTC Grade 1

Primary outcomes:
measure: Objective response rate
timeFrame: after 6 cycles of therapy (at least 18 weeks after start of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Dept. of Medicine, Cologne University Hospital
Study officials:
affiliation: University Hospital of Cologne
name: Peter Borchmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02021630: The Collateral Impact of Bariatric Surgery on Families
Official title: The Collateral Impact of Bariatric Surgery on Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery Candidate
Weight Loss
Keywords: Obesity
Bariatric Surgery
Weight Loss
Physical Activity
Body Composition
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in the bariatric surgery program at Geisinger Medical Center's Center for Nutrition and Weight Management along with their spouse/partner and/or child(ren) ages 5-16.

Brief summary: This proposal is designed to examine the impact of bariatric surgery on the health of patients and their families. The shared environment of spouses/cohabitating partners suggests that patients' families are exposed to the extensive diet and lifestyle changes required of patients following bariatric surgery.

Detailed description: The specific aims of this proposal are to:

1. Collect clinical data (e.g., weight, blood pressure, body composition, blood sample), as well as monitor physical activity and eating patterns, before and after bariatric surgery (Adults Only).
2. Analyze clinical data, physical activity and eating patterns to determine how the health of patients and their families change after one family member completes bariatric surgery (Adults Only).
3. Determine the feasibility of recruiting patients, spouses/partners and their children.

Eligibility criteria: Inclusion Criteria:

* All patients who receive surgery have been cleared medically and psychosocially for surgery. Thus, surgical candidacy criteria will serve as eligibility criteria for the current study for surgical patients.
* Cohabitation with patients will be considered inclusion criteria for partners/spouses.
* Children between the ages of ≥5 - ≤ 16, who cohabitate with the patient the majority of the time will be asked to participate by providing assent.

Exclusion Criteria:

* Report current or planned use of weight loss medications (including OTC), or other weight loss strategy.
* Report pregnancy, lactation, or plans to become pregnant during study duration.

Primary outcomes:
measure: Weight
timeFrame: Pre-operatively, post-operatively 6 months and 12 months
Secondary outcomes:
measure: Percent body fat
timeFrame: Pre-operatively, post-operatively 6 months and 12 months
measure: Physical Activity
timeFrame: Pre-operatively, post-operatively 6 months and 12 months
Other outcomes:
measure: Laboratory outcomes
timeFrame: Pre-operatively, post-operatively 6 months and 12 months
measure: Questionnaires
timeFrame: Pre-operatively, post-operatively 6 months and 12 months
Locations:
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Christopher D Still, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04811430: Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization: A Pilot Study
Official title: Comparative Effectiveness, Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization for Midline Catheter Insertion: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter Related Complication
Keywords: Visualization
Needle Guidance
Midline Catheter
Emergency Department Nurse
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Department and Critical Care Nurses

Brief summary: The purpose of this study was to assess the impact of a continuous needle tracking system on the accuracy, speed, and quality of ultrasound-guided peripheral venous catheter insertion.

Detailed description: A pilot study using simulated tissue was conducted with 49 US-based emergency department nurses to compare insertion of a midline catheter using traditional ultrasound guidance versus an advanced needle-tracking technology along with traditional ultrasound guidance.

Eligibility criteria: Inclusion Criteria:

* US-based emergency department nurse who have placed 10 peripheral intravenous catheters in the past 60 days
* have placed less than or equal to 15 ultrasound-assisted vascular access devices in the past 60 days and have been practicing ultrasound-assisted vascular access no more than 18 months

Exclusion Criteria:

* Nurses that don't meet that predetermined inclusion criteria

Primary outcomes:
measure: Insertion Success
timeFrame: 1 hour
measure: Insertion Time
timeFrame: 1 hour
measure: Backwalling Events
timeFrame: 1 hour
measure: Needle redirects
timeFrame: 1 hour
measure: Accuracy of Needle Placement
timeFrame: 1 hour
Secondary outcomes:
measure: Self-reported subjective measurements
timeFrame: 1 hour
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Convention Center
state: Texas
Study officials:
References:
Clinical trial NCT03299530: Accuracy of Corneal Astigmatism in Different Region Modes
Official title: Accuracy of Corneal Astigmatism in Different Region Modes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Astigmatism
Cornea
Keywords: Corneal Astigmatism
Scheimpflug
pupil size
Toric
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received cataract surgery in The Eye Hospital of Wenzhou Medical University

Brief summary: To analyze the difference between measured total corneal astigmatism and actual corneal astigmatism under different region modes and optimize the region setting.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients who had received phacoemulsification surgery with or without implantation of toric IOL are with a certain amount of corneal astigmatism.
* Best corrected visual acuity ≥ 0.66 (20/30 Snellen)

Exclusion Criteria:

* Corneal diseases or severe irregular astigmatism (e.g., pterygium, keratoconus), existence of corneal opacification;
* Ocular disease which may affect visual acuity (e.g., glaucoma, uveitis, retinal disease, pathologic myopia);
* History of ocular surgery or ocular trauma before this cataract surgery;
* Decentration of IOL \> 0.3mm or tilt \> 5°
* Implantation of multifocal IOL
* history of wearing of rigid contact lens within the past 4 weeks or soft contact lens within 1 week;

Primary outcomes:
measure: Vectorial difference
timeFrame: ≥1 month after surgery
measure: pupil size
timeFrame: ≥1 month after surgery
measure: pupil size 2
timeFrame: ≥1 month after surgery
measure: residual astigmatism
timeFrame: ≥1 month after surgery
measure: total corneal astigmatism
timeFrame: ≥1 month after surgery
measure: Anterior chamber depth
timeFrame: ≥1 month after surgery
measure: actual corneal astigmatism
timeFrame: ≥1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hispital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: AYong Yu, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03213730: Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery
Official title: Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Post-Concussion Symptoms
Concussion
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-07-11
Enrollment: 63
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is part of a larger, multi-centered project done with the collaboration of University Of Victoria. This study holds three separate studies on the mild traumatic brain injured population and the use of perceptual-cognitive training (3D-MOT).


Eligibility criteria: Inclusion Criteria:

* The child experienced a head injury (a direct or indirect blow to the head) resulting in concussion-like symptoms (e.g. headache, nausea, balance problems, tiredness, visual problems, cognitive issues) in the previous 72 hours
* Parent/legal guardian speak English or French
* The child speak English or French

Exclusion Criteria:

* Previous concussion in the last 6 months, or any previous concussion with unresolved symptoms
* Multi-system injuries requiring admission, operating room, procedural sedation in the Emergency Department
* Other co-existing injuries, co-morbidities or diagnoses preventing participation to intervention/assessment of gait and balance
* Pre-morbid or co-morbid condition affecting visual function
* Patient intoxicated at the time of injury
* Significant developmental delay
* Loss of consciousness prior to head injury

Primary outcomes:
measure: Post Concussion Symptom Inventory
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital, MUHC
state: Quebec
Study officials:
References:
citation: Teel E, Brossard-Racine M, Corbin-Berrigan LA, Gagnon I. Perceptual Cognitive Training Does Not Improve Clinical Outcomes at 4 and 12 Weeks Following Concussion in Children and Adolescents: A Randomized Controlled Trial. J Head Trauma Rehabil. 2021 Mar-Apr 01;36(2):E97-E107. doi: 10.1097/HTR.0000000000000633.
Clinical trial NCT00576030: Action of Caffeinated and Decaffeinated Espresso on Autonomic Function
Official title: Short-term Autonomic Effects of Caffeinated and Decaffeinated Espresso in Young Healthy Individuals
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Influence of Espresso on Heart Rate Variability
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: More than 80% of the population in the USA consume coffee each day. However there not many studies on change of heart rate variability and placebo effects after consumption of coffee.

In our study we aim to test the following hypotheses:

1. Habitual caffeinated espresso coffee drinkers show an increase in blood pressure, heart rate variability and parasympathetic activity (high frequency band) of the heart.
2. Non-habitual caffeinated espresso coffee drinkers show an increase of blood pressure. The heart rate variability and the parasympathetic activity of the heart will decrease.
3. Caffeinated or decaffeinated espresso induces comparable changes in habitual or non-habitual coffee drinkers.


Eligibility criteria: Inclusion Criteria:

* 18- 50 years old, healthy

Exclusion Criteria:

* Medication, obese(BMI \> 30)

Primary outcomes:
measure: Heart rate variability
timeFrame: 70 minutes
Secondary outcomes:
measure: blood pressure
timeFrame: 70 min.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychosomatic Medicine and Psychotherapy, Charité University
Study officials:
References:
Clinical trial NCT00760630: Measurements to Assess Severity of Epicardial Stenoses
Official title: Simultaneous Measurements of Pressure Gradient, Blood Flow and Percentage Area Stenosis of Coronary Epicardial Lesions to Assess Severity of Epicardial Stenosis and Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: abnormal stress test
fractional flow reserve
pressure drop coefficient
lesion flow coefficient
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2008-09-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.

Detailed description: The pressure drop coefficient (CDP) is a functional index based on hyperemic dp and u measurements. The lesion flow coefficient (LFC) combines the functional index CDP with an atomic measure (percentage area stenosis) as a single parameter.

Eligibility criteria: Inclusion Criteria:

* Abnormal Myocardial stress perfusion (SPECT) LV EF \> 25%

Exclusion Criteria:

* LV \< or + to 25% Serum Creatinine \> 2.5 gm/dL Type II HIT Significant co-morbidities Pregnant women

Primary outcomes:
measure: to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements
timeFrame: Upon Diagnostic Angiogram and Flow Wire
Secondary outcomes:
measure: To compare novel measurements, Pressure Drop Coefficient (CDP) & Lesion Flow Coefficient (LFC), against measured current parameters called Fractional flow reserve (FFR) & Coronary flow reserve (CFR).
timeFrame: Upon Diagnostic Angiogram and Flow Wire
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Department of Veterans Affairs
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Mohamed Effat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Kranthi K Kolli, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Massoud Leesar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Rupak Banerjee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Tarek Helmy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Srikara Pellukhana, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00674830: Self-help Treatment for Insomnia in Breast Cancer Patients
Official title: Self-help Treatment for Insomnia in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Research Alliance
First posted: 2008-05-08
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this population-based study is to assess the efficacy of two forms of cognitive-behavioral therapy (CBT) to treat various levels of insomnia symptoms in women with breast cancer: a professionally administered form and a patient self-administered form. It is hypothesized that the two treatment conditions will be associated with significantly greater improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of life, relative to the control condition (i.e., usual care). It is also hypothesized that the magnitude of effect sizes obtained in association with treatment at each time assessment will be greater for the professionally administered treatment than the self-administered treatment.


Eligibility criteria: Inclusion Criteria:

* To be receiving treatment for a diagnosis of breast or gynaecological cancer
* To obtain a score of 8 or higher on the Insomnia Severity Index (ISI) or to be using a hypnotic medication ≥ 1 night per week

Exclusion Criteria:

* To have received a diagnosis or being treated for :

  * a sleep disorder other than insomnia (e.g., sleep apnea)
  * a severe psychiatric disorder (e.g., psychotic disorder)
  * a severe cognitive disorder (e.g., dementia)

Primary outcomes:
measure: sleep diary indices, actigraphy, Insomnia Severity Index
timeFrame: pre-treatment, post-treatment, 3 follow-up
Secondary outcomes:
measure: EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs
timeFrame: pre-treatement, post-treatment, 3 follow-up
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de recherche de l'HDQ
state: Quebec
Study officials:
affiliation: Centre de recherche de l'HDQ
name: Josée Savard, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savard J, Ivers H, Savard MH, Morin CM. Long-Term Effects of Two Formats of Cognitive Behavioral Therapy for Insomnia Comorbid with Breast Cancer. Sleep. 2016 Apr 1;39(4):813-23. doi: 10.5665/sleep.5634.
citation: Savard J, Ivers H, Savard MH, Morin CM. Is a video-based cognitive behavioral therapy for insomnia as efficacious as a professionally administered treatment in breast cancer? Results of a randomized controlled trial. Sleep. 2014 Aug 1;37(8):1305-14. doi: 10.5665/sleep.3918.
Clinical trial NCT03239730: Arterial pH Selectively Predicts Intensive Care Unit Transfer From the Emergency Department in Obese Patients With Acute Dyspnea
Official title: Arterial pH Selectively Predicts ICU Transfer in Obese Patients With Acute Dyspnea Presenting to the Emergency Department: a Prospective Comparative Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Respiratory Failure
Keywords: dyspnea
pH
blood gas analysis
emergency department
Intensive care unit
Lead sponsor: Association pour la Formation du Personnel à la Medecine d'Urgence
Sponsor class: OTHER
Collaborators: name: University Hospital, Montpellier
First posted: 2017-08-04
Enrollment: 400
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: Study population was derived from a cohort of adult patients admitted to the ED with acute dyspnea

Brief summary: This study evaluates the prognostic value of arterial blood gas analysis in a cohort of Emergency Department patients presenting with shortness of breath of any cause, comparing obese and non-obese patients.

Detailed description: Factors associated with admission to intensive care unit (ICU) or ED mortality before transfer to the ICU are analyzed in obese (BMI ≥ 30kg.m-2) and non-obese patients subgroups.

Eligibility criteria: Inclusion Criteria:

* patients who presented with acute dyspnea in the ED
* patients who had an ABG analysis as part of the ED standard management

Exclusion Criteria:

* Patients with treatment limitation decisions made by the medical teams against ICU admission, including severe cognitive impairment or palliative care ,
* Patients with immediate transfer to ICU due to shock and hemodynamic instability at ED admission

Primary outcomes:
measure: Composite of admission to the ICU or in ED mortality before ICU admission
timeFrame: up to 1 day (direct admission to ICU from ED)
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University hospital
Study officials:
affiliation: Emergency Department, University Hospital, Montpellier
name: Mustapha SEBBANE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: