louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05443737: Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients
Official title: Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cancer
Fertility Preservation
Keywords: Oncofertility
Fertility preservation
Adolescent and young adult cancer
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Rady Children's Hospital, San Diego
name: City of Hope Medical Center
First posted: 2022-07-05
Enrollment: 2800
Sex: ALL
Minimum age (years): 0
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant oncofertility care.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed cancer or cancer relapse
* Primary language English or Spanish
* Receiving oncology care at participating clinical sites
* Ages 0 to 42 years if female
* Ages 0 to 50 years if male

Exclusion Criteria:

* Non-melanoma skin cancer, because primary treatment is excision with no infertility risk
* Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis

Primary outcomes:
measure: Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care
timeFrame: 12 weeks after oncology visit
measure: Decisional Conflict
timeFrame: 12 weeks after oncology visit
Secondary outcomes:
measure: Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care
timeFrame: 12 weeks after oncology visit
measure: Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care
timeFrame: 12 weeks after oncology visit
measure: Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care
timeFrame: 12 weeks after oncology visit
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: El Centro
country: United States
facility: Cancer Resource Center of the Desert
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: H. Irene Su, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02306837: Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies
Official title: A Phase II Trial of Consolidation Chemothetapy for Patients With Relapse or Refractory Lymphoid Malignancies After Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Effects of Chemotherapy
Keywords: lymphoma, consolidation chemotherapy, auto-HSCT
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation

Detailed description: Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.

Eligibility criteria: Inclusion Criteria:

* Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
* ECOG: 0-2
* Tbil \< 1.5x ULN and AST/ALT \<2.5x ULN
* With informed consent

Exclusion Criteria:

* Life expectancy \< 3 months
* Women in pregnancy
* uncontrollable infection disease
* serum Cr \>400mmol/l
* uncontroled diabetis and heart disease

Primary outcomes:
measure: progression free survival
timeFrame: 2-year
Secondary outcomes:
measure: overall survival
timeFrame: 2-year
measure: progression
timeFrame: 2-year
measure: transplantation-related mortality
timeFrame: 2-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
city: Shanghai
country: China
facility: Shanghai No 10 Hospital
Study officials:
affiliation: Rui Jin Hospital, Shanghai Jiaotong Unic\versity School of Medicine
name: Jiong Hu, M.D,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01149837: Evaluation of InnoLIA HTLV I/II Score
Official title: In Vitro Diagnostic Study for Supplemental Testing of Anti-HTLV-I/II Reactive Human Blood Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human T-Lymphotrophic Virus Type I and/or Type II
Keywords: HTLV
HTLV I
HTLV II
HTLV Type I and/or HTLV Type II antibody
Lead sponsor: Creative Testing Solutions
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 3305
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Whole blood and HCT/P donor samples found repeatedly reactive for anti-HTLV-I/II using an FDA approved donor screening test

Brief summary: The InnoLIA HTLV I/II Score is an in vitro diagnostic test for confirmation of antibodies to human T-cell lymphotropic virus (HTLV) type I and type II in human blood samples. It is intended as a supplemental test for blood donor samples that are reactive in routine anti-HTLV screening tests. This study will determine if the test is useful for donor counseling purposes.

Detailed description: The InnoLIA HTLV I/II Score study consists of three sub-studies. The first sub-study will determine the sensitivity, specificity and accuracy of HTLV type assignment using well-characterized samples from the NIH-funded HTLV Outcomes Study (HOST). The second sub-study will compare automated reading and interpretation of test results with manual reading and interpretation using a sub-set of samples tested in the initial study. The third sub-study allows for use of the InnoLIA HTLV I/II Score as a supplemental test for whole blood and HCT/P donors testing repeatedly reactive with an FDA-approved donor screening test for anti-HTLV-I/II.

Eligibility criteria: Inclusion Criteria:

* Subjects completing a health history evaluation for routine donor screening
* Subjects willing and able to provide informed consent
* Subjects testing repeat reactive on a licensed screening test for HTLV antibodies

Exclusion Criteria:

* Subjects not meeting health history criteria for routine donor screening
* Subjects unwilling and unable to provide informed consent
* Subjects testing negative on a licensed screening test for HTLV antibodies

Primary outcomes:
measure: INNO-LIA HTLV I/II Score Testing
timeFrame: September 2013 through December 2013, up to 3 months
measure: INNO-LIA HTLV I/II Score Testing
timeFrame: January 2014 through December 2014, up to one year
measure: INNO-LIA HTLV I/II Score Testing
timeFrame: January 2015 through December 2015, up to one year
measure: INNO-LIA HTLV I/II Score Testing
timeFrame: January 2016 through May 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Creative Testing Solutions
state: Arizona
Study officials:
affiliation: Creative Testing Solutions
name: Phillip C Williamson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05733637: HRAD-Vascular Access
Official title: Validation of a Novel Anxiety Scale (HRAD) During Vascular Access Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Vascular Access
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergo vascular access procedure.

Brief summary: The perioperative setting is a common site of pediatric anxiety and distress. Perioperative anxiety in pediatric patients can result in uncooperative behavior, poor postoperative outcomes, and trauma. Given the fast-paced nature of the perioperative environment, many anxiety measures are too time consuming for clinical implementation prior to surgery. Pediatric anesthesiologists need reliable and efficient assessment tools to quickly measure childhood distress to target prophylactic and therapeutic interventions.


Eligibility criteria: Inclusion Criteria:

* participants who is undergoing vascular access

Exclusion Criteria:

* Clinically unstable

Primary outcomes:
measure: Correlation of HRAD± to mYPAS during vascular access procedure
timeFrame: during vascular access procedure
Secondary outcomes:
measure: Correlation of HRAD± to OBDS-R during vascular access procedure
timeFrame: during vascular access procedure
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Childrens Hospital Stanford
state: California
Study officials:
affiliation: Stanford University
name: Thomas Caruso, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02731937: Clinical Evaluation of a Dual Energy CT System
Official title: Clinical Evaluation of a Dual Energy CT System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General CT Imaging
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2016-04-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to collect clinical raw scan data and Scanner user feedback using dual energy CT (computed tomography) scan modes on the investigational CT scanner. Additionally, image quality using prototype reconstruction algorithms that are in development will be evaluated and compared to standard-of-care images acquired with regulatory cleared diagnostic CT scanners for feasibility assessment and engineering development. Compared to standard clinical single energy (kilovolt,kV) scanning, dual energy (kV) scanning s provides more information about the material composition of the scanned patient and may allow for improved tissue, tumor characterization, and improved image quality.


Eligibility criteria: Inclusion Criteria:

1. Who are 18 year of age or older;
2. Able to sign and date the informed consent form; AND
3. Who have in the past year undergone a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities

Exclusion Criteria:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
4. For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are in need of urgent or emergent care;
6. Diabetic patients on metformin (Glucophage)
7. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; AND
8. Who are unwilling to have GEHC personnel present for the CT exam

Primary outcomes:
measure: Raw CT Scan Data
timeFrame: 3 months
Secondary outcomes:
measure: Image Quality assessment
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: St. Joseph's Helathcare
name: Ali Islam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00532337: Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
Official title: A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Osteopenia
Keywords: ONO-5334
osteoporosis
osteopenia
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2007-09-20
Enrollment: 285
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.


Eligibility criteria: Inclusion Criteria:

1. Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR

* Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (T-score \<-1 and \>2.5) at the lumbar spine (L1 to L4) or total hip.

Exclusion Criteria:

1. Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score \<-3.5) at the lumbar spine (L1 to L4) or total hip.
2. Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive.
3. Osteopenia patients (T-score \<-1 and \>-2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR

   * Osteopenia patients (T-score \<-1 and \>-2.5) who have two or more vertebral fragility fractures between T4 and L4 inclusive.
4. Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD.
5. Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism.
6. Other exclusion criteria as specified in the study protocol.

Primary outcomes:
measure: Mean bone mineral density of the lumbar spine (L 1-4 BMD)
timeFrame: 12 months
Secondary outcomes:
measure: Bone mineral density at hip, Biochemical markers of bone turnover
timeFrame: during course of treatment of 12 months
Other outcomes:
Locations:
city: Damsterdiep 9
country: Netherlands
facility: Andromed Noord Groningen
state: Groningen
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Tomohiro Kuwayama
role: STUDY_DIRECTOR
References:
citation: Eastell R, Nagase S, Small M, Boonen S, Spector T, Ohyama M, Kuwayama T, Deacon S. Effect of ONO-5334 on bone mineral density and biochemical markers of bone turnover in postmenopausal osteoporosis: 2-year results from the OCEAN study. J Bone Miner Res. 2014 Feb;29(2):458-66. doi: 10.1002/jbmr.2047.
Clinical trial NCT02582437: MAC Bipsectral Index Below 50 for Chronic Opioid User
Official title: The Effect of Chronic Opioid Use on Minimum Alveolar Concentration of Sevoflurane for Maintaining Bispectral(BIS) Index Below 50 ; Prospective, Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Minimum Alveolar Concentration
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2015-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 41
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find difference in Minimum Alveolar Concentration(MAC) for maintaining Bispectral Index (BIS) below 50 between chronic opioid users and opioid naive patients.

Detailed description: 1. Patients selection in elective surgery which need general anesthesia.
2. MAC BIS50 data was collected in each patients (by blinded investigator)
3. The data collection will be continued for enough sample size for using Dixon Up Down Method Analysis
4. After Data collection, MAC BIS below 50 will be analyzed in both groups ( Chronic opioid users versus opioid naive patients)

Eligibility criteria: Inclusion Criteria:

* The patients(ASA class I-III) who receive elective surgery
* signed in informed consent to participate in this trial voluntarily.

Exclusion Criteria:

* History of Monoamine Oxidase (MAO) inhibitor use
* Chronic alcoholics
* Acute alcohol abuser
* Contraindication for inhalation agent use (Sevoflurane)
* BMI \>30
* History of medication use, which affect in the minimum concentration of sevoflurane;(barbiturates, chlorpromazine, diazepam, hydroxyzine, verapamil, marijuana)
* Craniotomy

Primary outcomes:
measure: Minimum Alveolar Concentration below BIS 50 in Sevoflurane; percentage (eg: 1.2%)
timeFrame: 15 minutes after pre-set of the concentration of sevoflurane
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, National Cancer Center
state: Gyeonggi-do 10408
Study officials:
References:
citation: Matsuura T, Oda Y, Tanaka K, Mori T, Nishikawa K, Asada A. Advance of age decreases the minimum alveolar concentrations of isoflurane and sevoflurane for maintaining bispectral index below 50. Br J Anaesth. 2009 Mar;102(3):331-5. doi: 10.1093/bja/aen382. Epub 2009 Jan 24.
citation: Oh TK, Eom W, Yim J, Kim N, Kwon K, Kim SE, Kim DH. The Effect of Chronic Opioid Use on End-Tidal Concentration of Sevoflurane Necessary to Maintain a Bispectral Index Below 50: A Prospective, Single-Blind Study. Anesth Analg. 2017 Jul;125(1):156-161. doi: 10.1213/ANE.0000000000001791.
Clinical trial NCT00997737: Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing
Official title: Diaphragm Mobility During Respiratory Exercises With Incentive Spirometry in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diaphragm Mobility
Breathing Exercises
Incentive Spirometry
Diaphragmatic Breathing
Keywords: incentive spirometry
diaphragm mobility
ultrasound
diaphragmatic breathing
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to evaluate diaphragm activity during three breathing exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and volume-oriented (Voldyne) incentive spirometry.

Seventeen healthy subjects will be studied (8 man and 9 woman).

Detailed description: Right diaphragmatic mobility will be evaluated by determining the craniocaudal displacement of the left branch of the portal vein using a B-mode ultrasound device (Logic 500, Pro Series®; General ElectricMedical Systems, Milwaukee, WI, USA). The ultrasound technician will use a 3.5 MHz convex transducer positioned in the right subcostal region, with the incidence angle perpendicular to the craniocaudal axis, in the direction of the inferior vena cava. Next, an intraparenchymal portal branch will be identified in the field of vision and its position will be traced with the curser during the forced inspiration and expiration. The craniocaudal displacement of these points will be considered to be the amount of right diaphragmatic mobility.

Eligibility criteria: Inclusion Criteria:

* Being 18 to 40 years old
* Having a normal body mass index
* Being a non-smoker
* Not knowing the DB and the IS techniques
* Reporting the absence of respiratory diseases.

Exclusion Criteria:

* Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity
* Inability to understand or perform the procedure.

Primary outcomes:
measure: ultrasound evaluation of the diaphragm mobility
timeFrame: six - eight months
Secondary outcomes:
measure: pulmonary function test
timeFrame: six - eight months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa do Hospital Sírio Libanês
state: SP
Study officials:
affiliation: Hospital Sírio-Libanês
name: Wellington P Yamaguti, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamaguti WP, Sakamoto ET, Panazzolo D, Peixoto Cda C, Cerri GG, Albuquerque AL. Diaphragmatic mobility in healthy subjects during incentive spirometry with a flow-oriented device and with a volume-oriented device. J Bras Pneumol. 2010 Nov-Dec;36(6):738-45. doi: 10.1590/s1806-37132010000600011. English, Portuguese.