louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05291871: Immunogenicity of Fractional Dose of the HPV Vaccines
Official title: Immunogenicity of Fractional Dose of the HPV Vaccines
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HPV Infection
HPV Vaccine
Keywords: HPV, vaccines
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 92
Sex: ALL
Minimum age (years): 27
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized phase IV trial compares intramuscular and intradermal fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, and 12 months


Eligibility criteria: Inclusion Criteria:

* Age 27-45 years at enrollment
* Not intending to receive the HPV vaccine series for the duration of the study participation
* Willing and able to: provide written informed consent, undergo clinical evaluation, adhere to follow-up schedule

Exclusion Criteria:

* Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
* Currently pregnant or breastfeeding
* Immunedeficiency disease/condition or cancer that causes clinically significant immunosuppression
* Known HIV infection
* Chemotherapy (current or within 12 months) or currently taking a medication that causes clinically significant immunosuppression.
* Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes)
* Known allergy to vaccine components
* Prior history of HPV-associated cancer
* Any medical condition which, in the opinion of the investigator, may compromise the subject's ability to safely complete the study.

Primary outcomes:
measure: HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Virology Research Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Helen Stankiewicz Karita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03421171: Ethical Dilemmas in Anaesthesiology in the Netherlands; a Qualitative Interview Study.
Official title: Ethical Dilemmas in Anaesthesiology in the Netherlands; a Qualitative Interview Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ethical Dilemmas
Ethical Issues
Moral Issues
Moral Dilemmas
Anaesthesiology
Anaesthesiologist
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anaesthetist employed in the Netherlands working in a academic of non-academic hospital.

Brief summary: This study will describe which ethical dilemmas are experienced by anesthesiologist in the Dutch Healthcare system and what the current solving strategies are for these issues. Semi- structured interviews will be conducted with anaesthesiologists employed in different hospitals in the Netherlands..

Detailed description: Ethical considerations are part of a doctors daily practice. The development of anaesthesiologists as ' perioperative' doctors is increasingly giving anaesthesiologists a treatment function. As the third largest medical specialty, they are also involved in ethical dilemmas. Examples of common themes in the literature include:' informed consent' and professionalism. Nevertheless, good research into ethical dilemmas in the field of anaesthesiology is lacking.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Employed as anaesthesiologist
* Employed in an academic or non-academic hospital in the Netherlands

Exclusion Criteria:

* Other medical specialists
* language barrier

Primary outcomes:
measure: interviews (qualitative interview study)
timeFrame: 10 years (depends on working experience of the respondent)
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
Study officials:
affiliation: AIDS Malignancy Consortium
name: M. W Hollmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04881071: Efficacy of a Scarf to Facilitate Mother-newborn Contact Designed to Facilitate Skin-to-skin Contact
Official title: Randomized Clinical Trial to Evaluate the Efficacy of a Scarf Designed to Facilitate Skin-to-skin Contact Between Parents and Healthy Term Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Full-term Newborn Babies
Keywords: Kangaroo-Mother Care Method
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The skin-to-skin contact maneuver (kangaroo) has shown benefits in newborn babies. This is two-arm randomized open clinical trial to evaluate whether the use of a scarf specifically designed to facilitate the skin-to-skin method is effective in terms of increasing the skin-to-skin mother-neonate time, compared to traditional clinical practice. Mothers of full-term babies with expected delivery in the study centers will be included. Those mothers with a language barrier that prevents collaboration in the study procedures, cognitive impairment or morbid obesity will be excluded. The primary endpoint is the average daily skin-to-skin time during hospital admission days. A superiority analysis will be made in terms of the skin-to-skin time of the intervention arm, compared to the control arm.


Eligibility criteria: Inclusion Criteria:

- Moders attending the first hospital visit with the midwife, with delivery planned in either of the two study hospitals

Exclusion Criteria:

* Language barrier that prevents collaboration in the study procedures
* Cognitive impairment preventing collaboration in the study procedures
* Morbid obesity

Primary outcomes:
measure: Mother-neonate skin-to-skin contact time (number of hours)
timeFrame: 72 hours
Secondary outcomes:
measure: Time in arms or in physical contact of the neonate with the mother / father
timeFrame: 72 hours
measure: Time of crying
timeFrame: 72 hours
measure: Newborn weight loss
timeFrame: 72 hours
measure: Parents satisfaction with hospital care
timeFrame: 72 hours
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Consorci Sanitari Alt Penedes i Garraf
state: Barcelona
Study officials:
affiliation: Consorci Sanitari Alt Penedes i Garraf
name: Marta Bernadó
role: PRINCIPAL_INVESTIGATOR
affiliation: Consorci Sanitari Alt Penedes i Garraf
name: Alejandro Rodríguez-Molinero
role: STUDY_DIRECTOR
References:
Clinical trial NCT01230671: The Physical and Psychological Benefits of Yoga and Breast Cancer
Official title: The Physical and Psychological Benefits of Yoga in Patients With Breast Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast Cancer is the most common cancer amongst Canadian women. Studies report that breast cancer patients are the most likely to use complementary medicine within the oncologic population. Yoga has become especially popular with this group as it promises to improve the mind, body and soul holistically. The investigators yoga program specifically focuses on rebuilding physical strength, increasing flexibility and reducing the pain and stress associated with the post-operative period. This study will examine how yoga can help improve the overall quality of life and its effects on the physical well-being of women with breast cancer. With positive statistical results, the investigators hope to implement yoga as part of their rehabilitation services at the Cedars Breast Clinic.

Detailed description: Proposed Intervention:

1-hour hatha yoga classes, once a week for a 12-week period. One class will be offered in French, another in English. The class will begin with approximately 10 minutes of pranayama (breathing exercises) and meditation, followed by 30 minutes of yoga poses and ending with 10 minutes of sivasana (rest period.) The first couple of classes in the 12 week series will begin with restorative postures and will gradually progress to more gentle exercises. If health permits, the last couple of classes will involve some strengthening poses. A small portion of the class will work with the physical body in general and there will be a specific emphasis on the physical difficulties faced by most breast cancer patients, i.e. neck, chest, shoulders arms and hands.

Eligibility criteria: Inclusion Criteria:

* Ages between 18-70
* Stage I to II breast cancer
* Minimum of 6 weeks Post Operative status

Exclusion Criteria:

* Previous/Current psychiatric history
* Concurrently involved in a yoga program
* Inability to undergo yoga training secondary to physical/health limitations outlined by the treating team

Primary outcomes:
measure: Range of motion of the shoulders
timeFrame: 12 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Cedar's Breast Clinic, Royal Victoria Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT03607071: Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma
Official title: Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Inflammation
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Moderate dose steroid therapy
Primary purpose: TREATMENT

Brief summary: Primary myocardial involvement is common in scleroderma, effected to pericardium, vascular, conducting defect and especially myocardium. Cardiac MRI is widely used for assessment of cardiac involvement in scleroderma, both structural and functional pathology. Cardiac MRI has a diagnostic accuracy of 85% for the detection of myocardial inflammation. Nowadays, the treatment of myocardial inflammation in scleroderma is uncertain. The investigator's study aims to define the cardiac outcome after moderate dose steroid therapy in the patients who have myocardial inflammation detection by cardiac MRI.


Eligibility criteria: Inclusion Criteria:

• The adult scleroderma patients who were defined as having myocardial inflammation by cardiac MRI.

Exclusion Criteria:

* Current infection that needs systemic antibiotic therapy
* Active viral hepatitis B or C
* Uncontrolled diabetes mellitus

Primary outcomes:
measure: Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Department of Medicine, Faculty of Medicine, Khon Kaen University
Study officials:
References:
citation: Pussadhamma B, Tipparot T, Chaosuwannakit N, Mahakkanukrauh A, Suwannaroj S, Nanagara R, Foocharoen C. Clinical Outcomes of Myocarditis after Moderate-Dose Steroid Therapy in Systemic Sclerosis: A Pilot Study. Int J Rheumatol. 2020 Dec 19;2020:8884442. doi: 10.1155/2020/8884442. eCollection 2020.
Clinical trial NCT03219671: Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)
Official title: A Phase 2 Study of Nivolumab Plus Ipilimumab in Previously Treated Classical Kaposi Sarcoma (CKS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Classic Kaposi Sarcoma
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-07-17
Enrollment: 20
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: A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma (CKS)

Detailed description: A prospective, single arm, interventional study. All patients will receive IV nivolumab 3mg/kg every two weeks and ipilimumab 1mg/kg every 6 weeks. Patients will be treated until disease progression or intolerable toxicity for a maximal period of two years, with an option to re-initiate therapy upon progression in patients with prior documented response to investigational therapy (unless treatment was held for progression of disease).

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed KS
* Age \> 18
* ECOG PS \< 2
* At least one prior treatment modality (palliative radiation or chemotherapy)
* Measurable disease as defined by RECIST version 1.1 by physical exam and/or PET-CT (previously irradiated lesions should not be counted as target lesions).

Exclusion Criteria:

* Patients with HIV-related KS or HIV positive serology.
* Ongoing immunosuppressive therapy
* Active autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

Primary outcomes:
measure: ORR
timeFrame: 6-months
Secondary outcomes:
measure: PFS rate
timeFrame: 6-months
measure: Safety - Incidence of Treatment-Emergent Adverse Events according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE v4)
timeFrame: during the study, through study completion, an average of 1 year
measure: Tolerability - treatment related adverse events (AEs) that caused study drug interruption and discontinuation
timeFrame: during the study, through study completion, an average of 1 year
Other outcomes:
measure: Exploratory Biomarkers
timeFrame: 6-months
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Alona Zer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00682071: Ultrasound Guided Embryo Transfer: Abdominal Versus Transvaginal, a RCT
Official title: Abdominal Versus Transvaginal Ultrasound Guided Embryo Transfer: Results of a Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
in Vitro Fertilization
Keywords: Ultrasound-guided
embryo transfer
in-vitro fertilization
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 224
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing assisted reproductive cycles at the University of Wisconsin REI Program

Brief summary: Ultrasound (US) guided embryo transfer (ET) appears to improve pregnancy outcomes in IVF-ET. Most reports are done using a transabdominal (TAS) approach, in contrast to a transvaginal ultrasound (TVS) which does not require a full bladder. We sought to determine if either approach was better with respect to clinical outcomes.


Eligibility criteria: Inclusion Criteria:

- All patients undergoing assisted reproductive cycles including autologous IVF, oocyte donation, and frozen embryo transfer (FET) cycles

Exclusion Criteria:

- Cases of severe ovarian hyper-stimulation requiring embryo cryopreservation and gestational surrogate cycles

Primary outcomes:
measure: pregnancy rates for TAS and TVS ultrasound-guided ET groups
timeFrame: August 2003 to June 2007
Secondary outcomes:
measure: Length of time required for embryo transfer
timeFrame: August 2003 to June 2007
measure: differences between transferring physicians
timeFrame: August 2003 to June 2007
measure: multiple pregnancies
timeFrame: August 2003 to June 2007
measure: ectopic pregnancy rates
timeFrame: August 2003 to June 2007
Other outcomes:
Locations:
Study officials:
affiliation: Fertility Specialists Medical Group
name: Steven R Lindheim, MD, MMM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02854371: Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI
Official title: Evaluation of Hepatic Function Using Gd-EOB-DTPA Enhanced Liver Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis
Keywords: gadoxetic acid
T1 map
MRI
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2016-08-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: gadoxetic acid MRI and ICG R15 test
Primary purpose: DIAGNOSTIC

Brief summary: Liver function is a key factor that can help predict the clinical outcome in patients with cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG) or other radionucleotides. Recently, gadoxetic acid has been reported to show liver function in several studies. There have been several approaches to measure liver function using gadoxetic acid, and hepatocyte fraction is one of the promising methods. Since gadoxetic acid enhanced liver MRI is clinically used world widely, it would be valuable if we can measure liver function using hepatocyte fraction.


Eligibility criteria: Inclusion Criteria:

* patients with chronic liver disease or liver cirrhosis
* clinically scheduled for gadoxetic acid enhanced liver MRI
* signed informed consent

Exclusion Criteria:

* under 18 years
* transarterial chemoembolization, radiation therapy for liver or bile duct within 2 weeks
* systemic chemotherapy within 6 weeks
* any contraindication for contrast enhanced MRI
* hepatic iron deposition at prior imaging
* bile duct obstruction

Primary outcomes:
measure: Liver function assessed by hepatocyte fraction
timeFrame: 1 month after MRI
Secondary outcomes:
measure: Liver function assessed by ICG R15 test
timeFrame: 3 days after MRI
measure: Hepatocyte uptake rate
timeFrame: 1 month after MRI
Other outcomes:
measure: Liver stiffness value (kPa)
timeFrame: 1 month after MRI
measure: Spleen stiffness value (kPa)
timeFrame: 1 month after MRI
measure: adverse effect after contrast media administration
timeFrame: within an hour after contrast media administration
measure: adverse effect after ICG administration
timeFrame: within an hour after ICG administration
measure: T2* value (msec)
timeFrame: 1 month after MRI
measure: Bile duct excretion of contrast media on hepatobiliary phase
timeFrame: 1 month after MRI
measure: ADC
timeFrame: 1 month after MRI
measure: D
timeFrame: 1 month after MRI
measure: D*
timeFrame: 1 month after MRI
measure: f
timeFrame: 1 month after MRI
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06035471: Can we Use a Simple Blood Test to Reduce Unnecessary Adverse Effects From Radiotherapy by Timely Identification of Radiotherapy-resistant Rectal Cancers? MeD-Seq Rectal Study
Official title: Can we Use a Simple Blood Test to Reduce Unnecessary Adverse Effects From Radiotherapy by Timely Identification of Radiotherapy-resistant Rectal Cancers? MeD-Seq Rectal Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pathological Response Rate, Circulating Tumour DNA
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 75
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: Locally advanced rectal cancer patients scheduled for preoperative chemoradiation

Brief summary: Chemoradiation therapy (CRT) followed by surgery is currently the standard of care to treat patients with locally advanced rectal cancer (LARC). CRT reduces local recurrences, but is associated with significant damage to the surrounding healthy tissue that can severely impact quality of life. Additionally, a proportion of patients (hardly) benefit from CRT. We aim to develop a diagnostic innovation, which can enable a more selective and thereby more effective use of the available therapies for rectal cancer patients.

The objective of this study is to investigate whether patients can be identified who will response to CRT prior to start of the CRT in rectal cancer and therefore avoid possible severe side effects in patients who will not reponse on CRT.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed rectal adenocarcinoma
* Scheduled for neoadjuvant chemoradiation
* Written informed consent.

Exclusion Criteria:

* Scheduled to another neoadjuvant schedule that comprises systemic chemotherapy or short-course radiation
* Not able to read or understand Dutch language or mentally not capable.

Primary outcomes:
measure: cfDNA methylation markers
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: