louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04854980: Serologic Response to the SARS-CoV-2 (COVID-19) MRNA-1273 Vaccine in Select Subsets of Oncology Patients
Official title: Serologic Response to the SARS-CoV-2 MRNA-1273 Vaccine in Select Subsets of Oncology Patients - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Cancer
Keywords: Covid19
Cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are between 50 and 75 years of age

Brief summary: To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population.

Detailed description: The purpose of this study is to measure the immune response to the COVID-19 vaccine in cancer patients and compare to the general population. This information can help optimize the timing of the mRNA-1273 vaccine relative to starting treatment for cancer, adding booster immunizations or incorporation of medications that to enhance the immune response.

Eligibility criteria: Inclusion Criteria:

* Subjects are between 50 and 75 years of age;
* Have not had known or suspected infection with SARS-CoV-2 at any time;
* Subjects must fall into one of the following subsets of cancer patients:

  * Localized prostate cancer on radiotherapy or have completed radiotherapy in the last three months
  * Prostate cancer on androgen-deprivation therapy for biochemical recurrence
  * Colon cancer on adjuvant chemotherapy for stage III disease
  * CLL on a BTK inhibitor as a first-line single agent for at least 3 months
  * Melanoma patients on adjuvant immunotherapy with PD-1 checkpoint inhibitors for at least 3 months
* Have received both doses of SARS-CoV-2 mRNA-1273 vaccine with proof of vaccination or are scheduled to do so;
* Have at least a one-year life expectancy;
* Prior radiation therapy is allowed, as long as it was completed more than 6 months prior to vaccination

Exclusion Criteria:

* Subjects have a known hypersensitivity to a vaccine component;
* Have had known or suspected infection with SARS-CoV-2 at any time;
* Are organ transplant recipient on immunosuppression;
* Had received or are scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post second dose;
* Had received or are scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post second dose;
* Received high-dose corticosteroids at any time after receiving the vaccine;
* Are unable to give informed consent;
* Are receiving treatment for CLL with another agent (such as rituximab) in addition to a BTK inhibitor

Primary outcomes:
measure: Immunological response to the vaccine
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT06334380: VR for Surgical Prehabilitation and Rehabilitation
Official title: Virtual Reality for Surgical Prehabilitation and Rehabilitation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer
Frailty
Surgery
Keywords: Prehabilitation
Rehabilitation
Virtual Reality
Physical Therapy
Breast Surgery
Breast Cancer
Breast Reconstruction
Axillary Surgery
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to one of two arms, VR self-paced modules with live PT guidance and VR without live PT guidance.
Primary purpose: OTHER

Brief summary: This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery.


Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* English speaking
* Will undergo breast or axilla surgery at Stanford
* Have access to internet and stable Wifi at home
* Have access to a space with stable chair at home
* Ability to sit-to-stand without significant balance issues
* Absence of chronic vertigo or nausea/vomiting
* Agreeable to up to 4 weeks of prehab prior to surgery and up to 8 weeks of post-operative rehab

Exclusion Criteria:

* Inability to engage in PT due to physical limitations identified by the participant and/or care team
* Inability to complete a brief online survey at three time points during the duration of the study
* Inability to consent

Primary outcomes:
measure: VR for remote Physical Therapy (PT)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
References:
Clinical trial NCT00260780: An STD Prevention Intervention for Men Newly Released From Jail
Official title: The MISTERS Project: An STD Prevention Intervention for Men Newly Released From Jail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Risk Behavior
Keywords: sexually transmitted diseases
Risk Behavior
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: STAND, Inc.
First posted: 2005-12-02
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Study participants who are exposed to the intervention will: 1)report more condom use during sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk reduction, communication, and anger management skills; 4) report fewer substance use behaviors, and 5)report more health care seeking activities, than the participants in the control group

Detailed description: The MISTERS study is a randomized control trial of a cognitive-behavioral skill building multi-session intervention that targets men who are newly released from jail and have a history of drug use. Men 45 days or less post release with self reported HIV negative and substance use histories were randomized into either a 5-session intervention or control group. Study participation included four time-sensitive interviews and STD testing at three time periods. The interview questions included demographics, STD history and knowledge, sexual risk behaviors, as well as an assessment of anger management, communication, and condom use skills.

Eligibility criteria: Inclusion Criteria:

* ages 18 to 60, English speaking, not in jail for sexual offenses (rape or child molestation), reported risk behavior in two months prior to incarceration, weekday and evening availability, viable contact information, self-reported HIV negative status, released from jail no more than 45 days prior, and not visibly under the influence of drugs or alcohol at the time of eligibility determination

Exclusion Criteria:

* Opposite of the above

Primary outcomes:
measure: Change in risk behaviors
Secondary outcomes:
measure: Reported STDs
Other outcomes:
Locations:
city: Decatur
country: United States
facility: STAND, Inc.
state: Georgia
Study officials:
affiliation: CDC/NCHSTP/DSTDP/BIRB
name: Samantha P Williams, Ph.D.
role: STUDY_CHAIR
affiliation: STAND, Inc.
name: Charles Sperling, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05962580: Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients
Official title: of Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Between High Demand Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Keywords: anterior cruciate ligament tear
anterolateral instability
retear
extra articular tenodesis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients

Detailed description: It is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (IKDC and Lysholm)

Eligibility criteria: Inclusion Criteria:

* High demand patients (manual workers, athletes,...etc.).
* Normal average body mass index ( 18.5 - 24.9 ).
* Age \<40 years old.
* Patients will be diagnosed as ACL tear by the following:

  1. History of knee traumatic event.
  2. Clinical examination ( positive Lachman test and pivot shift test).
  3. Radiological evidence of ACL tear by MRI.
* patient with high pivot shift test.

Exclusion Criteria:

* Generalized ligamentous laxity.
* Other intra or extra articular knee injuries.
* Previous ACL surgery on the affected knee.
* Bilateral ACL injuries.
* Significant Articular surface injury.
* Medical comorbidities
* Patients with malalignment ( genu varum, genu valgum or genu recurvatum )
* Neuromuscular disorders
* Knee arthritic changes.

Primary outcomes:
measure: failure rate
timeFrame: one year follow up
Secondary outcomes:
measure: International knee documentation committee score (IKDC)
timeFrame: at 3,6,9,12 months
measure: Lysholm score
timeFrame: at 3,6,9,12 months
measure: antero-posterior instability measure
timeFrame: at 3,6,9 and 12 months
measure: side to side KT 1000 lachmeter difference
timeFrame: one year follow up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdel Salam Abdel Halim
state: Abbasia
Study officials:
affiliation: Faculty of medecine, Ain shams university
name: Amr Mo Abdelhady, Professor
role: STUDY_CHAIR
affiliation: Faculty of medecine, Ain shams university
name: Mohamed Ha Sobhey, Professor
role: STUDY_DIRECTOR
affiliation: Faculty of medecine, Ain shams university
name: Moustapha Al ElAbd, lecturer
role: STUDY_DIRECTOR
affiliation: Faculty of medecine, Ain shams university
name: Yehia Mo Haroun, Lecturer
role: STUDY_DIRECTOR
affiliation: Faculty of medecine, Ain shams university
name: Ahmed Ab Amer, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01984580: Effect of Zinc on Barrett's Metaplasia
Official title: Effect of Zinc on Barrett's Metaplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Barrett's Metaplasia
Keywords: Barrett's esophagus
Esophagus
Adenocarcinoma
Lead sponsor: Main Line Health
Sponsor class: OTHER
Collaborators: name: Sharpe-Strumia Research Foundation
First posted: 2013-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions:

1. can this zinc administration cause molecular-level changes in the Barrett's tissue?
2. are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?

Detailed description: 14 days prior to already-scheduled upper endoscopy (EGD) procedures for routine surveillance of Barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc BID) or a placebo (molar equivalent of sodium gluconate BID) for 14 days. At the time of endoscopy, 4 biopsies are taken (and pooled) from the Barrett's tissue and 4 from proximal normal esophageal tissue. Biopsies are flash frozen for later analyses by atomic absorption spectroscopy, PAGE and Western immunoblot or RNA microarray.

Eligibility criteria: Inclusion Criteria:ages 18-80; prior diagnosis of Barrett's esophagus -

Exclusion Criteria:unable to provide written, informed consent; prior history of Barrett's dysplasia or esophageal adenocarcinoma; drug exclusions: hormone replacement therapy, cholestyramine, amiloride diuretics, oral quinolone antibiotics, glucocorticoids, corticosteroids, anticoagulants (other than aspirin)

-

Primary outcomes:
measure: Changes in zinc-regulated cellular proteins within Barrett's tissue
timeFrame: in biopsy tissue after 14 days of Zn exposure
Secondary outcomes:
measure: Changes in cellular microRNA profile; changes in protein cancer biomarkers
timeFrame: in biopsy tissue after 14 days of Zn exposure
Other outcomes:
Locations:
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04338880: Academic Performance and Refractive Error
Official title: The Associations of High Academic Performance With Childhood Ametropia Prevalence and Myopia Progression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Refractive Errors
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 10000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective multicohort observational study of schoolchildren who studied in the 1st to 9th grades was performed.

Brief summary: Refractive errors constitute the leading cause of visual disability worldwide and that myopia progresses dramatically when students reach school age. Studies from different countries have reported inconsistent associations between educational outcomes and refractive errors. Therefore, our study aimed to assess the associations of high academic performance with ametropia prevalence and myopia progression in Chinese schoolchildren base on a multicohort observational design.


Eligibility criteria: Inclusion Criteria:

* schoolchildren in the 1st to 9th grades

Exclusion Criteria:

* schoolchildren unwilling to participate
* had a history of wearing rigid contact lenses, medical treatment or diseases that could cause poor vision or negatively affect the academic outcomes
* with unreliable auto-refraction values

Primary outcomes:
measure: the changes of spherical equivalent refractive (RSE)
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00620880: IVN-CAT-001A Performance of CAST With Different Allergens in Patients With Cat Dander Allergy
Official title: Performance of CAST With Different Allergens in Patients With Cat Dander Allergy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy to Cats
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ImVision AG
First posted: 2008-02-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Primary objective of the trial:

To determine at which concentration the fusion protein MAT Fel d1 degranulates basophils of cat dander allergic patients, in comparison to a cat dander extract and to Fel d1 alone


Eligibility criteria: Inclusion criteria: 1. Patient with Cat Dander Allergy evidenced by positive history 2. Age: 18 to 75 years

Exclusion criteria: 1. Use of oral corticosteroids, Chromoglycin, Ketotifen, or any immunosuppressive drugs within the last 2 months 2. Psychiatric disorder resulting in malcompliance 3. Neg. IgE to Cat dander

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT02816580: Biological MArkers of FRAilty in Elderly Subjects
Official title: PTMDP (Post-translational Modification Derived Products) as Markers of Frailty in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Persons
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 254
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Epidemiological data from Europe have shown that around 30% of subjects aged over 65 years of age are pre-frail, and 15% are frail. Recent research has demonstrated that identifying frailty and implementing preventive measures can help to slow cognitive decline. Screening and treating frailty seem to be a good start towards preventing dependency.

On the premise that this frailty is the result of more pronounced tissue alterations in certain elderly subjects, assessment of post-translational modification derived products (PTMDP) represents an innovative evaluation method. These include advanced glycation end-products (AGE), and carbamylation-derived products (homocitrulline). Indeed, the intensity of these modifications increases with ageing, and assessing the products resulting from these alterations could show the existence of differences according to frailty status. This would make it possible to adapt treatment accordingly in elderly subjects.


Eligibility criteria: Inclusion Criteria:

* With social security coverage
* Accept to participate in the study and sign informed consent for the study and for the collection of biological samples

Exclusion Criteria:

- \< 65 yo

Primary outcomes:
measure: post-translational modification derived-products (PTMDP) quantification by Multidimensional Chromatography Coupled withTandem Mass Spectrometry (LC/LC-MS/MS)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT01819480: Efficacy and Safety of TORS for SCCA
Official title: A Single Arm Study of Efficacy and Functional Quality of Life in Patients Treated With Transoral Robotic Surgery for Oropharyngeal and Supraglottic Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Oropharyngeal Squamous Cell Carcinoma
Supraglottic Squamous Cell Carcinoma
Keywords: Surgery
Robotic
Carcinoma
squamous cell of head and neck
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 110
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: The purpose of this study is to learn more about the outcomes of treatment of throat and voice box cancers using transoral robotic surgery (TORS). TORS is a relatively new option involving the use of the da Vinci surgical robot to remove these cancers through the mouth.


Eligibility criteria: Inclusion Criteria:

* Adult male or female
* Diagnosis of either oropharyngeal or supraglottic squamous cell carcinoma

Exclusion Criteria:

* Metastatic disease

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Disease specific survival
timeFrame: 3 years
Other outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Functional quality of life
timeFrame: 3 years
measure: Incidence of adverse events
timeFrame: 3 years
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia School of Medicine
name: Katherine L Fedder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05796180: Sexual Health Counseling Based on the BETTER Model
Official title: The Effect of Sexual Health Counseling Based on the BETTER Model on Postpartum Sexual Life Quality: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Sexuality
Keywords: Sexual Health Counseling
Sexual Life Quality
Postpartum
Postpartum Sexual Life Quality
BETTER Model
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
First posted: 2023-04-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the investigators wanted to examine the effect of sexual health counseling to women in the postpartum period on the quality of life of the participants.


Eligibility criteria: Inclusion Criteria:

* Primiparous,
* Have had a vaginal birth,
* Those who will live with their partner in the period after birth,
* Having started sexual intercourse before starting training,
* Without a diagnosed chronic disease (DM, HT, Heart disease, etc.),
* 18 years or older,
* Able to speak and understand Turkish,

Exclusion Criteria:

• Edinburgh Postpartum Depression Scale score of 12 and above,

Primary outcomes:
measure: Postpartum Sexual Life Quality Scale
timeFrame: 8 week
measure: Arizona Sexual Experiences Scale
timeFrame: 8 week
measure: VAS satisfaction scale
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Lokman Hekim Etlik Hospital
state: Keçiören
Study officials:
affiliation: Lokman Hekim Üniversitesi
name: Nurgül ŞİMAL YAVUZ, Lecturer
role: STUDY_DIRECTOR
References: