louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05786664: Breast Cancer Survivorship Biorepository
Official title: A Comprehensive Breast Cancer Survivorship Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Invasive Breast Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-27
Enrollment: 1300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women diagnosed with invasive breast cancer (stages I-III) who have completed active treatment.

Brief summary: This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes.

Detailed description: PRIMARY OBJECTIVE:

I. To create an annotated biorepository with prospectively collected blood samples from breast cancer survivors.

SECONDARY OBJECTIVES:

I. To collect comprehensive data on social determinants of health (e.g., race/ethnicity, acculturation, socioeconomic status, and access to care), environmental exposures (based on zip codes/geocoding), lifestyle (e.g., diet, tobacco use), clinicopathologic characteristics, treatment history, follow-up and current disease status, survivorship-related issues.

II. To establish an efficient process for researchers to utilize the biorepository for breast cancer and survivorship-related studies.

OUTLINE:

Patients complete surveys, undergo collection of blood samples, and review of medical records on study.

Eligibility criteria: Inclusion Criteria:

* Women of all racial and ethnic groups 18 years of age or older
* Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years
* Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation)
* Prior participation on clinical trials is allowed

Exclusion Criteria:

* Current receipt of interventional clinical trial participation
* Stage IV (metastatic) cancer
* Prior history of recurrence (except recurrence following ductal carcinoma in situ)
* Inability to give informed consent
* Unable to speak English, Spanish, Chinese, or Korean

Primary outcomes:
measure: Biorepository
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Bodour Salhia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05633264: A Study to Assess Deucravacitinib Post-marketing Surveillance in Participants With Psoriasis in Japan
Official title: Deucravacitinib Post-marketing Surveillance in Patients With Psoriasis in Japan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Keywords: Psoriasis
Deucravacitinib
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of Psoriasis (PsO) participants (participants with plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis) who initiate treatment with Deucravacitinib will be enrolled. Participants receiving Deucravacitinib for an off label indication will be excluded.

Brief summary: The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.


Eligibility criteria: Inclusion Criteria:

* Psoriasis (PsO) participants who received Deucravacitinib for the first time of the approved indications at medical institutions in Japan will be enrolled in this PMS

Exclusion Criteria:

* Participants receiving Deucravacitinib for an off-label indication will be excluded from this PMS.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Proportion of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period
timeFrame: Up to 52 weeks
measure: Change from Baseline in Body Surface Area (BSA) during study period
timeFrame: Up to 52 weeks
measure: Proportion of participants achieving Global Improvement Score (GIS) during study period
timeFrame: Up to 52 weeks
measure: Distribution of demographic characteristics: Age
timeFrame: Up to 52 weeks
measure: Distribution of demographic characteristics: Sex
timeFrame: Up to 52 weeks
measure: Distribution of demographic characteristics: Height
timeFrame: Up to 52 weeks
measure: Distribution of demographic characteristics: Weight
timeFrame: Up to 52 weeks
measure: Distribution of demographic characteristics: Past history /complication
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Tosima-ku
country: Japan
facility: EP Pharmaline
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05613764: Message From Local Pharmacy Team
Official title: Message From Local Pharmacy Team
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
behavioral science interventions
vaccination promotion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 520000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the different arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. The focal comparison in this experiment is between a message encouraging vaccination that comes from a patient's local pharmacy team and a control message telling patients that an updated COVID booster vaccine is waiting for them. The intervention testing if text messages encouraging vaccination that come from a patient's local pharmacy team will produce more vaccinations than otherwise identical messages.


Eligibility criteria: Exclusion Criteria:

1. The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message
2. The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.

Primary outcomes:
measure: Patient uptake of COVID bivalent booster
timeFrame: During the 30 days after receiving the SMS/MMS intervention
Secondary outcomes:
measure: Patient uptake of COVID bivalent booster
timeFrame: 60 days after receiving the SMS/MMS intervention
measure: Patient uptake of COVID bivalent booster
timeFrame: 90 days after receiving the SMS/MMS intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01696864: Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function
Official title: Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke Patients
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to examine monitored rehabilitation therapy over the internet to improve upper limb function for stroke patients. Home rehabilitation for stroke patients will avoid the burden of arrival to the health facilities, making it easier on them and improve their quality of life and the lives of their caregivers. To achieve this goal the investigators will examine the effectiveness and feasibility of home rehabilitation system of upper limb, consisting of ergonomic accessories (hand and arm tutors).

The quantitative indices will be based on the quantitative clinical measures that are used in regular evaluations of stroke patients and function and range of motion indices as received from the system.


Eligibility criteria: Inclusion Criteria:

* Stroke patients who had at least eight conventional rehabilitation treatments lasted at least until a month before the start of the experiment,
* not affected cognitively (to be determined by the score on the mini mental exam greater than 23).
* patients have daily access to a computer and the Internet, and use a personal caregiver or family member can supervise the use of the system.

Exclusion Criteria:

* Global or sensory aphasia, unilateral spatial neglect, apraxia and other acute neurological or orthopedic conditions.

Primary outcomes:
measure: Fugl-Meyer Assessment upper extremity part (FMA)
timeFrame: 10 minutes
measure: Arm and Hand Activity Inventory (CAHAI)
timeFrame: 10 minutes
measure: Motor Activity Log (MAL)
timeFrame: 10 minutes
measure: System Usability Scale (SUS)
timeFrame: 10 minutes
measure: Box& Block Test of Manual Dexterity
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center rehabilitation facility
Study officials:
affiliation: Sheba Medical Center
name: Gabi Zeilig, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00647764: Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas
Official title: Phase 1 Study Of SNX-5422 Mesylate In Adults With Refractory Solid Tumor Malignancies And Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor Malignancy
Lymphoid Malignancy (Lymphoma and CLL)
Leukemia
Lymphoma
Lead sponsor: Esanex Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in patients with cancer.


Eligibility criteria: Inclusion Criteria:

* Solid tumors or lymphoid malignancies refractory to standard therapy
* measurable disease
* recovery to Grade \< 1 toxicity due to prior adverse event or chemotherapy
* no chemotherapy within 4 weeks of entering study
* Age \> 18 years
* Karnofsy \>= 60%
* Life expectancy \> 3 months
* normal or adequate organ and marrow function

Exclusion Criteria:

* receiving other investigational agents
* brain metastases
* uncontrolled medical illness
* HIV+ receiving combination antiretroviral therapy
* significant GI disease

Primary outcomes:
measure: MTD, safety and toxicity
timeFrame: continuous
Secondary outcomes:
measure: pharmacokinetic profile of SNX-5422
timeFrame: first cycle
measure: tumor response measured by X-rays or scans
timeFrame: after every 2 cycles
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00509964: Second-Line Irinotecan vs. ILF for AGC
Official title: A Randomized Phase II Trial of Irinotecan Monotherapy Versus Irinotecan, Leucovorin and 5-FU (ILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasm
Metastatic
Second-Line
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2007-08-01
Enrollment: 50
Sex: ALL
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: Patients with recurrent or metastatic gastric cancer can benefit from palliative chemotherapy. However, over half of patients with metastatic gastric cancer who received chemotherapy failed to achieve response and even in these responders, the duration of responses was as short as a few months. Patients with metastatic gastric cancer who fail to respond or have relapse after first line chemotherapy have a grim prognosis and a standard salvage treatment is not available.

We designed this phase II trial to determine the efficacy and safety of irinotecan monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed gastric cancer
* inoperable, recurrent, or metastatic
* performance status 0 to 2
* failed after one or more prior chemotherapy for advanced disease
* informed consent

Exclusion Criteria:

* active infection
* severe co-morbidities
* previously treated with irinotecan or similar drugs

Primary outcomes:
measure: response rate
Secondary outcomes:
measure: safety
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center, Incheon, Korea
name: Se Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00805064: Combined Triple Procedure in Retinal Vein Occlusion (RVO)
Official title: Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retinal Vein Occlusion
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).

Detailed description: This prospective study of a case series was conducted in 47 patients (n = 47 eyes; f/m: 21/26; mean age: 66.6 years) with ischemic central RVO (CRVO) (n = 15), non-ischemic CRVO (n = 7), or branch RVO (BRVO) (n = 25). A core pars plana vitrectomy with aspiration of 1.5 ml vitreous and infusion of balanced salt solution (BSS; 1 ml), 8 mg (0.4 ml) triamcinolone, and 1.25 mg (0.1 ml) bevacizumab was performed with a single sutureless sclerotomy and a 23 gauge probe tip. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Eligibility criteria: Inclusion Criteria:

* Ischemic central RVO (CRVO)
* Non-ischemic CRVO
* Branch RVO (BRVO)

Exclusion Criteria:

* Visual deterioration due to acute or chronic inflammation
* Post trauma
* Macular edema of other origin
* Intravitreal drug treatment within last 4 months

Primary outcomes:
measure: BCVA
timeFrame: day of exam
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of VitreoRetinal Surgery ZAU JWGU
name: Michael Koss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03631264: The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants.
Official title: The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infants
Keywords: preterm infants
kinesiotape
swallowing
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 74
Sex: ALL
Minimum age (years): 34
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Problems such as poor nutrition, weak sucking, lack of suck-swallow-respiration coordination, low weight gain are among the factors increasing the risk of morbidity in late preterm infants. Early support of sucking and swallowing muscles for the development of suck-swallow coordination can shorten the maturation process and provide early discharge of late preterm infants. The aim of this study is to document kinesiotape technique to support sucking and swallowing muscles for treating nutritional problems and for reducing nutrition risks and accelerating maturation. According to power of analysis of this study, 74 infants planned to assign to kinesiotaping group or control group randomly. In kinesiotaping group, infants feeding performance will be evaluated by measuring the amount of milk invested, maximum heart rate, oxygen saturation, speed of milk intake and counting the number of swallow during feeding. Kinesiotape will be applied to masseter and hyoid muscles 24 hours later after the birth of the infant. Infants will be evaluated before kinesiotape application, 3 hour later and 24 hour later after the application.


Eligibility criteria: Inclusion Criteria:

* Infants born in Baskent University Ankara Hospital, age between 34-36.6 weeks.

Exclusion Criteria:

* Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, intraventricular and intracranial hemorrhage, necrotizing enterocolitis, tracheoesophageal fistula, diaphragmatic hernia, hydrocephalus, and respiratory distress.

Primary outcomes:
measure: digital stethoscope
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
state: Bahçelievler
Study officials:
affiliation: Associate Professor
name: Deniz Anuk Ince, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02127164: Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries
Official title: Prospective Evaluation of Wound Management Using Vacuum Assisted Instillation Therapy in Emergent Contaminated Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Injury
Complicated Diverticulitis
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2014-04-30
Enrollment: 18
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: Emergent abdominal surgeries have very high rate of wound contamination due to exposure to bacteria from GI tract. There are several different approaches to wound management in these patients including wet-to-dry dressing or application vacuum assisted device on the wound. The investigators propose using the vacuum assisted device with Dakin's solution on patients undergoing emergency surgery for hollow viscus perforation installed immediately at the end of operation and remained there for the first 3 postoperative days, followed by delayed primary closure on postoperative day 4. The investigators believe this technique can achieve earlier wound closure, decrease patient discomfort, improve cost savings, and potentially standardize and revolutionize the investigators management of heavily contaminated wounds.


Eligibility criteria: Inclusion Criteria:

* Emergent surgery involving hollow viscus perforation or necrotic bowel
* Admitted to the University of Arizona Medical Center, Tucson, AZ

Exclusion Criteria:

* Prisoners
* Pregnancy
* Patients with allergy to Dakin's (sodium hypochlorite) solution.

Primary outcomes:
measure: Rate of Surgical Site Infection
timeFrame: 2 weeks
Secondary outcomes:
measure: Wong-Baker Faces Pain Rating Scale
timeFrame: 1 week
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
Study officials:
affiliation: Assistant Professor
name: Andrew M Tang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02309164: The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).
Official title: The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm
Adult Disease
Neuropathy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the effectiveness of the use of acupuncture in relieving sensory and motor symptoms as well as functional impairment and quality of life of patients with chemotherapy induced peripheral neuropathy

Detailed description: The trial is a clinical, single-center, randomized trial study that will involve 30 adult cancer patients with chemotherapy-induced peripheral neuropathy randomized into two groups (control and acupuncture treated with 10 sessions, 2X per week). Both CIPN patients groups will be submitted to a complete physical examination and to clinical assessments with National Cancer Institute Common Terminology Criteria for Adverse Events Scale Version 2.0, Functional Independence Measure Scale, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Scale and Visual Analogue Scale for pain before treatment and in 5 weeks of follow-up after treatment.

Eligibility criteria: Inclusion Criteria:

Cancer adult patients with CIPN -

Exclusion Criteria:

Other neuropathy

-

Primary outcomes:
measure: neurological symptoms
timeFrame: up to 7 weeks
Secondary outcomes:
measure: functional impairment
timeFrame: up to 7 weeks
measure: quality of life
timeFrame: up to 7 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo ICESP
state: SP
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Rebeca B Cecatto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Alessandro EG, Nebuloni Nagy DR, de Brito CMM, Almeida EPM, Battistella LR, Cecatto RB. Acupuncture for chemotherapy-induced peripheral neuropathy: a randomised controlled pilot study. BMJ Support Palliat Care. 2022 Mar;12(1):64-72. doi: 10.1136/bmjspcare-2018-001542. Epub 2019 Jun 29.