louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04196517: PALS for Nutrition Education
Official title: Can the Patient Activated Learning System (PALS) Serve as a Better Model for Nutrition Education Than Other Online-based Educational Material?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nutrition Disorders
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of this inquiry is to determine whether PALS is more effective than comparable online resources at educating patients in the outpatient clinic setting about nutrition. Participants will be randomly assigned to view either a PALS article or WebMD article on the same nutrition topic. Participants will then fill out a post-survey to assess knowledge uptake and attitudes regarding healthy eating.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years of age.
* Ability to speak and read in English.
* Passing the screener - Mini-Mental Status Examination.
* Patient at WCIMA clinic on Upper East Side of Manhattan, NY.

Exclusion Criteria:

* Non-English speakers
* Inability to read in English
* Being younger than 18
* Not passing the screener
* Not a patient at WCIMA clinic on Upper East Side of Manhattan, NY.

Primary outcomes:
measure: Knowledge, as measured by assessment questions on the nutrition information provided
timeFrame: Day 1, Immediately after reading article
Secondary outcomes:
measure: E-health usability, as measured by questions from the Kelly et al. scale
timeFrame: Day 1, Immediately after reading article
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Monika Safford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02927717: An Italian Experience on Grade 3b Follicular Lymphoma
Official title: An Italian Experience on Grade 3b Follicular Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Grade 3b Follicular Lymphoma
Keywords: Grade 3b Follicular Lymphoma
2016 WHO Criteria
Front-line treatment
Rituximab
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with grade 3b Follicular Lymphoma treated with Rituximab containing chemotherapy as front-line treatment

Brief summary: Study purpose is to evaluate baseline clinical data, outcome after front-line Rituximab containing chemotherapy and survival in patients with grade 3b Follicular Lymphoma.

Also an histological central review is planned in order to re-assess baseline diagnosis according to new 2016 World Health Organization (WHO) criteria.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of grade 3b Follicular Lymphoma
* Age \> 18 years
* Front-line treatment with Rituximab containing chemotherapy
* Availability of histological sample for central review

Exclusion Criteria:

* Other lymphoma diagnosis

Primary outcomes:
measure: Overall Response Rate
timeFrame: End of front-line treatment (evaluated from diagnosis up to 30 months)
Secondary outcomes:
measure: Progression Free Survival
timeFrame: From first response to last follow-up for at least 2 years (up to 15 years)
measure: Overall Survival
timeFrame: Date of last follow-up for at least 2 years (up to 15 years)
Other outcomes:
Locations:
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Barbara Botto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04431817: KinetiGait- Analysis of Depth Camera to Assist Gait Analysis for Unilateral Transtibial/Transfemoral Amputees
Official title: Operational Analysis of Depth Camera to Assist Gait Analysis in Outpatient Rehabilitation for Unilateral Transtibial and Transfemoral Amputees
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Limb Amputation
Keywords: depth camera, gait analysis, LE loss, SMs and Veterans
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Telemedicine & Advanced Technology Research Center
First posted: 2020-06-16
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include individuals who are DEERS-eligible between the ages of 18 and 65 and in K2-K4 Medical Functional Classification levels. The providers must be MHS providers.

Brief summary: This is a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb disfunction. There will be questionnaires completed by participants and surveys completed by both participant and provider.

Detailed description: We propose a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb dysfunction. Up to 100 subjects will be consented, with the expectation that 80% (e.g., n=80) will complete the study with a complete dataset. Baseline sessions will consist of 7 minutes of walking at a self-selected speed between 0.7 and 1.3 m/s, after which participants will take the PLUS-M 12 Item Short Form and PROMIS-29 questionnaires, as well as a short survey. Participants will complete the questionnaires again at 1 month and 3 month. Providers who observed/operated the KinetiGait system will also take a short survey on ease of use and satisfaction.

Eligibility criteria: Inclusion Criteria:

* Unilateral transfemoral or transtibial amputee
* Fitted by a prosthetist at a Military Treatment Facility
* K2-K4 Medicare Functional Classification Levels
* DEERS-eligible.
* For providers: MHS provider

Exclusion Criteria:

* K0-K1 Medicare Functional Classification Levels
* Physically unstable or requires an ambulatory device
* Pregnant women

Primary outcomes:
measure: Prosthetic Limb Users Survey of Mobility (PLUS-M)
timeFrame: 5-10 minutes
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-29
timeFrame: 5-10 minutes
Secondary outcomes:
measure: Provider survey
timeFrame: 5-10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: WRNMMC
name: Gabriel M Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152217: Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
Official title: Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Stomach cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with TS-1 within 45 days after curative resection (curability A or B). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.


Eligibility criteria: Inclusion Criteria:

* Age 20 to 80
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 mg/dL
* Renal Creatinine ≤ULN

Exclusion Criteria:

* Prior anticancer treatment

Primary outcomes:
measure: Overall survival
timeFrame: every course for first three courses, then every other course
Secondary outcomes:
measure: Relapse-free survival, adverse events
timeFrame: any time
Other outcomes:
Locations:
city: 5-1-1, Tsukiji, Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
Study officials:
affiliation: Department of Upper Gastrointestinal Surgery, Hyogo College of Medicine
name: Mitsuru Sasako, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.
citation: Ito S, Ohashi Y, Sasako M. Survival after recurrence in patients with gastric cancer who receive S-1 adjuvant chemotherapy: exploratory analysis of the ACTS-GC trial. BMC Cancer. 2018 Apr 20;18(1):449. doi: 10.1186/s12885-018-4341-6.
Clinical trial NCT04271917: Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
Official title: Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Acute
Keywords: cannabidiol
CBD
acute pain
alternative pain management
simple extraction
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 68
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: The purpose of this study is to evaluate the analgesic effects of cannabidiol for patients who have undergone simple tooth extraction. Participants will be randomized to one of four arms: treatment-as-usual (TAU), cannabidiol 17mg/mL, cannabidiol 37mg/mL, or placebo.


Eligibility criteria: Inclusion Criteria:

* Presenting for an operatory appointment at University of Tennessee Health Science Center College of Dentistry Oral and Maxillofacial Surgery Department
* Operation must be a simple tooth extraction which does not result in an opioid prescription
* 18 years of age or older
* Have regular and direct access to a device that can send and receive texts and willing to accept any associated charges for 24 text messages

Exclusion Criteria:

* Contraindication to ibuprofen
* Contraindication to acetaminophen
* Contraindication to cannabidiol or hemp oil
* Contraindication to peppermint oil
* Contraindication to almond or other tree nuts
* Currently taking a form of cannabidiol and unwilling to stop use for one week post surgery

Primary outcomes:
measure: Worst pain following surgery using Wong Baker Faces pain scale
timeFrame: 1-week post-op
measure: Amount of medication used
timeFrame: 1-week post-op
measure: Pain levels following surgery using Wong Baker Faces pain scale
timeFrame: First 72 hours post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Karen J Derefinko, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Ammaar H Abidi, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02052817: Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing
Official title: Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Pedal Ulcers
Lead sponsor: Toad Medical Corporation
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2014-02-03
Enrollment: 74
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: The TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and has been shown to heal ulcers at a rapid rate in preliminary experience in patients with plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates will be determined clinically and by blinded, computer-assisted planimetry of digital images over a 12 week period. The pressure on the plantar surface will be measured via a pressure sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.


Eligibility criteria: Inclusion Criteria:

* Men or women \>18 years old
* One or more foot ulcers without clinical evidence of osteomyelitis
* Diagnosis of Diabetes Mellitus\*
* University of Texas Grade 1A, 1C, 2A, or 2C ulcer15
* ABI \>0.7 and Toe pressure \>30mmHg

Exclusion Criteria:

* Limited life-expectancy
* Wounds on calf or shin that would be in contact with the TAG Brace
* Gangrene, active infection
* Osteomyelitis of the foot with the ulcer
* Chronically bedridden/Non ambulatory
* Unable to keep research appointments
* Wide spread malignancy or systemically immunocompromising disease
* Ipsilateral revascularization procedure within the last 30 days.
* Unreliable, unwilling or unable to comprehend informed consent

Primary outcomes:
measure: Change from baseline measured wound area
timeFrame: Every 3 weeks for a period of 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: UH Hospitals of Cleveland d/b/a University Hospitals Case Medical
state: Ohio
Study officials:
References:
Clinical trial NCT03140917: Multimodal Assessment of Liver Volume and Function
Official title: Multimodal Assessment of Liver Volume and Function in Patients With Colorectal Liver Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Liver Metastases
Keywords: Liver function
Future liver remnant
Chemotherapy
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy

Brief summary: In liver surgery peroperative assessment och the future liver remnant (FLR) is pivotal in order to avoid posthepatectomy liver failure. To date this is mainly performed by measuring the volume of the FLR. Of course FLR volume acts as a surrogate measure of FLR function and the correlation between volume and function is not always accurate. Several techniques to assess FLR function has been proposed. Hepatobiliary scintigraphy (HBS) and Dynamic MRI are the two such methods. In this study we compare HBS and MRI, in addition to contrast-enhanced CT and ICG, repeatedly performed before and after right hepatectomy in patients with colorectal liver metastases treated with neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy

Exclusion Criteria:

-

Primary outcomes:
measure: Correlation between HBS and MRI in assessment of FLR function preop
timeFrame: Preop
Secondary outcomes:
measure: Correlation between HBS and MRI in assessment of FLR function POD 7
timeFrame: POD 7
measure: Correlation between HBS and MRI in assessment of FLR function POD 28
timeFrame: POD 28
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Magnus Nilsson, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06979817: Machine Learning Model Guided by TLS Predicts Survival and Immune Features in Gastric Cancer
Official title: TLS-Informed Machine Learning Model Predicts Survival and Immune Landscape in Locally Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Gastric Cancer
Tumor Immune Microenvironment
Tertiary Lymphoid Structures (TLS)
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include patients with histologically confirmed locally advanced gastric adenocarcinoma who have undergone curative-intent surgical resection at participating medical centers. The population will consist of both retrospective and prospective cohorts, with all patients having available tumor tissue for TLS analysis and complete clinical, pathological, and follow-up data. The study aims to capture a representative sample of real-world gastric cancer patients, reflecting a diversity of clinical characteristics, treatment modalities, and outcomes.

Brief summary: This study aims to develop and validate a machine learning model that uses information from tertiary lymphoid structures (TLSs)-specialized immune-related cell clusters found near tumors-to predict survival outcomes and immune characteristics in patients with locally advanced gastric cancer. By analyzing clinical data, pathology, and imaging results, the model may help doctors better understand a patient's prognosis and personalize treatment strategies. The study will also explore how TLS-related immune patterns relate to the effectiveness of certain therapies, potentially offering new insights for immune-based treatment planning.


Eligibility criteria: Inclusion Criteria:

Histologically confirmed locally advanced gastric adenocarcinoma (clinical stage cT2-T4 and/or N+)

Underwent curative-intent gastrectomy (with or without neoadjuvant therapy)

Availability of adequate tumor tissue specimens for TLS assessment via digital pathology

Complete baseline clinical, pathological, and follow-up data

Age ≥ 18 years

Written informed consent provided (if prospective study component is included)

Exclusion Criteria:

Distant metastases at the time of diagnosis or surgery (M1 stage)

Prior history of other malignancies within the past 5 years, except for adequately treated in situ carcinoma or non-melanoma skin cancer

Incomplete or missing essential clinical, pathological, or survival data

Poor-quality tissue samples not suitable for TLS quantification or digital analysis

Participation in another clinical trial that may interfere with the study outcomes

Primary outcomes:
measure: Overall Survival Predicted by TLS-Informed Machine Learning Model
timeFrame: Up to 5 Years Post-Surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04234217: Mechanisms of Prediabetic States in Sleep Apnea
Official title: Mechanisms of Prediabetic States in Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
Pre-diabetes
Keywords: Sleep
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: National Heart, Lung, and Blood Institute (NHLBI)
name: AdventHealth
First posted: 2020-01-21
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.

Detailed description: Substantial evidence indicates that obstructive sleep apnea (OSA) is associated with impaired glucose metabolism, however, metabolic mechanisms underlying this association remain unclear. This mechanistic study will determine systemic and cellular metabolic pathways that contribute to impaired glucose metabolism in obstructive sleep apnea (OSA). Understanding of how obstructive sleep apnea (OSA) affects glucose metabolism may help identify novel targets for risk prediction and/or treatment of metabolic impairments beyond continuous positive airway pressure (CPAP). Obstructive sleep apnea (OSA) patients with prediabetes will be studied under three in-laboratory conditions in a randomized cross-over design: untreated condition (obstructive sleep apnea), treated condition (continuous positive airway pressure), untreated but pharmacologically suppressed lipolysis condition (Niacin). The investigator will perform whole body and cellular assessments under each study condition.

Eligibility criteria: Inclusion Criteria:

* Overweight or obese
* Prediabetic
* Sleep apnea

Exclusion Criteria:

* Diabetic
* Severe hypertension
* Taking medications that can confound assessments
* Any history of known bleeding disorders
* Any underlying disease likely to limit life span or increase risk of intervention
* Currently pregnant, trying to get pregnant or nursing

Primary outcomes:
measure: Plasma norepinephrine levels
timeFrame: Untreated, within 4 months of screening
measure: Plasma norepinephrine levels
timeFrame: CPAP, within 4 months of screening
measure: Plasma norepinephrine levels
timeFrame: Niacin, within 4 months of screening
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Esra Tasali, MD
role: PRINCIPAL_INVESTIGATOR
References: