louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02651701: Rectal Cancer Staging Using Whole Body MR-PET
Official title: Preoperative Imaging for Rectal Cancer Staging Using Whole Body MR-PET
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2016-01-11
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients newly diagnosed with rectal cancer.

Brief summary: The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Adult patients newly diagnosed with rectal cancer on colonoscopy or sigmoidoscopy, who are potentially eligible for neoadjuvant chemoradiotherapy.
2. Patients who sign informed consent.

Exclusion Criteria:

1. Patients who are contraindication for CECT
2. Patients who are contraindication for MRI/CE-MRI
3. patients who are diagnosed with Tis or T1 cancer after polypectomy or EMR
4. Patients who were already diagnosed with an active other cancers.
5. Premenopausal female patients who are pregnant.
6. Patients with fasting serum glucose level (\>200mg/dL) on blood glucose meter prior to WB MR-PET.
7. Patients who are physically compromised to undergo WB MR-PET.

Primary outcomes:
measure: the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI
timeFrame: 12 months
Secondary outcomes:
measure: incidence of recommendation for further workup after examination
timeFrame: 12 months
measure: concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT.
timeFrame: 12 months
measure: concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up
timeFrame: 18 months
Other outcomes:
measure: Transient dyspnea
timeFrame: within an hour after MR contrast media administration
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Hee Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoon JH, Lee JM, Chang W, Kang HJ, Bandos A, Lim HJ, Kang SY, Kang KW, Ryoo SB, Jeong SY, Park KJ. Initial M Staging of Rectal Cancer: FDG PET/MRI with a Hepatocyte-specific Contrast Agent versus Contrast-enhanced CT. Radiology. 2020 Feb;294(2):310-319. doi: 10.1148/radiol.2019190794. Epub 2019 Dec 3.
Clinical trial NCT00960401: A Study of Atherosclerosis in Patients After Radiation Treatment for Breast Cancer
Official title: Pilot Study "A Study of Atherosclerosis in Patients After Radiation Treatment for Breast Cancer"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: coronary calcium scoring
breast cancer patients
radiation treatment
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2009-08-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: breast cancer patients after radiation treatment

Brief summary: The purpose of this study is to compare plaque burden in the coronary and carotid arteries 5 years after adjuvant radiotherapy in women with right sided breast cancer vs left sided breast cancer.

Detailed description: This study reviews case series of patients with a history of breast cancer treated with radiotherapy for at least five years. The study measures atherosclerosis by using coronary and carotid artery calcium scoring.

Eligibility criteria: Inclusion Criteria:

* women dx with ductal carcinoma in situ or breast cancer, stage 0 to stage IIIc, who received conservative surgery and radiotherapy at least 5 years ago
* less than or equal to age 60

Exclusion Criteria:

* hx of coronary disease prior to tx of ductal carcinoma in situ or breast cancer

Primary outcomes:
measure: Number of Participants Analyzed for Coronary Calcium Burden by AGS
timeFrame: Year 5 Post-Initiation of Radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Alexander Hindenburg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang M, Suh J, Kirtani V, Dobrescu A, Haas J, Zeldis S, Shayani S, Hindenburg AA. Coronary Calcium Scanning in Patients after Adjuvant Radiation for Early Breast Cancer and Ductal Carcinoma In situ. Front Oncol. 2013 Sep 25;3:253. doi: 10.3389/fonc.2013.00253. eCollection 2013.
Clinical trial NCT06428201: The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement
Official title: The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement in Multiple Sclerosis (MS) Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sclerosis, Multiple
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: "This study investigates the feasibility of tele-rehabilitation combined with targeted training for cognitive enhancement in individuals with Multiple Sclerosis (MS). Multiple sclerosis (MS) is a chronic illness that affects the central nervous system, often resulting in cognitive impairments that significantly impact quality of life. Tele-restoration provides an accessible and effective method for delivering therapeutic interventions, particularly beneficial for those with mobility limitations.

Detailed description: The study was a randomized controlled trial with multiple sclerosis patients divided into two groups: one receiving tele-rehabilitation-based task-specific training and the other receiving conventional care. The mediation group participated in structured cognitive training sessions conducted using a tele-rehabilitation platform, focusing on tasks designed to enhance memory, attention, and executive functions. Psychological assessments were conducted during the mediation period to measure improvements.

Eligibility criteria: Inclusion Criteria:

* Individuals with a diagnosis of MS confirmed by a neurologist.
* Between 18 and 65 years of age.
* Presence of psychosis confirmed by standardized psychometric testing.
* A stable treatment environment that allows intervention.
* Internet access with camera and computer/tablet.
* Ability to understand and follow course directions.
* Willingness to give informed consent.

Exclusion Criteria:

* Severe psychiatric co-morbidities affecting cognitive function.
* Concurrent intervention with other psychological rehabilitation programs.
* Lack of availability or use of technology necessary for tele-rehabilitation.
* Further research interventions.
* Unstable medical condition

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA) scale
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: District Head Quarters Hospital Narowal, Circular Road, Near Jassar Bypass, Narowal Location: Khalid Eye & Medical Care Block C Commercial Area, Jubilee Town, Lahore
state: Punjab
Study officials:
References:
Clinical trial NCT04382001: Heart Rate Variability During the Menstrual Cycle
Official title: Further Investigations of Heart Rate Variability During the Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovulation
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2020-05-11
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: In this study, women will be required to wear a chest heart rate monitor and wrist heart rate monitor daily and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.

Detailed description: This study is a prospective observational study of women's heart rate and heart rate variability throughout one complete menstrual cycle. A minimum of 10 volunteers aged 18 years of age or over will be recruited via a variety of methods according to the criteria detailed in section 9. They will be required to wear a chest heart rate monitor and wrist heart rate monitor for 1 hour each day, and throughout the night for one menstrual cycle. In addition, a daily early morning urine sample will be collected throughout the study.

Urine samples will be returned to SPD on a regular basis for measurement of urinary hormones related to pregnancy and fertility. Data collected via the monitors including heart rate and heart rate variability will be downloaded for comparison.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years of age and over
* Regular menstrual cycles (23-35 days in length)-

Exclusion Criteria:

* Taking any hormonal medications
* Taking any medications that may affect heart rate
* Known heart condition or use of a pacemaker
* Skin condition where there is sensitivity to wearing a skin monitor
* Currently suffering with anxiety or panic attacks
* Pregnant or breastfeeding
* Undertaking any frequent travel or long-haul flights during the course of the study
* Does not have access to an Apple iPhone or iPad with Bluetooth 4.0 (or later) and iOS 10.0 (or later)

Primary outcomes:
measure: Heart rate
timeFrame: 1 month
measure: Heart Rate
timeFrame: 1 month
measure: Day of Ovulation
timeFrame: 1 month
measure: Fertile Window
timeFrame: 1 month
measure: Fertile window
timeFrame: 1 month
Secondary outcomes:
measure: Comparisons between wrist and chest band monitors
timeFrame: 1 month
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development Company
name: Sarah Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT02958501: Vitamin D Substitution During Winter Time
Official title: Optimal Substitution Dose of the Vitamin D During Winter Time in Patient With Inflammatory Bowel Diseases (IBD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitamin D Substitution
Keywords: Vitamin D
Inflammatory Bowel Diseases
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
Collaborators: name: Nemocnice T.Bati, Zlin
name: Brno University Hospital
First posted: 2016-11-08
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 confirm anticipated substitution dose of the vitamin D for sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)

Detailed description: Vitamin D substitution is widely recommended. Suggested substitution doses are increasing over the time. No exact body requirement is known for patients with IBD at present. Aim of the study was to confirm substitution dose obtained from model.

Eligibility criteria: Inclusion Criteria:

* Subjects with inflammatory bowel disease

Exclusion Criteria:

* Liver disease
* Renal disease
* Hypercalcemia
* Hyperparathyreoidism
* Chronic pancreatitis
* Concomitant vitamin D medication
* Pregnancy
* Sarcoidosis
* Malignancy
* Inability to obtain valid data from subject

Primary outcomes:
measure: Change in vitamin D blood level after follow-up interval
timeFrame: 4 Months
Secondary outcomes:
measure: Change in vitamin D after follow-up interval according to weight
timeFrame: 4 Months
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Faculty Hospital Kralovske Vinohrady
Study officials:
References:
Clinical trial NCT03542201: Comparison of Blogshot Formats With Standard Cochrane Plain Language Formats
Official title: Comparison of Blogshot Formats With Standard Cochrane Plain Language Formats: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Participants will receive in random order on format of brief description of systematic review summary on health intervention. One group will receive standard plain language summary, while another will receive Cochrane blog shot, containing only few information about the efficacy of the intervention. After reading, their task will be to answer several questions about the material they have read.


Eligibility criteria: Inclusion Criteria:

* Patients visiting their family doctor, students of biomedical studies.

Exclusion Criteria:

* None

Primary outcomes:
measure: Understanding
timeFrame: 3 months
Secondary outcomes:
measure: Reading experience
timeFrame: 3 months
measure: Health numeracy
timeFrame: 3 months
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
affiliation: PhD student
name: Ivan Buljan, MPsy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schapira MM, Walker CM, Cappaert KJ, Ganschow PS, Fletcher KE, McGinley EL, Del Pozo S, Schauer C, Tarima S, Jacobs EA. The numeracy understanding in medicine instrument: a measure of health numeracy developed using item response theory. Med Decis Making. 2012 Nov-Dec;32(6):851-65. doi: 10.1177/0272989X12447239. Epub 2012 May 25.
citation: Buljan I, Tokalic R, Roguljic M, Zakarija-Grkovic I, Vrdoljak D, Milic P, Puljak L, Marusic A. Comparison of blogshots with plain language summaries of Cochrane systematic reviews: a qualitative study and randomized trial. Trials. 2020 May 25;21(1):426. doi: 10.1186/s13063-020-04360-9.
Clinical trial NCT02291601: Preoperative CHG Cloth on Healthy Subjects
Official title: Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 879
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.

Detailed description: Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area post CHG application.

Eligibility criteria: Inclusion Criteria:

* Males or Females
* 16 years of age or older
* Signed informed consent
* Good Health
* Six inches of abdomen and groin areas without tattoos, or skin disorders

Exclusion Criteria:

* Dermatological Conditions
* Sensitivity to latex
* Sensitivity to CHG

Primary outcomes:
measure: Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites
timeFrame: 10 minutes to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Butte
country: United States
facility: BioScience
state: Montana
Study officials:
affiliation: BS
name: C Beausoleil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04770701: Protect and Improve Cluster of Differentiation 4 (CD4) Cells and B Cells Lymphocytes
Official title: Extracts of Plants Eclipta Prostrata, Dioscorea Cirrhosa, Phyllanthus Urinaria, Adenosma Glutinosum, Impatiens Balsamina and Ascorbic Acid Use for in Protecting and Increasing CD4+ T Lymphocytes; B Lymphocytes Level in HIV/AIDS Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1-infection
AIDS
Lead sponsor: Trieu, Nguyen Thi, M.D.
Sponsor class: INDIV
First posted: 2021-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 people were recruited HIV / AIDS positive between the ages of 20 and 60 and divided into 2 groups according to a random distribution.
Primary purpose: TREATMENT

Brief summary: This is a plant-based medication used to increase the amount, protect, and reduce HIV's impact on T and B lymphocytes.

Detailed description: Dioscorea cirrhosa, impatiens balsamina, eclipta prostrata, phyllanthus urinaria, adenosma glutinosum, and ascorbic acid are used to elevate T and B lymphocytes level, protect their cells membrane, decrease the damage of HIV on CD4+ T.

In detail, Diosgenin presented in dioscorea cirrhosa is a precursor of cortisol. Dioscorea cirrhosa when combined with ascorbic acid helps to balance cortisol levels which reduces cell inflammation. Flavonoids of dioscorea cirrhosa also help to increase CD4+ T levels.

impatiens balsamina can be used as an antitoxin alternative against bacteria or viruses. Flavonoids in impatiens balsamina, such as kaempferol, quercetin, rutin, astragalin, have the ability to reduce the virus's impact on T lymphocyte, protect their cell membrane, produce antihistamine, protect the cell from inflammation.

Targeted flavonoids in eclipta prostrata, phyllanthus urinaria, adenosma glutinosum are used to cell repair, protect and increase CD4+ T production.

Ascorbic acid in combination with herbal extracts creates a favorable environment for body metabolism, improves the medication's effectiveness.

Eligibility criteria: Inclusion Criteria:

* Participants have a decline in CD4 + T-lymphocytes is the hallmark of HIV-1 infection.

Characterized by rapid loss of resistance: AIDS

* Dermatitis, mouth ulcers, skin rash, itching, weight loss
* HCV (+), HBV (+), Tuberculosis (+)

Exclusion Criteria:

* Cancer under all form

Primary outcomes:
measure: The CD4 cell count measurement
timeFrame: - 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Saigon Biopharma LLC
state: Delaware
city: Ho Chi Minh City
country: Vietnam
facility: Saigon Biopharma Company Limited
Study officials:
affiliation: Trieu, Nguyen Thi, M.D.
name: Tran Minh Duc, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05120401: Causal Relationship Between Dry Eye and Accommodative Spasm
Official title: Causal Relationship Between Dry Eye and Accommodative Spasm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian population with dry eye

Brief summary: To investigate the causal relationship of Sicca dry eye patients with presbyopic refractive error and accommodative spasm.

Detailed description: Dry eye is a disease of the ocular surface. Severe dry eye produce symptom of discomfort in and around the eye that drastically affect life quality of the patient. OSDI index is retrieve from a questionnaire specific for these dry eye symptoms, it is an internationally accepted level to reveal the severity of Dry eye disease. One part of the symptom is pain and soreness around the eye. Hyperalgesia is an increase response to a stressful/ noxious stimulus whereas allodynia is a painful response to a normally innocuous stimulus. Our hypothesis state that Sicca Dry eye upregulated inflammatory cytokine in the eye has pre-sensitized the nociceptor nerve fiber in the cornea and orbit, therefore the normally innocuous effort of accommodation and ciliary muscle contraction produce intolerable retro-orbital eye pain, which drives the patient to seek medical attention, on presentations these patient show an elevated OSDI and Pain Index (PI).

Eligibility criteria: Inclusion Criteria:

- dry eye

Exclusion Criteria:

* under 20 year old

Primary outcomes:
measure: Improve of dry eye / OSDI
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Elsa LC MAI, MPH, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01584401: Temperature Measurement Using a Non Invasive Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Body Temperature Measurement
Keywords: Body temperature
Thermometers
Non invasive
Medisim's non invasive thermometers
Lead sponsor: Medisim Ltd
Sponsor class: INDUSTRY
First posted: 2012-04-25
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-blinded, randomized study format. Study population includes 500 patients at all ages and from both genders.

Brief summary: Main study objectives:

1. To compare the temperature measured using Medisim's thermometers to the temperature measured using mercury or equivalent reference thermometers.
2. To develop more accurate algorithms for measuring on the forehead as well as behind the ear.
3. To test the difference between various forehead measurement locations in order to allow more convenient measuring that is not depended on the exact location.


Eligibility criteria: Inclusion Criteria:

* Patients arriving to the emergency room
* A signed consent by the patient or the guardian.

Exclusion Criteria:

* The medical staff decides that patient is not allowed to participate.
* The patient refuses to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Yehezkel Weissman, Proffessor
role: PRINCIPAL_INVESTIGATOR
References: