louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04692987: Effectiveness of Decision-aid Video on Colorectal Cancer Screening
Official title: Effectiveness of Decision-aid Video on Colorectal Cancer Screening in Primary Healthcare Setting: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Screening
Primary care
Video
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial will be conducted in 3 months duration, with intention-to-treat.
Primary purpose: SCREENING

Brief summary: Colorectal cancer (CRC) is the second most common cancer in Malaysia. Diagnosing CRC at early stage is crucial to reduce their mortality risk. To achieve this aim, CRC screening promotion intervention is deemed necessary.

Detailed description: High-quality CRC screening interventions and approaches should be delivered to a large proportion of target population.

To our knowledge, there is no interactive video been developed, that can be used as educational tool for CRC screening in Malaysia. By developing an educational video, we hope that it can be used by health professionals to promote CRC screening, favoring their empowerment for prevention and control of disease.

Eligibility criteria: Inclusion Criteria:

* Malaysian aged 50 - 74 years old
* No previous history or family history of CRC
* Asymptomatic of CRC
* Never participated in CRC screening

Exclusion Criteria:

* Acute patients
* Patients on aspirin, warfarin or any blood-thinning agent
* Illiterate or having a significant vision or hearing impairment

Primary outcomes:
measure: Number of participants with colorectal cancer screening completion
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with colonoscopy completion among those with positive fecal occult blood test
timeFrame: 3 months
measure: Period time from intervention to fecal occult blood test uptake
timeFrame: 3 months
measure: Barriers towards the colorectal cancer screening uptake
timeFrame: 3 months
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: The National University of Malaysia
state: Kuala Lumpur
Study officials:
affiliation: The National University of Malaysia
name: Azmawati Mohammed Nawi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609387: Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)
Official title: Postoperative Vitamin Supplementation in Morbidly Obese Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Vitamin Deficiency
Keywords: Vitamine
mineral
obese patients
Vitamine en mineral shortage in obese patients
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a double blind randomized controlled trial.

Detailed description: Based on evidence-based literature on vitamins and minerals, there is a cooperation of a manufacturer multivitamin specifically designed for patients with a gastric band and Roux-en-Y gastric bypass (RYGB). These preparations are the proportions adjusted so that the risk of shortages should decrease and on the other hand, excessive levels of nutrients should be avoided. Main objective of this study is to examine whether these new supplements in particular the number of deficiencies in iron, vitamin B12 and vitamin D can be reduced.

Eligibility criteria: Inclusion Criteria:

* Patients on the waiting list for RYGB or gastric band and meets
* Age between 18-65 years

Exclusion Criteria:

1. Creatinine \> 150micromol / L
2. Liver enzymes \> 2 times the upper limit
3. Previous surgery on the gastrointestinal tract
4. Intercurrerence disease
5. Gastrointestinal Diseases
6. Psychiatric illness
7. Drugs that affect bone metabolism
8. Known pregnancy

Primary outcomes:
measure: Reduction of iron deficiency in obese patients
timeFrame: one year
Secondary outcomes:
measure: Reduction of vitamin D and vitamin B12 deficiency
timeFrame: one year
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Wagnerlaan 55
Study officials:
affiliation: Rijnstate Arnhem
name: Frits Berends, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heusschen L, Schijns W, Ploeger N, Deden LN, Hazebroek EJ, Berends FJ, Aarts EO. The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT. Obes Surg. 2020 Apr;30(4):1280-1290. doi: 10.1007/s11695-019-04252-1.
Clinical trial NCT04309487: Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus
Official title: Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus - A Cross-sectional Analytic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydrocephalus, Normal Pressure
Keywords: Asymptomatic Normal Pressure Hydrocephalus
Ventriculoperitoneal Shunt
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: NeuroDx Development
First posted: 2020-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of NPH hydrocephalus research subjects who have a VP shunt with a single ventricular catheter implanted for adult hydrocephalus are suspected of shunt obstruction and are scheduled for a radionuclide SPS.

Brief summary: The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Detailed description: The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Eligibility criteria: Inclusion Criteria:

* Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent

Exclusion Criteria:

* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
* Presence of an interfering open wound or edema over any portion of the VP shunt.

Primary outcomes:
measure: Sensitivity of ShuntCheck compared to radionuclide shunt patency study
timeFrame: 15 minutes
measure: Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study
timeFrame: 60 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Department of Neurological Surgery and Brain Repair
state: Florida
Study officials:
affiliation: University of South Florida
name: Naomi Abel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06065787: NeuroGlove Anxiety and Depression Study
Official title: Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Anxiety and Depression: Assessing Safety and Effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Anxiety Depression
Depression, Anxiety
Keywords: Anxiety
Depression
Lead sponsor: NeuroGlove LLC
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, homebased, interventional clinical study containing 10 subjects who will be enrolled. Approximately 10 (10) subjects with active anxiety and depression symptoms will receive treatment using the NeuroGlove.

Detailed description: This is a prospective, homebased, interventional clinical study containing 10 subjects who will be enrolled. Approximately 10 (10) subjects with active anxiety and depression symptoms will receive treatment using the NeuroGlove.

Subjects will be recruited in from the community. Inclusion in the study will not impact the care management of the subject. Informed consent will be obtained from all subjects before inclusion in the study.

Eligibility criteria: Inclusion Criteria:

* Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
* Men and women ≥18 and \<85 years of age.
* Carry an active diagnosis of anxiety and/or depression.
* Suffer from anxiety and/or depression symptoms that impact subject's daily activities and quality of life.

Exclusion Criteria:

* Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
* The subject lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
* Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)

Primary outcomes:
measure: Change in anxiety symptoms using GAD-7
timeFrame: 4 weeks
measure: Change in depression symptoms using PHQ-9
timeFrame: 4 weeks
measure: Rate of Adverse Events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: NeuroGlove
state: Minnesota
Study officials:
affiliation: NeuroGlove LLC
name: Eric Nussbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03561987: Biomarkers Derived From Adipose Tissue Useful for Diagnosis and Prognosis of Cardiovascular Risk (CVR) in Obese Patient
Official title: Identification of Biomarkers Derived From Adipose Tissue With Potential Utility in the Diagnosis and Prognosis of Cardiovascular Risk of the Obese Patient.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Diabetes Mellitus
Inflammatory Response
Keywords: ADIPOSE TISSUE, CARDIOVASCULAR, OBESE PATIENTS
Lead sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Sponsor class: OTHER_GOV
First posted: 2018-06-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbid obese patients candidates to bariatric surgery.

Brief summary: This study evaluates the relationship between the adipose tissue, as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Detailed description: Bariatric surgery induces a significant reduction in co-morbidities associated with obesity, such as Diabetes mellitus, dyslipidemia, liver disease, arterial hypertension, obstructive apnea and cardiovascular risk. However this does not happen in all obese patients, even when there is a weight reduction.

It is known that the adipose tissue is actively involved in synthesis of cytokines and its role in metabolic phenotypes has been suggested. It is possible that the intrinsic mechanisms of adipose tissue participate in several benefits observed in morbidly obese patients who undergo to an anti-obesity surgery.

So this study explores the involvement of adipose tissue as an active component, which can define metabolic phenotypes linked to cardiovascular risk modification post bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Above 18 years old.
* Morbid obese patients candidates to bariatric surgery.

Exclusion Criteria:

* Second bariatric surgery

Primary outcomes:
measure: Evaluate the association of the cardiovascular benefit of the obese patient after bariatric surgery with the basic mechanisms of adipose tissue (metabolic profile)
timeFrame: 3 years
Secondary outcomes:
measure: Correlation between serum concentration of pro-inflammatory biomarker and the reduction of subclinical endothelial disfunction.
timeFrame: 9 months
measure: Determine the association of the cardiovascular prognosis modification (risk subgroups) with the basal metabolic profile.
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03162887: Educational Module and Decision Counseling Program in Increasing Mammography Screening Rates in Formerly Homeless Women With Serious Mental Illness
Official title: Mammogram Decision Support for Formerly Homeless Women With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast - Female
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2017-05-22
Enrollment: 23
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This pilot clinical trial studies how well an educational module and decision counseling program works in increasing mammography screening rates in formerly homeless women with serious mental illness. An educational module and decision counseling program may be an effective tool and have the potential to help with early detection and treatment.

Detailed description: PRIMARY OBJECTIVES:

I. Increase mammography screening rates in women age 40 and over with experiences of homelessness and serious mental illness (SMI).

II. Increase knowledge, decease psychological distress, and advance decision stage and intention to get a mammogram in study participants.

Eligibility criteria: Inclusion Criteria:

* 30 formerly homeless women with a diagnosis of a serious mental illness in the Pathways to Housing or Project HOME supportive housing programs
* Only women that have never received a mammogram are eligible to participate (self-report)
* Participants must be willing to participate in all aspects of research

Exclusion Criteria:

* Participants cannot be decisionally impaired, actively psychotic, or have unstable mental illness that prevents participation in the decisional counseling session
* Women who have had a mammogram will be excluded from the study

Primary outcomes:
measure: Change in decisional conflict score assessed by pre- and post-intervention survey
timeFrame: Baseline up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Lara Weinstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01298687: Divided Dose of TRAVATAN®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: open-angle glaucoma
ocular hypertension
divided dose
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 67
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 compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).


Eligibility criteria: Inclusion Criteria:

* Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria:

  1. Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1;
  2. Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1.
* Must sign an informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures.
* Current or history of ocular inflammation or infection in either eye within the past 3 months.
* Corneal thickness greater than 620 µm as determined by pachymetry in either eye.
* Severe visual field loss.
* Cup to disc ratio greater than 0.8 in either eye.
* Intraocular surgery within the past 6 months in either eye.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: 24-hour Area Under the Curve (AUC) in IOP Reduction
timeFrame: Day 5
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Matt Walker, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01866787: Study on Baroreceptor Function in Relation to Orthostatic Blood Pressure Regulation After Hip Surgery
Official title: Baroreceptor Function and Inflammation in Relation to Orthostatic Intolerance During Early Mobilization After Elective Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension, Orthostatic
Total Hip Replacement
Keywords: Postoperative orthostatic intolerance
Surgical inflammatory response
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2013-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective unilateral hip arthroplasty at Frederiksberg Hospital.

Brief summary: The purpose of this observational study is to evaluate the baroreceptor function in relation to surgical inflammation and orthostatic intolerance after elective hip arthroplasty.

The main hypothesis is that baroreceptor function is attenuated after surgery and related to surgical inflammation.

Detailed description: Orthostatic intolerance and hypotension is prevalent during early mobilization after major surgery.

This observational study aims to evaluate the baroreceptor function during using a standardized evaluation protocol before, 6- and 24 hours after elective primary unilateral hip-arthroplasty.

The study hypothesis is that baroreceptor function as expressed by the valsalva ratio is attenuated after surgery and related to surgical inflammation.

Eligibility criteria: Inclusion Criteria:

* Scheduled for unilateral hip arthroplasty
* 18 years or older
* Able to give informed consent

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) class 3 or higher
* Chronic arrythmia (Atrial fibrillation or other arrythmia)
* Incompensated ischaemic heart disease
* Mobilization restriction due to surgical reasons
* Medical complications during admission requiring transferral to other department

Primary outcomes:
measure: Change in baroreceptor function from preoperatively to 6 hours after surgery
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: Orthostatic response in blood pressure
timeFrame: Preoperative, 6 and 24 hours after surgery
measure: Orthostatic response in heart rate variability
timeFrame: preoperative, 6 and 24 hours postoperative
measure: Orthostatic intolerance
timeFrame: preoperative, 6 and 24 hours after surgery
measure: Inflammatory markers
timeFrame: preoperative, 6 and 24 hours postoperative
measure: Orthostatic Hypotension
timeFrame: Preoperative, 6 and 24 hours postoperative.
measure: Baroreceptor function
timeFrame: On the day of surgery: preoperatively, 6- and 24 hours after surgery
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital, Department of orthopaedic surgery
Study officials:
affiliation: Rigshospitalet, Denmark
name: Øivind Jans, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152087: A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.
Official title: Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Cancer
Keywords: Liver cancer
Brachytherapy
Lead sponsor: St. Joseph's Hospital, Florida
Sponsor class: OTHER
First posted: 2005-09-09
Enrollment: 25
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: Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.

Detailed description: Protocol Objectives include:

* Determine the proportion of patients with HCC in whom the treatment plan can be completed
* Evaluate the response to therapy
* Evaluate toxicities and adverse experiences associated with TheraSphere treatment
* Evaluate survival time

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age of any sex, race
* Histological proof of HCC
* Able to give Informed Consent
* ECOG performance equal or less than 2
* Life expectancy equal to or greater than 3 months
* Non- pregnant with acceptable contraception in premenopausal women
* Greater than 4 weeks since prior radiation therapy or surgery
* 1 month post chemotherapy
* Serum Bilirubin \< 2.0
* Acceptable white blood count

Exclusion Criteria:

* Co-morbid disease that would place patient at undue risk.
* Pre-existing diarrhea/illness
* Pregnant
* Fail preliminary MAA testing

Primary outcomes:
measure: Efficacy
measure: - Response to treatment
measure: - Survival time from treatment
measure: Safety:
measure: - Adverse experience
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
Study officials:
affiliation: St. Joseph's Hospital, Tampa, FL
name: Alison R. Calkins, MD
role: PRINCIPAL_INVESTIGATOR
References: