louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03251014: Thrombotic Effects of Yellowstripe Scad
Official title: The Thrombotic Effects of Yellowstripe Scad (YSS) Compared to Salmon Among Healthy Overweight Subjects: A Randomized Cross Over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombosis
Keywords: Thrombosis
Yellowstripe scad
Salmon
Healthy overweight subjects
Randomized crossover trial
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Science, Technology and Innovation (MOSTI) Malaysia
First posted: 2017-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic effects and the effects may be similar with salmon.

Detailed description: The project was a randomized, two-period, crossover trial with 8-week treatment periods and 8-week washout period. A total of 50 healthy overweight adults were recruited among staff and students in UPM. All the subjects were randomized into two groups. Each group was served with either cooked YSS (\~265 g/ day) or salmon (\~246 g/day) thrice per week. Blood and urine samples were collected for laboratory assessment.

Eligibility criteria: Inclusion Criteria:

* Malaysian
* Overweight participants (BMI 23-27.4 kg/m2)

Exclusion Criteria:

* Regular use of fish oil supplements during the last one month
* Regular consumption of fish twice or more per week
* Vegetarian who excluded all meat, fish, and poultry from their diet
* Diagnosed with cardiovascular disease, haemostasis disorder, inflammatory disease, diabetes mellitus, hypertension, or other significant medical history that may prohibits the participation
* Receiving warfarin or aspirin treatment, or medication to lower serum lipids, blood pressure, and inflammation
* Women who are menopause, pregnant or lactating

Primary outcomes:
measure: Changes in hemostatic status assessed by immunoassay method
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in lipid and glucose profiles analysed by medical diagnostic laboratory
timeFrame: 8 weeks
measure: Changes in liver enzymes analysed by medical diagnostic laboratory
timeFrame: 8 weeks
measure: Changes in renal function analysed by medical diagnostic laboratory
timeFrame: 8 weeks
measure: Changes in body mass index (BMI)
timeFrame: 8 weeks
measure: Changes in blood pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universiti Putra Malaysia
name: Su Peng Loh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00804414: Efficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers
Official title: A Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Soluble Beta-1,3/1,6-glucan (SBG) in Chronic Foot Ulcers in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetic Ulcer
Keywords: Diabetes
Diabetic ulcer
Chronic ulcer
SBG
Lead sponsor: Biotec Pharmacon ASA
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 133
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: Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot ulcers.

Detailed description: The objective of this study is to evaluate efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) on chronic diabetic foot ulcers.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic diabetic foot ulcer

Exclusion Criteria:

* Insufficient nutritional status, renal function or diabetes control

Primary outcomes:
measure: Compare the proportion of patients in the two arms who have complete healing of target ulcer
timeFrame: Maximum 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References:
Clinical trial NCT05961514: the Beijing Randomized Study Of Prostate Cancer Screening
Official title: The Randomized Controlled Trial of Prostate Cancer Screening in Beijing, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
MRI
Biopsy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 30000
Sex: MALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: BROPCS is a randomized trial study comparing the effectiveness of traditional systematic biopsies and bpMRI followed targeted biopsies with PSA \> 4ng/ml in initial screening.

Detailed description: The aim of BROPCS study is to explore a suitable prostate cancer screening model for Chinese population, which can increase the specificity in early detection of prostate cancer without decreasing the sensitivity of clinically significant prostate cancers, and can reduce prostate cancer-specific mortality.This study will use a cluster randomized controlled trial method with a total of approximately 30,000 participants. The subjects will be randomly assigned to a control group (about 20,000 people) and a screening group (about 10,000 people), and some basic information will be obtained through a questionnaire survey. The screening group will undergo initial prostate-specific antigen (PSA) screening, and high-risk subjects (PSA \> 4ng/ml) will be randomly assigned to two groups. The standard biopsy group will undergo traditional systematic biopsy, while the precision screening group will undergo further MRI examination and targeted fusion biopsy for those with positive MRI results.

Eligibility criteria: Inclusion Criteria:

1. Healthy men aged 60-75 with a life expectancy of more than 10 years;
2. Residing continuously in the community for more than 3 years and not previously diagnosed with prostate cancer;
3. Willing to participate in this project.

Exclusion Criteria:

1. Previously diagnosed with prostate cancer;
2. Previously diagnosed with any malignant tumor within the past 5 years;
3. Used medication within the past 3 months that can affect PSA values, mainly finasteride, dutasteride, and ketoconazole;
4. Recently had acute prostatitis, acute urinary retention, or underwent transurethral procedures (such as urethral dilation, urinary catheterization, cystoscopy, etc.) within the past week;
5. Have other serious illnesses or cannot perform activities of daily living independently.

Primary outcomes:
measure: detection of clinically significant prostate cancer （Gleason Score ≥7）
timeFrame: At 2 months after the last included biopsy procedure
Secondary outcomes:
measure: detection of clinically insignificant prostate cancer （Gleason Score 3+3）
timeFrame: At 2 months after the last included biopsy procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital &institute
state: Beijing
Study officials:
References:
Clinical trial NCT00786214: Treatment of Functional Dyspepsia With Acupuncture
Official title: Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Keywords: Functional Dyspepsia
Acupuncture
Traditional Chinese Medicine
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2008-11-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders affecting humans. Existing therapies for FD are still far from satisfactory and new therapies are constantly being sought. Acupuncture has been used for the alleviation of functional gastrointestinal symptoms in several non-controlled studies. This study aims to investigate the therapeutic efficacy of acupuncture in patients with FD.


Eligibility criteria: Inclusion criteria:

- female and male patients with functional dyspepsia between the ages of ≥18 and ≤70 years. FD will be diagnosed according to the Rome-III criteria. Onset of FD symptoms should begin at least 6 months before clinical presentation and must be fulfilled for the last 3 months and his or her FD symptoms score must be of at least moderate severity.

Exclusion criteria:

* Subjects unable to give informed consent
* Pregnant or breast-feeding females or women who get pregnant midway
* Subjects who have received acupuncture treatment before
* Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy
* Any significant past or concurrent disease or disorder which, in the opinion of the investigator, may either put subject at risk in the study, influence the results of the study or influence subject's ability to participate in the study
* Maintenance treatment with PPIs (proton pump inhibitors) and H2RAs (H2-receptor antagonists) continuously (every day) in the last 6 months prior to entry into the study
* Treatment with PPIs and H2RAs, prokinetics, antibiotics, prostaglandins or bismuth-containing compounds during the last 2 weeks prior to entry into the study
* H. pylori eradication treatment within the past 12 months before study start
* H. pylori positive patients
* Patients with bleeding diathesis
* Known or suspected hypersensitivity to acupuncture.

Primary outcomes:
measure: Resolution of symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Health-related quality of life and hospital anxiety & depression scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Khek Yu Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05511714: Expanded Access [11C] Methionine PET Imaging
Official title: Expanded Access [11C] Methionine PET Imaging
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Central Nervous System Tumor
Head and Neck Neoplasms
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2022-08-23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The participants are being asked to get this PET scan because the participants have or may have cancer in the central nervous system (head, neck, or spine), and the investigator and the patient's physician thinks that this scan may provide useful information for the participant's treatment.

Primary Objective

To provide expanded access to L-\[11C\]methionine as a positron-emitting tracer in children and young adults for the positron emission tomography (PET) imaging of neoplasms of the central nervous system (CNS) and head and neck to guide therapeutic management of disease.

Detailed description: Participants receive an intravenous injection of a small (tracer) dose of L-\[11C\]methionine. Approximately 10 minutes later, patients undergo PET scanning to evaluate localization of the tracer.

Eligibility criteria: Inclusion Criteria:

* All participants under the care of a SJCRH physician with known or suspected neoplastic disease of the CNS or head and neck are eligible for participation.
* No limit on age.
* Patients of all genders and all ethnic groups under the care of a SJCRH physician.
* Female participants of child-bearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
* Informed consent signed by participant, parent, or guardian according to the guidelines of the Institutional Review Board.

Exclusion Criteria:

* More than six L-\[11C\]methionine PET scans within the previous 12 months.
* Inability or willingness of patient, parent, or guardian to consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Barry L. Shulkin, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00896714: Factors Influencing Anesthetic Drug Requirement
Official title: Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 3278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing scheduled surgery under general anesthesia, agreeing to participate in the study

Exclusion Criteria:

* Age under 18 years
* Pregnancy, breastfeeding woman
* Allergy to propofol, soybeans or peanuts
* Allergy to sufentanil, remifentanil, morphine,
* Allergy to a muscle relaxant or to any of its excipients
* Known hypersensitivity to sufentanil, remifentanil, or to other derivates of fentanyl
* History of central neurological disorder or brain injury
* Patient with dementia
* Patient with pacemaker
* Patient receiving psychotropic drugs or morphine agonist-antagonists
* Surgery on the skull and/or operating position preventing the use of a bispectral index sensor in suitable conditions

Primary outcomes:
measure: The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia
timeFrame: during anesthesia
Secondary outcomes:
measure: Propofol dose required for anesthesia induction
timeFrame: intraoperative period
measure: Remifentanil dose required for anesthesia induction
timeFrame: intraoperative period
measure: Remifentanil dose requirements for maintenance of anesthesia
timeFrame: intraoperative period
measure: Wake up time
timeFrame: intraoperative period
measure: Explicit memorisation
timeFrame: post-operative period
measure: Propofol and remifentanil requirements according to the surgical technique
timeFrame: post-operative period
measure: Analysis of subgroup of patients according to their clinical status
timeFrame: post-operative period
measure: Analysis of subgroup of patients according to the surgical approach
timeFrame: post-operative period
measure: Analysis of subgroup of patients according to their pathology
timeFrame: post-operative period
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Dreux
country: France
facility: Centre Hospitalier de Dreux
city: Paris
country: France
facility: Hôpital Tenon
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01460914: Outcomes of Cutaneous T-Cell Lymphoma and Graft-Versus-Host Disease With Extracorporeal Photopheresis Treatment
Official title: Outcomes of Cutaneous T-Cell Lymphoma and Chronic Graft-Versus-Host Disease in Patients Treated With Extracorporeal Photopheresis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous T Cell Lymphoma
Graft Versus Host Disease
Keywords: ECP
CTCL
Extracorporeal photopheresis
Cutaneous T Cell Lymphoma
GVHD
Graft versus host disease
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2011-10-27
Enrollment: 34
Sex: ALL
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: Patients who receive ECP treatment at DHMC

Brief summary: Extracorporeal Photopheresis (ECP) is a form of apheresis and photodynamic therapy in which the peripheral blood is treated with 8-methoxypsoralen, which is then activated with UV light. ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL) and is also effective for graft-versus-host disease (GVHD). The investigators would like to study the outcomes (response rates) of patients receiving ECP treatment and other factors relating to their disease and treatment, as well as procedural events, such as complications.

Detailed description: The investigators intend to report outcomes from the inception of this procedure at Dartmouth-Hitchcock Medical Center (DHMC) in May 2008 through 9/30/11. Additionally, the investigators would like to maintain a prospective database of these patients so that new patient data can be collected for updating of outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients who receive Extracorporeal Photopheresis treatment
* Treated at Dartmouth-Hitchcock Medical Center
* Must be 18 years or older

Exclusion Criteria:

- None specified

Primary outcomes:
measure: Response rates
timeFrame: 1 year
Secondary outcomes:
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Frederick Lansigan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weber LL, Dunbar NM, Meehan KR, Szczepiorkowski ZM, Lansigan F. Successful implementation of a rural extracorporeal photopheresis program for the treatment of cutaneous T-cell lymphoma and chronic graft-versus-host disease in a rural hospital. J Clin Apher. 2015 Dec;30(6):359-63. doi: 10.1002/jca.21382. Epub 2015 Feb 17.
Clinical trial NCT00060814: Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients
Official title: Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2003-05-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to examine the effects of combined pharmacotherapy (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy patients.

Detailed description: This is a one-arm, open label pilot study of MMT patients to determine whether bupropion, nicotine replacement therapy, and behavioral counseling is a feasible and potentially effective intervention for smoking cessation. The smoking behaviors of participants will be be followed for 6 months post quit-date to determine effect-size estimates for a future, large scale trial.

Eligibility criteria: Inclusion Criteria:

* Patients in long-term methadone maintenance treatment
* Patient smokes at least 10 cigarettes per day, are stable on their use of methadone (phase 2 or higher treatment), smoked for at least 1 year, be willing to participate for 6 months, and not have used bupropion or nicotine replacement therapy for 6 months

Exclusion Criteria:

* Patients who use prescription drug regimens that might affect methadone or bupropion metabolism
* Patients with cardiovascular disease, asthma, COPD
* Patients who are pregnant or breastfeeding
* Patients with regular use of alcohol, other illicit drugs, or other types of tobacco (chewing or pipe for example)

Primary outcomes:
measure: Behavioral
timeFrame: 6 months
Secondary outcomes:
measure: Number of cigarettes smoked per day
timeFrame: six months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kimber Richter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01683214: Brain Network Activation Analysis to Diagnose/Assess Treatment of Unipolar Major Depression and Bipolar I Depression
Official title: Potential Use of Brain Network Activation (BNA) Analysis Using Evoked Response Potentials to Diagnose Unipolar Major Depression and Bipolar I Depression and Assess Response to Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Depression
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 30
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: This study will only enroll subjects who are participating in another specified clinical trial.The inclusion/exclusion criteria will depend on the criteria for each of the studies utilizing subjects with depression or bipolar type I disorder

Brief summary: The investigators are conducting this study to test the usefulness of a new type of analysis of electroencephalographic (EEG) recordings called brain network activation or BNA. BNA allows to identify patterns of activation in brain networks and to track their changes over time. The investigators want to examine the possible role of brain network activation (BNA) in the diagnosis of mood disorders and predicting improvement over time. The procedure conducted with patients diagnosed with a mood disorder will be compared to people who do not have a mood disorder.

Detailed description: Novel approach to ascertain use of BNA strategy and technology for the use in confirming diagnosis and predicting effect of specific treatment(s)in the various stages of affective/mood disorders. The goal is to develop non-invasive technology to confirm diagnosis via biological outcomes, and to study the preliminary data of predicting response/non-response to specific interventions before clinical effects are shown.

Eligibility criteria: Only subjects participating in another specific clinical trial will be invited to participate in this study.

The inclusion/exclusion criteria for this observational study are based on the individual inclusion/exclusion criteria for each of the studies and can be found for each of the studies on this website.

The specific studies and their numbers are found on their individual ClinicalTrials.gov site.

INCLUSION CRITERIA:

Bipolar I, depressed Major depression Meeting all criteria to sign the informed consent for each study included in this study who currently have a major depression (unipolar or bipolarI)

EXCLUSION CRITERIA:

Medically unstable (based on opinion of sponsor and PI Unable to meet the criteria to conform to the Rush University informed consent process

Primary outcomes:
measure: Correlation of changes in BNA with changes in mood symptoms
timeFrame: Beginning of study to end of study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: RushUMC ; Rush University Medical center
name: John M Zajecka, MD
role: PRINCIPAL_INVESTIGATOR
References: