louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00803699: Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
Official title: Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Requirements
Keywords: selenium
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-05
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.

Detailed description: Results of studies with animal tumor models and human clinical trials suggest that the essential nutrient selenium can be anti-tumorigenic if consumed at levels greater than nutritional requirements. If it is possible to increase plasma selenium concentrations above 120 nanograms per milliliter with less than 200 micrograms of selenium daily, then it is possible that supplementation can be accomplished through the use of selenium-containing foods.

Eligibility criteria: Inclusion Criteria:

* able to swallow capsules
* body mass index less than 40

Exclusion Criteria:

* Pregnancy
* Chronic liver or kidney disease
* taking medication that might affect liver and/or kidney
* blood pressure 140/90 or higher
* already taking more than 50 micrograms of selenium

Primary outcomes:
measure: Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations
timeFrame: Baseline, and after 3, 6, 9, and 12 months of supplementation
Secondary outcomes:
measure: Biomarkers of selenium status will be determined in urine, buccal cells, and plasma. White blood cells will be analyzed to identify DNA damage, reflecting the degree of oxidative damage and evaluate the status of antioxidant repair mechanisms.
timeFrame: Baseline and after 12 months of supplementation
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Gerald F Combs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson MI, Combs GF Jr. Selenium and anticarcinogenesis: underlying mechanisms. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):718-26. doi: 10.1097/MCO.0b013e3283139674.
Clinical trial NCT01046799: Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir
Official title: Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplantation
Hepatitis B
Liver Disease
Keywords: hepatitis B
liver transplantation
shortterm HBIg
lamivudine resistance
Lead sponsor: HepNet Study House, German Liverfoundation
Sponsor class: NETWORK
Collaborators: name: Hannover Medical School
First posted: 2010-01-12
Enrollment: 20
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 purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.


Eligibility criteria: Inclusion Criteria:

* liver transplantation for hepatitis B induced endstage liver disease
* absence of coinfection with HIV and HCV
* female and male patients \>= 18 years of age

Exclusion Criteria:

* any evidence of other causes for endstage liver disease
* patients that do not fulfill the criteria for liver transplantation

Primary outcomes:
measure: prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy
timeFrame: one year
Secondary outcomes:
measure: hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation
timeFrame: two years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Clinic Essen
city: Hannover
country: Germany
facility: Hannover Medical School
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: Hannover Medical School
name: Michael P Manns, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Heiner Wedemeyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05260099: Remove LPS Registry
Official title: Post Market Clinical Follow up (PMCF) Medical Device (MD) Registry of the Alteco® LPS Adsorber to Remove Lipopolysaccharide (LPS) in Patients With Suspected Endotoxemia, With Severe Symptom(s)/Complication(s) and Their Stabilization Outcomes: REMOVE LPS Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria
Lead sponsor: Alteco Medical AB
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected or diagnosed sepsis caused by gram-negative bacteria.

Brief summary: This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have suspected endotoxemia. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.


Eligibility criteria: Inclusion Criteria:

* Weight \> 30 kilos

Specific sub-registry criteria are possible.

Exclusion Criteria:

* None

Primary outcomes:
measure: The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment.
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Outcomes will be to document the change in a patient's symptoms of infection over time.
timeFrame: 30 days
measure: Rate of complaints and incidents related to the medical device during the whole registry.
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03858699: Brain Vital Signs M-Score: Point-of-care Monitoring for Motor Recovery After Stroke
Official title: Brain Vital Signs M-Score: Point-of-care Monitoring for Motor Recovery After Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke
Lead sponsor: HealthTech Connex Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-01
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Number of Participants: Up to 30 healthy participants and 30 individuals with stroke.

Brief summary: The purpose of this study is to investigate brain signals relating to motor function, using electroencephalography (EEG) technology. The aims of the study can be separated into 3 specific study objectives:

1. Record EEG data from control participants and individuals with stroke during basic motor tasks and build a database of EEG signals to enable analysis of motor control.
2. Apply signal processing algorithms to extract EEG features related to motor control.
3. Develop a framework/the motor score (M-Score) that uses the EEG signals, in combination with machine learning approaches, to quantify motor control ability.


Eligibility criteria: Inclusion Criteria:

* Age requirements:

  * Younger adult control participants (19-40 years old)
  * Older adult control participants (41-80 years old)
  * Individuals with stroke (19-80 years old)
* Capacity to follow single stage commands
* Stroke specific inclusion criteria

  * Upper-limb disability as a result of a stroke (\>1 month ago)

Exclusion Criteria:

* Cognitive difficulties that undermine ability to give informed consent (Montreal Cognitive Assessment (MoCA) score below 23).
* Severe paralysis such that the participant cannot perform simple movements (such as finger tapping, clicking a mouse, etc.)
* History of head trauma, a major psychiatric diagnosis, neurodegenerative disorder or substance abuse

Primary outcomes:
measure: Resting state EEG measures
timeFrame: 1 day
measure: Motor task EEG measures
timeFrame: 1 day
measure: Imagery task EEG measures
timeFrame: 1 day
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: 1 day
measure: Fugl-Meyer Assessment
timeFrame: 1 day
measure: Box-and-Block Test
timeFrame: 1 day
measure: Nine-Hole Peg Test
timeFrame: 1 day
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: HealthTech Connex Centre for Neurology Studies
state: British Columbia
Study officials:
References:
Clinical trial NCT01751542: Mindfulness and Acceptance Group Therapy for Substance Use
Official title: Mindfulness and Acceptance Group Therapy for Substance Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Substance Use Disorder
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 150
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: Randomized clinical trial comparing standard residential substance abuse treatment to standard residential treatment plus Mindfulness and Acceptance Group Therapy for substance use.


Eligibility criteria: Inclusion Criteria:

* participating in inpatient substance use treatment at treatment facility

Exclusion Criteria:

* psychosis and mental impairment

Primary outcomes:
measure: Substance use after discharge from treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tenneessee & Cornerstone of Recovery
state: Tennessee
Study officials:
References:
Clinical trial NCT03328442: Patient Satisfaction After Root Coverage Using VISTA Technique Compared to MCAF Technique With PRF.
Official title: Evaluation of Patient Satisfaction After Root Coverage Procedure Using VISTA Technique Compared to Modified Coronally Advanced Flap Technique in Conjunction With Platelet Rich Fibrin-membrane.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: VISTA technique with PRF compared to MCAF technique with PRF to treat gingival recession

Detailed description: Comparison between two techniques for root coverage divided in two groups the first (test group) VISTA technique in conjunction with PRF-membrane and the second (control group)MCAF technique in conjunction with PRF-membrane for treating Miller's class I and II gingival recession defects.

Clinical Periodontal Records will be taken at baseline, 3 months and 6 months respectively.

Visual analogue scale for pain during one week after operation. Patient satisfaction record using questionnaire after 6 months.

Eligibility criteria: Inclusion Criteria:

- Age (18-55) Miller's classI and II multiple GR width of KG\>2 mm

Exclusion Criteria:

* Systemic diseases Poor oral hygiene Smoking Patient allergy Miller's class III and IV

Primary outcomes:
measure: Patient satisfaction
timeFrame: after 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Azza Ezzelarab, PhD
role: STUDY_DIRECTOR
References:
citation: Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession defects by vestibular incision subperiosteal tunnel access and platelet-derived growth factor BB. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):653-60.
citation: Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
citation: Zuhr O, Rebele SF, Schneider D, Jung RE, Hurzeler MB. Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage: a RCT using 3D digital measuring methods. Part I. Clinical and patient-centred outcomes. J Clin Periodontol. 2014 Jun;41(6):582-92. doi: 10.1111/jcpe.12178. Epub 2013 Nov 10.
Clinical trial NCT01340742: Remote Ischemic Preconditioning Before Abdominal Surgery
Official title: Remote Ischemic Preconditioning Before Abdominal Surgery and the Prevalence of Perioperative Complications
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Perioperative/Postoperative Complications
Keywords: Remote ischemic preconditioning
Abdominal surgery
Perioperative complications
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Major abdominal surgeries are associated with perioperative cardiac morbidity of up to 10%.

Ischemic preconditioning may have a protective effect. The purpose of this study is to find out remote ischemic conditioning by inflating a blood pressure cuff on the arm will have a protective effect.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing abdominal surgery:large bowel, pancreatic and hepatic surgery

Exclusion Criteria:

* Chronic inflammatory disease.
* Glyburide use before surgery.

Primary outcomes:
measure: Cardiovascular Events: incidence of MI, TIA/stroke, death in both groups
timeFrame: One week
Secondary outcomes:
measure: Renal function deterioration in the first week after surgery
timeFrame: One week
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Ronit Lavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06055842: Different Implant Positions for Implant Retained Mandibular Overdenture
Official title: Retrospective Study on the Effect of Different Implant Positions for Implant Retained Mandibular Overdenture: Radiographic Evaluation of the Circumferential Bone Level and Bone Remodeling in the Anterior and Posterior Mandible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Keywords: implant
overdenture
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will aim to evaluate the effect of two different implant positions, lateral incisors, and canine areas, on anterior and posterior ridge resorption and bone remodeling after different periods of denture insertion.

Detailed description: Twelve patients will be recruited from a previous study (14), having two-implant mandibular overdentures. Patients recalled from the database set of the clinic of the Removable Prosthodontic Department, Faculty of Dentistry, Mansoura University. The patients will be grouped based on the position of the two implants.

All patients will be informed about all prosthetic procedures that will be done. Also, they will sign the consent form of the ethical committee of the faculty of dentistry, at Mansoura University.

All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will excluded from the study Patients will be divided into two groups Group A (6 patients): Patients having two mandibular implants in lateral incisor positions.

Group B (6 patients): Patients having two mandibular implants in canine positions.

Eligibility criteria: Inclusion Criteria:

* Patients with mandibular two implants retained overdenture opposing complete edentulous maxillary arch,
* attended the previous follow-up recalls with previous CBCT examination.

Exclusion Criteria:

* Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.

Primary outcomes:
measure: implant survival rate
timeFrame: 5 years
measure: circumferential bone loss
timeFrame: 5 years
measure: posterior bone changes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Khloud Ezzat
Study officials:
affiliation: Lecturer
name: Khloud Ezzat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292342: An Investigation of the Dose-dependent Vascualr Effects of (-)-Epicatechin in Healthy Men
Official title: An Acute, Double-blind, Randomised, Placebo-controlled, Crossover Intervention Trial Investigating the Dose-dependent Vascular Effects of Pure (-)-Epicatechin (≤1 mg/kg BW) in Healthy Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vasodilation
Keywords: Flow mediated dilatation
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 \& 1.0 mg/kg BW) in healthy men.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index 20-27.5 kg/m2
* Normal blood pressure at screening (\< 150/90)
* Non-smoker
* Non-vegetarian
* 'Normal - low' chocolate consumer (\<2 potions per week)
* 'Normal - low' coffee/ tea drinker (\<3 cups per day)
* Regular exercise routine
* Signed consent form

Exclusion Criteria:

* Haemoglobin (anaemia marker) \< 125 g/l
* Gamma GT (liver enzymes) \> 80 IU/l
* Cholesterol \> 6.5 mmol/l
* Suffered a myocardial infarction or stroke in the last 12 months
* Suffers from any cardiovascular or metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
* Suffers from any blood-clotting disorder, and/or takes supporting medication
* Any dietary restrictions or on a weight reducing diet
* On any lipid-modifying or blood pressure lowering medication
* Consuming any specific vitamin/ herbal supplements or fish oils

Primary outcomes:
measure: Flow mediated dilatation
timeFrame: baseline to 2h
Secondary outcomes:
measure: Laser Doppler Imaging with Iontophoresis
timeFrame: baseline to 2h
measure: Plasma (-)-epicatechin metabolites
timeFrame: baseline to 24h
measure: Plasma nitrate/nitrite
timeFrame: baseline to 2h
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences
state: Berkshire
Study officials:
affiliation: University of Reading
name: Jeremy Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03302442: Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis
Official title: Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RRMS Patients who initiated either DMF or Teriflunomide and with an available MRI scan and EDSS assessment respectively within 12 and 6 months before treatment initiation

Brief summary: The aim of this observational study is to compare Dimethyl fumarate (DMF) and Teriflunomide on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from French Observatory of Multiple Sclerosis (French MS cohort )


Eligibility criteria: Inclusion Criteria:

* RRMS Patients with an EDSS score ranging between 0 and 5.5, who initiated either DMF or Teriflunomide before 1/01/2016 and with an available MRI scan and EDSS assessment respectively within 12 and 6 months before treatment initiation Patients who had consent to OFSEP registry Naive patient or treated with prior first line treatment : interferon, glatiramer acetate

Exclusion Criteria:

* Patient with progressive multiple sclerosis
* Patients with prior second line Patient with no MRI or EDSS score within the year before DMF or Teriflunomide initiation.

Primary outcomes:
measure: Relapse within first year of treatment
timeFrame: 12 months
Secondary outcomes:
measure: Occurrence of clinical event at Two years
timeFrame: 24 months
measure: Progression of disability
timeFrame: 12 months and 24 months
measure: Radiological disease activity
timeFrame: 12 months and 24 months
measure: Adverse drug reaction
timeFrame: 12 months and 24 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References: