louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03741309: Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate on Dentinal Hypersensitivity
Official title: Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate and to a Placebo on Dentinal Hypersensitivity : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentinal Hypersensitivity
Keywords: dentinal hypersensitivity
visual analog scale
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
Collaborators: name: Group Pharma
First posted: 2018-11-14
Enrollment: 131
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro calcium phosphosilicate and dentifrice containing calcium sodium phosphosilicate on Dentinal Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.

Detailed description: A total of 131 subjects were divided into 3 groups randomly. Group I was given the dentifrice containing 5% fluoro calcium phosphosilicate ,Group II was given the dentifrice containing calcium sodium phosphosilicate and group III was given placebo. Sensitivity scores (VAS score) were recorded at baseline, 2 weeks, 6 weeks.

Eligibility criteria: Inclusion Criteria:

* The volunteers selected at baseline were in good general health and should have at least 20 natural permanent teeth and history of hypersensitivity to hot, cold, sour stimuli on at least two teeth with a VAS score of ≥4.

Exclusion Criteria:

* Patients with active cervical caries or deep abrasion requiring cervical filling, chipped teeth or fractured cusps, tender tooth in same quadrant as the hypersensitive teeth, Subjects using any type of desensitizing paste or desensitizing therapy for last 6 months, Pregnant/ lactating women or subjects with history of chronic use of anti-inflammatory and analgesic medications were excluded.

Primary outcomes:
measure: Visual Analogue Scale score for Dentinal Hypersensitivity
timeFrame: Change in VAS score from Baseline to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Department of Periodontics, GDCRI Bangalore
state: Karnataka
Study officials:
affiliation: GDCRI, Bangalore, INDIA
name: Avani R Pradeep, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01960309: Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.
Official title: Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardium; Injury
Coronary Artery Disease
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive techniques in patients with asymptomatic troponin elevation after noncardiac surgery. The primary objective is to quantify coronary artery disease, as determined by coronary CT and MR, as a cause of postoperative myocardial injury. The secondary objective is to correlate coronary calciumscore to postoperative levels of troponin.


Eligibility criteria: Inclusion Criteria:

* Major noncardiac surgery with a planned minimal postoperative hospital stay of 2 days
* Age \> 59 years
* Troponin_I elevation \> 0.06 ng/ml in the first 3 post-operative days
* No clinical symptoms of myocardial ischemia

Exclusion Criteria:

* Perioperative troponin elevation due to other factors than coronary artery disease such as proven pulmonary embolism or sepsis
* Perioperative ST-elevation myocardial infarction (STEMI)
* Perioperative symptomatic angina with troponin elevation
* Patients with a history or ECG-signs of myocardial infarction
* Patients with pre-existent heart failure, left ventricular dysfunction, significant valvular disease or left ventricle hypertrophy
* Patients with significant valvular disease or left ventricle hypertrophy determined postoperatively with echocardiography.
* Contra-indication for CMR such as claustrophobia or metal prosthesis
* Allergic reaction to CT-contrast or gadolinium
* Renal dysfunction with GFR \< 50 ml/min, as determined after the operation
* Unstable hemodynamics or other conditions disabling transport to the Radiology department
* Expected major discomfort or substantial increase in pain sensation by undergoing CCTA or CMR
* Admission at the ICU
* Poor prognosis due to other medical conditions e.g. malignancy

Primary outcomes:
measure: Coronary artery disease
timeFrame: During hospital admission
Secondary outcomes:
measure: Coronary calcium score
timeFrame: During hospital admission
measure: Extent of coronary artery atherosclerosis
timeFrame: During hospital admission
measure: Minimal myocardial injury
timeFrame: During hospital admission
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Hendrik M. Nathoe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02802709: A Trial of SB-061 in Osteoarthritis of the Knee
Official title: A Placebo-controlled, Double-blind, Randomized Trial of an Intra-articular Device, SB-061, in Symptomatic Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Keywords: knee
Lead sponsor: Symic OA Co.
Sponsor class: INDUSTRY
Collaborators: name: Nordic Bioscience Clinical Development
First posted: 2016-06-16
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.

Detailed description: The treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. Subjects will receive 2 intra-articular injections of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.

Eligibility criteria: Inclusion Criteria:

* Femorotibial osteoarthritis of the knee
* Radiological OA Kellgren-Lawrence grade 2 or 3
* WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9

Exclusion Criteria:

* Hypersensitivity to medications or to intra-articular injections
* Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study
* High dose systemic corticosteroid treatment of longer (\>14 days) duration w/in 6 months of study
* Major surgery or arthroscopy of the target knee within year prior to study
* Planned surgery in the target knee within the next 3 months
* Concomitant inflammatory disease affecting either knee

Primary outcomes:
measure: Pain
timeFrame: Baseline, 3 months
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Through 3 months
Secondary outcomes:
measure: Pain
timeFrame: Baseline, 3 months
measure: Physical function
timeFrame: Baseline, 3 months
measure: Pain
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: CCBR
city: Tartu
country: Estonia
facility: Medita Kliinik
Study officials:
affiliation: Symic OA Co.
name: Nathan Bachtell, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06658509: Regulation of Different IT on Vascular Function of Overweight Female University Students
Official title: Regulation of Different Types of Interval Training on Vascular Function of Overweight Female University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: High intensity interval training
Sprint interval training
Overweight
Female
Vascular function
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the effects of different interval training methods, specifically high-intensity interval training (HIIT) and sprint interval training (SIT), on vascular function in overweight female university students. A randomized controlled trial was conducted over an 8-week period.

Detailed description: This study aimed to evaluate how different types of interval training (HIIT and SIT) influence vascular function in overweight female university students. Participants were initially enrolled and randomly assigned to HIIT, SIT, or control groups. The participants in HIIT and SIT groups underwent an 8-week supervised exercise program 3 times per week on a treadmill. Both pre- and post-intervention measurements were taken, including vascular function, morphological indicators, and blood markers. This study highlights the potential of interval training as a time-efficient and effective intervention for improving cardiovascular health and body composition in this population.

Eligibility criteria: Inclusion Criteria:

* Participants aged between 18 and 25 years, female.
* Participants' BMI more than 24 kg·m-2.
* Participants without regular exercise habits.

Exclusion Criteria:

* Participants underwent other interventions (e.g., nutrition, psychology, exercise, health education, et al).
* Participants had a history of systematic and professional exercise habit.
* Participants presenced of disease or condition restricting participation, such as injuries, respiratory disease or cardiovascular diseases.

Primary outcomes:
measure: Brachial-ankle pulse wave velocity (baPWV)
timeFrame: 8 weeks
measure: Ankle-brachial index (ABI)
timeFrame: 8 weeks
measure: Nitric oxide (NO)
timeFrame: 8 weeks
measure: Endothelin (ET)
timeFrame: 8 weeks
measure: Body weight (BW)
timeFrame: 8 weeks
measure: Body mass index (BMI)
timeFrame: 8 weeks
measure: Body fat% (BF%)
timeFrame: 8 weeks
Secondary outcomes:
measure: Height
timeFrame: 8 weeks
measure: Blood pressure (BP)
timeFrame: 8 weeks
measure: Maximal oxygen uptake (VO2max)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation, Beijing Sport University
Study officials:
References:
Clinical trial NCT01810809: Hip Viscosupplementation: What is the Best Dosage?
Official title: Hip Viscosupplementation: What is the Best Dosage?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Hip
Viscosupplementation
Clinical Trial
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to determine the optimal dosis for hip viscosupplementation

Detailed description: Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. Any osteoarthritic joint is eligible to this treatment modality, but the great majority of studies are for knee viscosupplementation. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. We will prospectively enroll 80 patients with hip osteoarthritis and will randomize them into four groups: Group zero will receive joint lavage with saline injection. Group 1 will receive joint lavage with saline injection and 2 ml of Hylan GF-20 (1 ampoule of Synvisc Classic®). Group 2 will receive joint lavage with saline injection and 4 ml of Hylan GF-20 (2 ampoules of Synvisc Classic®). Group 3 will receive joint lavage with saline injection and 6 ml of Hylan GF-20 (3 ampoules of Synvisc Classic®). The Visual Analogic Scale of Pain (VAS), the Western Ontario and McMaster Universities Index (WOMAC®), and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24. Our objective is to determine the optimal dosis for hip viscosupplementation

Eligibility criteria: Inclusion Criteria:

* Met the American College of Rheumatology criteria for hip osteoarthritis
* No hip intraarticular injections in the last 6 months

Exclusion Criteria:

- Severe reaction to the procedure

Primary outcomes:
measure: WOMAC
timeFrame: 6 months
measure: VAS
timeFrame: 6 months
measure: Lequesne
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia HC-FMUSP
state: SP
Study officials:
affiliation: FMUSP
name: Gustavo C de Campos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00915109: Gait Stability of People With Lower-limb Amputations
Official title: Gait Stability of People With Lower-limb Amputations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gait
Balance
Keywords: amputees
lower limb
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2009-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prosthetic outpatient clinic of one rehabilitation centre

Brief summary: The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, between people with unilateral below-knee amputations from vascular reasons or from trauma reasons.


Eligibility criteria: Inclusion Criteria:

* be over the age of 18;
* be able to walk comfortably for a minimum of two (2) minutes;
* be willing to take part in the study, including signing the consent after carefully reading it;
* be able to read and understand English and follow verbal and visual instructions;
* are competent to give informed consent or have a proxy with power of attorney.
* have an unilateral, transtibial amputation;
* been fitted with a prosthesis for over six weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation Centre
state: Nova Scotia
Study officials:
References:
Clinical trial NCT02888509: Neural and Cognitive Mechanisms of Depression and Anxiety: a Multimodal MRI Study
Official title: Neural and Cognitive Mechanisms of Depression and Anxiety: a Multimodal MRI Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Keywords: depression
anxiety disorder
bipolar disorder
Magnetic Resonance Imaging
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with major depression, bilopar, anxiety disorders were recruited from the mental health center of Chengdu, Sichuan, China.

Brief summary: To explore the neural and cognitive mechanisms of depression (including unipolar depression and Bipolar disorder) and anxiety using multimodal MRI techniques.


Eligibility criteria: Inclusion Criteria:

* Age range from 16 to 55 years old.
* All patients were interviewed by two experienced psychiatrists using the Structured Clinical Interview for DSM-IV (patient edition)

Exclusion Criteria:

* Schizophrenia, mental retardation or personality disorder, any history of loss of consciousness, substance abuse, serious medical or neurological illness.
* Subjects with contraindications to MRI

Primary outcomes:
measure: Brain structural and functional changes in patients
timeFrame: one time point
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology
state: Sichuan
Study officials:
References:
citation: Chen Y, Cui Q, Sheng W, Tang Q, Lu F, Pang Y, Nan X, He Z, Li D, Lei T, Chen H. Anomalous neurovascular coupling in patients with generalized anxiety disorder evaluated by combining cerebral blood flow and functional connectivity strength. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Dec 20;111:110379. doi: 10.1016/j.pnpbp.2021.110379. Epub 2021 Jun 7.
citation: Yang Y, Cui Q, Pang Y, Chen Y, Tang Q, Guo X, Han S, Ameen Fateh A, Lu F, He Z, Huang J, Xie A, Li D, Lei T, Wang Y, Chen H. Frequency-specific alteration of functional connectivity density in bipolar disorder depression. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Jan 10;104:110026. doi: 10.1016/j.pnpbp.2020.110026. Epub 2020 Jul 2.
citation: Wang Y, Wang X, Ye L, Yang Q, Cui Q, He Z, Li L, Yang X, Zou Q, Yang P, Liu D, Chen H. Spatial complexity of brain signal is altered in patients with generalized anxiety disorder. J Affect Disord. 2019 Mar 1;246:387-393. doi: 10.1016/j.jad.2018.12.107. Epub 2018 Dec 26.
Clinical trial NCT03613909: Acceptance of the CP950 Sound Processor
Official title: Acceptance of the CP950 Sound Processor With Experienced CP810/CP910/CP920 BTE Sound Processor Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measures, single-subject experiment. Each subject received the same treatment.
Primary purpose: OTHER

Brief summary: Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.


Eligibility criteria: Inclusion Criteria:

1. Eighteen years of age or older
2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Native speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Able to score 30% or more at +15 SNR with CI alone

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Nucleus 22 Implant

Primary outcomes:
measure: Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score.
timeFrame: 14 days
Secondary outcomes:
measure: Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .
timeFrame: in booth testing 1 day.
measure: Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor
timeFrame: In booth testing 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02490709: Local Excision of Clinical T3 Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy
Official title: Local Excision of Clinical T3 Mid- or Low-Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy: Prospective Multicenter Single-arm Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Rectal neoplasms
Colorectal neoplasms
Local excision
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2015-07-07
Enrollment: 86
Sex: ALL
Minimum age (years): 20
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 evaluation of the safety and the efficacy of transanal local excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after neoadjuvant chemoradiotherapy.

Detailed description: This study is a prospective multicenter single-arm phase II clinical trial. Rectal cancer patients with cT3 stage will receive neoadjuvant chemoradiotherapy, and be evaluated the response of the tumor in 6 to 10 weeks after completion of neoadjuvant chemoradiotherapy. For those who have good response (ycT0-1) will underwent transanal local excision under the patients' agree.

Eligibility criteria: Inclusion Criteria:

* age: more than 20 years
* biopsy-proven adenocarcinoma of the rectum
* clinical staging, cT3NxM0
* Rectal cancer located 8 cm from the anal verge
* Restaging in 6-10 weeks after completion of neoadjuvant chemoradiotherapy, ycT0-1N0M0
* ECOG performance status 2 or less

Exclusion Criteria:

* Synchronous colon cancer or other malignancy
* Obstructing rectal cancer
* Pregnant or breast-feeding
* Receiving any other study agents
* History of prior colorectal cancer or inflammatory bowel disease
* Hereditary colorectal cancer (FAP, HNPCC)

Primary outcomes:
measure: 3-year disease free survival
timeFrame: 1-5 years
Secondary outcomes:
measure: Complete response rate
timeFrame: 1-5 years
measure: Overall survival rate
timeFrame: 1-5 years
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Republic of Korea
name: Oh Jae Hwan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: