louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01616355: Evaluation of Sodium Hypochlorite as a Denture Cleanser
Official title: Denture Condition: Influence on Masticatory Performance, Volatile Sulfur Compounds and Presence of Biofilm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problems With Dentures
Keywords: denture, complete;
sodium hypochlorite;
disinfection;
surface roughness;
color stability.
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The present study tried to integrate all aspects of denture care: patient satisfaction with the treatment, denture decontamination and base material defects after decontamination processing.

Detailed description: Considering that it is necessary to stipulate a simple and effective routine protocol for denture cleaning the aim of this study was to evaluate, in vivo, the efficacy of 0.5% sodium hypochlorite (NaOCl) as a denture cleanser and its effect on color stability and surface roughness of complete dentures. The patients' satisfaction with the denture cleaning method was also assessed.

Eligibility criteria: Inclusion Criteria:

* complete denture wearers; adequate general health conditions
* ability to comply with the experimental protocol
* time of denture use: at least one year prior the study
* denture base material: heat-polymerized acrylic resin.

Exclusion Criteria:

* the use of antifungal agents or antiseptic mouthwashes during the pre-experimental and experimental period.

Primary outcomes:
measure: Microorganisms reduction
timeFrame: Baseline, 30, 60 and 90 days
measure: Changes in base acrylic resin
timeFrame: Baseline, 30, 60 and 90 days
Secondary outcomes:
measure: Patients' satisfaction with the denture cleaning protocol
timeFrame: 30, 60 and 90 days
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: School of Dentistry of Piracicaba, UNICAMP
state: São Paulo
Study officials:
affiliation: School of Dentistry of Piracicaba, State University of Campinas
name: Altair A Del Bel Cury, PhD
role: STUDY_CHAIR
affiliation: School of Dentistry of Piracicaba, State University of Campinas
name: Sheila RS Porta, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04523155: Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes
Official title: Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes: A Randomized, Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effect of medically-tailored meal delivery (10 meals per week for 3 months) on glycemic control in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Adult men and women with non-insulin dependent diabetes.
* Ages 25 to 75 years.
* Fasting blood sugar of greater than 140 mg/dl, on no oral hypoglycemic agents and a hemoglobin A1C less than 13%.
* Stabilized patients on oral hypoglycemic agents for one month or longer prior to starting the study and a hemoglobin A1C between 7.5% - 13%.

Exclusion Criteria:

* Insulin use.
* Substance abuse.
* Any documented medical problem that would inhibit full participation in the study.
* BMI less than 25 or great than 40.
* Vegans or Vegetarians
* Individuals with food allergies.
* Individuals currently on a commercial weight loss or diet program.

Primary outcomes:
measure: Change in Glucose Metabolism
timeFrame: Baseline, 3 monts
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline, 3 months
measure: Change in Blood Pressure
timeFrame: Baseline, 3 months
measure: Change in High Density lipoprotein (HDL)
timeFrame: Baseline, 3 months
measure: Change in Low Density Lipoprotein (LDL)
timeFrame: Baseline, 3 months
measure: Change in Triglycerides
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Bryan Farford, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01252914: A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent
Official title: A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subject With Primary Open-angle Glaucoma (POAG)
Keywords: Open angle
Glaucoma
Surgery
Ocular Hypertension
Eye Diseases
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Detailed description: The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subjects on two topical hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled

Primary outcomes:
measure: Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
timeFrame: 12 months
Secondary outcomes:
measure: Mean diurnal Intraocular Pressure < 18 mmHg at month 12
timeFrame: 12 months
Other outcomes:
measure: Safety
timeFrame: 0-61 months
Locations:
city: Yerevan
country: Armenia
facility: S.V. Malayan Ophthalmology Centre
Study officials:
affiliation: SV Malayan Ophthalmological Center, Yerevan, Armenia
name: Lilit Voskanyan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06861114: Exploring the Value of Urine Proteomics-based Dynamic Surveillance for Early Recurrence After Radical Surgery for Hepatocellular Carcinoma: a Prospective Cohort Study
Official title: Exploring the Value of Urine Proteomics-based Dynamic Surveillance for Early Recurrence After Radical Surgery for Hepatocellular Carcinoma: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: urinary proteomics
Hepatocellular carcinoma recurrence after surgery
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatocellular carcinoma whose tumor stage at the time of initial diagnosis is consistent with BCLC staging 0/stage A/stage B, who can undergo radical surgical resection, and who have not received other antitumor therapy preoperatively.

Brief summary: In this study, we explored and validated the predictive value of the longitudinal monitoring model of urinary proteomics for postoperative recurrence of hepatocellular carcinoma and the predictive value of minimal residual disease (MRD) status, verified whether it is earlier than the recurrence suggested by imaging tests, and initially explored its clinical feasibility in guiding the adjuvant treatment of hepatocellular carcinoma in the postoperative period, so as to provide a new idea for the strategy of early intervention in the postoperative period of hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients with hepatocellular carcinoma whose tumor stage at the time of initial diagnosis is consistent with BCLC staging 0/stage A/stage B, who can undergo radical surgical resection, and who have not received other antitumor therapy preoperatively.

Exclusion Criteria:

* Unable to provide specimens for testing such as urine proteomics; patients with a previous diagnosis of renal or urologic disease, two or more tumors at the same time; patients with non-primary foci of liver disease. Previously received anti-tumor therapy such as targeted immunotherapy.

Primary outcomes:
measure: 2-year relapse-free survival
timeFrame: 2-year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT05646914: Plyometric and Complex Training in Male Cricket Players
Official title: Effect of Plyometric and Complex Training on Physical Performance in Male Cricket Players: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Functional Performance
Keywords: Muscle strength
Fitness
Athletes
Exercise
Power
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized control study with a pretest-posttest design.
Primary purpose: OTHER

Brief summary: The complex training starts with a high load of resistance training that is succeeded by plyometric training. This combination aims at improving the efficacy of the plyometric training stimulus, thus increasing the neuromuscular response, explosive strength, and power. This response might further be improved by making appropriate variations in the dosage parameters of complex training. Previously available literature reports conflicting evidence, with some studies supporting the effectiveness of complex training for improving power output in sports, whereas others contradict this rationale. There is a paucity of research evidence that directly compares the efficacy of plyometric and complex training for the outcomes of physical performance in cricket players.


Eligibility criteria: Inclusion Criteria:

* University-level cricket players
* Age of 18 to 26 years
* Playing competitively at least once a month
* Involved in resistance training for at least six months
* Working knowledge of the english language

Exclusion Criteria:

* A history of severe neurological deficit, injury or concussion in the past six months,
* Operative treatment for lower or upper limb in the past six months,
* Current musculoskeletal pain (any level of chronicity)

Primary outcomes:
measure: Core Muscle Strength
timeFrame: 4 weeks.
measure: Multistage Fitness
timeFrame: 4 weeks.
measure: Push-Up
timeFrame: 4 weeks.
measure: Lateral Cone Jump
timeFrame: 4 weeks.
measure: Stationary Vertical Jump
timeFrame: 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, M.P.Th
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01401114: Wellnara Post-marketing Surveillance in Japan
Official title: Drug Use Investigation of Wellnara Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Keywords: Wellnara
Postmenopausal osteoporosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 411
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is patients who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist. The study is expected to collect data of 400 patients in about 80 gynecological practices in Japan.

Brief summary: This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Wellnara for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Wellnara in clinical practice. A total 400 patients will be recruited and followed 3 years since starting Wellnara administration.


Eligibility criteria: Inclusion Criteria:

* Patients who received Wellnara for postmenopausal osteoporosis

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions and serious adverse events in subject who received Wellnara
timeFrame: After Wellnara administration, up to 3 years
Secondary outcomes:
measure: Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Wellnara
timeFrame: At baseline and after Wellnara administration, up to 3 years
measure: Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse
timeFrame: At baseline and after Wellnara treatment, up to 3 years
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01111214: Child Pneumococcal Serotype Epidemiology In Greece
Official title: Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Disease
Keywords: Invasive Pneumococcal Disease (IPD)
pneumococcal serotypes
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 457
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized children in participating centers

Brief summary: Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar has been included in the Greek National Immunization Program.

The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the occurring invasive pneumococcal disease, is an important factor to consider for the introduction of the 13-valent pneumococcal conjugate vaccine.

Detailed description: open label, one group Purposive sampling of hospitalized children ≤14 years of age with confirmed IPD

Eligibility criteria: Inclusion Criteria:

* Children aged 14 years old or less.
* Hospitalized in a participating healthcare facility with an IPD.
* IPD will be confirmed by isolation of S. pneumoniae from a sterile body site.

Exclusion Criteria:

* Children \> 14 years of age
* Unconfirmed IPD

Primary outcomes:
measure: The serotype distribution of invasive S. pneumoniae isolates of hospitalized children up to 14 years of age after the introduction of the 7-valent conjugate pneumococcal vaccine
timeFrame: yearly
Secondary outcomes:
measure: Serotype distribution of resistant S. pneumoniae isolates
timeFrame: yearly
measure: Serotype distribution of IPD between immunized and non immunized children ≤14 years of age
timeFrame: yearly
measure: Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin
timeFrame: yearly
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agia Sophia Children's Hospital
state: Attiki
city: Alexandroupoli
country: Greece
facility: University Hospital of Alexandroupolis
city: Herakleion
country: Greece
facility: University Hospital of Herakleion
city: Herakleion
country: Greece
facility: Venizeleion General Hospital of Herakleion
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Larissa
country: Greece
facility: University of Thessaly School of Medicine
city: Thessaloniki
country: Greece
facility: Ahepa Hospital Paediatric Outpatient Special Clinic 1st Kyri
city: Thessaloniki
country: Greece
facility: Ippokrateion Peripheral Hospital of Thessaloniki
city: Trikala
country: Greece
facility: Peripheral Hospital of Trikala
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05457114: Association Between the Use of Pulmonary Artery Catheter and Clinical Outcomes After Liver Transplantation
Official title: Association Between the Use of Pulmonary Artery Catheter and Clinical Outcomes After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Liver DIsease
Liver Transplant; Complications
Liver Cirrhosis
Liver Diseases
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 1970
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients received liver transplantation surgery in a single tertiary care university hospital

Brief summary: The investigators attempted to evaluate whether the use of PAC is associated with better clinical outcomes after liver transplantation compared with the case without PAC.

Detailed description: Pulmonary artery catheter (PAC) has been used for advanced hemodynamic monitoring during liver transplantation. However, recent advances in less invasive monitoring could provide continuous cardiac output monitoring by arterial waveform analysis. Using this technology, stroke volume variation (SVV) is monitored as a preload index. Calculated systemic vascular resistance (SVR) can be monitored if central venous pressure (CVP) is provided. Therefore, this less invasive form of hemodynamic monitoring may replace the PAC. The investigators attempted to evaluate whether the use of PAC is associated with better clinical outcomes after liver transplantation compared with the case without PAC.

Eligibility criteria: Inclusion Criteria:

* Adult patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2006 and 2022

Exclusion Criteria:

* Patients with baseline renal dysfunction
* Missing baseline or outcome variables
* Retransplantation
* Patients who received intraoperative transesophageal echocardiography (TEE) monitoring

Primary outcomes:
measure: Number of Participants with acute kidney injury
timeFrame: the first 7 postoperative days
measure: Number of Participants with early allograft dysfunction
timeFrame: the first 7 postoperative days
Secondary outcomes:
measure: In-hospital mortality
timeFrame: the first month after admission
measure: One-year mortality
timeFrame: one year after transplantation
measure: Length of intensive care unit (ICU) stay
timeFrame: the first month after admission
measure: Length of hospital stay
timeFrame: the first month after admission
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital
name: Won Ho Kim, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01744314: Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma
Official title: Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elbow Trauma Requiring Operative Management
Keywords: Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who present to our institution with a traumatic injury to their elbow who need operative management will be randomized to one of two groups; a treatment arm and a control arm. The treatment arm will receive a three-week postoperative course of indomethacin while the control group will not. We will follow both groups to assess whether or not indomethacin prophylaxis affects the rate of heterotopic ossification.


Eligibility criteria: Inclusion Criteria:

* Terrible Triad
* Radial head fracture surgical treatment
* Monteggia and Trans-olecranon Fracture Dislocations
* Distal Biceps Tendon Injuries
* Distal Humerus Fractures
* Coronoid Fractures
* Capitellar-Trochlear fractures
* Olecranon Fractures

Exclusion Criteria:

* Associated Traumatic Brain Injury
* Burn Injuries associated with elbow trauma
* History of Gastric Ulcers
* Documented allergies to any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
* Severe Asthma
* Previous operative fixation to affected elbow
* Participation in other research study
* Inability to speak / understand English

Primary outcomes:
measure: change in post operative radiographic evaluation
timeFrame: 6 weeks and 3, 6 and 12 mfup
Secondary outcomes:
measure: change in range of motion
timeFrame: 6 weeks and 3, 6 and 12 mfup
measure: Patient Rate Elbow Evaluation
timeFrame: 6 weeks and 3, 6 and 12 mfup
measure: The Mayo Elbow Performance score
timeFrame: 6 weeks and 3, 6 and 12 mfup
measure: Disabilities of the Arm, Shoulder and Hand
timeFrame: 6 weeks and 3, 6 and 12 mfup
Other outcomes:
Locations:
city: London
country: Canada
facility: HULC, St Joseph's Health Care
state: Ontario
Study officials:
References: