louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04694690: Clinical Performance of Different Resin Cements
Official title: Clinical Performance of Resin Cements in the Adhesion of CAD/CAM Restorations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Restoration of Posterior Teeth
Keywords: CAD/CAM
Inlay
Onlay
Hybrid ceramic
Adhesive resin cement
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical performance of different resin cements in adhesion of hybrid ceramic inlay and onlay restorations produced with CAD/CAM will be evaluated and compared. After obtaining a signed informed consent form from all the patients, all restorations will be placed by a single clinician. All hyrid ceramic restorations (Cerasmart, GC, Tokyo, Japan) will be produced using the same CAD/CAM CEREC Omnicam (Sirona Dental, Bensheim, Germany) system. 70 restorations will be divided into 2 groups: a self adhesive resin cement (RelyX U200 Automix, 3M ESPE, Seefeld, Germany), and an adhesive cement (G-Cem LinkForce, GC, Tokyo, Japan) which is applied after surface treatment (etch\&rinse). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after baseline, 6,12, 18, 24, 36 and 48 months. Descriptive statistics will be performed using Friedman test and Chi-square test.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals with or without systemic disease
* Patiens older than 18 years old
* Good oral health
* Patients who at least have1 large and deep carious lesion or broken restoration in a vital tooth
* Patients who agreed to participate in the study after being informed about this study

Exclusion Criteria:

* Patient with periodontal disease
* Patients with partial dentures
* Patients with bruxism
* Patients with malooclusion
* Non vital or endodontically treated teeth
* Preparetions under the cemento-enamel junction

Primary outcomes:
measure: Clinical performance
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00507390: Omega 3 Polyunsaturated Fatty Acid Supplements (PUFAs) and Microvolt T Wave Alternans (TWA) in Patients With Ventricular Arrhythmia
Official title: The Effect of Omega-3 Polyunsaturated Fatty Acid Supplements on Microvolt T Wave Alternans in Patients With Ventricular Arrhythmia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Arrhythmia
Defibrillators, Implantable
Keywords: fish oils
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2007-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a hypothesis testing study, the hypothesis being that dietary supplements of n-PUFAs concentrates are anti-arrhythmic in ventricular arrhythmic substrates.

Study Aims: To investigate whether dietary supplements of n-3 polyunsaturated fatty acid concentrates (2g PUFAs/day, Omacor) reduces MTWA (a surrogate endpoint for ventricular arrhythmia substrate) in patients with ICDs for malignant ventricular arrhythmias.

Detailed description: Patients from the Department of Cardiology ICD out-patient clinic, Ninewells Hospital and Medical School, will be recruited. All these patients have a history of documented ventricular arrhythmia. Data from previous studies predict that 90% of these patients will have abnormal MTWA. A total of 45 ICD patients will be recruited. The study design will be a double blind randomised placebo controlled crossover design. A baseline MTWA test will be performed and patients with an abnormal test will be selected. The patients will be randomised to receive fish oil supplements (2g/day) or placebo for 8 weeks each. At the end of each intervention period, a repeat MWTA test will be performed. A 10 ml venous blood sampled will also be collected at baseline, and after each intervention period (3 samples in total). Patients in atrial fibrillation, frequent atrial or ventricular ectopics, or with ventricular pacing from the ICD, unstable angina, NYHA IV heart failure, pregnancy or child bearing potential will be excluded from the study.

End Points of the Study. The primary endpoint will be quantitative and qualitative measures of MTWA during n-3 PUFAs treatment compared to placebo.

Statistical Analysis: Quantitative differences in MTWA measurements will be analysed by a Student's t-test and qualitative differences by a chi squared test. A probability of 0.05% will be considered significant.

Eligibility criteria: Inclusion Criteria:

* implantable cardiovertor defibrillators
* microvolt Twave alternans positive

Exclusion Criteria:

* unstable angina
* CHF

Primary outcomes:
measure: Change in microvolt T wave alternans status
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and medical School
Study officials:
affiliation: University of Dundee
name: Allan Struthers, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02726490: Glyburide vs Glucovance in the Treatment of GDM
Official title: Glyburide vs Glucovance in the Treatment of Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Gestational Diabetes
Keywords: gestational diabetes, pregnancy, diabetes
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.

Detailed description: This study will be a randomized open label trial of glyburide compared to glucovance in the management of gestational diabetes. We hypothesize that glucovance will provide improved glycemic control and a lower failure rate with no increase in neonatal adverse outcomes. Sixty-seven patients will be randomized by computer to each arm of the study. Outcomes will be glycemic control, failure rate of the drug to achieve glycemic goals, and neonatal outcomes.

Eligibility criteria: Inclusion Criteria:

* Gestational diabetes
* Pregnancy \> 12 weeks gestation
* Ability to give consent

Exclusion Criteria:

* Inability to consent to the study
* Pre-existing diabetes
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Serum creatinine \>1
* Liver disease
* Allergy to sulfa;
* Allergy to glyburide;
* Allergy to metformin;
* Fetal anomalies

Primary outcomes:
measure: efficacy of glyburide compared to glucovance
timeFrame: during the index pregnancy
Secondary outcomes:
measure: maternal hypoglycemia
timeFrame: during the index pregnancy
measure: neonatal birthweight
timeFrame: at birth
measure: neonatal apgar scores
timeFrame: at birth
measure: neonatal admission to the newborn intensive care unit (NICU)
timeFrame: at birth or within the first 24 hours after birth
measure: neonatal hypoglycemia
timeFrame: up to 24 hours after delivery
Other outcomes:
Locations:
city: El Paso
country: United States
facility: TTUHSC El Paso
state: Texas
Study officials:
affiliation: Texas Tech Health Sciences Center El Paso
name: Lisa E Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moore LE, Briery CM, Clokey D, Martin RW, Williford NJ, Bofill JA, Morrison JC. Metformin and insulin in the management of gestational diabetes mellitus: preliminary results of a comparison. J Reprod Med. 2007 Nov;52(11):1011-5.
citation: Moore LE, Clokey D, Rappaport VJ, Curet LB. Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):55-59. doi: 10.1097/AOG.0b013e3181c52132.
Clinical trial NCT05894590: Post-Marketing Non-Acute Safety Study in Japan After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons at High Risk of Severe COVID-19
Official title: Cohort Survey on Non-Acute Safety in Persons With Underlying Diseases Who Are Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 13680
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was selected from participants who were registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database whose start date of observation in the claim database was within 6 months or more before vaccination with mRNA-1273 vaccine, and those who met the definition of underlying disease based on the claim data for 6 months.

Brief summary: The goal of this study is to assess serious adverse events associated with hospitalizations in the non-acute phase after vaccination with the mRNA-1273 vaccine in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19.

Detailed description: Data collected from the JMDC Claims database from May 2020 to October 2022.

Eligibility criteria: Inclusion Criteria:

* Participants registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database
* Participants who have a history of vaccination with the mRNA-1273 vaccine in the Pep-Up vaccination history Database and the observation start date is at least 6 months prior to vaccination with the mRNA-1273 vaccine and have underlying diseases.

Exclusion Criteria:

* Underlying diseases that were determined undetectable by the pre-screening of JMDC
* Participants who did not consent to the questionnaire.

Primary outcomes:
measure: Number of Participants With Serious Events Associated With all-Cause Hospitalizations
timeFrame: Up to 1 year post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: CMIC Co., Ltd
Study officials:
References:
Clinical trial NCT05433090: An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies
Official title: An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancies
Keywords: Advance Care Planning Intervention
Serious Illness Conversation
Hematologic Malignancies
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 88
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention used in this study is an inpatient advance care planning intervention. We will adapt the Serious Illness Care Program, an evidence-based intervention that promotes serious illness conversation between patients and clinicians, to be used by advance practice providers and hematology/oncology fellow physicians in the inpatient setting.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot study to assess the preliminary efficacy of an inpatient advance care planning intervention on outcomes in older patients with hematologic malignancies

Detailed description: Older adults with hematologic malignancies receive more aggressive inpatient care at the end of life compared to patients with solid tumors. Advance care planning may promote early serious illness conversations for patients with hematologic malignancies, leading to less aggressive healthcare utilization at the end of life. This pilot aims to assess the preliminary efficacy of an inpatient advance care planning intervention on outcomes in older patients with hematologic malignancies.

Eligibility criteria: Inclusion Criteria:

* Age ≥60 years
* A diagnosis of hematologic malignancy \[including but not limited to acute leukemia, myeloid malignancies (e.g., atypical CML, MDS/MPN overlap syndromes, CMML), multiple myeloma, lymphoma, or any other hematologic malignancies based on the primary oncologist's judgment\]
* Able to provide informed consent
* Being managed in the inpatient setting
* English-speaking

Exclusion Criteria:

• None

Primary outcomes:
measure: Completion of advance directives
timeFrame: 12 weeks
Secondary outcomes:
measure: End of life quality indicators
timeFrame: Up to 5 years following their participation in the study or death
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kah Poh Loh
role: PRINCIPAL_INVESTIGATOR
References:
citation: LoCastro M, Baran AM, Liesveld JL, Huselton E, Becker MW, O'Dwyer KM, Aljitawi OS, Baumgart M, Snyder E, Kluger B, Loh KP, Mendler JH. Portable medical orders and end-of-life measures in acute myeloid leukemia and myelodysplastic syndromes. Blood Adv. 2021 Dec 28;5(24):5554-5564. doi: 10.1182/bloodadvances.2021004775.
Clinical trial NCT03208790: Clinical and Immunohisochemical Evaluation of Chemopreventive Effect of Thymoquinone on Oral Potentially Malignant Lesions.
Official title: Clinical And Immunohistochemical Evaluation Of The Cancer Chemopreventive Effect Of Thymoquinone Compared To A Placebo On Oral Potentially Malignant Lesions Among An Egyptian Population : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premalignant Lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present randomized, controlled, parallel-grouped trial includes 48 patients (aged 18 to 75 years) suffering from oral potential premalignant lesions. Patients will be randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)

Detailed description: The present randomized, controlled, parallel-grouped trial included 48 patients (aged 18 to 75 years) suffering from oral potentially premalignant lesions. Patients were randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Patients with age range 18-75 years.
* Patients with any known potentially malignant lesion confirmed histologically and clinically.

Exclusion Criteria:

* Patients with systemic illness.
* Patients received previous treatment for the condition.
* Current malignancy.
* Pregnant or lactating women.
* Hypersensitivity to the intervention.

Primary outcomes:
measure: clinical response
timeFrame: baseline
measure: clinical response
timeFrame: 3 months
Secondary outcomes:
measure: Molecular evidence of malignant transformation
timeFrame: baseline
measure: Molecular evidence of malignant transformation
timeFrame: 3 months
measure: Molecular evidence of malignant transformation
timeFrame: baseline
measure: Molecular evidence of malignant transformation
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
name: Fatheya Zahran
role: STUDY_CHAIR
affiliation: Lecturer of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
name: Basma Abdelalim
role: STUDY_DIRECTOR
References:
citation: Singh M, Krishanappa R, Bagewadi A, Keluskar V. Efficacy of oral lycopene in the treatment of oral leukoplakia. Oral Oncol. 2004 Jul;40(6):591-6. doi: 10.1016/j.oraloncology.2003.12.011.
Clinical trial NCT06513390: Development of an Exoskeleton for Patients' Mobility.
Official title: The Development of an Exoskeleton System for Assisting and Enhancing Patients' Mobility.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Exoskeleton
Gait
Kinematics
Temporal spatial
Muscle activity
Oxygen consumption
Lead sponsor: Vidyasirimedhi Institute of Science & Technology (VISTEC)
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the performance of a state-of-the-art adaptive CPG-based exoskeleton control system (intelligent mode) under a multi-metric analysis (involving three-dimensional gait analysis, muscle activity, oxygen consumption, user comfort, and exoskeleton performance scores) and comparing it to a standard commercial exoskeleton control system (default mode)

The main question it aims to answer is: Could the adaptive version improve natural walking and essential lower limb motions?

Participants will:

All participants were assigned into two groups to receive an alternate sequence of walking with the intelligent mode or the default mode of the lower-limb exoskeleton Exo-H3 at high and normal speed.


Eligibility criteria: Inclusion Criteria:

* healthy Thai adults
* age between 18 and 60 years old
* body mass index between 18.5 and 24.9 kg/m2
* walk independently
* willing to participate in the study

Exclusion Criteria:

* a history of surgery in the back, hip, knee, or ankle area
* previous injury or pain in the hip, knee, or ankle area that would affect walking patterns within the past 6 months
* a history of musculoskeletal or neuromuscular disease such as multiple sclerosis, myasthenia gravis
* a balance disorder
* unable to continue or withdrawal from the study

Primary outcomes:
measure: gait kinematic of pelvic hip, knee and ankle joint.
timeFrame: 1 day
Secondary outcomes:
measure: Temporal spatial data of velocity
timeFrame: 1 day
measure: Temporal spatial data of cadence
timeFrame: 1 day
measure: Temporal spatial data of step length, step width, and stride length
timeFrame: 1 day
measure: Temporal spatial data of stance phase and swing phase time
timeFrame: 1 day
measure: Muscle activity
timeFrame: 1 day
measure: Oxygen consumption
timeFrame: 1 day
measure: user comfort scores
timeFrame: 1 day
measure: exoskeleton performance scores
timeFrame: 1 day
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University
Study officials:
References:
Clinical trial NCT02844790: A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects
Official title: A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart in healthy Chinese subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female Chinese subject aged 18-45 years (both inclusive)
* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the investigator
* Body mass index 19.0-24.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
* Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening
* Smoking more than 5 cigarettes (including nicotine substitute products), or the equivalent, per

Primary outcomes:
measure: Area under the serum insulin degludec concentration-time curve
timeFrame: From 0 to 120 hours after single dose
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours after single dose
Secondary outcomes:
measure: Maximum observed serum insulin degludec concentration
timeFrame: After single dose (within 0 to 120 hours after dosing)
measure: Maximum observed serum insulin aspart concentration
timeFrame: After single dose (within 0 to 12 hours after dosing)
measure: Time to maximum observed serum insulin degludec concentration
timeFrame: After single dose (within 0 to 120 hours after dosing)
measure: Time to maximum observed serum insulin aspart concentration
timeFrame: After single dose (within 0 to 12 hours after dosing)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Aixin S, Yang L, Panpan X, Qi W , Lei Y, Hongfei X, Ran LZ, Haahr H. A study investigating the pharmacokinetic properties of insulin degludec/insulin aspart in healthy Chinese subjects. Diabetes Manag. 2019; 9 (2): 48-56.