louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02890524: Tokushima Night Guard for Recurrent Aphthous Stomatitis
Official title: Effects of a Night Guard on Aphthous Stomatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphthous Stomatitis
Keywords: aphthous stomatitis
night guard
inflammatory cytokine
Lead sponsor: University of Tokushima
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators will investigate whether the night guard can suppress the development of recurrent aphthous stomatitis (RAS). The investigators will record the patients' oral condition for 60 days before and after intervention with the night guard made of Ethylene-Vinyl Acetate copolymer (EVA). The patients' saliva will be analyzed for measurement of inflammatory cytokines or oxidative stress.

Detailed description: The study involved 20 patients (8 male and 12 female) with RAS. These patients suffered from RAS at least once a month. The investigators will record their oral condition for 60 days before and after intervention with the night guard made of EVA. Their saliva will be analyzed for further studies including measurement of inflammatory cytokines or oxidative stress.

Eligibility criteria: Inclusion Criteria:

* Patients suffered from recurrent aphthous stomatitis at least once a month

Exclusion Criteria:

* People do not have a experience of recurrent aphthous stomatitis

Primary outcomes:
measure: number of developed aphthous stomatitis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: days until healing
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kakogawa
country: Japan
facility: Tada Dental Clinic
state: Hyogo
city: Tokushima
country: Japan
facility: Tokushima University Hospital
Study officials:
affiliation: Tokushima University
name: Yasusei Kudo, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914224: Combined Dietary Education of Low Sodium and High Potassium Consumption
Official title: Research for the Effectiveness of Combined Dietary Education of Low Sodium and High Potassium Consumption
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prehypertension
Hypertension
Keywords: Prehypertension
Hypertension
Sodium
Potassium
renin
aldosterone
Lead sponsor: DongGuk University
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2013-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reduction in sodium consumption is important approach in public health care. In general population, reduction of sodium intake can reduce the future development of hypertension and cardiovascular event. Meanwhile, enhancement of potassium consumption is also important to reduce blood pressure and cardiovascular events. We hypothesized that combined education of low sodium and high potassium consumption is more effective in reducing blood pressure compared to dietary education of low sodium consumption only.

The present survey study was designed to test the effectiveness of combined education of low sodium and high potassium consumption in blood pressure reduction and improvement of other variables.


Eligibility criteria: Inclusion Criteria:

1. Prehypertension: with a systolic pressure from 120 to 139 mm Hg or a diastolic pressure from 80 to 89 mm Hg
2. Stage 1 hypertension: with a systolic pressure from 140 to 159 mm Hg or a diastolic pressure from 90 to 99 mm Hg

Exclusion Criteria:

1. Urinary tract disease
2. Secondary hypertension
3. Previous history of unstable angina, heart failure, myocardial infarction, coronary revascularization, cerebrovascular disease within 12 months
4. Ventricular tachycardia, atrial fibrillation and flutter
5. Hypertrophic cardiomyopathy
6. Known chronic kidney disease: serum creatinine = or \> 2.0 mg/dL
7. Hypokalemia (\<3.5 mmol/L) or hyperkalemia (\>5.5 mmol/L)
8. Type 1 diabetes mellitus
9. Poorly controlled diabetes mellitus (HbA1C = or \> 9%)
10. Unable to collect 24 hour urine sample
11. Pregnancy
12. Alcoholics
13. Severe liver disease
14. Night workers
15. Mental retardation

Primary outcomes:
measure: changes of 24-hour ambulatory systolic and diastolic blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: changes of 24-hour urine sodium and potassium excretion
timeFrame: 3 months
measure: changes of renin and aldosterone
timeFrame: 3 months
Other outcomes:
measure: Changes of renin and aldosterone
timeFrame: 3 months
measure: Changes of pulse wave velocity
timeFrame: 3 months
measure: Changes of left ventricular mass index
timeFrame: 3 months
Locations:
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi
Study officials:
affiliation: DongGuk University
name: Moo-Yong Rhee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02005224: Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women
Official title: Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Weight
Keywords: Insulin sensitivity
Lipid profile
Body composition
Weight
Lead sponsor: Atlantis Medical University College
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2013-12-09
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Intervention studying the effect of a low-carbohydrate/high-fat (LCHF) diet as well as on bout of exercise in combination with either a normal diet or a LCHF diet, in relation to glucose metabolism, insulin sensitivity, lipid profile and body composition.


Eligibility criteria: Inclusion Criteria:

* Females
* Normal weight
* BMI between 18.5 and 25
* Moderately trained

Exclusion Criteria:

* Smokers/tobacco users
* pregnancy
* familial cardio-vascular-disease
* diabetes or reduced glucose tolerance
* under- or overweight (BMI under 18.5 or over 25)
* top athletes

Primary outcomes:
measure: Area under the curve glucose (0, 15, 30, 45, 60, 90 and 120 min)
timeFrame: -1 week, 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sport Sciences
Study officials:
affiliation: Norwegian School of Sport Sciences - Department of Physical Performance
name: Jorgen Jensen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00446524: Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
Official title: A 54-week Extension to the Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of VAA489 (Valsartan and Amlodipine Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAA489 in Patients With Essential Hypertension (Extension From A1301 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, Valsartan, Amlodipine, high blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-13
Enrollment: 403
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients who successfully complete the core study (Study CVAA489A1301.
* Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 had to be well controlled defined as MSDBP \< 90 mmHg and MSSBP \< 140 mmHg. At the investigator's or sub-investigator's discretion, those patients who were not well controlled (MSDBP ≥ 90 mmHg or MSSBP ≥ 140 mmHg), and whose MSDBP was \< 100 mmHg and MSSBP was \< 160 mmHg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.
* Male or female outpatients.
* Patients who have written informed consent to participate in this study.

Exclusion Criteria:

* Presence of major protocol violation in Study CVAA489A1301.
* Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
* Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
* Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.
* Patients who have gout or gouty arthritis.
* Patients hypersensitive to diuretics (except for potassium sparing diuretics).

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Safety assessed by serious and non-serious adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure
timeFrame: 12 months
measure: Laboratory tests
timeFrame: 12 months
measure: Vital signs
timeFrame: 12 months
measure: Electrocardiogram (ECG)
timeFrame: 12 months
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT01889524: Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects
Official title: RADIOAEROSSOL PULMONARY DEPOSiTION USING MESH AND JET NEBULIZERS DURING NONINVASIVE VENTILATION IN NORMAL SUBJECTS: A RANDOMIZED CROSSOVER CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Subjects
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
Collaborators: name: Georgia State University
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-06-28
Enrollment: 10
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: In vivo deposition studies of aerosol administration during noninvasive ventilation are scarce in the current literature.

We assessed 10 normal subjects in a crossover study evaluated by pulmonary scintigraphy aiming to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) of radiotagged aerosol administered using vibrating mesh nebulizers (VMN) and conventional jet nebulizer (JN) during noninvasive ventilation (NIV).


Eligibility criteria: Inclusion Criteria:

* No history of lung disease;
* Forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values (Pereira et al., 1992),
* No history of smoking;
* Without respiratory or cardiovascular disease;
* Ability to understand verbal commands;
* Willing to provide signed consent to participate in this study.

Exclusion Criteria:

* Pregnant;
* Were unable to tolerate NIV (Metha and Hill, 2001).

Primary outcomes:
measure: Radioaerosol deposition index
timeFrame: 4 m
Secondary outcomes:
measure: Radioaerosol mass balance in pulmonary and extrapulmonary compartments
timeFrame: 4 m
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Hospital das Clínicas
state: Pernambuco
Study officials:
affiliation: UFPE
name: Valdecir C Galindo Filho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newman SP, Pitcairn GR, Hirst PH, Rankin L. Radionuclide imaging technologies and their use in evaluating asthma drug deposition in the lungs. Adv Drug Deliv Rev. 2003 Jul 18;55(7):851-67. doi: 10.1016/s0169-409x(03)00081-4.
citation: Nobre ME, Lopes F, Cordeiro L, Marinho PE, Silva TN, Amorim C, Cahalin LP, Dornelas de Andrade A. Inspiratory muscle endurance testing: pulmonary ventilation and electromyographic analysis. Respir Physiol Neurobiol. 2007 Jan 15;155(1):41-8. doi: 10.1016/j.resp.2006.04.005. Epub 2006 May 19.
citation: Galindo-Filho VC, Ramos ME, Rattes CS, Barbosa AK, Brandao DC, Brandao SC, Fink JB, de Andrade AD. Radioaerosol Pulmonary Deposition Using Mesh and Jet Nebulizers During Noninvasive Ventilation in Healthy Subjects. Respir Care. 2015 Sep;60(9):1238-46. doi: 10.4187/respcare.03667. Epub 2015 Jun 23.
Clinical trial NCT06667024: Dexmedetomidine as an Intrathecal Adjuvant to Hyperbaric Bupivacaine for Postoperative Analgesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries
Official title: Dexmedetomidine as an Intrathecal Adjuvant to Hyperbaric Bupivacaine for Postoperative Analgesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexmedetomidine
Intrathecal
Adjuvant
Hyperbaric Bupivacaine
Analgesia
Arthroscopic Anterior Cruciate Ligament Reconstruction
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effect of adding low doses of dexmedetomidine to hyperbaric bupivacaine during spinal anesthesia on post operative analgesia characteristics in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgeries

Detailed description: The anterior cruciate ligament (ACL) is injured frequently during sports participation. Arthroscopic evaluation of patients with acute traumatic hemarthrosis of the knee has repeatedly demonstrated a 60% to 70% incidence of ACL injury.

Postoperative pain should be effectively treated because it represents an important component of postoperative recovery. Effective treatment serves to blunt autonomic, somatic, and endocrine reflexes with a resultant potential decrease in perioperative morbidity.

Dexmedetomidine is a highly selective α2-adrenergic agonist that has been used for premedication and as an adjunct to general anesthesia. It reduces opioid and inhalational anesthetics requirements.

Eligibility criteria: Inclusion Criteria:

* Aged from 21 to 50 years.
* Both genders.
* American society of anesthesiologists (ASA) physical status I and II.
* Patients scheduled for arthroscopic anterior cruciate ligament reconstruction surgeries under spinal anesthesia.

Exclusion Criteria:

* Patient refusal.
* Body Mass Index (BMI) more than 40 kg/m2.
* Patients who were taking analgesics for chronic pain on opioid therapy or have a history of drug abuse.
* Uncooperative patient.
* Patients with coagulation disorders.
* History of local anesthetics allergy.
* Infection at the needle puncture site.
* Patients with significant respiratory, cardiac, renal or hepatic disorders

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time to first rescue analgesia request
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Duration of motor block
timeFrame: Intraoperatively
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of side effects
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT02565134: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus
Official title: Multi Center, Double-blind, Randomized, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Antipruritic Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Skin Pruritus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Pruritus
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 296
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 19 - 70 years
* Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg)
* Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more
* Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more

Exclusion Criteria:

* Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease
* Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases
* Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound
* Patients with the symptom of systemic infection at the time of the participation in the clinical study
* Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks
* Patients with a history of taking oral steroid agent within 4 weeks
* Patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks
* Pregnant or breast-feeding women
* Women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period

Primary outcomes:
measure: Change in intensity of pruritus as measured by 10 cm VAS
timeFrame: Week 4 from baseline
Secondary outcomes:
measure: Treatment success rate (A decrease in VAS by 2 or more is judged as a success)
timeFrame: Week 4 from baseline
measure: Change in Overall Dry Skin (ODS) score
timeFrame: Week 4 from baseline
measure: Change in Transepidermal Water Loss (TEWL)
timeFrame: Week 4 from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Amorepacific R&D Center
name: Miyoung Park, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02367534: Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein
Official title: Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Islet transplantation is one of the effective and promising options for type 1 diabetes mellitus treatment1-4. The liver is the primary target location for infusion and portal vein catheterization is generally used. Percutaneous transjugular, percutaneous transhepatic, laparoscopically transmesenteric and laparoscopically transumbilical approaches were often utilized to access the portal. Current islet infusion approach via portal vein of liver has various defects. Percutaneous trans-hepatic puncture is risk of possible severe hemorrhage and portal thrombosis. The laparoscopic entry techniques require longer surgical duration and have an increased rate of catheterization failure. Moreover, the catheters were not allowed to indwell for subsequent infusions.

In the current study, the investigators aim to performed open surgery, catheterized the umbilical vein and infused islets into the portal vein. The catheter was indwelled for one month after surgery. Therapeutic effects, surgical parameters and complications were observed to evaluate feasibility and safety.


Eligibility criteria: Inclusion Criteria:

* Male and female patients age 18 to 60 years of age.
* Ability to provide written informed consent.
* Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(2007) on the Diagnosis and classification of Diabetes Mellitus.
* manifest signs and symptoms that are severe enough to be incapacitating.
* Basal C-peptide\<0.5ng/mL
* patients with poor diabetes control (HbA1c \>7% but \<12%)
* progressive diabetic complications.

Exclusion Criteria:

* age \<18 years or \>60 years
* diabetic history \<5 years
* BMI\>27
* body weight \>80kg
* exogenous insulin requirement \>1 unit/kg/day
* severe anemia (male \<8g/dl, female \<7g/dl)
* low white blood cell count (\<3000/dl)
* liver dysfunction
* Symptomatic peptic ulcer disease
* Any malignancy
* Active infection including hepatitis B, hepatitis C, HIV, or TB
* panel reactive antibody \>20%
* Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Primary outcomes:
measure: hemorrhage
timeFrame: 1 month
Secondary outcomes:
measure: Infection
timeFrame: 6 month
measure: Exogenous insulin requirement
timeFrame: 1 year
measure: Glucose
timeFrame: 1 year
measure: C-peptide
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: