louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05005767: Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis
Official title: The Adjunctive Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis: Clinical and Microbiological Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Periodontitis
Keywords: chronic periodontitis.
Frankincense
non surgical treatment
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: twenty patients will be randomly be selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days.
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of the subgingival application of Frankincense extract gel as an adjunct to scaling and root planning (SRP) in chronic periodontitis.

Detailed description: : twenty patients will be randomly selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days. Clinical measurements included pocket depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). Real-time PCR was carried out to determine the effect of the treatment on Porphyromonas gingivalis (Pg). Clinical measurements and Plaque samples for PCR were recorded at baseline (before treatment), one, and three months after treatment.

Eligibility criteria: Inclusion Criteria:

* systemically healthy patients were selected
* patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
* Patients should demonstrate their ability to maintain good oral hygiene

Exclusion Criteria:

* Smokers and pregnant patients.
* Medically compromised patients and systemic conditions precluding periodontal surgery.

Primary outcomes:
measure: probing pocket depth
timeFrame: baseline
measure: probing pocket depth
timeFrame: 1 month
measure: probing pocket depth
timeFrame: 3 month
measure: clinical attachment level
timeFrame: baseline
measure: clinical attachment level
timeFrame: 1 month
measure: clinical attachment level
timeFrame: 3 month
measure: bleeding on probing
timeFrame: baseline
measure: bleeding on probing
timeFrame: 1 month
measure: bleeding on probing
timeFrame: 3 month
measure: PCR for Porphyromonas gingivalis count
timeFrame: baseline
measure: PCR for Porphyromonas gingivalis count
timeFrame: 1 month
measure: PCR for Porphyromonas gingivalis count
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Doaa Ahmed yousef bayoumi
state: Gharbiya
Study officials:
References:
Clinical trial NCT02569567: Comparison of Smart-Shear Wave Elastography and Transient Elastography
Official title: Applicability, Reliability and Accuracy for Staging Hepatic Fibrosis: Comparison of Smart-Shear Wave Elastography and Transient Elastography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibrosis, Liver
Keywords: Smart-Shear Wave(SSW)
Transient Elastography(TE)
Liver cirrhosis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 105 participants will be enrolled. Participants are patients with liver disease who are planning to undergo liver surgery, and potential liver donors for living related liver transplantation.

Study population size was calculated by considering a power of 80%(1-sided alpha of 25%), and an expected dropout rate of 10%.

Brief summary: The aim of this prospective study was to evaluate the applicability and diagnostic performances of Smart-Shear wave(SSW) imaging, in comparison with Transient elastography(TE) for the staging of liver fibrosis using pathologic results as the reference standard.


Eligibility criteria: Inclusion Criteria:

1. Patients with liver disease: plan to undergo liver surgery
2. Potential liver donors
3. Smart-Shear wave \& transient elastography were performed within one month from liver surgery
4. Aged between 20 to 80 years
5. Compliance with scheduled visits, evaluation plans and other study procedures

Exclusion Criteria:

1. Previous history of hepatic surgery
2. Previous history of transarterial chemoembolization
3. Huge or infiltrative tumor in the right lobe of the liver
4. Bile duct dilatation in the right lobe of the liver
5. Older than 80 years
6. The opinion of the investigator would make the patient unsuitable for enrollment

Primary outcomes:
measure: Non-inferiority of Smart-Shear Wave(SSW) imaging compared to Transient elastography(TE) in diagnosis for hepatic fibrosis.
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of diagnostic accuracy to predict the degree of hepatic fibrosis.
timeFrame: 1 year
measure: The correlation between two US elastography techniques
timeFrame: 1 year
measure: Reliability of Smart-Shear Wave(SSW) comparing diagnostic performance according to the reliable measurement index(RMI) results
timeFrame: 1 year
measure: Precision of Smart-Shear Wave(SSW)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: So Yeon Kim, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03452267: Insulin Signaling in Skeletal Muscle
Official title: Effect of Metformin and Pioglitazone on Insulin Signaling in Skeletal Muscle
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Insulin Sensitivity
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. Our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans.


Eligibility criteria: Inclusion Criteria:

* Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL

General Inclusion Criteria:

* Able to communicate meaningfully with the investigator and legally competent to provide informed written consent.
* Female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control.

Exclusion Criteria:

* Oral glucose tolerance test \<140 or \>200mg/dL
* Treated with any of the following medications:

  * Systemic glucocorticoids (more than 2 weeks), antineoplastic agents, transplant medications, fibrates, anti-retroviral medications, or thiazolidinediones within 6 months prior to screening
  * Start or change of hormonal replacement therapy within 3 months prior to screening
  * Short-acting insulin (more than15 units per day) in DMT2 subjects, indicating severe insulin deficiency within 6 months prior to screening
* History or presence of any of the following conditions:

  * Clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG)
  * Peripheral vascular disease (history of claudication)
  * Clinically significant pulmonary disease.
  * Current uncontrolled hypertension (systolic BP\>160 mmHg, diastolic BP\>100 mmHg)
  * History or presence of malignancy other than basal cell or squamous cell skin cancer
  * Autonomic neuropathy
  * Clinically significant hematologic disease
* Any of the following abnormal laboratory values:

  * Hematocrit \< 35 vol%
  * Serum creatinine \> 1.6 mg/dl
  * AST, ALT or Alkaline phosphatase \> 2.5 times the upper limit of normal
  * PT, PTT outside the normal reference range
  * TSH outside the normal reference range
  * Triglycerides \> 400 mg/dl
  * Platelet count \< 50,000
* Current or history of drug abuse or alcohol abuse
* Blood donation within 2 months prior to screening
* Engage in exercise with moderate to hard intensity for greater than 1 hour per day for 5 or more days per week.
* Diagnosed with Type 1 diabetes

Primary outcomes:
measure: Proteomic
timeFrame: 3 months
measure: Proteomic 2
timeFrame: 3 months
Secondary outcomes:
measure: Epigenomic
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03249467: Validation of the French Version of the Health Assessment Questionnaire II (HAQ-II) for Rheumatoid Arthritis
Official title: Validation of the French Version of the Health Assessment Questionnaire II (HAQ-II) for Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: HAQ-II
Rheumatoid arthritis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with rheumatoid arthritis

Brief summary: The purpose of the study is to develop a validated French version of the HAQ-II questionnaire for rheumatoid arthritis.

Detailed description: The HAQ is the original Health Assessment Questionnaire used in rheumatology. It is available in more than 60 languages and includes 42 items. However the questionnaire is not easy to use in the clinic : complicated questions, long to answer for the patient and not easy to score for the doctor.

The HAQ-II is a reliable and valid 10-item questionnaire that performs at least as well as the HAQ and is simpler to administer and score. It includes 5 items already translated in English and 5 new items not yet translated.

The aim of the study is the validation of the French version of the HAQ-II for rheumatoid arthritis.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* Patient with rheumatoid arthritis

Exclusion Criteria:

* None

Primary outcomes:
measure: Internal validity, scale HAQ-II
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT02264067: Pharmacokinetics and Safety of WAL2014 (Talsaclidine) in Healthy Male Volunteers
Official title: Phase I Clinical Study of WAL2014 (Talsaclidine) Capsule: A Single Oral Dose Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single dose to healthy adult male volunteers in double blind manner.


Eligibility criteria: Inclusion Criteria:

Subjects for the study are healthy male adult volunteers who meet all the inclusion criteria listed below and do not fall into the exclusion criteria.

1. Age: 20-30 years old
2. Body weight: 50-80 kg
3. Obesity index: within +/-20% of the standard body weight
4. Those who have received screening examinations listed in protocol within one month prior to the start of the clinical study and have been judged as eligible by the investigator. Results of the simple test for gastric acidity are not used as the basis of the judgment.
5. Those who belong to volunteer members' association which has an office in Clinical Pharmacology Center, Ohsaki Clinic

Exclusion Criteria:

1. Those who have a history of allergic reaction or hypersensitivity to drugs
2. Those who have received any kind of drug(s) within one month prior to the administration of the investigational product
3. Those who have ingested alcoholic drink within two days before the administration of the investigational product
4. Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product
5. Those who have participated in a phase I clinical study of a drug which contains a new active ingredient or a similar study within 4 months before the administration of the investigational product
6. Those who have a history of liver or renal disease
7. Those who are judged as ineligible for the clinical study by the investigator.

Primary outcomes:
measure: Maximum concentration of the analyte in plasma (Cmax)
timeFrame: up to 24 hours after drug administration
measure: Time to reach maximum plasma concentration (tmax)
timeFrame: up to 24 hours after drug administration
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: up to 24 hours after drug administration
measure: Distribution volume
timeFrame: up to 24 hours after drug administration
measure: Total clearance
timeFrame: up to 24 hours after drug administration
measure: Mean residence time (MRT)
timeFrame: up to 24 hours after drug administration
measure: Urinary excretion rate
timeFrame: up to 24 hours after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 8 days after administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04068467: Evaluation of mHealth for Serious Mental Illness
Official title: Evaluation of mHealth for Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Major Depressive Disorder
Bipolar Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Mobile Application
SMI
EHealth
E-Health
Health Technology
mHealth
m-Health
Mobile Health
Serious Mental Illness
Electronic Health
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Owns an Android or iPhone smartphone with WiFi or 3G/4G capabilities (required for data transmission)
* Has diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder or Major Depression
* English speaker

Exclusion Criteria:

* Does not live in the U.S.
* Has already participated in the study
* Unavailable for 60 days
* Currently incarcerated or hospitalized

Primary outcomes:
measure: Change in Depressive Symptoms
timeFrame: Baseline, 30 days, 60 days
measure: Change in Paranoid Thinking
timeFrame: Baseline, 30 days, 60 days
measure: Change in Anxiety Symptoms
timeFrame: Baseline, 30 days, 60 days
measure: Change in Psychotic Symptoms
timeFrame: Baseline, 30 days, 60 days
measure: Participant Acceptability
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Dror Ben-Zeev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ben-Zeev D, Chander A, Tauscher J, Buck B, Nepal S, Campbell A, Doron G. A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE. J Med Internet Res. 2021 Nov 12;23(11):e29201. doi: 10.2196/29201.
Clinical trial NCT01159340: Icare Versus Haag-Streit Applanation Tonometer
Official title: Design Compliance Testing of the Icare One Rebound Tonometer According to the American National Standard ANSI Z80.10-2001 and International Standard ISO 8612.2 for Tonometers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Lead sponsor: Icare Finland Oy
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were eligible for the study if they had no exclusion criteria specified in the ANSI/ISO standard. One eye from 260 subjects was selected for the study. The minimum sample size according to the ANSI standard is 150. In order to aid enrollment of at least 40 eyes in each pressure range (7-16 mmHg, \>16 to \<23 mmHg and 23 mmHg or higher), subjects were invited to participate on the basis of prior knowledge of their IOP range. One eye of each subject was selected for the study by an investigator, based on the history of the patient, results of an external examination of the eye with slit lamp, keratometry readings, and prior knowledge of the IOP range.

Brief summary: The clinical performance of Icare ONE Tonometer TA02 was compared to a Goldmann type applanation tonometer (Haag-Streit). Data was collected according to ANSI Z80.10-2003 (ISO 8612.2) standard. Subjects were eligible for the study if they had no exclusion criteria specified in the ANSI/ISO standard. One eye from 260 subjects was selected for the study. The minimum sample size according to the standard is 150. One eye of each subject was selected for the study by an investigator, based on the history of the patient, results of an external examination of the eye with slit lamp, keratometry readings, and prior knowledge of the intraocular pressure (IOP) range. The Icare ONE Tonometer TA02 in comparison to the reference tonometer (Goldmann type tonometer).


Eligibility criteria: Inclusion Criteria:

* subjects were eligible for the study if they had no exclusion criteria as specified by the ANSI/ISO standard

Subjects were selected according to the following exclusion criteria (as given in ANSI Z80.10-2003 and ISO 8612):

* subjects with only one functional eye
* those with one eye having poor or eccentric fixation
* high corneal astigmatism (i.e. those eyes displaying an oval contact image with the Goldmann tonometer)
* those with corneal scarring or who have had corneal surgery, including corneal laser surgery
* microphthalmos
* buphthalmos
* contact lens wearers
* dry eyes
* lid squeezers (blepharospasm)
* nystagmus
* keratoconus
* any other corneal or conjunctival pathology or infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Glaucoma Service, Department of Opthalmology, Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Päivi Puska, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02087540: Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
Official title: A Randomized, Double-blind, Multi-center, Factorial Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 310
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Men and women \>18 years of age
* Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent

Exclusion Criteria:

* Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,.
* Other exclusions applied

Primary outcomes:
measure: •Change in seated diastolicblood pressure at 8 weeks compared to the base value
timeFrame: at the 8 weeks
measure: Change in LDL-Cat 8 weeks compared to the base value (% change)
timeFrame: at the 8 weeks
Secondary outcomes:
measure: Change in seateddiastolic blood pressure
timeFrame: at 2,4 8 weeks
measure: Change in seated systolic blood pressure
timeFrame: at 2,4,8weeks
measure: Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)]
timeFrame: at 2, 4 and 8 weeks
measure: Change in LDL-Cat compared to the base value (% change)
timeFrame: 2, 4 and 8 weeks
measure: Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change)
timeFrame: at 2, 4 and 8 weeks
measure: Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL)
timeFrame: at 2, 4 and 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Saint Mary's Hosiptal
Study officials:
References: