louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05874882: Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment Periodontitis:
Official title: Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment for Periodontitis:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Periodontitis
Keywords: mouthwash
periodontitis
resveratrol
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study include three groups. one of them is the study group in which the patient will use resveratrol mouthwash as adjunct to scaling, the second group use chlorhexidine mouthwas as adjunct to scaling while the third group will use a placebo. all the participants and the examiner are blinded regarding the type of the mouthwash they will be using
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effectiveness of resveratrol mouthwash as adjunct to NSP treatment of periodontitis

Detailed description: * Measuring and comparing the efficacy of RV mouth wash in comparison with CHX and placebo mouth wash in improving the clinical periodontal parameters;
* Measuring the salivary cytokines (IL-6) before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
* Measuring the salivary RANKL before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
* Correlate the salivary cytokines IL-6 and salivary RANKL with clinical periodontal parameter and with each other.
* Evaluate the intervention by using Visual analog scale (VAS)- score-based questionnaire will be filled out by each participant at the end of the trial.

Eligibility criteria: Inclusion Criteria:

-

The inclusion criteria:

1. Participants need to be systemically healthy with age \> 18 years old.
2. Not taking antibiotic and anti-inflammatory drugs in the last three months.
3. At least 20 teeth should be present
4. Should have unstable periodontitis (PPD ≥ 5 or BOP at 4mm pocket)

The exclusion criteria:

1. Patients wearing fixed prosthesis (crowns, bridges or orthodontic appliances)
2. Those with chronic disease, immunocompromised patients, pregnant, on contraceptives or lactating women.
3. Those currently using any mouthwash.
4. Those on antibiotic therapy and anti-inflammatory medications during the study and in the last 3 months before the study.
5. Those having a history of hypersensitivity to any product used in the present study.
6. Those who are smokers or alcoholics.
7. Those who refuse to participate in the trial.

   -

Primary outcomes:
measure: bleeding on probing
timeFrame: at1 month from the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry
state: None Selected
Study officials:
References:
Clinical trial NCT02063282: The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers
Official title: The Risk for Clostridium Difficile Colitis During Hospitalization in Asymptomatic Carriers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile
Colitis
Keywords: Asymptomatic
Carriage
Colonization
Clostridium difficile
Colitis
Rectal swab
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 394
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly admitted patients in the Emergency Department and Internal wards, .

Brief summary: The investigators hypothesize that development of symptoms characteristic of Clostridium difficile infection will be 2-3 times higher in asymptomatic carriers, compared to that of non carriers and expect to find risk factors for development of symptomatic clostridium difficile.


Eligibility criteria: Inclusion Criteria:

* History of hospitalization in recent year, residence of a nursing home or institutions
* Expected more than 48 hours hospitalization

Exclusion Criteria:

* Colitis/ diarrhea
* Rectal swab performed ≥48 hrs post arrival to hospital.

Primary outcomes:
measure: Development of colitis
timeFrame: Daily follow-up
Secondary outcomes:
measure: Duration until development of colitis
timeFrame: Daily follow-up
measure: Severity of colitis
timeFrame: Daily follow-up
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
References:
Clinical trial NCT01033682: Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging
Official title: Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving radiotherapy to the rectum

Brief summary: The purpose of this study is to implement and access a newly developed bladder filling protocol for patients receiving radiotherapy for rectal cancer using imaging on the treatment unit.


Eligibility criteria: Inclusion Criteria:

* Patients receiving radical radiotherapy to rectal malignancies.
* Age \> 18 years old
* No previous lower GI radiotherapy
* Written informed consent according to good clinical practice (GCP) and national / local regulations.

Exclusion Criteria:

* Patients receiving palliative radiotherapy to rectal malignancies.
* Patients receiving radical short course preoperative radiotherapy for rectal malignancies.
* Patients unable to give informed consent.

Primary outcomes:
measure: The percentage of patients who are able to achieve a bladder volume within +/- 30% of planning volume, on all treatment CBCT (cone beam computed tomography) scans
Secondary outcomes:
measure: The per-patient standard deviation of bladder volume throughout the course of radiotherapy
measure: The percentage of patients who are unable to follow the bladder filling protocol at any point during their treatment.
measure: The correlation between bladder volume and small bowel volume planning target volume
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Dr Diana Tait
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487682: Dose-finding Study of ASP2151 in Subjects With Herpes Zoster
Official title: Dose-finding Study of ASP2151 in Subjects With Herpes Zoster- A Multicenter, Randomized, Double-blind, Valacyclovir Hydrochloride-controlled, Parallel-group, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Keywords: Valacyclovir hydrochloride
herpes zoster
ASP2151
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-06-18
Enrollment: 403
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of three different doses of ASP2151, as compared to valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended clinical dose.


Eligibility criteria: Inclusion Criteria:

* Subjects aged from 20 years to under 80 years on the day informed consent is obtained
* Subjects to whom the study drugs can be orally administered within 72 hours after the onset of rash due to herpes zoster
* Subjects in whom protocol-specified observations and assessments are considered possible

Exclusion Criteria:

* Subjects with extremely compromised immune function due to underlying diseases, treatment with Immunosuppressive agents etc., or radiotherapy
* Subjects with a serious underlying disease that corresponds to Grade 3 in the Classification Criteria for teh Seriousness of Adverse Drug Reactions
* Subjects with concurrent malignant tumors, or those with a history of malignant tumors within the past 5 years

Primary outcomes:
measure: To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
timeFrame: 3 months
Secondary outcomes:
measure: Improvement of cutaneous symptoms and pain
timeFrame: 3 months
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kanto
country: Japan
city: Kinki
country: Japan
city: Kyusyu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00966082: EBL Versus EBL and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment
Official title: RCT Comparing the Efficacies of Endoscopic Band Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding in Patients With Previous Endoscopic Variceal Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cirrhosis
Variceal Bleeding
Keywords: Cirrhosis
Esophagus Disorders
Varicose Veins
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol
Primary purpose: PREVENTION

Brief summary: This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Detailed description: Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. In addition, most of all recent studies included patients without previous endoscopic treatment for varices. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis
* Age between 18 and 70 years
* Successful control of esophageal variceal bleeding within 6 weeks before enrollment

Exclusion Criteria:

* Gastric variceal bleeding
* Patients with systolic blood pressure \<100 mmHg or basal heart rate \<60/min
* Portal vein thrombosis
* Prominent hepatic encephalopathy
* Coexisting untreated malignancy
* Severe cerebrovascular or cardiovascular disease, renal failure
* No previous history of endoscopic, radiologic, or surgical treatment for varices or ascites
* Contraindication to beta-blocker
* Pregnancy
* Refusal to give consent to participate in the trial

Primary outcomes:
measure: Rebleeding from esophageal varices
timeFrame: 2 years
Secondary outcomes:
measure: Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University
name: Soon Ho Um, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04465682: Dip Home-Based Dipstick Analyzer Performance Evaluation
Official title: A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urine Detectable Acute and Chronic Diseases
Lead sponsor: Healthy.io Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Men and women 18-80 years of age
* Subjects who are healthy or pregnant; or
* Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite
* Subject is capable and willing to provide informed consent.
* Subject has facility with both hands.
* Subject is capable and willing to adhere to the study procedures

Primary outcomes:
measure: Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.
timeFrame: 11 months
Secondary outcomes:
measure: Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions
timeFrame: 11 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Methuen
country: United States
facility: Activmed Practices & Research, Inc.
state: Massachusetts
city: Garden City
country: United States
facility: AccuMed research associates
state: New York
Study officials:
References:
Clinical trial NCT00005482: Homocyst(e)Ine, Vitamin Status, and CVD Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Cerebrovascular Accident
Coronary Disease
Myocardial Infarction
Heart Diseases
Hyperhomocysteinemia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To test the hypotheses that the risk of myocardial infarction and/or stroke is associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6.

Detailed description: BACKGROUND:

Elevated plasma homocyst(e)ine is a risk factor for vascular disease in middle-aged men. Supplementation with folate, and to some extent vitamins B12 and B6, can reduce plasma homocyst(e)ine levels. There is also evidence from in vitro studies that the adverse atherogenic or thrombotic effects of Lp(a) may be greatly enhanced by homocyst(e)ine. The high prevalence of low levels of folate and vitamins B12 and B6 among the elderly in the United States has led to the hypothesis that a substantial portion of cardiovascular morbidity and mortality among older persons could be prevented by increasing intake of these nutrients to reduce plasma levels of homocysteine. Little is known, however, regarding the relationship of homocysteine, folate, B vitamins, and Lp(a) to cardiovascular disease among the elderly, among whom CVD represents the leading cause of morbidity and mortality.

DESIGN NARRATIVE:

In this ancillary study to the prospective Cardiovascular Health Study (CHS), a case-cohort design was used to test hypotheses that the risk of myocardial infarction and/or stoke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6. Further, a determination was made whether elevated plasma levels of homocysteine and Lp(a) interacted to increase substantially the risk of myocardial infarction and/or stroke above that due to either factor alone. The sub-cohort was used to study the relationship between the factors under study and progression of sub-clinical atherosclerosis. For each case and sub-cohort member, an aliquot of fasting plasma drawn at baseline was analyzed for homocysteine, folate B12, and B6 concentrations. \[Values of plasma Lp(a) were determined at baseline.\] Results of these assays were combined with other CHS data to address the hypothesis that the risk of myocardial infarction and/or stroke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04715282: The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
Official title: Effectiveness of the Epley Maneuver Versus Vestibular Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Observation of the effects of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in BPPV patients.

Detailed description: Study Objective:

To observe the efficacy of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in patients with posterior canal BPPV.

Study Design:

Single-blind randomized controlled study

Sample Size:

Thirty-six patients were recruited in the study and were randomized equally into Epley maneuver (EpleyM) and Epley maneuver and exercise (EpleyM\&Exe) groups.

Study Method:

All patients were treated with the Epley maneuver, while CawthorneCooksey exercises were given to the EpleyM\&Exe group as home exercises for 6 weeks. Static and dynamic balance, vertigo and associated symptoms, and quality of life were assessed with the Nintendo Wii Balance Board, Berg Balance Test, Vertigo Symptom Scale, and Dizziness Handicap Inventory, respectively. The assessments were repeated at the 1st, 3rd, and 6th weeks.

Eligibility criteria: Inclusion Criteria:

1. having posterior semicircular canal BPPV with upbeating-torsional nystagmus and positional vertigo as evaluated by the Dix-Hallpike Test
2. agreeing to undergo the Epley maneuver after that test
3. agreeing to participate in the study

Exclusion Criteria:

1. having history or symptoms of vestibular system disorders other than BPPV or central nervous system disorders causing dizziness
2. having cervical and/or lumbar pathology due to which the Epley maneuver could not be performed
3. having lower extremity pain or an operation that prevented standing and/or weight bearing
4. having anterior or horizontal canal BPPV
5. having previously undergone a vestibular rehabilitation program

Primary outcomes:
measure: Nintendo Wii Balance Board (WBB)
timeFrame: one hour
measure: Berg Balance Test (BBT)
timeFrame: one hour
Secondary outcomes:
measure: Vertigo Symptom Scale (VSS)
timeFrame: one hour
measure: Dizziness Handicap Inventory (DHI)
timeFrame: one hour
Other outcomes:
Locations:
Study officials:
affiliation: Dr. Sami Ulus Maternity, Children Health and Diseases Education and Research Hospital
name: Ekin Taçalan
role: PRINCIPAL_INVESTIGATOR
affiliation: Istinye University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
name: H.Serap İnal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06571682: Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries
Official title: Comparison of the Effect of Anesthesia Applied by Target Controlled Infusion Method and Inhalation Anesthesia Method on Patient Outcomes in Pediatric Patients Undergoing Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Laparoscopic Surgery
Target Controlled Infusion
Keywords: Pediatric Laparoscopic Surgery
Target Controlled Infusion
Propofol
Sevoflurane
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 3-12 with ASA I-II undergoing laparoscopic surgery

Brief summary: Comparison of Target Controlled Infusion Anesthesia and Inhalation Anesthesia in Pediatric Laparoscopic Surgeries

Detailed description: In pediatric age group patients undergoing laparoscopic surgery, total intravenous anesthesia (TIVA) and inhalation anesthesia methods are used as anesthesia methods in the intraoperative period; It is compared in terms of its effects on blood pressure, pulse, postoperative awakening time and awakening agitation.

Eligibility criteria: Inclusion Criteria:

* Children aged 3-12 years
* Patients weighing over 10 kilograms
* Patients who will undergo inguinal hernia surgery
* ASA (American Society of Anesthesiologists) classification I and II pediatric patients.

Exclusion Criteria:

* Absence of systemic illness.
* ASA (American Society of Anesthesiologists) classification III and above pediatric patients.

Primary outcomes:
measure: Modified Aldrete Scoring System
timeFrame: Aftet surgery 1 hour
Secondary outcomes:
measure: Blood pressure (mmHg)
timeFrame: After surger 1 hour
measure: Heart rate (beats/minute)
timeFrame: After surgey 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Özlem OZ GERGİN, MD
role: STUDY_DIRECTOR
References: