louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06204185: Clinical and Biochemical Evaluation of 1% Metformin in Non-surgical Treatment of Periodontitis
Official title: Clinical and Biochemical Evaluation of the Use of Locally Delivered Metformin as an Adjunctive Therapy to Non Surgical Periodontal Treatment of Periodontitis Patients (Randomized Controlled Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluate the clinical parameters ( Probing Depth, Clinical Attachment Level, Gingival and Plaque Indices) before \& after the application of locally delivered metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
Primary purpose: TREATMENT

Brief summary: The aim of the study to evaluate the clinical and biochemical efficacy of 1% Metformin gel in treatment of periodontitis patients


Eligibility criteria: Inclusion Criteria:

* Patients with Stage III Grade A Periodontitis.
* Systemically free according to the modified Burkitt's health history questionnaire, Group I. (Glick et al., 2021).
* Good compliance with the plaque control instructions following initial therapy.
* Availability for follow up and maintenance program.

Exclusion Criteria:

* Smokers
* Pregnant and lactating females.
* Vulnerable groups of patients' e.g (prisoners, handicapped patients and decisionally impaired individuals).

Primary outcomes:
measure: RANKL and Osteoprotegrin levels in Gingival Crevicular Fluid before & after application of metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
timeFrame: Baseline and 1 month after the gel application
Secondary outcomes:
measure: Plaque index (PI)
timeFrame: Baseline, 3 Months and 6 Months post operatively.
measure: Gingival Index (GI)
timeFrame: Baseline, 3 Months and 6 Months post operatively.
measure: Probing depth (PD)
timeFrame: Baseline, 3 Months and 6 Months post operatively.
measure: Clinical attachment level (CAL)
timeFrame: Baseline, 3 Months and 6 Months post operatively.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sameh Magdy Abou El-Kheir
Study officials:
References:
Clinical trial NCT05121285: Distribution of FMT After Delivery by · Lower GI Endoscopy vs Enema With and Without Positioning of the Patient
Official title: Distribution of FMT After Delivery by · Lower GI Endoscopy vs· Enema With and Without Positioning of the Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Microbiota Transplantation
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: While delivery of an FMT-treatment to the cecum is visualized in a lower GI-endoscopy, it is uncertain whether delivery by enema distributes the FMT to the proximal segments of the colon. Positioning of the patient during the enema procedure may improve distribution to the proximal colon. Differences in distribution may explain the wide effect range and inferiority when enema is compared to delivery by lower GI endoscopy. Thus, in this study we will compare the distribution of FMT from delivery by lower GI endoscopy versus enema with and without positioning of the patient. We will use contrast fluid as a surrogate liquid for FMT to project the distribution on colon X-ray pictures. To our knowledge this is not done in any previous study.


Eligibility criteria: Inclusion Criteria:

* Scheduled for colonoscopy at the medical department at UNN Harstad
* Able to complete the positioning procedure during the enema

Exclusion Criteria:

* Confirmed malignancy
* Inflammatory bowel disease
* Referral highly suspicious of cancer, inflammatory bowel disease or obstructive GI disease
* Contraindications for rectal catheter insertion (including known damage to pelvic floor, sphincter or the pudendal nerve)
* Use of anticoagulants. Use of acetylsalicylic acid is allowed
* Symptomatic cardiovascular or lung disease
* Kidney failure
* Known allergic reaction to any component in Liquid Polibar Plus
* Pregnant, lactating or planning pregnancy
* Asthma

Primary outcomes:
measure: Proportion of cecum projection after CF delivery by lower GI endoscopy versus enema with positioning versus enema without positioning of the participants.
timeFrame: 10 minutes after contrast fluid delivery
Secondary outcomes:
measure: Proportion of transverse colon projection after CF delivery by the lower GI endoscopy versus enema with positioning versus enema without positioning of the participants.
timeFrame: 10-20 minutes after contrast fluid delivery
Other outcomes:
Locations:
city: Harstad
country: Norway
facility: University Hospital of North Norway, Harstad
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Peter H Johnsen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00808756: Study on Fermentable Carbohydrates in Healthy Infants
Official title: Study on Fermentable Carbohydrates in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant
Growth
Nutrition
Healthy
Keywords: Carbohydrates
Infant
Intestine
Faeces
Growth
Diet
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Joan XXIII de Tarragona.
name: Hospital Universitari Sant Joan
name: Institut Investigacio Sanitaria Pere Virgili
First posted: 2008-12-16
Enrollment: 388
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.

Detailed description: Breast-fed infants have a lower occurrence of episodes of sickness compared with formula-fed infants, and this has been ascribed to their different flora composition. The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants. Additionally, other metabolic parameters will be investigated and compared to breast-fed infants.

Eligibility criteria: Inclusion Criteria:

* Infants born in Reus and Tarragona area
* Healthy
* Normal feeding behaviour

Exclusion Criteria:

* Serious respiratory, neurological, gastrointestinal or metabolic disorders
* Infections or other serious diseases that could interfere in normal feeding or growth
* Parents or guardians cannot be expected to comply with protocol
* Parents or guardians have not command on Catalan or Spanish language

Primary outcomes:
measure: Children well-being and appropriate growth
timeFrame: up to 4 months
Secondary outcomes:
measure: Secondary outcomes will be metabolic parameters.
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
Study officials:
affiliation: University Rovira i Virgili & Hospital Universitari Joan XXIII
name: Ricardo Closa, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Rovira i Virgili. Hospital Universitari Sant Joan de Reus.
name: Joaquin Escribano, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Rovira i Virgili
name: Veronica Luque, PhD
role: STUDY_DIRECTOR
References:
citation: Closa-Monasterolo R, Gispert-Llaurado M, Luque V, Ferre N, Rubio-Torrents C, Zaragoza-Jordana M, Escribano J. Safety and efficacy of inulin and oligofructose supplementation in infant formula: results from a randomized clinical trial. Clin Nutr. 2013 Dec;32(6):918-27. doi: 10.1016/j.clnu.2013.02.009. Epub 2013 Feb 26.
Clinical trial NCT03936556: A Clinical Study to Assess the Effects of a Stannous Fluoride Dentifrice on Plaque and Gingivitis
Official title: A 3-Month Clinical Study to Assess the Effects of a Stannous Fluoride Dentifrice on Plaque and Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2019-05-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 16 gradable teeth;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study;

Exclusion Criteria:

* Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
* Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Removable oral appliances;
* Fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Any diseases or condition that might interfere with the safe participation in the study; and
* Inability to undergo study procedures.

Primary outcomes:
measure: Löe-Silness Gingivitis Evaluation
timeFrame: Baseline
measure: Löe-Silness Gingivitis Evaluation
timeFrame: 1 Month
measure: Löe-Silness Gingivitis Evaluation
timeFrame: 3 Months
Secondary outcomes:
measure: Turesky Modified Quigley-Hein Index
timeFrame: Baseline
measure: Turesky Modified Quigley-Hein Index
timeFrame: 1 Month
measure: Turesky Modified Quigley-Hein Index
timeFrame: 3 Months
Other outcomes:
Locations:
city: Whittier
country: United States
facility: University Health Resources Group
state: California
Study officials:
References:
Clinical trial NCT00971256: Urine Cytology and Utility in Bladder Recurrence
Official title: Urine Cytology and Utility in Bladder Recurrence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Bladder
Cancer
Cytology
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with bladder cancer.

Brief summary: Review bladder cancer patients and form a database in regards to urine cytology.

Detailed description: In 2008 there was an estimated 68,810 new cases of bladder cancer, and 14,100 deaths. On the list of morbidity due to cancer, bladder cancer ranks number nine, yet is number one in dollars spent per cancer diagnosis and treatment.

Guidelines include cystoscopy and cytology/urine study every three months for the first 2 years and then every 6 months for the next 2 years, with the cycle being reset with every recurrence.

Urine cytology currently considered the gold standard for urine tests has many pros and cons. The points that keep it in use include: its high specificity, the ability to detect upper tract occurrence, and the ability to monitor the small population of those with bladder cancer whose disease becomes more aggressive. Opponents to cytology refer to the fact that is has low sensitivity that it is fairly subjective and that newer markers in comparison are improved.

There are multiple journal article which document the performance of cytology and the newer markers, the new markers versus cytology and then the performance of cytology in tandem with these new markers. The bottom line that is often overlooked is that cytology is expensive and each of the newer markers are at least as expensive as cytology. With the fact that a person who is diagnosed with non invasive bladder cancer can have up to 13 urine cytology's in 5 years without any recurrence we believe newer rational recommendations need to be made in regards to urine studies and bladder cancer follow up.

Eligibility criteria: Inclusion Criteria:

* Bladder cancer patients from Dr. Jay Hollander's private practice.

Exclusion Criteria:

* Patients with diagnosis of bladder cancer without initial cytology available.
* Patients who received outside nephrectomy or cystectomy without pathology available.
* Those who had recurrence without cytology results available.
* Those who were followed by Dr Hollander and another urologist in which records are missing for a significant number of follow ups.

Primary outcomes:
measure: Review bladder cancer patients and form a database in regards to urine cytology.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beaumont Hospitals
name: Joseph Mashni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03328715: iOCT for Patients With Diabetic Macular Edema
Official title: iOCT in Patients With Diabetic Macular Edema Scheduled for Phakoemulsification - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients will be examined before and after surgery with a stand-alone OCT and intraoperative microscope integrated OCT

Detailed description: 48 patients with and 48 patients without diabetic macular edema will be recruited for the study. Macular thickness measured with a stand-alone OCT and an intraoperative OCT will be assessed before and after phakoemulsification with intraocular lens Implantation.

Eligibility criteria: Inclusion Criteria:

* Cataract with the indication for surgery (visual symptoms) for both groups (study and control group)
* Diabetic macula edema - for the study group
* Age 21 and older
* written informed consent prior to surgery

Exclusion Criteria:

* Any relevant corneal disease
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Primary outcomes:
measure: macular thickness
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03479515: Ultrasound, Peds Body Composition, and Neurodevelopmental Outcomes
Official title: Use of Bedside Ultrasound to Monitor Body Composition and Neurodevelopmental Outcomes in Formerly-Premature Toddlers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic

Brief summary: The overall objective of the proposal is to evaluate the ability of ultrasound to predict the body composition of toddlers in the outpatient clinical setting and to evaluate the relationship between body composition and neurodevelopment.

Detailed description: The investigators will address the hypothesis in the following Specific Aims:

Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat-free mass in toddlers. Body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (ADP).

Specific Aim 2: Determine the effect of a handheld Force-Measuring Ultrasound Probe on intra- and inter-observer variability in ultrasound measurements. A device which measures the force applied to the ultrasound probe will be used to obtain measurements of muscle and adipose tissue thickness (biceps, abdomen, and quadriceps) in toddlers.

Eligibility criteria: Inclusion Criteria:

* toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic
* written consent obtained from a parent before or at time of visit

Exclusion Criteria:

* toddlers who require medical support that prevents them from having ADP measurements taken
* those with an inability to sit in a supported seat for 5 minutes
* those weighing less than 10 kg

Primary outcomes:
measure: Ultrasound Measurements
timeFrame: through study completion, up to 2 years
Secondary outcomes:
measure: Body Composition Measurements
timeFrame: through study completion, up to 2 years
measure: Neurodevelopmental Status for 2 year olds
timeFrame: through study completion, up to 2 years
measure: Neurodevelopmental Status for 3 and 4 year olds
timeFrame: through study completion, up to 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sara Ramel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02872415: Effect of Site on Pain in Preterm Neonates
Official title: Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Great Premature Newborn
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 81
Sex: ALL
Minimum age (years): 3
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Numerous experimental and clinical studies have shown that preterm neonates are particularly sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each situation causing pain or discomfort can alter their development and cause short term cardiovascular consequences but also have long-term neurocognitive influences. Repetitive procedural pain can also lead to changes in the pain sensitivity threshold therefore. The most common painful procedures are lancing for blood glucose testing. In adults, infants and term newborns, forearm blood glucose testing has been demonstrated to be less painful than conventional sites (heel, fingers). But data is lacking in preterm neonates.

The primary purpose of this study is to demonstrate a significant reduction in pain response during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born up to 32 weeks gestation.

This study is an interventional multicenter (3 centers), randomized, double bind trial with a cross over assignment. 60 premature neonates born between 23 to 32 weeks.

Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose pricks will be included. The different sites will be randomly successively tested.


Eligibility criteria: Inclusion Criteria:

* Premature neonates 23 to 32 weeks gestation
* Infant born with a postnatal age greater than or equal to 3 hours and less or equal to 72 hours
* Infant born with at least 3 blood glucose testing in less than 72 hours

Exclusion Criteria:

* Severe congenital anomalies that could alter pain perception or expression
* Extremities congenital anomaly impeding blood glucose testing on different sites
* Infants born to mothers known to be receiving opiates
* Severe haemodynamic disturb
* Severe neurologic injury
* Neonate with opioids or sedatives medications
* No parental consent

Primary outcomes:
measure: The pain assessment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
Clinical trial NCT01611415: Drug to Drug Interaction Study With Ipragliflozin and Furosemide
Official title: A Clinical Pharmacological Study to Assess Pharmacodynamic and Pharmacokinetic Interactions Between Furosemide and Ipragliflozin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Pharmacokinetics of Ipragliflozin
Keywords: Phase 1
Ipragliflozin
Furosemide
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions between furosemide and ipragliflozin (ASP1941) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria:

* Any of the liver function tests above the upper limit of normal
* Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse \<40 or \>90 bpm; mean systolic blood pressure \>140 mmHg; mean diastolic blood pressure \>90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
* A QTc interval of \>430 ms (males) or \> 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

Primary outcomes:
measure: Assessment of urine sodium excretion, following multiple doses of furosemide alone compared to furosemide + ipragliflozin in healthy subjects
timeFrame: 6 days
Secondary outcomes:
measure: Assessment of urine sodium excretion, following multiple doses of ipragliflozin alone compared to furosemide + ipragliflozin in healthy subjects
timeFrame: 6 days
measure: Assessment of pharmacodynamic parameters (i.e. calcium, chloride, potassium, phosphate and magnesium in blood and urine) following multiple doses of furosemide alone, ipragliflozin alone, and furosemide + ipragliflozin in healthy subjects
timeFrame: 9 days
measure: Assessment of the pharmacokinetics of ipragliflozin when co-administered with furosemide compared to ipragliflozin alone
timeFrame: 10 days
measure: Assessment of the pharmacokinetics of furosemide when co-administered with ipragliflozin compared to furosemide alone
timeFrame: 10 days
measure: Assessment of the safety and tolerability of furosemide and ipragliflozin following multiple doses of furosemide alone, ipragliflozin alone, and furosemide + ipragliflozin in healthy subjects
timeFrame: 39 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_DIRECTOR
References: