louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06637384: Effect of Hyaluronic Acid and Single Dose Corticosteroid Injection to Improve Wound Healing in Controlled Diabetic Patients Post Tooth Extraction.
Official title: Effects of Hyaluronic Acid and Corticosteroid in Post Extraction Wound Healing of Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Wound Healing Delayed
Keywords: Wound healing post extraction, Single dose corticosteroid, Diabetes Mellitus, Hyaluronic acid
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 128
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn if hyaluronic acid and corticosteroid improves wound healing in diabetic patients after oral extraction.

Detailed description: After sample size estimation via Open Epi of 128, randomized clinical trial was performed on the patients from Oral and Maxillofacial Surgery Department in Madinah Teaching Hospital, Faisalabad. Patients were divided into three groups. Group 1 was subjected as control group, Group 2 was treated post extraction with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) and Group 3 was treated with single dose Hy-Cortisone Injection 250 mg (Generic name: Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals Pakistan) intramuscularly after extraction. Wound healing was assessed through Landry Healing Index. One-way ANOVA test was applied for comparative analysis and Post Hoc Tuckey's test was applied for pairwise comparisons between the groups

Eligibility criteria: Inclusion Criteria:

* • Controlled diabetic patients who had random blood glucose levels of 80 to 130 mg/dl, according to World Health Organization.

  * Age was defined from 25-55, irrespective of the gender.
  * Tooth extractions in maxilla or mandible without the presence of an acute infection or compromised periodontal state.

Exclusion Criteria:

* • Patients who declined to participate.

  * Patients below the age of 25 and above the age of 55.
  * Patients with uncontrolled diabetes mellitus (blood sugar levels high than the defined range)
  * Patients with history of adverse effects to local anesthetics or who are currently taking corticosteroids.
  * Patients with unmaintained oral hygiene and smoking habits.
  * Confirmation of any chronic illness, including those with hypertension or cardiac disorders.
  * Patients who have undergone any recent major surgical procedure.

Primary outcomes:
measure: Wound healing
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Department of Oral and Maxillofacial Surgery, Madinah Teaching Hospital, Faisalabad
state: Punjab
Study officials:
affiliation: The University of Faisalabad
name: Rimsha Rasheed, BDS, MPhil Physiology
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01957384: Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care
Official title: An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured


Eligibility criteria: Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Be able to handle the bags themselves or with help from caregiver
* Have an ileostomy with a diameter between 15 and 45 mm
* Have had their ostomy for at least three months
* Currently use a 1-piece flat standard care product with open bag
* Negative result of a pregnancy test for women of childbearing age
* Custom-cut product user
* Be suitable for participation in the investigation

Exclusion Criteria:

* Use irrigation during the study (flush the stoma with water)
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy
* Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
* Are pregnant or breastfeeding
* Participating in other interventional clinical investigations or have previously participated in this investigation
* Max three days wear time
* Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Primary outcomes:
measure: Degree of Leakage
timeFrame: Up to 14 days per test product
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Birte Petersen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04795284: Biomechanical Parameters of Gait in Patients with Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
Official title: Biomechanical Parameters of Gait in Patients with Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Stenosis
Healthy Elderly
Keywords: Lumbar Spinal Stenosis
Healthy elderly
Walking capacity
Biomechanical parameters
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 135
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: Patients with a symptomatic lumbar spinal stenosis Group 2: Healthy elderly from the community

Brief summary: The aim of this study is to compare biomechanical walking parameters between patients with symptomatic lumbar spinal stenosis and healthy elderly.


Eligibility criteria: Inclusion Criteria:

Patients with lumbar spinal stenosis

* Having a diagnosis of lumbar spinal stenosis (at least 1 level)
* Having neurologic claudication due to the lumbar spinal stenosis

Healthy elderly

* Being over 50 years old of age
* No back or leg pain during walking

Exclusion Criteria:

* Symptomatic hip or knee Ostearthritis
* Not able to give their free consent
* Being in a wheelchair (not able to walk 30 meters)

Primary outcomes:
measure: biomechanical walking parameters (gait cycle, stride length, walking time, walking speed, swing width, minimal toe clearance)
timeFrame: During the 30-meter walking test
measure: Quality of life (Euro-Qol - 5D)
timeFrame: One time (before the completion of the 30-meter walking test)
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: One time (before the completion of the 30-meter walking test)
Secondary outcomes:
measure: French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ)
timeFrame: One time (before the completion of the 30-meter walking test) - Only for patients with lumbar spinal stenosis
Other outcomes:
Locations:
city: Trois-Rivieres
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
References:
Clinical trial NCT02843984: Influence of Vaginal Lactoferrin on Amniotic Fluid Cytokines to Avoid Pregnancy Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Amniocentesis
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid concentration of 47 cytokines, chemokines and growth factors.

Detailed description: 60 women undergoing genetic amniocentesis will be enrolled at the Obstetric Unit, University of Ferrara. The selected patients will be randomly assigned to receive 300 mg of vaginal Lactoferrin to obtain 3 groups: A, 20 untreated patients; B and C (20 patients each one) respectively treated 4 and 12 h before amniocentesis. Cytokines, chemokines and growth factors concentrations will be quantified by a magnetic bead Luminex multiplex immunoassays panel technology.

Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not required for clinical purposes will be centrifuged to remove particulate material and the supernatants will be aliquoted and stored at -80°C until assay.

Eligibility criteria: Inclusion Criteria:

* singleton physiological pregnancy;
* maternal age as the only indication to foetal karyotyping

Exclusion Criteria:

* assumption of drugs interfering with the immune system;
* previous miscarriages;
* pregnancy at risk for maternal or foetal disease;
* lactose intolerance.

Primary outcomes:
measure: Amniotic fluid concentration of mediators involved in inflammation
timeFrame: 1 month after the enrollment of patients will be concluded.
Secondary outcomes:
Other outcomes:
Locations:
city: Cona
country: Italy
facility: Obstetric Unit, University of Ferrara
state: Ferrara
Study officials:
References:
Clinical trial NCT00565084: Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)
Official title: A Randomized, Placebo-Controlled Single-Dose 3-Period Crossover Study to Assess the Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-11-29
Enrollment: 33
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.


Eligibility criteria: Inclusion Criteria:

* The primary source of pain is the study knee of one lower extremity
* Patient is willing to limit alcohol and caffeine intake
* Aside from osteoarthritis, patient is in generally good health
* Patient is capable of completing protocol specified walks
* Patient is able to understand and complete questionnaires in English
* Patient has previously benefited from the use of either NSAIDs, COX-2 inhibitors, or acetaminophen

Exclusion Criteria:

* Patient has another condition which could interfere with evaluating pain in the knee being tested
* Patient is not able to take a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen
* Patient has a history or current evidence of stroke, transient ischemic attack, liver disease or cancer
* Patient has a history or current evidence of dizziness, unsteadiness, or falling
* Patient has congestive heart failure, unstable angina or uncontrolled high blood pressure
* Patient has a history of stomach, digestive track, or small intestine surgery
* Patient is unable to complete the study questionnaires in English

Primary outcomes:
measure: Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks
timeFrame: All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Peeva E, Beals CR, Bolognese JA, Kivitz AJ, Taber L, Harman A, Smugar SS, Moskowitz RW. A walking model to assess the onset of analgesia in osteoarthritis knee pain. Osteoarthritis Cartilage. 2010 May;18(5):646-53. doi: 10.1016/j.joca.2009.12.008. Epub 2010 Feb 6.
Clinical trial NCT01690884: Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
Official title: Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: Adenosine
Ticagrelor
Microdialysis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators are trying to determine if a single dose of Ticagrelor will increase delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with adenosine reuptake blockade.

Detailed description: The investigators will compare adenosine interstitial levels using a parallel design study with three groups of subjects. Forearm interstitial adenosine levels will be measured at baseline and after intrabrachial infusion of adenosine at two doses. Subjects will then randomly receive Ticagrelor 180 mg, Dipyridamole 200 mg, or placebo. Two hours later the investigators will repeat the dialysate collections at baseline and after adenosine infusions.

Eligibility criteria: Inclusion Criteria:

1. Subjects will be healthy volunteers, without significant pulmonary, cardiovascular gastrointestinal, hematological or renal diseases
2. Not taking any regular medications
3. Able to provide signed consent prior to study participation.

Exclusion Criteria:

1. History of asthma
2. Pregnancy
3. Exposure to an investigational drug in the last 2 months.
4. Known hypersensitivity to study medications

Primary outcomes:
measure: Interstitial levels of adenosine
timeFrame: After each dose of intrabrachial adenosine
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Autonomic Dysfunction Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Italo Biaggioni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01776684: Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis
Official title: Detection of Resistance Genes From Serially Collected Plasma DNA in Non-small Cell Lung Cancer Patients Harboring EGFR Activating Mutation Who Are Being Treated With EGFR TKIs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: EGFR Mutation Positive Non-small Cell Lung Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2013-01-28
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.


Eligibility criteria: Inclusion Criteria:

* 1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent

Exclusion Criteria:

* 1. Active infection 2. Active bleeding

Primary outcomes:
measure: detection of resistant gene
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT06932484: Delta Variation to Guide Hemodynamic Optimization
Official title: A NEW APPROACH IN THE MANAGEMENT OF INTRAOPERATIVE ARTERIAL HYPOTENSION BASED ON DELTA VARIATION OF HEMODYNAMIC PARAMETERS: A RANDOMISED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodynamic MAP Stability
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: intraoperative hemodynamic optimization will be based on the percentage of variation of the parameters


Eligibility criteria: Inclusion Criteria: All patients \> 18 years old scheduled for major abdominal

Exclusion Criteria:

Body Mass Index \> 35 kg/m2 Pregnancy Refusal to sign written informed consent Urgent and/or emergency surgery

Primary outcomes:
measure: time weighted average of mean arterial pressure
timeFrame: the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06473584: Study of the Prevalence of Diabetes and Pre-diabetes in Réunion Island
Official title: Study of the Prevalence of Diabetes and Pre-diabetes in Réunion Island
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: Agence Régionale de Santé de La Réunion
First posted: 2024-06-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In view of the new priority given to diabetes in Réunion and the implementation of an ambitious plan to combat the disease at regional level, which includes the identification and management of pre-diabetes, the need for up-to-date data on the extent of these 2 diseases (diabetes and pre-diabetes) has become essential.

These two diseases have known risk factors: age, overweight, obesity, high waist circumference, family history, hypertension, eating habits and physical activity, all of which form part of a risk score for developing diabetes: the Findrisk recommended by the Haute Autorité de Santé for identifying people at risk of diabetes. Given the specific population characteristics of Réunion compared with Finland, where this score has been validated, it would seem important to be able to measure these risk indicators in the population as a function of carbohydrate status in order to check that the proposed thresholds are appropriate for the population of Réunion.

Finally, cardiovascular risk has been described as early as the pre-diabetes stage. Given the young age of onset of diabetes in Réunion and the high proportion of diagnoses of diabetes made following the occurrence of a cardiovascular complication, the study of the prognosis of carbohydrate status on the occurrence of complications using the social security information system will be offered on a voluntary basis to study subjects (via a probabilistic social security link).


Eligibility criteria: Inclusion Criteria:

* Have lived in Réunion island for at least one year
* Be aged between 18 and 75
* Affiliated to or benefiting from a social security scheme
* Free, informed and signed consent

Exclusion Criteria:

* No main residence on the island or fixed address for at least one year on the island
* Participation in experimental research
* Pregnant women
* Adults under guardianship or legal protection
* Not understanding French

Primary outcomes:
measure: Estimating the prevalence of glycaemic abnormalities (diabetes and pre-diabetes) in Réunion
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: St Denis
country: Réunion
facility: CHU La Réunion
Study officials:
affiliation: CHU La Réunion
name: Catherine MARIMOUTOU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00991484: Collagen Analysis and Genetic Analysis of Families With Tendency to Hernias
Official title: Collagen-subtype Analysis in Subcutaneous Tissue and Genetic Analysis on Patients From Families With a Tendency to Hernias
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hernia
Keywords: ventral
inguinal
hernia
inheritance
genetics
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in Denmark operated or diagnosed with hernias who are member of a family with tendency to hernias.

Brief summary: Analysis of collagen subtype subcutaneously and genetic analysis of patients from families with a tendency to hernias. Furthermore circulating biomarkers and biomarkers extracted from the subcutaneously tissue such as MMP's (matrix metallo proteinases) and TIMP's (tissue inhibitor of metallo proteinases) will be measured.

Detailed description: Research has shown relationship between hernias and collagen subtype I/III ratio, biomarkers such as MMP's TIMP's and other diseases such as Ehlers-Danlos, Marfans syndrome, AAA (abdominal aortic aneurysms), diverticulosis and rectal prolapse. Furthermore has research raised hypothesis about inheritance of hernias. The investigators are performing genetic examination combined with analysis of collagen and biomarkers on patients belonging to families with tendency to hernias.

Other examinations performed on the patients enrolled in this study:

* Ultrasound (US) examination of the abdominal aorta to discover possible abdominal aortic aneurysms.
* Beightons score to evaluate the degree of joint hypermobility.

Eligibility criteria: Inclusion Criteria:

* adults over 18 years
* adults must be members of a family where there are presence of hernias in minimum generation.

Exclusion Criteria:

* infections
* pregnant
* mentally ill patients

Primary outcomes:
measure: Expression of collagen-genes or other relevant genes by microarray analysis compared with presence of hernia
timeFrame: 1 year
Secondary outcomes:
measure: Amount of collagen subtypes measured subcutaneously.
timeFrame: 1 year
Other outcomes:
Locations:
city: DK-2730, Herlev
country: Denmark
facility: Herlev Hospital
state: Herlev
Study officials:
affiliation: Herlev Hospital
name: Jacob Rosenberg, Prof. MD
role: STUDY_DIRECTOR
affiliation: Herlev Hospital
name: Jakob Burcharth, MD
role: PRINCIPAL_INVESTIGATOR
References: