louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04857346: Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus
Official title: Indocyanine-mediated Antimicrobial Photodynamic Therapy Promotes Superior Clinical Effects in Stage III and Grade C Chronic Periodontitis Among Different Forms of Diabetes Mellitus: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes Mellitus
Prediabetic State
Chronic Periodontitis
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With this design, this study hypothesizes that; (i) ICG-PDT would produce superior clinical, microbiological, and immune-inflammatory outcomes as compared to RSD and (ii) ICG-PDT would produce equal efficacy among different forms of diabetes as produced in non-diabetic subjects and that diabetes mellitus would not produce negative impact on the therapeutic outcomes of ICG-PDT. Therefore, the aim of this randomized controlled clinical trial was to evaluate the efficacy of ICG-mediated aPDT in the treatment of stage III grade C periodontitis among patients with prediabetes, T2DM and non-diabetic subjects.


Eligibility criteria: Inclusion Criteria:

1. aged ≥30 years
2. clinically diagnosed with mild to moderate periodontitis
3. self-reported type-2 DM for ≥2 years confirmed by a physician with HbA1c levels ≥6.5%
4. patients who complied with the treatment protocol.

Exclusion Criteria:

(i) pregnancy and lactation (ii) who had taken antibiotics in the previous 3 months (iii) who had undergone periodontal therapy or any decontamination treatment in their oral cavity in the previous 6 months (iv) former/current smokers (v) failure to provide a signed informed consent.

Primary outcomes:
measure: Probing depth
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 6 months
Secondary outcomes:
measure: Plaque scores
timeFrame: 6 months
measure: Bleeding on probing
timeFrame: 6 months
measure: Porphyromonas gingivalis
timeFrame: 6 months
measure: Interleukin-6
timeFrame: 6 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: College of Applied Medical Sciences, King Saud University
Study officials:
References:
citation: Al-Momani MM. Indocyanine-mediated antimicrobial photodynamic therapy promotes superior clinical effects in stage III and grade C chronic periodontitis among controlled and uncontrolled diabetes mellitus: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102379. doi: 10.1016/j.pdpdt.2021.102379. Epub 2021 Jun 1.
Clinical trial NCT03601546: Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam
Official title: Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C Infection
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hepititis C recruited during consultation in the infections and tropical disease service of the Viet Tiep hospital in Hai Phong, Vietnam

Brief summary: The purpose of this study is to evaluate the feasibility of implementing a cohort of patients with Hepatitis C in order to generate a larger cohort for future studies


Eligibility criteria: Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient is at least 18 years old
* The patient is HCV RNA positive

Exclusion Criteria:

-

Primary outcomes:
measure: Patient inclusion rate
timeFrame: End of study: 12 months
measure: Rate of missing data of patient variables
timeFrame: Day 0-1
measure: Lost to follow-up rate
timeFrame: Month 6
measure: Lost to follow-up rate
timeFrame: Month 12
measure: Archival of all signed consent forms
timeFrame: End of study: Month 12
Secondary outcomes:
measure: Social-demographic characteristics of patients at inclusion
timeFrame: Day 0
measure: drug and alcohol consumption,
timeFrame: Day 0
measure: treatment at inclusion
timeFrame: Day 0
measure: commencement of treat
timeFrame: Day 1
measure: initial HCV viral load,
timeFrame: Day 0
measure: HCV genotype
timeFrame: Day 0
measure: Fibrosis stage
timeFrame: Day 0
measure: HIV viral load
timeFrame: Day 0
measure: Lymphocyte T4 level
timeFrame: Day 0
measure: Fibrosis stage
timeFrame: Day 0
measure: Hepatic ultrasound
timeFrame: Day 0
measure: Transaminase levels
timeFrame: Day 0
measure: HIV co-infection
timeFrame: Day 0
measure: Hepititis B co-infection
timeFrame: Day 0
measure: Methadone treatment
timeFrame: Day 0
measure: Access to health cover
timeFrame: Day 0
measure: Commencement of treatment
timeFrame: Day 1
measure: Type of treatment
timeFrame: Day 0
measure: Treatment side effects
timeFrame: ay
measure: Early viral response
timeFrame: Week 4
measure: Sustained viral response
timeFrame: Week 12
measure: HCV re-infection
timeFrame: Month 12
measure: Risk factors associated with reinfection
timeFrame: 3 months after clearance
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
city: Hai Phong
country: Vietnam
facility: Hospital Viet Tiep
Study officials:
affiliation: CHU Nimes
name: Didier Laureillard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06661746: Efficient Postoperative Pain Management With Multimodal IV
Official title: Multimodal Intravenous Analgesia Using Half-dose of Ketamine, Lidocaine and Magnesium Sulfate Provides Efficient Postoperative Analgesia for Patients Undergoing Major Abdominal Surgery: Randomized, Case-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain remains a prevalent concern despite ongoing improvements in surgical methods and pain management strategies. Opioids, while commonly prescribed, frequently lead to undesirable side effects. Epidural analgesia, though a viable option, carries its risks and complications. Recent research indicates that combining intravenous lidocaine and ketamine can significantly alleviate postoperative pain and decrease the reliance on opioids within the initial 24 hours following surgery. This approach offers a promising alternative with minimal additional adverse effects, suggesting a potential shift in pain management practices.


Eligibility criteria: Inclusion Criteria:

* Patients were assigned for surgical intervention;
* Patients of ASA grade I-III;
* Patients were free of exclusion criteria;

Exclusion Criteria:

* Patients who are not in ASA grade I-III;
* Patients who had uncontrolled hypertension and/or diabetes mellitus;
* Patients who had uncompensated cardiac, renal, or hepatic diseases;
* Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
* Patients who refused to sign the informed consent were excluded from the study.

Primary outcomes:
measure: Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative follow up.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: El Qalyoubia
Study officials:
References:
Clinical trial NCT06574646: Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
Official title: Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract
Keywords: intraocular lens
LAL+
Clareon Vivity Toric IOLs
Lead sponsor: The Eye Associates
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 250
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs

Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.


Eligibility criteria: Inclusion Criteria:

* Adult (≥45) subjects who are astigmatic and require bilateral, routine small-incision, surgery for age-related cataracts with femtosecond laser;
* All subjects will be required to be targeted for refractive emmetropia (plano or first minus closest to plano);
* Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator;
* Subjects will have regular corneal astigmatism (1.00 to 2.00 D), which can be corrected with a toric power IOL of T3-T5;
* Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes;

Exclusion Criteria:

* Moderate-severe corneal pathology;

  * Irregular astigmatism;
  * Subject desire monovision correction;
  * Preexisting macular disease or other retinal degenerative diseases that is expected to cause future vision loss;
  * History of glaucoma;
  * Severe dry eye disease;
  * History of uveitis;
  * History of ocular herpes simplex virus;
  * History of nystagmus;
  * Zonular laxity or dehiscence;
  * History psueudoexfoliation;
  * History of corneal refractive and intraocular surgery or requiring any other planned ocular surgical procedures;
  * Currently taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina;
  * Pregnant or breastfeeding.

Primary outcomes:
measure: Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
timeFrame: at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for LAL+ implanted subjects and >2 weeks post YAG, if done.
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: The Eye Associates of Manatee, LLP
state: Florida
Study officials:
affiliation: The Eye Associates of Manatee
name: Cathleen M McCabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02167646: Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Injuries
Keywords: Soft tissue defect
dorsal branch of the digital nerve
dorsal branch of the digital artery
dorsal digital flap
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2014-06-19
Enrollment: 73
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.

Detailed description: Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma.

Eligibility criteria: Inclusion Criteria:

* a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger
* the defect associated with the transected digital nerves in both sides
* a defect greater than 1.5 cm
* a patient aged 15 to 60 years

Exclusion Criteria:

* injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
* injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap
* a defect less than or equal to 1.5 cm
* patient age \< 15 years or \> 60 years

Primary outcomes:
measure: Static 2PD test
timeFrame: 18 months to 24 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
References:
citation: Chen C, Tang P, Zhang X. The dorsal homodigital island flap based on the dorsal branch of the digital artery: a review of 166 cases. Plast Reconstr Surg. 2014 Apr;133(4):519e-529e. doi: 10.1097/PRS.0000000000000016.
citation: Chen C, Tang P, Zhao G. Bilaterally innervated dorsal digital flap for sensory reconstruction of digits. Injury. 2014 Dec;45(12):2018-24. doi: 10.1016/j.injury.2014.09.012. Epub 2014 Sep 22.
Clinical trial NCT00332046: fMRI Study Comparing BOLD Activation Patterns Using GW679769 In Subjects With Social Anxiety Disorder
Official title: A Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Parallel Group, fMRI Study Comparing BOLD Activation Patterns Before and After 12 Weeks of Treatment With Placebo, Comparator and GW679769 in Subjects With Social Anxiety Disorder (SAD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Social Anxiety Disorder
Keywords: fMRI placebo GW679769 Social Anxiety Disorder SAD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evidence suggests the use of neuroimaging to detect therapeutic effects of anxiolytic treatment when appropriate cognitive-emotional tasks are use to activate the emotional brain neurocircuitry believed to be involved in the core symptoms of the disease.


Eligibility criteria: Inclusion criteria:

* Primary diagnosis of Social Anxiety Disorder.
* Willing to restrict alcohol to a limited intake.

Exclusion criteria:

* History of schizophrenia, schizoaffective disorder or a bipolar disorder.
* Left-handed.
* Suffer from claustrophobia.
* Any reason why subject could not go into the fMRI, for example have metal implants.

Primary outcomes:
measure: Change in images of the brain, when stimulated, after once daily dosing for 12 weeks with GW679769, comparator or placebo in subjects with SAD.
Secondary outcomes:
measure: Blood levels of GW679769 and comparator at the Week 1 and Week 12 Change in clinical rating scales from baseline to Week 12 Safety & tolerability
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: GSK Investigational Site
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04937946: Efficacy and Safety of Fentanyl for Pain Control in Newborn on Mechanical Ventilation
Official title: Efficacy and Safety of Fentanyl for Pain Control in Newborns on Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mechanical Ventilation Complication
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the efficacy and safety of Fentanyl for pain control in Newborns on mechanical ventilator.

Detailed description: This Randomized Controlled Trial will be conducted in the Department of Neonatology, BSMMU, Dhaka after approval by Institutional Review Board (IRB). A Written informed consent will be obtained before enrollment in the study from the parents or guardians. . The study cohort will comprise all inborn and outborn newborns admitted to the neonatal intensive care unit (NICU) who receive mechanical ventilation administered through an endotracheal tube . The enrolled neonates will be randomly assigned with computer-generated random number tables via software named 'Random Allocation Software', to receive either of the intervention.

Once the parents will agree to the study and provide signed informed consent, all eligible neonates will be randomized to start treatment within 24 hours from the initiation of mechanical ventilation. Randomized infants will be allocated to the fentanyl group to receive a continuous infusion of fentanyl or to the placebo group to receive a continuous infusion of iv fluid.

Fentanyl will be administered as an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour. The infusion will be administered through a peripheral line. Fentanyl infusion will be initiated within 24 hours after the start of mechanical ventilation and will be continued until the end of mechanical ventilation, and not longer than 5 days .

Eligibility criteria: Inclusion Criteria:

1. All inborn and outborn newborns admitted to the neonatal intensive care unit (NICU) who received mechanical ventilation administered through an endotracheal tube.
2. Newborn on mechanical ventilator for at least 72 hours.

Exclusion Criteria:

1. Known genetic or chromosomal disorders,
2. The need for postoperative analgesic therapy during the study period,
3. Major congenital anomaly,
4. Those who received drugs like midazolam, paracetamol, morphine, muscle relaxants, phenobarbital, phenytoin, and chloral hydrate during the study period.
5. Probable rapid extubation.

Primary outcomes:
measure: Decrease in Neonatal Pain Agitation and Sedation Scale (NPASS) score.
timeFrame: 5 days
Secondary outcomes:
measure: Adverse effects of fentanyl
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Bngabandhu Sheikh Mujib Medical University
name: BSMMU
role: STUDY_CHAIR
References:
Clinical trial NCT02050646: The Role of Sodium Chloride and the Treg/Th17 Axis in Autoimmune Hepatitis
Official title: The Role of Sodium Chloride and the Treg/Th17 Axis in Autoimmune Hepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Hepatitis
Keywords: Autoimmune hepatitis
Liver dysfunction
Elevated serum auto antibodies
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether a salt restriction diet improves immune parameters in patients with autoimmune hepatitis.

Detailed description: The etiology of autoimmune hepatitis (AIH) is unknown although both genetic and environmental factors are thought to be involved. A defect in immune regulation affecting regulatory T cells (Tregs) has been demonstrated in AIH. Tregs function in the maintenance of immune homeostasis by controlling autoreactive immune responses to self-antigens.

Rationale: the western diet has been postulated as a potential environmental risk factor for the increasing incidence of autoimmune diseases in developed countries. Data from the investigators' laboratory also suggests that increased dietary salt intake might represent an environmental risk factor for the development of autoimmune diseases through the induction of pathogenic Th17 cells. The dramatic in vitro effects of high salt on the induction of pathogenic Th17 cells from naïve human CD4 cells {Kleinewietfeld, Hafler. Nature. 2013 Apr 25;496(7446):518-22. doi: 10.1038/nature11868.}, and block of in vitro Treg suppression, in line with in vivo effects on worsening murine experimental autoimmune encephalomyelitis (EAE), have prompted the investigators to examine the effects of increased dietary sodium chloride in a human in vivo system.

The investigators hypothesize that excess dietary salt may function as an environmental trigger that favors induction and expansion of pathogenic Th17 cells and leads to functional impairment of Tregs, thereby favoring development of autoimmunity. The investigators aim to study their established in vitro model in humans by altering the salt intake in patients over a 20-day period.

Eligibility criteria: Inclusion Criteria:

* Adults 18-50 years of age
* Children 1-17 years of age
* ALT and/or ALP/GGT level \> 2X upper limit of normal
* ANA or SMA \>/= 1:40
* ANA or SMA \>/= 1:80
* or LKM \>/= 1:40
* or SLA positive
* IgG \> upper limit of normal

Exclusion Criteria:

* Chronic hepatitis C
* Decompensated Liver Disease

Primary outcomes:
measure: Change from baseline in production of pathogenic TH17 cells.
timeFrame: 26 days
Secondary outcomes:
measure: Change from baseline in regulatory T cell function.
timeFrame: 26 days
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Udeme Ekong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03866746: Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema
Official title: Aflibercept With Adjuvant Micro-Pulsed Yellow Laser Versus Aflibercept Monotherapy in Treatment of Diabetic Macular Edema.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: Aflibercept
Anti-VEGFs
micropulsed diode laser
subthreshold
Lead sponsor: Al Hadi Hospital
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 51
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: prospective study evaluating the impact of subthreshold micropulsed laser on the number of Aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old
* diagnosed with DME with central macular thickness (CMT) more than 250 µm measured by OCT
* best corrected visual acuity (BCVA) between 20/400 and 20/40.

Exclusion Criteria:

* patients with intra-ocular surgery as cataract surgery within 6 months
* prior intravitreal injection of any drug within the preceding 6 months
* panretinal photocoagulation (PRP) within the former 4 months.
* Patients with previous macular laser
* patients with vitreo-macular traction (VMT) syndrome
* severe glaucoma
* other retinal vascular diseases
* conditions that impede the OCT interpretation

Primary outcomes:
measure: the number of intravitreal injections
timeFrame: 18th month follow-up.
measure: Central macular thickness
timeFrame: 18 month
Secondary outcomes:
measure: best corrected visual acuity measured in ETDRS.
timeFrame: 18 months
Other outcomes:
Locations:
city: Ḩawallī
country: Kuwait
facility: AlHadi hospital
state: AlJabryia
Study officials:
affiliation: Al Hadi Hospital
name: Abeer M Khattab, MD
role: PRINCIPAL_INVESTIGATOR
References: