louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02249689: Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
Official title: Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: Contamac Ltd
Sponsor class: INDUSTRY
Collaborators: name: Hartwig Research Center
First posted: 2014-09-25
Enrollment: 60
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: Comparison of different contact lens materials.

Detailed description: This will be a 3-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.

Eligibility criteria: Inclusion Criteria:

* willing and able to sign the informed consent form
* ages 18 years or older
* Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
* spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
* astigmatic power equal to or less than 0.75 D

Exclusion Criteria:

* eye injury or surgery within 3 months immediately prior to enrolment for this trial
* pre-existing ocular irritation that would preclude contact lens fitting
* currently enrolled in an ophthalmic clinical trial
* evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses use of as determined by the investigator
* any use of medications for which contact lens wear could be contradicted, as determined by the investigator
* current extended-wear users (sleep-in overnight)
* current monovision leans wearers
* pregnant women and nursing mothers
* best-corrected visual acuity worse than 6/9 (logMAR: +0.20; Snellen decimal: 0.63)

Primary outcomes:
measure: questionnaire addressing subjective comfort and wear time
timeFrame: subjects will be followed-up for three months
measure: limbal redness - ocular biomicroscopy
timeFrame: subjects will be followed-up for three months
measure: corneal staining - ocular biomicroscopy
timeFrame: subjects will be followed-up for three months
Secondary outcomes:
Other outcomes:
Locations:
city: Kassel
country: Germany
facility: Siehste
city: Würzburg
country: Germany
facility: Kresinsky
Study officials:
affiliation: Hartwig Research Center
name: Andreas Hartwig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04350489: IL-32 Isoforms Levels in GCF and Plasma of the Patients With Periodontitis
Official title: Increased Levels of Interleukin-32 Isoforms Alpha, Beta, Gamma, and Delta in the Gingival Crevicular Fluid and Plasma of the Patients With Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 54
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. group (Control): Periodontally and systemically healthy
2. group: Systemically healthy and periodontitis

Brief summary: Interleukin (IL)-32, which has been recently reported to be associated with periodontitis, has been suggested to have pleiotropic effect due to its 9 different isoforms. The aim of this study was to investigate the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in gingival crevicular fluid (GCF) and plasma before and after nonsurgical periodontal treatment in patients with periodontitis (P).Twenty-seven P and 27 periodontally healthy controls (C) were recruited in this study. Periodontitis patients were performed nonsurgical periodontal treatment. GCF and plasma sampling and clinical periodontal parameters were evaluated before and 1 month after treatment. Enzyme-linked immunosorbent assay was used to analyze the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in GCF and plasma samples.


Eligibility criteria: Inclusion Criteria:

* Have at least 20 natural teeth, excluding third molars.
* Periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting \>30% of the teeth, as detected on clinical and radiographical examinations.
* Periodontally healthy control group had no sign of gingival inflammation, no PD \> 3mm and no evidence of attachment or bone loss

Exclusion Criteria:

* History of systemic disease.
* Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.
* Periodontal treatment during last 6 months that could affect periodontal status.
* Smoking.
* History of radiotherapy or chemotherapy.
* Current pregnancy, lactation or menopause.

Primary outcomes:
measure: IL-32 isoforms levels
timeFrame: baseline
measure: IL-32 isoforms levels
timeFrame: 1st month after treatment
Secondary outcomes:
measure: correlation
timeFrame: baseline and 1st month after treatment
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
Study officials:
References:
Clinical trial NCT02832089: Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation
Official title: Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
rate reduction
Lead sponsor: Andhra Medical College
Sponsor class: OTHER_GOV
First posted: 2016-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Oral carvedilol administered in escalating doses in patients with atrial fibrillation among patients with AF with fast ventricular rate.

Detailed description: Patients with AF with FVR of any etiology were evaluated and given escalating doses of oral carvedilol in doses - 3.125mg OD, then 3.125 bid, then 6.25mg bid, then 12.5mg bid. The ECG was recorded regularly and analysed for rate reduction or control.

Eligibility criteria: Inclusion Criteria:

* AF with fast ventricular rate

Exclusion Criteria:

-

Primary outcomes:
measure: reduction in ventricular rate in AF patients
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06954389: Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability
Official title: Hyperbaric Oxygen Therapy as a Neuroprotective Modality in Pediatric Acquired Brain Injury With Motor Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperbaric Oxygen Therapy
Neuroprotective
Pediatric
Acquired Brain Injury
Motor Disability
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to assess the efficacy of hyperbaric oxygen therapy as a neuroprotective intervention in children with acquired brain injury.

Detailed description: Pediatric acquired brain injury (ABI) represents a significant challenge in modern medicine, necessitating innovative therapeutic approaches to enhance recovery and minimize long-term neurological deficits.

Hyperbaric oxygen therapy (HBOT), which delivers oxygen at pressures exceeding atmospheric levels, has emerged as a promising neuroprotective intervention for various forms of pediatric brain injury, including traumatic brain injury (TBI), anoxic-ischaemic encephalopathy (AIE), and stroke.

Eligibility criteria: Inclusion Criteria:

* Age 4-12 years.
* Diagnosed with pediatric acquired brain injury confirmed by neurological examination and magnetic resonance imaging.
* Presence of neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infection, stroke, tumor, hypoxia).

Exclusion Criteria:

* Positive family history of degenerative brain insults.
* Behavioral problems.
* Contraindications to hyperbaric oxygen therapy :

  * Active epilepsy.
  * Respiratory insufficiency.
  * Uncontrolled heart failure.
  * Eustachian tube dysfunction.
  * Tympanic membrane rupture.
  * Mechanical ventilation dependency.

Primary outcomes:
measure: Spasticity assessment
timeFrame: Eight months post-intervention
Secondary outcomes:
measure: Evaluate changes in gross motor function temporally
timeFrame: Eight months post-intervention
measure: Upper limb function assessment
timeFrame: Eight months post-intervention
measure: Assessment the fine motor function progression
timeFrame: Eight months post-intervention
measure: Evaluate feeding capabilities
timeFrame: Eight months post-intervention
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT05092789: Comparison of Kinesio Taping and Cervical Thrust Manipulation in Neck Pain
Official title: Comparison of Kinesio Taping and Cervical Thrust Manipulation in Patients With Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Mechanical neck pain
Kinesio taping
Cervical manipulation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of kinesio taping, cervical thrust manipulation and conventional therapy on neck pain, functional status and range of motion

Detailed description: Neck pain is most prevalent condition affecting globally, which also create threats to the individuals. Mechanical neck pain affects mainly two third of population at some time in life possibly in middle age, some people may be acute mechanical neck pain while some leading to chronic stage. Mechanical neck disorders usually associated with pain, decreased cervical mobility, spasm. Often neck pain is mechanical in nature, according to literature mechanical neck pain is defined as, that pain originating from cervical spine which may be aggravated with cervical motion, prolonged posture, muscular stiffness. Due to widespread occurrence of mechanical neck pain mainly in modern society, proper interventional strategies of this problem is needed to facilitate that problem. Incidence of neck pain may range from 10.4-23.3%in one year, while according to previous literature prevalence of neck pain was 0.4 to 86.8%, with high proportion in office workers, computer users, and females especially 35 to 55 years. Pain, stiffness, tenderness and restricted mobility is most common symptoms associated with neck pain, manual therapy techniques, exercises, mobilization, manipulations, kinesio taping are treatment strategies used for this problem may improve neck pain.

The main purpose of my study is to improve neck pain, discomfort and functional status in patients with mechanical neck pain.

Eligibility criteria: Inclusion Criteria:

* Subjects having mechanical neck pain.
* participants having neck pain more than 1 month.

Exclusion Criteria:

* History of serious pathology (Malignancy, inflammatory disorders).
* Cervical spinal surgery.
* History of trauma or fracture.
* Vascular syndromes.
* Neurological and cardiac pathologies.

Primary outcomes:
measure: Cervical range of motion
timeFrame: 6 weeks
Secondary outcomes:
measure: Numerical pain rating scale
timeFrame: 6 weeks
Other outcomes:
measure: Neck functional stability
timeFrame: 6 weeks
Locations:
city: Islamabad
country: Pakistan
facility: Natural Medicine and Rehabilitation Center
state: Federal
Study officials:
affiliation: Riphah International University
name: Saad Rauf, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03749889: Low Carb vs Normal Carb in Pregnancy
Official title: Bump to Baby Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall purpose of this intervention study is to examine whether low-carbohydrate dietary intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk pregnant women. The results of this study should help further our understanding of how pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower carbohydrate diet will prevent the development of GDM.


Eligibility criteria: Inclusion Criteria:

* 18 - 40 years old
* BMI \> 30 and/or history of gestational diabetes mellitus
* Currently in first trimester of pregnancy with single fetus (e.g. not twins, triplets, etc.)
* Newborns of current participants

Exclusion Criteria:

* Diabetes (types 1 and 2)
* History of major chronic disease or blood clotting disorders (e.g., cancer, heart disease, kidney disease, hypertension)
* Known fetal anomaly
* History of eating disorders
* Current use of medications that affect appetite or insulin secretion/sensitivity (e.g. stimulants)
* Current use of illegal substances, antipsychotic or opioid substitution medications, alcohol, or tobacco

Primary outcomes:
measure: Birth Outcome Questionnaire
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: SUNY Buffalo
state: New York
Study officials:
affiliation: SUNY Buffalo
name: Kai Ling Kong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06929689: Evaluation of the All-on-three Concept in Mandible.
Official title: Clinical and Radiographic Evaluation of All-on-three Immediately Loaded Mandibular Fixed Detachable Restorations (a Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Prosthesis
Dental Implant
Keywords: Three implants
Fixed detachable restorations
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the clinical and radiographic treatment outcomes of immediately loaded three implants by fixed-detachable prostheses for the management of totally edentulous mandibles.

The hypothesis is that mandibular immediately loaded fixed detachable restorations supported only by three implants in the inter-foraminal region will not adversely affect the clinical or radiographical treatment outcome.

Detailed description: The ideal amount of implants for edentulous mandible rehabilitation continues to be a subject of scholarly debate. Traditionally, at least four implants are required for fixed detachable prostheses, but increasing implant numbers raises costs and complexity, leading to patient reluctance. Reducing the number to three implants may simplify surgery, minimize trauma, and encourage patient acceptance.

Eligibility criteria: Inclusion Criteria:

* Completely edentulous patients with skeletal Class I maxilla-mandibular relationship.
* Adequate inter-arch space (22 mm), measured using the "try in" before any intervention.
* Male or female patients aged between 40 and 60 years.
* Maxillary and mandibular ridges with no history of recent extraction.
* Mandibular ridge should be ≥15 mm in height and ≥7 mm in width to accommodate three implants in the intra-foramina area of the mandibular arch, verified by using cone beam computed tomography (CBCT).

Exclusion Criteria:

* History of radiotherapy in the head and neck region.
* History of hard tissue augmentation.
* Presence of any intra-oral pathological condition.
* Any medical disorder that could complicate the surgical phase or affect osseointegration, such as osteoporosis, uncontrolled diabetes, and hypertension.
* Smoker and bruxer patients.

Primary outcomes:
measure: Radiographic evaluation
timeFrame: 12 months
measure: Peri-Implant Probing Depth (PIPD)
timeFrame: 12 months
measure: Clinical Attachment level (CAL)
timeFrame: 12 months
measure: Implant stability
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Ahmed M Abdelhamid, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Enaya Sharara, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Rania A Fahmy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02271789: Low-cost, Noninvasive Method to Assess Pulpal Vitality
Official title: Low-cost, Noninvasive Method to Assess Pulpal Vitality
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Other Dental Disease/Condition of Teeth/Supporting Structure
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2014-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from affiliated researcher at Dentists clinic in Orange Country and will be referred to investigator at University of California Irvine

Brief summary: The purpose of this research study is to find a new way of using light to measure the blood flow within the tooth.

The researcher develop dental Laser Speckle imaging system tool that can use for exam condition of the tooth. This device is reliable method to provide information to dentists and endodontists during oral examination.

Detailed description: In additional to routine oral exam the researcher can use the Laser Speckle imaging system probe with low-level light shine to the problematic tooth to collect blood flow information.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 30.
* Have one or more teeth requiring endodontic treatment.

Exclusion Criteria:

* Participation in other study within 3 months of enrollment in this study,
* Pregnant Women.

Primary outcomes:
measure: Healthy tooth
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute, UCI
state: California
Study officials:
affiliation: Beckman Laser Instiute, UCI
name: Petra Wilder-Smith, DDS., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04822389: Telerehabilitation and Lymphoma Patients
Official title: Effect of the Physical Exercise Training Using Telerehabilitation Among Lymphoma Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Rehabilitation
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to examine the feasibility and effect of a home-based short-term telerehabilitation exercise intervention using heart rate monitor and internet platform in patients with lymphoma.

Detailed description: Fifteen lymphoma cancer patients post-treatment (except adjuvant treatment) will be enrolled in the study. Cardiorespiratory fitness (peak oxygen consumption), adverse events, body composition and adherence to exercise prescription will be evaluated at baseline, 12-week, and year after enrollment.

Eligibility criteria: Inclusion Criteria:

* Lymphoma patients post-treatment (except ongoing adjuvant treatment)
* Post-treatment period not exceeding 3 months
* Internet connection at home
* Literacy with information and communication technology
* Patients who agreed with informed consent

Exclusion Criteria:

* Inability to perform a cardiopulmonary exercise test
* Psychological severe or cognitive disorders
* Contraindications for cardiopulmonary exercise testing
* Other exercise limitations (musculoskeletal disorders)
* Planned intervention or operation
* Participants who are enrolled in or participate in other rehabilitation program
* Participants who plan to be or are included in other studies

Primary outcomes:
measure: Cardiorespiratory fitness (CRF)
timeFrame: Change from baseline to 12 weeks and 1-year
Secondary outcomes:
measure: Body composition (Total muscle mass in kilograms)
timeFrame: Change from baseline to 12 weeks and 1-year
measure: Body composition (Body fat mass in kilograms)
timeFrame: Change from baseline to 12 weeks and 1-year
measure: Body composition (Body weight in kilograms)
timeFrame: Change from baseline to 12 weeks and 1-year
measure: Incidence of treatment-emergent adverse events assessed by 5 grade scale
timeFrame: Data will be recorded continuously from the baseline to 12 weeks
measure: Exercise adherence
timeFrame: 12 weeks
measure: Exercise compliance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: Department of Rehabilitation, University Hospital Brno, Czech Republic
name: Ladislav Batalik
role: PRINCIPAL_INVESTIGATOR
References: