louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06329986: Crossover RCT of TAMER Lenses in Myopia Control
Official title: A Randomized, Crossover Controlled Trial of the Effect of TAMER Lenses Versus Single Vision Lenses on Myopic Progression in Myopic Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Progressive
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses.


Eligibility criteria: Inclusion Criteria:

* Race: Chinese children and adolescents.
* Age 6-12 years, gender unrestricted.
* Cycloplegic refraction SER: -0.75DS\~-5.0DS in both eyes.
* Best corrected visual acuity of both eyes reaches 0.8 (0.00 logMAR).
* Cylinder power and astigmatism are no more than 1.5D.
* During the study period, willing to wear glasses provided by the researcher only and without additional interventions.
* Willing to be randomly assigned.
* Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.

Exclusion Criteria:

* Allergic or intolerant to medications used for cycloplegia.
* Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within half a year before the study.
* Diagnosed with any eye disease other than nearsightedness, including strabismus, corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
* History of eye surgery (including strabismus correction surgery).
* Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
* Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
* Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.

Primary outcomes:
measure: Spherical Equivalent change
timeFrame: 6 months
Secondary outcomes:
measure: Axial Length change
timeFrame: 6 months
measure: Spherical Equivalent change
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention and Treatment Center
state: Shanghai
Study officials:
References:
Clinical trial NCT01348386: Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum
Official title: Efficacy and Tolerance of the Topical Application of Potassium Hydroxide (10% and 15%) in the Treatment of Molluscum Contagiosum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Molluscum Contagiosum
Keywords: Potassium hydroxide.
Molluscum Contagiosum
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2011-05-05
Enrollment: 53
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND:

Molluscum contagiosum is a non-serious children viral infection. Because of its natural history, being highly contagious and the aesthetic and psychotherapeutic effects of its treatment, the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care setting.

METHODS:

A double blind, randomized clinical trial, in three groups of topic treatment is designed. The intended treatment consists on a daily application of potassium hydroxide in aqueous solution at 10% and 15% concentration, versus a placebo administered to the control group. 4 follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and tolerance.

The main target of the trial is to determine the healing rate, defined as lesion disappearance in the affected zones after the topic application of the treatment. Secondary targets are the main characteristics and evolution of the affected zone (surface, number of lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching, burning, pain), recurrence rate estimation and natural evolution of lesions in the control group.


Eligibility criteria: Inclusion Criteria:

* Who are diagnosed with a molluscum contagiosum (MC) infection (clinical diagnosis).
* Who are between the ages of two and six.
* Whose parents or guardians have provided written informed consent for participation.

Exclusion Criteria:

* Immunocompromised patient (congenital or acquired).
* Patient has received other topical treatment within the last month.
* Patient has lesions on face, neck or genital area.
* Patient who, in the view of the attending physician, will not comply with treatment and/or scheduled visits.

Primary outcomes:
measure: Efficacy (diseappearance of lesions)
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: CAP Rambla Ferran
state: Catalunya
Study officials:
References:
citation: Marsal JR, Cruz I, Teixido C, Diez O, Martinez M, Galindo G, Real J, Schoenenberger JA, Pera H. Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15%) in the treatment of molluscum contagiosum: randomized clinical trial: research protocol. BMC Infect Dis. 2011 Oct 19;11:278. doi: 10.1186/1471-2334-11-278.
Clinical trial NCT06687486: Effect of Autogenic Relaxation Therapy on Caregivers on Perceived Stress Quality of Life and Caregiver Burden
Official title: Effect of Autogenic Relaxation Therapy on Caregivers on Perceived Stress Quality of Life and Caregiver Burden: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caregiver Burnout
Caregiver
Care Burden
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals assigned as intervention and control will complete the research in these groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Caregivers are also faced with multiple stress factors. Autogenic relaxation therapy will help caregivers relax and take time for themselves by getting away from the stressful life they have lived. Although there are various studies on this subject (Chegeni et al. 2018, Seo and Kim 2019, Ramiraz-Garcia et al. 2020, Wang et al. 2021, Bagheri et all 2021, Ozhanlı and Akyuz 2022), there is no study on caregivers as far as we could reach. As a result of this study, nurses will help caregivers, whom they work one-on-one in most areas, to relax, thus helping to increase the quality of patient care in home environments and contributing to the increase in the quality of life of the caregiver. Thus, caregivers will be able to manage care more actively and effectively both at home and in clinics.

Based on this purpose, the aim of the study is to reduce the anxiety level of caregivers, increase the quality of life and reduce the burden of care after autogenic relaxation therapy to be applied to caregivers.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Being able to answer data collection forms
* Being able to speak Turkish
* Being able to provide continuous or partial care to a patient for at least 3 months
* Being able to communicate

Exclusion Criteria:

* Having epilepsy
* Not speaking or understanding Turkish
* Having a neurological disability
* Having had an acute myocardial infarction
* Being diagnosed with schizophrenia and major depression
* Being addicted to alcohol or drugs
* Having a history of loss of consciousness

Primary outcomes:
measure: Principial
timeFrame: 1 month
Secondary outcomes:
measure: second
timeFrame: 3 month
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan Üniversitesi
Study officials:
References:
Clinical trial NCT02953886: The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions
Official title: The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions Using HOMINGS Technology. A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caries
Keywords: Caries
Cavity
Silver Diamine Fluoride (SDF)
HOMINGS
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: The Forsyth Institute
First posted: 2016-11-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.

Detailed description: To assess the effect of silver diamine fluoride (SDF) treatment on microorganisms present in root caries or cervical lesions by collecting microbial deposits before and 1 month after SDF application. Bacterial samples will be collected from 20 adult subjects at the initial visit before application of SDF and one month after. At the 1 month recall, examination for caries arrest will be performed. All 40 bacterial samples will be sent to the Forsyth Institute to verify bacterial composition using HOMINGS technology.

Eligibility criteria: Inclusion Criteria:

* Generally healthy adult participants 18 years of age and older.
* At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft active carious lesions exposing dentin).

Exclusion Criteria:

* Adult participants who suffer from serious life-threatening medical diseases that interfere with basic daily self care activities.
* Patients taking antibiotics within the last two weeks.
* Patients using chlorhexidine or fluoride mouth washes within the last two weeks.
* Pregnant or breastfeeding women.
* Teeth with arrested (hard) cervical or root caries lesions.
* Teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are mobile.

Primary outcomes:
measure: Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
timeFrame: baseline, One month after SDF
measure: Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
timeFrame: One month
Secondary outcomes:
measure: Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
timeFrame: One month
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Heba Mitwalli, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Margherita Fontana, DDS, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01192386: Eosinophil Markers and Development of Disease in Allergic Rhinitis
Official title: Eosinophil Markers and Development of Disease in Allergic Rhinitis. A 15-year Follow-up of Patients With Grass Pollen Induced Hayfever.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2010-09-01
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Follow-up on participants in Allergic Rhinitis study 1995.

Brief summary: Inflammatory proteins from eosinophil granulocytes in blood from patients with seasonal allergic hayfever have been shown to predict development of asthma at a six-year follow-up. This study is a 15-year follow-up of the same patients to verify earlier results and study disease development.

Detailed description: The study consists of a single visit at which patients fill in a questionnaire on actual hayfever and asthma symptoms as well as current treatment. Blood samples and nasal lavages are drawn and analysed for eosinophils as well as eosinophil cationic protein and tryptase. Spirometry is performed.

If patients use drugs which can interfere with results, ie. corticosteroids or beta-agonists, biochemistry and/or spirometry are omitted.

Eligibility criteria: Inclusion Criteria:

* Participant in earlier study (1995)

Exclusion Criteria:

* Treatment with any kind of corticosteroid within two months will exclude from study of inflammatory parameters

Primary outcomes:
measure: Asthma morbidity
timeFrame: Single measurement - May 2010
Secondary outcomes:
measure: Rhinitis morbidity
timeFrame: Single measurement - May 2010
Other outcomes:
Locations:
Study officials:
affiliation: Department of Respiratory Research, Aarhus University Hospital, DK-8000 Aarhus C, Denmark
name: Lars Peter Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04350086: Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection
Official title: Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: COVID-19 Infection
Sars-cov-2
Respiratory Failure
Palliative Situation
Keywords: COVID-19
sars-cov-2
infection
respiratory failure
palliative situation
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations.

Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics.

The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.


Eligibility criteria: Inclusion Criteria:

1. Major patient
2. Relating to palliative care
3. With sars-cov-2 infection
4. Requiring light to moderate sedation corresponding to a RASS score of -1 to -3

Exclusion Criteria:

1. Pregnant, lactating woman.
2. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics
3. Advanced heart block (level 2 or 3) unless a pacemaker.
4. Uncontrolled hypotension.
5. Acute cerebrovascular pathologies.
6. Use of other sedative drugs

Primary outcomes:
measure: Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.
timeFrame: Day 30
Secondary outcomes:
measure: Overall survival of patients on Dexmedetomidine
timeFrame: Day 30
measure: Daily analgesic effect of Dexmedetomidine
timeFrame: Day 30
measure: Other sedative pharmacological agents
timeFrame: Day 30
measure: Average dosage required for Dexmedetomidine to achieve mild to moderate sedation
timeFrame: Day 30
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT03486886: PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility
Official title: PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A promising imaging technique involving new prostate specific membrane antigen (PSMA) positron emission tomography (PET) tracers is emerging in metastatic prostate cancer (PCa). This approach has demonstrated higher sensitivity in detecting metastases, prior to and during therapy, than current imaging standard of care (CT and bone scan).

PSMA is expressed in the vast majority of PCa tissue specimens and its degree of expression correlates with a number of important metrics of PCa tumor aggressiveness.

\[18F\]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. Studies employing second-generation PSMA PET/CT imaging in men with biochemical progression after definitive therapy suggest detection of metastases in over 60% of men imaged. In fact, PSMA-based PET has so far proven to have higher sensitivity than any other modality for localization of the site of recurrence. Applications that show promise and require further investigation include the characterization and risk stratification of primary PCa, complete staging of metastatic PCa to allow for PSMA-targeted radiotherapy and improved identification of patients with oligometastatic disease.

The objective of this study is to explore the detection yield of PSMA-PET in a pilot cohort of patients at CHUM and establish the repeatability of the technique before investigating it more widely.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent
* Metastatic prostate cancer.
* At least 18 years of age
* Standard imaging (bone scan, CT abdo/pelvis/chest) within 6 weeks of consent.

Exclusion Criteria:

-

Primary outcomes:
measure: Metastasis detection yield
timeFrame: 6 weeks
Secondary outcomes:
measure: Reproducibility of PSMA radiotracer uptake
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT05660486: Aromatherapy Effect on Anxiety Prior to Ultrasound Guided Musculoskeletal Procedures
Official title: The Effects of Aromatherapy on Anxiety Prior to Ultrasound Guided Musculoskeletal Procedures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety State
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to evaluate the effect of lavender essential oil on pre-procedure anxiety for patients undergoing ultrasound guided musculoskeletal procedures


Eligibility criteria: Inclusion criteria: Adults ages 18-85. Those undergoing ultrasound guided musculoskeletal procedures including joint, tendon, bursa, or periarticular structure injection/ aspiration. Proficient with English.

Exclusion criteria:

Patients currently on benzodiazepine anxiolytic therapy Those with significantly impaired sense of smell Allergy/aversion to lavender essential oils Patients with asthma Patients with history of migraines Patients with any other condition that, in the opinion of the investigator, would compromise the well-being of the patient or prevent the patient from meeting or performing study requirements Adults unable to consent Individuals who are not yet adults Pregnant women Prisoners

Primary outcomes:
measure: Anxiety state as measured by VASA
timeFrame: Up to 10 minutes after aromatherapy administration
Secondary outcomes:
measure: Number of participants with an aborted ultrasound guided procedure
timeFrame: Up to 60 minutes post aromatherapy administration
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Tricia Prince, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02419586: Effectiveness of Gum Chewing on Ileus in Chinese Colorectal Patients Underwent Laparoscopic Colorectal Surgery
Official title: Effectiveness of Gum Chewing on Reduction of Postoperative Paralytic Ileus for Chinese Colorectal Cancer Patients Underwent Laparoscopic Colorectal Surgery and Enhanced Recovery Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2015-04-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Gum chewing group will have less ileus and early resume of bowel motion than control group.

Detailed description: The standardize surgical techniques, less used of epidural analgesia, early ambulation and used of naso-gastric tube for decompression are aimed to reduce the paralytic ileus after abdominal surgery . Most Western studies have examined and found that gum chewing are able to prevent postoperative ileus or promotes early bowel function after abdominal surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed colorectal cancer undergoing laparoscopic resection in in Queen Mary Hospital
* At least 18 years
* Speak Cantonese
* Able to follow study protocol and chewing gum study

Exclusion Criteria:

* Cognitive disability
* Requirement of epidural analgesia
* Requirement of intensive care unit/ High dependency unit care postoperatively
* Inability to chew
* Presence of procedure other than colorectal resection
* Non Chinese

Primary outcomes:
measure: Time to first flatus
timeFrame: from postoperative day 0 till an expected average of day 7
Secondary outcomes:
measure: Time to first sense of hunger
timeFrame: from postoperative day 0 till an expected average of day 7
measure: Time to first bowel movement,
timeFrame: from postoperative day 0 till an expected average of day 7
measure: Length of stay
timeFrame: from postoperative day 0 till an expected average of day 7
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Hospital Authority, Queen Mary Hospital
name: Nga Fan Shum
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shum NF, Choi HK, Mak JC, Foo DC, Li WC, Law WL. Randomized clinical trial of chewing gum after laparoscopic colorectal resection. Br J Surg. 2016 Oct;103(11):1447-52. doi: 10.1002/bjs.10277.