louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05602545: Periodontal Status in Fermented Food and Food Consumption
Official title: Comparison of Consumption of Some Fermented Foods and Nutrient Intakes in Individuals with Periodontal Disease and Periodontal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: fermented foods
periodontal health
periodontal disease
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: observational study
Primary purpose: DIAGNOSTIC

Brief summary: Lack of certain nutrients and foods may negatively affect oral health. Therefore, nutrition plays an important role in maintaining oral health. This study aimed to evaluate and compare the nutrient intakes, consumption of food groups and some fermented foods of individuals with periodontal disease and health.

Ninety-three patients who applied to Periodontology Clinic were divided into three groups: periodontal health, gingivitis and periodontitis. In addition, plaque, gingival indices, bleeding on probing, periodontal pocket depth, and clinical attachment level were evaluated. To determine individuals' daily energy and nutrient intakes and the consumption amounts of food groups, food consumption records were kept by the nutritionist for three consecutive days, with one of them was weekend, using the 24-hour recall method. Data on individuals' frequency and amount of consumption of some fermented products were recorded, considering the foods available in our culture and the market.


Eligibility criteria: Inclusion Criteria:

* Patients with three teeth other than 20-year-old teeth in each jaw

Exclusion Criteria:

* Pregnancy and lactation,
* Patients with an acute oral lesion or necrotizing ulcerative periodontitis, -
* Patients with history of diabetes, rheumatic fever, lung and kidney disorders, and use of drugs that affect periodontal tissues (regular use of antibiotics, anti-inflammatory and mouthwashes),
* Patients who smoke, or patients who did not quit until last year were not included in the study.

Primary outcomes:
measure: bleeding on probing
timeFrame: baseline
measure: periodontal pocket depth
timeFrame: baseline
measure: Frequency of consumption of fermented foods
timeFrame: baseline
measure: food consumption record
timeFrame: 1 or 3 days
Secondary outcomes:
measure: plaque index
timeFrame: baseline
measure: gingival index
timeFrame: baseline
measure: clinical attachment level
timeFrame: baseline
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University
Study officials:
References:
Clinical trial NCT05473845: The Effect of Acupressure and Reiki on Pain and Fatigue Levels
Official title: The Effect of Acupressure and Reiki on Pain and Fatigue Levels in Cancer Patients Receiving Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupressure
Cancer Pain
Fatigue
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 156
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: This research was conducted with the aim of determining the effect of levels of pain and fatigue of acupressure and Reiki application on cancer patients receiving palliative care. The research was a single-blind, repeated measures, randomized controlled study. Research data were collected between February and July 2022. The research sample consisted of acupressure and Reiki application groups and a control group with 52 patients in each group, a total of 156 patients. Data was collected by means of a Patient Description Form, an Analgesic Follow-up Form, the Eastern Cooperative Oncology Group Performance Status Scale, the Numeric Pain Rating Scale, and the Brief Fatigue Inventory.


Eligibility criteria: Inclusion Criteria:

1. having a diagnosis of third or fourth-stage cancer,
2. being aged 18 years or older,
3. having had pain for at least one month in connection with cancer treatment or the symptoms of the disease,
4. using NSAII or non-opioid analgesics,
5. having a status of 3 or more on the Numeric Pain Rating Scale (NPRS),
6. having a score of 0-3 on the ECOG-PS scale

Exclusion Criteria:

1. having a diagnosis of first or second-stage cancer,
2. being aged less than 18 years,
3. having bone or brain metastasis,
4. using opioid analgesics,
5. having a status of less than 3 on the NPRS,
6. having a status of between 4 and 5 on the ECOG-PS scale

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: on the second day of the starting week
measure: Brief Fatigue Inventory
timeFrame: on the second day of the starting week
Secondary outcomes:
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Hediye Utli
Study officials:
References:
Clinical trial NCT03051945: Endogenous Opioid Modulation by Ketamine
Official title: Endogenous Opioid Modulation by Ketamine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.

Detailed description: This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* DSM-5 major depressive disorder
* Current moderate-to-severe, treatment-resistant, depressive episode
* Patient Health Questionnaire (PHQ-9) total score ≥ 10
* PHQ-9 item score ≥ 2 on "Little interest or pleasure" item
* PHQ-9 item score ≥ 2 on "Feeling down, depressed, or hopeless" item
* Medical documentation of depression for at least 2 months
* Inadequate response to at least one adequate antidepressant medication trial in the current episode

Exclusion Criteria:

* Current episode duration \>5 years
* Moderate-to-severe DSM-5 substance use disorder (past year)
* Cognitive disorder (past year)
* Post-traumatic stress disorder (past year)
* Obsessive compulsive disorder (past year)
* Personality disorder (past year)
* Positive urine drug screen
* Psychotic symptoms
* Mania
* Significant neurologic disorder or injury
* Breastfeeding or pregnancy
* Imminent suicide risk
* Current use of CYP3A4 inhibitors (e.g., ketoconazole or erythromycin)
* Other unstable psychiatric or medical condition requiring a higher level of care
* Contraindication to ketamine, MRI, or PET

Primary outcomes:
measure: Hamilton Depression Rating Scale at 24 hours, change from baseline
timeFrame: 24 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References:
Clinical trial NCT02980445: Time Outdoors as an Intervention for Myopia in Children
Official title: Time Outdoors as an Intervention for Myopia in Children--School-based Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Keywords: Myopia
Outdoor time
Children
Intervention
Prevention
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
Collaborators: name: Brien Holden Vision
First posted: 2016-12-02
Enrollment: 7200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether improved outdoor time has an effect on the onset and progression of myopia in children.

Detailed description: 1. To evaluate the effect of increased time outdoors on the incidence of myopia in non-myopic children;
2. To evaluate the effect of increased time outdoors on the progression of myopia in myopic children;
3. To explore if there is dose-response effect of time outdoors on the incidence and progression of myopia.

Eligibility criteria: Inclusion Criteria:

1. at baseline be enrolled in grade 1 and 2 of primary schools;
2. have a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent;
3. Children verbally consent when registration for examination

Exclusion Criteria:

1. Any systemic or ocular pathology that may affect the refractive error status of the eye;
2. Strabismus and amblyopia;
3. Intellectual disability;
4. Using any anti-myopia treatments (orthokeratology, atropine, accommodation function training, acupuncture, auricular point sticking, progressive addition spectacle lenses or other anti-myopia contact lenses).
5. Not suitable for inclusion in the study as deemed by the investigator.

Primary outcomes:
measure: Cycloplegic refractive power（auto-refractor instrument）
timeFrame: 1 year
Secondary outcomes:
measure: Axial length(IOL Master instrument)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Eye Disease Prevention and Treatment Center
name: Xun Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gong W, Cheng T, Wang J, Zhang B, Chen J, Zhu J, Zou H, Liu K, He X, Xu X. Role of corneal radius of curvature in early identification of fundus tessellation in children with low myopia. Br J Ophthalmol. 2023 Oct;107(10):1532-1537. doi: 10.1136/bjo-2022-321295. Epub 2022 Jul 26.
citation: He X, Sankaridurg P, Wang J, Chen J, Naduvilath T, He M, Zhu Z, Li W, Morgan IG, Xiong S, Zhu J, Zou H, Rose KA, Zhang B, Weng R, Resnikoff S, Xu X. Time Outdoors in Reducing Myopia: A School-Based Cluster Randomized Trial with Objective Monitoring of Outdoor Time and Light Intensity. Ophthalmology. 2022 Nov;129(11):1245-1254. doi: 10.1016/j.ophtha.2022.06.024. Epub 2022 Jun 30.
Clinical trial NCT06207045: The Effects of Limb Elevation During Gout Flare Episodes
Official title: The Effects of Limb Elevation During Gout Flare Episodes : A Pilot, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gout Flare
Keywords: Gout, arthritis, gout flare
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 30
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: The goal of this open-label randomized controlled trial is to explore the benefit of limb elevation in inpatient gout flare episodes, compared with standard treatment The main questions are;

* Is limb elevation able to reduce pain during gout flare episodes to a greater degree compared with standard treatment ?
* Is Is limb elevation able to reduce joint swelling during gout flare episodes to a greater degree compared with standard treatment ?

Participants will be divided into 2 group;

1. Limb elevation group
2. control group All participants will receive standard medical therapy consisting of colchicine 0.6 mg per day plus prednisolone 30 mg per day for 2 days

Pain score and joint circumference will be recored at recruitment, 24 hour and 48 hour

Detailed description: Limb elevation has shown benefit in ankle sprain and venous insufficiency, but its benefit has not been studied in people with gout flare. In this open-label randomized controlled trial, 30 adults diagnosed with gout flare during their hospitalization will be randomized to receive limb elevation plus standard medication for gout flare (limb elevation group) or standard medication only (control group). Primary outcome is reduction in 10-point visual analogue scale for pain at 48 hours after enrollment and the secondary outcome is the reduction of the circumference of affected joint at 48 hours after enrollment. Comparison of pain score and joint circumference reduction will be made using Wilcoxon Rank-sum test. Our study results may provide some evidence in support of limb elevation as a supplementary non-pharmacological therapy for relief of gout flare.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* Diagnosis of Gout according to 2015 The ACR/EULAR gout classification criteria

Exclusion Criteria:

* Receive Non-Steroidal Anti-inflammatory Drugs or Intra-articular corticosteroids or prednisolone \> 10 mg within 24 hours before enrollment
* Unstable vital sign
* Receiving joint aspiration for release joint effusion ≥ 10 ml after enrollment
* Gout flares involve axial joints e.g. hip
* Glomerular Filtration Rates \< 30 ml/min/1.73m2
* Communication problems

Primary outcomes:
measure: Reduction of pain score
timeFrame: 48 hours
Secondary outcomes:
measure: Joint circumference
timeFrame: 48 hours
Other outcomes:
Locations:
city: Pathum Thani
country: Thailand
facility: Thammasat University
Study officials:
affiliation: Thammasat University
name: saitip sangkamanovet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02056145: Ultrasound Guided Lateral Femoral Cutaneous Block (LFCNB) And Femoral Nerve Block (FNB) For Postoperative Pain Control After Hip Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: -Postoperative Pain
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.

Detailed description: Clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (VAS scores) and postoperative opiate consumption.

Eligibility criteria: Inclusion Criteria:

* Primary hip arthroplasty with posterolateral approach.

Exclusion Criteria:

* Known allergy to levobupivacaine and / or piritramide
* Known neurological disorders or peripheral neuropathies
* Existing drug or alcohol abuse
* Chronic use of pain medication (\> started 3 months ago) not related to the hip suffering
* Coagulopathy (international normalized ratio) \> 1.4
* Thrombocytopenia \<70,000 platelets,
* Dementia
* Pregnancy
* Local infection hip
* Hepatic and / or renal impairment
* BMI\> 45.

Primary outcomes:
measure: Use of opioids
timeFrame: 48 hours
Secondary outcomes:
measure: Visual analog scale (VAS) scores (0-10)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: AZ Sint Augustinus
state: Antwerpen
Study officials:
affiliation: Department of Anesthesiology, Antwerp University Hospital
name: Sultan TEMURZIEV, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01766245: A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
Official title: A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Keywords: mm
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Body mass index (BMI) of 18.5-30 kg/m\^2 (both incl.)

Exclusion Criteria:

* History of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders
* Use of prescription or non-prescription medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
* Smoking, drug or alcohol abuse
* Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or not using adequate contraceptive methods for the duration of the trial and for 3 months following the last dose of semaglutide

Primary outcomes:
measure: Area under the plasma semaglutide concentration curve
timeFrame: 0-4 weeks after a single dose s.c. semaglutide administration
measure: Cmax, the maximum plasma semaglutide concentration
timeFrame: 20-40 hours after a single dose s.c. semaglutide administration
Secondary outcomes:
measure: The area under the plasma semaglutide concentration curve
timeFrame: From time 0 to infinity after a single dose s.c. semaglutide administration
measure: tmax, time to Cmax of semaglutide
timeFrame: 20-40 hours
measure: t½, terminal elimination half-life of semaglutide
timeFrame: 140-200 hours
measure: Incidence of adverse events (AEs)
timeFrame: From first dosing to follow-up (5-7 weeks after the second dosing)
measure: Hypoglycaemic episodes
timeFrame: From first dosing to follow-up (5-7 weeks after the second dosing)
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05284045: Nocebo Effect in OSA Patients With CPAP Treatment
Official title: Study of the Nocebo Effect in Patients With Obstructive Sleep Apnea Syndrome and Treatment With Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is aimed to evaluate whether the information provided by health care professionals in the visits previous to start with CPAP treatment may influence the number of reported adverse effects and compliance in patients with obstructive sleep apnea (OSA) in treatment with CPAP.

Detailed description: Background: The presence of side effects in the first few weeks of treatment with CPAP is common. However, it has never been evaluated whether side effects could be related to the presence of the nocebo effect in this population.

Main objective: To assess whether the information provided by health care professionals may influence the number of reported adverse events and compliance in patients with obstructive sleep apnea (OSA) in treatment with CPAP.

Methodology: Unicentric randomized clinical trial that will include 80 patients over 18 years of age with a recent diagnosis of OSA and indication for treatment with CPAP. Participants will be recruited consecutively and will be randomly assigned in a 1: 1 ratio to receive usual information or more detailed information in possible adverse effects of treatment during the CPAP adaptation visit. Follow-up will be performed at 1 month and 3 months after starting CPAP treatment. Side effects and treatment compliance in each of the groups will be blindly assessed. Descriptive statistics and differences in the number of side effects and hours of compliance between the two groups will be performed.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with OSA with indication for CPAP treatment
2. To be over 18 years old
3. Sign informed consent for study participation.

Exclusion Criteria:

1. Patients previously treated with CPAP.
2. Patients with other previous treatments for OSA (surgery, mandibular advancement device, etc.)
3. Presence of any other previously diagnosed sleep disorder
4. Patients with\> 50% central sleep apnea or Cheyne-Stokes respiration
5. Diagnosis of a mental or physical condition that makes difficult to complete questionnaires

Primary outcomes:
measure: Number of side effects
timeFrame: at 1 month
Secondary outcomes:
measure: Hours of CPAP use
timeFrame: at 3 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Mireia DALMASES CLERIES
role: PRINCIPAL_INVESTIGATOR
References: