louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06763419: Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement
Official title: Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Disorders
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study was to compare the efficacy of internal versus external photobiomodulation (PBM) in the management of patients with TMJ internal derangements (TMJ-ID).


Eligibility criteria: Inclusion Criteria:

* Painful click at temporomandibular joint (TMJ) area.
* Pain at the lateral pterygoid muscle.
* Presence of full or nearly full complement of natural teeth with acceptable occlusion

Exclusion Criteria:

* Patients who have radiographic evidence of degenerative conditions of TMJ.
* Patients under current dental or physical therapy that could affect TMD.
* History of recent trauma.
* The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
* Pregnant and lactating females.
* Presence of open bite.

Primary outcomes:
measure: Pain level assessment using Visual Analogue Scale
timeFrame: after one month from the last laser session
measure: Oral health-related quality of life using OHIP-TMD
timeFrame: after one month from the last laser session
measure: Maximum mouth opening evaluation using the Miller index
timeFrame: after one month from the last laser session
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Nermeen Rady, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mariam M Bahgat, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Aly Atteya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Hoda MA Abdel-Naby, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03872219: Biodiversity Intervention and Atopic Sensitization
Official title: The Effect of Plant and Soil-based Material on the Incidence of Atopic Sensitization
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atopy
Allergy
Allergic Rhinitis
Allergic Sensitisation
Keywords: biodiversity intervention
IgE
atopy
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Tampere University
name: Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri)
name: Business Finland (National Innovation Agency)
First posted: 2019-03-13
Enrollment: 350
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.
Primary purpose: PREVENTION

Brief summary: Children will receive biodiversity intervention or placebo. The proof of concept trial is double blind. Intervention will start at the age of 2 months and last 10 months. Children will be randomized to arms. IgE sensitization is the primary outcome.

Detailed description: Newborns will start to be exposed to biodiversity intervention or placebo at the age of two months. The proof of concept trial will be double blind. Intervention will start at the age of 2 months and it will end when children become 12 months old. Children will be randomized to the two arms. IgE sensitization is the primary outcome at the age of two and three years.

Eligibility criteria: Inclusion Criteria:

* both parents have atopy
* newborn

Exclusion Criteria:

* severe disease, particularly immune system deficiency or down syndrome or cancer
* medication affecting immune system
* birth before week 35 in pregnancy
* being a twin
* only one of the parents have atopy
* none of the parents have atopy
* children have passed the age of two months
* immune system disorder such as rheumatoid disease, colitis ulcerosa, Crohn disease, diabetes or genetic risk to type 1 diabetes
* no participation in national vaccination programme

Primary outcomes:
measure: IgE sensitization
timeFrame: 2-3 years
Secondary outcomes:
measure: Allergic symptoms
timeFrame: 2-3 years
Other outcomes:
measure: IL-10: IL-17 ratio
timeFrame: 2-3 years
measure: TGF-beta level
timeFrame: 2-3 years
measure: IL-10 levels
timeFrame: 2-3 years
Locations:
Study officials:
References:
Clinical trial NCT02177019: Assessment of a Personalized Health Care Intervention for Frequent Headache
Official title: Assessment of a Personalized Health Care Intervention for Frequent Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frequent Headaches
Keywords: frequent headaches
personalized health plan
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The research project is a component of a mentored research career enhancement award. The purpose of the award is to help the PI and his collaborators prepare for future research grant opportunities through the Patient Centered Outcomes Research Institute (PCORI). The research project is a feasibility study with the following specific aims; 1) to assess outcomes associated with a personalized health plan for frequent headaches; 2) to identify measurable outcomes that are meaningful to patients with frequent headaches; and 3) to create a patient stakeholder group to inform patient-centered outcomes research for frequent headaches. Specific Aim #1 will be achieved by recruiting and enrolling 40 established patients at the Duke Family Medicine Center who have frequent headaches. The intervention consists of 3 study visits with the PI, 2 clinical consultations with subjects' established primary care provider at the Duke Pickens Family Medicine Center, and participation in 2 focus groups. Personalized health plans might consist of a combination of medical management, lifestyle changes, nutrition counseling, or other therapeutic modalities as appropriate. Data analysis will be descriptive; no formal hypotheses will be tested.


Eligibility criteria: Inclusion Criteria:

* patients with chronic headache

Exclusion Criteria:

* patients who do not understand english language

Primary outcomes:
measure: Change in Daily headache scores,
timeFrame: Daily from baseline to 3 months
measure: Change in Quality of life
timeFrame: Baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke
name: Remy Coeytaux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03349619: Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing IL-5 in Children With Allergic Rhinitis
Official title: ReNIM Study - Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing Nasal Interleukin-5 (IL-5) Measurements in Children With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 88
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single-center, randomized, placebo-controlled study to:

* characterize the subjects at baseline and discriminate groups of children based on IL-5, IL-17, IL-23 and INF-γ;
* investigate the effect of Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) for nostril three times/day for 4 weeks, in comparison with placebo, in reducing nasal interleukin-5 (IL-5) in children with Allergic Rhinitis (AR).

Secondary objectives are to examine the effect of resveratrol plus carboxymethyl-β-glucan, in comparison with placebo, on subjective parameters, i.e. symptom scores, visual analogue scales for rhinitis, quality of life and quality of sleep, and the effect on objective parameters, i.e. nasal nitric oxide (nNO) levels, nasal cytology and acoustic rhinometry.


Eligibility criteria: Inclusion Criteria:

* history of AR in the previous year;
* positive skin prick test to seasonal allergens.

Exclusion Criteria:

* acute upper respiratory infections in the last 4 weeks;
* lifetime history of asthma (doctor diagnosis);
* use of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines in the last 4 weeks;
* anatomic nasal defects (ie, septum deviation), or nasal polyps;
* active smoker.

Primary outcomes:
measure: Nasal Interleukin-17 (IL-17)
timeFrame: Baseline
measure: Nasal Interleukin-23 (IL-23)
timeFrame: Baseline
measure: Nasal Interferon-γ (INF-γ)
timeFrame: Baseline
measure: Nasal PH
timeFrame: Baseline
measure: Nasal Interleukin-5 (IL-5)
timeFrame: Baseline and 28 days
Secondary outcomes:
measure: Total 5 Symptom Score (T5SS)
timeFrame: Baseline and 28 days
measure: Visual Analogue Scale for Rhinitis (VAS)
timeFrame: Baseline and 28 days
measure: Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
timeFrame: Baseline and 28 days
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and 28 days
measure: Nasal Exhaled Nitric Oxide (nNO)
timeFrame: Baseline and 28 days
measure: Nasal Cytology
timeFrame: Baseline and 28 days
measure: Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)
timeFrame: Baseline and 28 days
measure: Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5)
timeFrame: Baseline and 28 days
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo
Study officials:
References:
Clinical trial NCT06847919: Exploring the Potential Benefits of Probiotic Yogurt
Official title: Exploring the Potential Benefits of High-activity Probiotic Yogurt: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Constipation
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of a high-activity probiotic yogurt on improving symptoms of chronic constipation, observing its regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 21-day intervention period.


Eligibility criteria: Inclusion Criteria:

1. Meet the Rome IV diagnosis criteria for chronic constipation;
2. Patients who are able to understand clinical studies and are committed to complying with study requirements and procedures;
3. Age 18-65. -

Exclusion Criteria:

1. Systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or liver diseases known to be associated with alterations in the gut microbiota;
2. Patients who are pregnant or lactating;
3. have taken antimicrobials, probiotics, or drugs that inhibit stomach acid or gastrointestinal motility in the past 6 weeks;
4. Patients who changed their diet type during the study;
5. Patients who are allergic or intolerant to any component of the investigational product formulation;
6. Patients with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious diseases and endocrine diseases, mental patients;
7. Stop taking the tested sample or add other drugs in the middle, unable to judge the efficacy or incomplete data;
8. short-term use of objects related to the function of the test, affecting the judgment of the result;
9. have been dieting, exercising excessively, taking weight loss medications or taking medications that may affect appetite in the past 3 months;
10. Current or past excessive use of alcohol, drugs, or supplements that may cause intestinal dysfunction or interfere with the evaluation of the efficacy of the study product -

Primary outcomes:
measure: Constipation symptom improvement
timeFrame: 3 weeks
Secondary outcomes:
measure: Gut microbiota composition and diversity
timeFrame: 3 weeks
measure: Emotional state changes
timeFrame: 3 weeks
measure: Emotional state changes
timeFrame: 3 weeks
measure: Weight management impact
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT03480919: Acupuncture for Pre-Procedure Anxiety
Official title: Shen Men Acupuncture for Anxiety Preceding Lumbar Epidural Injections in Acupuncture-naive Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is common for patients undergoing spinal injections to report anxiety prior to the injection. Although sedation, general anesthesia, and medications can be used to reduce anxiety, the use of sedative agents during the procedure can increase the risk of spinal cord injury. The purpose of this study is to see if receiving acupuncture before a spinal injection can effectively reduce patients' anxiety. Only patients who are scheduled to receive a spinal injection at this institution will be eligible for the study.


Eligibility criteria: Inclusion Criteria:

* Age 18+
* Spine pathology that meets criteria for lumbar epidural injection

Exclusion Criteria:

* Unable to provide consent
* Contraindications to acupuncture (e.g., rash, skin infection, sensory loss in ear)
* Previous experience of acupuncture
* Age \<18
* Pregnant women
* Non-English or Non-Spanish speaking

Primary outcomes:
measure: Anxiety
timeFrame: Up to 30 min post-acupuncture intervention
Secondary outcomes:
measure: Belief of Acupuncture
timeFrame: Up to 30 min post-acupuncture intervention
measure: Anxiety Medication Use
timeFrame: Up to 30 min post-acupuncture intervention.
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT00959218: Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis
Official title: Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Neuropathic Pain in Multiple Sclerosis
Keywords: Dronabinol
(-)trans-delta9-tetrahydrocannabinol
central neuropathic pain
multiple sclerosis
analgesic
Central neuropathic pain related to multiple sclerosis
Lead sponsor: Bionorica Research GmbH
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.

Detailed description: Multiple sclerosis (MS) is in all probability an autoimmune disease causing severe neurological disability due to inflammation and degeneration in the central nervous system (CNS). MS affects over 1 million people worldwide. Central neuropathic pain is associated with approximately 30% of all patients with MS. MS-accompanying pain has a major impact on the patients' quality of life as usual conventional analgesics are little effective. The aim of this clinical study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple sclerosis acc. to McDonald diagnostic criteria
* EDSS score between 3 and 8 (incl.)
* Patients who are in a stable phase of multiple sclerosis
* Patients with MS-related central neuropathic pain for at least 3 months

Exclusion Criteria:

* Severe concomitant diseases
* Certain concomitant therapies (in particular: pain influencing concomitant therapies)
* Dronabinol intake within the last 12 months prior to study entry or Marihuana use within one month prior to study entry

Primary outcomes:
measure: Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary
timeFrame: max. 2.5 years
Secondary outcomes:
measure: Likert Numerical Rating Scale pain relief
timeFrame: max. 2.5 years
measure: Pain-related sleep interference
timeFrame: max. 2.5 years
measure: SF-36 (QoL-questionnaire)
timeFrame: max. 2.5 years
measure: Intake of rescue medication
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Luedenscheid
country: Germany
facility: Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie
Study officials:
affiliation: Klinikum Luedenscheid
name: Sebastian Schimrigk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03958318: Multi-component Exercise Program and Nutritional Supplementation in Frail Older Adults
Official title: The Effectiveness of a Multi-component Exercise Program Plus Oral Nutritional Supplementation, on the Functional Capacity in Frail Institutionalized Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fragility
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the effects of a multi-modal group-based exercise program and nutritional supplementation on physical performance in frail institutionalized older adults.

Participants will be randomly allocated to the intervention groups; exercise (EG) or exercise plus nutritional supplementation (SG), or to the control group (CG). During 6 months, participants in the intervention groups will be performing the exercise routine based on the Otago exercise programme. Additionally, participants in the SG will receive a daily oral nutritional supplement.

Detailed description: Objectives: Evaluate the effects of a multi-modal group-based exercise program and nutritional supplementation on physical performance and the capacity to perform daily tasks in frail institutionalized older adults.

Design: Randomized controlled trial, with a 6-month intervention period. Participants: 122 frail institutionalized older adults aged 65 and older with no cognitive impairment.

Intervention: After a baseline assessment, the participants will be randomly assigned to the control group or one of two intervention groups; multi-modal exercise program (EG) or exercise plus nutritional supplementation (SG). During 6 months, participants in the intervention groups will be performing the exercise routine based on the Otago exercise programme. Additionally, participants in the SG will receive a daily oral nutritional supplement.

Measurements: The primary outcome measure will be mobility measured with the timed up and go test. Secondary outcomes will be the functional balance, hand-grip strength, lower limb functional capacity, gait speed and distance covered during the 6-minute walk test.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years;
* Frail institutionalized.

Exclusion Criteria:

* Cognitive impairment;
* Fracture;
* Neurological disorder;
* Unable to follow verbal instructions;
* Score lower than 60 in the Barthel Index.

Primary outcomes:
measure: Timed up and go test
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Alfara Del Patriarca
country: Spain
facility: Vicent Benavent Caballer
Study officials:
affiliation: Cardenal Herrera University
name: JUAN FRANCISCO L PÁRRAGA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04841018: Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
Official title: Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy
Keywords: caudal block
low dose dexamethasone
postoperative pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 273
Sex: MALE
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients enrolled are allocated into one of the following two groups: control group (group C) who receive a higher dose of dexamethasone known to enhance the effect of caudal block from previous study (0.5mg/kg) and dexamethasone group (group D) who receive a lower, antiemetic dose of dexamethasone (0.15mg/kg)
Primary purpose: PREVENTION

Brief summary: Caudal block is one of the most effective modalities to reduce pain both during and after the surgery involving areas under the umbilicus. According to previous research, 0.5mg/kg-1.5mg/kg dexamethasone is known to enhance the analgesic quality of caudal block in children. Despite the fact that this high dose of dexamethasone is used to treat airway edema in actual practice and no adverse side effect related to dosage has been reported, it is 3 to 15 times higher than the daily antiemetic dose of dexamethasone that is used in standard care of anesthesia. Therefore, our study aims to assess the effect of the more practical, antiemetic dose of dexamethasone (0.15mg/kg) as an adjuvant to enhance the quality of caudal block through a non-inferiority trial.


Eligibility criteria: Inclusion Criteria:

1. Ages from 6 months old to 6 years old
2. Body weight Less than or equal to 16.7kg
3. American Society of Anesthesiologists (ASA) classification I or II
4. Patients receiving orchiopexy under general anesthesia

Exclusion Criteria:

1. Patients with uncorrected cardiac anomalies
2. Patients with vertebral anomalies
3. Diagnosis of diabetes mellitus
4. Diagnosis of adrenal disease
5. Currently on steroid
6. Body temperature above 37.5'C preoperatively
7. Allergy to dexamethasone
8. Laparoscopic surgery

Primary outcomes:
measure: The need for additional analgesics during the first 48 hrs after surgery
timeFrame: Until 48 hours after the surgery
Secondary outcomes:
measure: Time to the first additional analgesic
timeFrame: Until 48 hours after the surgery
measure: total number of additional analgesic
timeFrame: Until 48 hours after the surgery
measure: pain score at each time point
timeFrame: Until 48 hours after the surgery
measure: scale of satisfaction at each time point
timeFrame: Until 48 hours after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Jeong-Rim Lee
role: PRINCIPAL_INVESTIGATOR
References: