louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06811818: Masticatory Performance in Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture
Official title: Comparison of Masticatory Performance of Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Masticatory Performance
Keywords: Masticatory performance , Bilateral balanced occlusion , Lingualized occlusion
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 146
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized control trial to compare masticatory performance in complete dentures with bilateral balanced occlusion or lingualized occlusion.

Detailed description: This study is a randomized control trial to compare the masticatory efficiency of complete dentures with bilateral balanced occlusion with that of lingualized occlusion . Grouping of participants was carried out. Participants divided into two groups one receiving complete dentures with bilateral balanced occlusion and the other group receiving complete dentures with lingualized occlusion . Each participant provided with 15g of peanuts and instructed to chew until ready to swallow . The chew material than spat into the designated container and participants asked to rinse their mouth with water , with the rinse being collected in the same container . The collected material than sieved through 10-Mesh sieve followed by drying the sieved content on blotting paper for 30 minutes. The dried material subsequently weight with an electric balance with precision of 0.01 grams . Masticatory efficiency assessed through mean weight of chewed peanuts.

Eligibility criteria: Inclusion Criteria:

1. Participants aged 45-65 years.
2. Both genders included.
3. Edentulous patients requiring complete denture.
4. Patients willing to participate in the study .

Exclusion Criteria:

1. Participants not willing to participate in the study.
2. Participants with systemic disease .
3. Participants with neuromuscular disorders .

Primary outcomes:
measure: Masticatory Efficiency in Complete Dentures by weighing the dried chewed material through electric balance
timeFrame: upto 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute Of Dentistry
state: Punjab
Study officials:
affiliation: Armed Forces Institute of Dentistry
name: Seema Khattak, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03015818: Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)
Official title: Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Bioprosthesis Structural Valve Dysfunction
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.

This study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.


Eligibility criteria: Inclusion Criteria:

* age \> 18
* written informed consent
* SVD defined on echocardiography by an alteration of bioprosthesis leaflets function with a mean transvalvular gradient \> 20 mmHg and maximal velocity ≥ 3 m/s and effective orifice area ≤1.2 cm², and/or an aortic regurgitation more or equal to grade 2 on 4.

Exclusion Criteria:

* Inability to give informed consent
* Pregnancy
* Concurrent antibiotherapy
* Certain infectious endocarditis
* Concurrent anti-inflammatory therapy, including corticosteroid therapy

Primary outcomes:
measure: 18F-Fluoride activity
timeFrame: The day of the inclusion
Secondary outcomes:
measure: TBR in 18F-FDG
timeFrame: 6 months
measure: Both 18F-Fluoride and 18F-FDG TBR correlation
timeFrame: 6 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
Clinical trial NCT06696118: Electromagnetic Transduction Therapy on Osteoarthritis in the Foot and Ankle
Official title: Electromagnetic Transduction Therapy (EMTT) on Mid-foot Osteoarthritis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Ankle
Osteoarthritis Foot
Keywords: Electromagnetic Transduction Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 20
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 purpose of this study is to determine if Electromagnetic Transduction Therapy (EMTT) is a viable treatment option in patients with osteoarthritis of the foot and/or ankle.


Eligibility criteria: Inclusion Criteria:

• Men and women with osteoarthritis of the foot and/or ankle confirmed via radiographs.

Exclusion Criteria:

• Pacemaker, active cancer, shrapnel, metal in eye, implantable devices that are not compatible with MRIs, concurrent foot or ankle condition or injury, prior foot or ankle surgery for osteoarthritis, steroid, platelet rich plasma, or hyaluronic acid injection within 2 months of the treatment.

Primary outcomes:
measure: Visual Analog Scale (VAS) for Pain
timeFrame: Baseline, 3 weeks, 3 months, 6 months
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: Baseline, 3 weeks, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Elizabeth Bondi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02788318: Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)
Official title: Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sudden Unexpected Death in Epilepsy (SUDEP)
Keywords: Epilepsy
SUDEP
Serotonin
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with epilepsy who died

Brief summary: The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental and clinical data strongly suggest that most of SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration of serotonergic systems of the brainstem and limbic regions may play a central role in the occurrence of SUDEP. The objective of this work is to look for abnormalities of the serotonergic transmission within regulatory regions of respiratory and autonomic functions in brain samples prospectively collected in patients died from SUDEP.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Postmortem time before autopsy \<30 hours

Exclusion Criteria:

* Age \<18 years
* postmortem time before autopsy \> 30 hours
* Any subject whose brain would be of forensic interest
* Any patient who expressed an opposition to organ donation.

Primary outcomes:
measure: Density of Medullary 5-HT Neurons
timeFrame: between 1 to 30 hours following death
Secondary outcomes:
measure: Other markers of 5HT within the medulla
timeFrame: between 1 to 30 hours following death
measure: Serotoninergic pathway in the pons, the hippocampus and the insula
timeFrame: between 1 to 30 hours following death
measure: Catecholaminergic pathway
timeFrame: between 1 to 30 hours following death
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Institut Médico-Légal
Study officials:
References:
Clinical trial NCT06463041: How Does Implementing a GetUp Assist Device in Addition to a Daily Low-intensity Functional or Traditional Training Program Affect Norwegian Female Office Workers' Physical Health After 12 Weeks?
Official title: 12 Weeks Randomized Controlled Trial Investigating Standing Transition Behaviour With Additional Traditional or Functional Training on Physical Health in Female Office Workers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck, Shoulder and Arm Syndrome
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2024-06-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This study aims to quantify the effect of daily transition routines between sitting and standing behaviour with an additional daily low-intensity traditional or functional training program on the physical health of sedentary Norwegian female workers after 12 weeks of implementation into their working environment.


Eligibility criteria: Inclusion Criteria:

* Females are included in this study due to the approximately twice-high prevalence of work-related musculoskeletal disorders.
* No experience with office fit training or participation in an ongoing similar training intervention is allowed.
* Working more than 6 hours a day at a computer workstation
* Physical inactivity (less than two sessions or bouts of exercise totalling 30 minutes/week).
* Musculoskeletal complaints are accepted as long as the pain is not a restricting factor. when performing the testing and training intervention exercises.

Exclusion Criteria:

* Participants not able to perform the testing battery.

Primary outcomes:
measure: Norwegian Short-Form Health Survey (SF-36)
timeFrame: 3 months
measure: Neck and shoulder trouble questionnaire from the Nordic musculoskeletal questionnaire
timeFrame: 3 months
measure: Numeric rating scale
timeFrame: 3 months
measure: Y-balance test
timeFrame: 3 months
measure: The Danish step test
timeFrame: 3 months
measure: Chair-sit-and-reach test
timeFrame: 3 months
measure: Back scratch test
timeFrame: 3 months
measure: CS-30 test
timeFrame: 3 months
measure: Hand Grip Strength test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Steinkjer
country: Norway
facility: SSA Steinkjer
state: Nord-Trøndelag
Study officials:
References:
Clinical trial NCT04674241: Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections
Official title: Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Brain Tumor Resections: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexmedetomidine
Postoperative Delirium
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 260
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: Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing selective frontotemporal tumor resection.
* Age ≥18 years.
* Obtain written informed consent.

Exclusion Criteria:

* Refusal to provide written informed consent.
* Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20).
* Allergic to the study drug.
* History of psychotropic drugs within past 30 days.
* Pregnant or lactating women.
* History of traumatic brain injury or neurosurgery.
* Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
* Severe hepatic or renal dysfunction.

Primary outcomes:
measure: The incidence of postoperative delirium
timeFrame: postoperative 5 day
Secondary outcomes:
measure: Pain score
timeFrame: within 5 days after surgery
measure: Sleep quality
timeFrame: within 3 days after surgery
measure: Quality of recovery from surgery
timeFrame: 1 day after surgery
measure: Intraoperative cardiovascular event.
timeFrame: From the study drug infusion to the end of surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TianTan Hospital,Capital Medical University
state: Beijing,China
city: Beijing
country: China
facility: PLA General Hospital
Study officials:
affiliation: Beijing Tian Tan Hospital
name: Yu Ming Peng, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang D, Li R, Li S, Wang J, Zeng M, Dong J, Liu X, Lin N, Peng Y. Effect of dexmedetomidine on postoperative delirium in patients undergoing brain tumour resections: study protocol of a randomised controlled trial. BMJ Open. 2021 Nov 10;11(11):e051584. doi: 10.1136/bmjopen-2021-051584.
Clinical trial NCT00745641: Abdominal Computed Tomography and the Blood Reactive Oxygen Species Level
Official title: Effect of Abdominal X-ray Computed Tomography Examination on the Blood Reactive Oxygen Species Level
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Radiation Injury
Keywords: radiation injury
computed tomography
reactive oxygen species
free radicals
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with abdominal illness that needs a computed tomography examination

Brief summary: The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body \[ref. 1-5\]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if the routinely applied abdominal X-ray computed tomography examination may induce a higher level of ROS in the peripheral blood.

Study subjects will be patients who are admitted to our hospital because of abdominal diseases that need to receive abdominal X-ray computed tomography examination for diagnosis. In total, sixty cases will be enrolled for the study. The formal consent will be delivered and explained to the patients and families several hours before the performance of abdominal X-ray computed tomography. The formal consent will be retrieved and then the peripheral blood will be sampled just before the performance of computed tomography.ROS level in the sampled peripheral blood, before and after the performance of abdominal X-ray computed tomography, will be measured, compared, and analyzed. Totally 120 blood samples, including 60 samples just before and 60 samples 2 hours after the performance of computed tomography, will be collected from 60 study subjects within 5 months (August 10 \~ December 30, 2008). Reactive oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).


Eligibility criteria: Inclusion Criteria:

* patients with abdominal illness that needs a computed tomography examination

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: NTUH
name: Zei-Shung Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01578941: An Investigation of the Safety and Utility of Treximet in the Treatment of Menstrual Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menstrual Migraine
Keywords: menstrual migraine
migraine
treximet
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2012-04-17
Enrollment: 12
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is to primarily investigate whether Treximet® (Imitrex RT/naproxen sodium 500mg) taken at the first onset of menstrual migraine will both terminate the acute headache and assist in preventing headache recurrence and the need for repeat abortive therapy over the ensuing days of menses.


Eligibility criteria: Inclusion Criteria:

1. Actively and regularly cycling females age 19 years or greater.
2. Normal (for subject) menses within 6 weeks prior to randomization
3. History of migraine of ≤ 1 years duration by International Classification of Headache Disorders (ICHD) criteria
4. History of menstrual migraine by ICHD criteria

Exclusion Criteria:

1. Not actively practicing adequate contraception or intending to continue to do so during the treatment.
2. 15 or more days of headache during each of the prior 3 months
3. Prior use of Treximet for the treatment of menstrual migraine
4. Uncontrolled hypertension
5. Hemiplegic or basilar migraine
6. Clinical evidence of coronary artery disease or other clinically significant and relevant cardiac disease (e.g. vasospastic angina)
7. History of stroke or transient ischemic attack
8. History of ischemic bowel disease
9. Clinically significant hepatic disease
10. History of allergy to any NSAID or triptan
11. History of gastritis, peptic ulcer disease, GI bleeding, gastric surgery

Primary outcomes:
measure: Total dose of study medication
timeFrame: 90 days
Secondary outcomes:
measure: total doses of rescue medication taken
timeFrame: 90 days
measure: total "headache days"
timeFrame: 90 days
measure: days of functionally incapacitating headache
timeFrame: 90 days
measure: work-related absenteeism
timeFrame: 90 days
measure: unscheduled visits for acute headache treatment
timeFrame: 90 days
measure: cost of unscheduled visits for acute headache treatment
timeFrame: 90 days
measure: safety and tolerability
timeFrame: 90 days
measure: patient satisfaction
timeFrame: 90 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: J Ivan Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06221241: Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 220
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: A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain

Detailed description: Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain

Eligibility criteria: Inclusion Criteria:

1. Able to understand the procedures of this trial and provide written informed consent voluntarily;
2. Age ≥ 18 years, male or female;
3. Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;
4. Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;
5. HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.

Exclusion Criteria:

1. With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;
2. Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;
3. Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;
4. Known treatment failure on pregabalin or gabapentin;

Primary outcomes:
measure: Change of the Average Daily Pain Score (ADPS) from baseline to Week 12. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]
timeFrame: baseline，Week 12
Secondary outcomes:
measure: Change of the Average Daily Pain Score (ADPS) from baseline to Week 5. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]
timeFrame: baseline，Week 5
measure: Adverse Events
timeFrame: baseline，Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: