louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06429917: Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis
Official title: Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis- An Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Bruxism
Keywords: Inflammation
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to explore the mechanisms by which periodontal disease affects the bruxers and to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis .

Detailed description: Patients with chronic periodontitis usually describe itching and persistent pain of moderate intensity. Applying masticatory pressure provides relief in these symptoms. However, this practice may lead to the development of bruxism habits in patients over time.

A deeper comprehension of the dynamic interplay between periodontal health and bruxism is crucial for crafting holistic treatment approaches aimed at addressing both symptoms and root causes effectively.

Till now, there has been no report examining the effect of subgingival instrumentation on probable bruxers in periodontitis patients.

. This study aims to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers in patients with periodontitis

Eligibility criteria: Inclusion Criteria:

* 1. Systemically healthy patients 2. Patient having habit of bruxism diagnosed with periodontitis 3. Age between 30-40 years 4. Minimum 20 teeth present in oral cavity

Exclusion Criteria:

1. History of systemic disease such as diabetes or autoimmune disease
2. History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs.
3. Pregnant or lactating females.
4. Post-menopausal women.
5. Patients diagnosed with temporomandibular disorders- pain and tenderness in the masticatory muscles
6. Patients receiving interventions for bruxism.
7. History of Psychological disorders

Primary outcomes:
measure: Jaw symptoms
timeFrame: baseline , 2 months , 3 months and 6 months
Secondary outcomes:
measure: Bleeding on probing
timeFrame: baseline , 2 months , 3 months and 6 months
measure: Gingival index
timeFrame: baseline , 2 months , 3 months and 6 months
measure: Probing pocket depth
timeFrame: baseline , 2 months , 3 months and 6 months
measure: tooth mobility
timeFrame: baseline , 2 months , 3 months and 6 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
affiliation: PGIDS, ROHTAK
name: VARSHA KAPOOR, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06704841: Effect of Music and Mindfulness Meditation
Official title: Effect of Music and Mindfulness Meditation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to explore the effect of music and mindfulness meditation on anxiety and mindful interoception in undergraduate music students.


Eligibility criteria: Inclusion Criteria:

* Participants must be undergraduate college students majoring in a music degree.
* Participants must self-report feeling general anxiety at a level of 7/10 recently.
* Participants must be proficient English-readers and -speakers and be full-time enrolled students.
* Students of any gender and race/ethnic group may be included.
* Participants must be novice meditators, having fewer than 10 total meditation experiences.
* Students of any year will be accepted if they are considered undergraduate students by the university.

Exclusion Criteria:

* Self-reporting feeling general anxiety below a 7/10 recently.
* Having more than 10 total meditation experiences.

Primary outcomes:
measure: Change in State-Anxiety Inventory-5 questionnaire
timeFrame: Baseline, up to 1 hour post intervention
Secondary outcomes:
measure: Change in Mindfulness Interoception measured by Likert scale
timeFrame: Baseline, 2 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Teresa Lesiuk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01840241: Effect of Sodium Bicarbonate on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass (OPCAB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: sodium bicarbonate
acute kidney injury
OPCAB
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 162
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this single-site, randomized, controlled and double-blind clinical trial, the investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury in high risk patients undergoing off pump coronary bypass surgery.


Eligibility criteria: Inclusion Criteria:

* Patients older than 20 years
* scheduled for elective coronary artery bypass grafting.
* preoperative estimated glomerular filtration rate (eGFR) : 30 \~ 89 %
* LVEF \< 35%
* NYHA class III or IV
* age \> 70
* DM
* reoperation

Exclusion Criteria:

* acute renal impairment
* patients who receive dialysis
* patients who receive steroid ( \> 10mg/day prednisolon or equivalent)
* hemo-alkalosis
* hypernatremia
* pulmonary edema
* Hemoglobin \< 10 mg/dL

Primary outcomes:
measure: compare the incidence of acute kidney injury
timeFrame: Change of Indexes of renal function including SCr, cystatin C, creatinine clearance from 24 hrs before operation to postoperative day (POD) 5.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of anesthesiology and pain medicine
Study officials:
References:
citation: Soh S, Song JW, Shim JK, Kim JH, Kwak YL. Sodium bicarbonate does not prevent postoperative acute kidney injury after off-pump coronary revascularization: a double-blinded randomized controlled trial. Br J Anaesth. 2016 Oct;117(4):450-457. doi: 10.1093/bja/aew256. Epub 2016 Oct 17.
Clinical trial NCT03712241: Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults
Official title: A Phase I, Open-label, Randomized, 4-period Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of K-285 Compared With a Single Oral Dose of Indomethacin Capsule in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study specific evaluation is performed.
* Subject is a healthy adult male or female aged 18 to 45 years, inclusive.
* Subject has a BMI of 18 to 30 kg/m2, inclusive.
* Subject meets all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

* Subject has abnormal findings or assessments that are clinically noteworthy at Screening or Admission (Day -1).
* Subject has a supine blood pressure after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 50 mm Hg diastolic at Screening or Admission (Day -1).
* Subject has a supine heart rate after resting for 5 minutes that is outside the range of 40 to 100 beats per minute at Screening or Admission (Day -1).
* Subject does not meet any exclusion criteria outlined in the clinical study protocol.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
measure: Area under the plasma versus concentration time curve (AUC)
timeFrame: Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: Through study completion approximately 33 to 38 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
References:
Clinical trial NCT06253741: Rhomboid Intercostal and Subserratus / Paravertebral Block
Official title: "Comparison of Rhomboid Intercostal and Subserratus Plane Blocks Applied for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery With Thoracic Paravertebral Block"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Analgesia
Thoracic
Anesthesia
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Postoperative pain is a significant concern following video-assisted thoracoscopic surgery (VATS). Pain after thoracic surgery not only causes a strong stress reaction and adverse emotional experience but also affects postoperative rehabilitation. Hence, different analgesia techniques, including local anesthetic infiltration, intercostal nerve block, paravertebral block, and thoracic epidural anesthesia, have been described to attenuate the intensity of acute postoperative painparavertebral block (PVB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after video-assisted thoracoscopic surgery (VATS). This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of ultra- sound-guided PVB and RISS block after video-assisted thoracoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Planned for VATS
* American Society of Anesthesiologists (ASA) class I and II
* Patients aged between 18-80

Exclusion Criteria:

* Contraindications to local anesthetic allergy or bupivacaine
* Known or suspected coagulopathy
* Injection site infection
* History of thoracic surgery
* Severe neurological or psychiatric disorder
* Severe cardiovascular disease
* Liver failure
* Renal failure (glomerular filtration rate \<15 ml/min/1.73 m2)
* Chronic opioid use

Primary outcomes:
measure: VAS scores
timeFrame: up to 24 hours
Secondary outcomes:
measure: morphine consumption
timeFrame: up to 24 hours
measure: first analgesia requirement
timeFrame: up to 24 hours
measure: Side effects
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludag University
Study officials:
affiliation: Uludag University
name: SEDA CANSABUNCU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05073341: Effectiveness of Nurse-led Family Intervention on Stress, Engagement With Patient's Care and Satisfaction Among Primary Caregivers of Chronic Liver Disease Patients Admitted in High Dependency Unit of ILBS, New Delhi
Official title: Effectiveness of Nurse-led Family Intervention on Stress, Engagement With Patient's Care and Satisfaction Among Primary Caregivers of Chronic Liver Disease Patients Admitted in High Dependency Unit of ILBS, New Delhi
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Family Members of the Patients
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi experimental design
Primary purpose: SUPPORTIVE_CARE

Brief summary: Quasi experimental study to check the effectiveness of Nurse-led family Intervention on stress, engagement with patient care and satisfaction among primary caregivers of chronic liver disease patients admitted in high depency unit ILBS, two group pre test post test design non randomisation with the Nurse-led family intervention with the sample size of 80 using purposive sampling technique and having independent variable as Nurse-led family intervention and dependent variables are stress, Engagement with patient care and satisfaction and these variables are assesed by using kingston caregivers scale(KCSS) caregiver health engagement scale (CHEW-S)and one knowledge questionnaire based on engagement and satisfaction scale

Detailed description: study having different inclusion and exclusion for criteria CLD patients and Caregiver sof patint's admitted in HDU inclusion criteria of primary caregivers between the age group of 18-65years understand hindi and english duration of hjospitalization should be more than 6 hours exclusion criteria is primary are givers who cannot understand hindi or english and age more than 65 years of age , craegivers of patients who are having disease other than CLD and those who are not willing to participate inclusion for criteria CLD patients decompensated CLD patients , understand hindi and english , duration of hospitalization more than 6 hours , patient is concious and in semi concious state and patient with hepatic encephlopathy

Eligibility criteria: Inclusion Criteria:between age group of 18-65 years

* primary caregivers of CLD patient's understand hindi and english duration of hospitalization more than 6 hours

Exclusion Criteria:

* primary caregivers who cannot understand hindi and english age more than 65 years of age caregivers of patient's who are other than CLD not willing to participate

Primary outcomes:
measure: to reduce stress, increase satisfaction and increse the engagement with patient care
timeFrame: one month data collection
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT06745141: Myocardial Infarction and Periodontitis: Periodontal Health Intervention.
Official title: Oral Health Intervention Study in Patients with Myocardial Infarction and Periodontal Disease: a Simulated RCT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction (AMI)
Periodontal Disease
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a simulated randomized controlled trial (RCT) design to evaluate the effects of periodontal health interventions on patients with myocardial infarction (MI) complicated by periodontitis.

The study mimics the framework of a traditional randomized controlled trial but does not involve formal randomization of participants.

Participants are allocated into intervention and control groups in a structured manner to minimize bias, ensuring comparability.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction patients with periodontitis, so as to promote the application of oral health intervention in clinical practice.


Eligibility criteria: Inclusion Criteria:

* 1)Patients diagnosed with ST-segment elevation myocardial infarction (STEMI). 2)Patients with severe periodontal disease, defined as:

  * 5 teeth with clinical attachment loss (CAL) ≥ 4 mm.

    * Subgingival probing depth (PD) ≥ 6 mm. ③≥ 8 teeth with gingival bleeding on probing (BOP). 3）Age ≥30 years. 4）Written informed consent provided.

Exclusion Criteria:

* 1) under 30 years old; 2) HIV positive, chronic inflammation, tumor disease, drug dependence, use of anticonvulsants, use of immunosuppressive agents, pregnancy, and lactation; 3) significant tooth loss (number of remaining teeth \< 8); 4) long hospital stay (\>10 days), new myocardial infarction before randomization, and stent thrombosis; 5) Refusal to sign informed consent.

Primary outcomes:
measure: Changes in ejection fraction
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Cardiovascular death and MACE events were recorded
timeFrame: From enrollment to the end of treatment at 6 months, a maximum of 12 months.
measure: level of proBNP
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03200041: Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
Official title: Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Patau Syndrome
Edward's Syndrome
Lead sponsor: Premaitha Health
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate the performance of the IONA® test which is a non-invasive prenatal test (NIPT) for Down's syndrome and other chromosomal abnormalities in twin pregnancies, from a maternal blood sample.

Detailed description: 350 low risk and 150 high risk women with twin pregnancies will be recruited to produce a large cohort evaluation the use of the IONA test in twin pregnancies for Downs, Edwards and Patau syndrome. Reserve samples will also be used to further develop the test for other chromosomal abnormalities.

Eligibility criteria: Inclusion Criteria:

* Currently pregnant with twin foetuses at time of entry to study
* Have had or are about to have a conventional screening test (combined/quad test, ultrasound scan or other NIPT)
* If identified as high risk, intend to undergo prenatal invasive diagnosis and/or undergoing invasive prenatal therapy such as laser treatment for TTTS where a sample of amniotic fluid is taken for karyotyping.

Exclusion Criteria:

* Participant herself has down syndrome or other chromosomal abnormality

Primary outcomes:
measure: Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Premaitha Health
Study officials:
affiliation: National Health Service, United Kingdom
name: Asma Khalil, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02149641: Parotid-sparing IMRT for Nasopharyngeal Cancer
Official title: Phase II Study of Parotid Sparing IMRT for Nasopharyngeal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Cancers
Intensity Modulated Radiotherapy With Chemotherapy
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: nasopharyngeal cancers

Brief summary: In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

Detailed description: The purpose of this study was to determine the feasibility in delivering induction chemotherapy and concomitant chemotherapy with IMRT in the treatment of locally advanced nasopharyngeal cancers and to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

Eligibility criteria: Inclusion Criteria:

* nasopharyngeal cancers

Exclusion Criteria:

* Patients \<16 years old or with a previous malignancy other than non-melanomatous skin cancer were excluded

Primary outcomes:
measure: the incidence of ≥G2 xerostomia at 1 year using the subjective component LENTSOMA
timeFrame: 12 months
Secondary outcomes:
measure: Acute radiation toxicities
timeFrame: 0-3 months
measure: Late radiation toxicities
timeFrame: 3-24 months
measure: loco-regional disease-free survival (LRDFS), progression-free survival (PFS) and overall survival (OS)
timeFrame: 2 years
measure: chemotherapy compliance and toxicities
timeFrame: 0-12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Christopher M Nutting, FRCR
role: PRINCIPAL_INVESTIGATOR
References: