louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04682275: Effect of Gender on Depression and Periodontal Status
Official title: Gender Differences in Periodontal Status of Depressive and Non-Depressive Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Depression
Gender
Gingival Diseases
Keywords: periodontal diseases
depression
gender
gingival diseases
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.

Detailed description: Background: Depression is a multifactorial disease characterized by a variety of symptoms. Individuals with psychiatric disorders seem to be more prone to periodontitis. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal diseases can also be an effect on depression. The purpose of the present study was to evaluate the gender-related differences in the relationship between periodontal diseases and depression in male and female adults.

Material and methods: The study population consisted of 339 subjects. Two groups were formed from these patients: 171 females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis); 168 males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis). Clinical periodontal and psychological measures were performed on females and males group.

Eligibility criteria: Inclusion Criteria:

* the presence of periodontal diseases

Exclusion Criteria:

* the presence of any systemic disease other than depression
* smoking and alcohol consumption
* the use of any drugs (antidepressants, anti-inflammatory, and antimicrobial medicaments, and hormonal supplements) that affect the periodontal condition
* have received any periodontal treatment in the last six months
* hormonal condition such as pregnancy or lactation

Primary outcomes:
measure: Depression level
timeFrame: Baseline
Secondary outcomes:
measure: Probing pocket depth
timeFrame: Baseline
measure: Gingival index
timeFrame: Baseline
measure: Plaque index
timeFrame: Baseline
measure: Bleeding on probing
timeFrame: Baseline
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
affiliation: Necmettin Erbakan University
name: Fatma Ucan Yarkac, 1
role: PRINCIPAL_INVESTIGATOR
affiliation: Abant Izzet Baysal University
name: Ozge Gokturk, 1
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01924975: Saphenous Vein Cannulation in Infants and Small Children
Official title: Ultrasound-image Guided Versus Traditional Landmark Technique for Saphenous Vein Cannulation in Infants and Small Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Saphenous Vein Cannulation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2013-08-19
Enrollment: 102
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the two different saphenous vein cannulation techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional landmark technique (Landmark group).


Eligibility criteria: Inclusion Criteria:

1. Pediatric patient undergoing scheduled surgery which requires venous cannulation.
2. Term neonates and children \< 4 years old weighing \>/= 3 kg

Exclusion Criteria:

1. Patient with visible saphenous vein
2. Patient with no detectable saphenous vein under ultrasound
3. Patient with a skin wound or infection around puncture site
4. Patient with recent venous puncture at the puncture site (less than 1 month)
5. Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound.
6. Patient with any emergency surgery

Primary outcomes:
measure: Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation
timeFrame: 10 minutes
Secondary outcomes:
measure: Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period.
timeFrame: 10 minutes
measure: Time Required for Overall Successful Venous Cannulation.
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: University of Iowa Hospitals & Clinics
name: Satoshi Hanada, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Triffterer L, Marhofer P, Willschke H, Machata AM, Reichel G, Benkoe T, Kettner SC. Ultrasound-guided cannulation of the great saphenous vein at the ankle in infants. Br J Anaesth. 2012 Feb;108(2):290-4. doi: 10.1093/bja/aer334. Epub 2011 Oct 27.
citation: Riera A, Langhan M, Northrup V, Santucci K, Chen L. Remember the saphenous: ultrasound evaluation and intravenous site selection of peripheral veins in young children. Pediatr Emerg Care. 2011 Dec;27(12):1121-5. doi: 10.1097/PEC.0b013e31823ab926.
citation: Joshi M, Wilson G, Engelhardt T. Comparison of landmark technique and ultrasound guidance for localisation of long saphenous vein in infants and children. Emerg Med J. 2010 Jun;27(6):443-5. doi: 10.1136/emj.2008.069310.
Clinical trial NCT06738875: Monitoring Changes in Endotracheal Tube Cuff Pressure During Laparoscopic Bariatric Surgery
Official title: Monitoring Changes in Endotracheal Tube Cuff Pressure During Laparoscopic Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 28

Brief summary: This prospective observational cohort study was designed to assess the relationship between ETT cuff pressures and airway pressures in obese patients undergoing laparoscopic bariatric surgery. We hypothesized that the ETT cuff pressures will rise in direct relationship to increases in the peak and mean airway pressures.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) risk indicators I-III manage to undergo Laparoscopic bariatric surgery between the ages of 18-70

Exclusion Criteria:

* Patients with drug allergies, chronic pain, long-term opioid use, history of psychiatric illness, and need for emergency surgery were excluded from the study.

Primary outcomes:
measure: ETT cuff pressure
timeFrame: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation
Secondary outcomes:
measure: Peak airway pressures
timeFrame: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation
Other outcomes:
Locations:
city: Kayapinar
country: Turkey
facility: Health Sciences University Gazi Yaşargil Training and Research Hospital
state: Di̇yarbakir
Study officials:
References:
Clinical trial NCT05697575: Non-immunogenic Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice
Official title: Non-interventional Observational Study to Evaluate the Efficacy and Safety of Non-immune Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Keywords: stroke thrombolysis
acute ischemic stroke
reperfusion
Lead sponsor: National Society for Neurosonology and Cerebral Circulation
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women aged 18 to 85 years (inclusive), who meet the inclusion criteria and do not have contraindications for thrombolysis, with a diagnosis of acute ischemic stroke.

Brief summary: The study will collect data from aged 18 to 85 years with a diagnosis of acute stroke, who received thrombolytic treatment with a new agent, nonimmunogenic staphylokinase. Outcomes will be checked for safety and compared to the results of treatment with the other thrombolytic drug, alteplase.


Eligibility criteria: Inclusion Criteria:

* Age 18-85 ;
* Diagnosis of acute ischemic stroke eligible for thrombolytic therapy;
* Thrombolytic therapy with the drug "non-immunogenic staphylokinase" is planned or has already been performed.

Exclusion Criteria:

* Individual intolerance or known hypersensitivity to a recombinant protein containing the amino acid sequence of staphylokinase;
* The presence of a contraindication to thrombolytic therapy of ischemic stroke;
* Pregnancy or lactation.

Primary outcomes:
measure: Proportion of intracerebral hemorrhage
timeFrame: 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze
Study officials:
affiliation: First St. Petersburg State Medical University named after I.P. Pavlov
name: Igor A Voznjuk, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03988075: Non-opioid Based Pain Control After Thyroidectomy
Official title: Use of Enhanced Recovery After Surgery (ERAS) in Minimizing Opioid Use for Patients Undergoing Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Thyroidectomy
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to one of two study groups
Primary purpose: TREATMENT

Brief summary: Pain control modalities were evaluated after thyroidectomy.

Detailed description: Pain control modalities were evaluated after thyroidectomy. Patients were randomized to one of two pain control regimens. The control group received conventional opioid based post operative analgesia while the test group received an enhanced recovery after surgery (ERAS) based anesthesia with use of acetaminophen and non-steroidal anti-inflammatory drugs for the post operative period with opioid medications available for break through pain only. Pain scores (measured on visual analog scale) and opioid use (measured in morphine equivalent dose) were measured after completion of the operation.

Eligibility criteria: Inclusion Criteria:

* thyroid disease

Exclusion Criteria:

* currently on opioid pain medications
* on opioid pain meds in last 30 days
* cannot take non-opioid medications
* require more extensive operation than thyroidectomy

Primary outcomes:
measure: visual analog scale pain level
timeFrame: 1 hour post operatively
measure: visual analog scale pain level
timeFrame: 6 hour post operatively
measure: visual analog scale pain level
timeFrame: 24 hour post operatively
measure: visual analog scale pain level
timeFrame: 7 days post operatively
Secondary outcomes:
measure: opioid use
timeFrame: with the first 24 hours post operatively
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Erin Felger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Francis DO, Randolph G, Davies L. Nationwide Variation in Rates of Thyroidectomy Among US Medicare Beneficiaries. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1122-1125. doi: 10.1001/jamaoto.2017.1746.
citation: Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
citation: Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.
citation: Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.
Clinical trial NCT05906875: A Novel Balance Program to Improve Balance in People With Parkinson's Disease
Official title: A Novel Balance Program to Improve Balance in People With Parkinson's Disease: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation Exercise
Physical Therapy
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this exploratory single-blinded randomized control trial is to explore the effects of a lateral stepping program integrated into an existing community-based group exercise program for people with PD. The researchers hypothesize that participation in a lateral stepping program a minimum of 2 times/week for 8 weeks, in addition to RSB class participation, will decrease fall risk factors, increase balance confidence, and decrease fear of falling in participants in the experimental group compared to the control group. The researchers also hypothesize that the integration of this program into an existing community-based RSB program will be deemed feasible as shown by the number of sessions attended by each participant and their satisfaction


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of idiopathic PD stages I, II, or III of the Hoehn and Yahr scale
2. 50-85 years inclusive
3. Subjects must be enrolled in RSB at NY Tech and attend at least 1 day per week for a minimum of 4 weeks prior to the first baseline assessment
4. English speaking.
5. Stable PD medication regime.

Exclusion Criteria:

1. Any cardiovascular or other medical condition that would affect participation
2. Any hip and/or knee surgery or other injury that would prevent full participation in the intervention
3. Neurological conditions other than PD
4. Montreal Cognitive Assessment of ≤21
5. Pain that interferes with testing 13
6. Current participation in other strengthening, stretching or balance programs other than Rock Steady Boxing at NY Tech
7. Inability to understand and fully participate in this study

Primary outcomes:
measure: The Mini-BESTest
timeFrame: 10-15 minutes
measure: The Functional Gait Assessment
timeFrame: 5-20 minutes
measure: The Multidirectional Functional Reach Test
timeFrame: Less than 5 minutes
measure: The Four-Square Step Test
timeFrame: less than 5 minutes
measure: The Activities Balance Confidence Scale
timeFrame: 5-10 minutes
measure: The Parkinson's Disease Questionnaire-39
timeFrame: approximately 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology
state: New York
Study officials:
References:
Clinical trial NCT05033275: Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy
Official title: Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infant of Diabetic Mother
Sacral Agenesis
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born to mothers with pregestational diabetes

Brief summary: Babies born to mothers with pregestational diabetes will be screened with parental consent for sacral agenesis

Detailed description: Parent/s of babies born to mothers with pregestational diabetes who have normal clinical examination and have no radiographs showing a normal sacrum will be approached for a spinal US

Eligibility criteria: Inclusion Criteria:

* Infants born to mothers with pregestational diabetes
* Normal spinal examination

Exclusion Criteria:

* Infants born to mothers with pregestational diabetes
* Abnormal spinal examination such as a sacral dimple
* Radiograph with abnormal sacrum
* Spanish speaking parents

Primary outcomes:
measure: Babies with sacral agenesis identified with screening of asymptomatic babies with a spinal ultrasound
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: MU
state: Missouri
Study officials:
affiliation: MU
name: Akshaya J Vachharajani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543075: Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function
Official title: A Phase I Pharmacokinetic Study of Genasense® in Subjects With Normal Renal Function and Mildly and Moderately Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Renal Function
Mildly Impaired Renal Function
Moderately Impaired Renal Function
Keywords: Renal Function
Adult
Genasense
oblimersen
G3139
Genta
Pharmacokinetics
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous intravenous infusion for 2 days (48 hours).


Eligibility criteria: Key inclusion criteria:

* Age \> 18 years
* Adequate organ function as determined \< 7 days prior to starting study medication (except for renal function, as specified per protocol)
* Creatinine clearance \> 80 mL/min based on the Cockcroft-Gault formula for subjects in Group 1; or 50 to less than or equal to 80 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 2; or 30 to 49 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 3

Key exclusion criteria:

* Significant medical disease
* Prior organ allograft
* Coexisting condition that would require the subject to continue therapy during the treatment (infusion) phase of the study with a drug known to alter renal function

Primary outcomes:
measure: Pharmacokinetics of oblimersen (G3139)
timeFrame: Up to 58 hours after start of Genasense infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: Davita Clinical Research
name: Harry Alcorn, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06398275: Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty
Official title: Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Remimazolam
Emergence Delirium
Rhinoplasty
Keywords: Remimazolam
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 80
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: PREVENTION

Brief summary: The aim of this research is to confirm the effectiveness of remimazolam in preventing delirium during recovery from anesthesia in adult patients who have undergone one of the rhinological surgeries (septoplasty, rhinoseptoplasty or functional endoscopic sinus surgery).

Patients aged 18-65, ASA classification I-II will be anesthetized with balanced anesthesia maintained with sevoflurane and will be randomized into two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline solution.

The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be the postoperative pain level, the length of stay in the recovery room, the presence of unwanted events in the recovery room, and the presence of postoperative mood changes.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for rhinoplasty, rhinoseptoplasty or FESS
* ASA I or II

Exclusion Criteria:

* pregnancy
* patients treated with psychiatric medication (in the time of operation or 6 months prior to operation)

Primary outcomes:
measure: Richmond agitation sedation scale
timeFrame: Immediately after extubation and every five minutes after that for half hour
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: UH Split
Study officials:
References:
Clinical trial NCT06074575: Do Emotions Affect Mechanical Pain Thresholds?
Official title: The Effect of Positive and Negative Emotions on Mechanical Pain Thresholds: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Linnaeus University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Within-subjects design.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate if different emotional states could influence mechanical pain thresholds.

Detailed description: Participants will be randomized into 4 different groups watching different short video-clips (2.20 min). The negative emotions group will watch an uncomfortable short video containing violence and blood, the positive emotions group will watch a video containing a stand-up comedy show, the neutral emotions group will watch a video with Swedish nature, and the control group will just wait for 2.20 min, without any instructions about what to think about. Pressure pain thresholds will be measured with an algometer before and after the video-clip interventions.

Eligibility criteria: Inclusion Criteria:

* Above 18 years of age, fluent in Swedish.

Exclusion Criteria:

* Pain anywhere in body during the test session, known neurological disease.

Primary outcomes:
measure: Pressure pain threshold
timeFrame: Measurements will be conducted at the test session, which will have a duration of approximately 20 minutes for each participant.
Secondary outcomes:
Other outcomes:
Locations:
city: Växjö
country: Sweden
facility: Helena Gunnarsson
state: Kronoberg
Study officials:
affiliation: Linnéuniversitetet
name: Helena Gunnarsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: