louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05383794: Role of miRNAs in CVD and Periodontitis
Official title: Analysis of Gingival Crevicular Fluid Levels of miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 200b-3p, miRNA 200b-5p, miRNA 100-5p, miRNA 125-5p in CVD and Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Periodontal Diseases
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 115
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy controls (n=28), periodontitis (n=30), CVD (n=28), and a combination of periodontitis + CVD (n=29)

Brief summary: Several micro-RNA plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease. The investigators compared the impact of gingival health, periodontitis (CP), cardiovascular disease or of both diseases (CP +cardiovascular disease) on gingival crevicular fluid miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 200b-3p, miRNA 200b-5p, miRNA 100-5p, miRNA 125-5p levels.

Detailed description: The investigators compared the impact of gingival health, periodontitis (CP), cardiovascular disease or of both diseases (CP +cardiovascular disease) on gingival crevicular fluid miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 200b-3p, miRNA 200b-5p, miRNA 100-5p, miRNA 125-5p levels.

Eligibility criteria: Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Clinical Attachment level
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
state: CT
Study officials:
affiliation: Università degli Studi di Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01570894: Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar I Disorder
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to quetiapine or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
References:
Clinical trial NCT04273594: FemBloc® Permanent Contraception - Confirmation Feasibility Trial
Official title: BLOC: Prospective, Multi-Center, Study of Subjects Undergoing FemBloc Permanent Contraception With Two Confirmation Procedures (FemBloc With FemChec and Fluoro HSG)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Contraception
Keywords: permanent contraception
birth control
pregnancy prevention
Lead sponsor: Femasys Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-18
Enrollment: 45
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The trial objectives include evaluating the adequacy of proposed mitigations for the previous pivotal trial of the FemBloc Permanent Contraceptive System and validating the confirmation procedure by comparing FemChec (ultrasound) to fluoroscopic hysterosalpingogram (fluoro HSG) for post-occlusion in the same patient.


Eligibility criteria: Inclusion Criteria:

* Female, 21 - 45 years of age desiring permanent birth control
* Sexually active with male partner
* Regular menstrual cycle for last 3 months or on hormonal contraceptives

Exclusion Criteria:

* Uncertainty about the desire to end fertility
* Known or suspected pregnancy
* Prior tubal surgery, including sterilization attempt
* Prior endometrial ablation
* Presence, suspicion, or previous history of gynecologic malignancy
* Abnormal uterine bleeding requiring evaluation or treatment
* Scheduled to undergo concomitant intrauterine procedures at the time of procedure(s)
* Allergy to shellfish, betadine or iodinated contrast

Primary outcomes:
measure: Reliance Rate
timeFrame: within 1 year
measure: Concordance
timeFrame: within 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: New Horizons Clinical Trials
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials AZ, LLC
state: Arizona
city: Columbus
country: United States
facility: Midtown OB GYN North
state: Georgia
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group
state: Michigan
city: Beachwood
country: United States
facility: University Hospitals - Cleveland Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT00289094: Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
Official title: Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Juvenile Rheumatoid Arthritis
Avascular Necrosis of Bone
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Detailed description: This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis
* Rheumatoid Arthritis
* Other inflammatory arthritis
* Avascular necrosis of bone

Exclusion Criteria:

* Prior ipsilateral TKA
* Metabolic disorders
* Joint replacement due to autoimmune disorders

Primary outcomes:
measure: Knee Society Scores
timeFrame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary outcomes:
measure: Complications/Revisions
timeFrame: On-going to end of study.
measure: Medical Imaging
timeFrame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
measure: SF-12 Patient Outcomes
timeFrame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Other outcomes:
Locations:
city: Billings
country: United States
state: Montana
city: Vancouver
country: United States
state: Washington
Study officials:
affiliation: DePuy Orthopaedics
name: Tammy L O'Dell, EMT, CCRA, CCRC
role: STUDY_DIRECTOR
References:
Clinical trial NCT05136794: LIdocaine veRsus Sufentanil Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass
Official title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Free Anaesthesia
Opioid Anaesthesia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 1772
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac surgical

Brief summary: Since the 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, the sympathetic reaction and the inflammatory reaction can be controlled by other therapeutic classes than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In this hypothesis, OFA is more and more practiced in various situations without the real impact in terms of clinical benefit being clearly demonstrated. In cardiac surgery, some centers practice OFA with various protocols.The purpose of this work is to retrospectively evaluate over a defined period the incidence of postoperative complications, length of stay in the ICU/hospital, and death rate between patients managed with/without OFA based on lidocaine.


Eligibility criteria: Inclusion Criteria:

age over 18 years Cardiac surgery with cardiopulmonary bypass performed between January 2019 and June 2021

Exclusion Criteria:

LVAD Heart transplantation Incomplete data in relation to outcomes

Primary outcomes:
measure: ICU stays (days)
timeFrame: Day 30
Secondary outcomes:
measure: Complications
timeFrame: Day 30
measure: Hospital stays (days)
timeFrame: Day 30
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT02474394: Effects of Videolaryngoscope on Intraocular Pressure
Official title: The Comparison of the Effects of McGrath Video Laryngoscope and the Macintosh Laryngoscope on Intraocular Pressure: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation Complication
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.

Detailed description: The stability of the intraocular pressure plays an important role during ophthalmic surgery. The systemic blood pressure, aqueous humor dynamics, choroidal blood volume, central venous pressure, extra-ocular muscle tone, and also conventional laryngoscopy affect the intraocular pressure.It was shown that the new devices for laryngoscopy, such as video laryngoscopes provide minimal hemodynamic changes when compared to direct laryngoscopes. However there is no current data about the effects of the intubation with McGrath videolaryngoscope on intraocular pressure. The main objective of this study to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologist physical status I
* Non-ophthalmic elective surgery under general anesthesia

Exclusion Criteria:

* A history of pre-existing glaucoma or previous intraocular surgery
* Thyromental distance below 6cm
* Maximum mouth opening below 3cm
* Mallampati score of III or IV
* Pre-anesthetic intraocular pressure above 20 mmHg
* Number of intubation attempts more than 2
* Obstetric or laparoscopic surgery

Primary outcomes:
measure: Intraocular pressure
timeFrame: during laryngoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Medical School
Study officials:
affiliation: Gaziosmanpasa University Medical School
name: Tugba Karaman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06028594: Compassionate Use of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria
Official title: An Expanded Access Program of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-09-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This program is designed to provide access to pozelimab and cemdisiran and document the long-term safety of pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare immune disease that causes red blood cells in your body to break apart.


Eligibility criteria: Key Inclusion Criteria:

1. Patients who have completed either the end of treatment visit of the open-label treatment period or open-label extension period in one of the following parent studies:

   * An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria (R3918-PNH-2050 \[NCT05744921\])
   * A Randomized, Open-Label, Two-Arm Study to Evaluate the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Treatment in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy (R3918-PNH-2092 \[NCT04811716\])
   * A Single Arm, Open-Label Study to Assess the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Switch from Eculizumab Therapy (R3918-PNH-20105 \[NCT04888507\]). Note: In some countries, patients that would normally enter into the R3918-PNH-2050 (NCT05744921) parent study before entering this expanded access program, may be given the opportunity to skip R3918-PNH-2050 (NCT05744921) and go straight into this expanded access program, with Regeneron's permission
2. Patients who have been enrolled in R3918-PNH-2022 (NCT05131204), with Regeneron's permission
3. Willing and able to comply with clinic visits and related standard-of-care procedures
4. With Regeneron's permission, patients who have been enrolled in other PNH studies as appropriate

Key Exclusion Criteria:

1. Significant history or concerns of non-compliance that could impact the patient's safety per the treating physician
2. Any new condition or worsening of an existing condition which, in the opinion of the treating physician, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the program

NOTE: Other protocol defined inclusion / exclusion criteria apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03389594: Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Sizes
Official title: Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Size in Computer Guided Implantology Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accuracy of Surgical Guide in Implants
Keywords: Surgical guide
Computer guided implantology
CBCT voxel size
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.

The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes .

Detailed description: Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.

The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes (voxel size 0.4mm \& 0.2mm)

Eligibility criteria: Inclusion Criteria:

* partially edentulous patients seeking for dental implant
* Bucco-lingual width more than 6 mm
* Medically free patients

Exclusion Criteria:

* patients with thin ridges that may need augmentation
* patients with systematic diseases that may affect bone quality
* completely edentulous patients
* patients with limited mouth opening

Primary outcomes:
measure: Angular deviation
timeFrame: Immediate post operative
measure: Linear deviation
timeFrame: Immediate post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University, Faculty of dentistry
name: Cairo university
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02668094: The Effect of Pregabalin on Pain of Propofol Injection
Official title: The Effect of Pregabalin on Pain of Propofol Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: propofol
lidocaine
pregabalin
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pain is a common side effect of propofol injection. The purpose of this study was to compare the efficacy of pregabalin and lidocaine in reducing propofol injection pain.

Detailed description: In a randomized, double blind, prospective trial, 120 patients were allocated to one of three groups (each n=40) receiving intravenous lidocaine 40mg (group L), oral pregabalin 75 mg (group LP), and oral pregabalin 150 mg (group HP) as pretreatment, followed by injection of 25% of 2 mg/kg propofol. Pain was assessed by a four point scale (0=no, 1=mild, 2=moderate, 3=severe pain).

Eligibility criteria: Inclusion Criteria:

* Patient underwent elective dental surgery.

Exclusion Criteria:

* Patient with a history of adverse response to lidocaine or pregabalin,
* Patient with cardiovascular or respiratory disease,
* Patient who takes any sedatives, analgesics, or anticonvulsants within 24 hours before surgery.

Primary outcomes:
measure: Propofol injection pain
timeFrame: 10 seconds after injection of propofol
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National Hosptial
name: Younghoon Jeon, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06885294: Physiotherapy/hypnosis for AVC Patients
Official title: Impact of Physiotherapy Combined to Hypnosis on Superior Limb Functional Capacities of AVC Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Keywords: Hypnosis, Stroke, physiotherapy
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 84
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: SUPPORTIVE_CARE

Brief summary: Impact of physical therapy with hypnosis on the functional capacity of the upper limb in stroked patients.

Detailed description: The cerebrovascular accident (CVA) is a pathology generating many disabled people. Physiotherapy is one of the usual rehabilitation techniques for a patient with sequelae of ischemia or cerebral hemorrhage. Combined with another therapeutic approach, hypnosis, it could increase the patient's motor performance.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 80 years old
* Having experienced a stroke more than 3 months ago
* Understanding and proficient in the French language
* Having a functional capacity deficit in at least one of the two upper limbs
* Being able to independently travel to the Yerne medical center for necessary study appointments.

Exclusion Criteria:

* Being under 18 or over 80 years old
* Having a history of upper limb injuries (fractures, prosthetics, etc.)
* Having Wernicke's aphasia (language comprehension disorder)
* Having frontal lobe syndrome
* Undergoing chemotherapy
* Having respiratory disorders (respiratory failure of more than 70%) or receiving oxygen therapy
* Having epilepsy
* Having dementia
* Having untreated hearing impairments
* Being diagnosed with schizophrenia or paranoïa
* Experiencing significant concentration difficulties

Primary outcomes:
measure: Measurement of joint ranges of motion
timeFrame: 8 weeks
measure: assessment of spasticity
timeFrame: 8 weeks
measure: functional tests for the upper limb
timeFrame: 8 weeks
measure: scales for assessing disability and functional independence
timeFrame: 8 weeks
measure: evaluation of muscle strength
timeFrame: 8 weeks
measure: Box and Block Test (BBT)
timeFrame: 8 weeks
measure: Modified Rankin Scale (mRS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: GIGA Science and Perception Research Group CHU Liège
Study officials:
affiliation: University of Liege
name: Audrey Vanhaudenhuyse, PhD
role: STUDY_DIRECTOR
References: