louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04097197: Factors Influencing Flu Vaccination in Primary Health Care
Official title: Factors Influencing Flu Vaccination in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flu, Human
Keywords: Influenza Vaccines
Influenza, Human
Primary Health Care
Lead sponsor: Agrupamento de Centros de Saúde de Dão Lafões
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before-after study
Primary purpose: PREVENTION

Brief summary: This study aims to study the barriers to flu vaccination among at-risk people at the Primary Health Care level in order to increase the vaccination rates as recommended by the World Health Organization.

Detailed description: People from vulnerable groups (e.g., those diagnosed with Diabetes, Chronic Obstructive Pulmonary Disease, Asthma) are at increased risk of developing complications from infection with influenza virus, that could ultimately result in death.

Flu vaccination is recommended by many authorities, including the World Health Organization, as a means to decrease the risk of developing such life-threatening conditions. However, vaccination rates are well below the recommended threshold.

Eligibility criteria: Inclusion Criteria:

* People 65+ otherwise healthy;
* Patients of any age diagnosed with at least one of the following conditions: Diabetes, Asthma, COPD, Coronary Disease or Hearth failure;
* No history of flu vaccination in the previous year.

Exclusion Criteria:

* Patients who have been vaccinated against the flu but who have no record of it in the clinical records;
* Patients with contraindications to flu vaccination;
* Patients that cannot be reached either by phone or letter.

Primary outcomes:
measure: Flu vaccination refusal rate
timeFrame: up to 6 months
Secondary outcomes:
measure: Prevalence of barriers to flu vaccination
timeFrame: up to 6 months
measure: Flu vaccination acceptance rate post-intervention
timeFrame: up to 6 months
measure: Flu vaccination rate
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Viseu
country: Portugal
facility: Dão Lafões Grouping of Primary Health Care Centres
state: Dão Lafões
Study officials:
References:
Clinical trial NCT01356797: Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery
Official title: Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: knee arthroscopy
hyperbaric bupivacaine
hypobaric levobupivacaine plus fentanyl
Lead sponsor: USP Hospital La Colina
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 54
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: Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been validated for this surgery. Both selective techniques are specially indicated for ambulatory surgery because of PACU fast track, low discharge home time and high patient satisfaction. This study compares both spinal techniques for knee arthroscopy surgery.


Eligibility criteria: Inclusion Criteria:

* adults scheduled to undergo knee arthroscopy

Exclusion Criteria:

* a previous history of neurological impairment
* insulin-dependent diabetes mellitus
* intolerance to the study drug or related compounds and additives
* BMI \> 38 kg/m2
* height \<155 cm or \>180 cm
* any existing contraindications for spinal anaesthesia
* surgery in which a complete block of the lower limb

Primary outcomes:
measure: time to discharge home
timeFrame: every 30 minutes for an average of 3 hours
Secondary outcomes:
measure: Ambulation time after surgery
timeFrame: every 30 minutes for an average of 3 hours
Other outcomes:
Locations:
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital La Colina
state: Santa Cruz
Study officials:
affiliation: USP La Colina
name: Jesus Santiago Moragas
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Hospital La colina
name: Javier Santos-Yglesias
role: STUDY_CHAIR
References:
Clinical trial NCT03548597: Evaluation of the Diagnostic of Hepatic Fibrosis With the in Severe Obese Patients Candidates to Bariatric Surgery
Official title: Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Steatosis
Obesity
Fibrosis, Liver
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
Collaborators: name: Echosens
First posted: 2018-06-07
Enrollment: 132
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: Severe obese patients candidate to bariatric surgery

Brief summary: Background:

The XL probe of FibroScan was recently developed to realize liver stiffness measurements (LSM) in overweight patients.

Severe obese patients have a high prevalence of liver injuries and could benefit of liver evaluation prior to bariatric surgery.

Objectives:

Assess the FibroScan applicability, reliability and diagnostic performances in severe obese patients' candidates for bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Severe obese patients candidate to bariatric surgery with no history of liver disease have a large prevalence of liver lesions.

Primary outcomes:
measure: Elasticity measured with the Fibroscan XL
timeFrame: 3 years
Secondary outcomes:
measure: 53/5000 Evolution of elasticity after bariatric surgery
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
citation: Barsamian C, Carette C, Sasso M, Poghosyan T, Bedossa P, Emile JF, Parlier D, Miette V, Bouillot JL, Czernichow S, Rives-Lange C. Diagnostic of hepatic fibrosis with the XL probe of the Fibroscan versus biopsies in patients candidates to bariatric surgery. Clin Nutr ESPEN. 2020 Jun;37:226-232. doi: 10.1016/j.clnesp.2020.02.010. Epub 2020 Mar 12.
Clinical trial NCT02206997: Evaluation of a Patient Warming Concept Following the German S3 Guideline for Prevention of Intraoperative Hypothermia
Official title: Evaluation of a Patient Warming Concept Following the New German Speaking S3 Guideline for Prevention of Intraoperative Hypothermia With Respect to Incidence and Complications of Perioperative Hypothermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia
Hypothermia, Accidental
Keywords: perioperative hypothermia
prewarming
treatment guideline
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of FEK Hospital Neumünster scheduled for elective surgery under defined conditions (see below)

Brief summary: The aim of the study is to evaluate a patient prewarming concept following the recommendations of the S3-guideline "Prevention of perioperative hypothermia" with respect to incidence and complications of perioperative hypothermia. The study hypothesis is that postoperative core temperature in adult patients after prewarming is significantly higher than in patients who were treated following actual standard protocol (passive insulation).

Detailed description: The aim of the study is to evaluate a patient prewarming concept following the recommendations of the new german S3-guideline "Prevention of perioperative hypothermia" with respect to incidence and complications of perioperative hypothermia. Prewarming should enable the patients to preserve their core temperature for a longer period and to avoid perioperative hypothermia.The study hypothesis is that postoperative core temperature in adult patients after prewarming is significantly higher than in patients who were treated following the actual standard protocol (passive insulation).

Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective general or orthopedic surgery with expected duration \> 45 min
* American Society of Anesthesiologists physical status 1-3
* age \> 17 years

Exclusion Criteria:

* emergency surgery
* patient's denial
* unexpected decrease of duration of anesthesia \< 45 min
* preoperative body temperature \> 38 °C

Primary outcomes:
measure: Incidence of postoperative hypothermia at admission to PACU
timeFrame: admission to PACU
Secondary outcomes:
measure: Type and duration of surgery as influence factors for postoperative hypothermia at admission to PACU
timeFrame: admission to PACU
Other outcomes:
Locations:
city: Neumünster
country: Germany
facility: FEK Hospital Neumünster
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
name: Jan H Hoecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06812897: Sallie Life U Feasibility Study
Official title: Assessing the Feasibility of a Patient-Driven Chiropractic Patient Portal (SallieTM Life U) for Research Purposes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Lead sponsor: Life University
Sponsor class: OTHER
Collaborators: name: Power of Patients
First posted: 2025-02-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No specific population

Brief summary: This feasibility trial explored the usability of the patient-driven chiropractic patient portal, Sallie™ Life U. The study aimed to recruit 30 participants to track their daily symptoms, triggers, and habits over 30 days while completing three questionnaires about their experience with the portal. The first questionnaire was administered after participants created their accounts, the second at the midpoint of tracking (day 15), and the third upon completing the tracking period (day 30). All participation in the study was conducted remotely using the participants' personal devices.


Eligibility criteria: Inclusion Criteria:

* Have daily access to technology (smartphone, tablet, or computer)
* Currently receiving chiropractic care (for the purposes of this feasibility study, this requires at least one chiropractic adjustment each month)

Exclusion Criteria:

- Given software restrictions, participants must also be able to read and write in English and not be visually impaired.

Primary outcomes:
measure: Participant Recruitment
timeFrame: 30 days
measure: Participant Adherence - Weekly
timeFrame: 30 days
measure: Participant Adherence - Monthly
timeFrame: 30 days
measure: Participant Retention
timeFrame: 30 days
Secondary outcomes:
measure: Personalized Tracking Metrics (PTMs)
timeFrame: 30 days
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Dr. Sid E Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Dr. Sid E Williams Center for Chiropractic Research
name: Stephanie Sullivan, DC, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06620497: SFI Bars and Milled Bars Supporting Mandibular Overdentures. Three-year Randomized Clinical Trial
Official title: Marginal Bone Loss, Prosthetic and Mucosal Complications of Stress-free Implant Bars and Milled Bars Supporting Mandibular Overdentures. Three-years Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Alveolar Ridge in Mandible
Keywords: SFI bar
milled bar
bone loss
mucosal complications
prosthetic complications
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 8
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: The aim of this study will be to evaluate the marginal bone loss and prosthetic complications of stress-free implant (SFI) and milled bars used to assist mandibular 4-implant overdentures after 3 years

Detailed description: Eight edentulous participants with insufficient stability of mandibular dentures will receive 4 implants in the mandibular ridge (2 implants in the canine areas and 2 implants in the first molar areas), and then after 3 months, patients will be randomly assigned into 2 groups; 1) group 1: will include 4 participants who will receive milled bar overdentures, and 2) group 2: will include 4 participants who will receive SFI bar overdentures. For both groups, marginal bone loss will be evaluated using the standardized digital periapical films at the time of insertion, 6 months, 1 year, and 3 years after insertion. Prosthetic and mucosal complications will be evaluated after 3 years.

Eligibility criteria: Inclusion Criteria:

* mandibular edentulous ridge

Exclusion Criteria:

* severe atrophy in mandibular ridge

Primary outcomes:
measure: marginal bone loss
timeFrame: time of insertion, 6 months, 1 year and 3 years
Secondary outcomes:
measure: prosthetic complications as denture fracture, adjustment of denture margins, acrylic teeth wear/fracture, abutment fracture, abutment screw loosening/fracture, prosthetic screw loosening/fracture, metal housing loosening/wear, clip wear/replacement
timeFrame: 3 years
measure: mucosal complications include; mucositis/soreness of mandibular mucosa, ulcer of mandibular mucosa, hyperplasia under the bar
timeFrame: 3 years
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: fayoum University
Study officials:
References:
Clinical trial NCT02535897: Protein Ingestion and Muscle Carnitine Uptake
Official title: The Effects of an Insulinotropic Protein-carbohydrate Beverage on L- Carnitine Absorption and Muscle Carnitine Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Muscle, Skeletal
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and carbohydrate-only controls, and to determine whether increasing plasma carnitine availability can impact upon insulin-stimulated muscle carnitine uptake.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Body mass index of 18-25 kg/cm2

Exclusion Criteria:

* Unhealthy
* Smoker
* Taking any medication that interferes with skeletal muscle metabolism

Primary outcomes:
measure: Muscle carnitine uptake
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04446897: Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction
Official title: Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction Immobilised on a Biodegradable Carrier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Periodontitis, Chronic
Keywords: Periodontitis
Mesenchymal stem cells
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian Medical Academy of Post-Graduate Education
First posted: 2020-06-25
Enrollment: 10
Sex: ALL
Minimum age (years): 70
Maximum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of chronic medium-severe periodontitis with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

Detailed description: The bone defect will be filled with a porous membrane based on bone collagen measuring 5x5 mm or more with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction

Eligibility criteria: Inclusion Criteria:

- chronic medium-severe periodontitis

Exclusion Criteria:

* pregnancy
* breast-feeding
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders

Primary outcomes:
measure: number of patients cured
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
name: Igor Volotovski, Prof
role: STUDY_DIRECTOR
affiliation: Head of the Department of Prosthodontics of BMAPE
name: Sergey Rubnikovich, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01625897: A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
Official title: A Long-term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic Agents
Mental Disorder
Psychotropic Drugs
Dopamine Agents
Risperidone
Central Nervous System Agents
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-22
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the patient before the initiation of any study-specific procedures
* Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* Patients who meet at least one of the following:

  * current diagnosis of schizophrenia of chronic phase
  * between 65 and 74 years of age
* Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 60 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aizuwakamatsu
country: Japan
state: Fukushima
Study officials:
References:
Clinical trial NCT00611897: N-acetylcysteine and NMDA Antagonist Interactions
Official title: N-acetylcysteine and NMDA Antagonist Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cognitive Dysfunction
Keywords: NMDA
glutamate
N-acetylcysteine
P3
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-02-11
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study tests the hypothesis that extrasynaptic mechanisms are critically linked with cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in healthy humans.


Eligibility criteria: Inclusion Criteria:

* Ages of 21-45 years from all ethnic backgrounds.
* Male or female.
* Written informed consent.

Exclusion criteria

* DSM-IV diagnosis for a psychotic, depressive or anxiety disorder.
* A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox, Urine pregnancy test) .
* History of severe allergies or multiple adverse drug reactions.
* Any medication that in the opinion of the PI could interfere with either the safety of the study and/or the outcome measures.
* Any other conditions which in the opinion of the investigator would preclude participation in the study.
* History of major psychiatric disorder in first degree relatives.
* Current substance abuse/dependency determined by urine toxicology.
* Current treatment with medications with psychotropic effects.
* Treatment with benzodiazepines within one week prior to testing.
* Current pregnancy, unsatisfactory birth control method report for females.
* Education \< 10th grade.
* IQ \< 70, MR as determined by Wechsler Abbreviated Scale of Intelligence.
* Non-English speaking.

Primary outcomes:
measure: Target P300
timeFrame: daily
measure: Novel P300
timeFrame: daily
Secondary outcomes:
measure: Mismatch Negativity (MMN) Intensity
timeFrame: daily
measure: Mismatch Negativity (MMN) Frequency
timeFrame: daily
measure: Mismatch Negativity (MMN) Duration
timeFrame: daily
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VHA Connecticut
state: Connecticut
Study officials:
affiliation: Yale University
name: Handan Gunduz-Bruce, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03678597: Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
Official title: Latrunculin B Supplementation to ICSI Handling Medium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
First posted: 2018-09-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Latrunculin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Latrunculin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,


Eligibility criteria: Inclusion Criteria:

* All ICSI cycles

Exclusion Criteria:

-

Primary outcomes:
measure: oocyte survival rate after ICSI
timeFrame: 6 days of culture
Secondary outcomes:
measure: Fertilisation rate
timeFrame: 6 days of culture
measure: Rates of blastocyst formation and quality
timeFrame: 6 days of culture
measure: Clinical pregnancy rate
timeFrame: three months
measure: Implantation rate
timeFrame: 7 weeks
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center, IbnSina Hospital
Study officials:
References: