louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00668928: Effect of Dietary Polyphenols on Insulin Sensitivity
Official title: Effect of Dietary Polyphenols on Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Resistance
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2008-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A large and growing segment of the population is prediabetic. Dietary interventions that improve insulin sensitivity may be important in preventing the progression to full-blown diabetes in these individuals. Foods and dietary compounds that increase insulin sensitivity are likely to help maintain a healthier body composition. This pilot study will provide data to evaluate the role of dietary plant polyphenols in improving insulin sensitivity.

Detailed description: How does the amount consumed of cocoa and tea polyphenols (flavon-3-ol monomers and oligomers) affect insulin sensitivity in insulin resistant individuals?

Eligibility criteria: Inclusion Criteria:

* Individuals who are insulin resistant based on routine clinical measurements (Stern et al., 2005).

Exclusion Criteria:

* BMI \< 27 kg/m²
* Age \< 25 and \> 65 years
* Pregnant women or women who plan on becoming pregnant during the study
* Postpartum women
* Lactating women
* Diabetes mellitus
* Kidney disease
* Liver disease
* Certain cancers
* Smokers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ARS/USDA/BHNRC
name: David J Baer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04327128: Selfcare MAnagement InteRvenTion in Heart Failure II (SMART HF II)
Official title: Evaluation of a Digital Support and Communication Platform for Heart Failure:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure.

To evaluate whether a digital support and communication platform for heart failure patients after 6 months can provide:

1. Improved self-care
2. Improved quality of life and reduced number of patient-assessed symptoms
3. Reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits


Eligibility criteria: Inclusion Criteria:

* Diagnosed heart failure I.50 (newly discovered or existing) in NYHA Class I-IV in principle with ESC guidelines 2016.

  * Have completed the "consent form" or consent form, see §4.2 Exclusion criteria: \* Patient who refuses to participate in the trial.
  * It is assessed that they can handle the intervention themselves or with the help of personal or relatives.

Exclusion Criteria:

* Patient who declines to participate in the trial.

  * Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
  * Life expectancy \<8 months
  * In other ways, by the treating physician, it is deemed inappropriate to participate in the study, e.g. due to participation in another study.

Primary outcomes:
measure: Self-care behaviour
timeFrame: 6 month
measure: Cardiovascular events and deaths
timeFrame: 12 month
measure: Hospitalization and hospital days
timeFrame: 12 months
measure: Health care visits
timeFrame: 12 months
measure: Patient-reported symptoms
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
state: Skåne
Study officials:
affiliation: Lund University
name: Sofia Gerward, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02085811: Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine
Official title: Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thoracolumbar Spine
Keywords: Kyphoplasty
at a single level
(between T11 and L5)
associated surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone kyphoplasty

Brief summary: The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures.

Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU.

An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination.

The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.


Eligibility criteria: Inclusion Criteria:

* Men or women aged at least 18;
* who underwent Kyphoplasty between T11 and L5,
* Patients who had Kyphoplasty at a single level without associated surgery,
* Magerl type-A fracture.
* Non-tumoral and non-osteoporotic cause.

Exclusion Criteria:

* Compression fracture outside the T11-L5 segment, or fracture other than Magerl type A.
* Osteoporotic vertebral fracture
* Association with other post-traumatic fractures.
* History of Balloon Kyphoplasty, or of thoracic or lumbar spine surgery except simple discectomy.
* Pregnant or breast-feeding women
* Patients not covered by national health insurance

Primary outcomes:
measure: Measure of Spinal kyphosis angle
timeFrame: Between the post-operative period (D1) and a minimum of one year of follow-up
Secondary outcomes:
measure: Evaluation of pain (VAS)
timeFrame: At least 1 year after the kyphoplasty
measure: Number of new vertebral fractures
timeFrame: At least 1 year after the kyphoplasty
measure: Evaluation of quality of life (OSWESTRY and EIFEL)
timeFrame: At least 1 year after the kyphoplasty
measure: Evolution of the regional angle of vertebral kyphosis
timeFrame: At least 1 year after the kyphoplasty
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References:
Clinical trial NCT02929511: Reciprocation vs Rotational Single-file Systems in Postoperative Pain
Official title: Influence of Reciprocating and Rotational Single-file Systems on the Postoperative Pain: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apical Periodontitis
Assessment, Pain
Dental Pulp Necrosis
Lead sponsor: Isparta Military Hospital
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 91
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the researchers will investigate the effect of single-file reciprocating versus single-file rotational file systems on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. The participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (Reciproc Blue) and rotational single-file system (OneShape). As a reference, Mtwo multi-file (full-sequence) will be used.

Detailed description: The infected root canal treatments will be performed using one-visit approach with either a reciprocating single-file system or a continuous rotational single-file system. (Reciproc Blue reciprocating single-file system vs OneShape rotational single-file system). The root canals will be completed in single-visit. The patients will record their postoperative pain during the follow-up period using a VAS scale.

Eligibility criteria: Inclusion Criteria:

* Participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis.

Exclusion Criteria:

* Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.

Primary outcomes:
measure: Pain level
timeFrame: 7 days.
Secondary outcomes:
measure: Analgesic usage
timeFrame: 7 days.
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Askeri Hastane
Study officials:
affiliation: Devlet hastanesi
name: Ibrahim E YAYLALI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01009411: Labor Progress Indices and the Dynamics of the Individual Contraction During the Active Stage of Labor
Official title: Physiological Study of the Active Stage of Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
Collaborators: name: Barnev Ltd
First posted: 2009-11-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nulliparous women over 18 years admitted to the labor in active labor

Brief summary: Objective of the study: to obtain new data on the dynamics of the labor process, cervix dilatation and head station on the labor process and to develop a new progress indices.

Background: the best method used today to supervise the labor process is to follow cervix dilatation and head station. Today, the physician or the midwife use manual examination to estimate cervix dilatation and head station. This examination is perform many times in a normal labor process, and even more if there is any delay. The information from these examinations is inaccurate and non-continuous. In case of delay in the labor process, the delay will diagnosed late, because the frequency of the manual examination is about once an hour.

With the assistance of the BirthTrack device we can get continuous data on the labor process and get indices to estimate the labor process progress without the use of vaginal (manual) examination.

40 women in an active labor will take part in the study.

Method: by connecting sensors to the woman abdomen, to the cervix and to the baby head we follow the cervix dilatation and the fetus head station.


Eligibility criteria: Inclusion Criteria:

1. Nulliparous women 18 years or older admitted to the labor and delivery unit in active labor (3cm dilatation and contractions).
2. Parturients with epidural anesthesia
3. Singleton fetus in vertex presentation
4. Gestational age 37 or more
5. Reassuring fetal heart tracing
6. The woman is able to read and understand the consent form

Exclusion Criteria:

1. Parturients in natural birth without epidural anesthesia
2. Low lying placenta
3. Known or suspected fetal or maternal infection
4. Maternal thrombocytopenia
5. Maternal bleeding disorder
6. Known major fetal malformation
7. Suspected fetal growth restriction
8. Subjects with significant psychiatric history
9. Subjects with indication for immediate delivery
10. Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes

Primary outcomes:
measure: Birth Track measurements versus manual measurements
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Westren Gallilie Hospital
Study officials:
affiliation: Barnev Ltd
name: Prof. Ofer Barnea, Phd.
role: STUDY_CHAIR
affiliation: Barnev Ltd
name: Prof. Ofer Barnea, Phd.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06642311: Bladder Distension for Pain Relief in Patients With Excessive Anteflexion of Uterus Undergoing Office Hysteroscopy
Official title: Bladder Distension for Pain Relief in Patients With Excessive Anteflexion of Uterus Undergoing Office Hysteroscopy: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hysteroscopy
Keywords: Full bladder
Pain
Excessive anteflexion of the uterus
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Bedaya Hospital
First posted: 2024-10-15
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted to assess whether the passive uterine straightening of the uterus by means of bladder filling is associated with less pain experienced by patients with excessive anteflexion of the uterus during office hysteroscopy.


Eligibility criteria: Inclusion Criteria:

* Patients with excessive anteflexion of the uterus

Exclusion Criteria:

* Cervical pathology
* Previous cervical surgery
* Severe vaginal bleeding

Primary outcomes:
measure: Intensity of pain
timeFrame: : Immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Study officials:
affiliation: Cairo University
name: Usama M Fouda, Prof,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fouda UM, Elshaer HS, Elsetohy KA, Youssef MA. Misoprostol versus uterine straightening by bladder distension for pain relief in postmenopausal patients undergoing diagnostic office hysteroscopy: a randomised controlled non-inferiority trial. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:326-30. doi: 10.1016/j.ejogrb.2016.06.024. Epub 2016 Jul 1.
Clinical trial NCT05003011: Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire
Official title: Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodynamic Instability
Lead sponsor: Respirix, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated patients in the ICU

Brief summary: This study is designed as an observational study to collect Cardiospire cardiogenic oscillation signal (COS) and CO output parameters from the Pulmonary Artery Catheter in intubated patients.

Detailed description: Respirix has developed a non-invasive hemodynamic monitoring device called the Cardiospire. The Cardiospire detects minor, cyclic waveforms caused by Cardiogenic Oscillations (COS) and uses features of the COS waveform to provide information about hemodynamics.

This study is designed as an observational study to collect paired readings of the Cardiospire cardiogenic oscillation signal (COS) and the ground truth CO output parameters, including Pulmonary Artery Pressure diastolic (PAPd), systolic (PAPs), Stroke Volume (SV), and Cardiac Output (CO) from the Pulmonary Artery Catheter in intubated patients.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Intubated
* Pulmonary artery catheter
* Patient or patient's legally authorized representative is able to provide informed consent

Exclusion Criteria:

* Subjects who, at the principal investigator's determination, would not be appropriate for this study

Primary outcomes:
measure: Repeatable Data Verification
timeFrame: 3 months
measure: Correlation and Validation of data
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT06087211: Pain Relieving Potentials of Combination of Oral Duloxetine and Intravenous Magnesium Sulphate in Post Mastectomy Pain
Official title: Pain Relieving Potentials of Preoperative Combination of Single Dose Oral Duloxetine and Intravenous Magnesium Sulphate in Acute and Chronic Post Mastectomy Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duloxetine
Magnesium Sulphate
Post-mastectomy Pain Syndrome
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 90
Sex: FEMALE
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: This study aims to evaluate the effect of combined duloxetine and IV Magnesium sulphate to decrease acute and chronic post mastectomy pain.

The study will be conducted in National Cancer Institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general anesthesia in National Cancer Institute, Cairo University.

Detailed description: It has been reported recently that Duloxetine improved the quality of recovery in patients subjected to hysterectomy. In this context, mastectomy has a negative consequence starting from cancer diagnosis to the squeal of cancer-related treatments and it has been estimated that 20%-30% of patients with breast cancer suffer from depression and anxiety. Magnesium also antagonizes the release of inflammatory mediators such as histamine, serotonin, and cytokines in peripheral tissues.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years old.
* American Society of Anesthesiologists (ASA) physical I-II
* Scheduled for modified radical mastectomy (MRM) under general anesthesia.

Exclusion Criteria:

* Liver or kidney disease
* Patient with previous chronic pain on opioids
* Patients on antidepressants and antipsychotics.
* Allergies to study drugs

Primary outcomes:
measure: Time to first analgesic request
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Total morphine consumption
timeFrame: 48 hours postoperatively
measure: Degree of pain
timeFrame: 48 hours postoperatively
measure: Incidence of post-mastectomy pain syndrome
timeFrame: 12 weeks postoperatively
measure: Degree of patient satisfaction
timeFrame: 48 hours postoperatively
measure: Incidence of adverse events
timeFrame: at 8 weeks postoperative and 12 weeks postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National cancer institute
Study officials:
References:
Clinical trial NCT06306911: Bioavailability of Aronia Melanocarpa
Official title: Evaluating Kinetics and Bioavailability of Aronia Melanocarpa Extract in Healthy Young and Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bioavailability
Kinetics
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: BioActor
First posted: 2024-03-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified.


Eligibility criteria: Inclusion Criteria:

* BMI between 18-35 kg/m2
* Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg
* Stable body weight (weight gain or loss \< 3 kg in the past three months)
* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study

Exclusion Criteria:

* Smoking or smoking cessation \< 12 months
* Severe medical conditions, including asthma, kidney failure, auto-inflammatory diseases, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, gastrointestinal disorders such as Crohn's disease, colitis
* Use of dietary supplements or medication affecting the main outcomes of the study (e.g. affecting gut metabolism, blood pressure medication)
* Use of an investigational product within another biomedical intervention trial within the previous month
* Abuse of drugs
* More than 3 alcoholic consumptions per day
* Known pregnancy or lactation
* Known allergy to study product
* Difficult venepuncture

Primary outcomes:
measure: Aronia metabolites in blood
timeFrame: time = 0 hours until t = 48 hours
measure: Aronia metabolites in urine
timeFrame: time = 0 hours until t = 48 hours
Secondary outcomes:
measure: Aronia metabolites in feces
timeFrame: time = 0 hours
measure: length - baseline characteristics
timeFrame: time = 0 hours
measure: weight - baseline characteristics
timeFrame: time = 0 hours
measure: blood pressure (systolic and diastolic) - baseline characteristics
timeFrame: time = 0 hours
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Jogchum Plat, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01945411: Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: Airway Management
Ventilation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 113
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the facial measurements for determining the proper sizes of oropharyngeal airway. Investigators hypothesized that the length between incisors and mandible angle is more appropriate to estimate the size of oropharyngeal airway compared with the length between mouth corner and mandible angle.


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing surgery that requires general anesthesia

Exclusion Criteria:

* anticipated difficult intubation
* patients without teeth or with loose teeth
* cervical spine disease
* upper airway disease
* body mass index over 35 kg/m2
* pregnancy

Primary outcomes:
measure: proper size of oropharyngeal airway
timeFrame: up to 10 minutes after the start of anesthetic induction
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Kim HJ, Kim SH, Min NH, Park WK. Determination of the appropriate sizes of oropharyngeal airways in adults: correlation with external facial measurements: A randomised crossover study. Eur J Anaesthesiol. 2016 Dec;33(12):936-942. doi: 10.1097/EJA.0000000000000439.