louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01923623: The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.
Official title: The Effect of Combined Popliteal and Saphenous Block in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Ankle Fracture in Need of Surgical Fixation
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical, randomized, and controlled study will provide valuable scientific evidence regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle surgery. In particular, the investigators want to determine if the need for postoperative opioids will be reduced and whether this will lead to shorter admission to recovery room and fewer instances of side effects such as postoperative nausea and vomiting. In addition, the investigators will determine whether the functional outcome is improved i.e. faster and more successful rehabilitation. This would have profound benefits not only to the individual patient but also to society by reducing expenses during admission, the cost of sick leave etc.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Patients in need of anaesthesia for operative fixation of ankle fractures.
* American Society of Anesthesiologists (ASA) score 1-3.
* BMI \> 18 og \< 35.
* Oral and written consent

Exclusion Criteria:

* Weight \< 50kg
* Allergy towards drugs used in the study
* Patients for re-operation
* Other fracture at the same time
* Pregnancy
* Daily use of opioids within two weeks before operation
* Infection near the application site
* Patients in need of dialysis
* Patients with neuropathy in lower extremities

Primary outcomes:
measure: Use of Morphine
timeFrame: 24 hours
Secondary outcomes:
measure: Functional rehabilitation outcome
timeFrame: 10-14 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Herlev Hospital
name: Rune Sort, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev Hospital
name: Ann M. Møller, Dr.med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04328623: Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand
Official title: Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ultrasound-guided infiltration is a common procedure and is known to be locally painful. This care-induced pain leads to strong apprehension in patients who need to benefit from this procedure.

The practice of hypnosis to improve the patient's comfort during a treatment has appeared progressively in hospital departments.

Among the various existing conversational hypnosis techniques, there is the "magic glove" technique. This is the technique that will be used in this study.

The investigators wish to evaluate the interest of hypnosis on the pain felt by the patient when performing an echo-guided infiltration of the hand, one of the most painful extremities during infiltrations.


Eligibility criteria: Inclusion Criteria:

* Patient with an indication of a first hand infiltration under ultrasound examination
* Major patient
* Patient with capacity to understand the protocol and has given oral consent to participate in the research,
* Patient with social security coverage.

Exclusion Criteria:

* Patient having preventively applied a pain patch to the area to be infiltrated
* Contraindication to infiltrations ( imbalanced diabetes, imbalanced,hypertension, ongoing infections).
* Hearing impaired patient
* Patient under guardianship/curtel
* Minor
* Pregnant woman
* Patient participating in another intervention research protocol
* Patient unable to follow the protocol as judged by the investigator.

Primary outcomes:
measure: Evaluate the Pain Felt in Patients Who Have Benefited From a Hypnosis Session Before a Hand Infiltration Versus Hand Infiltration Without Hypnosis
timeFrame: 5 minutes after ultrasound-guided infiltration of hand
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
Study officials:
affiliation: CHD Vendée
name: Adeline Trojet-Bossard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03162523: Experiences With HDR-brachytherapy in Norway
Official title: Norwegian Experiences With Interstitial Radiation Treatment (Brachytherapy) for Men With High-risk Localised Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2017-05-22
Enrollment: 325
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men are included from the south-east area of Norway and for control Groups from the entire country so that the study population is generalised.

Brief summary: There are 3 articles that will be written about the experience with HDR-brachytherapy (HDR-BT) in patients with high-risk prostate cancer in Norway as part of a doctorial thesis-project. The project will focus on survival, side-effects and dosimetry variables as the main points of interest.

Detailed description: First article will compare overall and prostate cancer specific-mortality in patients who has received HDR-BT compared to patients who has received external beam radiation therapy only (EBRT). Patients who have been treated with HDR-BT have been enrolled in an approved registry at Oslo University Hospital since 2004. The control group (EBRT only) data are from the Lancet published hallmark study SPCG-7 (Scandinavian Prostate Cancer Group). This is a case-control study.

Second article will focus on side-effects of HDR-BT compared to EBRT patients. Patients included in the registry described above have been sent (and completed with a 72% answer rate) a questionnaire of the standard Expanded Prostate Cancer Index (EPIC-26) form. This will be compared to patients who already have answered the same questionnaire in a previously published study (approved by the Norwegian Ethical Committee).

The Third article will investigate if there are any association between patients reporting severe adverse effects after HDR-BT and the patients dosimetry reports (i.e are there a larger dose to the urethra or rectum in these patients?)

Eligibility criteria: Inclusion Criteria:

* age, high-risk prostate cancer, general good Health, anatomical favourable condition for brachytherapy

Exclusion Criteria:

* poor Health, metastasis, T3b stage tumour, Prostate Specific Antigen (PSA) Levels \> 75, biological age \> 75 years

Primary outcomes:
measure: Overall- and Prostate-Cancer specific mortality in patients treated with HDR-BT compared to EBRT alone
timeFrame: 24 weeks
measure: Patient-reported side-effects after HDR-BT compared to conventional EBRT
timeFrame: 1 year
measure: Are there an Association between rectal dosage after HDR-BT and self-reported rectal bother in patients undergone HDR-BT treatment ?
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Trude Wedde, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06053723: Bruxism and Severity of Temporomandibular Dsyfunction
Official title: The Effect of Bruxism on Masticatory Functionality and Severity of Temporomandibular Dsyfunction: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Dysfunction
Keywords: temporomandibular dysfunction
bruxism
chewing functionality
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: diagnosed with TMD

Brief summary: The aim of the study was to investigate the effect of bruxism on Temporomanbular joint functionality and dysfunction severity in individuals with Temporomandibular Dysfunction (TMD).

Detailed description: The study included 91 individuals aged 20-55 years with TMD. Participants who volunteered to participate in the study signed the Informed Consent Form and completed the Descriptive Data Form including demographic characteristics. The presence of bruxism in individuals with TMD was questioned and the maximum mouth opening measurement was recorded. TMD severity was assessed by Fonseca's Anamnestic Questionnaire (FAQ), pain severity was assessed by Numeric Pain Scale (NPS), and masticatory and TMJ functioning was assessed by JAW Functional Limitation Scale-20 (JFLS-20). The evaluations of the participants were performed only once.

Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 55 years,
* Diagnosed with TMD,
* volunteer to participate in the study

Exclusion Criteria:

* having a non-reduced disc problem,
* surgical operation due to spine, abdomen and/or TMJ problem,
* trauma, cancer, neurological problems, congenital anomalies, musculoskeletal system problems,
* systemic disease,
* facial paralysis
* Less than 6 months of receiving any treatment related to the spine and TMJ

Primary outcomes:
measure: Bruxism evaluation
timeFrame: April 2023- September 2023
measure: Maximum mouth opening
timeFrame: April 2023- September 2023
measure: Severity of Temporomandibular dysfunction
timeFrame: April 2023- September 2023
measure: Pain intensity
timeFrame: April 2023- September 2023
measure: Jaw Functionality
timeFrame: April 2023- September 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Bandirma Onyedi Eylul University
Study officials:
References:
Clinical trial NCT05067023: Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging
Official title: Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Nodules
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of dynamic contrast-enhanced MR imaging (DCE-MRI) to discriminate of malignant from benign lesions.

Detailed description: Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of DCE-MRI to discriminate of malignant from benign lesions.In this study, the investigators are going to validate the efficacy of the DCE-MRI for diagnosing early lung cancer by comparing results of the pre-surgery MRI imaging with the post-surgery pathology.

Eligibility criteria: Inclusion Criteria:

* Ground-glass pulmonary nodules found by CT scan
* Plan to accept surgery or puncture due to the pulmonary nodules
* Absence of treatment such as chemotherapy or radiotherapy and biopsy
* Adequate renal function to tolerate intravenous gadolinium
* Agree to sign informed consent
* Able to lie still during DCE-MRI

Exclusion Criteria:

* Fail to understand or agree to sign informed consent
* Implanted pacemaker or cardiac defibrillator
* Contraindications to undergoing MRI
* Uncontrolled intercurrent illness
* Pregnant or breastfeeding

Primary outcomes:
measure: Volume transfer constant (Ktrans)
timeFrame: 12 months
measure: the fractional volume of extravascular extracellular space of the target tissue (ve)
timeFrame: 12 months
measure: the rate constant (kep)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02950623: Microbiological Study on Maxillary Complete Dentures of Two Different Materials
Official title: Microbiological Comparative Study Between Single Maxillary Denture Fabricated From Rapid Heat Cured Resin and Conventional Acrylic Resin Modified by Titanium Dioxide Nanoparticles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Denture Stomatitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Cross over design the investigator divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticles and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from dentures to count the anaerobic bacteria.

Detailed description: First the investigator will take primary impression, and pour it obtain primary cast, then will fabricate special tray an take secondary impression and obtain master cast after that duplication of master cast will be done the investigator will make cross over design.and divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticle and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticle AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from the different dentures to count the anaerobic bacteria by (CFU).

Eligibility criteria: Inclusion Criteria:

1. Completely edentulous maxillary arch and partially dentate mandibular arch with adequate interarch space.
2. The edentulous ridges should be covered by firm healthy mucosa. 3-Angle class I maxillomandibular relation. 4-Healthy and cooperative patient

Exclusion Criteria:

1. Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
2. Previous history of radiotherapy or chemotherapy.
3. Any skeletal problem dictates surgical intervention

Primary outcomes:
measure: Microbiological investigation: Count of anaerobic bacteria on the fitting surface of denture by (CFU) unit
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04235023: PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea
Official title: PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Inflammation
Atherosclerosis
Keywords: PTP1B
macrophage
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-01-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients with OSA 'apnea hypopnea index ≥ 15 per hour) as compared to controls (an apnea hypopnea index \< 15 per hour)
Primary purpose: OTHER

Brief summary: Obstructive sleep apnea (OSA) syndrome is associated with increased vascular dysfunction and atherosclerosis. Especially, it has been shown that OSA associated intermittent hypoxia represents a pro inflammatory stimulus resulting in macrophage polarization.

Protein tyrosine phosphatase 1B (PTP1B) is a negative regulator of insulin signaling pathways involved in atherosclerosis. It has been shown that myeloid PTP1B deficiency protects against atherosclerosis.

As hypoxia has also been shown to increase PTP1B expression and activity, this study will evaluate the myeloid PTP1B expression and activity in patients with OSA as compared to controls and will investigate myeloid PTP1B involvement in the vascular pro inflammatory precess described in OSA.


Eligibility criteria: Inclusion Criteria:

* Overnight polysomnographic recording for suspected OSA
* Apnea hypopnea index ≥ 15 per hour for OSA patients
* Apnea hypopnea index \< 15 per hour for non OSA patients

Exclusion Criteria:

* past history of cardiovascular diseases
* diabetes
* dyslipidemia
* hypertension
* obesity (body mass index \> 35 kg/m2
* past history or ongoing inflammatory diseases
* cognition impairment

Primary outcomes:
measure: myeloid PTP1B expression
timeFrame: baseline
measure: myeloid PTP1B activity
timeFrame: baseline
Secondary outcomes:
measure: PTP1B exosomal expression.
timeFrame: baseline
measure: in vitro PTP1B implication on macrophage inflammatory response
timeFrame: baseline
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
affiliation: Angers University Hospital
name: Wojciech Trzepizur, MD Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01892423: Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion
Official title: Daily Advance Cetaphil Moisturizing Lotion: Human Repeat Insult Patch Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Irritation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-07-04
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Good health
* willingness to cooperate and participate
* willingness to avoid topical products at test sites
* willingness to avoid direct sun exposure to test sites

Exclusion Criteria:

* Individuals with active psoriasis or eczema
* individuals with sunburn, acne, abrasions, scar tissue, or tattoos on test sites, or disease of skin that might interfere
* individuals who have had a mastectomy with axillary nodes were removed
* individuals receiving anticancer, immunosuppressive treatments or medications, or radiation
* pregnant, nursing, or planned to become pregnant
* use of topical steroids or drugs at test sites
* active or untreated skin cancer
* active hepatitis
* current routine or frequent use of high doses of anti-inflammatory drugs
* individuals who have had les than two week rest period since completion of previous patch testing on upper back or upper arms
* individuals with uncontrolled metabolic diseases

Primary outcomes:
measure: Irritation responses
timeFrame: average of 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Carrollton
country: United States
facility: Thomas J Stephens and Associates Inc
state: Texas
Study officials:
name: James H Herndon, MD, FAAD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05693623: The Effect of Cold Application to the Sacral Area on Labor Comfort:
Official title: The Effect of Cold Application to the Sacral Area in the Transition Phase of Labor on Labor Comfort:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Birth
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: Cold application is considered as an effective alternative treatment for labor comfort because of its low side effects and easy availability. This study aims to determine the effect of cold application to the sacral area in the transition phase of labor on labor comfort.

Materials and methods: The study was done as a randomised controlled experimental study. While the women in the experimental group received cold application for 10 minutes every 20 minutes after 8 cm of cervical dilatation, the women in control group received routine care protocol of the unit.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were having a full-term pregnancy (pregnancies between 37th and 42nd weeks),
* having a single fetus, having a cephalic presentation,
* fetal weight of 2,5- 4 kg,
* pregnant women's having normal body mass index and receiving no antenatal trainings,
* having an 8 cm cervical dilation.

Exclusion Criteria:

* The women who had any kind of pregnancy complications (placenta previa, preeclampsia,
* premature rupture of membranes, oligohydramnios and polyhydramnios, presentation disorder,
* intrauterine growth retardation, intrauterine dead fetus,
* macrosomia babies, fetal distress, etc.),
* who had any systemic or neurologic diseases
* contraction anomalies (hypotonic or hypertonic contractions),
* who had induced labor,
* who received narcotic analgesics,
* who had occiput posterior,
* who were in the latent and active phases of labor,
* who had irregular contractions were excluded from the study

Primary outcomes:
measure: Cold Application to the Sacral Area on Labor Comfort
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: