louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00993577: Stretching Exercises and Temporomandibular Disorders
Official title: Global Postural Reeducation and Static Stretching Exercises in the Treatment of Myogenic Temporomandibular Disorders. A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Temporomandibular Disorders
Keywords: Stretching
Pain
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2009-10-12
Enrollment: 24
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of global postural reeducation (GPR) with static stretching exercises (SS) in the treatment of women with temporomandibular disorders (TMD).

Physical therapy is of importance in the treatment of myogenic temporomandibular disorders (TMD). Both stretching exercise and global posture reeducation are equally effective in the treatment of TMD.

Detailed description: Purpose: To compare the efficacy of global postural reeducation (GPR) with static stretching exercises (SS) in the treatment of women with temporomandibular disorders (TMD).

Methods: A total of 24 subjects with TMD were randomized into two treatment groups: GPR, where therapy involved muscle global chain stretching, or SS, with conventional static stretching. Eight treatment sessions lasting 40 minutes each (weekly) were performed. Assessments were conducted at baseline, immediately after treatment end, and again two months later. Measurements included pain intensity at the temporomandibular joint, headache, cervicalgia (visual analogue scale - VAS) and teeth clenching. Additionally, electromyographic activity and pain thresholds were measured at the masseter, anterior temporalis, sternocleidomastoid, and upper trapezius muscles. Two-way analysis of variance (ANOVA) with Tukey post-hoc test was used for in-between group comparisons. Significance level was 0.05.

Eligibility criteria: Inclusion Criteria:

* Helkimo index III,
* Myogenic TMD, AND
* Presence of para-functional habits, such as: bruxism, teeth clenching, mouth-breathing and lip biting.

Exclusion Criteria:

* Surgery or trauma in the orofacial region,
* Systemic or degenerative diseases, OR
* Undergoing odontological, psychological, or physical therapy treatments.

Primary outcomes:
measure: Pain
timeFrame: 2
Secondary outcomes:
measure: Quality of life
timeFrame: 2
Other outcomes:
Locations:
city: Rua Cipotânea, 51
country: Brazil
facility: Physicaltherapy, Speech and Ocupational Therapy Department
state: São Paulo
city: São Paulo
country: Brazil
facility: Clinical Hospital of University of São Paulo
Study officials:
References:
Clinical trial NCT00448877: Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia
Official title: Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedures, Operative
Keywords: No specific disease is being studied, few procedures are excluded.
The focus of the study is to rule out the efficacy of the device, so the aim is to include as wide a variety of procedures as possible.
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2007-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether or not a new brain function monitor can distinguish between anesthetized and awake patients. The device implemented utilizes functional near-infrared (fNIR) technology to detect anesthesia depth as well as reaction to stimuli during surgical procedure.

After obtaining consent the device is placed across the forehead of the patient. A baseline signal is obtained prior to induction. The fNIR signal is continuously recorded throughout the procedure. Key events as well as administration of drug are recorded in order to observe changes in the signal trend. Neither the device nor the light emitted is hazardous to the patient - no risks or discomforts are involved.


Eligibility criteria: Inclusion Criteria:

* All patients who will have surgery
* 18-80 years old
* No restrictions on gender, race, or religion

Exclusion Criteria:

* Head and face surgery
* Induced hypotension
* Profound anemia
* Scar/tattoo on forehead
* Prior history of frontal lobe surgery
* Hemoglobinopathies
* Patients not undergoing general anesthesia
* Surgeries in the prone position
* Allergy to adhesive tape

Primary outcomes:
measure: This is a proof of concept study, primary outcome measure includes observation and calculation of causal relationships of oxygenated and de-oxygenated hemoglobin during administration of anesthetic.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Jay Horrow, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01312077: The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement
Official title: Postoperative Analgesia in Total Hip Replacement: a Comparison of the Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic With Intrathecal Morphine.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Total Hip Arthroplasty
Keywords: total hip arthroplasty
total hip replacement
local infiltration analgesia
wound infusion
patients undergoing total hip replacement (total hip arthroplasty)
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 50
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: Total hip replacement is a major surgical procedure usually associated with significant pain in the early postoperative period. In our hospital, total hip replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus opioid in the form of preservative free morphine. The use of 'local infiltration analgesia' as an alternative postoperative analgesic technique has been investigated.In this technique the surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a catheter under direct vision which remains in situ and is used to administer local anaesthetic in the postoperative period until such time as it is removed (when no longer deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48 hours). We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for unilateral total hip replacement
* Consent to spinal anaesthesia
* ASA Grade I to III

Exclusion Criteria:

* Patient refusal
* Mini-Mental Score \< 25
* Allergy to bupivacaine, morphine, paracetamol, diclofenac
* Skin lesions/infection at site of injection
* Uncorrected renal dysfunction
* Coagulation disorders
* chronic pain condition other than hip pain

Primary outcomes:
measure: Quality of analgesia at 24 hours postoperatively as assessed by visual analogue score (VAS) for pain at rest and on movement.
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Opioid consumption in the first 48 hours postoperatively.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: St Mary's Orthopaedic Hospital
Study officials:
affiliation: Cork University Hospital
name: Denise M McCarthy, MB FCARCSI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06028477: Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
Official title: Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as Levodopa and/or deep brain stimulation. Patients will be followed for 14 months.

Detailed description: The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.

Eligibility criteria: Inclusion Criteria:

Ages 18 or older

* Diagnosed with idiopathic Parkinson's Disease
* Fluent in English
* Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit.
* Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures.

Exclusion Criteria:

* Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
* Pregnancy, breast-feeding or wanting to become pregnant
* Physical limitations unrelated to PD that would affect motor ratings
* Has implantation of a medical device
* Sensory abnormalities of the fingertips

Primary outcomes:
measure: Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score
timeFrame: Baseline and month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Vivek P Buch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04040777: Cardiometabolic Risk Factors Registry
Official title: Cardiometabolic Risk Factors Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis
Metabolic Syndrome
Diabetes
Cardiovascular Risk Factor
Cardiovascular Diseases
Obesity
Keywords: Subclinical Atherosclerosis
Metabolic Syndrome
Primary Prevention
Lead sponsor: Austral University, Argentina
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary prevention population. Most of the population are low and moderate cardiovascular risk.

Brief summary: CARFARE (CARDIOMETABOLIC RISK FACTORS REGISTRY) is a registry done in the context of a cardiovascular primary prevention program of the Cardiometabolic Unit Officia of the Cardiology Department of the Austral University Hospital. The structured and sequential evaluation include measurement of anthropometric parameters (body mass index, BMI), laboratory with metabolic profile, baseline electrocardiogram, blood pressure (BP) measurement, arterial stiffness, subclinical atherosclerosis screening in the carotid and ileo-femoral territories using echo-doppler, echocardiogram, and ergometry test.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old.

Exclusion Criteria:

* Previous cardiovascular and/or cerebrovascular event
* stable chronic angina
* advanced chronic kidney disease (Stage IV or V)
* cancer

Primary outcomes:
measure: Incidence of Major Adverse Cardiovascular Events (MACE)
timeFrame: 5 years
measure: Mortality rate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
Study officials:
affiliation: Austral University, Argentina
name: Maximo A Schiavone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austral University, Argentina
name: Sergio Gonzalez, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06508177: CPK Levels After LC and Association With Analgesic Modalities
Official title: Does Postoperative Analgesic Modalities Effect Blood Creatin Phosphokinase Levels After Laparoscopic Cholecystectomy Surgery?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myotoxicity
Keywords: creatine phosphokinase
cholecystectomy
interfascial plane blocks
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent laparoscopic cholecystectomy ASA 1-3. age:18-70

Brief summary: Regional anesthesia and analgesia technics are widely and securely used during general surgery procedures. Interfascial plane blocks are the latest used ones for analgesia. There are studies in literature indicating that bupivacaine cause myotoxicity. The investigators aimed to examine plasma creatine phosphokinase (CPK) levels to see whether myotoxicity occurs or not after fascial plane blocks are applied to patients undergoing laparoscopic cholecystectomy.

Detailed description: During 3 months period all elligible patients undergoing laparoscopic cholecystectomy surgery will be included in the study. Different postoperative analgesic modalities will be used according to the anesthesists experience. During routine blood sample tests plasma creatin phosphokinase (CPK) levels will be tested 3 times of all patients(preoperative, postoperative 6th hour, postoperative 24th hour). Data will be analysed and patients will be grouped according to the analgesic modalities used.

Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* Laparoscopic cholecystectomy
* under General Anesthesia

Exclusion Criteria:

* Morbidly obesity or cachexia
* local anesthetic allergies
* myopathies
* coagulopathies
* Obstructive sleep apne syndrome
* hearth diseases
* liver diseases
* kidney diseases
* thyroid-parathyriod dieseas
* hiperlipidemias using Statins(HMG-CoA reductase inhibitors)
* pregnancy

Primary outcomes:
measure: CPK levels
timeFrame: at postoperative 24th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
affiliation: Samsun University
name: Serkan Tulgar
role: STUDY_CHAIR
References:
citation: Rakhi V, Kaushal S, Singh S. Measurement of bupivacaine induced myotoxicity in interfascial plane blocks: A randomised controlled trial. Indian J Anaesth. 2021 Dec;65(12):886-891. doi: 10.4103/ija.ija_848_21. Epub 2021 Dec 22.
Clinical trial NCT03450577: International Bifurcation Study
Official title: International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Bifurcation Lesion
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2018-03-01
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary bifurcation lesion treated during PCI

Brief summary: The IBS registry is an observational, multi-center, real-world registry of stenting in coronary bifurcation lesions that will collect information on procedures and outcomes from various participating centers.

The aim of this registry is to investigate long-term clinical results and predictors of adverse outcomes after PCI for coronary bifurcation lesions among various participating centers.

Detailed description: Patients with coronary bifurcation lesions, if they meets all the study inclusion criteria and none of the exclusion criteria, after signing the informed consent, they will underwent PCI according to the current standard of care and will be entered in the registry. Follow-up for all subjects will continue for 5 years.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Any type of bifurcation lesion in major epicardial artery

Exclusion Criteria:

* Patient refused informed consent to participate in the registry

Primary outcomes:
measure: Procedural success
timeFrame: 1 day
Secondary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events
timeFrame: 6 months, 1 year, 3 years, 5 years
measure: All cause mortality
timeFrame: 6 months, 1 year, 3 years, 5 years
measure: Death from cardiac causes
timeFrame: 6 months, 1 year, 3 years, 5 years
measure: Myocardial infarction
timeFrame: 6 months, 1 year, 3 years, 5 years
measure: Target vessel revascularization
timeFrame: 6 months, 1 year, 3 years, 5 years
measure: Stent thrombosis
timeFrame: 6 months, 1 year, 3 years, 5 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin National Research Center
state: Novosibirskaya Oblast
Study officials:
affiliation: Meshalkin National Medical Research Center
name: Dmitrii Khelimskii, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02805777: Vent Flow Study of Prototype Nasal CPAP Mask
Official title: Long Term Vent Flow Study of Prototype Nasal CPAP Mask System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 0
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: As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology. This is done by characterizing the mask flow over time and compare the performance between patients who apply 2 different washing procedures to the mask. The study will also subjectively assess breathing comfort and performance of the mask system.


Eligibility criteria: Inclusion Criteria:

* Participants willing to give written informed consent
* Participants who can read and comprehend English
* Participants using APAP for \>6 months
* Participants who are willing to use the mask system for the 3 month duration of the trial.
* Participants who are over 18 years of age
* Participants who currently use a nasal mask system

Exclusion Criteria:

* Participants not willing to give written informed consent
* Participants who cannot read and comprehend English
* Participants using an inappropriate mask system
* Participants on a Bilevel or ASV therapy
* Participants who are pregnant
* Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer lung injury; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection
* Participants or whose bed partner with implantable metallic implants in the head, neck and chest region affected by magmetic fields (Non-ferrous implants may be acceptable)
* Participants that weight \<30 kg
* Participants who are unsuitable to participate in the study in the opinion of the researcher

Primary outcomes:
measure: Changes in vent flow of the mask system, which will be recorded on a flow testing rig (units= LPM). Baseline flow in LPM will be compared to that at the conclusion of the trial.
timeFrame: 12 weeks
Secondary outcomes:
measure: Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed
timeFrame: 12 weeks
measure: Questionnaire to assess the perceived overall performance of the mask by the participant. Questions around comfort will be asked.
timeFrame: 12 weeks
measure: Bioburden quantification by laboratory testing of venting components at end of trial
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: ResMed/The University of New South Wales
name: Klaus Schindhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05906277: Biobanking and New Biomolecular Metrics
Official title: Melanoma 4p: Biobanking and New Biomolecular Metrics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma (Skin)
Liquid Biopsy
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Istituti Fisioterapici Ospitalieri
First posted: 2023-06-15
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The recruiting of two simultaneous cohorts is scheduled. a) patients of illness onset (Cohort 1); b) patients with locoregional disease and/or metastatic designed for systemic therapies (cohort 2).
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this Interventional study aims to apply, in our Institutes, a 4p oncological model i.e. predictive, personalized, of precision and participated (Regina Elena and San Gallicano).

Detailed description: Patients will be recruited with an innovative and systematic scheme: collection and biobanking of biological materials (tissue biopsy, re-biopsy and liquid biopsy) followed by a molecular monitoring thanks to genomic and epigenomic methods. It's an open-ended study. In particular we will try to identify new "actionable" signatures and we will try to insert the patients to innovative clinical trials, thanks to the evaluation of all cases with a Molecular Tumor Board.

The main objectives are:

* Introduce a new methodology to improve and integrate the already existent institutional PDTA
* Evaluate and measure the applicative value
* Establish a biostatistical platform

Eligibility criteria: Inclusion Criteria:

* Melanoma affected patients

Exclusion Criteria:

* No patiens affected by other pathology

Primary outcomes:
measure: Oncology target therapy
timeFrame: 12 months
measure: Oncology target therapy
timeFrame: 12 months
measure: Oncology target therapy
timeFrame: 12 months
measure: Oncology target therapy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRE
Study officials:
References: