louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03456154: Botox vs Occlusal Splint for Masseter Pain
Official title: Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Face
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. For the splint group, a rigid splint will be worn by the patient every night. For the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. Oral health related quality of life, pain, and cervical neck position will be evaluated. Paired t-test and chi-square will be used for statistical analysis.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 70 years old;
* at least 20 teeth in the mouth;
* occlusal stability;
* presenting pain in face muscles.

Exclusion Criteria:

* Angle's Class III
* Kennedy's Class II or I removable partial denture wearer;
* Complete denture wearer;
* Individuals that have taken any anti inflammatory drugs in the last 3 months;
* Individuals with temporomandibular joint disorders.

Primary outcomes:
measure: Masticatory muscle pain
timeFrame: baseline, 3 and 6 months
Secondary outcomes:
measure: Oral health related quality of life
timeFrame: baseline, 3 and 6 months
measure: Cervical Position
timeFrame: baseline, 3 and 6 months
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT04379154: Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by SARS-COV-2 (COVID-19)
Official title: Analysis of Volatile Organic Compounds by Electronic Noses in Hospitalised Patients for an Infection by (SARS-CoV-2): Predictive Interest in Short-term Evolution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study of volatile organic compounds (VOCs) detected in exhaled air is an innovative research area for respiratory diseases. This analysis can be done by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOCs without identifying them. The VOCs in exhaled air in patients hospitalized for COVID-19 infection are analysed in this study, using electronic noses.


Eligibility criteria: Inclusion Criteria:

* Patients infected by SARS-CoV-2 whose medical condition warrants hospitalisation (out of intensive care) for oxygen therapy less or equal to 4 l/min
* Patients must be 18 years of age or older
* Fluent in the French language
* Have signed a consent form
* Being affiliated with healthcare insurance

Exclusion Criteria:

* Pregnant woman
* Patient deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Profiles of volatile organic compounds (VOCs) in exhaled air between 2 health conditions
timeFrame: 1 day
Secondary outcomes:
measure: Profiles of volatile organic compounds (VOCs) in exhaled air on 1 health condition
timeFrame: 2 weeks
measure: Profiles of volatile organic compounds (VOCs) in exhaled air between 2 periods
timeFrame: 4 months
measure: Profiles of volatile organic compounds (VOCs) in exhaled air by mass spectrometry at each visit based on patient evolution status.
timeFrame: 4 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Pneumology unit
name: Hélène Salvator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01425554: Doppler Sonography, MR Venography, Plethysmography for the Diagnosis of CCSVI
Official title: Doppler Sonography, Magnetic Resonance Venography, Air-plethysmography in the Non-invasive Diagnostics of Chronic Cerebrospinal Venous Insufficiency (CCSVI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Cerebrospinal Venous Insufficiency
Keywords: Vascular malformations in the internal jugular veins
Lead sponsor: Euromedic Specialist Clinics, Poland
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is aimed at evaluation of diagnostic value of Doppler sonography, MR venography and air-plethysmography for the assessment of abnormalities in the internal jugular veins, with catheter venography as the reference test.


Eligibility criteria: 1. Patients group

   Inclusion Criteria:
   * confirmed diagnosis of multiple sclerosis

   Exclusion Criteria:
   * coexisting another neurologic pathology (e.g. stroke, Parkinson disease)
   * significant stenosis of carotid or vertebral arteries
   * other significant abnormalities of blood vessels of the upper part of the body
   * tricuspid valve incompetence
   * allergy to iodine contrast dye
   * chronic renal failure
   * pregnancy
   * other severe comorbidities or significant abnormalities in standard lab tests
2. Healthy volunteers.

Inclusion Criteria:

* none

Exclusion Criteria:

* confirmed diagnosis of multiple sclerosis or related pathologies (CIS, NMO)
* coexisting another neurologic pathology (e.g. stroke, Parkinson disease)
* significant stenosis of carotid or vertebral arteries
* other significant abnormalities of blood vessels of the upper part of the body
* tricuspid valve incompetence

Primary outcomes:
measure: Positive and negative predictive value of Doppler sonography, MR venography and air-plethysmography
timeFrame: All non-invasive test are done up to 14 days prior to catheter venography
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Euromedic Specialis Clinics; ul. Rolna 18
Study officials:
References:
Clinical trial NCT04964154: Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs About COVID-19 Testing and Vaccination Study
Official title: Building Resiliency and Vital Equity (BRAVE) Project: Understanding Native Americans' Perceptions/Beliefs About COVID-19 Testing and Vaccination Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19 Virus Infection
Keywords: COVID-19 testing
Lead sponsor: North Carolina Central University
Sponsor class: OTHER
Collaborators: name: Lumbee Tribe of North Carolina
name: University of North Carolina at Pembroke
First posted: 2021-07-15
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive information about testing and vaccination based on zip code.
Primary purpose: SCREENING

Brief summary: The Building Resilience and Vital Equity (BRAVE) project seeks to partner with American Indian tribal communities in North Carolina to establish COVID-19 services and resources for American Indian communities. The goal of this study is to 1) understand the barriers and social implications of COVID19 testing and vaccination among American Indians by designing and implementing culturally sensitive survey tools and intervention materials; 2) Implement BRAVE outreach and testing interventions to increase testing in American Indian communities; 3) analyze data and share back with tribal communities to improve perceptions of COVID-19 testing in the AI community and decrease in vaccine hesitancy.


Eligibility criteria: Inclusion Criteria:

- Self reports as Native American or American Indian

Exclusion Criteria:

* Does not self-report as Native American or American Indian

Primary outcomes:
measure: Increase in COVID-19 testing
timeFrame: 1 month
measure: Increase in COVID-19 vaccination
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Pembroke
country: United States
facility: Lumbee Tribe Tribal Housing Complex
state: North Carolina
Study officials:
affiliation: North Carolina Central University
name: Deepak Kumar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004754: Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension, Pulmonary
Keywords: cardiovascular and respiratory diseases
hypertensive disorder
primary pulmonary hypertension
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Baylor College of Medicine
First posted: 2000-02-25
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion to patients with severe primary pulmonary hypertension for whom no alternative therapy is available.

II. Obtain additional safety information on continuous infusion epoprostenol. III. Obtain additional information on economic resource health consumption.

Detailed description: PROTOCOL OUTLINE: Patients are treated with a chronic continuous infusion of epoprostenol.

The highest tolerated infusion rate is determined for each patient by gradually increasing the rate until the target dose is reached or the patient experiences at least 1 dose-limiting effect.

Patients are subsequently treated with a chronic continuous infusion, beginning at a rate below the highest tolerated rate. Attempts are made to increase the dose to the highest tolerated rate over the first 72 hours.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Severe primary pulmonary hypertension
* Able to prepare and self-administer medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: Adaani E. Frost
role: STUDY_CHAIR
References:
Clinical trial NCT02243254: Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ibuprofen
Remifentanil
Hyperalgesia
Pain, Postoperative
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 120
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: Postoperative hyperalgesia has been reported after intraoperative administration of small or high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the development of opioid-induced hyperalgesia. The aim of this study is to evaluate the preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia


Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for elective pancreaticoduodenectomy

Exclusion Criteria:

* Patients with chronic pain
* Patients with psychiatric disease
* Patients with nonsteroidal antiinflammatory drugs allergy
* Patients with renail dysfunction
* History of drug addiction
* Pregnant patient
* Inability to use a PCA device

Primary outcomes:
measure: cumulative morphine consumption
timeFrame: postoperative 48 hours
Secondary outcomes:
measure: Pain score
timeFrame: postoperative 1, 3, 6,12, 24, 48 hours Pain score
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01781533: Study to Test Software Algorithm for Insulin Therapy and New Glucose Sensor
Official title: An Open, Single-centre, Non-controlled Feasibility Study Using a Software-algorithm Based Insulin Therapy to Control Blood Glucose in Type 1 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 20
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: BASIC_SCIENCE

Brief summary: To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 75 years (both inclusive)
* Informed consent obtained after being advised of the nature of the study
* The subject has Type 1 diabetes (as defined by WHO) for at least 24 months
* The subject's HbA1c \<= 10%
* Body Mass Index (BMI) \<= 35 kg/m2
* The subject is treated with continuous subcutaneous insulin infusion for at least 3 month

Exclusion Criteria:

* Subject is actively enrolled in another clinical trial or took part in a study within 30 days
* Experienced recurrent severe hypoglycaemic unawareness
* Total daily insulin dose \>= 1.4 IU/kg
* Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration
* Allergy against insulin Lispro
* A history of drug or alcohol dependence
* Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator
* Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
* Patient is pregnant, or breast feeding during the period of the study
* Patient donated blood in the last 3 months

Primary outcomes:
measure: the percentage of glucose values obtained every 15 min in predefined glucose ranges
timeFrame: 15 minutes
Secondary outcomes:
measure: Injected insulin dose
timeFrame: 24 hours
measure: Accuracy of the glucose monitoring unit
timeFrame: 24 hours
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Thomas R Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01772433: Olive Oil Phonophoresis and Chronic Low Back
Official title: The Effect of Olive Oil Phonophoresis on Chronic Low Back Pain in Female Athletes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Low Back Pain
Topical Olive Oil
Phonophoresis
Lead sponsor: Ardabil University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Islamic Azad University, Sanandaj
First posted: 2013-01-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to evaluate the effect of olive oil phonophoresis on chronic law back pain in female athletes.

Detailed description: This study will enroll 60 female patients suffering from chronic low back pain. the study will run in single blind mode that only patients will kept unaware of treatment.

The duration of treatment is 10 days. patients will be assigned randomly to olive oil or placebo group. every day, they will take phonophoresis on lower back using phonophoresis gel as placebo or olive oil as treatment for 10 day. the questionnaires will be filled in baseline visit and day 10. any side effect of drugs or technique will be recorded

Eligibility criteria: Inclusion Criteria:

* Young female athletes suffering from low back pain for more than three months

Exclusion Criteria:

* Underlying systematic or visceral disease
* Specific conditions such as neoplasm and fractures, spondylolisthesis
* Previous low back surgery
* Pregnancy

Primary outcomes:
measure: Pain Score
timeFrame: Change from Baseline in McGill Low Back Pain Scale at day 10
Secondary outcomes:
measure: Physical function
timeFrame: Change from Baseline in Phycical Function Scale at Day 10
Other outcomes:
measure: Safety
timeFrame: Day 10
Locations:
city: Ardabil
country: Iran, Islamic Republic of
facility: Clinic of Physiotherpay
Study officials:
affiliation: Department of Pharmacology, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
name: Shahab Bohlooli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01763333: To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1026706 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability of BI 1026706 (Open-label, Randomised, Four-way Cross-over)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-01-08
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706


Eligibility criteria: Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Number of Subjects With Drug Related Adverse Events
timeFrame: From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
Secondary outcomes:
measure: Cmax
timeFrame: -2.0 hours (h) before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
measure: Tmax (Time From Dosing to Maximum Measured Concentration)
timeFrame: -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
measure: AUC0-inf
timeFrame: -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
measure: AUC0- tz
timeFrame: -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
measure: t1/2 (Terminal Half-life of the Analyte in Plasma)
timeFrame: -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
measure: f t1-t2 (SRD-Part)
timeFrame: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 1320.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04390633: Perception of Needs of Patients With Chronic Intestinal Failure and Their Practitioners: a Qualitative Study
Official title: Qualitative Assessment of the Needs and Knowledge of Patients With Chronic Intestinal Failure of Their Disease as Well as Those of Their Practitioners
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Intestinal Failure
Small Intestine Disease
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Société Francophone Nutrition Clinique et Métabolisme
First posted: 2020-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women aged 18 and over, fulfilling the conditions of major Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"

Brief summary: The SBS NEEDS Study is a qualitative transversal study aiming to describe and understand the needs and knowledge of patients with Chronic Intestinal Failure as well as the representations of their practitioners

Chronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth. CIF is the rarest organ failure. Home parenteral nutrition (HPN) is the primary treatment for CIF.

Semi-structured interviews will be conducted with patients in two nutrition unit and specialized in the small bowel diseases in two French region. 20 situations will be included.

After analysing the data of the individual interviews, focus groups will be conducted with health professionals from an accredited home parenteral nutrition department.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 and over
* With Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"
* medical follow-up in one of the two nutrition departments of the study
* Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study.

Exclusion Criteria:

* Persons with proven and significant cognitive impairment preventing the completion of semi-structured interviews
* Person who does not speak French easily
* Generally, any person unlikely to cooperate in the study
* Adults under guardianship

Primary outcomes:
measure: 20 semi-structured interviews
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: