louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03905304: Efficacy and Safety of MEDITOXIN® in Cervical Dystonia
Official title: A Prospective, Randomized, Multi-center, Phase III, Double-Blind, Activi Controlled, Parallel-group Study to Evaliate the Efficacy and Safety of MEDITOXIN® Comparison With BOTOX® in Treatment of Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Dystonia
Keywords: CD phase III
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-04-05
Enrollment: 152
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.

Detailed description: The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200\~300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.

Eligibility criteria: Inclusion Criteria:

* Men and women aged between 20 and 75.
* Patient who is diagnosed with primary cervical dystonia over 1 year.
* Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS.
* For patients with prior treatments of Botox®, over 12 weeks have passed.
* Patients who voluntarily sign the informed consent
* Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

* Patient who has been diagnosed with pure anterocollis.
* Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\\
* Severe respiratory function disorder or dysphasia
* Allergy in Investigational Product.
* Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method
* Investigator's decision.

Primary outcomes:
measure: Change in TWSTRS score
timeFrame: 1 month
Secondary outcomes:
measure: Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial
timeFrame: 1, 2, 3 months
measure: Change in TWSTRS score
timeFrame: 1, 2, 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05882604: MESNA Injection for TMJ Internal Derangement
Official title: Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Disorder
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pathogenesis of temporomandibular disorders focusing on the biochemistry of the synovial fluid in various stages of temporomandibular joint disease. The role of inflammation has been investigated and proposed as an underlying mechanism of pain and dysfunction of temporomandibular joint. MESNA (sodium 2-mercaptoethanesulfonate) was approved several years ago and marketed in several formulations as a mucolytic agent in the respiratory field, since it breaks the disulfide bonds between polypeptide chains of mucus. The tissue distribution of MESNA is negligible, and the elimination of the substance is rapidly and completely achieved by kidney


Eligibility criteria: Inclusion Criteria:

* patients with TMJ internal derangement with reduction

Exclusion Criteria:

* inflammatory or connective tissue disease
* autoimmune disease history
* neurologic problems

Primary outcomes:
measure: maximal interincisal opening (MIO)
timeFrame: 6 months
Secondary outcomes:
measure: Joint pain
timeFrame: 6 months
measure: clicking sound
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References:
Clinical trial NCT04169204: Very Old Intensive Care Patients - Perfusion
Official title: Very Old Intensive Care Patients - Perfusion (VIPPER)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Microcirculation
Intensive Care
Very Old Intensive Care Patients
Keywords: Microcirculation
Intensive Care
Critical care
shock
Very Old Intensive Care Patients
risk stratification
SDF-measurement
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 47
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very Old Intensive Care Patients with shock

Brief summary: Shock is a frequent, etiologically heterogeneous and often lethal clinical condition of intensive care medicine. This is particularly true for very old intensive care patients (VIPs), who are among the fastest-growing subgroups of all intensive care unit (ICU) patients and who suffer from a significantly impaired outcome. In addition to the treatment of the causes of shock, current therapeutic approaches focus on the stabilization of vital parameters, which in general all reflect macrocirculatory measured values such as blood pressure. In contrast, a disturbance of the microcirculation (blood circulation of the smaller blood vessels \<100 µm) is only poorly measurable and delayed. The last generation of AVA-Software (MicroVisionMedical) will calculate different parameters about the capillary densitiv and perfusion in a user-independent way. VIPPER investigates whether a non-invasive measurement of microcirculation using the sublingual mucosa in very old intensive care patients in shock leads to faster recognition and specific treatment of organ dysfunctions. Secondly, this study checks whether this measurement predicts outcome.


Eligibility criteria: Inclusion Criteria:

* ≥ 80 years
* Acute ICU admission
* Shock at the time point of admission to the ICU or in the first 3 hours defined as Lactate ≥ 2 mmol/l AND need for vasoactive substances to maintain a MAP ≥ 65 mmHg in the presence of adequate volume status

Exclusion Criteria:

* \< 80 years
* Inaccessibility for sublingual measurement
* no informed consent

Primary outcomes:
measure: bedside measurement of sublingual microcirculation
timeFrame: admission of the intensive care unit
measure: bedside measurement of sublingual microcirculation
timeFrame: after 24 hours
Secondary outcomes:
measure: Mortality
timeFrame: after 30 days, 6 months and 12 months
measure: Length of stay at ICU
timeFrame: tdays from admission of the intensive care unit until discharge
measure: Use of Vasopressors and fluids
timeFrame: days from admission of the intensive care unit until discharge
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
References:
Clinical trial NCT06653504: The Conus Brugada Syndrome Study
Official title: The CONUS-BRS STUDY: An Observational, Analytical, Cross Sectional Study Investigating the Effects of Conus Branch and Right Ventricular (RV) Branch Occlusion on Surface ECG and Intra-cardiac Electrograms in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brugada Syndrome
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients aged at least 18 years who have a chronic total occlusion of the RCA with no significant anterior ST elevation prior to an elective CTO procedure.
2. A Conus branch and or RV branch present to deploy an anchor balloon.

Brief summary: An observational, analytical, cross sectional study investigating the effects of Conus branch and Right Ventricular (RV) Branch occlusion on surface ECG and intra-cardiac electrograms in patients undergoing percutaneous coronary intervention (PCI).


Eligibility criteria: Inclusion Criteria:

* Aged 18-85
* Patients able and willing to give their written informed consent.
* Planned PCI of a CTO of a right coronary artery
* Planned use of an anchor balloon in the Conus branch or RV branch

Exclusion Criteria:

* Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures).
* Patients with a pre-existing, confirmed or possible diagnosis of Brugada Syndrome
* Marked ST elevation or J point elevation on baseline (prior to procedure) ECG in the precordial leads (V1-V3)
* Pregnancy. This will be tested by urine HcG measurement

Primary outcomes:
measure: ECG and/or electrogram changes
timeFrame: During Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
affiliation: Barts & The London NHS Trust
name: Pier Lambiase, PhD FRCP FHRS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06124404: Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
Official title: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mechanically Ventilated Patients
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Yichang Humanwell Pharmaceutical Co., Ltd., China
First posted: 2023-11-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18 and ≤ 30 kg/m2
* Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a ventilator for at least 6 hours
* Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)

Exclusion Criteria:

* Refusal to be included
* Allergy or unsuitability to any composition of study drugs or remifentanil
* Living expectancy less than 48 hours
* Myasthenia gravis
* Status asthmaticus
* Abdominal compartment syndrome
* Serious hepatic dysfunction (CTP 10-15);
* Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2
* Mean blood pressure less than 65 mm Hg or the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
* Possible requirement for surgery or bedside tracheostomy in 24 hours
* Possible requirement for renal replacement therapy in 24 hours
* Acute severe neurological disorder and any other condition interfering with sedation assessment
* Abuse of controlled substances or alcohol
* Pregnancy or lactation

Primary outcomes:
measure: The percentage of time in the target sedation range without rescue sedation
timeFrame: Within 24 hours while receiving the study drug
Secondary outcomes:
measure: The number and severity of treatment emergent adverse events (TEAEs)
timeFrame: Within 48 hours after the stop of the study drug
Other outcomes:
measure: Cmax
timeFrame: Within 24 hours while receiving the study drug
measure: The area under the plasma drug concentration-time curve
timeFrame: Within 24 hours while receiving the study drug
measure: t1/2
timeFrame: Within 24 hours while receiving the study drug
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT05482204: Do Sustainability Labels Lead to More Sustainable and Healthier Food Choices?
Official title: Do Sustainability Labels Lead to More Sustainable and Healthier Food Choices?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Attitude
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Time-sharing Experiments for the Social Sciences
First posted: 2022-08-01
Enrollment: 5055
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study tests the effect of two climate change menu labels, one indicating 'low climate impact' and the other indicating 'high climate impact' on ordering choices and perceptions of healthfulness of food ordered in an online randomized experiment.

Detailed description: The objective of this study is to examine how climate impact menu labels influence US adults' ordering and perceptions via an online randomized experiment. Participants were randomized to view one of 3 fast food menus online and then choose an item that they would like to order. One menu 'control' had QR code labels, the second had "low climate impact" labels on items with lower greenhouse gas emissions (vegetarian, chicken or fish items), the third had "high climate impact" labels on beef items. After the ordering task participants answered questions about what label they saw on the menu, how healthy they thought the item they ordered was, and how much the label discouraged them from eating high climate impact items.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Member of the National Opinion Research Center (NORC) Amerispeak Panel

Exclusion Criteria:

* \<18 years of age
* completed the survey in \< 1/3 of the median duration
* skipped or refused more than 50% of the survey questions

Primary outcomes:
measure: Sustainable vs. unsustainable selection from the menu
timeFrame: 1 minute
Secondary outcomes:
measure: Perceptions of healthfulness
timeFrame: < 1 minute
measure: Perceived Message Effectiveness (PME)
timeFrame: <1 minute
measure: Nutrition Profile Index of ordered item
timeFrame: < 1 minute
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Julia A Wolfson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05122104: Evaluation of Sarcopenia-Related Malnutrition in Older Adults
Official title: Evaluation of Sarcopenia-Related Malnutrition in Older Adults According to GLIM (Global
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Malnutrition
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
Collaborators: name: Umraniye Education and Research Hospital
First posted: 2021-11-16
Enrollment: 590
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community dwelling older adults

Brief summary: Sarcopenia and malnutrition are two geriatric syndromes that are frequently seen in the elderly and have multifactorial etiology and severe clinical effects. However, the results vary widely due to the many methods and criteria used in the diagnosis and prevalence rates of both syndromes. In this study, it is aimed to investigate the relationship between the GLIM (Global Leadership Initiative on Malnutrition) criteria and various sarcopenia levels, which are newly defined worldwide and have the widest spectrum so far in describing malnutrition.


Eligibility criteria: Inclusion Criteria:

* To get a score of 21 and above in the Mini-Mental State Examination
* To be able to walk independently or with the help of a device (cane, etc.)

Exclusion Criteria:

* Individuals with a serious orthopedic (advanced hip or knee arthrosis, etc.) or neurologic conditions that may affect ambulation

Primary outcomes:
measure: Malnutrition diagnosis according to GLIM criteria
timeFrame: 30 minutes
Secondary outcomes:
measure: Sarcopenia diagnosis according to the European Working Group on Sarcopenia in Older People (EWGSOP)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ümraniye Training and research hospital
Study officials:
References:
Clinical trial NCT01890304: Longitudinal Study of Traumatic Brain Injury (TBI) in (University of Florida) UF Athletes
Official title: Diffusion Tensor Imaging (DTI) Compared to Serum Biomarkers and Standard Clinical Measures of Concussion in Female and Male Collegiate Athletes: a Longitudinal Survey Across the College Years.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
TBI
Concussion
Sports related injury
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To identify the changes in the brain following repeated sports-related concussion in men's football, women's soccer, and women's lacrosse college athletes by reviewing the findings of MRI studies that look at the structure of the brain and the appearance of the white matter at baseline, during the acute phase of a concussive injury, and upon completion of collegiate athletic play and correlate these findings with standard clinical measures.

Detailed description: This proposal seeks to study Diffusion Tensor Imaging and functional MRI of the brain at 1) baseline, 2) after concussion and 3) at the end of an athlete's college career. Findings will be compared to standard clinical measures already performed in the management of concussion at the University of Florida Athletic Association and to serum biomarkers already being obtained as part of a UF/ Banyan Biomarker Study. As in the biomarker study, UF athletes on teams with higher incidences of sports related concussion; men's football, women's soccer, and women's lacrosse will be offered enrollment.

Longitudinal examinations will allow identification and quantification of concussive DTI findings as comparisons can be made to the individual athlete's baseline data. This will provide valuable correlation of imaging findings with severity of clinical symptoms at the time of injury and also with timing of return to play.

Eligibility criteria: Inclusion Criteria:

* Currently enrolled and active UF student athlete in Mens Football, Womens Soccer, or Womens Lacrosse.
* Age 18-30

Exclusion Criteria:

* Contraindications to MRI, such as retained metal
* Pregnancy

Primary outcomes:
measure: Fractional Anisotropy (FA)
timeFrame: Change in baseline up to 5 years.
Secondary outcomes:
measure: Neuropsychometric testing
timeFrame: Change in baseline up to 5 years.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
Study officials:
affiliation: Associate Professor of Radiology
name: Keith R Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04127604: Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
Official title: Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Substance Use Disorders
Keywords: Bipolar Disorder
Substance Use Disorders
Treatment Adherence
Veterans
Psychosocial intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Providence VA Medical Center
First posted: 2019-10-15
Enrollment: 140
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: This trial aims to evaluate the effectiveness of a novel intervention for Veterans with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.

Detailed description: This randomized controlled trial will evaluate the effectiveness of a psychosocial intervention designed to improve treatment adherence in Veterans with comorbid bipolar disorder and substance use disorders (BP-SUD) following a psychiatric hospitalization. Participants will be randomized to either the specialized psychosocial intervention or an enhanced safety monitoring program, both as adjuncts to VA treatment as usual. Veterans with BP-SUD will be recruited from the Providence VAMC inpatient psychiatric unit and assessed at baseline and at 3 (mid-treatment), 6 (post-treatment), and 9-month post-discharge.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a mood disorder
* Diagnosis of a substance use disorder (drug and/or alcohol)
* Taking at least one psychiatric medication

Exclusion Criteria:

* Unable to speak and read English
* Younger than age 18

Primary outcomes:
measure: Brief Adherence Rating Scale (BARS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: Jane Metrik, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence VA Medical Center, Providence, RI
name: Brandon A Gaudiano, PhD
role: PRINCIPAL_INVESTIGATOR
References: