louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03543280: Evaluation of the Value of Cerebral Perfusion Scintigraphy in the Study of Post-stroke Fatigability
Official title: Evaluation of the Value of Cerebral Perfusion Scintigraphy in the Study of Post-stroke Fatigability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fatigability Post Stroke
Keywords: fatigability post stroke
post stroke
high-speed CT
MRI
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with transient ischemic attack, stroke, dissection, TVC

Brief summary: At present there is no consensus for post-stroke imaging except for the realization of early cerebral CT at 24 hours post-thrombolysis. The use of cerebral perfusion scintigraphy would predict the course of a stroke. Indeed, it has been shown that a good perfusion is linked to a good evolution of the neurological deficit. This test is used routinely to evaluate cerebral perfusion in patients with stroke. This technique was also used to study the mechanisms of post-stroke aphasia and to highlight neuronal disconnections after stroke, a reflection of the functioning of neural networks.

Neuropsychological tests are almost always done at 3 months. Fatigue is studied: PSF scale at 3 months, 6 months and 2 years. Research needs to be continued in this area because the pathophysiology remains unknown and the symptoms are disabling for patients. Using cerebral perfusion imaging would bring elements of understanding of this mechanism and ultimately improve the management of patients.


Eligibility criteria: Inclusion Criteria:

* Patients: 18 to 60 years old at the initial diagnosis
* Admission for transient ischemic attack, stroke, dissection, TVC
* RANKIN less than or equal to 2
* Neuropsychological tests at +3 months: MoCA\> 26 (to eliminate cognitive deteriorations too important for the good realization of the battery)
* Absence of psychiatric history
* Absence of psychotropic medication
* No history of stroke
* No complaint of pre-stroke fatigue
* Having signed the consent form

Exclusion Criteria:

* Impossibility of giving the subject or his family enlightened information (subject in emergency situation, difficulties in understanding the subject, etc.)
* Subject under the protection of justice
* Subject under guardianship or curatorship
* Refusal of the patient to participate in the study

Primary outcomes:
measure: Evaluate fatigue symptoms in stroke patients
timeFrame: After the period following a stroke: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Biophysique et de Médecine Nucléaire
Study officials:
References:
Clinical trial NCT04901780: Pragmatic Posterior Capsular Stretch
Official title: Shoulder Stertching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement
Shoulder Pain
Adhesive Capsulitis
Rotator Cuff Tears
Posterior Capsule Tear
Glenohumeral Subluxation
Glenohumeral Dysplasia
Acromioclavicular; Sprain (Strain)
Internal Rotation Contracture-shoulder
External Rotation Contracture-Shoulder
Flexion Contracture
Extension Contracture-Shoulder
Lead sponsor: Helping Hand Institute of Rehabilitation Sciences
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Various stretches are used to lengthen the posterior shoulder capsule. No study has reported the comparison of the pragmatic posterior capsular stretch and cross body stertch

Detailed description: Background: Posterior capsular tightness (PCT) is a problem frequently seen in shoulder disorder. PCT leads to variation in scapular and humeral kinematics. Two techniques considered in our study for regaining normal range of motion at shoulder joint and improving PCT, one is the pragmatic posterior capsular stretch (PPCS) \& the other one is cross body stretch (CBS) Objective: The aim of our study id to compare the short term effect of PPCS versus CBS on range of motion on shoulder joint in healthy individuals. And to evaluate the feedback of subjects regarding both the interventions.

Methodology: Through RCT 30 asymptomatic subjects (15 males, 15 females) . A simple random sampling technique was used. Subjects were screen through a functional movement screening tool. The change in hand behind neck and hand behind back will be measured through measuring tape. Shoulder ROM and functional movements for both the stretches will be campared

Results:

Eligibility criteria: Inclusion Criteria:

* Age groups of males and females including 20-35 years
* Subjects who fall in grade 1 and 2 of functional movement screening of shoulder during the screening process.

Exclusion Criteria:

* Individual with shoulder pain, fracture or dislocation less than 1 year
* Individuals with any known shoulder pathology
* Subjects receiving current physiotherapy treatment
* Subjects having enough range of motion( can reach T2 hand behind neck)

Primary outcomes:
measure: shoulder flexion
timeFrame: 4 week
measure: shoulder abduction
timeFrame: 4 week
measure: shoulder internal rotation
timeFrame: 4 week
measure: shoulder external rotation
timeFrame: 4 week
measure: hand behind neck
timeFrame: 4 week
measure: hand behind back
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Mansehra
country: Pakistan
facility: Helping Hand Institute of Rehabilitation Sciences
state: Khyber Pakhtoon Khawa
Study officials:
References:
Clinical trial NCT02865980: Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle
Official title: Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Failure
Keywords: inflammation, infection
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized clinical trial will conducted involving 60 patients under hemodialysis and hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were assigned to experimental and control groups of 30 people, randomly (double block). In the both intervention and control group, first will be washed the Catheter with Betadine, but in intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence and severity of inflammation as well as infection of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.

Detailed description: This study is a randomized clinical trial that will conducted on 60 patients under hemodialysis and hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were assigned to experimental and control groups of 30 people, randomly (double block).

In the both intervention and control group, first will be washed the shaldon catheter with Betadine, but in intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence and severity of inflammation as well as infection of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.

Eligibility criteria: Inclusion Criteria:

* age between 18-80

Exclusion Criteria:

* lack of cooperation patient to participate in the post test

Primary outcomes:
measure: inflammation severity questionnaire
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad Faculty of Nursing and Midwifery
state: Khorasan Razavi
Study officials:
affiliation: Mashhad Faculty Nursing and Midwifery
name: Ali Bazzi, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaudhari LK, Jawale BA, Sharma S, Sharma H, Kumar CD, Kulkarni PA. Antimicrobial activity of commercially available essential oils against Streptococcus mutans. J Contemp Dent Pract. 2012 Jan 1;13(1):71-4. doi: 10.5005/jp-journals-10024-1098.
Clinical trial NCT00869180: Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Ankle Sprain
Keywords: diclofenac
ankle sprain
acute pain
topical
patch
Acute Pain due to Mild to Moderate Ankle Sprain
Lead sponsor: Cerimon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2009-03-25
Enrollment: 219
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.

Detailed description: This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild or moderate ankle sprains.

Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 17 - 75 years of age
* Sustained recent, painful unilateral mild to moderate ankle sprain
* Meet baseline pain criterion

Exclusion Criteria:

* Open wound or infection at site of injury
* Evidence of severe injury or ankle fracture
* Use of oral NSAIDs or opioids within 12 - 24 hours of injury
* Presence or history of peptic ulcers or GI bleeding
* A history of intolerance to NSAIDs, acetaminophen, adhesives
* Positive pregnancy test
* Positive drug screen

Primary outcomes:
measure: Change in average pain during daily activity at Day 3
timeFrame: Day 3
Secondary outcomes:
measure: Change in average pain during daily activity at Day 7
timeFrame: Day 7
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
References:
Clinical trial NCT05408780: A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin and Matching Placebo in Healthy Subjects
Official title: A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin, and Matching Placebo to Include Single-dose and Food Effect (Part A), and Titration Tolerability (Part B), in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a two-part study.

Part A (Food Effect Assessment): It is a randomized, double-blind (to IMP received), placebo-controlled, four-period, single-dose design. Subjects will be dosed in the fed state or the fasted state depending on the regimen.

Part B (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.


Eligibility criteria: Main Inclusion Criteria:

* Healthy males and non-pregnant, non-lactating healthy females aged 18 to 55 years inclusive at time of signing informed consent with a body weight ≥55 kg.
* Body mass index (BMI) 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.

Main Exclusion Criteria:

* Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
* Subjects with a history of fainting, dizziness, bradycardia or hypotension as considered clinically significant by the investigator
* Subject has a medical condition that may adversely affect taste or smell activity

Primary outcomes:
measure: Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part A)
timeFrame: 0 to 8 hours post-dose
measure: Incidence of Treatment Emergent Adverse Events (Part B)
timeFrame: Baseline to 28 days
Secondary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (Part A)
timeFrame: Baseline to 8 days
measure: Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part B)
timeFrame: 0 to 8 hours post-dose
measure: Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)
timeFrame: 0 to 8 hours post-dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences Miami
state: Florida
Study officials:
affiliation: Cerecin
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03198780: Mindful Breathing Awareness Through Pursed-Lip Breathing Training
Official title: A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Minnesota HealthSolutions
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2017-06-26
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot study
Primary purpose: DEVICE_FEASIBILITY

Brief summary: To establish the feasibility of a tool that monitors and motivates people with COPD to complete training in mindful pursed-lip breathing to enhance pulmonary rehabilitation at home.

Detailed description: For this pilot study patients who meet the conventional criteria for pulmonary rehabilitation at their clinical appointments will be recruited and scheduled to return for the study. After completing the informed consent, patients will be taught how to don and doff the pulse oximeter, the source of the heart rate and oxygen signals. Patients will participate in a demonstration on how to perform the intervention. Recruitment will continue until five patients have completed the pilot in a clinic setting. If necessary, the prototype will be modified and testing resumed. Once the prototype system has met the criteria for success in the clinic, five of patients will be asked to use the prototype at the clinic and to take it home for a week and perform the intervention at least five times.

Eligibility criteria: Inclusion Criteria:

* Patients must be ≥40 years old
* have a diagnosis of GOLD stage II, III, or IV COPD documented by pulmonary function testing
* have clinically significant breathlessness (breathless when walking on the level or walking a mild hill)
* be a current or previous smoker with at least 10 pack-years of cigarette smoking
* be hospitalized for an exacerbation of COPD.

Exclusion Criteria:

* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Primary outcomes:
measure: Participant assessment of device feasibility
timeFrame: up to 1 week
Secondary outcomes:
measure: Device Use Assessed by Pulse Oximetry Data
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Minnesota HealthSolutions
name: Kevin Kramer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06938880: Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors
Official title: A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors, Including Cervical Cancer, Hepatocellular Carcinoma, Neuroendocrine Tumors, and Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.


Eligibility criteria: Inclusion Criteria:

* Fully understand this study and voluntarily sign the ICF.
* Age 18-75 years, no gender restriction.
* Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology.

Exclusion Criteria:

* Medical history, CT scan, or MRI indicates the presence of CNS metastases.
* Other malignancies within 5 years.
* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Primary outcomes:
measure: Dose limited toxicity(DLT)
timeFrame: up to 21 days
measure: Adverse Event (AE)
timeFrame: Up to 2 years
measure: Maximum tolerated dose(MTD)
timeFrame: Up to 1 years
measure: Recommended phase II dose(RP2D)
timeFrame: Up to 1 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
measure: Immunogenicity
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT01237080: Intubation of Morbidly Obese Patients. A Clinical Trial, Comparing Glide Scope ® With Fastrach TM
Official title: Intubation of Morbidly Obese Patients. A Randomized Clinical Trial, Comparing GlideScope ® With Fastrach TM.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbidly Obese
Intubationtime
Intubationattempts
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 100
Sex: ALL
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: The purpose of this study is to compare the GlideScope ® and the Fastrach TM for intubation of morbidly obese. Mainly we will try to clarify which of the instruments that produce the shortest intubationtime and lowest number of intubationattempts.

The hypothesis is that intubation would be 1) quicker and 2) with the lowest number of attempts, using the GlideScope®.

Detailed description: The number of obese people rises. Thus 25.2% of Danish 9th graders are obese. As a result, surgery and anesthesia in obese patients becomes more frequent. Several potential problems related to anesthesia in this patient group exists, including airway management and sufficient oxygenation.

Anaesthesia of obese patients are more likely to require intubation. In light of the foregoing, it is therefore important to find the methods that provide the fewest complications related to intubation. Therefore this study compare two instruments (Fastrach TM and GlideScope ®) to find out which of the methods that provides the best airway management, measured primarily in time and numbers of intubation attempts.

Eligibility criteria: Inclusion Criteria:

* BMI \>/= 35

Exclusion Criteria:

* need for crash induction.

Primary outcomes:
measure: Number of Patients Intubated in the First Attempt
timeFrame: please see description
measure: Time to Intubate
timeFrame: From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.
Secondary outcomes:
measure: Lowest Saturation During Intubation.
timeFrame: measured on the monitor
measure: Mucosal Lesion
timeFrame: inspection during intubation and one hour postop.
measure: Subjectively Intubation Difficulty
timeFrame: measured immediately on a visual analogue scale.
measure: Intubation of the Esophagus.
timeFrame: detected immediately
measure: Postoperative Hoarseness.
timeFrame: one hour postoperative.
measure: Postoperative Throat Pain.
timeFrame: one hour postoperative
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Anesthesiology, Copenhagen University Hospital
state: Zeeland
city: Soeborg
country: Denmark
facility: Privathospitalet Hamlet
state: Zeeland
Study officials:
affiliation: Department of Anesthesiology, Copenhagen University Hospital, Glostrup, Denmark
name: Mogens VY Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References: