louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01253863: Diagnostic Accuracy of the Preoperative Clinical Examination in Upper Limb Injuries
Official title: Study of Accuracy of Preoperative Examination in Penetrating Wound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Penetrating Injury in Upper Limb
Keywords: Clinical Examination, Accuracy, Hand, Tendon, Injury.
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the accuracy of preoperative clinical examination in penetrating injuries

Detailed description: Penetrating injuries is a common cause of severe neurovascular damage, both in adults and children.we evaluated the accuracy of the preoperative clinical examination in depicting lesions caused by penetrating wounds of hands or forearms.

Eligibility criteria: Inclusion Criteria:

Deep penetrating injury to upper limb

Exclusion Criteria:

none

Primary outcomes:
measure: number of determined tendon
timeFrame: 5 min after admission
Secondary outcomes:
measure: number of determined injured nerves
timeFrame: 5 min after admision
measure: number of damaged arteries
timeFrame: 5 min after admission
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
affiliation: research comittee
name: hamidreza shemshaki, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04910035: The Effect of Square Stepping Exercises Training on Lower Extremity
Official title: The Effect of Square Stepping Exercises Training on Lower Extremity Motor Performance, Muscle Strenght and Muscle Quality in Healthy Young People: a Single-Blind, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Healthy Young Individuals
Keywords: Square-stepping exercises
Healthy young individuals
Motor performance
Muscle strength
Muscle quality
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
First posted: 2021-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Physical activity plays an indispensable role to lead a healthy life. Square-stepping exercises (SSE) are aerobic exercises.Our study was designed to investigate the effects of square-stepping exercise training on lower-extremity motor performance, muscle strength, and muscle quality of sedentary healthy young individuals.

Detailed description: A total of 120 volunteers within the age range of 20-25 participated in the research. Participants were randomly divided into two groups, as 60 participants were study group (35 females, 25 males) and 60 participants were control group (35 females, 25 males). Demographic data and exercise habit of the individuals were documented. Participants' lower-extremity motor performance was analyzed through Vertical Jumping, Side Jumping, One Leg Squat, and Step-Up tests. Participants' muscle strength was analyzed through Hand-Held Dynamometer. Also, participants' muscle quality was analyzed through Muscle Quality Index. Throughout 3 weeks SSE training was administered 4 days a week for a length of 45 minutes in each session. All the analyses were conducted at the start and at the end of 3-week long training

Eligibility criteria: Inclusion Criteria:

* 20-25 years old,
* Not attending any exercise program for the last 1 year,
* Not having a neurological, orthopedic disease or any disease affecting lower extremity,
* Not having any lower-extremity surgery,
* Individuals without vision and/or hearing problems were included in the study.

Exclusion Criteria:

* Having a vision and/or hearing problem,
* Having neurological, psychiatric, and/or orthopedic problems that affect walking,
* Individuals with lower-extremity surgery were excluded from the study.

Primary outcomes:
measure: Muscle Quality İndex
timeFrame: 3 weeks
measure: Muscle Strength
timeFrame: 3 weeks
measure: Motor Performance Assessment 1
timeFrame: 3 weeks
measure: Motor Performance Assessment 2
timeFrame: 3 weeks
measure: Motor Performance Assessment 3
timeFrame: 3 weeks
measure: Motor Performance Assessment 4
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir University
state: Bor
Study officials:
References:
Clinical trial NCT02744235: Mainstream Sleep Tracking Devices vs Polysomnography
Official title: Sensitivity and Specificity of Mainstream Sleep Tracking Devices Compared to Polysomnography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Severe Sleep Apnea
Severe Insomnia
Epileptiform Activity
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 0
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: DIAGNOSTIC

Brief summary: The purpose of this study is to compare two popular portable sleep monitoring devices-the Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app-to the "gold standard" Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep efficiency, and sleep staging. Specifically, this study will investigate the validity of the Jawbone UP®, Fitbit Charge®, and SleepTime app in detecting sleep and wakefulness in comparison to conventional Polysomnography (PSG).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing Polysomnography

Exclusion Criteria:

* severe sleep apnea
* severe insomnia with less than two hours of sleep per night
* epileptiform activity
* electrical status epilepticus of sleep

Primary outcomes:
measure: Time it takes subject to fall asleep
timeFrame: Up to 3 Months
measure: Number of Minutes of Sleep
timeFrame: Up to 3 Months
measure: Number of Arousals
timeFrame: Up to 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Alcibiades Rodriguez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00393835: A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis
Official title: A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin Sustained Release (SR) For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis In Japan Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Respiratory Tract Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-29
Enrollment: 99
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

Exclusion Criteria:

* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Primary outcomes:
measure: The primary endpoint is Investigator's Clinical efficacy at Day 8.
Secondary outcomes:
measure: Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 4, Day 15 and 29) Bacteriological efficacy (at Day 4, 8, 15 and 29) Safety Endpoints: Adverse events and safety Laboratory data
Other outcomes:
Locations:
city: Gobo
country: Japan
facility: Pfizer Investigational Site
state: Wakayama
city: Hashimoto
country: Japan
facility: Pfizer Investigational Site
state: Wakayama
city: Shinjo-cho, Tanabe
country: Japan
facility: Pfizer Investigational Site
state: Wakayama
city: Wakayama
country: Japan
facility: Pfizer Investigational Site
city: Wakayama
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00874835: Corneal Endothelium Delivery Instrument
Official title: Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Corneal Transplantation
Keywords: Endothelial Keratoplasty
EK
Descemet Stripping Endothelial Keratoplasty
Corneal Transplantation
Keratoplasty
DSEK
DSAEK
Lead sponsor: Ocular Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University
First posted: 2009-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps insertion method.

Detailed description: Laboratory studies and clinical functionality tests have shown that the study device safely forms the tissue without creasing or folding. It allows the allograft tissue to safely pass into the anterior chamber without compression, crushing, or squeezing the endothelial cells.

The device provides continuous irrigation into the eye to prevent collapse of the anterior chamber during insertion. Our study will focus on the safety and efficacy of the novel instrument over the current method of insertion (forceps).

FDA has classified the device as Class I, Reserved.

Eligibility criteria: Inclusion Criteria:

* Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.

Primary outcomes:
measure: 6-month post-operative endothelial cell density
timeFrame: 6-months post-operatively
Secondary outcomes:
measure: 12-month post-operative endothelial cell density
timeFrame: 12-months post-operatively
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Eye Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Eye Center
name: Keith A Walter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06081335: Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial
Official title: Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Irreversible Pulpitis
Apical Periodontitis
Keywords: pain
substance P
continuous rotation
reciprocation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance P levels in patients with irreversible pulpitis with symptomatic apical periodontitis. Twenty patients were randomly distributed into two groups; Continuous Rotation group(n=10): received mechanical preparation using EdgeEndo x7 rotary system (Albuquerque, New Mexico, USA), while Reciprocation group(n=10): received mechanical preparation using EdgeOne Fire reciprocating system (Albuquerque, New Mexico, USA). Apical fluid(AF) samples were collected, and substance P (SP) levels were measured using radioimmunoassay and postoperative pain was measured using Numerical Rating Scale (NRS) preoperatively, at 6h, 12h, 24h, 48h and 72h.


Eligibility criteria: Inclusion Criteria:

* Single rooted mandibular second premolar teeth with complete root formation
* Pulpal diagnosis: Symptomatic irreversible pulpitis
* Periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area
* Patients with pre-operative pain records above 4 on Numerical Rating Scale (NRS) to ensure standardization

Exclusion Criteria:

1. The presence of any systemic disease or allergic reactions
2. Pregnant and lactating females
3. Patients on antibiotic or anti-inflammatory medication
4. Use of analgesics a week prior to treatment
5. A radiographically untraceable canal or an excessively curved root
6. The presence of periapical radiolucency or sinus tract.
7. Teeth with open apices
8. Severe periodontal disease (generalized or localized to the tooth in question)
9. Absence of bleeding in the pulp chamber on access cavity preparation
10. Internal or external resorption

Primary outcomes:
measure: difference in substance P levels
timeFrame: pre-operatively and after 5 days at the beginning of the second visit
measure: post operative pain levels
timeFrame: pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Select A State Or Province
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: professor
name: maram obeid
role: STUDY_CHAIR
References:
Clinical trial NCT01670435: Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance
Official title: Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Ciprofloxacin
sepsis
infection
pneumonia
peritonitis
cholecystitis
cholangitis
anthrax
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 3274
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received Ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.

Brief summary: This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.


Eligibility criteria: Inclusion Criteria:

* Patients who received Ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.

Exclusion Criteria:

* Patients who are contraindicated based on the product label.

Primary outcomes:
measure: Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)
timeFrame: After 9 days
measure: Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion
timeFrame: After 9 days
Secondary outcomes:
measure: ADR incidence rates classified by patient's background factors
timeFrame: After 9 days
measure: Efficacy rate calculated with Response and Minor Response considered as responder
timeFrame: After 9 days
measure: Efficacy rates classified by patient's background factors
timeFrame: After 9 days
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00027235: Popcorn Lung: the Discovery of a New Disease
Official title: Popcorn Lung: the Discovery of a New Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases, Interstitial
Bronchiolitis Obliterans
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-11-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Recently, an epidemic of pulmonary disease has been recognized among workers in a popcorn factory in Jasper, Missouri. The exposure agent has not yet been identified, but suspects include butter flavoring and the powdered salt used in the mixing room. This disease resembles "Bronchiolitis Obliterans Syndrome", an illness that makes it difficult to breathe. Of the 117 workers studied, one year later, 25 subjects whom were working in the mixing room or in the microwave packaging area have had decreases in lung function seven times the norm for their age. Industrial hygiene experts revealed that dust concentrations of salt and other flavorings were much higher in the mixing room compared to the office and outdoor work areas. Recently, rats were exposed to vapors created by heating the butter flavor compound obtained from this plant. Six-hour exposure to vapors at very high concentration resulted in significant damage to the breathing apparatus. Thus, there is clinical, epidemiological, and animal toxicity data that appears to implicate some constituent present during the mixing of the butter flavoring, salt, and oil causing a form of obstructive airway disease that has been rapidly progressive in a number of workers. It is not clear what the pathophysiologic nature of this entity is, though it resembles Bronchiolitis Obliterans Syndrome. It is not known what the long term consequence of this will be on the active workers, nor is it clear whether preventive measures taken to reduce exposures in the mixing room and elsewhere in the plant are going to be effective.


Eligibility criteria: Current employees who have a decline in FEV1 larger than 200cc within the past year will be eligible to participate. All index cases will be eligible to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University, Division of Pulmonary and Critical Care Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT06455735: 68Ga-JH04 PET/CT in Patients With Various Types of Cancer
Official title: 68Ga-JH04 PET/CT in Patients With Various Types of Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Tumor
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 30
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: DIAGNOSTIC

Brief summary: As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-JH04 is promising as an excellent imaging agent for various cancers. In this study, we observed the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Detailed description: Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, showing high efficacy in tumor staging and restaging. As an emerging molecule targeting FAP, 68Ga-JH04, in this study, the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer were observed. Its imaging results were compared with those of 68Ga-FAPI or 18F-FDG PET/CT.

Eligibility criteria: Inclusion Criteria:

Various solid tumors with available histopathological findings Signed informed consent

Exclusion Criteria:

pregnant or lactational women who suffered from severe hepatic and renal insufficiency

Primary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: SUV of tumors
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital, Fujian Medical University
name: Weibing Miao, MD
role: PRINCIPAL_INVESTIGATOR
References: