louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05236088: The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy
Official title: The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of neuromuscular electric stimulation on urinary symptoms, quality of life, sexual function, perception of improvement and patient satisfaction in individuals with post-prostatectomy urinary incontinence

Detailed description: One of the two most common complications after prostatectomy surgeries is urinary incontinence (UI) and the other is erectile dysfunction. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is neuromuscular electrical stimulation application. Since electrical stimulation applications, used in the treatment of post-prostatectomy urinary incontinence, are usually given together with other treatment protocols, there are limitations in clearly demonstrating the effects of neuromuscular electrical stimulation on post-prostatectomy urinary incontinence.

Eligibility criteria: Inclusion Criteria:

* Being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery in the urology clinic
* Being over 40 years old
* Volunteering to participate in the study

Exclusion Criteria:

* Severe cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients ect.)
* Those with sensory loss
* Presence of ongoing urinary infection
* Only urgency urinary incontinence
* Having a pacemaker
* Active cancer treatment (radiotherapy, chemotherapy),
* Those who have undergone Transurethral Prostatectomy (TUR-P) surgery
* Those who have a problem that interferes with cooperation and understanding

Primary outcomes:
measure: Urinary incontinence severity
timeFrame: change from baseline at 4 weeks
Secondary outcomes:
measure: Presence of urinary incontinence symptoms
timeFrame: change from baseline at 4 weeks
measure: Life quality
timeFrame: change from baseline at 4 weeks
measure: Sexual function
timeFrame: change from baseline at 4 weeks
measure: Patients' subjective perception of improvement
timeFrame: after treatment (4th week)
measure: Patient satisfaction
timeFrame: after treatment (4th week)
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02997488: Comparison of Routine Endotracheal Intubation With McGrath Videolaryngoscope and Pentax AirwayScope
Official title: Comparison of Routine Endotracheal Intubation With McGrath Videolaryngoscope and Pentax AirwayScope
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Keywords: videolaryngoscope
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients scheduled for elective surgery requiring orotracheal intubation in our hospital

Brief summary: Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes provide easier intubation, help intubation difficulty, are used good tool for education. McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes.

The purpose of this study is to compare of routine endotracheal intubation with McGrath Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier and faster intubation.


Eligibility criteria: Inclusion Criteria:

* an American Society of Anesthesiologists physical status (ASA) 1 or 2

Exclusion Criteria:

* a suspected difficult airway (Mallampati score Ⅳ)
* known cervical spine injury
* required rapid sequence induction
* emergency operation

Primary outcomes:
measure: Time to intubation
timeFrame: 10 minutes around intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
name: Jiyoung Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05386888: A Trial of GFH018 and Toripalimab in Combination with Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC
Official title: A Phase 2 Trial of GFH018 and Toripalimab in Combination with Concurrent Chemoradiotherapy for Patients with Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: NSCLC, Stage III
Keywords: Locally Advanced
Unresectable NSCLC
TGF-βRI
PD-1
Lead sponsor: Genfleet Therapeutics (Shanghai) Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Primary Purpose: ORR
Primary purpose: TREATMENT

Brief summary: This is a phase II trial assessing the efficacy and safety of GFH018 and Toripalimab in combination with concurrent chemoradiotherapy (cCRT) in patients with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Newly diagnosed, pathologically (histologically or cytologically) confirmed, locally advanced, unresectable stage III NSCLC
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Measurable disease (according to RECIST v1.1 criteria)
* Life expectancy \> 6 months

Exclusion Criteria:

* Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements.
* Has received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for Stage III NSCLC
* Prior exposure to immune-mediated therapy, including but not limited to, TGFβ inhibitors, anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies.
* Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
* Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From the date of enrolment of the first patient up to 28 months , which is also16 months after the enrolment of the last patient
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT03146988: Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta
Official title: Randomised, Double-Blind, Single, 6 mg Fixed Dose, Two Treatment, Two-Period, Two-Sequence, Two-Way Crossover Comparative Pharmacokinetic and Pharmacodynamic (Phase I) Study of RGB-02 Compared to Neulasta® in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Gedeon Richter Plc.
Sponsor class: INDUSTRY
First posted: 2017-05-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years
* Body mass index ≥19.0 to ≤30.0 kg/m2
* Body weight \>55 kg"

Exclusion Criteria:

* Prior exposure to filgrastim, pegfilgrastim or lenograstim (Period 1 only)
* Subjects who have received any IMP in a clinical research study within the previous 3 months
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Current smokers who smoke more than 10 cigarettes per day
* Positive drugs of abuse test result
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

Primary outcomes:
measure: Pharmacokinetic parameter: AUC0-inf
timeFrame: 67 days
measure: Pharmacokinetic parameter: Cmax
timeFrame: 67 days
measure: Pharmacodynamic parameter: ANCmax
timeFrame: 67 days
measure: Pharmacodynamic parameter: ANC AOBEC0-tlast
timeFrame: 67 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical
state: Nottingham
Study officials:
References:
Clinical trial NCT05948488: Psychological Study in Children With Mucoviscidosis
Official title: Psychological Study of the Links Between Feeling and Fear of Pain, Anxiety and Quality of Life in Children With Mucoviscidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Children
Pain
Anxiety
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 160
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent.

Brief summary: Cystic fibrosis is the most common serious genetic disease in Europe. It is a multi-disciplinary disease, causing multiple organ damage. It is a painful disease and a source of anxiety and depression.

The aim of this study is to assess the link between pain experienced during care and anxiety in children aged over 8 with cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Have cystic fibrosis
* Child aged over 8 years and under 18 years
* Presence of at least one parent at the time of inclusion
* To be present for a scheduled hospitalisation at the Resources and Competence Centres for Cystic Fibrosis
* Do not object to the research

Exclusion Criteria:

* Under 8 or over 18 years of age
* Lack of at least one parent at the time of inclusion
* Presence of chronic co-morbidities
* Difficulty reading and understanding French
* Objection to taking part in research

Primary outcomes:
measure: Links between pain during care and anxiety
timeFrame: 1 day
Secondary outcomes:
measure: Links between pain-related fears and pain during care
timeFrame: 1 day
measure: Links between pain during care and quality of life
timeFrame: 1 day
measure: Links between pain during care and the severity of the disease
timeFrame: 1 day
measure: Links between the severity of the disease and anxiety
timeFrame: 1 day
measure: Links between parents' anxiety and the child's anxiety
timeFrame: 1 day
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Géraldine LABOURET
Study officials:
affiliation: University Hospital, Toulouse
name: Géraldine LABOURET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01765088: A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
Official title: A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anaplastic Oligoastrocytoma
Anaplastic Astrocytoma
Glioblastoma
Keywords: High-grade glioma
chemotherapy
Temozolomide
Interferon-alpha
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.

Detailed description: This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.

Eligibility criteria: Inclusion Criteria:

* Age: 18 years to 75 years
* newly diagnosed WHO III-IV glioma after operation and radiotherapy
* Karnofsky Performance Score ≥ 60
* Adequate bone marrow, liver and renal function
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent
* anticipating survival ≥2 months

Exclusion Criteria:

* Refusal to participate the study
* Known hypersensitivity or contraindication to temozolomide
* Incompletely radiation
* Pregnant or lactating females
* Malignant tumor other than brain tumor
* Contraindicated for MRI examination
* Unable to comply with the follow-up studies of this trial
* Purulent and chronic infected wounds
* Uncontrolled psychotic disorders or epilepsy

Primary outcomes:
measure: Over-all survival
timeFrame: 5-year
Secondary outcomes:
measure: Quality of life
timeFrame: 5-year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT06584188: The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients with Symptomatic Irreversible Pulpitis and Apical Periodontitis.
Official title: The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients with Symptomatic Irreversible Pulpitis and Apical Periodontitis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: * The aim of this study is comparative between:

  1. Intra-radicular cryotherapy using cold anti-inflammatory {ketorolac tromethamine at 2-5C}.
  2. Intra-radicular final flush anti-inflammatory {ketorolac tromethamine at room temperature}.
* In terms of:

C. Level of post-operative pain {POP} using a visual analog scale {VAS}. D. Level of substance P in periapical fluid will be analyzed by enzyme-linked immunosorbent assay (ELISA) kit.

Outcomes :

* Primary outcomes: Level of Post-operative pain.
* Secondary outcomes: Level of substance P expression


Eligibility criteria: Inclusion Criteria:

1. Patients that will be diagnosed with symptomatic irreversible pulpitis and apical periodontitis.
2. Patient age ranging from 18-40 years.
3. Males or females.
4. Lower premolars.
5. Medically free patients.
6. Teeth with mature apex.
7. Teeth without any type of root resorption.

Exclusion Criteria:

1. Patients with other pulpal diagnosis.
2. Medically compromised patients.
3. Vulnerable group; pregnant females, mentally ill, etc...
4. Patients taking analgesics or anti-inflammatory drugs.
5. Teeth with open apex.

Primary outcomes:
measure: Level of Post-operative pain.
timeFrame: 12 hours post operative
measure: Level of Post-operative pain.
timeFrame: 24 hours post operative
measure: Level of Post-operative pain.
timeFrame: 48 hours post operative
Secondary outcomes:
measure: Level of substance P expression.
timeFrame: 15 minutes following access cavity preparation.
measure: Level of substance P expression.
timeFrame: 30 minutes following access cavity preparation.
measure: Level of substance P expression.
timeFrame: Immediately prior to obturation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
Study officials:
References:
Clinical trial NCT00232388: Association of PICP Serum Marker in Patients With LVSD
Official title: Phase 1 Study of PICP Serum Marker of Myocardial Fibrosis and Diastolic Function in Patients With Systolic Dysfunction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Systolic Dysfunction
Keywords: Ejection Fraction <35%
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with left ventricular systolic dysfunction from the Texas Tech University Health Sciences Center outpatient clinic and University Medical Center, Lubbock, Texas

Brief summary: The purpose of this study is to determine if the carboxy-terminal of procollagen type I (PICP) can be a useful marker of different degrees of myocardial fibrosis.

Detailed description: Abnormality of diastolic function, particularly a more advanced form known as restrictive tilling pattern, has been correlated with worse outcome in patients with systolic dysfunction associated with chronic heart failure or following an acute myocardial infarction. Recently, the severity of diastolic dysfunction has also been shown to predict the response to cardiac synchronization therapy for refractory heart failure due to systolic dysfunction.

Varying degree of diastolic dysfunction has been reported among patients with comparable severity of systolic dysfunction. The underlying mechanisms responsible for the observed discordance between systolic and diastolic dysfunction in these patients remains incompletely understood.

The carboxy-terminal of procollagen type I (PICP), a peptide that is cleaved from procollagen type I during the synthesis of fibril-forming collagen type I, has been associated with myocardial fibrosis. Myocardial fibrosis is a major determinant of both systolic and diastolic function of the heart. We hypothesize that differential degrees of myocardial fibrosis may be responsible for these discrepancies.

Eligibility criteria: Inclusion Criteria:

1. Evidence of left ventricular systolic dysfunction (measured LVEF% less than 35%) measured by echocardiography within the previous three months at the time of enrollment
2. Greater than or equal to 18 years of age
3. Greater than or equal to 110 pounds in weight

Exclusion Criteria:

1.Non-sinus rhythm at the time of enrollment

Primary outcomes:
measure: There will be a significant relationship between the severity of diastolic dysfunction and PICP
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: TTUHSC
state: Texas
Study officials:
affiliation: TTUHSC
name: Chanwit Roongsritong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01852188: Intrapartum Study of Sterile and Clean Gloves
Official title: A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chorioamnionitis
Keywords: Intrapartum
Glove
Chorioamnionitis
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 507
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the membranes around the baby.

Detailed description: The importance of this study is that intrapartum vaginal exams (while patients are laboring) are performed routinely in modern obstetrical practice, and there is no randomized trial available assessing the relationship between the type of glove used and the rate of chorioamnionitis.

Eligibility criteria: Inclusion Criteria:

* Spontaneous or induced labor
* Rupture of membranes \< 12 hours
* Nulliparous or multiparous
* Gestational age greater than or equal to 34 weeks
* Age greater than or equal to 18

Exclusion Criteria:

* Contraindications to labor
* Multiple gestations
* Rupture of Membranes greater than 12 hours
* Gestational age less than 34 weeks
* Non-English speaking patients

Primary outcomes:
measure: Clinical chorioamnionitis
timeFrame: participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Laura Houston, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina, Obstetrics-Gynecology
name: Donna Johnson
role: STUDY_CHAIR
References: