louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05607901: A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone
Official title: A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone in Management of Atopic Dermatitis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatologic Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: • A randomized, controlled, and parallel study will comprise 100 patients with AD
Primary purpose: TREATMENT

Brief summary: One of the most frequent skin conditions is atopic dermatitis (AD), characterized by its pruritic inflammation effect. Where the prevalence of AD increased in the last three decades by two or three folds worldwide, especially in developed countries, AD is supposed to affect about 15% to 30% of children, and 2% to 10% of adults. This type of dermatitis is frequently linked to a family history of other atopic illnesses such as allergic rhinitis or asthma.


Eligibility criteria: Inclusion Criteria:

* Male or female, 2-16 years old AD patients.

Exclusion Criteria:

* patients diagnosed with other skin disorders of serious type and who are taking systemic corticosteroids or anti-inflammatory medications.

Primary outcomes:
measure: To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Unuversity
Study officials:
References:
Clinical trial NCT04071301: Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
Official title: An Explorative, Open, Single-arm Clinical Investigation to Collect Real-life Measurement Data in Order to Assess the Mathematical Algorithms Involved in TENA SmartCare Change Indicator.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Essity Hygiene and Health AB
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.

Detailed description: The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life measurement data using the TENA SmartCare Change Indicator. The collected data will be used to assess the device related algorithms. These algorithms have been established and verified in a laboratory environment. However, due to possible differences in parameters, real-life measurement data are to be collected to aid in further product development.

Eligibility criteria: Inclusion Criteria:

1. The subject is willing and able to provide informed consent and to participate in the clinical investigation.
2. The subject is ≥18 years of age.
3. The subject is diagnosed with urinary incontinence.
4. The subject is being cared for at Tre Stiftelser.

Exclusion Criteria:

1. The subject has ≥ 4 fecal "incidences" per week.
2. The subject has severe absorbent product related skin problems, as judged by the investigator.
3. The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
4. The subject has ≥ 2 intermittent urinary catheters per day.
5. The subject has a pacemaker or an implantable cardioverter-defibrillator.
6. The subject removes the incontinence product.
7. The subject demonstrates responsive behavior towards sensors.
8. The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
9. The subject is not cared for at Tre Stiftelser.
10. The subject is pregnant or lactating.

Primary outcomes:
measure: Urine Volume Quantification and Impedance Measurements
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Tre Stiftelser
Study officials:
affiliation: Avd. för Invärtes medicin och klinisk nutrition, Högsbo sjukhus, Göteborg
name: Ulla Molander, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02300701: Role of Anti-IgE in Severe Childhood Eczema
Official title: The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Eczema
Atopic Dermatitis
Child
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
name: National Institute for Health Research, United Kingdom
First posted: 2014-11-25
Enrollment: 62
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.

Detailed description: To address the value of anti-IgE in children with severe eczema.

Eligibility criteria: Inclusion Criteria:

1. Children between the ages of 4-19 years
2. Severe eczema
3. Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR
4. Clinical impression that allergic exposures cause worsening eczema.
5. Total IgE level \>300 kU/l
6. Clinically proven IgE-mediated allergic disease.
7. Written informed consent to participate.

Exclusion criteria:

1. Inability to comply with 2-4 weekly injections and clinic visits
2. Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
3. Uncontrolled infection or unstable eczema.
4. Malignancy or a history of malignancy.
5. Pre-existing hepatic or renal impairment
6. Known cardiovascular or ischaemic cerebrovascular abnormality.
7. Other serious or uncontrolled systemic disease.
8. Pregnancy or lactation.
9. Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
10. Insufficient understanding of the trial assessments.
11. Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
12. Investigator feels that there is a good clinical reason why the child would be unsuitable.

Primary outcomes:
measure: Improvement in atopic eczema
timeFrame: 24 weeks after treatment commences
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' Hospitals NHS Foundation Trust
name: S Chan, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan S, Cornelius V, Cro S, Harper JI, Lack G. Treatment Effect of Omalizumab on Severe Pediatric Atopic Dermatitis: The ADAPT Randomized Clinical Trial. JAMA Pediatr. 2020 Jan 1;174(1):29-37. doi: 10.1001/jamapediatrics.2019.4476.
citation: Chan S, Cornelius V, Chen T, Radulovic S, Wan M, Jahan R, Lack G. Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial. Trials. 2017 Mar 22;18(1):136. doi: 10.1186/s13063-017-1809-7.
Clinical trial NCT01229501: Fat Biology, Sleep Disorders, and Cardiovascular Disease
Official title: Fat Biology, Sleep Disorders, and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disordered Breathing
Cardiovascular Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: With sleep disordered breathing, Without sleep disordered breathing, With cardiovascular disease, Without cardiovascular disease, Sleep disordered breathing using CPAP.

Brief summary: Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to be a key process in the development of cardiovascular disease. Endothelial dysfunction appears to be caused by both sleep disordered breathing and obesity. As endothelial dysfunction is among the first clinical marker that predicts future cardiovascular events, understanding molecular mechanisms leading to impairment of endothelial function is very important. Endothelial function requires the proper functioning of endothelial nitric oxide synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in the formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate optimal nitric oxide synthesis in endothelial cells as caveolin-1 helps to spatially organize eNOS in close proximity to signaling proteins that are important for eNOS activation. In certain diseases however, the balance of caveolin-1 and eNOS can be disrupted resulting in impaired nitric oxide synthesis and leading to endothelial dysfunction.

The investigators therefore seek to characterize levels of caveolin-1, and correlate this with the presence or absence of sleep disordered breathing, obesity, and cardiovascular disease. The current IRB protocol covers the performance of fat biopsies on subjects who have recently completed a sleep study either in the Center for Sleep Medicine or in our sleep laboratory and were found to have sleep disordered breathing or no sleep disordered breathing, subject with sleep disordered breathing who have been treated successfully with continuous positive airway pressure for 3-6 months, and subjects undergoing other studies in our lab who are obese or non-obese and subjects who have known cardiovascular disease and subjects without known cardiovascular disease.


Eligibility criteria: Lac of contraindication for fat biopsy, inability to provide informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01065701: Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children
Official title: Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children - a Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 104
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intranasal dexmedetomidine has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain satisfactory sedation prior to anaesthetic induction when higher dose is used.


Eligibility criteria: Inclusion Criteria:

* Age 1-12 years old
* American Society of Anesthesiologists (ASA) 1-2
* Elective surgery
* Children with autism or pervasive personality disorder

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) 3-5
* Allergy or hypersensitive reaction to dexmedetomidine
* Known cardiac arrhythmia or congenital heart disease
* Mentally disabled

Primary outcomes:
measure: proportion of children attained satisfactory sedation
timeFrame: one hour
Secondary outcomes:
measure: time to onset of sedation
timeFrame: one hour
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: QUeen Mary Hospital
Study officials:
affiliation: Associate Consultant, Queen Mary Hospital
name: Vivian M Yuen, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00982501: WS®1442 in Slightly Overweight Subjects
Official title: Investigation of Safety of WS®1442 in Slightly Overweight Subjects With Pilot Assessment of Pharmacodynamic Effects of WS®1442 on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Keywords: (BMI 25-29,9 kg/m2)
Lead sponsor: Dr. Willmar Schwabe GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to test:

1. Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²)
2. Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking training in overweight subjects

Detailed description: 60 overweight subjects with a BMI of 25 to 29,9 kg/m2 are to be included. The safety of 900 mg/1800 mg per day WS® 1442 is determined by adverse events, laboratory parameters, vital signs as well as by a treadmill test at the beginning and the end of the study. Endothelial function measured before and after two different training modalities is compared to that measured before and after intake of two different doses of WS® 1442.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* male and female subjects aged 45-75 years
* untrained
* BMI between 25 and 29,9 kg/m²
* resting blood pressure in sitting position ≤ 140/90 mmHg
* inconspicuous ergometry

Exclusion Criteria:

* pregnancy or breastfeeding
* any other current medication
* intake of other hawthorn preparation or dietary supplements with possible influence on the interpretation of study results
* any known diseases
* alcohol or drug abuse/addiction
* nicotine abuse
* any known hypersensitivity to any of the ingredients of the investigated drug
* inability or inadequate ability to write or speak German
* not-postmenopausal women: positive pregnancy test or unsafe contraception
* any urinary test finding requiring diagnostic assessment or treatment
* deformation of the 2nd to 5th finger of both hands preventing an adequate measurement of endothelial function

Primary outcomes:
measure: Adverse events
timeFrame: 12 weeks
measure: Lab parameters
timeFrame: 12 weeks
measure: Vital signs
timeFrame: 12 weeks
measure: Treadmill test including lactate measurement
timeFrame: 12 weeks
Secondary outcomes:
measure: Endothelial function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Study officials:
affiliation: University Institute of Sports Medicine, Prevention and Rehabilitation
name: Josef Niebauer, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04180501: SRS Sequential Sindilimab in Brain Metastasis of NSLSC
Official title: A Phase II Study on the Treatment of Advanced Non-small Cell Lung Cancer With Brain Metastasis by SRS Sequential Sintilimab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC Stage IV
Brain Metastases
SRS
Sintilimab
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase II study on the treatment of advanced non-small cell lung cancer with brain metastasis by SRS sequential sintilimab


Eligibility criteria: Inclusion Criteria:

* non-small cell lung cancer patients with less than brain metastases
* Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment
* Patients who have not received intracranial local treatment before

Exclusion Criteria:

* Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds
* Patients with hemorrhage in intracranial metastasis

Primary outcomes:
measure: iPFSof NSCLC patients receiving SRS sequential sintilimab
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union hospital
state: Hubei
Study officials:
References:
Clinical trial NCT03743701: Endorectal Three-dimensional Ultrasound in the Diagnosis of Cryptogenic Fistulas of the Rectum.
Official title: A Prospective Comparative Study to Improve Preoperative Ultrasound Diagnosis of Rectal Fistulas in the Formation of Topical Diagnosis Using B-mode and Three-dimensional Image Reconstruction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2018-11-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Prospective comparative parallel ultrasound diagnostic transrectal study in the diagnosis of cryptogenic fistulas of the rectum

Detailed description: It is planned to investigate 150 patients with cryptogenic fistulas. Patients will be divided into two groups: complete and incomplete internal fistulas of the rectum. Patients of the first group will undergo preoperative examination in the framework of transrectal ultrasound in B-mode, three-dimensional reconstruction of the image with a contrast of the fistula course with a solution of 1.5% hydrogen peroxide. Patients with incomplete internal fistulas of the rectum will also undergo transrectal ultrasound examination in B-mode and with three-dimensional image reconstruction. The results obtained in the two groups will be compared with the intraoperative revision.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with "fistula of the rectum"
* Patients diagnosed with cryptogenic fistulas
* Patients who have signed informed consent

Exclusion Criteria:

* Patients with perianal complications of Crohn's disease
* Рatients with post-traumatic fistulas
* Рatients with fistulas, drain pararectal cysts
* Рatients with anal fissures, complicated by rectal fistula
* Рatients who refused to participate in the study of their own free will

Primary outcomes:
measure: Sensitivity
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Sceintific Centtre of Coloproctology
Study officials:
References:
Clinical trial NCT06458101: Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter
Official title: Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter: a Multicenter, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urolithiasis
Catheter-related Bladder Discomfort
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 172
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: A prospective, multicenter, randomized, controlled clinical trial was conducted to compare the efficacy and safety of non-indwelling catheter and indwelling catheter in relieving postoperative catheter-related complications after ureteroscopic lithotripsy. By comparing the pain score and urination urgency score (PPIUS) of patients after ureteroscopic lithotripsy (including flexible ureteroscopy) lithotripsy to provide a reliable scientific basis for indwelling catheter after ureteroscopic lithotripsy.


Eligibility criteria: Inclusion Criteria:

* Patients with upper urinary tract calculi undergoing rigid ureteroscopic and soft ureteroscopic lithotripsy;
* Normal renal function;
* Aged between 18 and 70 years old
* Complete the operation under general anesthesia

Exclusion Criteria:

* Solitary kidney;
* Previous history of renal transplantation or urinary diversion;
* Congenital malformation of urinary system;
* Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc.
* Severe heart or lung disease, Malignant tumor and immunodeficiency state
* Urethral stricture
* Neurogenic bladder
* Operation under epidural anesthesia or spinal anesthesia
* Large amount of bleeding during operation should be observed by indwelling catheter to observe urine color
* High risk factors such as large amount of pus fur should be observed during operation.
* Urethral injury during operation leads to false passage
* Operation time is more than 90 minutes. Higher risk of bleeding or infection

Primary outcomes:
measure: Pain score
timeFrame: 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)
measure: Urinary urgency score
timeFrame: 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)
Secondary outcomes:
measure: Painful Memory
timeFrame: 1 month after surgery
measure: Operation time
timeFrame: The end of operation
measure: blood routine
timeFrame: Before surgery and 4 hours after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
References: