louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05531409: Responsible Behavior With Younger Children Pilot Study
Official title: Responsible Behavior With Younger Children (RBYC) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: University of Maryland
First posted: 2022-09-08
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomized waitlist-controlled trial.
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to develop and pilot test a universal school-based prevention curriculum to prevent the onset of child sexual abuse (CSA) perpetration by early adolescents against younger children.

Detailed description: The proposed Responsible Behavior with Younger Children (RBYC) curriculum was developed and pilot tested in 6th and 7th grade classes in Baltimore City Public Schools. This study had three aims: 1) to develop and refine a new classroom-based universal curriculum to prevent the onset of CSA perpetration, 2) to evaluate the immediate effects (pre-post design) of RBYC on targeted constructs, and 3) to determine the feasibility and acceptability of RBYC to youth, parents, and school personnel.

Eligibility criteria: Inclusion Criteria:

* Student Assessments: 1) are in a 6th or 7th grade class within one of the four participating schools, 2) are fluent in English, and 3) have a "yes" consent form completed by their parent/legal guardian; students will also be asked to complete an electronic assent form at the beginning of each of the three student assessments.
* Educator Interviews: 1) have witnessed at least one session of the RBYC curriculum, 2) are fluent in English, and 3) have completed a consent form

Exclusion Criteria:

* Children residing in foster care will not be eligible for participation because of challenges associated with obtaining written parental consent from the legal guardian and other clinical concerns regarding this potentially vulnerable population that may arise with either students or parents. It is not feasible to address these challenges in the study.

Primary outcomes:
measure: Developmental Differences Between Children and Adolescents
timeFrame: 2 months
measure: Knowledge about CSA and Related Concepts
timeFrame: 2 months
measure: Peer Sexual Harassment Behaviors
timeFrame: 2 months
measure: Behavioral Intention to Avoid or Prevent Harm
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Elizabeth J Letourneau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05489809: Endotracheal Extubation With Suctioning Versus Positive Pressure in Children After General Anaesthesia.
Official title: Endotracheal Extubation With Suctioning Versus Positive Pressure in Children After General Anaesthesia. A Randomised Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Extubation
Lead sponsor: Pakistan Navy Station Shifa Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparing extubation of endotracheal tube in children after general anaesthesia by applying suctioning to the endotracheal tube versus applying positive pressure to the endotracheal tube.

Detailed description: Extubation after general anaesthesia involves removal of the endotracheal tube. This is done by either applying suctioning or applying positive pressure to the endotracheal tube. My study aims at identifying which technique is superior to the other.

Eligibility criteria: Inclusion Criteria:

* ASA I/II patients
* either sex
* consent given

Exclusion Criteria:

* not meeting the inclusion criteria

Primary outcomes:
measure: Endotracheal extubation
timeFrame: 3 months
Secondary outcomes:
measure: Pulse
timeFrame: 3 months
measure: Oxygen saturation
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: Supplemental oxygen
timeFrame: 3 months
measure: Airway suctioning
timeFrame: 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: PNS Shifa Hospital
state: Sind
Study officials:
affiliation: Pakistan Navy Station Shifa Hospital
name: Kenan Khan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01357109: Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes
Official title: Effect of Bosentan on Macro- and Microvascular Function in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Heart Lung Foundation
name: The Swedish Research Council
name: Actelion
First posted: 2011-05-20
Enrollment: 56
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate if oral treatment with bosentan improves endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy.


Eligibility criteria: Inclusion Criteria:

1. Diabetes mellitus type 2 of \>2 years duration
2. Albuminuria

Exclusion Criteria:

1. Age \>80 years
2. Myocardial infarction/unstable angina within three months prior to randomisation
3. Decompensated congestive heart failure or functional class 3 and 4.
4. Changes in dosage of any vasodilator drugs during the preceding six weeks
5. Women of fertile age.
6. Impaired hepatic function (2 times upper normal limit of aminotransferases ASAT and ALAT)
7. Ongoing treatment with glibenclamide, cyclosporin or warfarin
8. Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol
9. Participant in an ongoing study
10. Unwillingness to participate following oral and written information

Primary outcomes:
measure: Peripheral endothelial function
timeFrame: 4 weeks
Secondary outcomes:
measure: Inflammatory markers
timeFrame: 4 weeks
measure: Renal protein excretion
timeFrame: 4 weeks
measure: Myocardial perfusion
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: John Pernow, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rafnsson A, Bohm F, Settergren M, Gonon A, Brismar K, Pernow J. The endothelin receptor antagonist bosentan improves peripheral endothelial function in patients with type 2 diabetes mellitus and microalbuminuria: a randomised trial. Diabetologia. 2012 Mar;55(3):600-7. doi: 10.1007/s00125-011-2415-y. Epub 2011 Dec 27.
Clinical trial NCT02536209: A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-08-31
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy and free from clinically significant illness or disease
* Male Caucasian subjects aged 18 to 55
* A body weight of ≥60 kg

Exclusion Criteria:

* Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.
* Clinically relevant abnormal medical history, physical findings or laboratory values

Primary outcomes:
measure: Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test
timeFrame: up to 10 hours post dosing
Secondary outcomes:
measure: Safety and Tolerability as measured by vital signs
timeFrame: up to Day6 of treatment period 4
measure: Safety and Tolerability as measured by ECG
timeFrame: up to Day6 of treatment period 4
measure: Safety and Tolerability as measured by laboratory safety assessments
timeFrame: up to Day6 of treatment period 4
measure: Safety and Tolerability as measured by physical examination
timeFrame: up to Day6 of treatment period 4
measure: Safety and Tolerability as measured by number of participants with adverse events
timeFrame: up to Day6 of treatment period 4
measure: Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments
timeFrame: up to 10 hours post dosing
measure: Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments
timeFrame: up to 10 hours post dosing
Other outcomes:
Locations:
city: City name
country: United Kingdom
facility: Investigational center
Study officials:
References:
Clinical trial NCT04829409: The Effects of Three Different Ultrasound-guided Nerve Blocks in VATS
Official title: The Effects of Ultrasound-guided Mid-point Transverse Process to Pleura Block, Erector Spinae Plane Block and Paravertebral Block on Postoperative Pain in Video-assisted Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Anesthesia
Nerve Block
Pain, Acute
Keywords: ultrasound-guided nerve block
postoperative pain
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasound-guided mid-point transverse process to pleura block, erector spinae plane block and paravertebral block are three different methods of nerve block, used for relieving postoperative pain in thoracic anesthesia. This study is to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.

Detailed description: Ultrasound-guided nerve block is an important part of multi-mode analgesia to decrease the consumption of opioids. Thoracic paravertebral block is considered as an ideal regional analgesic choice for video-assisted thoracic surgery, but it still has some side effects, such as pneumothorax, vascular injury, especially for novices. Recent years, ultrasound-guided mid-point transverse process to pleura block and erector spinae plane block are reported for thoracic surgery. The insertion depth in these two methods is more superficial than traditional paravertebral block. They could have less side effects. Therefore, we design a randomised control study to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.

Eligibility criteria: Inclusion Criteria:

* selective lobetomy under VATS
* ASA classfication 1-3

Exclusion Criteria:

* history of thoracic surgery
* double lateral VATS
* allergy to local anesthetics
* coagulation disorders
* severe heart diseases, hepatic or renal insufficiency
* a history of chronic pain or chronic opioid use
* psychiatric disease or uncooperative
* BMI\>28 kg/m2
* VATS transfered to open thoractomy

Primary outcomes:
measure: postoperative morphine consumption
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Pain score at rest
timeFrame: at 0, 8, 24 hour after surgery
measure: Pain score while coughing
timeFrame: at 0, 8, 24 hour after surgery
Other outcomes:
measure: block level
timeFrame: 20 minutes after block
measure: intraoperative analgesic comsumption
timeFrame: intraoperative, from induction to emergence from anesthesia
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Ailin Luo, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06925607: Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis
Official title: A Phase l Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Radiation Proctitis
Lead sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Good physical condition (WHO performance status score 0-1).
3. Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors
4. Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.
5. The LENT-SOMA score was ≥1 during the screening period.
6. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.

Exclusion Criteria:

1. Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.
2. Patients with allergic constitution or severe systemic autoimmune diseases.
3. Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.
4. Pregnant or lactating women.
5. Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.
6. Patients with a LENT-SOMA score of 4 during the screening period.
7. Serum virology test (HBeAg, HCV antibody, HlV antibody, Treponema pallidum antibody) positive.
8. Patients with uncontrolled tumors, tumor recurrence or metastasis.
9. Subjects received any investigational drug within 3 months prior to the screening.
10. Subjects received stem cell treatment.
11. Participants considered inappropriate to participate in this clinical trial

Primary outcomes:
measure: Radioactive distribution
timeFrame: 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour
Secondary outcomes:
measure: Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events
timeFrame: Week1, Week 4, Week 24，Month 24
measure: Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement.
timeFrame: Week 4，Week 24
measure: Radiation exposure
timeFrame: Week 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04718207: Modelling in the Quantitative Analysis of Brain PET Scans in Patients With Alzheimer's Disease
Official title: Interest of PFS Modelling in the Quantitative Analysis of Brain PET Scans in Patients With Alzheimer's Disease Acquired on a Numerical System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Alzheimer's Disease
Keywords: Alzheimer disease
PSF modelisation
quantitative analyze
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with Alzheimer disease

Brief summary: PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. To complete the diagnosis, a semi-quantitative analysis of the images is recommended (European recommendations) in addition to the visual analysis.

Detailed description: PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. To complete the diagnosis, a semi-quantitative analysis of the images is recommended (European recommendations) in addition to the visual analysis.

PET technology is improving from year to year thanks to the arrival of a new PET technology called digital. In addition, correction methods have been developed to improve PET images and thus improve the detection of different pathologies in PET.

The PSF (Point Spread Function) tool enables partial volume effects to be corrected. The PSF consists of correcting the impulse response of the system, and allows a visual improvement of the images. Currently not recommended in brain PET/CT reconstructions, it remains to be evaluated for the quantitative analysis of acquisitions.

Eligibility criteria: Inclusion Criteria:

* Brain PET/CT scans at 18F-FDG of patients with Alzheimer's disease carried out in the nuclear medicine department of the Nancy-Brabois University Hospital since December 2017 on digital PET devices.

Exclusion Criteria:

* Patients who have expressed their opposition to the use of their data (poster in the service).

Primary outcomes:
measure: The results obtained in quantitative analysis with and without PSF modelling of PET brain scans of patients with Alzheimer's disease acquired on PET / CT scan
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: Nuclear medicine department CHRU de NANCY Brabois
Study officials:
References:
Clinical trial NCT04941807: Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
Official title: Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nail Diseases
Keywords: Nails
brittle nail syndrome
platelet-rich plasma
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Eclipse Aesthetics, LLC
First posted: 2021-06-28
Enrollment: 11
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: The purpose of this study is to assess the efficacy and safety of platelet-rich plasma therapy for brittle nail syndrome


Eligibility criteria: Inclusion Criteria:

* Patients who have been diagnosed with brittle nails
* Must understand and voluntarily sign an informed consent form
* Must be male or female and aged 18-95 years at time of consent
* Must be able to adhere to the study visit schedule and other protocol requirements
* A nail clipping with histopathology that is negative for the presence of dermatophyte infection
* Patient must present with at least a score of 2 on the PGA scale.

Exclusion Criteria:

* Inability of the patient to provide written informed consent for any reason.

  * Subject has psoriasis, lichen planus, dermatophyte infection or other confounding abnormalities that are severe enough to result in a clinically abnormal fingernail
  * Use of any medication within 90 days prior to start of study
  * Inability to abstain for nail polishes, nail gels during the study period
  * Subject is pregnant or planning pregnancy.

Primary outcomes:
measure: Physician Global Improvement Assessment (PGIA)
timeFrame: At 16 weeks
Secondary outcomes:
measure: Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between Baseline and Week 16
timeFrame: Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Shari R Lipner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01876407: Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oral Mucositis
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 126
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of using to low intensity laser as an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with squamous cell carcinoma of the oral cavity.
* Patients aged between 18 and 80 years.
* Patients who are to receive one of the following treatment
* Combined radiotherapy (conventional fractionation 70 Gy reaching the tumor and affected lymph nodes, and 50 Gy in the areas ganglion drainage) and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22 and 43 irradiation or cetuximab 400mg/m2 as a single dose pre-load radiotherapy and 250mg/m2 weekly for the same. Regardless of whether they have received previous surgical treatment.
* Treatment with radiotherapy of 70 Gy in 35 daily sessions 2Gy/día consecutive.
* Patients who voluntarily express their intention to participate by informed consent.

Exclusion Criteria:

* Patients who denied informed consent.
* Patients who have hypersensitivity or allergy to any of the components included in the study.
* Patients diagnosed with HIV, and autoimmune diseases.

Primary outcomes:
measure: Evaluate the effectiveness of using low-intensity laser compared with placebo as preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy.
timeFrame: 24 months
Secondary outcomes:
measure: Evaluate the effectiveness of using low level laser compared with placebo in the prevention of onset of oral mucositis induced by treatment of head and neck QRT.
timeFrame: 24 months
measure: Evaluate the effectiveness of the use of low laser intensity versus placebo in improving the healing of oral mucositis induced by treatment of head and neck QRT.
timeFrame: 24 months
measure: Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment.
timeFrame: 24 months
measure: Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment.
timeFrame: 24 months
measure: Assess the intervention tolerance and side effects of it.
timeFrame: 24 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Daniel Torres Lagares
role: PRINCIPAL_INVESTIGATOR
References: