louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02979912: Autologous Platelet Lysate in Corneal Epithelial Defects
Official title: The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Persistent Corneal Epithelial Defect
Keywords: Persistent corneal epithelial defect
Platelet Lysate
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.

Detailed description: Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be taken in multiple doses.

Eligibility criteria: Inclusion Criteria:

1. Cognitive ability to understand and sign the consent form.
2. Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment (therapeutic contact lenses, topical artificial tears, eye packs and antibiotic eye-drops).
3. Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy, corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal lesions due to a foreign body.
4. Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion Criteria:

1. Corneal ulcers which developed tissue scars.
2. Pregnant or lactating women.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops
timeFrame: 2 months
Secondary outcomes:
measure: Assessment of the efficacy by clinical judgment
timeFrame: 6 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center
Study officials:
affiliation: Cell Therapy Center
name: Abdallah Awidi, MD
role: STUDY_DIRECTOR
References:
citation: Abu-Ameerh MA, Jafar HD, Hasan MH, Al Bdour MD, Msallam M, Ababneh OH, Alhattab DM, Al-Kurdi B, Awidi AA, Awidi AS. Platelet lysate promotes re-epithelialization of persistent epithelial defects: a pilot study. Int Ophthalmol. 2019 Jul;39(7):1483-1490. doi: 10.1007/s10792-018-0968-1. Epub 2018 Jul 5.
Clinical trial NCT06578312: "Critical State" Early Warning Score After CHD Surgery and Rapid Response Team
Official title: A Study on Establishing a "Critical State" Early Warning Score After Congenital Heart Disease Surgery and an Integrated Treatment Model of a Multidisciplinary Rapid Response Team
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: congenital heart disease
Early warning system
machine learning
retrospective study
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 4115
Sex: ALL
Minimum age (years): 28
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included pediatrics with congenital heart disease who undergone surgery in our center.They should under 14 years old.

Brief summary: By establishing a warning scoring tool for the early \&#34;critical state\&#34; after congenital heart disease surgery, the multidisciplinary rapid response team is proactively activated, forming an integrated treatment model of early warning-team decision-making-organ assistance.

Detailed description: All children aged 0-14 years admitted to the PICU from 2021-2022 were enrolled continuously, and their baseline data such as gender, age, RACHS-1 score, cardiopulmonary bypass time, aortic clamping time, whether there was chromosomal lesions, whether there was preoperative endotracheal intubation/heart failure, changes in oxygenation index, lactate, and vasoactive drug scores were obtained. All variables that may lead to composite malignant events including death in the early postoperative period were included, including death, pulmonary hypertension crisis, malignant arrhythmias (supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, high-degree atrioventricular block) requiring antiarrhythmic drugs or pacemaker treatment, cardiopulmonary resuscitation, ECPR, emergency sternal expansion, severe AKI, severe ARDS, neurological complications (cerebral hemorrhage, cerebral infarction), gastrointestinal complications (gastrointestinal bleeding, intestinal obstruction, intestinal necrosis).The variables were included in the machine learning analysis to establish the model.

Eligibility criteria: Inclusion Criteria:

* pediatrics admitted to ICU

Exclusion Criteria:

* surgery without cardiopulmonary bypass
* neonatal
* using extra-corporeal circulation during surgery
* Delayed chest closing during surgery

Primary outcomes:
measure: event occurrence-an inclusion of composite clinical diagnose
timeFrame: Within 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xu Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02708212: Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: A Prospective Randomized Controlled Study
Official title: Optimal Procedural Sequence in Same-day Bidirectional Endoscopy With Moderate Sedation and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy
Moderate Sedation
Lead sponsor: Evergreen General Hospital, Taiwan
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 121
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However, the optimal sequence of performing a same-day BDE has not been well-established.The primary aims of this study are to compare the sedative doses and patient discomfort between the study groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD followed by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to assess colonoscopy performance, including the cecal intubation time and adenoma detection rate between the two endoscopic sequences.


Eligibility criteria: Inclusion Criteria:

* Outpatients, aged 20 to 75 years, who are scheduled for same-day bidirectional endoscopy examination for any indication are invited to participate in the study.

Exclusion Criteria:

* 1. previous gastrectomy or colectomy 2. inadequate bowel preparation, 3. obstructive lesions of the colon 4. severe colitis, gastrointestinal bleeding 5. allergy to fentanyl or midazolam 6. American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher, 7. mental retardation 8. regular use of narcotics 9. pregnancy 10. refusal to provide a written informed consent.

Primary outcomes:
measure: Sedative Doses of Fentanyl
timeFrame: On the day of endoscopic procedures.
measure: Sedative Doses of Midazolam
timeFrame: On the day of bidirectional endoscopy procedures
Secondary outcomes:
measure: Overall Duration of BDE Examinations
timeFrame: On the day of bidirectional endoscopy
Other outcomes:
Locations:
Study officials:
affiliation: Evergreen General Hospital, Taiwan
name: Chi-Liang Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01361412: Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy
Official title: An Optional Research Study to Identify Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy in Subjects Already Enrolled in Clinical Study TR002
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ragweed Allergy
Keywords: ragweed allergy
immunotherapy
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
name: Cetero Research, San Antonio
First posted: 2011-05-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.


Eligibility criteria: Inclusion Criteria:

* Enrolled in study TR002 but have not yet commenced dosing

Exclusion Criteria:

* None; no criteria additional to TR002 exclusion criteria are applicable to this study

Primary outcomes:
measure: Identification of potential plasma biomarkers of response to peptide immunotherapy
timeFrame: 6 months after start of dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: Cetero Research, San Antonio
name: Deepen Patel, MD, CCFP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03668912: Guided Participation Discharge Program for Very Preterm Infants
Official title: Feasibility of a Guided Participation Discharge Program for Very Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Very Premature Baby
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 30
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed at investigating the feasibility of a new guided participation (GP) discharge program for parents of very preterm infants. A randomized controlled trial was conducted in a neonatal intensive care unit. The intervention included three structured GP sessions and one follow-up phone call. The control group received usual care. Outcomes measured included parents' efficacy and satisfaction with parenting, and perceived stress. Data collection was conducted at baseline, on day of discharge, after the follow-up phone call, and 1 month after discharge. The outcomes were analyzed on the basis of intention-to-treat principles.


Eligibility criteria: For Infants:

Inclusion Criteria:

- A gestational age of ≤32 weeks at birth

Exclusion Criteria:

* Have congenital malformation(s)
* Need to undergo a major surgery

For Parents:

Inclusion Criteria:

- Must be the infant's primary caregiver

Inclusion Criteria:

- Diagnosed with a mental illness

Primary outcomes:
measure: Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks
timeFrame: Baseline, and at 3-, 4-, and 8-weeks after baseline
Secondary outcomes:
measure: Parents' change in score of Perceived Stress Scale from baseline to up to 8 weeks
timeFrame: Baseline, and at 3-, 4-, and 8-weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatrics, Prince of Wales Hospital
name: lsy307@ha.org.hk Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee SY, Chau JPC, Choi KC, Lo SHS. Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial. BMC Pediatr. 2019 Nov 4;19(1):402. doi: 10.1186/s12887-019-1794-y.
Clinical trial NCT00655512: Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound
Official title: Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream (Elidel® 1% Cream), Hydrocortisonacetat 1% Cream (Hydrogalen® Cream), Betamethasonvalerat 0,1% Cream (Betagalen® Cream) and Clobetasol-17-propionat 0,05% Cream (Clobegalen® Cream) Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound - a Single Blind, Placebo-controlled, Randomized, Monocenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pimecrolimus
hydrocortison
betamethasone
clobetasol-17-Propionat
Optical Coherence Tomography
skin healthy probands
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2008-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream


Eligibility criteria: Inclusion Criteria:

* male and female probands age between 18-40 years
* skin healthy
* skintype I-III according to Fitzpatrick

Exclusion Criteria:

* women of childbearing potential without adequate contraception
* pregnant or breastfeeding
* genetic defect of epidermal barrier
* external or systemic treatment with drugs, which probably have an effect to the thickness of skin or to the production of teleangiektasien within the last 6 month before study entry
* skin disease, which hinder the evaluation with OCT, ultrasound or dermaphot
* UV treatment within the last 4 weeks before study entry
* participation to another clinical trial within the last 30 days before study entry
* allergy against pimecrolimus or hydrocortison or betamethasonvalerat or Clobetasol-17-propionat
* severe systemic diseases; ongoing immunosuppressive treatment
* planned vaccination should realize before study entry or 28 days after end of treatment

Primary outcomes:
measure: thickness of epidermis
timeFrame: 9 times in 4 weeks
Secondary outcomes:
measure: atrophogenic effect assessed by dermaphot
timeFrame: 9 times in 4 weeks
measure: moisture of skin assessed by corneometer
timeFrame: 9 times in 4 weeks
measure: transpire of skin assessed by tewameter
timeFrame: 9 times in 4 weeks
measure: thickness of dermis
timeFrame: 9 times in 4 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Dermatology, Medical Faculty, TU Dresden
Study officials:
affiliation: Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
name: Roland Aschoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02484612: Exercise Intensity and Appetite in Adolescents
Official title: Effect of Acute Exercise Intensity on Energy Intake in Adolescents: Effect of Weight Status
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: Université Blaise Pascal, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 30
Sex: MALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Acute exercise has been shown to affect subsequent energy intake in obese adolescents. Indeed, it has been shown several times that an intensive bout of exercise (above 70% of the individual maximal capacities) can reduce energy intake at the following meal in obese adolescents, with no modification of his appetite feelings.

Although this results has been replicated several times, it remains unknown if those nutritional adaptations are due to post-exercise modifications of some gastro-peptides implicated in appetite control, as detailed in adults.

The aim of this work is to question whether or not post-exercise energy intake is explained by appetite-regulating hormones that are affected by the exercise bout in both lean and obese youth.

Detailed description: After an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations:

* anthropometric measurements
* Body composition assessed by dual energy x-ray absorptiometry
* Maximal aerobic test

They will then randomly complete the following conditions:

* CON: a control day without exercise;
* HIE: an exercise day with an exercise set at 75% of the capacities
* LIE: an exercise day with an exercise set at 40% of the capacities

The exercises or the rest condition will be done by the end of the morning and a buffet meal will be proposed during which the participants will be asked to eat as much as wanted.

Blood samples will be drawn before, after, 15 after and 30 minutes after the exercise to assess the main appetite regulating hormones involved in appetite regulation (PYY, Cholecystokinin ...) appetite feelings will be assessed throughout the day at regular interval using visual analogue scales.

Eligibility criteria: Inclusion Criteria:

* 12 to 15 years old adolescents
* Obese according to international values for BMI
* Being registered to the national social security insurance
* no eating disorders
* no medications
* metabolic disorders

Exclusion Criteria:

* metabolic disorders
* food disorders
* physical disability

Primary outcomes:
measure: energy intake in kcal
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00805012: Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)
Official title: A Randomized, Multicenter, Phase II Study of Docetaxel and TS-1 Combination as a First-line Treatment in Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: S-1
docetaxel
head and neck cancer
Recurrent or metastatic head and neck squamous cell carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Clinical Research Center for Solid Tumor, Korea
First posted: 2008-12-09
Enrollment: 96
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: To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma


Eligibility criteria: Inclusion Criteria:

* histologically confirmed HNSCC
* adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx)
* at least one measurable lesion
* no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted)
* 18 years or older
* ECOG 0 or 1
* adequate laboratory result
* written, informed consent

Exclusion Criteria:

* pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing)
* experimental drug clinical trial within 30 days
* other malignancy (exemption: treated basal cell carcinoma of skin, CIS, cured cancer with disease-free interval with more than 5 years)
* patient with organ transplantation
* grade 2 or more peripheral neuropathy
* grade 2 or more hearing loss
* severe, medical condition

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: progression-free survival
measure: duration of response
measure: overall survival
measure: safety
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03351881: Evaluation of Attitudes Towards Organ Donation in Individualistic or Collectivistic Countries
Official title: Nudging Policies in Asia: Evaluating Singapore's Opt-out System for Organ Donation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opt Out
Opt In
Opt Neutral
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: People make decisions every day, both for themselves and on behalf of others. In the case of organ donations, despite the opt-out systems used in Singapore where the default is a presumed consent on the part of the individual, the actualized donation rate is lower than expect. This is partially because family members are called in to make surrogate decisions on behalf of the patient, especially patients near brain death or have been certified to be brain dead.

To address the shortfall in organ donations, the investigators plan to run three studies:

* First, the investigators seek to conduct a representative survey of the public's perception towards organ donation. The investigators will focus on their views towards donating their own vs. family members' organs, and to explore the role of cultural influences on decision-making.
* Second, the investigators will conduct the survey focusing on NUS students and the ways they respond to an opt-out, opt-in, or mandatory organ donation system.
* Third, the investigators will conduct the survey on an online platform (MTurk) to gather the views of participants across India and USA about organ donation.

The studies have the potential to improve actualized organ donation rates, as well as to inform the medical community in their communication with family members.


Eligibility criteria: Inclusion Criteria:

* Research participants should be above the age of 21, able to understand English fully, and have no active mental disorder or intellectual impairment.

Exclusion Criteria:

* Below the age of 21, unable to understand English fully, or have active mental disorder or intellectual impairment.

Primary outcomes:
measure: Decision to Donate Organ
timeFrame: At the point of the survey, right after participants have read about the organ donation policy condition which they have been assigned.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References: