louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03139318: Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Official title: Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteosarcoma in Children
Radiation Toxicity
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 1
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.

Detailed description: Subjects will receive GRID radiotherapy. GRID radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. This protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.

Eligibility criteria: Inclusion Criteria:

* History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
* 5-21 years of age.
* Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
* Informed consent is obtained

Exclusion Criteria:

* Females with a positive urine pregnancy test.
* Unable to comply with study procedures

Primary outcomes:
measure: Number of Participants With Toxicities Associated With GRID Radiotherapy
timeFrame: An average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Leslie Harrell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04790318: Trans-incisional Quadratus Lumborum Block Versus Caudal Analgesia in Pediatric Open Renal Surgeries.
Official title: Trans-incisional Quadratus Lumborum Block Versus Caudal Analgesia in Pediatric Open Renal Surgeries, a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is scare literature about the usage of QLB in pediatric population, particularly the trans-incisional approach. Hence, the purpose of this study is to compare the postoperative analgesic efficacy of ultrasound-guided caudal epidural block versus ultrasound-guided QLB (trans-incisional) in combination with general anesthesia in pediatric patients undergoing elective open renal surgeries regarding pain scores, total analgesic consumption, and adverse effects.


Eligibility criteria: Inclusion Criteria:

1. patients who will be scheduled for indicated open pediatric renal surgery in the lateral decubitus position (nephrectomy, partial nephrectomy, pyeloplasty and nephrolithotomy for complex renal stones).
2. physical status American Society of Anesthesiologists (ASA) I or II.

Exclusion Criteria:

1. - patients whose guardians refuse to participate.
2. -ASA physical status \>II. 3-patients who have contraindications to regional analgesic procedures. 4-patients who have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological).

5-spine or chest wall deformity. 6-History of previous renal surgeries. 7-Coagulation abnormalities. 8-Infection at the injection site. 9-An allergy or contraindications to the drugs used in the study.

Primary outcomes:
measure: First time to analgesic requirement
timeFrame: 1st 24 hour
Secondary outcomes:
measure: total analgesic consumption
timeFrame: 1st 24 hour
measure: Face, leg, activity, cry, consolability scale (FLACC)
timeFrame: 1st 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT00635518: Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants
Official title: Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Feeding
Keywords: Health Plan Implementation
Feeding and Eating Disorders of Childhood
Breast Feeding
Overweight
Child
Infant Nutrition Physiology
Public Health
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study Withdrawn
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.

Detailed description: A cluster randomized controlled trial. Twenty health care service sites were randomly assigned to the intervention or control groups. Health care workers of the intervention health care service sites received training based on the programme "Ten steps for healthy feeding for children from birth to two years old".

Pregnant women, in their third term, were enrolled in the study. At 6 and 12 months of age, the mothers were interviewed at home using a semi-structured questionnaire with pre-coded close- and open-ended questions and the children were evaluated.

Eligibility criteria: Inclusion Criteria:

- All pregnant women in the last quarter of the gestation.

Exclusion Criteria:

* HIV-positive mothers
* congenital malformation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Márcia R Vitolo, postdoctoral
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00307918: Acupuncture for Elevated Intraocular Pressure
Official title: Acupuncture Treatment for Elevated Intraocular Pressure: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Elevated Intraocular Pressure
Keywords: acupuncture, intraocular pressure, glaucoma
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Glaucoma is the leading cause of irreversible blindness in the world, resulting from progressive axonal destruction of the optic nerve. Primary open-angle glaucoma is the most common form, and it is usually painless with insidious onset. Conventional treatment is focused on lowering intraocular pressure (IOP), the one risk factor that can be modified, which has been demonstrated to protect against further damage to the optic-nerve head. Acupuncture is an ancient treatment which has been found to be beneficial for many ailments, and may reduce IOP. We propose a pilot study to evaluate whether acupuncture is an effective and safe modality for reducing elevated IOP in patients with open angle glaucoma and primary ocular hypertension. Patients with elevated IOP on tonometric measurement (20mmHg \< IOP \< 30mmHg) will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment. Treatment will last for four-weeks (for a total of 8 treatments), and patients will be evaluated for IOP diurnal curves at 2 weeks (4 treatment), 4 weeks (end of treatment ) and then 4 weeks following the last treatment.


Eligibility criteria: Inclusion Criteria:

patients of either gender; age 21 years and older; intraocular pressure equal/greater than 20mmHg, equal/less than 30mmHg; ability to comply with study protocol

Exclusion Criteria:

patients with secondary or closed-angle glaucoma; patients with a history of laser or other surgical treatment of glaucoma; patients displaying symptoms of depression, anxiety or psychosis

Primary outcomes:
measure: Intraocular pressure curves.
Secondary outcomes:
measure: safety of acupuncture treatment
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Dept. of Ophthalmology, Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Menachem Oberbaum, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06102018: Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine
Official title: Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasm Female
Keywords: Serum and Urine Biomarkers,Machine Learning,Diagnostic Model
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: early breast cancer(Tis,T1-3N0-1M0)

Brief summary: The goal of this observational study is to find the diagnostic biomarkers in serum and urine from early breast cancer patients. The main questions it aims to answer are:

* compare the different biomarkers in serum and urine from breast cancer patients, benign lesions and healthy population.
* construct the best diagnostic model by machine learning to distinguish breast cancer and non-breast cancer patients.

Participants, including breast and non-breast cancer patients will be asked to provides blood and urine during their diagnosis and treatment process without changing the original treatment. When necessary, specimens will be collected during the surgery，without affecting pathological diagnosis.


Eligibility criteria: Inclusion Criteria:

1. Signing the consent of informedness;
2. Patients with breast mass who need surgery after examination;
3. Cardiac ultrasound indicates that the blood score of the heart is within the normal range;
4. ECOG≤0-2 points;
5. Oversure function is acceptable.

Exclusion Criteria:

1. Merge other malignant tumors such as gynecologic oncology;
2. After evaluation, the internal organs are not suitable.

Primary outcomes:
measure: The different biomarkers in malignant and benign breast diseases
timeFrame: It is expected to be one to two years.
measure: Diagnostic models used different biomarkers by machine learning
timeFrame: Within half a year after the completion of the test.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02277418: Venner a.p. Advance Video Laryngoscope
Official title: Intubation of Child and Infant Manikins During Resuscitation. Does the Venner™ A.P. Advance™ Video Laryngoscope Improve Nurses' Performance?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Resuscitation
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the Venner a.p. advance video laryngoscope to Miller laryngoscope during resuscitation with and without chest compressions.

Detailed description: Endotracheal intubation (ETI) is a life-saving procedure performed daily in emergency medicine. The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. However, ETI with uninterrupted chest compression in patients can be a very difficult skill to acquire.

Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Time to intubation
timeFrame: 1 day
Secondary outcomes:
measure: Success of intubation
timeFrame: 1 day
measure: POGO score
timeFrame: 1 day
measure: VAS score
timeFrame: 1 day
measure: Cormack-Lehan scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04336618: Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population
Official title: Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Perspectum
Sponsor class: INDUSTRY
First posted: 2020-04-07
Enrollment: 67
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: Adult volunteers willing to get an MRI scan for the assessment of their liver

Brief summary: To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek interest in participating in future studies.

Detailed description: This is a Registry where there will be no intervention to the standard of care.Participants will be required to attend a single visit that will involve having a multi-parametric MRI at no cost to them. In addition, the invesigators will collect contact information of participants including their email address, phone number and house address so that they can be contacted to discuss possible participation in future studies which may be sponsored by Perspectum or third parties, such as pharmaceutical companies, the participants personal information shall never be shared with these third-parties. Additionally, the contact information of the participants medical providers shall be collected so that, if requested, their LMS reports can be used in their diagnostic pathway.

Imaging will be performed at two Touchstone Imaging locations, one in downtown Dallas and the other in Southlake.

A total of 100 participants will be enrolled over a period of 1 year.

Eligibility criteria: Inclusion Criteria:

* Male or female volunteers aged 18 years and over•
* Participant willing and able to give informed consent for participation in the registry.

Exclusion Criteria:

* The participant may not enter the Registry if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria at the imaging center including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).

Primary outcomes:
measure: To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek their interest in participating in future studies
timeFrame: 12 months
Secondary outcomes:
measure: To use multi-parametric MRI (LMS) of the liver to assess the volunteer's liver health
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Perspectum Inc.
state: Texas
Study officials:
References:
Clinical trial NCT03326518: A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44
Official title: An Open, Randomized, Controlled, Single Centre Trial to Evaluate CT Image Quality and Diagnostic Feasibility of Lumentin® 44, in Comparison With Omnipaque and Movprep.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Subjects Referred to CT-examination of the Abdomen
Lead sponsor: Lument AB
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining) will be compared by the three contrast agents.


Eligibility criteria: Inclusion Criteria:

* Subjects of either gender at least 18 years at the time of signing the informed consent.
* Having a clinical indication for CT-examination of the abdomen

Exclusion Criteria:

* IV administration of iodine is contraindicated
* Known allergy to egg albumen
* Clinical suspicion, according to medical record, of fistula formation and/or leakage
* Referral indication of small bowel disease(s)
* Having known manifest thyrotoxicosis
* Having known phenylketonuria
* Having known Glucose-6-phosphatase deficiency

Primary outcomes:
measure: Relative Mean Difference in Contrast Density
timeFrame: Day 1
Secondary outcomes:
measure: Bowel Filling Properties, Extension
timeFrame: Day 1
measure: Bowel Filling Properties, Distension
timeFrame: Day 1
measure: Diagnostic Ability When Examining Abdominal CT
timeFrame: Day 1
measure: Degradation of Contrast Agent (Lumentin® 44)
timeFrame: Day 1
measure: Subjects' Assessment of Taste of the Contrast Agent
timeFrame: Day 1
measure: Subjects' Assessment of Smell of the Contrast Agent
timeFrame: Day 1
measure: Subjects' Assessment of Consistency of the Contrast Agent
timeFrame: Day 1
measure: Subjects' Assessment of Ability to Swallow the Contrast Agent
timeFrame: Day 1
measure: Subjects' Assessment of Fullness After Drinking the Contrast Agent
timeFrame: Day 1
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of medical imaging and function
Study officials:
affiliation: Skanes University Hospital
name: Peter Leander, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leander P, Stathis G, Casal-Dujat L, Boman K, Adnerhill I, Marsal J, Book O, Fork T. A novel food-based negative oral contrast agent compared with two conventional oral contrast agents in abdominal CT: a three-arm parallel blinded randomised controlled single-centre trial. Eur Radiol Exp. 2022 Apr 5;6(1):15. doi: 10.1186/s41747-022-00267-z.
Clinical trial NCT05086718: Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap
Official title: Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media Without Posterior Meatal Flap
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tympanic Membrane Perforation
Lead sponsor: Combined Military Hospital Quetta
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 300 cases of dry perforation CSOM
Primary purpose: TREATMENT

Brief summary: Composite Cartilage Perichondrium Graft for tympanoplasty in chronic suppurative otitis media (CSOM) Air Bone Gap (AB Gap) Closure will be taken as successful outcome Endoscopic technique without posterior meatal flap elevation

Detailed description: 300 eligible cases of dry CSOM will under go Composite Cartilage Perichondrium Graft tympanoplasty. Air Bone Gap Closure will be taken as successful outcome. The procedure will employ endoscopic technique without posterior meatal flap elevation.

Eligibility criteria: Inclusion Criteria:

1. Both genders between 21 to 55 years
2. Dry chronic suppurative otitis media
3. Air bone gap between 15 to 25 Deci bel

Exclusion Criteria:

1. Discharging ear
2. Pediatric population
3. Ossicular Necrosis
4. Previous ear surgery

Primary outcomes:
measure: Successful air bone gap closure on pure tone audiometry
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: CMH Quetta
state: Balochistan
Study officials:
References:
citation: Akyigit A, Sakallioglu O, Karlidag T. Endoscopic tympanoplasty. J Otol. 2017 Jun;12(2):62-67. doi: 10.1016/j.joto.2017.04.004. Epub 2017 Apr 28.
Clinical trial NCT01640418: Prevention of Sacral Pressure Ulcers With Preventive Dressings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grade I to Grade IV Pressure Ulcers in Higher Risk Patients
Keywords: pressure ulcer
dressing
prevention
higher risk patients
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-07-13
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk hospitalized patients?


Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years
* Admission in one of the ten high-risk departments of the azM
* Suspected hospital stay of 5 days or more after admission
* Braden score 19 or less

Exclusion Criteria:

* Age: \<18 years
* Pre-existing sacral pressure ulcer
* Pre-existing trauma to the sacrum
* Patient is unable to speak Dutch
* Patients with an inability to give informed consent
* Patients who are unable to give informed consent within 24h after admission
* Patients who are unable to give informed consent before surgery

Primary outcomes:
measure: To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B).
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academic Hospital of Maastricht
Study officials:
affiliation: Academic Hospital of Maastricht
name: Nicole Bouvy
role: PRINCIPAL_INVESTIGATOR
References: