louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00550706: Drug Utilization Prevalence in a Pediatric Care Medical Center
Official title: Drug Utilization Prevalence in a Pediatric Care Medical Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Diseases
Metabolic Diseases
Cancer
Keywords: Prescription point prevalence
Drug utilization
Define Daily Dose
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 567
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted children for medical treatment in two different pediatric departments

Brief summary: One year prospective analysis of drug utilization and prescription point prevalence of medications in a pediatric tertiary care university medical center. Off-label use of medications in the study population will be also registered.


Eligibility criteria: Inclusion Criteria:

* All admitted children receiving at least one prescribed or OTC medication.

Exclusion Criteria:

* All admitted children who do not get a prescribed or OTC medication.

Primary outcomes:
measure: Descriptive use of medications
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Norberto Krivoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03265106: A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Childhood R/R ALL and Lymphoma Subjects
Official title: A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Childhood Acute Lymphoblastic Leukemia and Lymphoma Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood
Refractory B-cell Acute Lymphoblastic Leukemia, Childhood
Relapsed/Refractory B-cell Lymphoma, Childhood
Lead sponsor: Shenzhen BinDeBio Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital of Fudan University
First posted: 2017-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in childhood patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.
* CD19+ leukemia or lymphoma
* Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
* Follicular lymphoma, previously identified as CD19+:
* Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
* ECOG result is 0, 1 or 2.
* With normal heart, liver and kidney functions.
* Negative serum DNA for EBV and CMV; negative antigen for HBV; negative serum antibody for HCV, HIV and syphilis.
* Negative in pregnancy test (female subject only).

Exclusion Criteria:

* ECOG result is 3, 4 or 5.
* Pregnant or lactating female
* Uncontrolled active infection
* Active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
* Previously treatment with any gene therapy products
* HIV infection
* Enrolled to other clinical study in the last 4 weeks.
* Subjects with systemic auto-immune disease or immunodeficiency.
* Subjects with CNS diseases.
* Subjects with secondary tumors.
* Subjects with tumor infiltration in liver, brain or GI tract.

Primary outcomes:
measure: Number of Participants With Adverse Events [Safety and Feasibility]
timeFrame: Study treatment until Week 24
Secondary outcomes:
measure: Overall Response [Efficacy]
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Shenzhen BinDeBio Ltd.
name: ZHONG HUA YANG
role: STUDY_DIRECTOR
References:
Clinical trial NCT00433706: Image Guided Radiation Therapy For Prostate Cancer
Official title: Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate adenocarcinoma treated by radiotherapy
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2007-02-12
Enrollment: 470
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate motion may lead to a mistargeting, which possibly decreases the local control. On the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive. The cost/effectiveness ratio is not well established, as well as the frequency of using such imaging during the course of radiation.


Eligibility criteria: Inclusion Criteria:

* prostate adenocarcinoma
* intermediate / high risk group
* N0 or N -
* treatment by conformal radiotherapy (including or not IMRT), with or without androgen deprivation

Exclusion Criteria:

* pelvic irradiation
* metal objects in the pelvis

Primary outcomes:
measure: Prostate position under the LINAC is checked by 3D OBI (mainly cone-beam imaging, CBI) performed before the fraction.
measure: To validate the optimal strategy of IGRT for prostate adenocarcinoma based on 2 and 5 year-disease free survival rates (events= biochemical failure or death).
Secondary outcomes:
measure: Rectal and bladder, acute and late toxicities (CTCAE, SOMA-LENT)
measure: Cost comparison and cost/effectiveness analysis
measure: 2 and 5 years clinical relapse free survival rates
measure: Lack of dose in the prostate in case of decreasing the CBI frequency (using the 1rst arm for testing)
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Renaud DE CREVOISIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03293706: Evaluation of Carbohydrates Part 2
Official title: Evaluation of Carbohydrates (CHO): Tolerance, Breath Hydrogen and Methane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Intestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2017-09-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal tolerance of carbohydrate blends.


Eligibility criteria: Inclusion Criteria:

* Males or non-pregnant females in good health.
* Eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.

Exclusion Criteria:

* Subject with any type of food allergy or with a known history of AIDS, hepatitis, diabetes, cardio-vascular disease or GI disease.
* Subject taking medication, or with any condition which might, in the opinion of the PI either make participation dangerous to the subject or to others or affect the results.

Primary outcomes:
measure: Breath hydrogen
timeFrame: 0 to 7 hours
Secondary outcomes:
measure: GI tolerance symptoms
timeFrame: 0 to 48 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc.
state: Ontario
Study officials:
affiliation: Abbott Nutrition
name: Vikkie Mustad, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01282606: Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
Official title: An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lumbar Vertebra Hernia
Keywords: Chemonucleolysis
Lumbar Vertebrae
Hernia
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
First posted: 2011-01-25
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.


Eligibility criteria: Inclusion Criteria:

* Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
* Patients assessed as positive in the SLR test.
* Patients with sciatica in either lower leg.
* Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.

Exclusion Criteria:

* Patients who have 2 or more lumbar disc herniations as assessed by MRI.
* Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI.
* Patients who have received nerve block within 3 weeks before screening.
* Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.

Primary outcomes:
measure: Adverse events
timeFrame: 52 weeks
Secondary outcomes:
measure: The leg pain
timeFrame: At each assessment time point
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: SKK
state: California
Study officials:
References:
Clinical trial NCT02283606: Sonoelastography of the Uterine Cervix Before Induction of Labor
Official title: Sonoelastography of the Uterine Cervix Before Induction of Labor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20-44 years old pregnant patients

Brief summary: The investigators aim to measure sonoelastographically the elasticity of the uterine cervix in pregnant patients at term before induction of labor and compare between patients with successful and failed inductions.

Detailed description: Softening of the uterine cervix in pregnant patients at term causes changes in its elasticity.these changes may affect success or failure in induction of labor.The elasticity of the uterine cervix is usually evaluated clinically and subjectively by vaginal examination (bishop's score) which is not very predictive.We aim to measure the elasticity quantitatively and objectively.The difference in strain, in the area of the internal os , is often illustrated by a color map, where low stiffness (soft tissue) is indicated in red, middle stiffness is in green and high stiffness (hard tissue) is in blue.The color maps will be compared between patients with successful and failed inductions.

Eligibility criteria: Inclusion Criteria:

* pregnant patients before induction of labor

Exclusion Criteria:

* pregnant patients undergoing caesaren section following induction of labor not in active labor

Primary outcomes:
measure: Elasticity of the uterine cervix as measured sonoelastographically in successful and failed inductions of labor
timeFrame: 48-72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Rami Aviram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04364906: Comparison of the Effects of QLB 2 and QLB 3 on Post-operative Analgesia in Cesarean Section Surgery
Official title: Comparison of the Effects of Quadratus Lumborum Block 2 and 3 (QLB 2 and QLB 3) on Post-operative Analgesia in Cesarean Section Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Acute Pain
Chronic Pain
Keywords: Regional Anesthesia
Acute and chronical pain
Quadratus Lumborum Blocks
Cesarean Section
Spinal Anesthesia
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the post-operative analgesic effects of quadratus lomborum block 2 and 3 (QLB 2, 3) in patients having cesarean section with spinal anesthesia. Spinal anesthesia will be performed to all patients for the surgery.

Detailed description: In this study, patients are divided into two groups. After the spinal anesthesia is performed and cesarean section surgery is over; QLB 2 block will be performed to patients in Group A ; while QLB 3 block will be performed to patients in Group B.

In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

Group A - Patients in group A will have QLB 2 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

Group B - Patients in group B will have QLB 3 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

Eligibility criteria: Inclusion Criteria:

* Being pregnant for at least 37 weeks
* Planning an elective cesarean operation
* Being between the ages of 18-45

Exclusion Criteria:

* ASA 3-4 patients with comorbitidies (Serious renal, cardiac, hepatic disease)
* Being operated with general anesthesia
* Obesity (\> 100 kg, BMI\> 35 kg / m2)
* Contraindication of regional anesthesia (quagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
* Hypersensitivity to local anesthetics or a history of allergy
* Patients with a history of opioid use longer than four weeks
* Patients with psychiatric disorders
* Patients with anatomic deformity
* Patients who do not want to participate

Primary outcomes:
measure: Opioid consumption in the first 24 hours after surgery
timeFrame: 1 day
Secondary outcomes:
measure: Post-operative acute pain
timeFrame: 1 day
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Faculty of Medicine
state: Other
Study officials:
affiliation: Ondokuz Mayıs University Faculty of Medicine
name: ERSİN KÖKSAL, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06979206: Effects of Binaural Beats on Inhaled Anesthetic Requirements During General Anesthesia in Pediatric Patients
Official title: Effects of Binaural Beats on Inhaled Anesthetic Requirements During General Anesthesia in Pediatric Patients: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: General Anesthesia
Children
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 68
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that continuously delivering binaural beats with a phase difference corresponding to the slow-delta frequency band during anesthesia in pediatric patients can clinically and significantly reduce the required dose of the commonly used inhalational anesthetic, sevoflurane. To test this hypothesis, the study will compare the average end-tidal concentration of sevoflurane between a group exposed to continuous binaural beats (approximately 1 Hz phase difference) during surgery and a control group not exposed to such auditory stimulation.


Eligibility criteria: Inclusion Criteria:

1. Pediatric patients under 3 years of age undergoing superficial surgery lasting more than 1 hour under general anesthesia (e.g., nevus excision, polydactyly/syndactyly surgery, dermoid cyst excision, thyroglossal duct cyst excision, preauricular fistula excision, inguinal hernia repair, orchiopexy, other mass excisions, strabismus surgery, etc.).
2. American Society of Anesthesiologists (ASA) physical status classification I or II.

Exclusion Criteria:

* Neonates or premature infants
* Children with hearing impairment or currently using hearing aids
* Children with neurological disorders
* Children with respiratory diseases
* Children undergoing neurosurgery or cardiac surgery
* Other patients deemed inappropriate for inclusion in the clinical trial at the discretion of the investigator or study staff

Primary outcomes:
measure: The average EtSevo (end-tidal sevoflurane concentration, vol%) maintained during surgery.
timeFrame: During surgery, more than 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03668106: Effect of Different Sperm Processing Methods in ICSI Outcome.
Official title: Effect of Different Sperm Processing Methods ( Swim up, Zeta, Sperm Gradient Centrifugation ) in ICSI Outcome. "A Sperm DNA Perspective"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Sperm DNA Fragmentation
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
First posted: 2018-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: swim up technique
Primary purpose: BASIC_SCIENCE

Brief summary: A total 180 semen samples from couples diagnosed with unexplained infertility were SDF index tested , then total 120 semen samples of patients' husbands with abnormal SDF index were randomly divided and then processed by swim up, sperm gradient centrifugation and Zeta methods. SDF and ICSI outcomes are monitored after semen processing.

Detailed description: A total 180 semen samples from couples diagnosed with unexplained infertility were SDF index tested , then total 120 semen samples of patients' husbands with abnormal SDF index were randomly divided and then processed by swim up (G1/ n=40), sperm gradient centrifugation (G2/ n=40) and Zeta (G3/ n=40) methods. SDF test was assessed by Halosperm kit, whereas sperm morphology was assessed by spermac stain according to strict criteria. Fertilization, division, blastulation, implantation and pregnancy rates will be tabulated and statistically tested.

Eligibility criteria: Inclusion Criteria:

* unexplained infertile couples for 2 years
* age from 20 years old to 37 years old

Exclusion Criteria:

* endometriosis cases
* uterine factors

Primary outcomes:
measure: Sperm DNA fragmentation
timeFrame: 30 minutes
Secondary outcomes:
measure: Oocyte fertilization rate
timeFrame: day 1
measure: Blastulation rate
timeFrame: day 5
measure: pregnancy rate
timeFrame: 15 days
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Ahmed Saad
state: Qalubiya
Study officials:
References:
Clinical trial NCT02216006: High Fresh Gas Flow After Intubation
Official title: High Fresh Gas Flow After Intubation - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Keywords: Atelectasis
Fresh gas flow
Prevention
Oxygenation
Anaesthesia
Lead sponsor: Region Västmanland
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Atelectasis is common during and after general anesthesia. Atelectasis develops early if preoxygenation with 100% oxygen is used and continuously used during induction until endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation maneuver immediately after confirming a successful intubation, reduces the area of atelectasis as investigated by computed tomography compared to a standard procedure.


Eligibility criteria: Inclusion Criteria:

* Healthy patients, American Society of Anesthesiology (ASA) I-II
* Patients scheduled for orthopaedic day case surgery in general anaesthesia

Exclusion Criteria:

* ASA class III or higher
* Body Mass Index (BMI) 30 or higher
* Arterial oxygen saturation (SpO2) \<94% breathing air
* Chronic Obstructive Pulmonary Disease (COPD)
* Ischemic heart disease
* Haemoglobin \<100g/L
* Known or anticipated difficult airway and/or intubation
* Active smokers and ex-smokers with a history of more than 6 pack years
* Need for interscalene or supraclavicular regional anaesthesia with risk of phrenic nerve paralysis

Primary outcomes:
measure: Atelectasis
timeFrame: Within 1-2 hours, just before emergence from anesthesia
Secondary outcomes:
measure: Arterial blood gases
timeFrame: Within 2-3 hours perioperatively
Other outcomes:
Locations:
city: Köping
country: Sweden
facility: Landstinget Västmanland
state: Västmanland
Study officials:
affiliation: Landstinget i Värmland
name: Mats Enlund, MD, PhD
role: STUDY_CHAIR
References: