louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05166720: Application of the Best Evidence of Neonatal Individualized Developmental Care Assessment Program (NIDCAP) in Very Low Birth Weight Infant (VLBWI)
Official title: Clinical Application of the Best Evidence of NIDCAP in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NIDCAP
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 14
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In order to help THE GROWTH and development of VLBWI in Neonatal Intensive Care Unit (NICU) and reduce the interference of external environment to them, we summarized the best evidence of NIDCAP care, and applied the evidence to the intervention group, and observed the compliance of nurses in the intervention group to the application of evidence, and the short-term outcomes of VLBWI.


Eligibility criteria: Inclusion Criteria:

* Birth weight \<1500g;
* admit within 24 hours of birth;
* The guardian signs the informed consent;
* OI (oxygenation index \>300)

Exclusion Criteria:

* Newborn with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
* Newborn who did not achieved discharge or death at the end of the study period

Primary outcomes:
measure: Mean length of stay of VLBWI
timeFrame: From the day the VLBWI admitted to the day VLBWI discharged, about two months.
Secondary outcomes:
measure: Nurse compliance with NIDCAP evidence content
timeFrame: From the beginning of the NIDCAP intervention to the end of the NIDCAP intervention, about three months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06863220: Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome
Official title: Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Keywords: Interstitial Cystitis
bladder pain syndrome
ozone therapy
intravesical ozone
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of intravesical ozone therapy in 60 patients with interstitial cystitis (IC). Participants were assigned to ozone therapy, placebo, or standard care groups for 3 weeks, with follow-up at 6 weeks. The primary outcome was the change in O'Leary-Sant ICSI score. Secondary outcomes included VAS pain score, SF-36 physical health, and urinary frequency.

Detailed description: Patients received either 50 mL ozonated saline (20-40 µg/mL), normal saline (placebo), or continued standard care twice weekly for 3 weeks. Assessments were conducted at baseline, week 3, and week 6. The study aimed to determine if ozone therapy reduces interstitial cystitis symptoms compared to placebo and standard care.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Histopathologically or clinically confirmed IC (per AUA guidelines)
* Symptoms for at least 6 months
* Willing to provide informed consent

Exclusion Criteria:

* Active urinary tract infection
* Bladder malignancy
* Pregnancy or breastfeeding
* Known ozone allergy
* Intravesical therapy within 3 months
* G6PD deficiency

Primary outcomes:
measure: Change in O'Leary-Sant ICSI Score
timeFrame: Baseline to Week 3
Secondary outcomes:
measure: VAS pain score
timeFrame: baseline to week 3
measure: Change in Daily Urinary Frequency
timeFrame: baseline to week 3
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Başakşehir Çam Ve Sakura Şehir Hastanesi
Study officials:
References:
citation: Pires MV, de Lima CJ, Carvalho HC, Moreira LH, Fernandes AB. Effectiveness of intravesical ozone in interstitial cystitis by the O'Leary-Sant symptom index. Int Urogynecol J. 2023 Jul;34(7):1437-1446. doi: 10.1007/s00192-022-05383-3. Epub 2022 Oct 15.
Clinical trial NCT02946320: Optimal Predilatation Technique for BVS Implantation
Official title: Optimal Predilatation Technique for BVS Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Stenosis
Keywords: PCI, bioabsorbable scaffold
Lead sponsor: Cardiology Center Agel
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 45
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 determine the optimal way of predilatation for BVS implantation.

Detailed description: Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).

Eligibility criteria: Inclusion Criteria:

* patients undergoing percutaneous coronary intervention (PCI)
* lesion no more than 25 mm in length with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment

Exclusion Criteria:

* patients with acurate myocardial infarction (STEMI)
* patients with specific complex lesion features (left main, aorto ostial, bifurcation with side branch ≥ 2 mm in diameter, extreme angulation proximal or within the target lesion, moderate or heavy calcification proximal or within the target lesion, chronic total occlusion)

Primary outcomes:
measure: Minimal lumen area (MLA) in the BVS (mm2)
timeFrame: Immediately after BVS implantation
Secondary outcomes:
measure: Clinically - driven target vessel revascularization
timeFrame: 12 months after the procedure
measure: Eccentricity index
timeFrame: Immediately after BVS implantation
measure: Expansion index
timeFrame: Immediately after BVS implantation
Other outcomes:
Locations:
Study officials:
affiliation: Cardiology Center AGEL a.s.
name: Ivo Varvařovský, MUDr, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04420520: Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools
Official title: Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Molar Incisor Hypomineralization
Keywords: MIH
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 135
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian children in Fayoum governorate schools.

Brief summary: Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools via clinical examination.

Participants from primary and preparatory schools in Fayoum governorate will be included in the study and Clinical examination will be carried out in the school laboratory or an empty class, in day light for both genders.

Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.

The results of the study will be regularly monitored by the supervisors who will have full access to these results.


Eligibility criteria: Inclusion Criteria:

* Acceptance for participation in the study.
* Eruption of four first permanent molars.
* Eruption of four permanent maxillary and mandibular incisors.
* Both genders.

Exclusion Criteria:

* Uncooperative children.
* Children with orthodontic appliances.
* Children with systemic diseases which may affect teeth development.
* Children suffering from any other type of enamel defect as enamel hypoplasia and amelogenesis imperfecta.

Primary outcomes:
measure: Prevalence of Molar Incisor Hypomineralization
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03188120: Specific Use-Result of Spiriva Respimat® in Asthmatics
Official title: Specific Use-Result Surveillance of Spiriva Respimat in Asthmatics (Patients With Mild and Moderate Persistent Asthma)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-06-15
Enrollment: 193
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with mild to moderate persistent bronchial asthma

Brief summary: The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

Detailed description: The study is Post-Marketing Surveillance on the Long-Term Use of Spiriva Respimat in Japanese patients with mild to moderate persistent asthma. The patient population who receive Spiriva Respimat and the safety profile is not expected to change. This study can investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with mild to moderate persistent bronchial asthma
* Patient aged ≥ 15 years
* Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS treatment.

Exclusion Criteria:

* Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
* Patients who have been enrolled in this study before.

Primary outcomes:
measure: Number of Participants With Suspected Adverse Drug Reactions (ADRs)
timeFrame: From first drug administration until 30 days after last drug administration; up to 337 days
Secondary outcomes:
measure: The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd
Study officials:
affiliation: zzCDMJP_PV_PMS@boehringer-ingelheim.com
name: Yukako Ogi
role: STUDY_CHAIR
References:
Clinical trial NCT03701620: Heart Rate Variability in Children With Traumatic Brain Injury
Official title: Heart Rate Variability in Children With Traumatic Brain Injury and Neurological Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Child Development
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 15
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children requiring PICU admission after TBI

Brief summary: Using a prospective cohort of children admitted to the PICU, the investigators will determine HRV monitoring is feasible, if a decreased HRV in the 7 days following moderate or severe TBI in children is associated with a worse outcome 6 months post-TBI and investigate HRV as a tool that can predict adverse events (neurological crisis) within 2 days following TBI.

Detailed description: This is a single center prospective cohort study of 15 children \<18 years, admitted to the PICU at the CHU Sainte-Justine (CHUSJ) with moderate or severe TBI (\<24 hours). Neurodevelopment outcome of children will be evaluated 6 months post TBI.

Eligibility criteria: Inclusion Criteria:

* \<18 years
* admitted to the PICU at the CHUSJ
* moderate TBI (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8) as - - assessed 30 minutes after TBI or upon arrival in the emergency room
* written parental consent.

Exclusion Criteria:

* children fulfilling brain death criteria at the time of PICU admission (GCS 3 and loss of all brain stem reflexes)
* children with a pacemaker or with previously diagnosed arrhythmia (HRV monitoring not reliable)
* inflicted trauma (different underlying pathophysiology)
* patients or parents who do not speak or read English or French.

Primary outcomes:
measure: % of the time with reliable HRVmonitoring in children with TBI
timeFrame: 1 year
Secondary outcomes:
measure: Rate of adverse events preceded by a decreased HRV
timeFrame: 1 year
measure: HRV and neurological outcome
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT04557774: Cognitive Function of Alcoholic Compensated Liver Cirrhosis
Official title: Cognitive Function of Alcoholic Liver Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Liver Disease
Keywords: Hepatic encephalopathy
Liver cirrhosis
Cognition
Alcohol
BMI
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 110
Sex: ALL
Minimum age (years): 22
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of them are agree to provide it to investigation.

Brief summary: Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis

Detailed description: Hepatic encephalopathy (HE) is one of the important complications of liver cirrhosis (LC). HE exhibits alterations in cognitive, psychomotor-intellectual, emotional, behavioral, or fine-motor functions. Approximately 22-74 % of patients with non-fulminant HE have MHE with a frequency proportional to the patient age and the severity of the liver disease. Patients with MHE exhibit disability in most functional behaviors such as social connection, alertness, emotional behavior, sleep, work, and leisure.

Alcohol consumption itself has a toxic effect on the brain. It has been documented that there is a neuronal loss in the cerebral cortex, hypothalamus, hippocampus, septal region, and cerebellum of an alcoholic brain.

The major causes of LC are hepatitis B/C viral infection and chronic alcohol consumption. The most widely accepted theory of HE pathogenesis is that toxic substances derived from the gut affect cerebral function after liver dysfunction or portosystemic shunting. This proposed pathogenetic mechanism could apply to viral compensated LC. However, it is difficult to explain the development of MHE in patients with alcoholic LC in this manner.

Therefore, patients with alcoholic LC may have different cognitive dysfunction as compared to patients with viral LC.

Eligibility criteria: Inclusion Criteria:

* Those who agreed to participate in this study and signed a written consent
* Those who have no evidence of neurological impairment

Exclusion Criteria:

* Those who have decompensated liver cirrhosis
* Those who have a high MELD score (≥20)
* Those who have OHE during admission
* Those who have parients' refusal

Primary outcomes:
measure: Liver function
timeFrame: 10 years
measure: Cognitive function (Neuropsychological test)
timeFrame: 10 years
measure: BMI
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
state: Gangwondo
Study officials:
affiliation: Hallym University Medical Center
name: Ki Tae Suk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00569374: Safety and Tolerability of Modafinil for Methamphetamine Dependence
Official title: Safety and Tolerability of Modafinil for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Methamphetamine Dependence
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-12-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* not currently enrolled in a treatment program
* subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
* subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
* women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study

Exclusion Criteria:

* current diagnosis of alcohol, opiate, or sedative physical dependence
* ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
* history of schizophrenia, or bipolar type I disorder
* present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
* medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine, or desipramine)
* Current suicidality or psychosis
* liver function tests (i.e., liver enzymes) greater than three times normal levels
* pregnancy or breastfeeding

Primary outcomes:
measure: Heart Rate
timeFrame: Thrice weekly for 7 weeks
measure: Systolic Blood Pressure
timeFrame: Thrice weekly for 7 weeks
measure: Diastolic Blood Pressure
timeFrame: Thrice weekly for 7 weeks
measure: "Modafinil Side Effects Checklist"
timeFrame: Weekly for 7 weeks
measure: Anxiety as Measured by the Hamilton Anxiety Scale
timeFrame: Thrice weekly for 7 weeks
measure: Depression as Measured by the Hamilton Depression Scale
timeFrame: Thrice weekly for 7 weeks
Secondary outcomes:
measure: Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.
timeFrame: Thrice weekly for the first three weeks
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: Dr. Janette McGaugh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06048874: FNB in ACL Recon Under SA
Official title: Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under Spinal Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Femoral Nerve Block
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under spinal anesthesia.

Detailed description: This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with anterior cruciate ligament rupture from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo spinal anesthesia for arthroscopic anterior cruciate ligament reconstruction. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.

Eligibility criteria: Inclusion Criteria:

* individuals who are scheduled to undergo arthroscopic anterior cruciate ligament reconstruction surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.

Exclusion Criteria:

* who require simultaneous surgery for concomitant cartilage injury, medial meniscus tear, and lateral collateral ligament tear.
* who have previously undergone surgical treatment within the knee joint.
* who have declined to participate in the research.
* where medical, surgical, or anesthetic complications occurred during surgery.
* other cases deemed necessary by the researchers.

Primary outcomes:
measure: postoperative pain after 24hours
timeFrame: 24hours
Secondary outcomes:
measure: postoperative pain after 1, 3, 6, 12, 18, 48 hours
timeFrame: 1, 3, 6, 12, 18, 48 hours
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon-do
Study officials:
References: