louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03818048: Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy
Official title: Inhaled Sevofluran vs Endovenous Propofol for Sedation Maintenance in Patients Submitted to Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: sedation
colonoscopy
Lead sponsor: Centro Medico Docente la Trinidad
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 32
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: SUPPORTIVE_CARE

Brief summary: To compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy.

A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both, intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* physical status I, II and III according to the criteria of the American Society of Anesthesiology (ASA)
* patients who are going to undergo diagnostic colonoscopies
* patients who signed the informed consent

Exclusion Criteria:

* Allergy or hypersensitivity to some of the reference drugs in the study
* patients with proven liver disease
* suspicion or confirmation of pregnancy
* antecedent or risk of malignant hyperthermia
* fasting less than 8 hours
* patients with psychic disorders or mental incapacity that make it difficult to understand their participation in the study
* patients who have acute illnesses that compromise their health for which the study cannot be performed

Primary outcomes:
measure: Heart rate
timeFrame: During the colonoscopy - an estimated mean time of 20 minutes
measure: The Recovery Time
timeFrame: 30 min
measure: Propofol dosage
timeFrame: During the colonoscopy - an estimated mean time of 20 minutes
measure: arterial pressure
timeFrame: During the colonoscopy - an estimated mean time of 20 minutes
measure: oxygen saturation
timeFrame: During the colonoscopy - an estimated mean time of 20 minutes
Secondary outcomes:
measure: adverse reactions in patients
timeFrame: 1 day (postoperative)
measure: Endoscopist Satisfaction
timeFrame: 60 min
measure: Qualitatively assess patient comfort after sedation.
timeFrame: Up to 1 hour after completing the study.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00037648: Juvenile Rheumatoid Arthritis
Official title: A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open-label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuIL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Juvenile Chronic Arthritis
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2002-05-20
Enrollment: 86
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of anakinra in patients with Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting children.


Eligibility criteria: * Male or female age 2-17 yrs inclusive \* Minimum weight 10 KG \* Diagnosis of Chronic Arthritis

Primary outcomes:
measure: The primary outcome of the study was to evaluate the safety of anakinra
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02610348: Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of Age
Official title: Persistence of Anti-Hep B Antibodies at 12 to 18 Months of Age in Children Having Received Hep B Vaccine at Birth and a DTaP-IPV-HB-Hib Hexavalent Vaccine (Hexaxim® or Infanrix Hexa®) Concomitantly With Prevnar® at 2, 4 and 6 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Keywords: Hepatitis B
Hexaxim®
Hexyon®
Hexacima®
Prevnar®
DTaP-IPV-HB-Hib hexavalent vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 122
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Primary Objective:

To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.

Detailed description: Sera from subjects who have participated in study PNA19 trial (NCT00594347) and for whom parents or legal representatives had given authorization to use the sera taken from their child will be used for this study.

Eligibility criteria: Inclusion Criteria:

* Subjects having received 4 Hep B doses in A3L12 (i.e. one dose at birth + three doses during study at 2, 4 \& 6 months of age)
* Subjects having participated in PNA19
* Subject's parents having given authorization to use serum collected in PNA19 for future research
* The initials, birth date, and gender of the subject are consistent between A3L12 and PNA19 databases
* Subjects for whom retention sera are of enough volume to allow a valid determination of the HBsAg antibody level.

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kosalaraksa P, Chokephaibulkit K, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S, B'Chir S, Da Costa X, Vidor E. Persistence of hepatitis B immune memory until 9-10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP approximately T vaccination at 2, 4 and 6 months. Hum Vaccin Immunother. 2018 May 4;14(5):1257-1265. doi: 10.1080/21645515.2018.1426418. Epub 2018 Feb 21.
Clinical trial NCT03244748: Amiodarone Usage After Ischemic Ventricular Tachycardia Ablation
Official title: Effect of Amiodarone After Ischemic Ventricular Tachycardia Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Cardiomyopathy
Ventricular Tachycardia
ICD Shock
Lead sponsor: Yuksek Ihtisas Hospital
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We enroll ischemic heart failure patients who had frequent ventricular arrhythymias causing multiple shocks.

Brief summary: Ventricular Tachycardia ablation in ischemic cardiomyopathy patients is required procedure in cases when anti-arrhythmic drugs failed. The concern is if adjunctive continuation amiodarone after ablation is needed.

Detailed description: Ischemic cardiomyopathy patients have implantable cardioverter defibrillators (ICD) to prevent arrhythmic deaths. Ventricular tachycardia (VT) events with frequent ICD interventions in ischemic cardiomyopathy patients is encountered frequently. Frequents ICD interventions is associated with worse outcomes. Anti-arrhythmic drugs ,mostly amiodarone, are given prevent ventricular arrhythmias and ICD interventions that may not be curative. Ablation of ventricular tachycardia is the suggested treatment when anti-drugs are without effect. After ablation of ventricular arrhythmia the continuation of amiodarone is not well elucidated.

In this study we aimed to enroll ischemic cardiomyopathy patients having frequent ICD interventions despite medical treatment. VT ablation is performed and patients divided into two groups; group one continues having amiodarone after ablation, group two does not have amiodarone after ablation. Both groups will be compared in terms of recurrence and death.

Eligibility criteria: Inclusion Criteria:

Ischemic cardiomyopathy patients applied with frequent ICD interventionor electrical storms and having ejection fraction below 50%. Frequent ICD defined as more than 1 ICD intervention within month. Electrical storm defined as more than 2 ICD intervention within one day.

Exclusion Criteria:

Patients with cardiomyopathies other than ischemic etiology

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Turkiye Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: MD
name: Firat Ozcan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01947348: Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
Official title: Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Institute of Regenerative and Cellular Medicine
Sponsor class: INDUSTRY
First posted: 2013-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction) has an effect on pain and inflammation associated with Osteoarthritis.

Detailed description: This is a prospective non-randomized, clinical study of 30 patients to determine safety and treatment potential of A3(Adult Autologous Adipose) SVF for the pain and inflammation associated with Osteoarthritis.

Patients will be treated for Osteoarthritis due to degeneration or chronic injury. They will be given autologous SVF extract derived by the A3 method mixed with activated platelets from a PRP(platelet rich plasma) preparation as direct injections to the effected joints. Outcomes will be tracked with WOMAC (Western Ontario and McMaster Universities Arthritis Index), AUSCAN(Australian Hand Osteoarthritis Index) scores, and a general blood panel in order to evaluate systemic effects.

Eligibility criteria: Inclusion Criteria:

* Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
* Patients range from 15-90 years of age.
* Female patients not pregnant or lactating.
* Patients with a history of or current corticosteroid therapy will only be eligible if use is suspended from 1 month prior to cell therapy.
* Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
* Patients with adequate renal function, creatinine ≤ 1.5 mg/dl.
* Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT \<1.5×control.

Exclusion Criteria:

* Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
* Signs and symptoms of clinically significant cardiac disease.
* Diagnosis of a transient ischemic attack in the 6 months prior to screening,
* Known allergy to anesthetic or any other components of study.
* Patients infected with hepatitis B, C or HIV.
* Patients with Body Mass Index (BMI) \> 39kg/m2 .
* Any other cardiovascular illness that in the opinion of the investigator would render a patient unsuitable to participate in the study.

Primary outcomes:
measure: Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel
timeFrame: one year
Secondary outcomes:
measure: Pain and Mobility Assessment
timeFrame: one year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dr John Huh
state: California
Study officials:
affiliation: Institute of Regenerative and Cellular Medicine
name: Barbara Krutchkoff
role: STUDY_CHAIR
affiliation: ICMS
name: John Huh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03476148: Home Rehabilitation Using Interactive Device Versus Inpatient Rehabilitation in Total Knee Arthroplasty
Official title: Effect of Home-Based Rehabilitation Using Interactive Motion Tracking Device on Function and Patient Satisfaction After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Arthroplasty
Rehabilitation
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rehabilitation after total knee arthroplasty is very important in terms of range of motion of the knee, muscle power, normal gait, pain control and consequently the patient's satisfaction. Convectional rehabilitation methods in assist of therapist required high demand of resources. Recently, outpatient clinic or tele-communication tool based rehabilitations were investigated and reported equivalent results. However, those methods also required group or one-to-one facing that restricted availability of the exercise.

With development of the motion tracking technology, new device that gives real time feedback with augmented reality images can be used for rehabilitation in home-based setting.

This study aims to compare the clinical outcomes after the rehabilitation by interactive home-based device or conventional inpatient setting.

Detailed description: The objective of this work is to compare the pain, stiffness, function and satisfaction between groups at 6 months after the total knee arthroplasty.

The investigators hypothesized that the clinical outcomes of rehabilitation by interactive home-based device are not inferior than that by conventional inpatient setting.

The study design is a single-blind non-randomized controlled trial. Patients takes different rehabilitation method but the outcome assessor is blinded. The clinical outcome is compared at preoperative, postoperative 6weeks, 3months. And clinical outcome consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index ) score, Knee Society Score, Time-up-go (TUG) test.

Eligibility criteria: Inclusion Criteria:

* over 19 year old
* Patients for total knee arthroplasty of one knee
* Patients who can understand and utilize the device

Exclusion Criteria:

* who don't agree with participation of the study
* who can not understand and utilize the device
* Rheumatoid arthritis, Other inflammatory arthritis
* Neuropsychiatric patients

Primary outcomes:
measure: Change in Western Ontario and McMaster Universities Index(WOMAC index)
timeFrame: preoperative, postoperative at 6, 12 weeks
measure: Change in Knee Society Score
timeFrame: preoperative, postoperative at 6, 12 weeks
measure: Change in Time-Up-Go (TUG) test
timeFrame: preoperative, postoperative at 6, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02945748: Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability
Official title: Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic Instability
Keywords: pediatric
cardiac output
fluid responsiveness
critically ill
hemodynamic monitoring
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric critically ill ventilated patients addmited to PICU \& PCICU

Brief summary: Hemodynamically unstable ventilated PICU \& PCICU patients, which a decision for commencement in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic measurements will be carried out before and after therapy have been made, including customary hemodynamic parameters, echocardiography and USCOM studies.

All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction. Trend in USCOM parameters will be compared to echocardiography CO parameters.


Eligibility criteria: Inclusion Criteria:

* Pediatric critically ill ventilated patients admitted to PICU \& PCICU
* Hemodynamically unstable which a decision for commencement in inotropic therapy or fluid bolus has been made
* parental concent

Exclusion Criteria:

* Cardiac shunt
* Aortal anomaly \\ Repair
* Tracheostomy
* Parental refusal to participate

Primary outcomes:
measure: Raise>10% in cardiac index following therapy
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Petach tikva
country: Israel
facility: Schneider's children medical center
Study officials:
References:
Clinical trial NCT01734226: Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Constipation
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Prunus Mume Extract on Improvement of Constipation. The investigators measured Improvement of Constipation parameters , including Colonic Transit Time, number of bowel movement, defecation time, stool type, color and stool amounts per defecation, and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 19-40 years old
* Subject who have functional constipation by ROME IIII criteria
* Subject who have over 36 hour colonic transit time
* Able to give informed consent

Exclusion Criteria:

* Subject who have Irritable bowel syndrome by ROME IIII criteria
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in Colonic Transit Time
timeFrame: 8 weeks
measure: Changes in number of bowel movement
timeFrame: 8 weeks
measure: Changes in defecation time
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in stool type
timeFrame: 8 weeks
measure: Changes in stool color
timeFrame: 8 weeks
measure: Changes in stool amounts per defecation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT06806826: The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study
Official title: Evaluatıon of the Effectıveness of Omalızumab Treatment In Patıents Wıth Allergıc Rhınıtıs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: allergic rhinitis
omalizumab
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between December 2018 and November 2019, 25 patients with both allergic rhinitis and chronic urticaria and 25 patients with allergic rhinitis only were included in the study. Patients with both allergic rhinitis and chronic urticaria received Omalizumab (300 mg/month) (Omalizumab group), while patients with allergic rhinitis received Montelukast 10 mg plus Desloratadine 5 mg daily (Desloratadine group). In addition, both groups received fluticasone propionate nasal spray (100 mcg/day in each nostril). At baseline and 8-10 weeks after the start of treatments (follow-up), allergic rhinitis symptoms such as nasal congestion, rhinorrhea, sneezing, and itchy eyes and quality of life were assessed. A self-report measure, a 10-cm linear visual analog scale (VAS), was used for the assessments.
Primary purpose: TREATMENT

Brief summary: We aimed to evaluate the usability and efficacy of omalizumab in allergic rhinitis and its potential as an alternative treatment option.

Detailed description: The study was conducted to determine the effectiveness of omalizumab on symptoms in patients diagnosed with allergic rhinitis and to compare it with current medical treatment options.

Eligibility criteria: Inclusion Criteria:

* Those who gave informed consent and wanted to participate in the study and did not have any additional systemic or nasal diseases were included.

Exclusion Criteria:

* under 18 years old,
* over 65 years old,
* with systemic comorbidities (diabetes mellitus, hypertension, chronic renal failure, hypothyroidism, etc.)
* patients with rhinosinusitis, nasal polyps, nasal septal deviation, tumors, smoking and nasal surgery, and non-compliant patients were excluded from this study.

Primary outcomes:
measure: omalizumab treatment process
timeFrame: Patients were followed up for 3 months after starting treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Yuzuncu Yıl üniversity dursun odabaş medical center
state: Tuşba
Study officials:
References: