louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00917319: Prevention and Control of Healthcare-Associated Infections
Official title: Randomized Controlled Study on Effectiveness of Implementing Bundling Infection Control Interventions for Prevention and Control of Healthcare-Associated Infections in General Medical Wards at Siriraj Hospital, Bangkok, Thailand
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nosocomial Infection
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 2000
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: Bundling infection control interventions should decrease incidence of Healthcare-Associated Infections in General Medical Wards at Siriraj Hospital, Bangkok, Thailand


Eligibility criteria: Inclusion Criteria:

* The patients hospitalized to general medical wards

Exclusion Criteria:

* The patients hospitalized less than 48 hours

Primary outcomes:
measure: Incidence of healthcare-associated infection
timeFrame: 7 months
Secondary outcomes:
measure: Incidence of hospital-acquired pneumonia and catheter-associated UTI
timeFrame: 7 months
Other outcomes:
Locations:
city: Bangkoknoi,
country: Thailand
facility: Department of Medicine, Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Visanu Thamlikitkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korbkitjaroen M, Vaithayapichet S, Kachintorn K, Jintanothaitavorn D, Wiruchkul N, Thamlikitkul V. Effectiveness of comprehensive implementation of individualized bundling infection control measures for prevention of health care-associated infections in general medical wards. Am J Infect Control. 2011 Aug;39(6):471-6. doi: 10.1016/j.ajic.2010.09.017. Epub 2011 May 12.
Clinical trial NCT00618319: An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)
Official title: An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST) Refractory to, Intolerant of, or Not a Candidate for Imatinib and Sunitinib Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: GIST
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the effect of BIIB021 on GIST growth and metabolism.


Eligibility criteria: Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
* Age greater than or equal to 18 years at the time of informed consent.
* Pathologically confirmed GIST refractory to, intolerant of, or not a candidate for imatinib and sunitinib therapy.
* FDG PET standard uptake value (SUVmax; averaged over a maximum of 5 lesions) greater than or equal to 2 at screening.
* ECOG performance status of less than or equal to 2.
* Lab values consistent with adequate renal hepatic and bone marrow function.
* Must utilize effective contraception.

Exclusion Criteria:

* Prior treatment with imatinib, sunitinib, or sorafenib with in 14 days of day 1.
* Prior treatment with Hsp90 inhibitors at any time.
* Prior antitumor therapies including prior experimental agents, approved antitumor small molecules (excluding imatinib, sunitinib, or sorafenib) and biologics, or radiotherapy with in 28 days or \<3 half lives (whichever is longer) before start of BIIB021treatment.
* Diabetes treated with insulin and/ or concurrent severe or uncontrolled other medical disease (i.e, systemic infection, hypertension, coronary artery disease, congestive heart failure).
* History of/ or predisposition to seizures.

Primary outcomes:
measure: Changes in FDG-PET imaging
timeFrame: 28 days
Secondary outcomes:
measure: Characterize the safety profile of BIIB021
timeFrame: Duration of study
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Reseach Facility
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: San Antonio
country: United States
facility: Reseach Facility
state: Texas
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04541719: Patient Controlled Remifentanil Analgesia for Normal Labour
Official title: Patient Controlled Remifentanil Analgesia vs. Epidural Analgesia for Normal Labour. A Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Labor Pain
Full Term Pregnancy
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Alexandria University
First posted: 2020-09-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patient controlled remifentanil analgesia might offer comparative overall patient satisfaction and improved quality of analgesia after normal labour with continuous epidural analgesia.

Detailed description: We are aiming to study the effects of patient controlled remifentanil analgesia and epidural analgesia for normal labour in full term parturients on:

* Peripartum analgesia
* Overall patient's satisfaction
* Maternal adverse effects
* Neonatal outcomes

Eligibility criteria: Inclusion Criteria:

* Gestational age \> 36 weeks
* American Society of Anesthesiologists physical class I to III

Exclusion Criteria:

* Allergy to study solution
* Contraindications to epidural analgesia
* Non consented parturients
* Communications barriers.
* Intrauterine foetal growth retardation
* Foetal distress

Primary outcomes:
measure: Overall patient's satisfaction
timeFrame: For 24 hours after labour
Secondary outcomes:
measure: Pain Visual Analog Score at rest
timeFrame: For 24 hours after the start of labour pain
measure: Pain Visual Analog Score on movement
timeFrame: For 24 hours after the start of labour pain
measure: Maternal nausea and vomiting
timeFrame: For 24 hours after the start of labour pain
measure: Maternal respiratory depression
timeFrame: For 24 hours after the start of labour pain
measure: Neonatal Apgar score at 1 min
timeFrame: For 5 min after birth
measure: Neonatal Apgar score at 5 min
timeFrame: For 5 min after birth
measure: Neonatal blood PaO2
timeFrame: For 5 min after birth
measure: Neonatal blood PaCO2
timeFrame: For 5 min after birth
measure: Neonatal blood pH
timeFrame: For 5 min after birth
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
state: DK
Study officials:
affiliation: Professor in Cardiothoracic Ananesthesia
name: Nabil A Abd El Raouf, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02933619: ProMRI ICD/CRT-D Post Approval Study
Official title: ProMRI ICD/CRT-D Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachyarrhythmia
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 24249
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.

Brief summary: Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.


Eligibility criteria: Inclusion Criteria:

* ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of ICD/CRT-D subjects with a ≥ 5 second delay in post-MRI VF detection.
timeFrame: Up to 5 years post-approval
measure: Proportion of LV pacing leads with a LV pacing threshold increase > 1V between pre-MRI and one-month post-MRI.
timeFrame: Up to 5 years post-approval
Secondary outcomes:
measure: Workflow compliance following MR exposure
timeFrame: Up to 5 years post-approval
measure: Left ventricular sensing attenuation
timeFrame: Up to 5 years post-approval
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01476319: Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing patients in the emergency department (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy. Eligible patients will be approached when patients will be scheduled and waiting for receiving percutaneous cholecystostomy in the emergency department.


Eligibility criteria: Inclusion Criteria:

* All patients 18 years of age or older
* scheduled to receive the percutaneous cholecystostomy

Exclusion Criteria:

* clinically unstable
* refuse to participate
* are unable to understand the study process

Primary outcomes:
measure: knowledge and satisfaction measure
timeFrame: immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT06366919: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients
Official title: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neck Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients

Detailed description: The proposed synopsis aims to compare the effectiveness of Alexander Technique nd Feldenkrais Technique in alleviating non spicific neck pain. Both AT and FT are somatic education methods focusing on improving body awareness and movement patterns. The study will involve non - specificc neck pain paytients randomly assigned to either AT Or FT intervention groups Outcome measures will include pain intensity, posture, functional ability and quality of sleep. Data will be collected at baseline, post - interventrion and on follow up to assess the short term and long term effects. Statistical analysis will be conducted to determine differences in outcomes between the two groups. Understanding the comparitive effectiveness of AT and FT could provide valuable insights for healthcare professionals in choosing appropriate intervention for non - specific neck pain patients management.

Eligibility criteria: Inclusion Criteria:

* Both male and female patients
* Patients who have compromised activity of daily living due to neck pain
* Patients with non - specific neck pain
* Patients aging from 20 to 25 years

Exclusion Criteria:

* Patients with diagnose dneck pathologysuch as cervical disc herniation and spondylosis etc.
* Patients who are unable to participate in any physical activity
* Patients with recent neck injury or trauma
* Patients with cognitive impairment

Primary outcomes:
measure: Northwick Park Neck Pain Questionnaire
timeFrame: 4 Months
measure: REEDCO Posture Assessment and Sleep Quality Scale
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT04212819: Before and After Erythrocyte Suspension Transfusion
Official title: Comparison of Oxidative Stress and Asymmetric Dimethyl Arginine Levels Before and After Erythrocyte Suspension Transfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Oxidative Stress
Keywords: Erythrocyte suspension
Total antioxidant status
Total oxidant status
Asymmetric dimethylarginine
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 50
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: Hypoperfusion, hypoxia and ischemia occurs in circulation as a result of anemia. All of these situations lead to oxidative stress and endothelial dysfunction in the organism. In this study, the investigators aimed to investigate the oxidant-antioxidant balance and asymmetric dimethylarginine (ADMA) levels in patients that have symptomatic anemia in need of erythrocyte suspension (ES) transfusion. To the best of the investigators knowledge, there have been few studies in the literature on anemia and total oxidant, total antioxidant and ADMA levels. We aimed to observe changes in oxidative - antioxidant ADMA levels before and after ES transfusion.


Eligibility criteria: Inclusion Criteria:

* Only patients with deep anemia and anemia due to gastrointestinal bleeding patients in need of erythrocyte suspension transfusion were included.

Exclusion Criteria:

* Patients with history of hypertension, diabetes, coronary artery disease, congestive heart failure, chronic renal failure, liver failure were not included to the study

Primary outcomes:
measure: Whole Blood Count Test
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Erhan BOZKURT, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00231218: Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers
Official title: the Effectiveness of Echinacea, Propolis and Vitamin C in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Gastroenteritis
Keywords: vitamin c
echinacea
propolis
upper respiratory tract infection
common cold
gastroenteritis
dietary supplement
herbal remedy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 104
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group.

Detailed description: This combination of herbs has been studied only once before in preschoolers. In a study of 430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004, a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory infections by 55% (308 to 138). We are repeating this study to see if our results confirm or contradict those of the previous study.

Eligibility criteria: Inclusion Criteria:

* Age 3-6

Exclusion Criteria:

* Cystic fibrosis
* Immunodeficiency
* Bronchopulmonary dysplasia
* Anatomic abnormalities of respiratory tract
* Intestinal malabsorption
* Allergy to sunflower seeds

Primary outcomes:
measure: upper respiratory tract infections
Secondary outcomes:
measure: gastroenteritis
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: michael l macknin, m.d.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04935918: EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
Official title: PROSPECTIVE STUDY EVALUATING THE SAFETY AND EFFECTIVENESS OF ADJUSTABLE CONTINENCE THERAPY (ACT) BALLOONS FOR THE MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN WITH BLADDER EXSTROPHY OR INCONTINENT EPISPADIAS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Exstrophy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 7
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of a minimally invasive surgical procedure with ACT (Adjustable Continence Therapy) balloons implantation for the treatment of urinary incontinence in children with bladder exstrophy or isolated epispadias.

The ACT therapy consists of two small adjustable silicone balloons connected with a tubing to a port, surgically placed around the bladder neck, one on each side of the urethra.


Eligibility criteria: Inclusion Criteria:

* Boys and girls \> 5 years with bladder exstrophy or isolated epispadias;
* sphincteric incontinence (leak point pressure \< 45 cm d'H20, open bladder neck during filling, stress urinary incontinence);
* normal renal function (eGFR \> 90ml/min);
* no (or stable) upper urinary tract dilatation in ultrasound.

Exclusion Criteria:

* under 5 years or more than 18 years old;
* renal insufficiency (acute or chronic);
* evolutive deterioration of the upper urinary tract (hydronephrosis);
* unmanageable detrusor instability;
* residual volume greater than 100 ml after voiding;
* bleeding disorders.

Primary outcomes:
measure: Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight
timeFrame: 24 months
Secondary outcomes:
measure: Number of pads per day (voiding diary)
timeFrame: 6, 12 and 24 months
measure: Number of incontinence episodes per day (voiding diary)
timeFrame: 6, 12 and 24 months
measure: PIN-Q questionnaire
timeFrame: 6, 12 and 24 months
measure: Incidence of urethral stricture and device erosion after ACT implantation
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
state: Paca
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Emilie GARRIDO-PRADALIE
role: STUDY_DIRECTOR
References:
Clinical trial NCT03431818: Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants
Official title: Effective Fraction of Inspired Oxygen in Premature Infants Receiving Support Via Nasal Cannula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants admitted to the newborn ICU will be screened. Infants who meet the inclusion criteria will be enrolled in the study after written informed parental consent is obtained:

Brief summary: The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

Detailed description: During routine nasal cannula (NC) use in the newborn ICU, the actual fraction of oxygen inspired by the infant, i.e. the effective FiO2 (Effective-FiO2) that reaches the infant's airways, cannot be easily determined. The effective FiO2 during NC use is generally lower than the FiO2 in the gas delivered by NC at the infant's nose due to dilution with ambient gas entrained by the infants during spontaneous inspiration. The factors influencing effective FiO2 include the set FiO2 of the gas delivered by NC (NC-FiO2), the NC-flow rate, and the entrainment of ambient gas by the infant during each spontaneous inspiration. The individual contribution of each of these factors to the variability in effective-FiO2 in extreme premature infants has not been systematically evaluated.

The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

Eligibility criteria: Inclusion Criteria:

* Premature infants born between 23 and 30 weeks of gestational age
* Receiving supplemental oxygen via nasal cannula
* Parental informed consent

Exclusion Criteria:

* Major congenital anomalies
* Clinically unstable

Primary outcomes:
measure: Nasal cannula FiO2
timeFrame: from birth upto 40 weeks corrected postmenstrual age
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: NICU at Holtz Children's Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Nelson Claure
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Eduardo Bancalari
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Deepak Jain
role: PRINCIPAL_INVESTIGATOR
References: