louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00597688: Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia
Official title: Oral Mucosal Decontamination With Chlorhexidine for Prevention of Ventilator Associated Pneumonia in Children - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ventilator Associated Pneumonia
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 86
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.

Detailed description: Ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the setting of mechanical ventilation. It accounts of 86% of nosocomial pneumonia and in contrast to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in certain settings. A number of preventive methods have been studied to reduce the rate of VAP but a consensus is lacking with regards to appropriate preventive strategies. Studies in adults have shown a beneficial effect of oral mucosal application of chlorhexidine but similar studies in pediatric population are not available. This research project aims at addressing the gap.

Eligibility criteria: Inclusion criteria:

1. Patients in PICU requiring mechanical ventilation
2. Above the age of 3 months
3. Oro or nasotracheal intubation

Exclusion criteria:

1. Known hypersensitivity to chlorhexidine
2. Inability to access the oral cavity for any reason
3. Patients with tracheostomy
4. Mechanical ventilation for more than 24 hours prior to PICU admission.
5. Death or extubation within 24 hours of ICU admission.

Primary outcomes:
measure: Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria
timeFrame: 21 days
Secondary outcomes:
measure: Antibiotic sensitivity of organism cultured
timeFrame: 21 days
measure: Duration of hospital stay
timeFrame: 21 days
measure: Duration of ICU stay
timeFrame: 21 days
measure: In hospital mortality rate
timeFrame: 21 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: RAKESH LODHA
role: STUDY_DIRECTOR
References:
citation: Sebastian MR, Lodha R, Kapil A, Kabra SK. Oral mucosal decontamination with chlorhexidine for the prevention of ventilator-associated pneumonia in children - a randomized, controlled trial. Pediatr Crit Care Med. 2012 Sep;13(5):e305-10. doi: 10.1097/PCC.0b013e31824ea119.
Clinical trial NCT06095388: Phase I/II Study of JR-441 in Patients With Mucopolysaccharidosis Type IIIA
Official title: Phase I/II Study of Weekly Infusions of JR-441 in Patients With Mucopolysaccharidosis Type IIIA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Mucopolysaccharidosis III-A
Lead sponsor: JCR Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase I/ II, open-label, randomized, 2-arm study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of MPS IIIA patients.


Eligibility criteria: Inclusion Criteria:

* Chronological age of ≥1 year and ≤18 years.
* Confirmed diagnosis of MPS IIIA.
* Body weight ≥ 10 kg.

Exclusion Criteria:

* Prior experience to gene therapy or HSCT with successful engraftment.
* Past use of another investigational drug or product in last 4 months or 5 half-lives (whichever is longer) before signing ICF.
* Current participation in a clinical trial or past participation (within 30 days of enrolment into this study) in a study involving invasive procedures.
* Past use of Genistein or Kineret (anakinra) within 4 months before signing ICF.
* Serious drug allergy or hypersensitivity.
* Contraindication for lumbar puncture or MRI.
* History of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following lumbar puncture.

The above information is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.

Primary outcomes:
measure: To evaluate the tolerability of JR-441 in MPSIIIA patients
timeFrame: up to 5 years (multiple visits)
measure: To assess the safety of JR-441 in MPSIII-A patients
timeFrame: up to 5 years (multiple visits)
Secondary outcomes:
measure: Plasma drug concentration
timeFrame: up to 5 years (multiple visits)
measure: Plasma PK parameters
timeFrame: up to 5 years (multiple visits)
measure: Change from baseline in heparan sulfate levels in cerebrospinal fluid (CSF), serum and urine
timeFrame: up to 5 years (multiple visits)
measure: Change from baseline in cognitive function
timeFrame: up to 5 years (multiple visits)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT05381688: VIM DBS Respiratory Modulation: N-of-1 Trial
Official title: Respiratory Modulation by VIM Deep Brain Stimulation: N-of-1 Trial of Breath-holding and Peak Expiratory Flow
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Essential Tremor
Dystonic Tremor
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sequential cohort of patients with movement disorders (ET and DT) who are scheduled for VIM DBS at John Radcliffe Hospital. All will be contacted by a member of clinical care team for the study to be offered.

Brief summary: Research from our group has demonstrated modulation of PEFR in patients with STN and PAG stimulation. However, the effect of VIM (motor thalamus) stimulation remains to be investigated. Our group has also been involved in research that indicates that VIM stimulation may reduce perception of breathlessness. However, methodological factors limit the conclusions that can be drawn from this prior work. N-of-1 trials, organised as a randomised multiphase crossover design, are uniquely well suited for DBS research where stimulation can be switched ON and OFF, and with simple tests that can be done quickly, multiple times. PEFR and breath-holding are simple tests that we will test in this way. Other respiratory tests will be carried out along side, as optional, in a single phase design. We aim to offer this study to a continuous cohort of patients scheduled to undergo VIM (ET/DT) DBS at our institution. We will establish a pre-operative baseline of respiratory function, and then perform the n-of-1 trial post-operatively, soon after the patient returns to hospital to receive their DBS programming.


Eligibility criteria: Inclusion Criteria:

* Scheduled for VIM DBS
* Diagnosis of ET or DT

Exclusion Criteria:

* None

Primary outcomes:
measure: Breath-hold (urge to breath)
timeFrame: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Secondary outcomes:
measure: Breath-hold (break point)
timeFrame: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
measure: Peak Expiratory Flow Rate
timeFrame: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
measure: Dyspnoea-12 Questionnaire
timeFrame: Baseline and 3 months post-operative
measure: Oscillometry
timeFrame: Baseline and 3 months post-operative ON and OFF
measure: Maximum inspiratory pressure
timeFrame: Baseline and 3 months post-operative ON and OFF
Other outcomes:
Locations:
Study officials:
affiliation: University of Oxford
name: Alex L Green, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02053688: Evaluation Study on Corneal Lens for Vision Correction
Official title: Evaluation Study on Corneal Lens for Vision Correction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: FORSIGHT Vision3
Sponsor class: INDUSTRY
First posted: 2014-02-04
Enrollment: 40
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 objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism.


Eligibility criteria: Inclusion Criteria:

1. Patient with good corneal health
2. Age 18-65.
3. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements.
4. Best corrected visual acuity of 20/20 or better in the study eye/s

Exclusion Criteria:

1. Any other anterior segment abnormality.
2. No previous corneal procedures, including Laser Vision Correction.
3. Any abnormalities associated with the eye lids.
4. Clinically significant inflammation or infection within six (6) months prior to study.
5. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
6. Participation in any study involving an investigational drug or device within the past 30 calendar days, or ongoing participation in a study with an investigational material except studies using corneal lenses.
7. Intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material.
8. Specifically known intolerance or hypersensitivity to contact lenses.
9. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

Primary outcomes:
measure: Visual Acuity
timeFrame: 30 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Cliff Leong
state: California
city: Fremont
country: United States
facility: Sara Chiu
state: California
city: Livermore
country: United States
facility: John Michelsen
state: California
city: Menlo Park
country: United States
facility: Nexis Vision
state: California
city: San Mateo
country: United States
facility: Nick Chan
state: California
city: Stockton
country: United States
facility: Josephine Vo-Laurel
state: California
Study officials:
affiliation: Nexisvision
name: Ashley Tuan, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00631488: A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)
Official title: A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 146
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.


Eligibility criteria: Inclusion Criteria:

* Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion Criteria:

* Participants have a history of Type 1 Diabetes Mellitus
* Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor \[PPAR\]-gamma agonists)
* Participants who have a contraindication to metformin or sitagliptin

Primary outcomes:
measure: Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
timeFrame: BL, 4 weeks (end of double-blind treatment period)
Secondary outcomes:
measure: Change From BL to Week 4 in Fasting Plasma Glucose (FPG)
timeFrame: BL, 4 weeks (end of double-blind treatment period)
measure: Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)
timeFrame: BL, 4 weeks (end of double-blind treatment period)
measure: Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC
timeFrame: BL, 4 weeks (end of double-blind treatment period)
measure: Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC
timeFrame: BL, 4 weeks (end of double-blind treatment period)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05596188: Anxiety Before Non-cardiac Surgery in Adults
Official title: Status and Independent Risk Factors of Preoperative Anxiety in Adults Undergoing Non-cardiac Surgery: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myoma of Uterus
Colon Cancer
Gastric Carcinoma
Prostate Cancer
Femoral Head Necrosis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who met the eligibilty criteria for elective surgery under general anesthesia.

Brief summary: Adult patients undergoing elective non-cardiac surgery were enrolled. Anxiety before the operation was evaluated by The State Anxiety Inventory (S-AI). Logistics regression would be used for identifying the independent factors of preoperative anxiety and prediction model would be established.


Eligibility criteria: Inclusion Criteria:

1. patients undergoing elective with general anesthesia surgery (gynecologic oncology, general surgery, orthopedics and urinary);
2. The estimated operation time is more than 2 hours. 3)18≤ age ≤ 80;

4)be able to communicate normally in daily life, without serious hearing and visual impairment; 5)ASA:I-II; 6)sign informed consent and volunteer to participate in this study.

Exclusion Criteria:

1. Having a history of brain diseases, such as stroke, epilepsy, psychosis other history of neuropsychiatry.
2. Patients with serious diseases of heart, liver, lung, kidney or other organs.
3. Having a definite diagnosis of cognitive impairment, such as Alzheimer's disease;
4. Those who use sedatives before evaluation in this study;
5. Drug addicts;
6. Alcoholics;
7. pregnant women;
8. participated in other clinical trials as a subject in the past 3 months.

Primary outcomes:
measure: Independent risk factors of preoperative anxiety and establishment of prediction model
timeFrame: From the 1 day before surgery to 7 days after surgery or discharge, whichever came first
Secondary outcomes:
measure: Incidence of preoperative anxiety
timeFrame: The 1 day before surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References:
Clinical trial NCT06706388: Personalized Antisense Oligonucleotide Therapy for a Single Participant with ATN1 Gene Mutation
Official title: An Open-label Single Center, Single Participant Study of an Experimental Antisense Oligonucleotide Treatment for ATN1 Gene Mutation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Dentatorubral-Pallidoluysian Atrophy
Lead sponsor: n-Lorem Foundation
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2024-11-26
Enrollment: 1
Sex: MALE
Minimum age (years): 17
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single participant with dentatorubral-pallidoluysian atrophy (DRPLA) due to a heterozygous pathogenic CAG trinucleotide expansion in ATN1

Detailed description: This is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (ASO) treatment in a single participant with DRPLA due to a heterozygous pathogenic CAG trinucleotide expansion in ATN1

Eligibility criteria: Inclusion Criteria:

* Informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s).
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.
* Genetically confirmed Dentatorubral-pallidoluysian atrophy (DRPLA) due to ATN1 mutation

Exclusion Criteria:

* Use of investigational medication within 5 half-lives of the drug at enrolment
* Participant has any condition that in the opinion of the Site Investigator, would ultimately prevent the completion of study procedures.

Primary outcomes:
measure: Ataxia
timeFrame: Baseline to 24 months
measure: Ataxia
timeFrame: Baseline to 24 months
measure: Ataxia
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Seizures
timeFrame: Baseline to 24 months
measure: Quality of Life
timeFrame: Baseline to 24 months
measure: Quality of Life
timeFrame: Baseline to 24 months
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Baseline to 24 months
measure: Incidence of Treatment-Emergent abnormalities in physical and neurological exams [Safety and tolerability]
timeFrame: Baseline to 24 months
measure: Incidence of Treatment-Emergent abnormalities in safety labs (CSF, chemistry, hematology, coagulation, and urinalysis) [Safety and tolerability]
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
References:
Clinical trial NCT01471288: Effect of Carum Carvi on Thyroid Hormones and TSH Level
Official title: Evaluation of the Effect of Carum Carvi on Levels of Plasma Thyroid Hormones and TSH Level in Patients on Thyroid Hormone Therapy and Normal Controls.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Thyroid Cancer Patients
Keywords: well differentiated thyroid cancer
Carum Carvi
Normal controls
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Pharmaceutical Research Center
First posted: 2011-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Carum Carvi has been frequently used in traditional medicine for a variety of disease ranging from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients with thyroid cancer who receiving Carum Carvi despite being on suppressive dose of levothyroxin. TSH level returned to normal after discontinuation of the Carum carvi. This observation led to a pilot study for evaluation of the effect of carum carvi on thyroid function.


Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Hypothyroid patients under treatment with levothyroxin
* Normal euthyroid patients with no goiter

Exclusion Criteria:

* Pregnancy or lactation
* Severe lung or gasterointestinal disease
* Heart failure or renal failure

Primary outcomes:
measure: Change of Thyroid and thyrotropin values from baseline at 2 and 6 weeks
timeFrame: 0-2-6 Weeks
Secondary outcomes:
measure: Change of hypothyroidism index from baseline at 2 and 6 weeks
timeFrame: 0,2 and 6 weeks
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Nuclear Medicine Department, Ghaem Hospital
Study officials:
affiliation: Nuclear Medicine Research Center
name: Seyed Rasoul Zakavi, MD. IBNM
role: PRINCIPAL_INVESTIGATOR
affiliation: Pharmaceutical Research Center
name: Mohammad Ramezani, Ph.D., Pharm.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01209988: Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-assisted Laparoscopic Radical Prostatectomy
Official title: A Prospective Randomized Study Examining the Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-Assisted Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatic Neoplasms, Prostatectomy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2010-09-28
Enrollment: 220
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of tamsulosin on voiding patterns following early urethral catheter removal after RALP for prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Patients must have localized or locally advanced prostate cancer
* Patients must receive robot assisted laparoscopic radical prostatectomy
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Patients must not have a history of treatment with alpha blockers within 4 weeks
* Patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate
* Patients must not have previously been diagnosed with neurogenic bladder
* Patients must not have hypersensitivity to trial drug or other alpha-blockers
* Patients must not have the participation of other clinical trial within the past 3 months

Primary outcomes:
measure: The incidence of acute urinary retention
timeFrame: within the 30 days after surgery
Secondary outcomes:
measure: Patient reported outcomes
timeFrame: 20 days after surgery (plus or minus 3 days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Department of Urology, Asan Medical Center, Seoul, Korea
name: Choung-Soo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: