louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05922072: Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia
Official title: Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Aspiration of Gastric Contents
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Total 120 patients will be randomly allocated into two groups using computerized generated numbers (60 in each group). Group A with 6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively. Group B with 6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively
Primary purpose: PREVENTION

Brief summary: Rationale of this study is to provide an evidence on minimal safe clear fluid fasting duration without the risk of aspiration of gastric contents during elective pediatric procedures under general anesthesia.

Detailed description: Pre-operative fasting is a specific time period before a procedure in which participants will be advised not to take any liquid or solid by mouth. Nil per oral (NPO) is a universally accepted practice before elective general anesthesia in order to reduce gastric contents aspiration. In the period of chloroform anesthesia NPO was introduced because of vomiting and discomfort associated with anesthesia. Hence prevention from aspiration of gastric contents was a main focus during general anesthesia. With introduction of better anesthesia drugs recommendations were given to keep minimal fasting time before general anesthesia.

Recent guidelines suggest six, four and two hours fasting for solids/ infant formula milk, breast milk and clear fluids respectively. It is common practice to keep children NPO for 6 hours before surgery. But many times, children have to suffer excessive unnecessary fasting due to delayed surgery that lead to reduction in systolic blood pressure, induce catabolic state and behavioral effects. Moreover prolonged fasting increases insulin resistance and may increase the inflammatory response to surgery.

Eligibility criteria: Inclusion Criteria:

1. Both male and female patients
2. Age between 1 to 12 years
3. Patients undergoing elective surgical procedures ( orchidopexy, lymph node biopsy, skin grafting, tongue ties and hernia repair ) under general anesthesia

Exclusion Criteria:

1.Patients with co-morbidities like acid peptic disease with history of dyspepsia and family history or self-history of diabetes mellitus.

Primary outcomes:
measure: Mean residual gastric volume
timeFrame: 6 Months
Secondary outcomes:
measure: Gastric pH
timeFrame: 6 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Paeds Surgery Department Mayo Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00738972: Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)
Official title: Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Fundación Lindavista del Corazón AC
Sponsor class: OTHER
First posted: 2008-08-21
Enrollment: 12
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: Evaluate pleiotropic effects of simvastatin in hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* Females Or Males Over 18 Years Old
* Patients With Systemic Arterial Hypertension Grade I And II According With The European Society Of Cardiology
* Left Ventricular hypertrophy Demonstrated By Echocardiography
* Mild To Moderated hypercholesterolemia
* Willing To Participate And Sign The Informed Consent Form (ICF)

Exclusion Criteria:

* Type 1 Or 2 Diabetes Mellitus
* Familiar hypercholesterolemia
* Low Density Lipoprotein-Cholesterol (LDL-C) \> 190 mg/dl
* History Of Myocardial Infarction Or Stable Chronic Angina
* Triglycerides \>250 mg/dl

Primary outcomes:
measure: Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients
timeFrame: 6 Month(s)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00533572: Recessive Dystrophic Epidermolysis Bullosa Screening for Possible Gene Transfer
Official title: Recessive Dystrophic Epidermolysis Bullosa Screening for Possible Gene Transfer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Epidermolysis Bullosa Dystrophica
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-09-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with RDEB

Brief summary: Recessive Dystrophic Epidermolysis Bullosa (RDEB) is a severe inherited blistering skin disease caused by absence of type VII collagen. Patients with RDEB develop large, severly painful blisters and open wounds from minor trauma to their skin. In the future, we hope to start a gene transfer study on a specific group of RDEB subjects and we are screening subjects for that potential trial now.

Detailed description: This study is a preparation for a gene transfer trial. In the gene transfer trial, we will transfect autologous RDEB keratinocytes with a type VII collagen containing retrovirus vector. We then plan to graft the genetically engineered and corrected autologous keratinocytes back on to wounds of the RDEB subject. We expect the grafts to attach as normal keratinocytes and replace the damaged skin with skin that is able to make type VII collagen and anchor normally to the dermis. We are trying to define the number of subjects 18 or older who meet the criteria for the gene transfer trial. We are offering the subjects the opportunity to be evaluated for the potential trial.

Eligibility criteria: Inclusion Criteria:1. Clinical diagnosis of RDEB by local dermatologist 2. 18 years of age or more and willing to give consent 3. Estimated to have at least 100 to 200 sq. cm. areas of open erosions on the trunk or extremities suitable for skin grafting 4. Ability to undergo adequate anesthesia to allow grafting procedures to take place 5. Parents are alive, do not have EB, and they are willing to give consent for genetic testing Exclusion Criteria:1. Medical instability limiting ability to travel to Stanford University Medical Center 2. Participation in another clinical trial without prior approval 3. The presence of medical illness expected to complicate participation and/or compromise the safety of this technique

Primary outcomes:
measure: Disease documentation
timeFrame: 1 year
measure: documentation of disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Alfred T Lane
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05937672: Cold Atmospheric Plasma Device Extension Study
Official title: Cold Atmospheric Plasma Device for the Treatment of Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients - Open-Label Extension Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Verruca Vulgaris
Molluscum Contagiosum
Keywords: Plasma
Warts
Molluscum
Pediatric
Dermatology
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: The Skin Center Dermatology Group
First posted: 2023-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label extension study. During a clinical care visit, if a patient is eligible and agrees to participate, lesions will be selected by the dermatologist prior to procedure. All lesions selected will be treated with non-thermal atmospheric plasma (NTAP).
Primary purpose: TREATMENT

Brief summary: Patients between 4-21 years of age with at least one wart or molluscum lesion are eligible to participate in this study. The duration of the study is a minimum of 4 weeks with the maximum duration of monthly treatments for one year, depending on lesion clearance. The number of lesions will be chosen by the dermatologist. Patients who opt to participate will receive non-thermal, or cold, atmospheric plasma to treat all lesions selected. Safety profile as well as changes in size, pain and appearance will be measured. Photographs and dermatologist impressions will be used to measure treatment response.


Eligibility criteria: Inclusion Criteria:

* All patients from 4-21 years old with at least 1 lesion of vercurra or molluscum.
* Willingness of the participant and their guardian to provide consent when applicable.

Exclusion Criteria:

* Unwillingness to participate in the study
* Received any treatment on the lesion in the past month determined by review of their medical record
* Immunodeficiency determined by review of their medical record.
* Adverse response to prior treatments determined by review of medical record.
* Signs of self-resolution determined by study team members.
* Conditions that lead to excessive scarring determined by study team members.
* Face and genital lesions determined by study team members.

Primary outcomes:
measure: Number of lesions with no response
timeFrame: Maximum of 12 months
measure: Number of lesions with partial response
timeFrame: Maximum of 12 months
measure: Number of lesions with complete response
timeFrame: Maximum of 12 months
measure: Number of treatments to complete lesion resolution
timeFrame: Maximum of 12 months
Secondary outcomes:
measure: Adverse events from CAP tolerability questionnaire
timeFrame: Maximum of 12 months
measure: Average score of visual analogue scale associated with treatment
timeFrame: Maximum of 12 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT03669172: Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia
Official title: Fase I/II, Unicentric, Historical Control Clinical Trial to Evaluate the Effectiveness of Donor IL-15 Stimulated NK Cells Post Transplant Infusion, in Acute Leukemia Patients With Poor Prognosis and Haploidentical Unmanipulated Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: ACUTE LEUKEMIA
Lead sponsor: Martín, José Luis Díez, M.D.
Sponsor class: INDIV
First posted: 2018-09-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical trial phase I and II, single-center, historical control, to evaluate the effectiveness of donor IL-15 stimulated NK cells post transplant infusion, in acute leukemia patients with poor prognosis and haploidentical unmanipulated transplant

Detailed description: This clinical trial wants to study the safety, effectiveness and efficacy of NK cells incubated infusion (CD56 +, CD3) incubated ex vivo with IL-15 infusion in patients with high risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with post-transplant cyclophosphamide administration.

Eligibility criteria: Inclusion Criteria:

1. More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical
2. Assessable disease by analytic, molecular or image techniques.
3. Comorbidity Sorror index less than 6.
4. Give informed consent according to the legal requirements.
5. Dispose of a donor without exclusion criteria.

Exclusion Criteria:

1. Positive HIV serology.
2. Patients with an active infection or other underlying serious medical statement.
3. Any medical process, analytical abnormality or important psychiatric disorder, according to the investigator's opinion, that prevent the participation of the patient in the study.
4. Participation of any other interventional clincal trial within 30 days of planned enrollment into this study.
5. Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Up to 2 years after first infusion
Secondary outcomes:
measure: Reevaluation of the Minimal residual disease (MRD)
timeFrame: Up to 1 year after first infusion
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
References:
Clinical trial NCT02891772: Carotid Artery Corrected Flow Time Measured by Ultrasonography as a Predictor of Hypotension After Induction of General Anesthesia
Official title: Carotid Artery Corrected Flow Time Measured by Ultrasonography as a Predictor of Hypotension After Induction of General Anesthesia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: General Anesthesia Induction for Elective Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were scheduled to undergo elective surgery under general anesthesia

Brief summary: Hypotension often happens immediately after anesthetic induction. Particularly in 5-10 minutes after anesthetic induction it is reported to happen more frequently. Patients may have preexisting hypovolemia resulting from dehydration and impaired compensatory responses, which increase the risk. However, it is still challenging to assess intravascular volume status in spontaneously breathing patients before anesthetic induction. Recently, the measurement of corrected flow time in carotid artery was introduced as quite useful, simple and noninvasive for the evaluation of circulating blood volume. The aim of this study is to evaluate whether corrected carotid artery flow time as determined by ultrasonography in spontaneously breathing patients before general anesthesia can predict hypotension after induction.


Eligibility criteria: Inclusion Criteria:

• adult patients (19-80 years of age) who were scheduled to undergo elective surgery under general anesthesia

Exclusion Criteria:

* mean blood pressure \< 70 mmHg before induction of general anesthesia
* Patients who have currently taken angiotensin-converting enzyme inhibitor
* Patients who have currently taken angiotensin receptor blocker
* the presence of carotid artery stenosis \> 50%
* cardiac rhythm other than sinus
* unstable angina
* a left ventricular ejection fraction of \< 40%
* severe vascular disease
* implanted pacemaker/cardioverter
* autonomic nervous system disorders
* anticipated difficult airway
* pregnancy

Primary outcomes:
measure: corrected flow time (FTc) in carotid artery
timeFrame: 10 minutes before induction of general anesthesia.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT05376072: Electromyographic Biofeedback Muscle Recovery Meniscectomy
Official title: Efficacy of Electromyographic Biofeedback in Muscle Recovery After Meniscectomy in Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feedback, Psychological
Lead sponsor: Western Norway University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: University of Malaga
First posted: 2022-05-17
Enrollment: 10
Sex: MALE
Minimum age (years): 24
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Electromyographic biofeedback (EMG-BF) is a therapeutic technique that has been used success-fully in rehabilitation of injuries. Although it has been applied in athletes, its use in this field is not very widespread. The objective of this study is to analyze its effectiveness in the recovery of electromyographic activity of the quadriceps after meniscectomy, evaluated through isometric contraction of the vastus lateralis. The sample comprised ten professional footballers in the Spanish League (2nd Division A) who had previously suffered a meniscus injury in their knee and had undergone a meniscectomy. The intervention consisted of EMG-BF treatment lasting between 6 and 10 sessions. The electromyographic signal was recorded using a Thought Tech-nology ProComp Infiniti 8-channel biofeedback unit with a sampling rate of 2048 sam-ples/seconds. For each session a within-subject ABA design of 6 or 10 trials per session was used, with three pre- and three post-measures, which determined the gain for each session.


Eligibility criteria: Inclusion Criteria:

* Partial meniscus tear
* Meniscectomy

Exclusion Criteria:

* Having an injury other than a partial meniscus tear

Primary outcomes:
measure: Changes in muscle tension level
timeFrame: Each participant performed a total of 10 session during 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Antonio Hernández Mendo
Study officials:
References:
Clinical trial NCT03185572: Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension in China
Official title: The Prevalence, Disease Course, Prognosis and Interaction of Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Pulmonary Hypertension
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 1708
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable COPD patients

Brief summary: Pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD). It is reported that over half of COPD patients develop pulmonary hypertension. COPD and pulmonary hypertension may have pathological or genetics interactions so that patients having both disorders tend to have poor prognosis. Echocardiography is widely used to detect pulmonary hypertension, but it's not accurate enough. Therefore, high-quality data reflecting the prevalence, disease course and outcome of pulmonary hypertension in COPD is very limited in China. The aim of the study is to detect pulmonary hypertension with right heart catheterization, describe its outcome in Chinese COPD patients and explore the underlying interaction mechanism.


Eligibility criteria: Inclusion Criteria:

* Stable chronic obstructive pulmonary disease (COPD) patients

Exclusion Criteria:

* Patients with other serious respiratory diseases
* Patients with pulmonary hypertension other than group 3
* Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
* Patients with limited life expectancy
* Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
* Psychopath or addict

Primary outcomes:
measure: COPD exacerbations
timeFrame: 3 years
Secondary outcomes:
measure: modified British medical research council (mMRC) score
timeFrame: 3 years
measure: COPD Assessment Test (CAT) score
timeFrame: 3 years
measure: 6 minutes walk distance
timeFrame: 3 years
measure: transplant-free survival rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00560872: Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation
Official title: Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Flutter
Keywords: atrial flutter
ablation
navigation
Lead sponsor: University Hospital Goettingen
Sponsor class: OTHER
Collaborators: name: Stereotaxis
First posted: 2007-11-20
Enrollment: 100
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 evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter.


Eligibility criteria: Inclusion Criteria:

* ECG documentation of at least 1 episode of typical atrial flutter

Exclusion Criteria:

* Prior right atrial ablation
* Ferromagnetic implants that may interfere with the magnetic navigation system
* Pregnancy

Primary outcomes:
measure: ablation duration and fluoroscopy time
timeFrame: 3 months
Secondary outcomes:
measure: total procedure duration, success, ablation characteristics, flutter recurrence, complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet
Study officials:
affiliation: Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen
name: Dirk Vollmann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vollmann D, Luthje L, Seegers J, Hasenfuss G, Zabel M. Remote magnetic catheter navigation for cavotricuspid isthmus ablation in patients with common-type atrial flutter. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):603-10. doi: 10.1161/CIRCEP.109.884411.