louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05519969: A Multicentre Preoperative Fasting Audit
Official title: A Multicentre Audit of the Incidence of Pulmonary Aspiration With Different Fasting Regimens - European Preoperative Fasting Audit (EUROFAST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Aspiration of Gastric Contents
Keywords: Preoperation fasting
General anesthesia
Children
Pulmonary aspiration of gastric contents
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 307162
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children less than 16 years old

Brief summary: The new European Society of Anaesthesiology and Intensive Care (ESAIC) preoperative fasting guideline recommends a one hour minimum fasting time for clear fluids. This represents a major change in the practice of pediatric anaesthesia.

During the transition to shorter fasting times on a global scale, we need a large multicenter audit to monitor the incidence of pulmonary aspiration.

Detailed description: The purpose of preoperative fasting is to achieve an empty stomach at the time of anaesthesia induction.

Most current fasting guidelines all take into account the balance between the risk of pulmonary aspiration and the harmful effects of prolonged preoperative fasting. However, there is increased awareness among pediatric as well as general anaesthesiologists that many patients suffer from prolonged duration of fasting in spite of the reasonable nominal respective limits of 6-4-2 hours. Prolonged fasting may be harmful, especially in small children, but also in adults with a poor nutritional status.

The new European Society of Anaesthesiology and Intensive Care (ESAIC, 2022) preoperative fasting guideline recommends a one-hour minimum fasting time for clear fluids. This represents a major change in the practice of paediatric anaesthesia. During the transition to shorter fasting times on a global scale, we need a large multicentre audit to monitor the incidence of pulmonary aspiration.

The primary aim of the European Preoperative Fasting Audit (EUROFAST) is to determine the safety of reducing the required fasting time for clear fluids to at least one hour in children fasting before elective procedures requiring general anaesthesia (as recommended in the ESAIC guideline).

Eligibility criteria: Inclusion Criteria:

* Children, age \< 16 years old
* General anesthesia

Exclusion criteria

* Age \> 15 years
* Procedure without general anesthesia
* General anesthesia performed at center with less than 1000 pediatric cases per year

Primary outcomes:
measure: Pulmonary aspiration
timeFrame: Intraoperative
Secondary outcomes:
measure: Suspected pulmonary aspiration
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Peter Frykholm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032369: The Additive Effect of Cognitive Behavioral Treatment (CBT) to Conventional Weight Loss Intervention Program for Young Adults With Intellectual Disabilities
Official title: The Additive Effect of Cognitive Behavioral Treatment - CBT to Conventional Weight Loss Intervention Program for Young Adults With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Learning Disability
Keywords: Over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this randomized case control study we will evaluate the additive effect of psychological intervention, i.e CBT-cognitive behavioral treatment in a multi-strategy weight loss program composed of physical activity intervention and nutritional programme.


Eligibility criteria: Inclusion Criteria:

* Subjects with over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community
* Subjects who sign an informed consent

Exclusion Criteria:

* Subjects with out over-weight or obese subjects with out learning disability subjects who have no completed "Nitzan Onim" two-year training program and live in housing within the community

Primary outcomes:
measure: To examine the effect of behavioral intervention-CBT on weight loss program (nutrition counselling and physical activity).
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
References:
Clinical trial NCT05672069: Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
Official title: Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Diseases
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 124
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: Men or women of legal age, for whom one of the devices is implanted according to the instructions for use. These patients will be monitored according to standard care. As the series is observational and has an additional procedure that is neither burdensome nor invasive, all implanted patients will be considered.

Brief summary: This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label, non-comparative.

The primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. The study will also collect performance and safety data to assess the subject's outcomes and functional status.

The target population for this study was any adult patient implanted with FAST screws, FAST plates, Toe FAST and VEOFIX screws between november 2021 and october 2022.

The investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the Medical regulations (including the Medical Devices Regulation 2017/745) and the ISO 14155:2020, as well as in accordance with the ethical principles described in the Declaration of Helsinki. The collection of personal data will also be compliant with RGPD 2016/679.


Eligibility criteria: Inclusion Criteria:

* Male or female subject of legal age at the date of implantation;
* Subject implanted with one or more implants: FAST Screw, FAST Plate, Toe FAST and VEOFIX Screw between November 2021 and October 2022;
* Subject able to understand the information and instructions given by the investigator;
* Subject with a social security affiliation.

Exclusion Criteria:

* Vulnerable persons
* People with contraindications (including pregnant women)

Primary outcomes:
measure: Reduction of the Patient's Pain and Restoration of Walking
timeFrame: 12 months
Secondary outcomes:
measure: Survival Rate
timeFrame: 12 months
measure: Foot Bone Consolidation
timeFrame: 12 months
measure: Patient Satisfaction
timeFrame: 12 months
measure: Adverse Event
timeFrame: Peroperative to 12 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital Privé Saint-Martin
Study officials:
References:
Clinical trial NCT01584869: Emergency Capsule Endoscopy in Severe GI-bleeding
Official title: Emergency Capsule Endoscopy in Severe GI-bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: GI-bleeding
Keywords: GI-bleeding
capsule endoscopy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-04-25
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: DIAGNOSTIC

Brief summary: Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe GI-Bleeding.


Eligibility criteria: Inclusion Criteria:

patients with signs of severe GI-bleeding (with melena or dark bloody stool) and hemodynamic instability (defined as (pre)collapse or MAP \< 80 mmHg or HR \> 110) and/or drop of hemoglobin \> 2g/dl/d and/or need of transfusion of minimum of 2 packed red cells

Exclusion Criteria:

missing consent form, pregnancy, origin of bleeding found in upper GI-endoscopy (e.g. blood in the stomach, ulcer, varices with signs of bleeding, mallory-weiss-tear, Angiodysplasia (with signs of bleeding), refluxesophagitis LA C or D) fresh bloody stool, known stenosis of the bowel, known site of bleeding, known inflammatory bowel disease

Primary outcomes:
measure: the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.
timeFrame: after complete recruitment
Secondary outcomes:
measure: frequency of mid-GI-bleeding in all patients
measure: diagnostic yield
timeFrame: after complete recruitment
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
References:
citation: Schlag C, Menzel C, Nennstiel S, Neu B, Phillip V, Schuster T, Schmid RM, von Delius S. Emergency video capsule endoscopy in patients with acute severe GI bleeding and negative upper endoscopy results. Gastrointest Endosc. 2015 Apr;81(4):889-95. doi: 10.1016/j.gie.2014.09.035.
Clinical trial NCT02732769: Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
Official title: Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Brain Metastases
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.

This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.


Eligibility criteria: Inclusion Criteria:

* Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery
* Subject requiring a radiosurgical treatment with LGK

Exclusion Criteria:

* Subject having hurts of the brainstem or para-optics
* Pregnant women or in feeding period
* Subject having received previously a whole brain radiotherapy

Primary outcomes:
measure: Evaluation of pain during the hospitalization (3 days)
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of tumor control at 3 months
timeFrame: 12 months
measure: Evaluation of tumor control at 6 months
timeFrame: 12 months
measure: Occurrence of clinical side effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
name: DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT01291069: Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
Official title: Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Single Ventricle
Keywords: Fontan
Tadalafil
Exercise performance
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic response to exercise and exercise capacity in patients with Fontan circulation. Data regarding effect size and drug tolerability will be used in the design of a randomized multicenter trial. The long-term goal of this investigation is to systematically evaluate the effect of tadalafil therapy on exercise performance, quality of life, and delay of functional deterioration in patients with single ventricle physiology.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone the Fontan procedure (regardless of type of Fontan connection or presence or absence of a fenestration)
* Age 8.0 to 35.0 years
* Stable clinical condition over the last 3 months (i.e. No change in medication, treatments, or development of new symptoms)
* Ability to perform exercise testing
* Consent and assent (as appropriate to participate in the study after receiving information concerning procedures, risks, and possible clinical benefits) o Patients will be enrolled without regard to gender, race, and ethnicity. All patients meeting study eligibility will be approached for consent.

Exclusion Criteria:

* Severe heart failure (New York Heart Association functional class III or IV)
* Presence of liver or renal dysfunction based on the latest lab test results
* Presence of hearing or visual deficit
* Transcutaneous arterial blood oxygen saturation (SaO2) \<80% at rest
* History of echocardiographic, MRI, or angiographic evidence of Fontan pathway obstruction
* History of exercise-induced life-threatening arrhythmias or unstable rhythm(i.e. atrial flutter)
* Known or suspected pregnancy. Females in the reproductive age group will be screened for pregnancy using serum beta hCG prior to administering study drug.
* Patients on open label sildenafil or tadalafil

Primary outcomes:
measure: To compare the effects of Tadalafil versus placebo on exercise capacity (maximal oxygen consumption: VO2 max) for patients (8-35 years)with the Fontan circulation (8 -18 years).
timeFrame: 2 years
Secondary outcomes:
measure: To evaluate the adverse effects of Tdalafil in patients (8-35 years)with the Fontan circulation and compare with the placebo group.
timeFrame: 2 years
Other outcomes:
Locations:
city: Salt lake City
country: United States
facility: Primary Childrens Medical Center
state: Utah
Study officials:
affiliation: University of Utah
name: Shaji C. Menon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964769: Study of Evaluation Indexes for Antibody Production in Sera After Immunization
Official title: A Study of Evaluation Indexes for Antibody Production in Sera After Immunization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aged
Keywords: Pneumococcal Vaccine
Aged
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief summary: The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.

Detailed description: To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from children, young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).

Eligibility criteria: Inclusion Criteria:

* elderly subjects over the age 65 years who had not received pneumococcal vaccination
* adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination)
* children subjects over the age of 2 years with no previous history of pneumococcal vaccination

Exclusion Criteria:

* immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine

Primary outcomes:
measure: Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly.
timeFrame: 1 month after vaccination
Secondary outcomes:
measure: Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay)
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Dongdaemun Hospital
Study officials:
affiliation: Ewha Womans University Dongdaemun Hospital
name: Kyung-Hyo Kim, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee H, Nahm MH, Kim KH. The effect of age on the response to the pneumococcal polysaccharide vaccine. BMC Infect Dis. 2010 Mar 10;10:60. doi: 10.1186/1471-2334-10-60.
Clinical trial NCT01197469: Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?
Official title: Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Keywords: Secondary Pulmonary Hypertension
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
name: NHS Tayside
name: NHS Fife
First posted: 2010-09-09
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension.


Eligibility criteria: Inclusion Criteria:

* COPD
* Forced expiratory volume in 1 second (FEV1) \<80% (FEV1/FVC \<0.70)
* Right ventricular systolic pressure (RVSP) \> 30 mmHg or Pulmonary Acceleration time \<120 ms

Exclusion Criteria:

* Pulmonary stenosis or echo left ventricular outflow tract obstruction
* Left ventricular ejection fraction \< 45%
* Patients taking nitrates, nicorandil or doxazosin.
* Drug contraindications:

  * Systolic Blood Pressure \<90 mmHg
  * recent stroke
  * unstable angina
  * past history of non arteritic anterior ischaemic optic neuropathy

Primary outcomes:
measure: 6 minute walking distance
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 3 months
measure: B- Natriuretic Peptide (BNP)
timeFrame: 3 months
measure: Diffusion lung capacity for carbon monoxide (DLCO)
timeFrame: 3 months
measure: Echocardiographic measurements
timeFrame: 3 months
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: University of Dundee
state: Tayside
Study officials:
affiliation: University of Dundee
name: Allan Struthers, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goudie AR, Lipworth BJ, Hopkinson PJ, Wei L, Struthers AD. Tadalafil in patients with chronic obstructive pulmonary disease: a randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2014 Apr;2(4):293-300. doi: 10.1016/S2213-2600(14)70013-X. Epub 2014 Mar 5.
Clinical trial NCT01886469: A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD)
Official title: A Phase II, Two-Stage, Open-Label, Single-Treatment, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of up to Three Separate HLD100 Modified Release Formulations of Dextroamphetamine Sulfate in Adolescent (Stage 1) and Pediatric (Stage 2) Patients With Attention-Deficit Hyperactivity Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Attention-Deficit Hyperactivity Disorder
Lead sponsor: Ironshore Pharmaceuticals and Development, Inc
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine the rate and extent of absorption of one or more modified release formulations of amphetamine (HLD100) in both adolescents and children with ADHD.


Eligibility criteria: Main Inclusion Criteria

* Male and female adolescents (12-17 years; Stage 1) and children (6-11 years; Stage 2).
* Diagnosis of ADHD and confirmed on Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS).
* ADHD symptoms controlled on a stable dose of Vyvanse, Adderall XR and or Dexedrine.
* Provision of informed consent (from parent\[s\] or legal representative\[s\]) and assent (from subject) for patients.

Main Exclusion Criteria

* Comorbid psychiatric diagnosis (e.g., psychosis, bipolar disorder).
* History of seizures or current diagnosis or family history of Tourette's disorder.
* Use of prescription drugs (except Vyvanse, Dexedrine or Adderall XR) the 14 days and over-the-counter drugs (except birth control) the 30 days before the study.

Primary outcomes:
measure: Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)
timeFrame: 48hrs
Secondary outcomes:
measure: Safety (AEs, ECG, laboratory parameters, physical examinations)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Saskatoon Centre for Patient-Oriented Research, Royal University Hospital, Room 5681, C Wing
state: Saskatchewan
Study officials:
References: