louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02490254: Childhood Uveitis Initial Management and One-year Outcomes
Official title: Childhood Uveitis Not Associated With Juvenile Idiopathic Arthritis: Incidence, Initial Management and One-year Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 500
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis.

Brief summary: The investigators wish to establish a robust estimate of the incidence of inflammation inside the eye (uveitis) in children age 0-16 years in the UK, which hospitals children present to, where they are referred to, which treatment they receive during the first year after diagnosis, and how well they can see at the end of the first year.

Detailed description: The investigators therefore propose to run a high quality surveillance study, together with the British Ophthalmological Surveillance Unit (BOSU) at the Royal College of Ophthalmologists and with the Scottish Ophthalmological Surveillance Unit (SOSU). BOSU and SOSU operate a monthly reporting card scheme. All UK consultant ophthalmologists and associate specialists receive a monthly 'report card' with a list of conditions being surveyed. Reporting clinicians will tick a box if they have seen a case of childhood uveitis in the preceding month, and return the card to BOSU/SOSU, who will inform us, the study investigators.

Following reporting of a new case, the investigators will directly contact reporting clinicians and send them a clinical proforma to collect clinical details about the case. At 12 months, a follow up questionnaire will be sent. The investigators will use only information available from patient case notes, with no direct patient contact. The investigators principal aim is to determine incidence of childhood uveitis in the UK. Secondary aims are to identify presentation patterns, referral pathways, associated medical conditions, management, and outcomes.

Eligibility criteria: Inclusion Criteria:

* Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis.

Exclusion Criteria:

* In England/Wales/Northern Ireland, children who are known to have pre existing juvenile idiopathic arthritis (joint inflammation) will be excluded. No exclusions will apply to the Scotland cohort.

Primary outcomes:
measure: The primary outcome measure will be the total number of reported cases of uveitis.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Annegret Dahlmann-Noor, Dr Med PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858754: Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Opioid-Induced Constipation
Keywords: opioid induced constipation
Cancer patients
methylnaltrexone
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2009-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.


Eligibility criteria: Inclusion Criteria:

* Is a man or woman aged 18 years or older.
* Has a body weight \>= 38 kg.
* Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
* Has a life expectancy of \>= 6 months.
* Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
* Is taking opioids for cancer-related pain, and not just as-needed doses.
* Has a diagnosis of OIC as determined by the investigator.
* Is willing to follow the protocol instructions on laxative use during the study.

Exclusion Criteria:

* Has a history of chronic constipation before starting opioids.
* Has renal disease receiving dialysis.
* Has an ostomy for stools.
* Is a pregnant or breastfeeding woman.

Primary outcomes:
measure: Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
timeFrame: 1 Day
Secondary outcomes:
measure: 1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Lancaster
country: United States
facility: Pfizer Investigational Site
state: California
city: Flat Rock
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Villejuif Cedex
country: France
facility: Pfizer Investigational Site
city: El Palmar
country: Spain
facility: Pfizer Investigational Site
state: Murcia/Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
Clinical trial NCT03622554: Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center
Official title: Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Falls
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Association Francaise pour la Recherche Thermale
First posted: 2018-08-09
Enrollment: 269
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preventing falls among people 65 years of age or older is a priority to promote healthy aging and reduce the number of hospitalizations, institutionalizations and years lived with disability. A preliminary study carried out at the Balaruc-les-Bains Thermal Center showed that one-third of people aged 65 are at significant risk of falling. Thermal establishments could therefore play a role in initiating measures to prevent falls among people aged 65 and over screened at risk.The main objective is to evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and a Therapeutic patient education (FTE) followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal


Eligibility criteria: Inclusion Criteria:

* Patient aged 65 and over,
* Presence of at least one chronic pathology justifying treatment and cure
* Subject having a history of fall in the last year (at least one fall)
* Subject having at least one risk factor of falling among the following 3: balance disorder, decreased muscle strength or gait disorder

Exclusion Criteria:

* Subject considered by the investigators as not being able to participate in the program (inability to answer questionnaires, to perform tests, for example).
* Patient under the protection of justice, under guardianship or curatorship

Primary outcomes:
measure: Incidence of falls at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
References:
Clinical trial NCT00073333: Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia
Official title: Social Phobia: Assessment and Treatment of Social Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Keywords: Phobic Disorders
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-11-21
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether people with social phobia are deficient in certain social skills.

Detailed description: Social phobia is a debilitating condition that can cause severe social, emotional, educational, and occupational functioning problems. Evidence suggests that individuals with social phobia are deficient in social skills, but the exact skills deficits have not been elucidated. This study will comprise two substudies: one will examine social skills deficits in social phobics and determine how they differ from those of people without social phobia; the other will determine if skills deficits in social phobics can be improved and whether improvements will affect overall social functioning.

Participants in this study will be randomly assigned to one of three groups for 16 weeks: an exposure group, a social skills training and exposure (SET) group, or a wait-list control group. Interviews, self-reports, and simulated role plays will be used to assess the social skills of participants.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Social Phobia

Exclusion Criteria:

* Axis II diagnosis of schizoid or schizotypal personality disorder or paranoia
* Axis II diagnosis of mental retardation, obsessive-compulsive disorder, and personality disorders, except for avoidant personality disorder
* Instability on any antidepressants
* Psychotic disorder

Primary outcomes:
measure: Social Phobia Remission
timeFrame: Measured at Month 12
measure: Social Phobia Remission Rate at 6 Month Follow-up
timeFrame: 6 month follow up
Secondary outcomes:
measure: Score on the SPAI
timeFrame: Measured at Month 12
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03943433: Oxygen Concentration During Alveolar Recruitment
Official title: The Effect of Oxygen Concentration During Alveolar Recruitment on Absorption Atelectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis, Postoperative Pulmonary
Keywords: Absorption atelectasis
Lung sono
Oxygen concentration
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position

Exclusion Criteria:

* American Society of Anesthesiologists physical status IV or more
* Severe cardiovascular disease
* Severe chronic obstructive pulmonary disease, emphysema
* History of pneumothorax, bullae
* History of lung resection surgery
* Conversion to laparotomy
* Refusal to participate

Primary outcomes:
measure: Modified lung ultrasound score
timeFrame: Intraoperative (at the end of operation, before emergence)
Secondary outcomes:
measure: Modified lung ultrasound score
timeFrame: Postoperative 30 minutes
measure: Intraoperative desaturation
timeFrame: Intraoperative
measure: Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
timeFrame: Intraoperative (20minutes after each recruitment)
measure: Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
timeFrame: Postoperative 30 minutes
measure: Postoperative pulmonary complication
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Hyon Bahk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim BR, Lee S, Bae H, Lee M, Bahk JH, Yoon S. Lung ultrasound score to determine the effect of fraction inspired oxygen during alveolar recruitment on absorption atelectasis in laparoscopic surgery: a randomized controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):173. doi: 10.1186/s12871-020-01090-y.
Clinical trial NCT01283633: Investigation of the Use of Remote Presence Robots in Delivery of Neuromodulation
Official title: Investigation of the Use of Remote Presence Robots in the Administration of Neuromodulation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Complications; Neurostimulator
Satisfaction
Keywords: neuromodulation
remote presence robotics
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In recent years, robotic devices are becoming more and more common in medical practice. Such devices provide an effective way to communicate within a clinical setting, but recent studies have shown far more diverse uses for these robots, ranging from training future surgeons to diagnoses of patients. In the investigators study, the investigators would like to investigate whether it is effective to employ robotic devices in the administration of neurostimulation treatment. It is the investigators hypothesis that the introduction of robotic devices will only yield minimal if any inaccuracies in a standard neuromodulation treatment protocol. In addition, the investigators also predict a high satisfaction rating from all participants involved in conditions involving the robot.

Detailed description: Patients with neuromodulation systems implanted for either movement disorders or chronic pain and who require programming of their systems will be approached to enter the study. Those who consent will be consecutively assigned to either the normal standard of care (i.e. programming of their systems with an experienced clinician) or programming of their systems with an inexperienced programmer (nurse) who will be directed by the experienced programmer via the remote presence robot. Both the nurses and the patients will complete questionnaires rating their satisfaction of the programming experience.

They will each only receive one questionnaire at the end of the programming session. There is no other test point.

Eligibility criteria: Inclusion Criteria:

* patients with neuromodulation systems, requiring programming
* nurses who have never programmed a neuromodulation system before

Exclusion Criteria:

* those who are unwilling to give consent

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Patients will complete the questionnaire once following the neuromodulation therapy. Day 1
Secondary outcomes:
measure: Nursing satisfaction questionnaire
timeFrame: Immediately following the neuromodulation session, the nurse will complete one questionnnaire. Day 1.
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Centre for Clinical Research, Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Capital Health and Dalhousie University
name: Ivar M Mendez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304433: Safety Profile of Hydroxyethyl Starch
Official title: Evaluation on the Safety Profile of Hydroxyethyl Starch (HES) 130/0.42
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasma Volume Replacement
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 1000
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: adult patients

Brief summary: The study is primarily aimed to collect further data on the safety of the investigational product in a large patient population when used in routine clinical practice in the Asian-Pacific region.


Eligibility criteria: Inclusion:

* patients with ASA risk score ≤ III,
* non-emergency patients, i.e. elective surgery

Exclusion:

* contraindications as listed for HES 130/0.42

Primary outcomes:
measure: number of adverse drug reactions
timeFrame: up to 48 hours
Secondary outcomes:
measure: change in haemodynamics during surgery or intensive care unit stay
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Nanjing, Jiangsu Province
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: The Sixth Hospital of Shanghai
city: Shanghai
country: China
facility: The First Hospital of Shanghai
city: Shanghai
country: China
facility: Dong Fang Gan Dan Hospital of Shanghai
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
Study officials:
References:
Clinical trial NCT01280851: Living Renal Donor MRI Study
Official title: Comprehensive Morphological and Functional Assessment of Living Renal Donor With Magnetic Resonance Imaging With Comparison to Computed Tomographic Angiography and Renal Scintigraphy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Living Renal Donor
Keywords: Living renal donor
Magnetic Resonance Imaging
Renal vascular anatomy
Renal function
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-01-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Accurate preoperative evaluation of a potential living renal donor's anatomy, vasculature and function is crucial to ensure optimal outcomes for both kidney donor and recipient in transplantation.

Currently abdominal ultrasound and spiral CT angiography are used to evaluate renal anatomy and vascular status, and renal scintigraphy to evaluate renal function. This imaging protocol exposes this relatively young and healthy population to a high radiation dose and potentially nephrotoxic contrast agents.

The investigators hypothesize that a single MR-based examination in the preoperative evaluation of potential kidney donor is a faster, safer, more cost effective and as accurate as the current multiple imaging work-up protocol.

Detailed description: An accurate preoperative assessment of the renal donor is essential to minimize the risks for the donor \& optimize the results for the recipient.

The current preoperative assessment includes Ultrasound, CT \& Renal Scintigraphy. The latter two tests subjects the patient to the risk of a high radiation dose. Moreover, the use of iodinated contrast media during CT angiography may increase the risk of renal \& systemic toxicity.

MRI can be a "one-stop shop" modality for preoperative assessment of living kidney donors. MRI also eliminates radiation exposure and the injection of potentially nephrotoxic iodinated contrast material.

The purpose of this study is to test the feasibility and evaluate the accuracy of a single MR-based examination, allowing for the comprehensive assessment of renal anatomy, function and vascular status in potential live kidney donors.

Eligibility criteria: Inclusion Criteria:

* Potential renal donors with no known renal disease (initial medical screening performed and scheduled for further imaging evaluation as renal donor);
* Age 18-65 years;
* No medications (birth control pills and vitamins are acceptable).

Exclusion Criteria:

* Pregnancy;
* Age \<18 years or \>65 years;
* MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.

Primary outcomes:
measure: Accuracy of MRI exam in kidney donors
timeFrame: 2 years
Secondary outcomes:
measure: cost analysis
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Kartik Jhaveri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05171751: Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia
Official title: Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Hyperinsulinaemic Hypoglycaemia
Octreotide Adverse Reaction
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with congenital hyperinsulinemia who received octreotide subcutaneous injection after diazazine treatment failed.

Brief summary: To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.

Detailed description: Octreotide subcutaneous injection is effective and safe in the treatment of congenital hyperinsulinemia in children with inefficacy of diazazine.

Eligibility criteria: Inclusion Criteria:

1. Consistent with the diagnosis of congenital hyperinsulinemia with ineffective diazine; With the maximum dose of diazine at 15mg/kg/d for 5 days, fasting blood glucose/postprandial blood glucose could not be stabilized at the target value of 3.3mmol/L without intravenous glucose infusion.
2. patients treated with octreotide subcutaneous injection.

Exclusion Criteria:

1. Before the diagnosis of CHI and the treatment related to CHI, the child had received total pancreatectomy without octreotide
2. Secondary hypoglycemia caused by diseases other than CHI
3. Patients who refused to take octreotide due to parents or family economic reasons, but not hospital treatment factors.
4. Patients who intervene/interfere with octreotide treatment regimen for parental reasons

Primary outcomes:
measure: blood glucose
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Endocrinology, Genetics, Metabolism
state: Beijing
Study officials:
affiliation: doctor of Beijing children's hospital
name: bingyan cao, doctor
role: PRINCIPAL_INVESTIGATOR
References: