louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02459600: Comparison of Refraction Measurments in Children Under General Anesthesia, With and Without Cycloplegic Drops
Official title: Methodes of Meausring Refraction in Children Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: General Anesthesia
Keywords: Eye surgery
Children
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Assessment of refraction measurements in children under general anesthesia, with or without cyclopelgic eye-drops

Detailed description: Comparing to adults, children have high ability to preform accommodation of the intraocular lens, that is due to the Ciliary muscle. In order to measure children's refraction in an accurate way the Ciliary muscle must be paralyzed and that is usually done be cycloplegic eye-drops .In case a child is undergoing a medical procedure under general anesthesia the assumption that the Ciliary muscle is paralyzed (complete or partially) due to anesthetic medications. In this study we would like to compare the refraction measurements in children under who undergo general anesthesia before and after applying cycloplegic eye-drops. In this way we can learn about the effect of anesthetic medication on the Ciliary muscle.

Eligibility criteria: Inclusion Criteria:

1. 1 - 12 years old
2. Eyes that didn't underwent surgical procedure

Exclusion Criteria:

1. eye operation

Primary outcomes:
measure: difference in refraction results with and without cyclopentolate drops under general anesthesia
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka
Study officials:
affiliation: Soroka University Medial Center, Israel
name: Zvi Gur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03298100: Risk Scoring Model for Endometrial Cancer
Official title: Assessment of Risk Scoring Model for Prediction of Endometrial Cancer Among Symptomatic Postmenopausal Women(a Prospective Cohort Study).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncology
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All postmenopausal women (who had their menses stopped for at least one year above age of 40) with vaginal bleeding.

Brief summary: A prospective cohort study to assess RHEA ( recurrent vaginal bleeding, hypertension, endometrial thickness and age) scoring model for prediction of endometrial carcinoma


Eligibility criteria: Inclusion Criteria:

- All postmenopausalwomen with vaginal bleeding and endometrial thickness more than 4 mm

Exclusion Criteria:

* all patients with vaginal bleeding arising from cervical or vaginal or vulval disease or due to hormonal replacement therapy (scheduled bleeding).

Primary outcomes:
measure: Specificity and sensitivity of RHEA scoring mdel
timeFrame: One year
Secondary outcomes:
measure: Variables to increase specificity and sensitivity of the score model
timeFrame: One year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Asmaa F Kasem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02806700: Twitter and Diabetes
Official title: Twitter and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Cardiovascular Disease
Keywords: Diabetes
Social Media
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-06-21
Enrollment: 628
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Twitter use is surprisingly well represented across broad demographic population segments and health-related messages. The promise of using Twitter is that its use is growing rapidly, it allows the investigators to view communications that were impossible to intercept before, and it potentially provides information faster and less expensively than collection from other media channels. Prior work also supports that social media interventions can improve health behavior change (e.g. weight loss, physical activity) and outcomes.The overarching goals of this proposal are to understand the uses and limitations of this communication channel to improve patients' ability to manage their CV health condition.

Detailed description: Use Twitter to deliver high impact CV health related content to improve patient activation and disease management for diabetes.

Eligibility criteria: Inclusion Criteria:

* diabetes
* uses social media

Exclusion Criteria:

* \<21 years of age
* pregnant

Primary outcomes:
measure: Change in Patient Activation Measure (PAM) Score From Baseline
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in Systolic Blood Pressure From Baseline
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05206500: NextGen - Clinical Implication of Next Generation Sequencing
Official title: Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Urinary Tract Infections
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with Urinary Tract Infection (UTI) symptoms and Colony-forming Units (CFU) \<10,000 have clinically significant UTIs. Characterizing the species of bacteria growing in low numbers and treating the patients based on bacterial sensitivity will help in resolving patients' symptoms.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recently more advanced techniques, including Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) are available to detect bacteria in urine based on bacterial genomes. Comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with Colony Count of less than 10,000 and more than zero.

Detailed description: Bacterial sensitivity test for different antibiotics are the most important guide for treatment of patients with UTI. Unfortunately, for patients with less than 10,000 Colony Count (CC), usually no sensitivity test is done and there is not any guide for appropriate antibiotic therapy for this group.

Eligibility criteria: Inclusion Criteria:

* Female at least 18 years of age
* U/C (Urinary Culture) growth of \<10,000 Colony-Forming Units (CFU)
* Understanding and acceptance of the need to return for all scheduled follow-up visits
* Able to give informed consent

Exclusion Criteria:

* Catheter in use (Foley or suprapubic or intermittent)
* Not able to provide clean midstream urine
* Antibiotic consumption in the past 2 weeks before signing the consent
* Pregnant or Planning to Conceive
* Incarcerated

Primary outcomes:
measure: Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
timeFrame: Baseline
measure: Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI)
timeFrame: 3 Weeks Post-Treatment
Secondary outcomes:
measure: Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000
timeFrame: Baseline
measure: Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000
timeFrame: 3 Weeks Post-Treatment
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Majid Mirzazadeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04076800: Acupuncture and Insulin Doses in Insulin-treated Type 2 Diabetes
Official title: Comparison of the Effects of a Standardized Acupuncture Treatment and Sham Acupuncture on Insulin Doses in Insulin-treated Patients With Type 2 Diabetes. A Randomized, Single-blind, Crossover Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: acupuncture
insulin sensitivity
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a randomized, single blinded, cross-over interventional study for evaluating the effect of acupuncture versus sham acupuncture in diabetic type 2 patient in insulin treatment. Primary end-point of the study is the difference of daily units of insulin between treatment and control group; secondary end point are the variation of glycated hemoglobin levels, lipids panel (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides), C reactive protein and adiponectin. Variation of epicardial fat thickness will be also evaluated by echography. Acupuncture and sham treatment will be administered twice a week for 3 months and, after a pause of one month and cross-over between groups for other three months. Acupuncture treatment will include use of somatic points (SP6; ST36; KI3; CV4; CV12; TE5; LI4; LI11; YinTang; ST28; BL23; BL22; BL20; BL13) and auricular points (most tender point on palpation with pressure feelers of 400 g on Stomach, Endocrine, Spleen, Kidney, Hungry, Shen man and Pancreas auricular points). Sham acupuncture will be applied distal from acupuncture points and areas used for treatment, with shallow insertion and without manipulation of the needle (15 needles in total on thorax, abdomen, back, arms and legs).


Eligibility criteria: Inclusion Criteria:

* type 2 Diabetes Mellitus
* insulin therapy \> 20 UI daily for at least 6 months
* HbA1c \< 69 mmol/mol

Exclusion Criteria:

* Class I Psychiatric illness not adequately treated
* Actual pregnancy or breastfeeding, or pregnancy planning.
* Corticosteroid treatment
* Severe heart failure (NYHA III-IV)
* Severe renal failure (pre-dialysis o dialysis),
* Severe liver insufficiency (overt cirrhosis)
* Severe respiratory failure (oxygen therapy)

Primary outcomes:
measure: Insulin daily doses
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Diabetologia AOU Careggi
Study officials:
References:
Clinical trial NCT06905600: Transient Pseudohypoaldosteronism Affecting Children With Urinary Tract Malformation
Official title: Transient Pseudohypoaldosteronism Affecting Children With Urinary Tract Malformation: Diagnosis and Management in a French Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pseudohypoaldosteronism
Keywords: Pseudohypoaldosteronism
pseudohypoaldosteronism in children
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor subjects aged less than 6 years at the time of diagnosis of pseudohypoaldosteronism in the context of urinary malformation and/or urinary infection between January 1, 2018 and December 31, 2023

Brief summary: Pseudohypoaldosteronism is a pathology affecting children under 6 months of age, little known but which can have serious consequences.

There are no real figures on the prevalence of this pathology in France. The exact pathophysiology is not known and the management is not currently codified.

This is why it is interesting to study this pathology and its treatment on a national scale in order to think about the best possible treatment, as well as to raise awareness of this pathology among different health professionals.


Eligibility criteria: Inclusion Criteria:

* Minor subjects aged less than 6 years at the time of diagnosis
* Diagnosis of pseudohypoaldosteronism in the context of urinary malformation and/or urinary infection between January 1, 2018 and December 31, 2023
* Subject (and/or their parental authority) having not expressed, after information, their opposition to the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Subject (or their parents) having expressed their (their) opposition to participating in the study

Primary outcomes:
measure: National comparison of clinical and therapeutic practices concerning the management of pseudohypoaldosteronism in children with urinary malformations and/or urinary infections
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service pédiatrie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT04443400: Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy
Official title: Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiation Therapy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with thoracic radiotherapy

Brief summary: The purpose of this study is to detecte and predict early subclinical cardiac damage induced by thoracic radiation therapy based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers.

Detailed description: This is a monocentric prospective cohort study in which 100 patients treated for malignant tumors and with cardiac radiation exposure will be included.All patient will be followed for 12 months after radiotherapy. Echocardiography, 2D STE parameters and circulating biomarkers will be collected.

Eligibility criteria: Inclusion Criteria:

* with malignant tumors
* will receive radiotherapy
* with cardiac exposure during the radiotherapy process
* could receive regular follow-up for 12 months
* written informed consent

Exclusion Criteria:

* satisfactory echocardiographic images could not be obtained
* moderate or severe valvular disease
* cardiomyopathy
* congenital heart disease
* refractory hypertension
* coronary artery disease\*
* heart failure
* arrhythmia requiring intervention
* pericarditis
* acute myocarditis
* participating in other clinical studies of drug intervention
* severe liver and kidney dysfunction
* autoimmune disease
* pulmonary hypertension

coronary artery disease: at least 50% stenosis besed on previous coronary angiography or CTA, or with a history of percutaneous coronary stent implantation.

\*: with LVEF\<50%, unstable angina，or acute myocardial infarction within 3 months.

Primary outcomes:
measure: Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy
timeFrame: 2020-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Dan Zhu
role: STUDY_DIRECTOR
References:
citation: Li T, Zhuang H, Wang Y, Li J, Zhu D, Cui M. Two-dimensional speckle tracking echocardiography in evaluating radiation-induced heart damage. Asia Pac J Oncol Nurs. 2021 Dec 25;9(2):119-124. doi: 10.1016/j.apjon.2021.12.008. eCollection 2022 Feb.
citation: Zhu D, Li T, Zhuang H, Cui M. Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy: Study Protocol for a Prospective Cohort Study. Front Cardiovasc Med. 2022 Jan 26;8:735265. doi: 10.3389/fcvm.2021.735265. eCollection 2021.
Clinical trial NCT04244500: Burden of Influenza at Emergency Department (ED) Level in European Countries
Official title: Burden of Influenza at Emergency Department (ED) Level in European Countries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza, Human
Keywords: emergency room
epidemiology
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: Klinikum Ernst von Bergmann Potsdam
name: Klinikum Suedstadt, Rostock
name: Sanofi Pasteur, a Sanofi Company
First posted: 2020-01-28
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients seeking care at the emergency department of participating hospitals

Brief summary: This study plans to conduct enhanced influenza surveillance at a hospital emergency department level independent of underlying influenza-like symptoms.

Detailed description: Study objectives

Primary:

- Measure the proportion of non-traumatic emergency department (ED) visits infected with influenza during the peak of the influenza season

Secondary:

* Describe the demographic and medical profile of influenza-related and non-influenza-related visits
* Identify socio-demographic or other risk factors associated with ED visit outcome
* Describe the influenza positivity rate among ED visits for different causes
* Measure the proportion of influenza positive patients without classical ILI symptoms

Eligibility criteria: Inclusion Criteria:

* All adult patients seeking care at participating ED during the influenza season
* Participants and/or guardian providing informed consent and/or assent, as appropriate, to participate.

Exclusion Criteria:

* Individuals reporting having suffered a traumatic injury without other conditions.

Primary outcomes:
measure: influenza status at admission to ED (positive vs. negative)
timeFrame: at admission to ED
Secondary outcomes:
measure: demographic and medical profile
timeFrame: at admission to ED
measure: socio-demographic or other risk factors
timeFrame: at admission to ED
measure: influenza without classical symptoms of influenza-like illness
timeFrame: at admission to ED
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock
Study officials:
References:
Clinical trial NCT02880800: Does IVPCA Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
Official title: Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Keywords: Analgesia, Patient-Controlled
Analgesics, Opioid
Drug-Related Side Effects and Adverse Reactions
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to compare the use of intravenous patient controlled analgesia (IVPCA) versus the delivery of pain relief (per oral and intravenous (IV) medications as rescues analgesia) on an as needed basis within a well defined fast track protocol that includes multimodal analgesia for patients who are undergoing elective primary knee replacement surgery. The investigators assumed that with the multimodal analgesia regimen without the use of IVPCA will demonstrate decreased consumption of postoperative opioids, reduced incidence of opioids related side effects and decreased length of stay in the hospital.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 18 to 80 years old
* Provision of written informed consent
* Patients scheduled to undergo primary knee surgery included in the fast track protocol under regional anesthesia only
* Patients with Body Mass Index (BMI) between 18 to 34.9
* Patients with American Society of Anesthesiologists (ASA) physical status classification of 1 to 3

Exclusion Criteria:

* Patients on chronic (more than twice a week) opioid treatment including Tylenol #3, percocet, morphine, methadone, hydromorphone, fentanyl patch and other potent opioids
* Patients with language barrier or difficulty in communication in English
* Patients who are allergic to morphine and hydromorphone, fentanyl, gabapentin, celecoxib or acetaminophen
* Patients with increased risk for respiratory depression with intrathecal morphine (OSA, central apnea)
* Patients with documented Renal or hepatic impairment

Primary outcomes:
measure: Total amount of opioid consumption postoperatively
timeFrame: Every 24 hours for up to 48 hours after randomization
Secondary outcomes:
measure: Opioid related side effects.
timeFrame: Every 24 hours for up to 48 hours after randomization
measure: Patient satisfaction
timeFrame: Once at 48 hours after randomization
measure: Pain scores measured at rest and movement
timeFrame: Every 12 hours for up to 48 hours after randomization
measure: Length of stay in hospital
timeFrame: One week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References: