louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03375359: First Trimester Screening for Trisomy 21, 18, 13 and 22q11.2 Deletion Syndrome
Official title: First Trimester Screening for Trisomy 21, 18, 13 and 22q11.2 Deletion Syndrome - ReFaPo02
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who are referred for FTS or for further follow-up examinations in case of a suspected anomaly or increased nuchal translucency at 11-13 weeks' gestation

Brief summary: Combined first-trimester screening represents the gold standard of risk assessment for the presence of trisomy 21, 18, and 13. The concept is based on the age risk, the measurement of fetal nuchal translucency (NT), and the determination of serum markers free beta-hCG and PAPP-A in maternal blood.

In recent years it has been shown that the risk assessment can be improved by combining in-depth ultrasound and cell-free DNA analysis from maternal blood. In their latest study, the investigators were able to detect all fetuses with trisomy 21, 18, and 13 through this procedure. No normal fetus displayed an increased risk. In contrast, the detection rate in classic, combined first-trimester screening is about 95% and the false-positive rate is 3-5%. In this study the investigator examine the test quality - especially the false positives - of cell-free DNA analysis on trisomy 21, 18 and 13 as well as on the microdeletion 22q in 1000 pregnancies.


Eligibility criteria: Inclusion Criteria:

* Maternal age of 18 years and more
* Crown rump length 45 - 84mm
* Referral for first trimester risk assessment
* Singleton pregnancy
* Written consent

Exclusion Criteria:

* No consent
* Known parental microdeletion 22q11.2
* Crown rump length \<45mm or \>84mm
* Multiple pregnancies including vanishing twins

Primary outcomes:
measure: Screen positive rate
timeFrame: 15 month
measure: Screen false-positive rate
timeFrame: 15 month
measure: Uninformative test rate in cfDNA screening for 22q11.2 deletion
timeFrame: 15 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of Women's Health
Study officials:
affiliation: University Hospital Tuebingen, Department of Women's Health
name: Karl-Oliver Kagan, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04750759: Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat
Official title: A Randomized, Single Blind, Placebo-controlled, Multiple Dose, Parallel-arm Study to Investigate the Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat to Treat COVID-19 ("NICCAM")
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: Charité Research Organisation GmbH
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2021-02-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Niclosamide (2000 mg QD) and Camostate (600 mg QID) are expected to be safe and well-tolerated as a combination therapy and to show clinically beneficial for COVID-19 patients.

Detailed description: Niclosamide is an approved drug for the treatment of intestinal worm infections that can potentially induce the process of autophagy and thus significantly limit viral replication in cells.

Camostat is approved in Japan for the treatment of chronic pancreatitis and reflux esophagitis. It has been shown to effectively block viral replication in a SARS-CoV-2 animal model.

Since the mechanisms of actions are different, it was hypothesized that a combination of both substances might have an additive or even synergistic effect in the treatment of patients with COVID-19.

This study is designed to investigate the safety, tolerability and preliminary efficacy of the treatment combination niclosamide and camostat in mild and moderately affected COVID-19 patients.

Eligibility criteria: Inclusion Criteria:

* Male and female patients in the age of 18 to 70 years
* Having a recent positive direct test for Sars-CoV-2
* Having mild or moderate COVID-19 symptoms with no indication for hospitalization due to SARS-CoV-2 infection (WHO Ordinal Scale 1-2)

Exclusion Criteria:

* Severe respiratory symptoms related to COVID-19 requiring oxygen or intensive care (high flow oxygen or mechanical ventilation or ECMO)
* Patients with preexisting pulmonary diseases requiring oxygen supply
* Patients with history of hypersensitivity to Camostat or Niclosamide or to any ingredients to any of the two drugs
* Patients with heart failure (NYHA III or NYHA IV)
* Patients with proven malignant tumor
* Patients diagnosed with influenza infection
* Pregnancy or breastfeeding
* Immunocompromised patients
* Creatinine clearance \< 60 mL/min
* aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \> 2 times upper limit of normal (ULN)

Primary outcomes:
measure: Treatment emergent number of Adverse Events
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
affiliation: Charite University, Berlin, Germany
name: Martin Witzenrath, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06743659: Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia
Official title: Alert-Based Computerized Decision Support for Identification and Management of Patients with Familial Hypercholesterolemia (FH-ALERT Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Familial Hypercholesterolaemia
Keywords: Familial Hypercholesterolemia
Computerized Decision Support
Electronic Alerts
High Cholesterol
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: During the first 6 months, the BPA will run in "silent mode" and will not provide notification to the clinician of record about the potential diagnosis of FH. For the following 18 months, the BPA will run in "alert mode" during which an on-screen alert will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH but has not been recognized as such.
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called Familial Hypercholesterolemia. The main question it aims to answer is whether the computer alert increases recognition of this high cholesterol disorder.

Detailed description: FH-ALERT is a single-center, time-series trial of a patient- and provider-facing EPIC BPA (alert-based CDS tool) to increase diagnosis, LDL-C lowering, and guideline-based therapy of outpatients with presentations consistent with FH. For the first 6 months, the BPA will run in "silent mode", identifying patients with presentations consistent with FH, but not alerting the clinician of record. Following this initial "pre-alert" 6-month period, the BPA will switch to "alert mode" for 18 months, which will provide the on-screen notification to the clinician of record. In other words, consecutive outpatients with presentations consistent with FH will be enrolled over two years: "pre-alert" (silent mode) for 6 months and "alert mode" for 18 months.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* seen in the BWH Endocrinology, Cardiovascular Medicine, and Primary Care Clinics
* Dutch Lipid Clinic Network score of at least 3 points

Exclusion Criteria:

* a Familial Hypercholesterolemia diagnosis already documented in the EHR medical history, visit history, or problem list

Primary outcomes:
measure: Frequency of documented FH diagnosis
timeFrame: 6 Months
Secondary outcomes:
measure: Mean Change in LDL-C
timeFrame: 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05923359: Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
Official title: Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to test whether Apple Watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Had a 10-second 12-lead ECG done at Mayo Clinic
* Have a high AI-ECG risk score indicating a high likelihood of previously unrecognized AF
* Men with CHA2DS2-VASc2 ≥2 or women with CHA2DS2-VASc ≥ 3

Exclusion Criteria:

* Diagnosed atrial fibrillation
* Diagnosed dementia
* Diagnosed end-stage kidney disease
* History of intracranial bleeding
* Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
* Missing date of birth
* Residence outside of the U.S. or missing address information

Primary outcomes:
measure: Atrial fibrillation
timeFrame: 2 years
Secondary outcomes:
measure: Change in individuals' maximum learning span
timeFrame: Baseline, 2 years
measure: Change in processing speed measure
timeFrame: Baseline, 2 years
measure: Ischemic stroke or systemic embolism events
timeFrame: 2 years
measure: Major bleeding
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Xiaoxi Yao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04576559: Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder
Official title: Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Autism
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There is a need to find an approach that is appropriate for managing children with Autism Spectrum Disorder in the dental clinic, to manage their behaviour and decrease their anxiety in this research we will apply our modified dental visual aids and test its effectiveness in managing the behavior of such children during the dental appointment.


Eligibility criteria: Inclusion Criteria:

* Patient age between 6-10 years.
* Child patient has to represent the typical triad symptoms of ASD that include: social interaction deficits, communication impairment, language impairment and rigidity of interests.
* Child patient with ASD diagnosis confirmed in the patient's files according to "the DSM-V criteria" (American Psychiatric Association, 2013).
* Child patient with mild to moderate ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).

Exclusion Criteria:

* Patient age younger than 6 years and older than 10 years.
* Child patient with other congenital anomalies, for example, "Cerebral Palsy" or "Down Syndrome".
* Child patient with previous dental experience.
* Child patient with severe ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).

Primary outcomes:
measure: Plaque Index Scoring
timeFrame: four weeks
measure: Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD)
timeFrame: four weeks
measure: The Observational Scale of Behavioral Distress (OSBD)
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
state: Select A State Or Province
Study officials:
References:
Clinical trial NCT02079259: CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure
Official title: CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure - A Pilot Study to Optimize Individualized Volume Depletion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic heart failure listed for LVAD

Brief summary: The number of patients with acute congestion on chronic heart failure is increasing. Ultrafiltration has recently been proposed as an alternative approach for the stabilization of volume balance, especially in patients with imminent diuretic resistance.

There is increasing evidence that ultrafiltration may relief cardiac congestion with lesser effects on blood pressure and activation of renin angiotensin system, respectively . However, recent studies revealed conflicting results: demonstration the superiority of ultrafiltration in comparison to diuretic treatment, and a lack of evidence of benefit, as well as an excess of adverse events with ultrafiltration.

Aquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer than aquaphesis with a constant ultrafiltration with comparable effectiveness


Eligibility criteria: Inclusion Criteria:

* Patients with chronic heart failure scheduled for LVAD
* Indication for CVVH/Aquapheresis

Exclusion Criteria:

* Renal Disease (GFR \<20 ml / min)

Primary outcomes:
measure: Changes in central venous pressure
timeFrame: Changes from Baseline to 48 h after intervention
Secondary outcomes:
measure: amount of net fluid loss
timeFrame: 48 h
measure: Measure of dyspnea using a visual analog scale
timeFrame: Changes from Baseline to 48 h after intervention
measure: heart function
timeFrame: 7 days
measure: Biomarker
timeFrame: Changes from Baseline to 48 h after intervention
measure: Time until impaired plasma refill rate
timeFrame: 48 h
measure: blood pressure
timeFrame: Changes from Baseline to 48 h after intervention
measure: heart rate
timeFrame: Changes from Baseline to 48 h after intervention
measure: Serum Creatinine level
timeFrame: 48 h
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
Study officials:
affiliation: Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
name: Ralf Westenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05183659: The Reliability of Myotonometer in Evaluating the Muscle Tone and Biomechanical Properties of the Forearm Muscles
Official title: The Reliability of Myotonometer in Evaluating the Muscle Tone and Biomechanical Properties of the Forearm Muscles: Investigation of the Effect of Grip Strength on Mechanical Features
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Tone
Viscoelasticity
Keywords: elasticity
hardness
forearm muscles
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Bitlis Eren University
name: Dokuz Eylul University
First posted: 2022-01-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults between 18-35 years old

Brief summary: The primary aim of this study was to evaluate the intra-rater and inter-rater reliability of MyotonPRO in measuring muscle tone and mechanical properties of the wrist extensor and flexor muscles in healthy young adults. The secondary aim is to examine whether grip strength has any effect on muscle tone and biomechanical properties.


Eligibility criteria: Inclusion Criteria:

* Age≥18 years
* Body mass index \< 30 kg/meter square
* Having no upper extremity injuries
* Willing and able to provide the written informed consent for the study

Exclusion Criteria:

* Use of medication that will affect muscle tone
* History of lateral or medial epicondylitis, trauma (elbow, hand or wrist), cervical radiculopathy, peripheral neuropathy or nerve injury (axillary, median, ulnar, radial, musculocutaneous), systemical diseases, muscle disorders (e.g. genetic diseases, neuromuscular disorders)

Primary outcomes:
measure: Muscle tone (Hz)
timeFrame: Day 1
measure: Stiffness (N/m)
timeFrame: Day 1
measure: Elasticity (Logarithmic decrement)
timeFrame: Day 1
Secondary outcomes:
measure: Grip Strength
timeFrame: Day 1
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
References:
Clinical trial NCT03164759: Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study
Official title: Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Implantation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving dental implants in healed non grafted sites in both arches

Brief summary: Correlate the implant stability quotient values measured by ostell device with radiographic bone density measured on CBCT by bluesky software pre-operatively

Detailed description: Dental implants have been widely used in the field of dental rehabilitation. Nowadays implant sucess rate is very high but to keep faliure rate as low as possible patient selection is very important especially regarding bone density to achieve high primary stability. Primary stability plays an important role in successful osteointegration of dental implants. This study was done to correlate between the bone density pre operatively measured on CBCT represented by HF unit and implant stability measured post operatively by ostell device represented by ISQ unit

Eligibility criteria: Inclusion Criteria:

* patients receiving dental implants in both arches
* patients should be free from any systemic diseases that may affect normal healing of bone, and predicated outcome
* no intra-oral soft tissue defect that would render primary closure of the intra-oral wound

Exclusion Criteria:

* patients with systemic diseases

  _ patients with ridge augmentation such as ridge expansion, ridge splitting and bone grafting
* patients with sinus lifting done to place implants
* immediate extraction sockets

Primary outcomes:
measure: Bone density
timeFrame: Baseline
measure: Implant stability
timeFrame: Immediate post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04453059: Study With Oral Isovue in Abdominopelvic CT
Official title: A Phase IIIB, Multicenter Study With Oral Administration of Isovue-300 for Opacification and Delineation of the Gastrointestinal (GI) Tract in Abdominopelvic Computed Tomography (CT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Requiring Abdominopelvic CT With Oral Administration of Contrast
Keywords: Oral Isovue
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2020-07-01
Enrollment: 218
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric patients who have previously undergone CT examination of the abdomen and pelvis with oral administration of Isovue-300 (2-3% concentration) as part of their clinical work-up.

Brief summary: This is a retrospective clinical study with prospectively designed blinded evaluation of CT images in adult and pediatric patients who underwent CT examinations of the abdomen and pelvis and were orally administered a solution of Isovue-300 to opacify the GI tract to distinguish it from adjacent abdominal and pelvic structures. The study will collect already existing data, such as demographic data, adverse events and CT images, for all chronologically enrolled patients who meet the inclusion/exclusion criteria prospectively defined in this protocol


Eligibility criteria: Patients will be included in the study if:

* Demographic and safety data are available for analysis
* Complete set of CT images performed after oral administration of Isovue-300 are available for assessment
* Isovue-300 was orally administered during an interval time of 60-20 minutes before the CT scanning.

Patients will be excluded from the study if:

* Oral contrast agent received within 1 week prior to the CT scan
* Undergone any abdominopelvic surgery procedure that resulted in alteration of the bowel transit time prior to the CT exam
* CT exam with oral administration of Isovue was performed because of a known or suspected condition of bowel obstruction
* Patient did not actively drink the contrast solution.

Primary outcomes:
measure: Proportion of patients with adequate visualization of anatomic delineation of the GI tract
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
References: