louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02042846: Clinical Evaluation of the SportWelding FijiAnchor® in Hand and Hand Wrist Surgery
Official title: Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lesion of Ligament of Wrist and/or Hand
Lead sponsor: SportWelding GmbH
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying ultrasonic energy. This provides an intimate bond between implant and bone delivering immediate stability.

The purpose of this study is to evaluate the surgical and clinical outcome of the SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.


Eligibility criteria: Inclusion Criteria:

* Having a condition requiring (re)fixation or (re)construction of ligaments in the hand or hand wrist
* Being able to comprehend, sign, and date the written informed consent form (ICF)); and
* Being able to visit the hospital to be examined the repaired region after the procedure.

Exclusion Criteria:

* Having serious concomitant disease
* Being pregnant
* Having the control hand not suitable to serve as comparator

Primary outcomes:
measure: Operation success
timeFrame: Day 1
measure: Procedure success
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical function
timeFrame: 3 and 6 months
measure: Adverse events
timeFrame: From Day 1 to 12 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Univ.-Klinik für Unfallchirurgie
state: Tyrol
Study officials:
affiliation: Univ.-Klinik für Unfallchirurgie Innsbruck, Austria
name: Rohit Arora, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00601146: Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease
Official title: Low-Dose Chest Computed Tomography Screening for Lung Cancer in Survivors of Hodgkin's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Hodgkin's disease
CT scan
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2008-01-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study of low-dose Chest CT screening for long-term Hodgkin lymphoma survivors
Primary purpose: SCREENING

Brief summary: This research study is being done because patients with a history of chest radiation treatment for Hodgkin's disease have been shown to be at increased risk for developing lung cancer a number of years out from treatment. The risk appears to be further increased among patients with a smoking history. Currently, the practice is to recommend annual low-dose chest CT scans in survivors of Hodgkin's disease who have received prior chest radiation treatment and who have at least a moderate smoking history. In this study, the CT scans will be read and interpreted by the study radiologist, and the results recorded in a consistent manner.

Detailed description: - Participants will undergo a chest computed tomography (CT) scan once a year for a 3-year period.

Eligibility criteria: Inclusion Criteria:

* 5 years or longer from initial Hodgkin's disease diagnosis
* Current age 18 or older
* Received mediastinal irradiation and/or alkylating-agent based chemotherapy
* Smoking history of 10-pack years or more, or current smoker
* Pre-approval from the participant's insurance company for the CT study

Exclusion Criteria:

* Patients with a history of lung cancer
* Currently receiving treatment for another cancer diagnosis
* Known diagnosis of any metastatic cancer
* Pregnant women

Primary outcomes:
measure: To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute/Brigham and Women's Hospital
name: Andrea K. Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06101446: Evaluation of the Effectiveness of Aromatherapy on Anxiety, Vital Signs, and Postoperative Complications in Lower Impacted Wisdom Tooth Surgery
Official title: Evaluation of the Effectiveness of Aromatherapy on Anxiety, Vital Signs, and Postoperative Complications in Lower Impacted Wisdom Tooth Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth, Impacted
Dental Anxiety
Keywords: aromatherapy
lavender oil
wisdom tooth extraction
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Dental anxiety is considered to be one of the fears and concerns associated with dental treatment. Lavender has a relaxing and anxiolytic aroma. The aim of this study was to evaluate the effects of aromatherapy on dental anxiety in bilateral impacted wisdom tooth surgery.


Eligibility criteria: Inclusion Criteria:

* Bilateral wisdom tooth in mandible

Exclusion Criteria:

* Lavender oil allergy
* Systemic disease
* Off-study drug use
* Smoking
* Pregnancy or breastfeeding

Primary outcomes:
measure: Modified Dental Anxiety Scale (MDAS)
timeFrame: baseline, pre-surgery
measure: Modified Dental Anxiety Scale (MDAS)
timeFrame: immediately after the surgery
measure: Visual Analog Scale (VAS) Pain Score
timeFrame: 0-7 days
measure: Facial Edema
timeFrame: 0-7 days
measure: Mouth Opening Measurements
timeFrame: 0-7 days
measure: Blood Pressure
timeFrame: baseline, pre-surgery
measure: Blood Pressure
timeFrame: immediately after the surgery
Secondary outcomes:
measure: Oxygen Saturation
timeFrame: baseline, pre-surgery
measure: Oxygen Saturation
timeFrame: immediately after the surgery
measure: Pulse Rate
timeFrame: baseline, pre-surgery
measure: Pulse Rate
timeFrame: immediately after the surgery
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yüzüncü Yıl University
Study officials:
References:
Clinical trial NCT06003712: Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI)
Official title: Exploring the Effects of a Mindfulness-Based Intervention on Physiologic and Quality of Life Markers in Individuals With Spinal Cord Injury (SCI): A Pre-post Test Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Quality of Life
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons with SCI


Eligibility criteria: Inclusion Criteria:

* Adult males and females aged 18-70 who are living with spinal cord injury
* C5 to the T10 levels
* Self-reported American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A-D
* Eligible participants must be able to understand and provide consent, be in good health operationalized as free from acute treatable illness, pressure injury, and cardiovascular disease.

Exclusion Criteria:

* Participants taking medications that alter chronotropic and pressor responses will be excluded.
* Pregnant women will not be eligible to participate

Primary outcomes:
measure: Change in Heart rate
timeFrame: baseline, 1 month
measure: Change in blood pressure
timeFrame: baseline, 1 month
measure: Change in metabolism as measured by maximum oxygen consumption (VO2)
timeFrame: baseline, 1 month
measure: Change in metabolism as measured by ventilation (VE)
timeFrame: baseline, 1 month
Secondary outcomes:
measure: Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
timeFrame: baseline, 1 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami - Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami
name: Eduard Tiozzo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01417312: Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple sclerosis
Green tea extract
Metabolism
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate metabolic effects of a standardized green tea extract, containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis patients.


Eligibility criteria: Inclusion Criteria:

* Patients with relapsing-remitting multiple sclerosis
* stable treatment with glatiramer acetate at least 6 months prior to inclusion
* Expanded disability status scale \< 4.5
* Normal weight, overweight

Exclusion Criteria:

* Primary or secondary progressive forms of multiple sclerosis
* Clinically relevant heart, lung, liver, kidney diseases
* Habitual caffeine intake over 300 mg per day
* Habitual consumption of green tea
* Alcohol or drug abuse

Primary outcomes:
measure: Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Franz-Volhard Clinical Research Center at the Experimental and Clinical Research Center, Charité University Medicine Berlin and Max Delbrueck Center for Molecular Medicine
Study officials:
affiliation: NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité University Medicine Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
name: Friedemann Paul, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Franz-Volhard Clinical Research Center at the Experimental and Clinical Research Center, Charité University Medicine and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
name: Michael Boschmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahler A, Steiniger J, Bock M, Klug L, Parreidt N, Lorenz M, Zimmermann BF, Krannich A, Paul F, Boschmann M. Metabolic response to epigallocatechin-3-gallate in relapsing-remitting multiple sclerosis: a randomized clinical trial. Am J Clin Nutr. 2015 Mar;101(3):487-95. doi: 10.3945/ajcn.113.075309. Epub 2015 Jan 14.
Clinical trial NCT04344912: Impact of COVID19 Outbreak in Cardiac Acute Care
Official title: Impact of COVID19 Outbreak in Cardiac Patients Admitted in Intensive Care Unit : the CCU-COVID19 Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Heart Failure
COVID
Keywords: COVID19
Acute Coronary Syndrome
Myocardial Infarction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Action, France
First posted: 2020-04-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated in the CCU at Cardiology Institute of the Pitié-Salpêtrière Hospital, from Friday, March 20, 2020

Brief summary: This registry will evaluate the impact of the COVID19 outbreak on Cardiac patients admitted in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France

Detailed description: Registry on Characteristics and outcomes of Cardiac patients (COVID- and COVID+) hospitalized in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Admitted in the Cardiac Intensive Care Unit from March 20th 2020
* Patient informed and having expressed his non-opposition to participate in the research

Exclusion Criteria:

* Minor patient
* Patient who expressed opposition to participation in the study

Primary outcomes:
measure: Incidence of recurrent Major Cardiovascular Events (MACE) and urgent rehospitalization
timeFrame: From admission to one year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Unité de Soins Intensifs de Cardiologie, Pitié Salpêtrière Hospital, AP-HP
Study officials:
affiliation: Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France
name: Johanne SILVAIN, MD PhD
role: STUDY_DIRECTOR
affiliation: Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France
name: Gilles MONTALESCOT, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04164212: Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection
Official title: Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Influenza
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. In a subset of participants, cystic fibrosis transmembrane conductance regulator (CFTR) function will also be evaluated via measurement of nasal potential difference (NPD)


Eligibility criteria: Inclusion Criteria:

* ages 18-49 years old,
* not yet received influenza vaccine for 2019-2020, and
* capable of giving signed informed consent.

Exclusion Criteria:

* Immunocompromising condition (e.g. HIV/AIDS, chemotherapy, immune suppressing medications),
* active smoking within past 6 months,
* asthma, chronic lung/liver/kidney /neurologic/hematologic/metabolic disorders,cardiovascular disease (excluding isolated hypertension), diabetes mellitus, disease, congestive heart failure,
* pregnancy,
* current or recent (within the past month) upper/lower respiratory tract infection, chronic sinusitis/nasal allergies requiring frequent or daily therapy (including topical corticosteroids),
* prior adverse reaction to influenza vaccine,
* history of Guillain-Barre syndrome,
* egg allergy,
* close contact with an individual with severe immunodeficiency/immunosuppression.

Primary outcomes:
measure: influenza virus replication
timeFrame: day 2
measure: markers of inflammation
timeFrame: change in inflammatory cytokines from baseline to day 2
measure: cystic fibrosis transmembrane conductance regulator function
timeFrame: change in NPD from baseline to day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Lung Health Center
state: Alabama
Study officials:
References:
Clinical trial NCT05560412: Zein Nanoparticles for Glycemic Control
Official title: Zein Nanoparticles for Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Overweight and Obesity
Adult ALL
Keywords: Prediabetes
Glycemia and glucose metabolism
Zein
Glucose monitoring
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, double blind crossover intervention
Primary purpose: PREVENTION

Brief summary: The use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. Thus, the present research on patients with prediabetes has been proposed. The objective is to assess the efficacy of zein nanoparticles on the glycemic control. For this purpose, a randomized, double blind crossover study has been designed.

Target sample size is 60.


Eligibility criteria: Inclusion Criteria:

* Overweight or obesity (BMI between 25 and 40 kg/m2
* Presence of prediabetes (fasting glycemia in blood between 100 and 126 mg/dL)
* No weight variations considered relevant (+/- 5%) in the last 3 months
* Metformin treatment is allowed, as far as dose is stable (at least 2 months with unvaried dose).
* Good physical and psychological state.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Fructosamine
timeFrame: 28 days
measure: Change in GLP-1 AUC
timeFrame: Baseline, 15, 30, 45 and 60 minutes
Secondary outcomes:
measure: Fasting Plasma glucose
timeFrame: 28 days
measure: Continuous glucose levels
timeFrame: 28 days
measure: Insulin Levels
timeFrame: 28 days
Other outcomes:
measure: Cholesterol
timeFrame: 28 days
measure: HDL-Cholesterol
timeFrame: 28 days
measure: LDL-Cholesterol
timeFrame: 28 days
measure: Triglycerides
timeFrame: 28 days
measure: Blood Pressure
timeFrame: 28 days
Locations:
city: Pamplona
country: Spain
facility: Centro de Investigacion en Nutricion. Universidad de Navarra
state: Navarra
Study officials:
References:
Clinical trial NCT00212212: Selenium Supplementation of Patients With Cirrhosis
Official title: Human Selenium Nutritional Requirement and Biomarkers in Health and Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cirrhosis
Keywords: selenium supplements
selenate
selenomethionine
biomarkers
plasma selenium concentration
plasma glutathione peroxidase
selenoprotein P
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-21
Enrollment: 99
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: This study is being conducted to determine if patients with cirrhosis (liver disease) are selenium deficient. The effect of supplementation with two chemical forms of selenium on plasma selenium biomarkers will be determined and correlated with the severity of the liver disease.

Detailed description: Selenium is an essential nutrient that plays a role in oxidant defense, among other functions. There is much interest in the role selenium may play in several disease processes. It is possible that certain diseases result in selenium deficiency because of the form of selenium taken in the normal diet.

We propose to measure the selenium biomarkers associated with supplemental intakes of 200 or 400 µg of selenium per day in the chemical form selenate, or with supplemental intake of 200 µg selenium as selenomethionine. 144 patients with cirrhosis will be randomized to one of 4 treatment groups, including a placebo. After treatement for 4 weeks, all participants will receive 400 µg of selenium per day as selenate for 4 weeks. Blood will be measured initially and at 4 and 8 weeks. Selenium, selenoprotein P and glutathione peroxidase will be measured in the plasma.

Eligibility criteria: Inclusion Criteria:

* adults with cirrhosis

Exclusion Criteria:

* Pregnancy or planning a pregnancy
* Selenium supplements of 25 µg or more within the past year

Primary outcomes:
measure: Plasma selenium biomarkers
timeFrame: 4 and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Raymond F Burk, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257112: Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation
Official title: Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Cardialen, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation during an acute testing procedure.

Detailed description: This is a research feasibility study to evaluate various parameters of the multistage low-energy pulses and their effect on atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* patients indicated for an atrial fibrillation ablation procedure

Exclusion Criteria:

-

Primary outcomes:
measure: Safety and Efficacy of Multistage low-energy pulses to organize, suppress, or terminate atrial fibrillation as determined by changes in atrial fibrillation cycle length, and atrial electrogram morphology.
timeFrame: Patients will be followed during the acute procedure which is expected to average 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital du Haut-Lévêque
Study officials:
References:
citation: Janardhan AH, Gutbrod SR, Li W, Lang D, Schuessler RB, Efimov IR. Multistage electrotherapy delivered through chronically-implanted leads terminates atrial fibrillation with lower energy than a single biphasic shock. J Am Coll Cardiol. 2014 Jan 7-14;63(1):40-8. doi: 10.1016/j.jacc.2013.07.098. Epub 2013 Sep 26.