louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04425811: The Effect of Kinesiological Taping Applied to the Tibialis Anterior Muscle on Gait Parameter in Stroke Patients
Official title: The Effect of Kinesiological Taping Applied to the Tibialis Anterior Muscle on Gait Parameter in Stroke Patients: Sham Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Kinesiological Taping
Walking
Tibialis Anterior
Lead sponsor: Istanbul Rumeli University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
First posted: 2020-06-11
Enrollment: 28
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sham Controlled Study
Primary purpose: OTHER

Brief summary: The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter in stroke patients: Sham controlled study

Detailed description: Objective: The aim of this study was to compare the immediate effect of kinesiological and / or sham taping to the tibialis anterior muscle on walking parameters in stroke individuals.

Methods: The study included 28 adults stroke patients . The subjects who received scores of 7 or more in the Hodkinson Mental Test and 3 and above in the Functional Ambulation Classification with subjects who gastrocnemius muscle spasticity 2 and below points according to Modified Ashworth Scale were included in the study. The walking parameters of the participants were evaluated with the BTS G-Walk Spatio-Temporal Walking Analysis System. The walking parameters of the participants who were selected by randomization method were evaluated separately by applying kinesiological taping and sham taping or without any taping or interference on a 10 meter track.

Eligibility criteria: Inclusion Criteria:

* 28 stroke individuals (hemiplegic / hemiparetic) who were treated in the Adult
* Neurological Rehabilitation Unit of Pamukkale University Medical Faculty Hospital were included in the study.
* Being between the ages of 25-70
* Volunteers with written consent
* With a 1-year history of stroke
* Who had a stroke for the first time
* Having a lesion in one brain hemisphere

Exclusion Criteria:

* Having neurological or orthopedic comorbid disease
* Patients with a gastrocnemius spasticity greater than 2 according to the modified ashworth scale
* Patients with communication problems
* Patients with cognitive functions below 7 points according to the Hodkinson Mental Test
* Patients with ambulation level below 3 according to Functional Ambulation Classification

Primary outcomes:
measure: non-taping walking parameter measurement
timeFrame: 2 hours
Secondary outcomes:
measure: With kinesiological taping walking parameter measurement
timeFrame: 2 hours
measure: With sham taping walking parameter measurement
timeFrame: 2 hours
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Emre Baskan, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01849211: Influence of Neuromuscular Block on Mask Ventilation
Official title: Influence of a Neuromuscular Block on Face Mask Ventilation Conditions During Induction of Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of a Neuromuscular Block on Ventilation
Keywords: ventilation
face mask
NMBA
Lead sponsor: Kreiskrankenhaus Dormagen
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Difficult mask ventilation might lead to a life-threatening situation, if endotracheal intubation is also impossible and neuromuscular blocking agents (NMBA) inhibit spontaneous ventilation. However, controversies exist if NMBA improve or impede face mask ventilation. Therefore, the effect of NMBAs on mask ventilation is assessed in patients with predictors for difficult face mask ventilation.


Eligibility criteria: Inclusion Criteria:

* Patients with risk factors for difficult face mask ventilation
* Patients scheduled for general anaesthesia with endotracheal intubation

Exclusion Criteria:

* Increased Risk for pulmonary aspiration
* scheduled for awake fiberoptic intubation
* pregnancy

Primary outcomes:
measure: minute volume
timeFrame: 15 min (from Induction of anaesthesia until onset of NMBA )
Secondary outcomes:
measure: incidence of difficult mask ventilation - tidal volume < 150 ml
timeFrame: 15 min
Other outcomes:
measure: airway pressure
timeFrame: 15 min
Locations:
city: Dormagen
country: Germany
facility: KKH Dormagen
Study officials:
affiliation: KKH Dormagen
name: Stefan Soltesz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02400411: The Glycemic and Insulinemic Responses Elicited by Meals Containing Whole Grain Rye Bread or White Wheat Bread
Official title: The Effects of Margarine and Ham or Vegetable Soup on the on the Glycemic and Insulinemic Responses Elicited by Whole Grain Rye Bread or White Wheat Bread
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Glucose Concentration
Keywords: Carbohydrate
Glycemic response
insulin
whole grain
meal
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Fazer Group
First posted: 2015-03-27
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses elicited by meals containing either whole grain rye bread or white wheat bread as such or combined with margarine and ham and vegetable soup are compared. Blood glucose concentrations are monitored from finger prick blood samples collected before the meal and at 15, 30, 45, 60, 90 and 120 min. Venous samples for insulin concentrations are taken at time-points 0, 30 and 60 min.


Eligibility criteria: Inclusion Criteria:

* female
* BMI 18-27 kg/m2

Exclusion Criteria:

* pregnant or breastfeeding
* diabetes, gastrointestinal disease
* regular use of medication
* strict vegetarian or vegan diet
* food allergy
* recent blood donation

Primary outcomes:
measure: Blood glucose concentration
timeFrame: 120 min
Secondary outcomes:
measure: Serum insulin concentration
timeFrame: 60 min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05614011: Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
Official title: Q-POC SARS-CoV-2 Assay (Q27001) Clinical Performance Study Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: QuantuMDx Group Ltd
Sponsor class: INDUSTRY
Collaborators: name: New Day Diagnostics
name: PathAI
name: Bright Research Center
First posted: 2022-11-14
Enrollment: 877
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective clinical study enrolling adult patients with signs and symptoms that are consistent with SARS-CoV-2. Positive and negative specimens will be run on the Q-POC SARS-CoV-2 Assay in comparison with an FDA-approved reference standard to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity)
Primary purpose: DIAGNOSTIC

Brief summary: Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation

Detailed description: The Q-POC SARS-CoV-2 Assay is a real-time PCR test intended for use on the Q-POC instrument for the qualitative detection of nucleic acids from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in nasal mid-turbinate swabs (MTSW) obtained from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity or moderate complexity tests.

The Q-POC SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Q-POC SARS-CoV-2 Assay in conjunction with the Q-POC instrument (Q29001).

Eligibility criteria: Inclusion Criteria:

* Participants must be over the age of 18 years.
* Participants must present with symptoms indicative of SARS-CoV-2 infection, within 0-5 days of symptom onset.
* Participants must have capacity to give informed consent.

Exclusion Criteria:

* Participant is under the age of 18 years.
* Participant does not have symptoms of SARS-CoV-2 infection.
* Participant lacks capacity to give informed consent.

Primary outcomes:
measure: Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
timeFrame: One hour
measure: Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bright Research Center
state: Florida
city: Knoxville
country: United States
facility: EDP Biotech
state: Tennessee
city: Memphis
country: United States
facility: PathAI
state: Tennessee
Study officials:
affiliation: QuantuMDx Group Ltd
name: Alice Neilson
role: STUDY_DIRECTOR
affiliation: New Day Diagnostics
name: Jason Liggett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05434611: Role of Calcium Binding Protein S100A12 in Diagnosis and Prognosis of Kawasaki Disease
Official title: Role of Calcium Binding Protein S100A12 in Diagnosis and Prognosis of Kawasaki Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diagnoses Disease
Lead sponsor: The First Affiliated Hospital of Yangtze University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The case group consisted of 50 hospitalized children with Kawasaki disease. The healthy control group consisted of 50 healthy children.

Brief summary: Recent studies showed that the value of c100A12 increased in children with Kawasaki disease, and decreased rapidly after treatment with gamma globulin. In kawasaki disease with coronary artery dilatation, S100A12 levels are elevated in the acute phase of Kawasaki disease and continue for some time in the convalescence phase before gradually decreasing. However, the number of patients included in previous studies was small and the follow-up time was short. In this study, 100 children with Kawasaki disease who were admitted to Wuhan Children's Hospital, Jingzhou First People's Hospital and Renhe Hospital affiliated to China Three Gorges University from December 2021 to December 2023 were selected as the research objects, and 100 children with healthy physical examination were selected as the control group during the same period. To investigate whether S100A12 increased significantly in the acute phase of Kawasaki disease compared with a healthy control group. To study whether S100A12 value increased rather than decreased in kawasaki disease that did not respond to gamma globulin treatment after gamma globulin treatment. At the same time, to study whether the increase of S100A12 in kawasaki disease convalescence indicates coronary aneurysm.

Detailed description: S100A12 was determined using the ELISA kit and according to the instructions.

Eligibility criteria: Inclusion Criteria:

▪Diagnostic criteria of Kawasaki disease revised by the American Heart Association in 2017

Exclusion Criteria:

* Scarlet fever
* Drug allergy syndrome
* Stevens-Johnson syndrome
* Toxic shock syndrome
* Adenovirus infection
* Epstein-Barr(EB) virus infection

Primary outcomes:
measure: S100A12
timeFrame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months
Secondary outcomes:
measure: CRP
timeFrame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Yangtze University
name: Qihong Fan, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01005511: Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
Official title: A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Sleep Bruxism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bruxism
Keywords: Bruxism
Lead sponsor: Medotech A/S
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.


Eligibility criteria: Inclusion Criteria:

* Signed and dated ICF
* 18 years or older
* Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b)

Exclusion Criteria:

* Contraindication of concommitant diseases for the study judged by investigator
* Patients who are using occlusal splints in the treatment period.

Primary outcomes:
measure: Reduction in the electromyography (EMG) activity per hour per night
timeFrame: 10 weeks after start of treatment
Secondary outcomes:
measure: Evaluation of long-term effect of FES on the EMG activity
timeFrame: a 4 weeks period after end og treatment with FES
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Odontologisk Institute
Study officials:
affiliation: Medotech A/S
name: pernille Wendelboe, MsSc (Odont)
role: STUDY_CHAIR
References:
Clinical trial NCT05305911: Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
Official title: Sodium Glucose Co-Transporter 2 (SGLT2) Inhibition Improves Left Ventricular Function and Reduces Adverse Left-Ventricular Remodeling in High-Risk Patients with Microvascular Obstruction (MVO) Following ST-elevation Myocardial Infarction (STEMI).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Heart Attack
Enlarged Heart
Keywords: Dapagliflozin
Sodium Glucose Co-Transporter 2
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to determine whether a class of medication called SGLT2 inhibitor will improve the heart's function and reduce its enlargement after a heart attack. Participation in this study will involve taking this class of medication (or a placebo) once daily for six months, one cardiac magnetic resonance imaging (MRI) test during your initial hospitalization, follow-up phone calls at 1 and 3 months, and one cardiac MRI and clinic visit at six months. This is a single center study.


Eligibility criteria: Inclusion Criteria:

* Patients with their first STEMI (\>18 years) who underwent successful primary PCI and able to give informed consent
* At least mild LV dysfunction (LVEF \< 50%) on echocardiogram, cMRI or Left Ventriculargram following PCI
* Infarct size that is \> 10% of LV mass
* The presence of MVO that is \> 10% of infarct size

Exclusion Criteria:

* Contraindication to cardiac MRI
* Life expectancy \< 1 year
* Previous CABG or Valve Surgery
* Previous STEMI
* Pregnant or planning to become pregnant or lactating women
* Cardiogenic shock (not resolved)
* Atrial fibrillation or recurrent sustained ventricular arrhythmias (excluding PVCs)
* GFR\<30 ml/min/1.73m2 or end-stage renal disease on dialysis
* Type 1 diabetes mellitus or history of diabetic ketoacidosis
* Type I or II diabetes with insulin use
* Prior intolerance of SGLT2 inhibitors
* Current use of SGLT2 inhibitors (randomized patients only)
* Contraindications to gadolinium

Primary outcomes:
measure: Change in LVESVI
timeFrame: 6 Months
measure: Change in LVEDVI
timeFrame: 6 Months
Secondary outcomes:
measure: Change in LV mass
timeFrame: 6 months
measure: Change in LVEF
timeFrame: 6 months
measure: MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: Jay Traverse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03046511: Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.
Official title: Comparison Between Post - Surgical Intraperitoneal Antibiotics Administration Vs. Intravenous Pre- Surgical Administration for the Prevention of Peritonitis After Insertion of Peritoneal Dialysis Catheter in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peritoneal Dialysis-associated Peritonitis
Peritoneal Dialysis Catheter Infection
Peritoneal Dialysis Complication
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis. Catheter insertion has been associated with infectious complication such as Exit Site Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the technique because the need of catheter removal. Most of international guidelines recommends the use of prophylactic antibiotics. Different protocols has been used, mostly intravenous single injection before the procedure. For the last 25 years our unit gives a single intraperitoneal dose of Cefazolin immediately after the catheter insertion. The aim of this study is compare the effect of a pre- operative IV dose os Cefazolin with a post- procedure intraperitoneal single dose administration of the same drug.


Eligibility criteria: Inclusion Criteria:

Subjects suffering from Chronic Kidney Disease, candidates to a intra- peritoneal catheter insertion

Exclusion Criteria:

Pregnancy; Active antibiotic treatment before the procedure; Known allergy to Cefazolin

Primary outcomes:
measure: Peritonitis
timeFrame: 14 days
Secondary outcomes:
measure: Exit site infection
timeFrame: 14 days
measure: Tunnel infection
timeFrame: 14 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Victor Frajewicki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03588611: Reduce Bolus Injection of Bivalirudin
Official title: The Noninferiority and Safety of Bivalirudin Between REDUCEd and Standard BOLUSin Percutaneous Coronary Intervention Patients Stratified by Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: bivalirudin
bolus injection
activated clotting time
Renal insufficiency
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are fewer studies on the bleeding risk of the currently administered bivalirudin bolus injection dose and the safety of bivalirudin in patients with CKD. A non-inferiority, randomized, stratified controlled trial study has been conducted to evaluate the non-inferiority and safety of the low dose (80%) bolus injections of bivalirudin in patients with or without CKD.This study will provide a safe, effective and economical anticoagulation strategy.


Eligibility criteria: Inclusion Criteria:

* 1 Age 18 to 80 years old; 2 Medically judge to require coronary angiography; 3 Patients agree to use bivalirudin 4 Patients signe informed consent.

Exclusion Criteria:

* 1.Cardiogenic shock; 2.Thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization; 3.Active or recent major bleeding or bleeding predisposition; 4.Major surgery within 1 month; 5.Clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis; blood pressure higher than 180/110 mm Hg; 6.Known hemoglobin less than 10 g/dL,platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal; 7.History of heparin-induced thrombocytopenia; 8.Ellergy to any of the study drugs or devices; 9.Eregnancy or lactation; 10.Any condition making PCI unsuitable or that might interfere with study adherence; 11.Patient unwilling or unable to provide written informed consent 12. Researchers think it is not suitable to participate in this study.

Primary outcomes:
measure: The area under the curve of the ACT values for both groups
timeFrame: During operation
Secondary outcomes:
measure: Incidence of bleeding and ischaemic events during hospitalization after surgery .
timeFrame: In hospital
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
Study officials:
References:
citation: Hu Q, Han YL, Zhou TN, Wang XZ, Zhang QY. Efficacy and Safety of the Reduced Bivalirudin in Patients Undergoing Coronary Angiography or Percutaneous Coronary Intervention Stratified by Renal Function (REDUCE BOLUS): A Single-Blind, Stratified Randomized, Non-inferiority Trial. Front Cardiovasc Med. 2022 Apr 25;9:864048. doi: 10.3389/fcvm.2022.864048. eCollection 2022.