louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03867214: Effects of Oral Care With Glutamine on Oral Health, Oral Flora and Incidence of Pneumonia After Neurosurgery With Microbiome Analysis
Official title: Effects of Oral Care With Glutamine on Oral Health, Oral Flora and Incidence of Pneumonia After Neurosurgery With Microbiome Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oral Mucositis
Pneumonia
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 100
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: A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty.

Detailed description: A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 1 months postoperatively

Eligibility criteria: Inclusion Criteria:

* Adult patients who plan to undergo simultaneous primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis;
* All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio;
* The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution.

Exclusion Criteria:

* Allergy to tranexamic acid;
* Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant;
* Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina);
* Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition;
* Preoperative anemia (a hemoglobin value of \<11 g/dL in females and \<12 g/dL in males), refusal of blood products;
* Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \[\>1.4 times normal\]).

Primary outcomes:
measure: Rate of Allogeneic Blood Transfusion as a Measure of Efficacy
timeFrame: one week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
Study officials:
affiliation: Air Force Military Medical University, China
name: Qingsheng Zhu
role: STUDY_DIRECTOR
References:
Clinical trial NCT04203914: Short Term Effect of Empagliflozin in Hypertension
Official title: Short Term Effect of Empagliflozin on Left Ventricular Relaxation in Non Diabetic Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Empagliflozin
Left ventricular diastolic function
Blood pressure
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-18
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label trial with before and after design
Primary purpose: TREATMENT

Brief summary: The investigators assessed the 6-week effect of once daily 25mg SGLT2-i Empagliflozin on left ventricular diastolic function and blood pressure profile in non diabetic hypertensive patients

Detailed description: Background: The rapid beneficial effects of Empagliflozin on cardiovascular mortality and hospitalizations rates for heart failure according to the Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) trial raise some question in the mechanism of myocardial action. The investigators conducted this study in a population of non-diabetic hypertensive patients in order to look for a short-term effect on left ventricular relaxation.

Methods: The investigators carried out a single arm non- randomized clinical trial and assigned patients to receive 25mg of empagliflozin once daily in additional therapy for six weeks at the National Center for Obesity and in the cardiology department of Yaounde Central Hospital in hypertensive patients with cardiac relaxation disorder. The objectives were to evaluate the left ventricular diastolic function and nycthemeral blood pressure profile.

Eligibility criteria: Inclusion Criteria:

* Grade 1 hypertension
* Grade 1 or 2 relaxation abnormalities (Doppler E/A ratio \<1)
* Unchanged antihypertensive treatment for at least 12 weeks

Exclusion Criteria:

* Diabetes mellitus
* eGFR \< 60 mL/min/1,73 m²
* Mitral stenosis
* Atrial fibrillation
* Alanine transferase above 2N

Primary outcomes:
measure: Left ventricular diastolic function
timeFrame: 6 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 6 weeks
measure: HbA1c
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: National Obesity Centre, Yaounde Central Hospital
state: Centre
city: Yaounde
country: Cameroon
facility: Yaounde Central Hospital
state: Centre
Study officials:
affiliation: University of Yaounde 1, Cameroon
name: Jean Claude Mbanya, MD, PhD
role: STUDY_CHAIR
affiliation: University of Yaounde 1, Cameroon
name: Eugene Sobngwi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02972814: Time Gain in the Diagnosis Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room
Official title: Time Gain in the Diagnosis of Non-ST Elevation Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non STEMI
Angina Pectoris
Angina, Stable
Angina, Unstable
Angina, Prinzmetal's
Keywords: Troponin
Point of care test
myocardial infarction
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 66
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: Patients presenting to the emergency room with thoracic pain due to a non-STEMI

Brief summary: The investigators prospectively want to compare 3 clinical tests for measuring blood troponin levels in patients presenting to the emergency room with thoracic pain probably related to a myocardial infarction with regard to the time necessary to obtain the test results.

The tests are one laboratory based test and two point of care tests.

Detailed description: Thoracic pain can be caused by a myocardial infarction. The diagnosis of a myocardial infarction can be made by an ECG (ST-elevation myocardial infarction, STEMI). However, some myocardial infarctions can also occur without ST-elevations on the ECG (non-ST-elevation myocardial infarction, non-STEMI). In the latter case, a quick acquisition of blood troponin levels is necessary to coin the diagnosis and initiate treatment. Therefore, the investigators prospectively want to compare 3 clinical tests for measuring blood troponin levels in patients presenting to the emergency room with thoracic pain probably related to a non-STEMI with regard to the time necessary to obtain the test results.

The 3 tests are:

1. A laboratory based test: Roche Cobas E 602
2. A point of care test: Radiometer AQT 90 Flex
3. A point of care test: Philips Minicare I-20

The measured timeframe is the time between venipuncture to the point the test results are known.

Eligibility criteria: Inclusion Criteria:

* Thoracic pain

Exclusion Criteria:

* Unable to give informed consent

Primary outcomes:
measure: time delay until troponin test results are known
timeFrame: From the time of venipuncture to the time the troponin test results are known: up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Member of Staff
name: Pascal Vanelderen, MD, PhDD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01470014: Cardiac Computed Tomography: Characteristics of Isolated Left Ventricular Non-compaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Noncompaction
Isolated Noncompaction of the Ventricular Myocardium
Keywords: isolated left ventricular non-compaction
cardiac computed tomography
cardiac magnet resonance imaging
echocardiography
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 39
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the Department of Cardiology and Cardiac Imaging Division. They will be asked if they want to participate in this study.

Brief summary: The diagnostic criteria for isolated left ventricular non-compaction cardiomyopathy (IVNC) have been well established for echocardiography and cardiac magnetic resonance, such validation is lacking for computed tomography (CT). Such criteria are of great clinical relevance as a growing number of patients undergo a cardiac CT scan in daily clinical routine.

The investigators aim to test the diagnostic accuracy of cardiac CT in distinguishing IVNC from lesser degrees of trabecular layering seen in potential differential diagnoses such as cardiomyopathies and left ventricular hypertrophy or dilation.

The investigators hypothesize that echocardiographic diagnosed pathological trabeculation can be distinguished by determining the ratio of non-compacted to compacted myocardium on cardiac CT.


Eligibility criteria: Inclusion criteria:

* Established diagnosis of IVNC or differential diagnosis
* Age: Men \> 30 years, women \> 50 years without menstruation for at least 2 month.
* Written informed consent to participate

Exclusion criteria: Contraindication for cardiac CT

* Renal insufficiency (GFR \< 60ml/min)
* Known allergy to iodinated contrast agent
* Known Hyperthyroidism
* Non-sinus rhythm
* Known premature ventricular or supraventricular beats
* Hypotension (systolic blood pressure \< 100mmHg)

Contraindication for CMR

* Implanted cardiac pacemaker or defibrillator
* Other implanted medical devices (e.g. implantable cardioverter-defibrillator)
* Claustrophobia
* Known premature ventricular or supraventricular beats
* Pregnancy
* Claustrophobia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: University Hospital Zurich, Division of Cardiology
name: Felix Tanner, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02799914: Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease
Official title: Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease: A Monocenter Post Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Venous Vascular Diseases and Syndromes
Lead sponsor: be Medical
Sponsor class: INDUSTRY
Collaborators: name: Archer Research
First posted: 2016-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with venous iliofemoral occlusive disease.

Brief summary: Post market clinical follow-up study about the Sinus-venous stent. Patients with venous iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational study will provide 1 year data about safety and efficacy.


Eligibility criteria: Inclusion Criteria:

1. Age at study entry is at least 18 years.
2. Patient must sign the informed consent form prior to the index-procedure.
3. Patient suffers from acute or chronic venous occlusive disease indicated to be treated with a venous stent.
4. Target lesion is located in the femoral vein, common femoral vein, external iliac vein, or common iliac vein.

Exclusion Criteria:

1. Intolerance to anticoagulant medication.
2. Contra-indication for prolonged anticoagulant treatment.
3. Life expectancy less than 1 year.
4. Target vessel has been stented before.
5. Coagulopathy or known uncorrectable bleeding diathesis.
6. Recent (\<1 year) pulmonary embolism.
7. Pregnancy.
8. Known hypersensitivity to nitinol and/or nickel.
9. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
10. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study.
11. Patients in custody by juridical order.
12. Patients who do not agree to the transmission of their coded data within the liability of documentation and notification.
13. Close affiliation with the investigational site: e.g. a close relative of the investigator or a possibly dependent person (e.g. employee or student of the investigational site).

Primary outcomes:
measure: Stent patency
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: Index-procedure (intraoperative)
measure: Revised venous clinical severity score
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Procedural complications
timeFrame: Index-procedure
measure: Reintervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Geert Lauwers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02110914: A Coaching Intervention to Young Adults With Cystic Fibrosis
Official title: Coach to Cope. Coaching Young Adults With Cystic Fibrosis - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Feasibility study
Coaching
Health related quality of life
Adherence
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2014-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The treatment burden for patients with cystic fibrosis (CF) is significant and poor adherence has been well-documented. The investigators hypothesize that a coaching intervention will empower young adults with CF to manage their lives with CF and improve health-related quality of life (HRQoL). The main aim of the study is to establish the feasibility and acceptability of a life-coaching intervention.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cystic fibrosis (CF), confirmed by clinical findings, identification of two disease-causing CF- mutations, and a positive sweat test
* Patient at the Copenhagen CF Centre

Exclusion Criteria:

* Severe intellectual impairment or insufficient mastery of the Danish language, determined by incapacity to independently complete the questionnaires

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: 12 months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: Up to 21 months
measure: Self-reported Adherence
timeFrame: 21 months
measure: Pharmacy Refill Histories
timeFrame: up to 1 year
measure: Self-efficacy
timeFrame: 21 month
measure: Clinical data
timeFrame: 21 months
Other outcomes:
measure: The participants' experiences with and acceptability of the intervention
timeFrame: 12 month
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Department of Public Health at the University of Copenhagen
name: Laust H Mortensen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06878014: Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery
Official title: Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Analgesics, Opioid
Anesthesia, Spinal
Total Hip Replacement
Adverse Anesthesia Outcome
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 120
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: Pain management after total hip replacement is one of the most important aspects of postoperative care for patients and clinicians alike. One of the most common techniques used in anesthesia for this procedure is spinal anesthesia with concurrent administration of opioids into spinal sac. Addition of opioids not only prolongs the anesthesia but also provides pain relief after the procedure for a limited amount of time. Because of its unique chemical properties morphine provides the longest pain relief amongst currently known opioids lasting up to 24 hours. Unfortunately this beneficial effect is associated with both minor and serious adverse effects, most important of which is respiratory depression.

To limit this potenitialy fatal adverse effect dosing of morphine must be very precise in order to balance advantages and risks.

The aim of the study was to assess effectiveness and safety profile of different doses of morphine administered during spinal anesthesia for pain control.


Eligibility criteria: Inclusion Criteria:

* Informed consent to participate in trial
* Qualification for total hip replacement surgery
* ASA physical status I-III
* BMI 19-30
* Lack of contraindications for drugs and interventions used in trial

Exclusion Criteria:

* Incapability to provide informed consent
* Contraindications for spinal anesthesia
* Preoperative chronic pain
* Chronic use of analgesics
* Obesity (BMI\>30)
* Allergies and other contraindications for drugs used in trial
* Mental or physical incapability to operate PCA syringe pump

Primary outcomes:
measure: Analgesic efficacy
timeFrame: 48 hours postoperatively
measure: Safety profile
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 48 hours postoperatively
measure: Length of stay
timeFrame: Up to one week.
measure: Time to rescue analgesia
timeFrame: 48 hours postoperatively
measure: Cumulative dose of oxycodone
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Sosnowiec
country: Poland
facility: Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary
state: Silesia
city: Końskie
country: Poland
facility: Zespół Opieki Zdrowotnej w Końskich
state: Świętokrzyskie
Study officials:
References:
Clinical trial NCT02757014: 18613 - Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment - Darkening Dose (MPPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05757414: Lighting Intervention to Improve Sleep
Official title: Dissecting Oligogenic Biomarkers in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Sleep Disturbance
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 57
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: 50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance, will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.

Detailed description: Participants will undergo one week of baseline data collection using the actigraph and light meter and one night of an overnight urine collection. At the completion of the baseline week, the lighting intervention will be installed in the participants home. Participants will be exposed to the lighting intervention for 2 hours each morning after awakening for 4 weeks. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days and collect one overnight urine sample. Participants will complete questionnaires before and after the intervention to further assess its effects.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's disease and
* Difficulties with sleep or cognition

Exclusion Criteria:

* There is no exclusion criteria

Primary outcomes:
measure: Sleep Duration using Actigraph
timeFrame: at baseline for 7 days
measure: Sleep Duration using Actigraph
timeFrame: at Week 4 for 7 days
Secondary outcomes:
measure: Sleep Effeciency using Actigraph
timeFrame: at Baseline for 7 days
measure: Sleep Effeciency using Actigraph
timeFrame: at Week 4 for 7 days
measure: Urine melatonin levels
timeFrame: at Baseline
measure: Urine melatonin levels
timeFrame: at Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
Study officials:
affiliation: Mount Sinai Beth Israel
name: Rachel Saunders-Pullman
role: PRINCIPAL_INVESTIGATOR
References: