louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00231426: ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations
Official title: Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachyarrhythmia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.


Eligibility criteria: Inclusion Criteria:

* Patients who meet current indications for an ICD including cardiac resynchronization therapy (CRT) devices
* Patients who sign and date a Patient Informed Consent form prior to the implant visit
* Patients who remain in the clinical care of the enrolling physician in approved centers
* Patients who receive only left-sided pectoral implantations with the ICD lead placed in the right ventricular apex
* Patients who have a minimum R wave of at least 7 mV; or for ICD replacement, patients who have a minimum chronic R wave of at least 5 mV

Exclusion Criteria:

* Patients who are involved in Non-Invasive Programming Stimulation (NIPS) studies
* Patients who undergo lead repositioning
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients who have or who are likely to receive a tricuspid valve prosthesis
* Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
* Patients who are younger than 18 years of age
* Patients who are pregnant or plan to become pregnant during the study
* Patients whose life expectancy is less than 12 months
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
Study officials:
affiliation: LDS Hospital, Salt Lake City, Utah
name: John D Day, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03367026: Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine
Official title: Reducing Elevated Heart Rate in Patients With Severe Sepsis by by the "Funny Channel" Current (If) Inhibitor Ivabradine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis, Severe
Keywords: ivabradine
sepsis
heart rate
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 70
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: REHSI is a prospective, multi-center, open label, randomized, controlled two arms, to evaluate the ability of ivabradine to reduce an elevated heart rate in septic shock patients. The primary end point is the reduction of heart rate within 24 hours. This trial will randomize 70 patients (men and women, aged ≥ 18 years) with newly diagnosed Septic Shock (despite adequate fluid resuscitation, were still requiring high-dose norepinephrine (NE) to maintain a mean arterial pressure (MAP) ≥65 mmHg , and had a tachycardia \>100 beats per minute (bpm). Treatment period will last 4 days. All patients will be followed for up to six months.


Eligibility criteria: Inclusion Criteria:

1. Severe sepsis due to coronary and non-coronary etiology
2. Severe sepsis diagnosed ≤ 24 h
3. Sinus rhythm with heart rate ≥ 100bpm
4. Written informed consent or identified or suspected positive will with respect to the trial treatment

Exclusion Criteria:

1. Patients who have not yet completed the 18th year of age
2. Pregnancy, lactation
3. Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate \<30ml/min
4. severe hepatic insufficiency
5. Sick sinus syndrome
6. Sinu-atrial block
7. pacemaker-dependency 8.3rd degree AV block

9.Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see Summary of Product Characteristics (SPC))

Primary outcomes:
measure: mean heart rate
timeFrame: 24 hours
Secondary outcomes:
measure: severity of illness
timeFrame: 4 days
measure: mean heart rate
timeFrame: 4 days
measure: mortality
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04629326: PD-L1 Targeting Molecular Imaging of Solid Tumors
Official title: PD-L1 Targeting Molecular Imaging of Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Tumors
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to constrcut a noninvasive approach WL12 PET/CT to detect the PD-L1 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from anti-PD-1/L1 treatment.


Eligibility criteria: Inclusion Criteria:

* 1. Aged \>18 years old; ECOG 0 or 1;
* 2. Patients with Gastrointestinal tumors;
* 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
* 4. life expectancy \>=12 weeks.

Exclusion Criteria:

* 1. Significant hepatic or renal dysfunction;
* 2. Is pregnant or ready to pregnant;
* 3. Cannot keep their states for half an hour;
* 4. Refusal to join the clinical study;
* 5. Suffering from claustrophobia or other mental diseases;
* 6. Any other situation that researchers think it is not suitable to participate in the experiment.

Primary outcomes:
measure: Standardized uptake value（SUV）
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00656565: Inspiratory Flow and Volumes in Bronchiectatics
Official title: Inspiratory Flow Rates and Volumes in Subjects With Bronchiectasis Using Low and High Resistance Dry Powder Inhaler Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Keywords: measure inspiratory spirometry with dry powder inhaler device in series with the spirometer
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2008-04-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects aged 18-80 years, with bronchiectasis and FEV1 greater or equal to 50% predicted and greater or equal to 1L

Brief summary: Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory flow rates and volumes. These vary according to the device being used and its resistance. The dry powder inhaler device under investigation is a device approved by the Therapeutic Goods Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is currently being investigated as a treatment for bronchiectasis. We wish to measure the inspiratory flow characteristics of both the low and high resistance devices amongst a group of subjects with bronchiectasis.

We propose that the majority of subjects investigated with varying lung function will achieve adequate flow during a controlled inspiration.


Eligibility criteria: Inclusion Criteria:

* non-cf bronchiectasis
* aged 18-80 inclusive
* FEV1 greater or equal to 50% predicted and greater or equal to 1L

Exclusion Criteria:

* uncontrolled asthma
* CF bronchiectasis
* have any condition for which spirometry measurement would be contraindicated

Primary outcomes:
measure: inspiratory flow
timeFrame: single visit
Secondary outcomes:
measure: inspiratory volume
timeFrame: single visit
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
Study officials:
References:
Clinical trial NCT06806566: Assessment of a Carvacrol-loaded Absorbable Gelatin Sponge Used As a Palatal Dressing Following Free Gingival Graft Harvesting: a Randomized Clinical Study
Official title: Clinical Evaluation of Carvacrol Loaded Absorbable Gelatin Sponge As a Palatal Bandage After Free Gingival Graft Harvesting : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palatal Wound
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effect of carvacrol loaded to absorbable gelatin sponge as a palatal bandage on the palatal donor site in post-operative pain reduction after free gingival graft harvesting


Eligibility criteria: Inclusion Criteria:

1 - Patients with mucogingival defects scheduled for free gingival graft. 2- Medically free patients 3- Palate with sufficient connective tissue to accommodate soft tissue defects. 4- Good oral hygiene

Exclusion Criteria:

1 - Smokers 2- Pregnancy 3- Medically compromised patients 4- Severe gag reflex 5- Patients allergic to the used agent 6- Occlusal trauma at the site of graft

Primary outcomes:
measure: Post-Operative Pain
timeFrame: 2 weeks
Secondary outcomes:
measure: Color Match
timeFrame: 42 days
measure: Wound Size
timeFrame: 21 days
measure: Post-Operative Pain (Indirectly)
timeFrame: 3 Weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The british university in egypt
Study officials:
References:
Clinical trial NCT01158066: Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification
Official title: Association Between NAFLD and Coronary Artery Calcification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Calcification
Keywords: NAFLD
Calcium score
Liver Fat
Visceral fat
excessive visceral fat
excessive liver fat accumulation
Biomarkers of insulin resistance (HOMA), inflammation (CRP) and (MDA-Paraoxonase)
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2010-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial

Detailed description: Coronary artery disease are 8 times more prevalent in patients with NAFLD that the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial. AIM: the aim is to evaluate the association between CAC score ( CT) and NAFLD (CT). the working hypothesis is that Beside the traditional risk factors including age, diabetes, NAFLD is also associated with moderate to high risk of CAD.

Eligibility criteria: Inclusion Criteria:

* Patients who will undergo cardiac CT for patients with low to intermediate risk for CAD

Exclusion Criteria:

* Patients with PCI or CABG will be excluded

Primary outcomes:
measure: Total calcium score measurement
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Safed, Israel
country: Israel
facility: Ziv medical center liver unit
Study officials:
References:
Clinical trial NCT00352066: Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together
Official title: A Phase I, Open Label, Controlled, Intra-subject Comparison Study to Investigate the Effect of Co-administration Upon the Pharmacokinetics of Tipranavir (Ritonavir Boosted) and Apricitabine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infection
Keywords: Human Immunodeficiency Virus
anti-retroviral therapy
nucleoside analogue
reverse transcriptase
apricitabine
tipranavir
bioequivalence
drug-drug interaction
pharmacokinetics
Lead sponsor: Avexa
Sponsor class: INDUSTRY
First posted: 2006-07-14
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.

Detailed description: Apricitabine is a new NRTI in development for treatment of drug resistant HIV. Tipranavir is a recently licensed protease inhibitor for treatment of drug resistant HIV. Tipranavir affects the plasma concentration of some other drugs when they are used together with tipranavir. This study will examine whether the pharmacokinetics of apricitabine are changed when it is dosed together with tipranavir compared to apricitabine alone. Also, the pharmacokinetics of tipranavir will be examined at steady state when it is dosed alone and when it is dosed together with apricitabine. Information on the safety and tolerability of the two drugs when dosed together will also be obtained.

Eligibility criteria: Inclusion Criteria:

* healthy males 18-40 years old
* non-smokers
* no clinically significant medical history

Exclusion Criteria:

* current or relevant previous medical history of significance
* hepatitis B, hepatitis C, or HIV positive
* current use of prescription or OTC medications
* use of illicit substances or alcohol (\>14 drinks/week)

Primary outcomes:
measure: To compare the single dose pharmacokinetics of apricitabine when administered alone and in the presence of steady state concentrations of tipranavir 500 mg administered twice daily in combination with ritonavir 200 mg twice daily.
timeFrame: day 1 and day 10
Secondary outcomes:
measure: To compare the steady state pharmacokinetics of tipranavir 500 mg administered twice daily with ritonavir 200mg in the presence and absence of apricitabine.
timeFrame: day 9 and day 10
measure: To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir.
timeFrame: day 10
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Jasper Clinic Inc
state: Michigan
Study officials:
affiliation: Avexa
name: Susan W Cox, Ph D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03265366: Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses
Official title: Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Bronchopulmonary Aspergilloses
Keywords: Ultrashort echo time magnetic resonance imaging
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to compare the concordance between chest computerized tomography-scan (CTscan) and Magnetic resonance Imaging (MRI) for the description of the abnormalities seen in Allergic BronchoPulmonary Aspergillosis (ABPA).

Detailed description: The ABPA is responsible for pulmonary exacerbations in chronic bronchial diseases. The treatment of ABPA consists in systemic corticosteroids and anti fungal therapy, which can have severe side effects. The diagnosis is difficult, based on several but non-specific characteristics. One of the radiologic abnormalities on CTscan could be more specific : high attenuation in impacted mucus, but this sign is found in about 30% of cases. Recent articles and investigators experience seem to demonstrate that MRI could provide an interesting tool for ABPA diagnosis, studying the signal of bronchial impactions. The aim of the study is to describe the MRI characteristics of patients with ABPA and compare the results with those obtained by CTscan, and in order to determine if there is a specific signal of impaction in ABPA.

Eligibility criteria: Inclusion Criteria:

* study patients have a diagnosis of ABPA
* control patients have severe asthma
* All the patients are ≥ 18 years old, have social security care, signature of consent form

Exclusion Criteria:

* cystic fibrosis
* other type of aspergilloses
* contraindication for MRI
* woman without effective contraception

Primary outcomes:
measure: Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Julie MACEY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02836366: Targon PH+ Follow-Up
Official title: Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Fractures
Keywords: Proximal humerus
Fracture
Nailing
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2016-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: With this study results of the Targon® PH+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. The primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult patients. Secondary aims are to examine the level of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications.

Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by Aesculap


Eligibility criteria: Inclusion Criteria: - patients with a three- or four-fragment-fracture of the proximal humerus, with dislocation on X-ray

* older than 60 years of age
* written and signed patient consent

Exclusion Criteria: - Fractures more than 14 days old

* multiple comorbidity
* multitrauma (Injury Severity Score \> 15)
* prev. surgery on the injured shoulder
* severely deranged function caused by a previous disease head-split proximal humerus fracture
* combined humerus head and shaft fractures
* pseudarthroses
* crushed head cap of the humerus head (AO 11 C3 fractures)
* isolated avulsion fracture of a tuberosity
* unwillingness or inability to follow protocol instructions and study requirements (follow-up visits)
* no signed informed consent
* treatment not in line with Instructions for Use (IfU)

Primary outcomes:
measure: Functional Capacity
timeFrame: 24 months
Secondary outcomes:
measure: Level of pain
timeFrame: 3, 12 and 24 months
measure: Patient satisfaction
timeFrame: 24 months
measure: Shoulder Function
timeFrame: 12 months, 24 months
measure: Radiological outcome (only if it could be raised in clinical standard)
timeFrame: 24 months
measure: Adverse Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
state: Bayern
Study officials:
affiliation: Klinikum Nürnberg Süd
name: Hermann Josef Bail, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01780766: Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging
Official title: Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI: What is the Added Value of Diffusion Weighted Imaging in Diagnosis and Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: Whole body MRI
Multiple myeloma
Diffusion Weighted MRI
Whole body scan
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 25
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 clinical and laboratory findings, highly suggestive for multiple myeloma. All patients underwent bone marrow biopsy.

Brief summary: Whole body MRI with diffusion weighted imaging is a useful imaging tool

* staging and diagnosis
* therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).


Eligibility criteria: Inclusion Criteria:

* Patients with clinical and laboratory findings, highly suggestive for multiple myeloma.

Exclusion Criteria:

* All patients who are not allowed to be scanned on MRI (Pacemaker, implants ed.)

Primary outcomes:
measure: Validation
timeFrame: 2 years
Secondary outcomes:
measure: Therapy assessment
timeFrame: 4 years
Other outcomes:
measure: outcome
timeFrame: 5 years
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Steven Pans, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bannas P, Hentschel HB, Bley TA, Treszl A, Eulenburg C, Derlin T, Yamamura J, Adam G, Stubig T, Kroger N, Weber C. Diagnostic performance of whole-body MRI for the detection of persistent or relapsing disease in multiple myeloma after stem cell transplantation. Eur Radiol. 2012 Sep;22(9):2007-12. doi: 10.1007/s00330-012-2445-y. Epub 2012 Apr 29.