louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01056432: Bone UltraSonic Scanner (BUSS) Clinical Optimization Study
Official title: Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: osteoporosis, bone fracture risk, bone ultrasonometry
Lead sponsor: Artann Laboratories
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will consist of groups with no history of osteoporosis, established osteoporosis and may include documented history of fracture.

Brief summary: The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.

Detailed description: The specific aims of this clinical study are:

1. To optimize the data collection technique and establish an examination procedure;
2. To collect data necessary for assessing the performance of BUSS sensors;
3. To evaluate the probe ergonomic design and participant tolerance to probe application;
4. To assess the clinical suitability of the software interface in data collection;
5. To adjust the BUSS diagnostic algorithms using dual-energy X-ray absorptiometry (DEXA) data as a "gold" standard in osteoporosis detection and characterization;
6. To evaluate BUSS performance including ease of use and consistency.

Eligibility criteria: Inclusion Criteria:

Any race or ethnical group DEXA examination scheduled within next two weeks or DEXA examination was completed within the last six months adn DEXA results are available

Exclusion Criteria:

Open wounds or rashes on the tibial testing area Active skin infection Recent tibia surgery Abnormal tibia Anatomy Current or previous tibial fracture Body Mass Index \>34.9 Hyperparathyroidism or hypoparathyroidism within 5 years Osteitis deformans Renal osteodystrophy Osteomalacia Stroke with total or partial paralysis with residual disability lasting more than 3 months Current or recent (within past 6 months) use of bone-active drugs Drugs under research protocols Chronic use of over the counter antacids

-

Primary outcomes:
measure: To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Health Smart Medical Center
state: Pennsylvania
Study officials:
affiliation: Artann Laboratories
name: Armen Sarvazyan, Ph.D., D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03079232: First Optical Coherence Microscopy in Dermato-oncology
Official title: In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Keywords: Optical biopsy
Skin cancer
Diagnostic performance
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: DAMAE Médical
First posted: 2017-03-14
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group of patients One group of non skin cancer patients
Primary purpose: DIAGNOSTIC

Brief summary: OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).

Detailed description: At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.

This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.

Eligibility criteria: FOR PATIENT

Inclusion Criteria:

* Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision
* Consent form signed
* Major patient

Exclusion Criteria:

* Allergy or intolerance to immersion oil (used for microscopy)
* If female, pregnant or breast-feeding
* Patient unable to stand still for 60 seconds
* Skin lesions located near patient eyes (\<3 cm)

FOR CONTROL GROUP

Inclusion Criteria:

* Aged between 18 to 40 years
* Consent form signed
* Patient of the dermatology department with non-pathological forearm skin

Exclusion Criteria:

* Allergy or intolerance to immersion oil (used for microscopy)
* If female, pregnant or breast-feeding
* Patient unable to stand still for 60 seconds

Primary outcomes:
measure: Sensitivity
timeFrame: Day 1
measure: Specificity
timeFrame: Day 1
Secondary outcomes:
measure: Measure of the thickness of the different skin layers (mm)
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Luc PERROT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Damae Medical
name: Cécile DUPONT, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01918332: Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia
Official title: A Multicenter, Randomized, Factorial, Double-blinded, Double-dummy Phase Ⅲ Trial to Evaluate the Efficacy and Safety of the Coadministration of Valsartan 160mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone in Patients With Hypertension and Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension,
Hyperlipidemia
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of the coadministration of valsartan (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered alone in patients with hypertension and hyperlipidemia.


Eligibility criteria: Inclusion Criteria:

1. Patient aged 20-80 years who has hypertension and hyperlipidemia
2. Patient who has a Hypertension
3. Patient who has a Hyperlipidemia according to NCEP-ATP III guideline(2004)
4. Patient who signed the Informed Consent Form after receiving an explanation on the purpose, methods, and effect of the study

Exclusion Criteria:

1. If blood pressure and fasting serum lipid level measured at screening and Visit 2 (0 week) satisfy the following criteria 1) sitSBP≥180mmHg or sitDBP≥110mmHg (For high risk group, sitSBP≥ 160mmHg or sitDBP ≥100mmHg ) 2) LDL-C\>250mg/dL , or TG≥ 400mg/dL
2. If sitSBP difference between the right and left arms \>20mmHg or sitDBP difference between the right and left arms \> 10mmHg at screening
3. When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg
4. Patient with orthostatic hypotension accompanying symptoms at screening (decrease in sitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )

Primary outcomes:
measure: sitDBP Changes at Week 8 From Baseline
timeFrame: 8 weeks
measure: LDL-C Percentage Changes at Week 8 From Baseline
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital
Study officials:
References:
Clinical trial NCT06656832: Peripheral Drivers of Heart Failure Progression - the Prospective PEDAL-HF Study
Official title: Peripheral Drivers of Heart Failure Progression - the Prospective PEDAL-HF Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure - NYHA II - IV
Keywords: Heart Failure Network Care
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 1000
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: PEDAL-HF is a registry-based randomized prospective multicenter study. We plan to include 1000 patients who were recently admitted with acute decompensated heart failure at five tertiary heart clinics in Germany. For the randomised part, 750 patients will be randomized to care within a heart failure network or usual care. The primary endpoint of the randomized trial is change in NT-proBNP from baseline to 6 months of follow-up.

All patients (randomized or not) will be followed for two years.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the participating study centres with acute decompensated heart failure (ADHF), defined as clinical signs and/or symptoms of heart failure, objective structural cardiac abnormalitites according to the ESC criteria.

Exclusion Criteria:

* Age \&lt; 18 years, pregnancy, any condition interfering with the informed consent process, patients placed in an institution by official or court order

Primary outcomes:
measure: Change in NT-proBNP plasma levels between baseline and 6 months visit
timeFrame: 6 months
Secondary outcomes:
measure: Change in KCCQ from baseline to 6 months of Follow-up
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00836732: Mesenchymal Stem Cells: Alterations in Genome
Official title: MESenchymal Stem Cells: Alterations in GEnome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pened Chest Surgery for Programmes Coronary Bypass
Keywords: celle therapy
cell culture
mesenchymal stem cells
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 35
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

Brief summary: The aim is to study small genetic alterations induced by cell culture in human mesenchymal stem cells in GMP condition.


Eligibility criteria: Inclusion Criteria:

* age \> 18 old
* age \< 75 old
* opened chest surgery for programmed coronary bypass

Primary outcomes:
measure: Presence of small genetic alteration in mesenchymal stem cells
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: nantes University Hospital
Study officials:
affiliation: Nantes UH - institut du thorax
name: Patricia Lemarchand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180232: An Open Clinical Trial to Assess the Influence of Newly Prescribed Aminobiphosphonates on Arterial Stiffness
Official title: An Open Clinical Trial to Assess the Influence of Newly Prescribed Aminobiphosphonates on Arterial Stiffness (Changes of the Aortal Elasticity Due to a Newly Established Aminobiphosphinate Therapy for the Treatment of Osteoporosis)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arteriosclerosis
Osteoporosis
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients starting an aminobisphosphonate therapy due to medical reasons Broca-index: between -20 and +25%

Brief summary: The study tries to reveal if aminobisphosphonates influence aside the bone density also the vascular status in the typical elderly patient population

Detailed description: The subjects - starting bisphosphonate treatment due to medical reasons - will be additionally investigated as outpatients (arterial stiffness, applanation tonometry), for each subject 3 individual dates with a duration of approx. 30 min each are scheduled, prior to therapy with bisphosphonate, after 3 and 6 month of treatment

Eligibility criteria: Inclusion Criteria:

* Patients starting an aminobisphosphonate therapy due to medical reasons Broca-index: between -20 and +25% who are willing and capable to confirm written consent to enrolment after ample information has been provided

Exclusion Criteria:

* patients with major cardiovascular disease patients participating in another clinical trial 1month prior to inclusion in this study patients unable or unwilling to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medizinische Fakultät der Technischen Universität Dresden
Study officials:
affiliation: Technische Universität Dresden
name: Joachim Siegert, MDDPharm,Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01341132: Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents
Official title: Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: HCC
Hepatocellular Carcinoma
MRI
Liver
Lead sponsor: San Francisco Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
name: University of California, San Francisco
First posted: 2011-04-25
Enrollment: 75
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: 75 patients of the San Francisco VA Medical Center with suspected HCC identified on contrast-enhanced multi-detector CT, or on ultrasound and referred to contrast-enhanced multi-detector CT.

Brief summary: This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma (Liver Cancer) comparison to multi-detector computed tomography (CT).


Eligibility criteria: Inclusion Criteria:

* Alpha-feto protein \> 400 ng / mL or
* prior ultrasound with mass suspicious for hepatic malignancy or.
* clinical risk of hepatocellular carcinoma or
* prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma

Exclusion Criteria:

* Glomerulo-filtration rate \< 50 mL/ min/1.73 m2 based on a creatinine measurement within three months of the MR study
* Previous diagnosis of hepatic malignancy
* Any conditions that would discount the ability to have an MRI scan

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: San Francisco VA Medical Center
name: Rizwan Aslam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04052932: A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout
Official title: A Phase3, Multicentre, Randomized, Double-Blind, Allopurinol and Placebo-Controlled Study to Evaluate the Efficacy and Safety of SHR4640 Monotherapy in Subjects With Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-12
Enrollment: 594
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: This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to placebo and Allopurinol in patients with gout


Eligibility criteria: Inclusion Criteria:

1. Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening;
2. 18 kg/m2 ≤Body mass index (BMI)≤ 35 kg/m2

Exclusion Criteria:

1. Subject who is pregnant or breastfeeding;
2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin\>1.5 upper normal limit;
3. Subject with a positive test for HLA-B\*5801;
4. Estimated glomerular filtration rate (MDRD formula) \<60ml/min;
5. HbA1c\>8%;
6. Subject with known hypersensitivity or allergy to SHR4640 and allopurinal, or any component of SHR4640;
7. Subject with kidney stones or suspicion of kidney stones;
8. Subject who has acute gout flares within 2 weeks before randomization;
9. Subject with a history of malignancy within the previous 5 years;
10. Subject with a history of active peptic ulcer within a year;
11. Subject with a history of xanthine urine.

Primary outcomes:
measure: Proportion of subjects with a serum uric level≤360μmol/l.
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of subjects with a serum uric level≤360μmol/l
timeFrame: Week 36
measure: Percentage change from baseline in serum uric level
timeFrame: Up to 36 weeks
measure: Actual change from baseline in serum uric level
timeFrame: Up to 36 weeks
measure: Proportion of subjects with a serum uric level≤360μmol/l
timeFrame: Up to 36 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Jiaotong University School of Medicine,Renji Hospital
name: Chunde Bao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04899232: Antithrombin III in Infectious Disease Caused by COVID-19
Official title: Antithrombin III (AT3) in Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)/ Coronavirus Disease of 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Antithrombin III Deficiency
Covid19
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Grifols Biologicals, LLC
First posted: 2021-05-24
Enrollment: 52
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: The purpose of this research study is to see if participants who have SARS-CoV-2 and low levels of AT3 in the blood will benefit by being given AT3.


Eligibility criteria: INCLUSION CRITERIA:

1. \>18y of age,
2. Subject or proxy who can provide informed consent
3. Positive SARS-COV-2 by Polymerase Chain Reaction (PCR) or as determined by clinical team

EXCLUSION CRITERIA:

1. Adults or Proxy unable to consent
2. Individuals who are not yet adults (infants, children, teenagers)
3. Pregnant women
4. Prisoners
5. Patients expected to die within 24 hours or with a "do not resuscitate" order,
6. Multi-organ failure,
7. History of hypersensitivity or allergy to any component of the study drug,
8. Ongoing massive surgical or unexplained bleeding,
9. History of bleeding or clotting disorder,
10. Severe traumatic brain injury (Glasgow Coma Scale \<6),
11. Spinal or multiple-trauma,
12. Cancer (incurable/terminal phase) and/or patients receiving palliative care,
13. Enrollment in another concurrent clinical interventional study if considered interfering with this study objectives
14. Per study team discretion, any condition(s) that may prevent safe treatment, preclude adequate evaluation or adding further risk to their underlying illness.

Primary outcomes:
measure: Change in ISTH DIC Score
timeFrame: Baseline, Day 9
Secondary outcomes:
measure: Change in D-Dimer Levels
timeFrame: Baseline, Day 9
measure: Change in Fibrinogen Levels
timeFrame: Baseline, Day 9
measure: Change in Prothrombin Time
timeFrame: Baseline, Day 9
measure: Length of Hospital Stay
timeFrame: Up to 60 days
measure: Mortality Rate
timeFrame: Up to 60 days
measure: Pulmonary Function
timeFrame: Up to 60 days
measure: Change in SOFA Scores
timeFrame: Baseline, Day9
measure: Change in SOFA Respiratory Sub Score
timeFrame: Baseline, Day 9
measure: Number of Events of Venous Thromboembolism
timeFrame: Up to 60 days
measure: Number of Events of Major Bleeding
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Enrique Ginzburg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02027532: Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin
Official title: Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infection
Closed Fractures
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period.

The hypothesis of this study is that patients undergoing surgical treatment for closed fractures who are treated prophylactically with Vancomycin will have a lower incidence rate of infection than patients who are treated prophylactically with Cefazolin.


Eligibility criteria: Inclusion Criteria:

* Between 18 years old and 85 years old
* Closed fracture
* Fracture treatment plan is for one operation on one day (one surgical setting)
* Likely to follow-up with surgeon until fracture is healed
* Ability to understand and agree to Informed Consent

Exclusion Criteria:

* Under 18 years old or over 85 years old
* Open fracture(s)
* Fracture requires multiple operations
* Other injuries requiring operations
* Documented allergy to Cefazolin or Vancomycin
* Previous history of Methicillin-resistant Staphylococcus aureus infection
* Previous surgery on the injured extremity within 1 year
* Use of antibiotics within 2 weeks before or after injury
* Use of antibiotics within 2 weeks before surgery
* Unlikely to follow-up until fracture is healed
* Unable to understand and agree to Informed Consent

Primary outcomes:
measure: incidence of infection
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
Study officials:
affiliation: UTCOM Chattanooga/Erlanger Health System
name: Peter J Nowotarski, M.D.
role: PRINCIPAL_INVESTIGATOR
References: