cyrilzakka/clinical-trials huggingface dataset:
Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)

This study evaluates the efficacy and safety of efprezimod alfa in hospitalized adult participants who are diagnosed with coronavirus disease 2019 (COVID-19) and receiving oxygen support.

The primary hypothesis of the study is clinical improvement in the experimental group versus the control group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with coronavirus disease 2019 (COVID-19) and confirmed severe acute respiratory syndrome coronavirus 2 (SARS-coV-2) viral infection
* Severe or critical COVID-19, or National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal score 2, 3 or 4 (Scale 2: requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Scale 3: non-invasive ventilation or high flow oxygen devices; Scale 4: supplemental oxygen support; a peripheral capillary oxygen saturation (SpO2) \</= 94% or tachypnea (respiratory rate \>/= 24 breaths/min). Intubation should be within 7 days

Exclusion Criteria:

* Participants who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment
* Participants previously enrolled in the efprezimod alfa study
* Intubation for invasive mechanical ventilation is over 7 days
* Documented acute renal or hepatic failure
* The investigator believes that participating in the trial is not in the best interests of the participant, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues)
Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)

The major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the

1. structural and functional features of skeletal muscle (SkM)
2. exercise capacity (as assessed by VO2 max)
3. parameters of diastolic heart function (as assessed by echocardiography)

We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead to a significant improvement in exercise capacity and diastolic function.

Patient Inclusion/Exclusion Criteria:

1. New York Heart Association Class II/III HF with preserved ejection fraction (EF) of \>50%.
2. Nonsmokers
3. Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug eluting stent will not be excluded.
4. Ages between 40-65. We will exclude any women of child bearing potential

Eligibility Criteria:
Inclusion Criteria:

* Medically Diagnosed Heart Failure with Ejection Fraction of \>55%
* BMI 27-32
* No Significant HbA1C fluctuations in past 6 months

Exclusion Criteria:

* Smoking or quit smoking less than 1 year prior to enrollment
* Substance Abuse
* Taking Coudmadin or Pradaxa
Cardioprotective Effects of Green Tea Versus Maté Intake

The investigators aim to study the effects of green tea and maté consumption on lipid and inflammatory profiles in dyslipidemic and overweight subjects.

Recommendations of lifestyle and dietary content changes are often made for primary prevention and improvement of many health conditions, including cardiovascular disease. For centuries, green tea (Camellia sinensis) has been linked to good health. Nowadays, it is considered a functional food because of its physiological benefits, mainly in terms of cardiovascular prevention. Green tea is considered one of the best sources of phenolic compounds, which possess antioxidant properties that may contribute to a reduction in the risk of cardiovascular disease. Lesser-known worldwide, but widely consumed in southern Latin America countries, yerba mate tea (Ilex paraguariensis) is also a good source of phenolic compounds. The antioxidant capacity of green tea has been extensively studied; however, few studies have reported that the antioxidant properties of maté tea is even greater than green tea. For this reason, the present study aims to compare the possible effects of the oral ingestion of maté and green tea on the lipid and inflammatory profiles in a southern Brazilian population.

Eligibility Criteria:
Inclusion Criteria:

* age 35-60 years
* non-treated dyslipidemia (TC \> 200mg/dL and/or TG \> 150 mg/dL and/or HDL-c \< 40 mg/dL for men and 50mg /dL for women)
* BMI 25-35 Kg/m²

Exclusion Criteria:

* use or indication for use of lipid-lowering agents and/or vitamin supplement
* non-steroids anti inflammatory use
* hormone replacement therapy
* contraceptive use
* pregnancy
* nursing
* unexplained weight loss (\>2 Kg) 2 months before the study
* altered hepatic function
* those who do not sign the informed consent
Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment

This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with GERDOff Plus added on top of the current PPI treatment in patients with GERD. The aim of the study is to evaluate the performance of GERDOff Plus, a class III medical device, consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition to the PPIs, in patients with GERD not fully satisfied with their current treatment with PPIs.

Patients will receive either GERDOff Plus or placebo q.i.d. for 21 days followed by a wash-out period of 3 weeks. After the wash-out period, the patients will receive either placebo or GERDOff Plus respectively


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent (ICF): a written informed consent must be obtained prior to any study related procedure being performed
* Male and female out-patients aged 18 to 80 years
* GERD diagnosis confirmed through a validated questionnaire (GERDQ score ≥ 8).
* EGD endoscopy performed within 1 year before screening
* Patients in continuous or intermittent treatment with PPI for at least 1 year and continuously for at least 4 weeks prior to study entry
* Patients not fully satisfied with current PPI treatment (1-3 score on 5-points Likert scale)

Exclusion Criteria:

* Dyspeptic patients or patients with overlapping symptoms with GI diseases other than GERD
* Histological evidence of Barrett's oesophagus \> 1 cm in EGD endoscopy
* Peptic stricture in EGD endoscopy
* Concurrent findings in the EGD endoscopy that might interfere with the participation to the study (e.g cancer, peptic ulcer) as judged by the investigator
* Known impaired kidney or liver function at screening
* Presence of any relevant severe condition or clinically relevant abnormal parameters that in the opinion of the investigator may interfere with the participation to the study
* Medication use (including H2 antagonists, alginates, baclofen, NSAIDS, prokinetics, antidepressants) that may interfere with GERD symptom assessment within 2 weeks before the start of the study or during the study
* Pregnancy or breast-feeding
* Females of childbearing potential not employing adequate contraceptive methods
* Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable)
* History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent
* History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements
* Treatment with any investigational drug within the previous 30 days
Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain

Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

Eligibility Criteria:
Inclusion Criteria:

* The subject has pain consistent with a diagnosis of chronic lumbosacral radiculopathy due to injury of the lumbosacral nerve root(s)
* The subject reports at least moderate pain intensity at screening.
* The subject's onset of leg pain due to LSRP is at least 3 months
* The subject has a magnetic resonance imaging (MRI) scan that is normal or shows incidental lesions
* The subject has a calculated creatinine clearance ≥30 mL/min
* The subject has clinical laboratory values within normal limits or abnormal values that the investigator deems not clinically significant.
* body mass index (BMI) \<40 kg/m2.

Exclusion Criteria:

* The subject has previously undergone back surgery
* The subject is unable to reliably delineate or assess pain by anatomical location/distribution on a body map.
* The subject has a history of peripheral neuropathy, evidence of peripheral neuropathy, or evidence of mononeuropathy in the same limb of LSRP.
* The subject has pain due to infection/abscess, hematoma, or malignancy or other pain that may interfere with the assessment of LSRP in the legs.
* The subject has clinically significant and/or unstable renal, hepatic, hematologic, endocrine, immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that would compromise participation in the study
* The subject has any neurological disease that could interfere with participation in the study (e.g., Huntington's disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, seizures, epilepsy, stroke).
* The subject has a history or current diagnosis of major psychiatric disorder(s)
* The subject has a has a history of substance abuse or dependence
* The subject has clinically significant abnormal electrocardiogram (ECG) findings
* The subject has received nerve blocks and/or steroid injections for LSRP within the 3 months before screening
* The subject is unwilling or unable to discontinue current medications for LSRP, including topical agents.
* The subject is unable to refrain from using prohibited meds during the study, including: NSAID, antiepileptic drugs, steroids, cannabinoids, or major opioids, antidepressants, muscle relaxants, tramadol, or tapentadol.
* The subject has used prohibited nonpharmacologic therapies, including acupuncture, transcutaneous electrical nerve stimulation, within 30 days the study.
* The subject is currently participating in another or the same clinical study or participated in another clinical study within 3 months before screening
* The subject is pregnant or lactating or not practicing adequate birth control
Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD

To test the hypothesis that nebulized Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two treatment arms among primary lung cancer patients with COPD required single lobectomy from 3days before operation to 7 days after operation.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed or existing COPD defined by GOLD, and FEV1 of\<80% predicted and FEV1/FVC\<70%
2. Diagnosed as primary lung cancer by China guidelines on diagnosis and treatment of primary lung cancer
3. .Consistent with indication of operation of pulmonary single lobectomy surgery by China guidelines on diagnosis and treatment of primary lung cancer
4. General anesthesia and double cavity intubation was used during operation
5. ASA Classification of Anesthesia Risk is in category 1-3 both in baseline
6. age from 40-80 years old
7. Smoking cessation more than two weeks before operation
8. SP O2\>90% before surgery
9. Hemoglobin \> 10g/dl
10. Estimated duration of surgery \< 4 hours
11. 18.5\<BMI \< 28

Exclusion Criteria:

1. Patients who had taken systemic corticosteroids in the preceding 1month before baseline
2. Patients who had pneumonia in the preceding 1month before baseline
3. Patients with a history of recent myocardial infarction, heart failure, tuberculosis
4. Subject with known or suspected human immunodeficiency virus infection
Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China

Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection. Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, and the rationality of the current therapy for the CRKP infection.

All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection

Eligibility Criteria:
Inclusion Criteria:

* new confirmed noscomial infection of CRKP

Exclusion Criteria:

* Age\<18, or \>85 years old; Mixed infection of CRKP and other microbes
Aerofit Post Market Investigation

The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.


Eligibility Criteria:
Inclusion Criteria:

* 50Kg\< body weight \< 136Kg
* Cognitive ability to understand all instructions and questionnaires in the study
* Intended for unilateral/bilateral individuals that fit the indications for use, fit within the specified criteria and with the limb length, shape and ability to use a prosthetic liner: Activity level: K1 - K4, Impact level: Low to high, Amputation level: transfemoral
* Congenital transverse deficiency at femoral level
* Using Seal-In Silicone Liner and Direct Socket or AeroFit Seal-In Liner and AeroFit Socket
* Able to use AeroFit Solution, see Figure 7 AeroFit Seal-In Liner Sizes and Figure 8 Minimum socket height per liner profile.
* Residual limb profile: Standard or conical
* Willing and able to participate in the study and follow the protocol
* Confident (all day) prosthetic users for more than 3 months
* Older than 18 years

Exclusion Criteria:

* Participating in another research study that may affect the participation or results of this study (in the opinion of the investigator)
* Users that have received Botox injection as treatment for residual limb sweat issue in the last 4 months
A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the treatment of patients with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Aged form 18 years to 75 years old
* Diagnosed with osteoarthritis of the knee according to the American College of Rheumatology
* Functional capacity class of Ⅰ-Ⅲ

Exclusion Criteria:

* Unstable angina
* History of myocardial infarction within the last 6 months
* Stroke in the 6 months before screening
* New York Heart Association class Ⅲ-Ⅳ congestive heart-failure
* Systolic blood pressure\>180mmHg,and/or Diastolic blood pressure\>100mmHg
* Peptic ulcer
* Known contraindications to non-steroidal anti-inflammatory drug（NSAID）
* Received aspirin within 3 days of baseline visit
* Aspirin dosage\>150mg/d
* Known to be Allergic to sulfa and COX-2 inhibitors
* Pregnancy or lactation
* Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase\>2 times upper limit of normal
* Blood urine nitrogen\>1.5 times upper limit of normal
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples

The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture.

The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of neonates (less than 1 month of age), paediatrics (between 1 month and 17 years of age) or adults (\>18 years of age).
* Admitted to ICU, Emergency Department, or other medical wards for acute illness with medical decision to perform blood culture for suspicion of bloodstream Infection.
* Single EDTA blood sample collected from one anatomical site.
* EDTA blood sample is stored according to Microbio's stability requirements.
* EDTA blood volume is \>1mL.

Exclusion Criteria:

* No suspicion of Blood System Infection.
* Any Inclusion Criterion not met.
* Multiple EDTA blood samples from the same patient.
* EDTA blood samples that have not been stored according to Microbio's stability requirements.
* EDTA blood volume \<1mL.
Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin vs Titanium Platelet Rich Fibrin

Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in the treatment of intrabony defects (IBDs).

Materials and methods: Study was conducted on subjects reporting to the Department of Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90 periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm in at least three teeth.


Eligibility Criteria:
Inclusion Criteria:

* presence of minimum 20 permanent teeth
* age group 20-55 years
* radiographic evidence of periodontal IBDs
* probing pocket depth (PPD) \>5mm in minimum two sextants in at least three teeth
* clinical attachment (CA) loss of ≥ 3mm.

Exclusion Criteria:

* Systemically compromised subjects
* those on medications (corticosteroids/ bisphosphonate therapy) that may interfere with wound healing
* grade III tooth mobility
* smokers and alcoholic subjects
* pregnant and lactating mothers
* subjects who underwent periodontal treatment within a period of 1 year.
The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer

The proposed clinical trial will study the effects of 12 months of therapy with ARN-509 alone, or in combination with an LHRH agonist (LHRHa), each compared with LHRHa alone, in men with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The endpoints selected reflect measurable short term effects of androgen deprivation therapy (ADT), including quality of life and several metabolic parameters. In addition, the relative effect of each treatment strategy on PSA suppression as well as testosterone recovery (and subsequent PSA progression) after 12 months of therapy will be evaluated.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically proven adenocarcinoma of the prostate
* Rising PSA after prior definitive local therapy (radical prostatectomy, external beam radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy with curative intent
* PSA doubling time less than or equal to 12 months
* No evidence of metastatic disease on imaging by whole body bone scan and computerized tomography (CT) or Magnetic Resonance Imaging (MRI) of the abdomen/pelvis within 6 weeks prior to randomization
* Minimum PSA 1.0 ng/mL if prior radical prostatectomy +/- adjuvant or salvage radiation; nadir + 2.0 ng/mL if prior RT without prior radical prostatectomy
* Prior androgen deprivation therapy (ADT) allowed if last dose was greater than (\>) 6 months prior to randomization
* No prior androgen deprivation therapy (ADT) or anti-androgen for biochemical relapse
* Serum testosterone \> 150 ng/dL at study entry
* No history of seizures or medical conditions which may lower seizure threshold

Key Exclusion Criteria:

* Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 6 weeks prior to randomization
* Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 6 weeks prior to randomization
* Prior bilateral orchiectomy
* Prior treatment with ADT for biochemically relapsed prostate cancer. Prior ADT as neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation therapy or prostatectomy for biochemically relapsed disease is allowed provided last dose of ADT is greater than (\>) 6 months prior to randomization and the Screening serum testosterone level is greater than or equal to (≥)150 ng/dL
* Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at randomization
* Any history of seizures or medical condition which lowers seizure threshold
Detection of Left Atrial Appendage (LAA) Thrombus: Comparison of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram

The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and women with atrial fibrillation presenting for cardioversion.

The identification of left atrial appendage (LAA) thrombus prior to cardioversion for patients with atrial fibrillation is crucial. LAA thrombus can be a frequent cause of cerebral stroke or peripheral embolism post cardioversion, and anticoagulation therapy is required in these instances to prevent cerebral events and avoid embolization. To date, TEE has been considered the clinical reference in detection of LAA thrombi with high diagnostic accuracy. However, diagnosis and size estimation of LAA thrombi remains challenging due to the complex anatomy of the LAA, and transesophageal echocardiography (TEE) is considered a semi-invasive procedure. To date, there have been few comparative studies involving TEE and cardiac magnetic resonance (CMR) imaging, and the results have been conflicting. With newer CMR Imaging techniques now available, we hypothesize that comparable results will be achieved in detecting LAA thrombus in subjects using a less invasive procedure.

Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation

Exclusion Criteria:

* ICDs
* pacemakers
* intracranial clips
* intracranial stimulator devices
* insulin pumps
* intra ocular metal foreign bodies
* cochlear implants
* LAA amputation as part of CABG and/or valve surgery
* GFR \< 60 mL/min