cyrilzakka/clinical-trials huggingface dataset:
Dapagliflozin And Pulmonary Artery Hemodynamics in Heart Failure With Reduced Ejection Fraction Patients With CardioMEMS®

The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.

Prior studies have demonstrated an association between the use of sodium-glucose cotransporter 2 (SGLT-2) inhibitors for diabetic patients and reductions in composite primary outcomes of cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke, as well as reductions in heart failure among patients with diabetes. The 2019 DAPA-HF trial studied whether the addition of the SCLT-2 inhibitor dapagliglozin could benefit patients with heart failure with reduced ejection fraction (HFrEF), either with or without diabetes. Results indicated that that SGLT-2 inhibitors resulted in 4.9% absolute reduction in the cardiovascular death or worsening heart failure and a 2.3% absolute reduction in all-cause mortality in patients with and without diabetes. Dapagliflozin is FDA approved to reduce the risk of cardiovascular death or hospitalization in patients with HFrEF with or without Type 2 diabtes. The mechanisms of cardiovascular benefit remain unclear, however it is likely to be driven by a reduction in heart failure death given that rates of myocardial infarction were similar between treatment arms.

The CardioMEMS® system is an implantable device that can measure pulmonary artery systolic, diastolic and mean pressure on a daily basis. It has been shown convincingly that monitoring the MEMS device results in reduced pulmonary pressures and in turn a reduction in heart failure hospitalizations.

The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.

Eligibility Criteria:
Inclusion Criteria

1. Diagnosis of HFrEF and existing CardioMEMs in place
2. Patients who have historically been compliant with CardioMEMS followup
3. Ejection fraction \< or = to 40%
4. New York Heart Association (NYHA) class II-IV heart failure
5. Able to read and write in English Exclusion Criteria

1. creatinine clearance less than or equal to 45 2. History of renal transplant 3. systolic blood pressure less than 85 on time of initiation of drug 4. intolerance/allergy to farxiga 5. pregnant patients or those who are planning to become pregnant during the study period 6. unable to read and write in English 7. acutely hospitalized patients or those who were hospitalized in the past 30 days 8. history of noncompliance with CardioMEMS followup 9. History of frequent mycotic urinary tract infections 10. History of organ transplantation
Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects

RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.

The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

Rempex is developing a fixed combination antibiotic of a carbapenem plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics of RPX7009, administered alone, in healthy adult subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and/or females (of Non Child-bearing potential), 18 to 55 years of age
* Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
* Medically healthy with clinically insignificant screening results
* Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
* Sexually abstinent or use acceptable methods of birth control

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
* Documented hypersensitivity reaction or anaphylaxis to any medication.
* Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
* Plasma donation within 7 days prior to Day 1.
* Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
"Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"

The aim of the research project is to investigate the uptake of omega-3 fatty acids into the blood plasma through the consumption of the microalgae Phaeodactylum tricornutum (PT) in a human study. In an open, crossover study, the volunteers will receive a drink enriched with the microalgae P. tricornutum or an omega-3 fatty acid preparation or (optionally) pollock for 14 days each. Since the microalgae P. tricornutum is rich in omega-3 fatty acids, the target parameter chosen is the uptake of omega-3 fatty acids in the blood plasma

A large number of diet-related diseases, such as obesity, are characterized by subclinical inflammation of the body. For this reason, anti-inflammatory foods such as omega-3 fatty acids, which are found in fish and nuts, are used. However, the disadvantage of fish as a resource is its limited availability. Therefore, it is of great interest to provide a resource-saving diet that still supplies us with all macro and micro nutrients. For this reason, microalgae have become the focus of science in recent years. Microalgae not only serve as a source of protein, but also contain a large number of nutrients that could have possible physiological and preventive effects in human nutrition. These include substances from the group of carotenoids and the various polyunsaturated FS found in microalgae.

The microalgae PT is rich in omega-3 FS eicosapentaenoic acid (EPA), which is otherwise found mainly in fatty fish, and could therefore be an alternative or vegetarian source of polyunsaturated fatty acids.

Previous work by U. Neumann has shown that the microalgae P. tricornutum could be used for human nutrition. No toxic effects could be observed in vivo and the bioavailability of fatty acids and proteins could also be successfully demonstrated. In vitro experiments also showed a more anti-inflammatory, anti-oxidative and anti-proliferative effect on human blood cells. For this reason, a health-promoting effect is also possible in human nutrition, but this must be proven in human studies.

Eligibility Criteria:
Inclusion Criteria:

* Signed declaration of consent
* Willingness to follow the prescribed diet for the duration of the study
* No participation in another clinical trial (current or within the last 30 days)

Exclusion Criteria:

* Taking intestinal therapeutics, antibiotics, immunosuppressive drugs or similar (if necessary, individual case decision)
* Pregnancy/nursing period
* Relevant violations of the food protocol
* Occurrence of relevant diseases (if necessary, individual case decision)
* Revocation of consent
* Accommodation in a clinic or similar institution due to official or court order
Spanish Cohort for the Study of the Effect of CPAP in Hypertension (CEPECTA)

AIMS:To know the effects of the treatment with nasal positive continuous airway pressure (CPAP) on systemic blood pressure and the expression of biological mediators, in systemic hypertension of recent diagnostic, whose have an apnea-hypopnea index \> 15.

METHODOLOGY: DESIGN: Prospective, multicenter, randomized study, of parallel groups and controlled with placebo, in patients diagnosed of systemic hypertension (SH) with an apnea-hypopnea index, by conventional polysomnography \> 15. A total of 340 patients with recently diagnosed of SH and without any pharmacological treatment will be studied. All patients will be randomized to receive, alternatively, CPAP treatment with optimal pressure titled with a proved system, or Sham-CPAP for 12 weeks.

MEASUREMENTS: A) Conventional polysomnography at baseline: B) Clinic: sleepiness (ATS, Basic Nordic Sleep Questionnaire and Epworth), quality of life (EuroQol); C) 24 hour blood pressure monitoring; D) Expression of biological mediators in blood: general determinations, endothelial, inflammatory, lipid, renin-angiotensin-aldosterone and adrenergic mediators.

ANALYSIS. Baseline measurements of all the variables will be compared with the situation at six and twelve weeks. We will use the chi square test and the Fisher´s exact test (categorical variables), the t test for continous variables and repeated measures ANCOVA for the primary objective. The analyses will be done under the criterion of intention to treat and for protocol. The variables will be controlled by the compliance with the CPAP..


Eligibility Criteria:
Inclusion Criteria:

* Patients, both sexes from 18 to 75 years old, with clinical suspected of OSAH defined by an apnea-hypopnea index \> 15 and having a recent diagnosis of hypertension which have not received any pharmacological treatment for hypertension.

Exclusion Criteria:

Inclusion Criteria:

* Patients with clinical suspected of OSAH defined by an apnea-hypopnea index \> 15 and having a recent diagnosis of hypertension which have not received any pharmacological treatment for hypertension.

Exclusion Criteria:

* Severe excessive daytime sleepiness; professional drivers; pregnant women; alcohol consumption more than 100 gr. Ethanol per day; sedative medication; psychiatric illness; malignant or complicated hypertension; renal insufficiency; severe chronically ilness or malignant ilness; severe craniomandibular disease
Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care

A pilot randomized, controlled trial comparing Birthly, (an online platform for live group prenatal classes taught by childbirth educators, nurses, and lactation consultants) plus standard prenatal care versus standard prenatal care alone among women with high risk pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18
* Willing and stable to give consent
* English-speaking
* Have access to high-speed internet available on a computer or mobile device
* Nulliparous women have a confirmed single, live intrauterine gestation and are \<20 weeks gestational age at their prenatal visit
* Women without indications for a scheduled cesarean delivery at the time of their index prenatal visit
* Women who have a high-risk pregnancy, as defined by all maternal conditions including hypertension, diabetes, auto-immune disorders, seizure disorder, substance use, etc
* Agree to participation in Birthly
* Obtaining prenatal care in the University of Pennsylvania Health System

Exclusion Criteria:

* Women who do not speak at least conversational English
* Women without internet access
* Multiparous women
* Women receiving group prenatal care
A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica

The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare. It is a multicentric, multinational study. The protocol will seek to enroll a total of 30 patients, who will be randomized to the 3 arms at a ratio of 1:1:1.

Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the case of a disease flare.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following features:
* Patients ≥ 50 and ≤ 85 years
* C-reactive protein (CRP) \> 1.0 mg/dl OR erythrocyte sedimentation rate (ESR) \> 30 mm/hr
* New bilateral shoulder and/or hip pain
* Early morning stiffness ≥ 60 min
* Duration of illness \> 1 week
* A negative 5 U purified protein derivative skin test (PPD) skin test (≤ 5 mm induration) at screening

Exclusion Criteria:

* Active infection or current use of antibiotics
* Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatits B virus (HBV)
* Previous therapy with methotrexate or other immunosuppressive agents within three months prior to baseline
* History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix within five years prior to study entry
* Presence of rheumatoid arthritis or other inflammatory arthritic processes (features of Giant Cell Artertitis (GCA), spondyloarthropathies), connective tissue disease, drug-induced myopathies, endocrine disorders, neurological disorders, chronic pain syndromes, as assessed by base line screening including thyroid-stimulating hormone (TSH), creatine kinase (CK), rheumatoid factor (RF), cyclic citrullinated peptide (CCP), antinuclear antibodies (ANA), serum protein electrophoresis, urinalysis.

Other protocol-defined inclusion/exclusion criteria apply
Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.

The purpose of this study is to compare different combinations of cognitive training in retired professional football players and military veterans with a history of repeated concussions and persistent symptoms of impaired memory, concentration, attention, focus, or thinking.


Eligibility Criteria:
Inclusion Criteria:

* History of \>1 Mild TBI: post traumatic amnesia/confusion ≤ 24 hour immediately after injury; or loss of consciousness \<30 min confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF).
* Age 25-55 years
* Minimum of 4 months post-injury
* Adequate visual, auditory, sensory-motor function for training program.
* Fluent in English
* Persistent cognitive dysfunction confirmed by Ruff Neurobehavioral Inventory score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive).

Exclusion Criteria:

* History of hypoxic event
* Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders.
* Current illicit drug use or alcohol abuse
* Unwilling or unable (e.g. language barrier) to participate
* Hospitalization during study
* Current Litigation
* Positive on malingering test
* Use of medications to enhance cognitive function (e.g. Ritalin)
* Initial Glasgow Coma Score \< 13 or penetrating head injury
* Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale. Subjects with a score of 4 or 5 (as recommended by the FDA for treatment trials) will be excluded and referred for appropriate treatment.
* Subjects should not be enrolled in a concurrent TBI clinical trial.
Urdu Version of Northwick Park Neck Pain Questionnaire: Reliability and Validity Study

* To adapt culturally Neck Pain Questionnaire in Urdu language.
* To check the reliability of Urdu version of Neck Pain Questionnaire
* To validate Neck Pain Questionnaire by Neck Disability Index and Visual Analogue Scale and Numeric Pain Rating Scale.

The original English version of Northwick Park Neck Pain Questionnaire will be translated and culturally adapted as per previous recommendation. In patients with neck pain, Urdu Version of Northwick Park Neck Pain Questionnaire will be distributed among 70 participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test reliability of inter/intra observer of ultimate final Urdu Version of Northwick Park Neck Pain Questionnaire will be filled from patients on the equivalent day, by 2 different bystanders, and for inter observer valuation, with an interval of 30 minutes between the first and second application. Third assessment will be carried out after 7 days of the Observer -1, for intra-observer assessment. Data will be entered and analyzed Cronbach alpha value. Test-retest reliability will be assessed using an intraclass correlation coefficient. Urdu Version of Northwick Park Neck Pain Questionnaire will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

1. Both Male and Female
2. Minimum age is 18 years
3. Maximum age up to 60 years
4. People with Chronic neck pain
5. Duration of pain more then 3 months
6. No history of neck therapy
7. Not had any neck therapy

Exclusion Criteria:

1. People with medical history regarding skeleton issues
2. People with traumas
3. Having Neck surgery
4. People with neurological deficits ( like malignancies or inflammatory arthritis)
5. People went for therapy were also excluded.
6. People with age more than 60 and less than 18 were excluded..
Viral Excretion Among COVID-19 Omicron Recurrence Patients

The study analyzes the viral nucleic acid excretion and its influencing factors of SARS-COV-2 Omicron recurrence patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with nucleic acid detection N gene and ORF gene Ct value \< 40 after discharge from hospital
* Being able to provide basic information, living habits, vaccination information, admission information

Exclusion Criteria:

* Single gene target positive
* Patients with incomplete baseline data
Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients

The objective of this study is to obtain an additional 36 months of safety and effectiveness data from all subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014 clinical trial.

VIS-2014-5YR is a multicenter, observational study to evaluate the long-term safety of the VisAbility™ Micro Inserts in subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014 clinical trial. Study subjects will be examined at 36, 48, and 60 months post-operatively (based on the anniversary of their first VisAbility™ surgery) with no planned interventions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014

Exclusion Criteria:

* N/A
Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine

To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo for preventive treatment in Episodic Migraine patients


Eligibility Criteria:
Inclusion Criteria:

* Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition \[beta version\] criteria) or clinical judgment suggests a migraine diagnosis
* Patient fulfills the criteria for Episodic migraine in baseline information collected during the 28 day screening period
* Not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.
* Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.

Exclusion Criteria:

Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses

- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
Serum Magnesium and Vascular Calcification

Both Kidney transplantation (KT) and Chronic Kidney Disease (CKD) patients have reduced kidney function. Low serum magnesium is more prevalent in KT recipients. The present study examines the difference in vascular calcification between KT and CKD and its association with serum magnesium.

Kidney transplantation (KT) improved quality of life and longevity of CKD patients. Nevertheless, kidney function deteriorates overtime in a manner not different from CKD counterparts. Hypomagnesemia is prevalent in KT recipients secondary to immunosuppressive therapy. In addition to serum calcium, phosphate and elemental calcium intake, the relationship between low serum magnesium and vascular calcification (VC) has been observed in small studies in CKD. Whether low serum magnesium associates with VC in KT has never been elucidated. The present study compares vascular calcification between KT and CKD and its association with serum magnesium.

Eligibility Criteria:
Inclusion Criteria:

* kidney transplant recipients at least 1 year post surgery
* predialysis chronic kidney disease with serum creatinine \> 1.1 mg/dL in female and 1.3 mg/dL in male

Exclusion Criteria:

* acute kidney injury
* parathyroidectomy
Natural History Study - Mitochondrial Disease

Carriers of the m.3242A\>G mutation often have clinical symptoms which can include migraines, seizures, strokes, hearing loss, balance issues, gastrointestinal issues, and many other symptoms. The investigators would like to learn more about these disorders and have designed a "Natural History Study" to monitor these conditions over time so that physicians and scientists can not only understand the problems that patients have, but work on developing treatments. The focus of the current work is to evaluate known mutation carriers of the m.3243A\>G (mitochondrial DNA) and their maternal relatives (carrier status not a requirement for participation). Paternal relatives will serve as controls. This study involves no treatment.

The purpose of this study is to investigate the neurological and biochemical consequences of the m.3243 A\>G mutation. Mitochondria are the powerhouses of the cell and are controlled by nuclear genetic material (DNA) and mitochondrial (mt) DNA. Mitochondrial DNA mutations impair mitochondrial function, and cause cellular energy failure. These mutations, when present in high abundance, cause neurological signs and symptoms that are clinically obvious. The investigators hypothesize that these mutations, when present in lesser abundance, will cause measurable alterations in the patient's neuropsychological profile and cerebral energy profile. This study does not involve any experimental or approved therapy. The investigators will evaluate the patient's condition with blood/urine tests, neurological exam, MRI/MRS, questionnaires, motor skills functioning, serum and urine biomarkers, and genetic testing.

Eligibility Criteria:
Inclusion Criteria:

Known carrier of a the m.3243 A\>G mitochondrial mutation, ,or Maternally related to someone who carries the m.3243A\>G mitochondrial mutation.

A family member who is not maternally related to someone who carries the m.3243A\>G mitochondrial mutation

Exclusion Criteria:

* Younger than 4 years of age
* No confirmed m.3243 A\>G mitochondrial DNA mutation in the family.