cyrilzakka/clinical-trials huggingface dataset:
Interaction With HIV Antiretroviral Agents

To investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure to riociguat in HIV patients on a stable dose of one of these therapies.

• To Assess the safety and tolerability of riociguat treatment in combination with these fixed-dose antiretroviral therapies.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged \>=18 to \<65 years with a confirmed diagnosis of HIV receiving a stable regimen of ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir in combination with (preferably) TRIUMEQ consistent with the most recent prescribing information documents for at least 6 weeks before concomitant administration of a single oral dose of 0.5 mg riociguat
* No clinical evidence of pulmonary hypertension
* Written informed consent

Exclusion Criteria:

* Severe diseases for which it can be assumed that the pharmacokinetics or effects of the study drug will not be normal
* History of coronary artery disease
* Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
* History of bronchial asthma or any other airway disease
* Renal impairment with creatinine clearance \<15 mL/min
* Severe hepatic impairment (Child-Pugh class C)
* Systolic blood pressure below 100 mmHg
Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours

An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours

Eligibility Criteria:
Inclusion Criteria:

* Adult hemodialysis patients ≥18 years of age.
* Signed informed consent to participate in the study.
* Stable on hemodialysis prescription for ≥3 months.
* Able to sustain hemodialysis 3x/week for 3 to 4 hours.
* Hemoglobin concentration \>9.5 g/dL.
* Serum TSAT ≥20%.
* Receiving hemodialysis via AV fistula or graft.
* Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.
* Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.
* Serum TIBC ≥ 150 µg/dL.

Exclusion Criteria:

* Active bleeding disorder (GI, skin, nasal...)
* Receiving hemodialysis via catheter.
* Receiving IV iron within 10 days of the first on-study hemodialysis treatment.
* Receiving oral iron within 10 days of the first on-study hemodialysis treatment.
* Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.
Surveillance Study of Viral Infections Following Lung Transplantation

The present study was conducted to study the impact community acquired respiratory virus (CARV) infections in an outpatient setting on graft function of lung transplant recipients. The study was aimed to identify risk factors for CARV infections.

The study was further intended to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.

Informed consent was obtained from the LTx recipients and the study was approved of by the institutional review board of Hannover medical school.

LTx recipients are screened for CARV infections during the cold season (end October until end April) in a single-centre outpatient clinic. Symptoms of upper (URTI) and lower respiratory tract infections (URTI) are recorded by questionnaires and findings.

Nasopharyngeal and oropharyngeal swabs (NOS) were performed to detect RV-antigens by immunofluorescence testing (IFT) of respiratory-syncytial virus (RSV), adenovirus, parainfluenza (PIV), influenza and cultures for CARV are performed. BAL was performed when clinically indicated and processed by IFT. Multiplex-PCR to detect 14 CARV are processed in symptomatic patients.

In addition blood samples are monitored at each contact to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.

Eligibility Criteria:
Inclusion Criteria:

* adults 18-70 years
* lung transplantation (including single, double, combination and re-do transplants)

Exclusion Criteria:

* refused consent
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).

A randomized prospective study of patients with HC-BPPV. Patients with apogeotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the Gufoni maneuver, head-shaking maneuver, and sham group in apogeotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning maneuver immediately after each treatment method based on resolves of vertigo and positional nystagmus.

Eligibility Criteria:
Inclusion Criteria:

* a history of brief episodes of positional vertigo,
* direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) or undermost (geotropic nystagmus) ear in both the lateral head turning positions,
* no spontaneous nystagmus during upright sitting position, and
* absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus.

Exclusion Criteria:

* central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus
Anti-psychotic Medication (Stable Dose) Weight Loss Study

This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight change and changes in body composition in subjects who have been taking a stable dose of certain anti-psychotic medications for longer than three months.

A total of 80 subjects will be enrolled in this study: 20 subjects will be randomized to receive placebo, and 60 will be randomized to receive the investigational product (20 who are on a stable dose of Seroquel, 20 who are on a stable dose of Risperdal, and 20 who are on a stable dose of Zyprexa). The investigational product or placebo will be taken 15 minutes prior to the three main meals of the day. Subjects will continue to take their prescribed anti-psychotic medications. Participation in this study involves four study visits.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 18 and older
* Agree to keep diet, exercise and all current health habits stable during participation in the study
* Currently on a stable dose of Risperdal (Risperidone), Seroquel (Quetiapine) and/or Zyprexa (Olanzapine) for at least three months

Exclusion Criteria:

* Current active acute psychotic episode
* Women who are pregnant, breastfeeding, or planning to become pregnant
* Prior bariatric surgery
* Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
* Obesity as a result of a clinically-diagnosed endocrine problem
Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment

A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.

Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with BP1.3656 to reduce alcohol consumption. The study will be a multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups to evaluate the effectiveness and the safety of BP1.3656.

Eligibility Criteria:
Inclusion Criteria:

* Male or female alcohol use disorder
* Ages 18-65
* Absent or minimal alcohol withdrawal symptoms assessed
* 18 kg/m2 ≤ BMI ≤ 35 kg/m2
* Excessive alcohol use during the 2 weeks between screening and baseline
* Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC\<0.05).

Exclusion Criteria:

* History of delirium tremens, epilepsy, or withdrawal seizures
* Clinical depression or suicidality: Beck Depression Inventory (BDI) ≥ 16 and suicidality (Item G ≠ 0)
* Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids
* Clinically significant cardiovascular, hematologic, severe hepatic impairment
* History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse
* Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox
* Receiving ongoing alcohol use disorder medication (e.g. Baclofen)
Evaluation of Patients With Knee Osteoarthritis Receiving a Prosthesis

Patients with osteoarthritis of the knee undergo visible joint changes in radiology and Magnetic resonance imaging (MRI) tests, but also clinically and histologically. The area of greatest change is at the subchondral/cartilage bone junction.

Investigators will determine the association between preoperative clinical evaluation (IKDC and Womac scores), radiological classifications and histopathology.

In addition, the role of inflammation in the pathogenesis of osteoarthritis is being given major interest, and inflammation is closely linked with vascularization. It was recently demonstrated that dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) could identify the subchondral bone marrow vascularization changes occurring in osteoarthritis in animals.

These changes appeared before cartilage lesions were visible and were correlated with osteoarthritis severity. Thus the opportunity to obtain an objective assessment of bone vascularization in non-invasive conditions in humans might help better understanding osteoarthritis pathophysiology and finding new biomarkers. Investigators hypothesized that, as in animals, DCE-MRI has the ability to identify subchondral bone marrow vascularization changes in human osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with knee osteoarthritis, classified Kellgren-Lawrence 3 or 4, with asymmetric femorotibial joint space narrowing
* Patients requiring a total knee prosthesis

Exclusion Criteria:

* Patients with a known progressive inflammatory pathology (rheumatoid arthritis,...).
* Patients with previous surgery of the knee
* Contra-indication for magnetic resonance imaging, chronic renal failure (creatinine clearance \< 30 ml/min), contrast media allergy, orthopaedic hardware around the knee. Patients in whom motion artifacts impaired image analysis will be excluded.
Effects of Colloid and Crystalloid on the Microcirculatory Alterations During Off-pump Coronary Artery Bypass Surgery

The purpose of this study is to compare the effects of crystalloid and colloid, which are used for pump priming solution, on the microcirculatory alterations during cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Off-pump Coronary Artery Bypass Surgery

Exclusion Criteria:

* Infection
* Postoperative use of steroid
* Liver cirrhosis, Child-Pugh C
* Renal disease on hemodialysis
* Patients who cannot receive vascular occlusion test (severe peripheral vascular disease, arteriovenous fistula, burn)
* EF \< 40% on the preoperative echocardiography
* Preoperative use of vasopressors or inotropic agents
Elacytarabine Mass Balance Study in Healthy Volunteers

This study is performed to measure the quantity of i.v. applied elacytarabine that leave the body, by which route and how fast.

This is a single centre, open-label, non-randomised single dose study in healthy male subjects. Each subject will receive a single 15 min IV administration of 14C labelled elacytarabine.

In this study, at least 6 subjects will be dosed in order to obtain data in 4 evaluable subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males 2. Age 50 to 65 years of age 4. Must be willing and able to communicate and participate in the whole study 5. Must provide written informed consent 6. Must agree to use an adequate method of contraception

Exclusion Criteria:

1. Participation in a clinical research study within the previous 3 months
2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
3. Subjects who have previously been enrolled in this study or in any other elacytarabine study
4. History of any drug or alcohol abuse in the past 2 years

7. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study 8. Subjects who do not have suitable veins for multiple venepunctures and IV administration as assessed by the investigator at screening 9. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator 10. Positive drugs of abuse test result 11. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results 12. History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator 13. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients 14. Presence or history of allergy requiring treatment. Hayfever is allowed unless it is active 15. Donation or loss of greater than 400 mL of blood within the previous 3 months 16. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration 17. Failure to satisfy the investigator of fitness to participate for any other reason
Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.

The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects. Secondary objectives of study are as follows: To estimate the PK parameters of single-ascending SC doses of HC022 in healthy subjects；To evaluate the immunogenicity of HC022 administered to healthy subjects.

This is a first-in-human study of HC022 to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single HC022 doses in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and comply with study requirements;
2. Aged 18 to 55 years old, inclusive, male or female;
3. 3.A body weigh ≥ 50 kg for male , and a body weigh ≥ 45 kg for female, and must have a body mass index between 19 and 28 kilogram per square meter (kg/m2)；
4. Be in good health as based on medical history, physical examination, vital signs, laboratory tests, chest radiographs, abdominal ultrasound and 12-lead ECG；
5. All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months (for female) or 3 months (for male) after their dose of study treatment；

Exclusion Criteria:

1. Have participated in other clinical trials within 3 months, or within the 5 half lives of the investigational drug prior to screening, whichever is longer;
2. History of or positive test results at screening for the following: for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCV Ab), hepatitis B virus (defined as positive for HBsAg or HBcAb or HBeAg)；
3. History of or current diagnosis of active tuberculosis (TB), or untreated latent TB infection (LTBI) at screening；
4. History of severe herpes infection or zoster viral infection；
5. Serious infection, serious injuries, or major surgical procedures within 6 months prior to Screening；
6. History of alcohol or substance abuse, a positive urine drug or alcohol test at Day -1；
7. History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by any component of the study drug；
8. Any disease or conditons that are not suitable for participation in this study as determined by the Investigator；
Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis

The goal of this clinical trial is to determine the clinical impact of restoring the anatomic-tension relationship of the long head of the biceps (LHB) when performing a biceps tenotomy and tenodesis. The main question it aims to answer is whether anatomic tensioning will improve functional outcome scores and decrease postoperative complications. The investigators hypothesize that through a standardized method of anatomically tensioning the LHB tendon during tenodesis, patient outcomes will improve. Researchers will compare these outcomes to a control group receiving the traditional tensioning technique. Participants will be randomized to either the anatomic tensioning treatment group or the traditional tensioning control group.

The long head of the biceps can be a source of anterior shoulder pain that is primarily due to inflammation or instability of the long head of the biceps (LHB) tendon . Patients that fail non-operative management become candidates for biceps tenotomy and tenodesis. Currently, there is no universal protocol or gold standard for how the LHB tendon is tensioned. At the investigators' institution, the LHB is tensioned based on individual surgeon feel for the correct tensioning. The purpose of this study is to conduct a randomized, single-blinded prospective study comparing patients with the current regimen of bicep tensioning vs. utilizing a standardized method of anatomically tensioning the LHB tendon. The primary aim of assessing change in the American Shoulder and Elbow Surgeon (ASES) scores from baseline to post-surgery between the control and intervention groups will be assessed using a student's t-test. In addition, longitudinal mixed effects models will be used to estimate changes in ASES scores, over all time-points using a random effect for surgeon. Other relevant patient characteristics such as age, sex, and Charlson score will be included to explore the adjusted relationship of the intervention and outcomes over time. A secondary aim of this study is to collect specific measurements of the myotendinous junction of the LHB tendon to potentially establish if any characteristics predispose patients to developing pathology of the LHB tendon.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age undergoing arthroscopic shoulder surgery
* Operations that occur at Loyola University Medical Center (Maywood, IL), Loyola Ambulatory Surgery Center (Maywood, IL), or Gottlieb Memorial Hospital

Exclusion Criteria:

* Previous shoulder surgery involving the long head of the biceps tendon
* Younger than 18 years old
* Current pregnancy. As per standard protocol with all surgeries, a urine pregnancy test is performed prior to surgery. If positive, the surgery will be cancelled and the patient will be excluded from the research study.
Evaluation of Effectiveness and Safety of PROMUS Element Stent (IRIS-ELEMENT )

This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.

The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex™ Dilatation Catheter technology, designed to enhance deliverability to complex lesions.

Currently, there have been limited data regarding comparison of PROMUS Element stent with first-generation DES in routine clinical practice. Therefore, we perform large-scale real-world registry of PROMUS Element stents.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving Promus Element stents
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Patients with a mixture of other DESs
* Terminal illness with life expectancy \<1 year
* Patients with cardiogenic shock
Impact of Pumps on Internal Thoracic Arteries (IPITA)

Cardiopulmonary bypass (CPB) induces a systemic inflammatory response and affects the organ vascular bed. Experimentally, the lack of pulsatility alters myogenic tone of resistance arteries and increases the parietal inflammatory response. The purpose of this study was to compare the vascular reactivity and the inflammatory response of the internal thoracic arteries (ITAs) between patients undergoing coronary artery bypass grafting (CABG) under CPB with a roller pump or with a centrifugal pump.

Eighty elective male patients undergoing CABG were selected using one or two internal thoracic arteries under CPB with a roller pump (RP group) or centrifugal pump (CFP group). ITA samples were collected before starting CPB (Time 1) and before the last coronary anastomosis during aortic cross clamping (Time 2). Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.

Eligibility Criteria:
Inclusion Criteria:

* male patients and elective coronary artery bypass grafting using at least one of the two ITAs.

Exclusion Criteria:

* female patients because their complement activation has been shown to be greater than that in men during surgery under cardiopulmonary bypass ; age \< 18 years; CABG requiring additional valve repair or replacement; emergency surgery and insufficient length of the internal thoracic artery