cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers

This study is to determine the effect of single and multiple oral doses of mifepristone on the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.

This is a fixed-sequence, drug-drug interaction study in healthy volunteers lasting up to a total of 9 weeks: up to 4 weeks screening, approximately 2 weeks for dosing (including a 1-week washout between periods), and approximately 3 weeks of a drug-free interval until termination. The purpose of this study is to determine the effect of single and multiple oral doses of CORLUX on the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy volunteers
* Body mass index (BMI) of 18-32 kg/m2
* Female subjects must have a negative serum pregnancy test result prior to entry into the study
* All female subjects must not be of child-bearing potential
* All male subjects with female partners of childbearing potential must consent to use a medically acceptable double-barrier method of contraception and not donate sperm throughout the study period and for at least 3 months (90 days) after the last dose of study medication
* The subject agrees to abstain from grapefruit or grapefruit juice for at least 2 weeks prior to the first dose and until completion of the pharmacokinetic sampling (Day 15)
* The subject must be able to provide written informed consent

Exclusion Criteria:

* Any acute or chronic disease state, including but not limited to cardiovascular, dermatological, endocrine, gastrointestinal, hepatic, pulmonary, and renal conditions determined to be clinically significant by the Investigator
* Any clinically significant abnormal clinical laboratory tests as determined by the Investigator
* Any concomitant medications (including prescription, over-the-counter or illicit) within either 30 days or five half-lives (whichever is shorter) prior to dosing
* Positive urine drug screen for any illicit drugs
* Use of tobacco or any nicotine-containing products during the previous three months
* Grapefruit juice within two weeks prior to first dose
* Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
* Signs and/or symptoms such as orthostatic hypotension, fatigue, anorexia, nausea, abdominal pain, joint and muscle pain if considered to be a marker of adrenal insufficiency
* History of an allergic reaction to mifepristone or fluvastatin
* Positive serum test for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus
* Blood donation within 30 days of dosing
FX Shoulder Prospective Clinical Study

Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.

To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices.

To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.

To provide data and analysis for presentations, abstracts, publications and other public release of results.

A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS):

* Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline Confidential FX Shoulder Post-Market Follow-Up Clinical Protocol Version 1.0 04 Aug 2022 9
* No continuous radiolucency or device migration/subsidence
* No revision surgery
* No serious device related adverse event

The Registry will continue to follow patients to 5 years post-operative to track survivorship.

Eligibility Criteria:
Inclusion Criteria:

Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.

Exclusion Criteria:

Patient who does not meet the inclusion criteria.
An Evaluation of the Pharmacokinetics and Safety of LIPO-102 in Healthy Volunteers

An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male and non pregnant female
* 18-55 years old
* Sufficient abdominal fat for injections
* Signed informed consent

Exclusion Criteria:

* Known hypersensitivity to study drugs
* Treatment with an investigational agent within 30 days before first dose
Treatment Efficacy of Leg Cycling as Part of Physiotherapy Treatment in Elderly Patients With Hip Fracture

This study aims to evaluate whether a combination of cycling training as part of physiotherapy treatment will contribute more than conventional physiotherapy treatment for elderly patients after hip fracture surgery in their subacute phase of rehabilitation.

Adults who have experienced a fall, followed by proximal hip fracture that required surgery, suffer from specific problems that interrupt the rehabilitation period in their subacute phase.

Various modes of treatment available as part of the physical rehabilitation but there is not enough data in the literature regarding the contribution of cycling training with leg cycle ergometer as part of conventional physiotherapy treatment in elderly patients after hip fracture surgery.

This study evaluates whether the additional cycling to physiotherapy treatment will improve the functional ability, the balance performance while standing, hip muscle strength and pain level in those patients.

Eligibility Criteria:
Inclusion Criteria:

* Proximal hip fracture with full or partial weight bearing indication.
* Surgical fixation ( nailing or total hip replacement or hemiarthroplasty)
* Pre-morbid function: walking independently or under supervision with or without assistance aid
* Cognitive function: Mini-mental state examination score above 21

Exclusion Criteria:

* Pathological hip fracture.
* Unstable heart or pulmonary disease.
* Presence of other fractures as a result of the current fall.
* Neurological comorbidities ( CVA, Parkinson, MS ).
* Entering the rehabilitation center more than three weeks after hip surgery
Comparison of Cervical Motion Restriction and Interface Pressure Between Two Cervical Collars

Cervical orthoses are used to restrict motion for the purpose of preventing spinal instability following trauma or pre- and post-surgery or to protect from pain. Modern cervical orthoses are able to effectively restrict motion of the head however load is concentrated on areas of occipital tissue and may, with long term wear, lead to tissue breakdown in the form of pressure ulcers. Previous research has shown that the Miami J collar (Össur Americas Foothill Ranch, CA) effectively reduced cervical movement while providing superior pressure relief. As new cervical orthoses are developed and become commercially available it is useful to examine their performance in comparison to existing well-tested devices. DJO Global (Vista, CA) have recently developed a cervical collar. The purpose of this study is to compare the ability of this newly developed collar to restrict cervical range of motion while at the same time limit the tissue interface pressure exerted by the collar on patients when they are in an upright seated or supine position Data will be collected in a fully equipped 3D motion analysis laboratory. Cervical range of motion will be tracked and analyzed. Interface pressures between the head and collar will be measured using custom pressure mats.


Eligibility Criteria:
Inclusion Criteria:

* English speaking.
* Subjects who have read and signed IRB approved informed consent for this study.

Exclusion Criteria:

* History of neck pain or neck injury requiring medical care within the previous 12 months.
* History of spinal surgery, physical or chiropractic therapy of the neck.
* History of cervical spondylosis or osteoporosis.
* Pregnant.
* Currently Incarcerated
Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m

To study whether oxygen therapy titrated to maintain oxygenation (SpO2) \> 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.

Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL

The purpose of this study is to determine the safety and recommended Phase 2 dose (RP2D) of JNJ-67856633 and ibrutinib in combination in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

Non-Hodgkin lymphoma (NHL) represents the most frequent hematologic malignancy in the world and represents a diverse set of diseases. JNJ-67856633-ZAF (referred as JNJ-67856633) is an orally bioavailable, potent, and selective first-in-class mucosa-associated lymphoid tissue lymphoma translocation protein-1 (MALT1) inhibitor. JNJ-67856633 binds to an allosteric site on MALT1 with a mixed-type mechanism. Ibrutinib is a first-in-class, orally administered, potent, orally administered covalently binding small-molecule inhibitor of Bruton's tyrosine kinase (BTK), as well as interleukin-2-inducible kinase (ITK), a tyrosine protein (Tec) kinase family member present in T cells. The doses will be escalated in the study and one or more recommended Phase 2 dose (RP2Ds) of JNJ-67856633 will be determined. The study is divided into 3 periods: a screening phase, a treatment phase, and a post-treatment follow-up phase. Efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy etc. Safety assessment like physical examination, vital signs, electrocardiogram (ECG), eastern cooperative oncology group (ECOG) performance status, and adverse events monitoring will be performed during the study. Total duration of the study will be up to 2 years and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
* Cardiac parameters within the specified range
* Women of childbearing potential must agree to all of the following during the study and for 3 months after the last dose of study drug: a) use a barrier method of contraception; b) use a highly effective contraceptive methods; c) not to donate eggs (ova, oocytes) or freeze them for future use for the purposes of assisted reproduction during the study; d) not to plan to become pregnant; e) not to breast-feed
* Willing and able to adhere to the lifestyle restrictions specified in this protocol
* Participants must have tumor tissue availability
* Adequate organ functions

Exclusion Criteria:

* Known (active) Central Nervous System (CNS) involvement
* Prior treatment with JNJ-67856633 or another MALT1 inhibitor that is associated with disease progression or intolerable toxicities
Management of Parapneumonic Pleurisy Guided by an Early Pleural Ultrasound

Parapneumonic pleurisies are a frequent complication of pneumopathies, but therapeutic management is poorly codified. Only the indication of thoracic drainage has benefited from expert recommendations. However, we find in the literature the major importance of early management of infectious pleurisy in order to minimize the sequelae. Pleural ultrasound, sensitive and specific in this pathology could bring us a real interest in terms of diagnostic speed and therefore of care. This study therefore seeks to show that pleural ultrasound can have a major interest in improving the management of patients with parapneumonic pleurisy, by reducing the number of medical treatment failures.

This is a prospective, multicentre, non-randomized study evaluating routine care, which includes all patients hospitalized in the departments participating in the study, for pneumonia with or without pleurisy. Patients benefiting from a daily pleural ultrasound for 96 hours, D1 being the day of hospitalization. The therapeutic course of action will depend on the presence or not, and on the type of pleural effusion according to a pre-established algorithm. In case of pleural effusion of type 1, the type of treatment will be left to the appreciation of the clinician (puncture or drainage), in case of pleural effusion of type 2, 3 or 4 the patient benefited from pleural drainage.

Patients included in the study will benefit from a pleural ultrasound on the day of their hospitalization, up to 96 hours after treatment. Ultrasound will then allow us to look for the presence of pleural effusion. In the event of effusion corresponding to a parapneumonic effusion or purulent pleurisy, the conduct to be followed will be defined according to the ultrasound type of effusion. Types 1 will benefit from an evacuating pleural puncture or drainage, depending on the clinician's judgment. Types 2, 3, and 4 will benefit from weeping drainage.

the target population: adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture in the departments participating in the study over the period concerned The main outcome measure is the failure of medical treatment, defined as the need to resort to surgery, with or without peeling, or death secondary to pleurisy. The secondary endpoint is the presence of radiological sequelae at 3 months and 6 months defined by a retraction of the hemithorax concerned with pachypleuritis or an ascent of the diaphragmatic dome or the persistence of pleurisy

Eligibility Criteria:
Inclusion Criteria:

* adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture.
* Patients affiliated to social security

Exclusion Criteria:

* patients with transudative pleurisy,
* patients with exudative pleurisy in the context of pulmonary neoplasia or tuberculosis,
* patients with pneumonectomy compartment infections,
* Patient under guardianship or curatorship,
* Subjects under 18 years of age,
* Pregnant women,
* patients in emergency situations
Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study

The objective of this study is to collect intravascular and extravascular echocardiogram (ECG) data from subjects receiving peripherally inserted central catheters (PICC) while using the Vascular Positioning System G4 and a 12 lead ECG machine. The data obtained will be used to update the G4 algorithm.

This study seeks to collect synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure. A copy of the data will be downloaded from the G4 and ECG machines and submitted to the sponsor. Both the G4 and the ECG machine used for data collection in this study are FDA cleared/approved.

Study Design: This is a single center prospective clinical study. All enrolled subjects will receive a 12-lead ECG during PICC insertion and a chest x-ray post insertion. ECG lead will be documented via photographic imaging.

Duration of Subject Study Participation: Each subject's participation will start at the time of signing the informed consent and terminate upon completion of the x-ray.

Eligibility Criteria:
Inclusion Criteria:

* Male

  * 21 years of age or older
  * Scheduled for PICC insertion using the VPS G4 system
  * Willing to allow thoracic photos to be obtained after ECG lead placement

Exclusion Criteria:

* Female

  * ˂ 21 years of age
  * Patient has a pacemaker
  * Patient condition precluding ECG use and lead placement
  * Patient condition precluding radiographic imaging
  * Unwilling to allow thoracic photos to be obtained after ECG lead placement
Oral Iron Supplementation for Patients With Chronic Kidney Disease

The hypothesis of this research is that oral iron prescribed in a single dose in alternate day could mitigate the side effects with regard to intestinal microbiota, inflammation, oxidative stress and improve the hematological profile when compared to daily oral iron prescription

chronic kidney disease triggers several changes in the body, anemia is one of the first disorders that appear in chronic kidney disease patients. The anemia in this patient is multifactorial, the main cause being relative erythropoietin deficiency, although iron deficiency is also common. In this context, the need for oral iron supplementation is a way of both treating iron deficiency and optimizing the use of agents that stimulate erythropoiesis. However, this replacement can cause iron overload, increasing the production of reactive oxygen species and, consequently, oxidative stress, and also alter the intestinal microbiota leading to poor iron absorption, worsening the prognosis of chronic kidney disease. The current routine for iron supplementation for these patients is to offer oral iron daily, which can be more harmful than when given on alternate days. However, there are few studies comparing the two prescriptions.

In this context, since no study to date has been carried out to show the aforementioned effects in the participant with chronic kidney disease, this randomized clinical trial aims to assess the effects of daily or alternate-day oral iron supplementation on gut microbiota composition in participants with chronic kidney disease (glomerular filtration rate (GFR) below 30 mL/min) for 3 months. The project will also compare the effects of both prescriptions on serum hepcidin levels, markers of oxidative stress and inflammation, and on routine hematological and biochemical parameters.

Eligibility Criteria:
Inclusion Criteria:

Aged 18 to 75 years Clinical diagnosis of Chronic Kidney Disease Conservative treatment group: chronic kidney disease stages 3 and 5

Exclusion Criteria:

* Patients pregnant
* Smokers
* Using antibiotics in the last 3 months
* Autoimmune diseases
* Clinical diagnosis of infectious diseases
* Clinical diagnosis of Cancer
* Clinical diagnosis of AIDS
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.

This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients currently receiving CNI treatment will be randomized into one of 2 groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or 2) CellCept 2.0g/day po bid + \>=75% reduction of CNI from baseline. The anticipated time on study treatment is 1 year, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* single organ recipients of liver allograft;
* CNI-based immunosuppressive regimen prior to study entry and regimen adjustment;
* \>=6 months post-transplant, with renal dysfunction (serum creatinine 140-300micromol/L at entry);
* negative pregnancy test for women of childbearing potential; contraception must be taken before beginning study drug therapy and until 6 weeks after last dose of study medication.

Exclusion Criteria:

* treatment with CellCept or any other product which delivers mycophenolic acid within the 3 months prior to the recent switch to CellCept relevant for enrollment;
* known contraindications to CNI, corticosteroids or CellCept.
Registry of IgA Nephropathy in Chinese Children

This study tries to identify the safe and effective treatment option for IgA nephropathy in children. Investigators will perform prospective registration study among 25 pediatric nephrology medical centers in China.

A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide, according to the following protocol.

1. Establishment of registration database online.
2. Participants will be enrolled according to the inclusion criteria and exclusion criteria.
3. The following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up.
4. SPSS software (version 14.0; SPSS, Inc., Chicago, IL, USA) will be used for statistical analysis. P value less than 0.05 will be considered significant.

Eligibility Criteria:
In-patients will be enrolled with the following criteria.

Inclusion Criteria:

* Clinical diagnosis of primary IgA nephropathy.
* Presenting with nephrotic proteinuria, defined as 24-hour urinary protein\>50mg/kg, or UPC\>2.0 mg/mg.
* Informed consent must be signed.

Exclusion Criteria:

* Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis B virus associated nephritis, etc.
The Effectiveness of Virtual Reality Training Program

Alzheimer's disease is the most common type of dementia, accounting for 50% of all cases. Advanced age is a significant risk factor for AD. Virtual Reality (VR) is an interactive video game technology that provides computer-generated environments that include physical activity and provide users with experiences similar to those in the real world. VR technology can be used for rehabilitation purposes in individuals with various orthopedic and neurological disorders due to its ability to enhance motor, cognitive learning and neural plasticity (1,2). The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community.

The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community. Prospective Randomized Controlled Single Blind Study After the patients and their relatives are informed in detail before the study, they will be asked whether they want to participate in the study and the individuals or relatives of the patients who approve of participating in the study will be asked to sign the informed consent form. Individuals who meet the inclusion criteria will be randomly divided into three groups by a single researcher: Virtual reality training program, cognitive exercise with traditional balance exercises, and traditional balance exercises only.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 55 years and older Diagnosed with AD according to DSM-IV diagnostic criteria by a neurologist, MOCA ≥ 16 Clinical Dementia Rating Scale \< 2

Exclusion Criteria:

* Various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.) Clinically significant aphasia (must be able to understand the therapist's commands) Significant visual or sensory impairment