cyrilzakka/clinical-trials huggingface dataset:
Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years

The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.


Eligibility Criteria:
Key Inclusion Criteria:

* Currently receiving a TDF and FTC or 3TC-containing 'backbone' (maximum 2 NRTIs) regimen plus a third agent for ≥ 6 consecutive months prior to screening visit. For individuals with 3 or more ART regimens, a regimen history must be provided for approval by the Sponsor.

Refer to assigned interventions for allowed third agents of the current regimen.

* Documented plasma HIV-1 RNA levels \< 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay). In the preceding 6 months prior to screening, one episode of "blip" (HIV-1 RNA \> 50 and \< 400 copies/mL) is acceptable, only if HIV-1 RNA is \< 50 copies/mL immediately before and after the "blip".
* Plasma HIV-1 RNA level \< 50 copies/mL at screening visit
* Adequate renal function
* Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula (eGFRCG) and are on ARVs that are appropriately dose adjusted for renal function per package insert
* All documented historical plasma genotype(s) must not show resistance to TDF or FTC, including, but not limited to the presence of reverse transcriptase resistance mutations K65R, K70E, M184V/I, or thymidine analog-associated mutations (TAMs) that include M41L, L210W, D67N, K70R, T215Y/F, K219Q/E/N/R. If historical plasma prior to first ART is not available or individual has 3 or more ART regimens, individuals will have proviral genotype analysis prior to Day 1 to confirm absence of archived resistance to TDF or FTC.
* Study performed dual energy x-ray absorptiometry (DXA) scan and T-score received prior to Day 1

Key Exclusion Criteria:

* Previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time) if the current regimen contains a PI/r
* Individuals will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV)
* A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4+ cell count and/or percentage criteria)
* Hepatitis C virus that would require therapy during the study
* Individuals receiving ongoing treatment for bone disease (eg, osteoporosis), including bisphosphonates, denosumab, and strontium ranelate

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Assessment Of Carotid Flow During General Anesthesia

Proper identification of patients who would benefit from fluid infusion (fluid responsiveness) is one of the most crucial challenges in anaesthesia and critical care. Reliability of several invasive measurements used for this purpose for many years have been questioned recently. The study will evaluate consistency between carotid artery flow derivatives and standard haemodynamic measurement (LIDCO rapid) in navigation of intraoperative fluid therapy.


Eligibility Criteria:
Inclusion Criteria:

* Major abdominal surgery
* Artery catheter required

Exclusion Criteria:

* Laparoscopic surgery
* Known history of carotid endarterectomy
* Known history of carotid stenosis
* Non-sinus rhythm
* Systolic or diastolic heart failure
* Chronic kidney disease
* Pulmonary hypertension
* Carotid artery anomaly
* Unable to visualise carotid artery
* Angle of correction \> 60
Videofluoroscopic of Deglutition Study of the Initiation of Pharyngeal Phase in Young Adults

This study has as objective to characterize the start of pharyngeal phase of swallowing, in the various food consistencies and volumes, with and without the influence of verbal orders, observed on videofluoroscopy of deglutition.

Quantitative study, transverse and observational study, in the period January to March 2010, in the Center Advanced Diagnosis and Treatment Trajan Almeida, in the city of Fortaleza, Ceará. The sample was composed by 40 individuals, with mean age 23.5 years, 35 (87.5 %) female and five (12.5%) male gender. was carried out an assessment videofluoroscopy swallowing in net consistencies (15 ml of water added to 15 ml of barium net), liquid paste (25ml of barium net), paste (two spoons of 5ml of thickening for 30ml of barium net) and solid (1/2 cracker waffer immersed the barium net), where the individuals remained seated and the images were carried out in the lateral position. From the beginning of the rapid movement of hyoid bone, verified the beginning of pharyngeal phase of swallowing in each consistency.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with ages ranging between 20 and 30 years
* Without complaint of deglutition
* Not submitted to surgeries and/or other treatments in the region of head and neck, with the exception of dental equipment.

Exclusion Criteria:

* Individuals submitted to cardiac surgeries, chest and/or abdominal prior
* Patients with diabetes mellitus and/or neurological diseases beyond craniofacial abnormalities.
Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children with Cerebral Palsy

Cerebral palsy (CP) is currently one of the major causes of disability in children. The presence of various disorders (muscle stiffness, architectural bone defects, spasticity) leads to a number of functional impacts, including severe impairment of mobility, particularly locomotion. Locomotion can be assessed using a motion capture system that enables 3-dimensional analysis, in order to help make treatment decisions and quantify them. Although these systems are currently considered to be the gold standard, the fact remains that they cause a certain amount of patient fatigue (long set-up times) and that walking is assessed in a laboratory rather than in real life.

Today, technological advances have brought to the fore other gait analysis devices, such as inertial measurement units (IMUs). Various systems incorporating IMUs in the feet, for example, respond to these problems of analysing walking in real-life situations. The IMUs record the movements and orientation of the foot in space; the data is then processed by algorithms to recognise walking steps and calculate the spatio-temporal parameters of locomotion. Additional IMUs positioned on the body can be grafted onto this system to provide a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. However, before such devices can be used in a pathological paediatric population, they must be validated in a healthy population. This validation must be conducted using a precise method that has been widely documented in the COSMIN recommendations (Consensus-based Standards for the selection of health Measurement Instruments). The first stage will assess the safety of the IMU devices in a healthy paediatric population, and the validity of the spatio-temporal parameters. If these properties are deemed to be compliant, these same parameters will be assessed in a paediatric population with cerebral palsy in the second stage.


Eligibility Criteria:
Inclusion Criteria:

* Children who have given their consent and whose legal representatives have given their consent
* Age between 7 and 17 years,
* Children able to understand simple commands and instructions.
* Children living within a maximum radius of 50 km of the investigation site.
* Child covered by national health insurance.

PATIENT GROUP (IN ADDITION TO THOSE ABOVE)

* Children with proven cerebral palsy resulting in locomotor impairment but able to move around without technical aids (cane, wheelchair).
* Child covered by national health insurance.

Exclusion Criteria:

* Children with a condition other than cerebral palsy that affects their ability to walk.
* Child subject to a measure of legal protection
* A child unable to give consent
* Pregnant, parturient or breast-feeding participant
Effects of Exercise on Patients With Hemiparetic Stroke

This randomized trial investigates the hypothesis that regular aerobic exercise training using a task specific gait training modality will improve cardiovascular fitness, functional mobility, and reduce risk factors for recurrent cardiovascular events in chronic hemiparetic stroke patients, when compared to matched controls performing just stretching.

The aims are to determine whether 6 months progressive graded treadmill training: 1) improves cardiovascular fitness levels and reduces the excessive energy demands of hemiparetic gait, as defined by oxygen consumption levels based on open circuit spirometry during peak and submaximal exercise ambulation tasks; 2) increases free living physical activity measured by portable kinematic recording devices and quantitative in vivo determination of energy expenditure using stable isotopes; and, 3) improves the cardiovascular-metabolic risk factor profile including measures of key endogenous fibrinolysis regulatory enzymes \[plasma tissue plasminogen activator (t-PA) and its main circulating inhibitor (PAI-1)\], fasting lipoprotein lipid profiles, blood pressure, and oral glucose tolerance and insulin responses. Measurements of body composition at baseline and after training will further determine the effects of aerobic exercise training on muscle mass and central obesity.

Eligibility Criteria:
Males or Females Ages 40 yrs to 80 yrs who are chronic hemiparetic stroke patients.
A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping

Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek with optional comparison to VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.


Eligibility Criteria:
Inclusion Criteria:

* The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted
* Subject has been diagnosed with melanoma, rhabdomyosarcoma, or other tumor where tumor resection or biopsy is planned and lymph node mapping is appropriate
* The subject is clinically node negative (cN0) at the time of screening
* Age \< 18 years
* Male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study
* Female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study

Exclusion Criteria:

* The subject has had preoperative radiation therapy
* Has had previous surgery or radiation to node basins that would be involved in the intraoperative lymph node mapping (ILM) procedure
* Has a known allergy to dextran or VBD (if intended to be used)
* Has a history of alcohol abuse or alcohol dependency in the 3 years before study entry, or is an alcoholic or drug addict, as determined by the investigator
* Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer

This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve \[AUC\]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Female participants, \>/= 18 years of age
* Metastatic breast cancer
* Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease
* Treatment-naïve for metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate hematological, renal and liver function
* Patients should have received Anthracyclines and Taxanes in the adjuvant setting
* Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products

Exclusion Criteria:

* Prior first line treatment for metastatic breast cancer
* Central nervous system (CNS) metastasis
* Uncontrolled hypertension (\> 170/95 mmHg)
* Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
* Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented \>6 months after the last exposure to the drug(s)
* Requirement of chronic use of immunosuppressive agents
* HIV, hepatitis B or hepatitis C infection
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)

Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH.

A past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. One of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight.

This is an extension study, which means people who took part in MK-7962-024 (LIGHTRAY) may be able to join this study. In this extension study, people will get weight-banded doses of sotatercept. The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION)
* Has not started treatment with commercially available sotatercept

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

- Has prior exposure to luspatercept and/or is planning to begin treatment with luspatercept while enrolled in the study
10 Year Follow up of RCT Comparing Different Regenerative Regenerative Procedures

Evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects.

This 10-year follow-up of a randomized controlled clinical trial (Cortellini \& Tonetti 2011) compares three treatment modalities in deep intrabony defects: i) a control group was treated with modified minimally invasive surgical technique alone (M-MIST, N=15); ii) a second group was treated with M-MIST combined with enamel matrix derivative (M-MIST EMD, N=15, Straumann, Switzerland); iii) a third group was treated with M-MIST+EMD plus Bone Mineral Derived Xenograph (M-MIST+EMD+BMDX, N=15, Geistlich, Switzerland) . The design of the original trial has been reported along with the one-year results and the details of randomization and allocation concealment (Cortellini \& Tonetti 2011). Clinical outcomes of the three groups were longitudinally followed for 10 years. The 10-year follow-up was approved by the local ethical committee for clinical research of the Health Service of Tuscany (University Hospital of Firenze protocol ATRO2019, registration n° 15106_oss). All patients gave informed consent to participate into the clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with periodontitis
* Presence of one intrabony defect not extending into furcation
* Good general health
* Adequate plaque control

Exclusion Criteria:

* Furcation involvement in the experimental tooth
* Inadequate control of periodontitis
Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.

Interest in tricuspid valve disease has grown exponentially over the past few years, in response to increased interest in the poor prognosis of patients with functional tricuspid regurgitation (TR). Tricuspid valve repair (TVR) using a prosthetic ring represents the first option in many centers worldwide, due to the low incidence of residual and recurrent TR and improved survival compared to suture techniques. The goal of ring annuloplasty is to restore the normal geometry of the annulus, thereby improving the coaptation of the leaflets and preventing further dilatation of the annulus. Recently, the three-dimensional geometry of the tricuspid valve has been shown and analyzed by means of data obtained from echocardiography, CT scan and magnetic resonance imaging. Normal tricuspid annulus is characterized by a more prominent part in the anteroseptal commissure area near the aortic valve and right ventricular outflow tract and a deeper part in the posteroseptal commissure area near the coronary sinus ostium . Based on these characteristics, new three-dimensional rings have been developed for tricuspid annuloplasty, such as the MC3 (Edwards Lifescience, Irvine, CA) and the Contour 3D (Medtronic, Minneapolis, MN).

There are few studies concerning the short-term results of tricuspid rings implantation and almost none on the long-term, therefore this study aims to analyze the long-term results of TVR by implantation of the two new prosthetic ring models mentioned above.

The aim of this study is the long-term analysis of the results of tricuspid annuloplasty with three-dimensional rings in patients with functional IT.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Operated for functional TR
* Implantation of three-dimensional tricuspid prosthetic ring MC3 or Contour 3D, isolated or concomitant to surgery on the left heart sections
* Surgical access in median sternotomy or minithoracotomy

Exclusion Criteria:

- emergency/urgency intervention
Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment

The study compares standard surgery for retinal detachment (RD) (vitrectomy, cryotherapy and gas) with a surgical variation that replaces the intraocular gas tamponade with suprachoroidal injection of viscoelastic underneath the break that caused the retinal detachment.

After being informed about the study and the potential risks, the eligible patients who have given written consent to the treatment will be randomized into treatment (vitrectomy, cryo and gas) or control (viscobuckle vitrectomy) group.

Eligibility Criteria:
Inclusion Criteria:

Patients requiring pars plana vitrectomy for the treatment of primary rhegmatogenous retinal detachment (RD) caused by a single break, or multiple breaks within one clock hour. The final determination of qualifying breaks is made at the time of surgery following 360-degree, internal, indented search using a wide-angle viewing system.

Exclusion Criteria:

* Hypersensitivity to hyaluronate or. HEALON5® PRO OVD
* Participation in another interventional study within 8 weeks of enrolment or planned to occur during this study.
* Bleeding disorders or the use of anticoagulants (such as warfarin, rivaroxaban) or dual anti-platelet drugs such as aspirin with clopidogrel. Monotherapy with low dose (≤100 mg) aspirin is permitted, and if clinically appropriate this should be stopped prior to surgery and recommenced only after satisfactory day 1 post-operative review.
* Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial.
* Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol, such as dementia, mental illness, or serious systemic medical disease.

Study eye:

* Presence of proliferative vitreoretinopathy (PVR) or any tractional RD
* Previous vitreoretinal surgery, open-globe injury or endophthalmitis
* Aphakia
* Previous or current congenital cataract
* Previous or current suprachoroidal haemorrhage
* Congenital or acquired ocular, orbital or periocular abnormality that, in the opinion of the attending vitreoretinal surgeon, would preclude the safe delivery of Healon 5 into the suprachoroidal space (detail the specific reason for exclusion in the source documents)
* Presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to prevent an accurate assessment of retinal attachment
* Current intraocular inflammation other than mild cellular activity thought to be secondary to RD
* Current ocular or periocular infection other than blepharitis
Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female inpatient or outpatients, ages 18-65

Exclusion Criteria:

* Participation in a clinical trial of another drug including olanzapine or aripiprazole within 30 days prior to study entry (visit 1).
* Treatment with clozapine within the past 12 months.
* Have known uncorrected narrow-angle glaucoma.
* Have a diagnosis of Parkinson's disease, dementia or related disorder