cyrilzakka/clinical-trials huggingface dataset:
ProMRI Study of the Entovis Pacemaker System

The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.


Eligibility Criteria:
Inclusion Criteria:

The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:

* Age greater than 18 years
* Subject body height greater than 140 cm (4' 7")
* Able and willing to complete MRI testing
* Able to provide written informed consent
* Available for follow-up visit at the study site
* Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or abandoned leads in the subject.)
* Pacemaker implanted pectorally
* All pacemaker system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
* Underling rhythm identifiable during sensing test
* All pacing thresholds are measureable and are less than or equal to 2.0 V @0.4 ms
* Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
* Pacing impedance is between 200 and 1500 ohm
* Able and willing to use the Cardio Messenger

At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:

* Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
* \|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline\| ≤ 0.5 V
* All pacing thresholds are measureable and are ≤ 2.0 V @ 0.4 ms
* The pacemaker system has been implanted for at least 6 weeks.
* Subject did not have a pacemaker or lead explant, exchange or reposition in the previous 6 weeks.
* All lead impedances are between 200 and 1500 ohm.
* Battery status is at least 30% of capacity

Exclusion Criteria:

* Enrolled in any other clinical study
* For pacemaker systems that include an atrial lead, subjects with either

  * Persistent atrial arrhythmia (lasting longer than 7 days or requiring cardioversion)
  * Permanent atrial arrhythmia
* Life expectancy of less than three months
* Pregnancy
* Cardiac surgery expected in the next three months
* Implanted with other medical devices that may interact with MRI, such as:

  * abandoned pacemaker/ICD leads
  * lead extensions
  * mechanical valves
  * other active medical devices
  * non-MRI compatible devices
  * other metallic artifacts/components in body that may interact with MRI
Mandibular Furcation III Regeneration (FURC-III-REGEN)

Teeth with furcation grade III defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 20 years
* Subject must have periodontal disease as determined by the World Workshop 2017 criteria
* Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD \>4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
* Competent to give consent

Exclusion Criteria:

The following must not be present at the time of enrolment;

* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
* Present or past use of bisphosphonate treatment
* Pregnant or nursing subjects
* Patients classified as \> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
* Previous surgical therapy of included furcation defects
* Inability to comprehend and respond to the quality of life questionnaire
* Dental restorations or prosthesis involving the furcation area
* Root fractures or suspected infractions
* Caries lesions in the furcation area
* No systemic antibiotic treatment within 3 months prior to intervention
A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients

Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the occurrence of AIDS-related conditions in HIV-infected patients.

Secondary: To compare the frequency and severity of adverse experiences in the three regimens. To compare the mortality rates in the three regimens. To compare the effects of antiretroviral regimens on CD4+ cell levels.

Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.

Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.

Approximately 1200 patients are randomized in a 2:1:1:2 ratio to one of the following four treatment arms: AZT plus ddI, AZT plus ddI placebo, AZT plus ddC placebo, and AZT plus ddC. Average follow-up is 2 years.

Eligibility Criteria:
Inclusion Criteria

Required:

* Documented HIV infection OR working diagnosis of HIV OR evidence of idiopathic suppression with an AIDS-defining opportunistic infection or malignancy (except Kaposi's sarcoma).
* CD4+ cell count = or \< 200/mm3 or = or \< 15 percent of total lymphocyte count within previous 90 days OR history of AIDS-defining opportunistic infection.
* Current PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Symptoms of pancreatitis or peripheral neuropathy of grade 2 or worse.
* Requirement for acute therapy for any active AIDS-defining opportunistic infection or systemic chemotherapy for malignancy.
* Stage 2 or worse (moderate) AIDS Dementia Complex.
* Other disorders or conditions for which the study drugs are contraindicated or that may prevent adequate compliance with study therapy.

Concurrent Medication:

Excluded:

* Acute therapy for active AIDS-defining opportunistic infection.
* Systemic chemotherapy for malignancy.
* Antiretroviral therapy other than that provided by this study.

Patients with the following prior conditions are excluded:

* History of pancreatitis or peripheral neuropathy of grade 2 or worse.
* History of intolerance to the study drugs at entry doses and/or frequencies.
* History of phenylketonuria.
Biomarkers for Tuberous Sclerosis Complex (BioTuScCom)

International, multicenter, observational, longitudinal study to identify biomarker/s for Tuberous Sclerosis Complex and to explore the clinical robustness, specificity, and long´-term variability of these biomarker/s

Tuberous Sclerosis Complex (TSC) is an autosomal dominant genetic disorder characterized by the growth of numerous tumors in different body parts related to dysregulation of the mechanistic target of rapamycin (mTOR) pathway. The overall incidence of TSC is estimated to be as high as 1 in 6000 to 10,000 live birth.The main aspects of TSC that influence the quality of life are associated with the brain: seizures, evelopmental delay, intellectual disability, and autism. However, the incidence and severity of the various aspects of TSC can vary widely.

TSC is generally caused by pathogenic variants in the tumor suppressor genes: TSC1 and TSC2. Confirmation of a clinical diagnosis of tuberous sclerosis is performed via TSC1 and TSC2 sequencing.

There is no cure for TSC, therefore symptomatic therapy is the best possible choice, including mTOR inhibitors, vigabatrin and other antiepileptic drugs for the seizures, and neurosurgery in cases of life-threatening neurological symptoms.

The aim of the study is established TSC specific biomarker/s. Such biomarkers aim to facilitate the diagnosis, treatment personalization and monitoring.

Eligibility Criteria:
INCLUSION CRITERIA

* Informed consent is obtained from the participant or from the parent / legal guardian
* Participant is aged between 2 and 50 years
* Diagnosis of TSC is genetically confirmed by CENTOGENE

EXCLUSION CRITERIA

* Inability to provide informed consent
* Participant is younger than 2 or older than 50 years
* Diagnosis of TSC is not genetically confirmed by CENTOGENE
Interactive Study to Increase Glaucoma Adherence to Treatment

Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma treatment compliance (e.g., medication-taking and refill compliance, return for clinical follow-up) and more positive eye health outcomes at 12-month follow-up than participants who receive the control group intervention.

The intervention is telephone-based and individually-tailored to participants' compliance knowledge, attitudes, and behaviors; psychosocial predictors of compliance; health literacy; race and culture; and prescribed medication regimen. The intervention calls utilize interactive voice recognition technology to facilitate interest, participation, and interaction with call recipients. We evaluated the intervention in a randomized controlled trial with telephone interviews administered to all participants at baseline, 6, 9, and 12-months

Eligibility Criteria:
Inclusion Criteria:

* Receive treatment at the Atlanta VA Medical Center or Grady Eye clinic for their eye condition
* Be between the ages of 18-80
* Be Caucasian or African American
* Possess a telephone (home telephone or cellular phone)
* Speak and understand English
* Be diagnosed with open angle glaucoma, be glaucoma suspect, or be ocular hypertensive for at least one year
* Be prescribed daily doses of topical treatments for at least one year
* Be able to read or have someone who can help the participant with reading written materials that we give to the participant

Exclusion Criteria:

* Having eye surgery within 3 months of baseline interview and enrollment
* Being legally blind (20/200 or worse)
Proprioception Testing in Persons With Sensorimotor Impairment

In this study, an FDA-cleared device and type of treatment called "AMES," which stands for Assisted Movement with Enhanced Sensation, will be used to determine whether sensation in the upper limb of individuals with incomplete spinal cord injuries, acquired brain injury, or stroke improves along with movement through treatment. We hypothesize that measureable improvement in the sensation of the upper limb will precede improvement in functional movement.

The AMES device performs tests of sensorimotor impairment as well as delivering therapy. In this study, we are testing 2 additional diagnostic tests (i.e., Joint Position Test and "Frisbee" Test), both of proprioception, in order to determine which of the two is the best test of proprioception. Our hypotheses are: (1) both sensation and movement recover with AMES treatment, (2) sensory recovery precedes that of movement, (3) robotic delivery of the Joint Position Test produces more reliable test results than does manual delivery of this test, and (4) the Frisbee Test results will parallel those of the Joint Position Test.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic incomplete SCI, stroke or acquired brain injured ABI subjects.
* Able to tolerate sitting upright at for at least 1 hour.
* Significant, but not complete, motor deficit in the hand and wrist, as determined by the Study Physician performing the screening.
* Significant, but not complete somatosensory deficit in the hand and wrist as determined by the Study Physician performing the screening.
* Cognitively and behaviorally capable of complying with the regimen.

Exclusion Criteria:

* Fracture of the treated limb resulting in loss of range of motion.
* Progressive neurodegenerative disorder.
* DVT of the treated extremity.
* Uncontrolled seizure disorder.
* Uncontrolled high blood pressure/angina.
* Osteo- or rheumatoid arthritis limiting range of motion
* Contractures equal to or greater than 50% of the normal ROM.
* Chronic ITB therapy.
* Peripheral nerve injury of the treated extremity.
* Pain in affected limb or exercise intolerance.
* Participation in another therapy or activity-based program.
* Skin condition not tolerant of device.
A Prospective Study of Pattern of Chronic Use of NSAIDS in Patients Admitted to Emergency Department in Alexandria Main University Hospital.

The goal of this observational study is to assess the pattern of chronic use of nonsteroidal anti inflammatory drugs in patients admitted to emergency department in Alexandria Main University Hospital. The main question it aims to answer is:

What is the prevalence of chronic use of nonsteroidal anti inflammatory drugs among patients admitted to emergency department in Alexandria Main University Hospital?

This is a prospective cross sectional study of pattern of chronic use of NSAIDS in patients admitted to emergency department in Alexandria Main University Hospital.

Three well trained emergency clinical pharmacists will start medication reconciliation process on admission by interviews with the patients or their care givers.

The study aims to assess the pattern of chronic use of NSAIDS and evaluate the patients' knowledge about doses, duration and adverse events and other use precautions .Finally to provide counseling service regarding NSAIDS medical information to patients admitted to emergency department in Alexandria Main University Hospital.

Eligibility Criteria:
Inclusion Criteria: all adults equal or more than 18 years -

Exclusion Criteria:Patients who cannot communicate or have no family members.

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Clear Vision Study

Vitreous floaters are tiny, cloudy, clumps of cells that appear in the otherwise clear fluid (vitreous) that fills the back 3/4 of the eye. Floaters are commonly caused by eye conditions such as posterior vitreous detachment (PVD), vitreous syneresis and asteroid hyalosis. While these symptoms are considered physiological in nature, they can be of considerable inconvenience to many patients which affect essential activities. The investigators wish to assess the safety and efficacy of floater treatment in patients with highly symptomatic floaters using an FDA approved nanosecond infrared yttrium aluminum garnet (YAG) lasers.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with symptomatic floaters lasting more than 2 months
* Willing to proceed with intervention
* Be able to provide informed consent
* Diagnosed with Posterior Vitreous Detachment
* Accept a 1% risk of complications

Exclusion Criteria:

* Less than 19 years of age
* Is a high myope (greater than -6 diopters)
* Has monocular vision
* Diagnosed with asteroid hyalosis
* Diagnosed with acute on-set of floaters (less than two months and may clear spontaneously)
* Has corneal or lenticular opacities or any media opacity which may interfere with treatment
* Has any concomitant ocular disease or pathology
* Has elevated intraocular pressure (IOP) or on IOP lowering medication
* Has floaters that are deemed to require more than five treatment sessions, where surgical intervention is the best treatment course
* Has floaters inaccessible with current lasers and lenses
* Has floaters located less than 2mm from the crystalline lens or the retina
* Found to have retinal tears or retinal detachment on initial examination or has had a history of retinal detachment repair within the last two years
* Has psychiatric problems that may recur or worsen
* Incapacity to provide informed consent
Clinical Evaluation of Bacitracin

The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.

Thin-layer Rapid Use Epicutaneous Test (T.R.U.E. Test®) is a ready-to-use patch test method designed for diagnosis of allergic contact dermatitis.

The standard panel consists of two tape strips, panel 1, with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. T.R.U.E. TestTM panels 1 and 2 contain 23 of the most frequent contact allergens. With the 23 allergens the test currently consists of, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in T.R.U.E.Test in order to detect more contact allergic reactions. Bacitracin is one of these allergens, and the purpose of this study is to determine a concentration for the patch by using a bacitracin dilution series.

Eligibility Criteria:
Inclusion Criteria:

* Positive bacitracin patch test within the latest 5 years.
* Age greater than or equal to 18 years.
* Signed informed consent.

Exclusion Criteria:

* Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
* Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
* Treatment with ultraviolet (UV)-light during the latest 3 weeks.
* Widespread active dermatitis or dermatitis on test area.
* Breast-feeding or pregnancy. Females of childbearing potential must demonstrate a negative pregnancy test before inclusion in the study.
* Subjects not able to cooperate.
Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure

In addition to the blood pressure lowering effects of aliskiren, it may have beneficial effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue level. An increase of angiotensin II is associated with progression of heart failure. Although the use of ACE-inhibitors in heart failure shows clinical benefit, an increase in angiotensin II due to an angiotensin II "escape" phenomenon is not desirable. It is not yet known if a direct renin inhibitor can reduce or even prevent the angiotensin II escape phenomenon associated with the use of an ACE-inhibitor. Therefore the study tested the effects of ramipril, aliskiren and the combination of both on levels of angiotensin II in the blood in patients with systolic heart failure


Eligibility Criteria:
Inclusion Criteria:

* Decompensated systolic heart failure, left ventricular ejection fraction ≤40%
* Brain natriuretic peptide (BNP) level ≥ 100 pg/mL

Exclusion criteria:

* Use of Angiotensin Converting Enzyme(ACE) or Angiotensin Receptor Blocker (ARB) inhibitor treatment following the run-in period or requirement of both treatments
* Acute heart failure secondary to acute myocardial infarction, acute coronary syndrome or new tachyarrhythmia
* Occurrence of unstable angina or myocardial infarction within 12 weeks prior to screening
* History of cardiomyopathy such as postpartum, restrictive, infective, hypertrophic obstructive
* History of right heart failure due to pulmonary disease
* History of untreated second or third degree atrioventricular heart block

Other protocol-defined inclusion/exclusion criteria applied
WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories

The aim is to develop a wearable-based ICU (intensive care unit) prediction algorithm for inpatients contracted with SARS-CoV-2. Inpatients with suspicion of COVID-19 or with confirmed SARS-CoV-2 infection will be included. The participants will be equipped with a smartwatch, which gathers physiological data throughout hospitalisation.

The SARS-CoV-2 pandemic puts an unprecedented burden on the healthcare system, specifically its healthcare providers and the resource demands for intensive care units (ICUs). To support effective care despite large case numbers, hospital operations urgently need improved decision support in early identification of patients at risk of an acute COVID-19 deterioration that requires ICU.

The investigators aim at developing a wearable-based ICU algorithm for inpatients contracted with SARS-CoV-2. Inpatients on the general ward with suspicion of COVID-19 or with confirmed SARS-CoV-2 infection will be included. The participant will be equipped with a smartwatch and wear the device throughout the hospital stay until the patient (1) is discharged home, (2) is transferred to the ICU, or (3) palliative care is initiated. The smartwatch collects several physiological parameters (e.g. heart rate, heart rate variability, respiration rate, oxygen saturation). The collected data will be used to develop an ICU prediction algorithm to detect patients at risk of an acute COVID-19 deterioration that requires ICU.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* Age \>= 18 years
* Suspicion of COVID-19 or patient tested positive for SARS-CoV-2
* Hospitalisation on the general ward

Exclusion Criteria:

* Smartwatch cannot be attached around the wrist of the patient
* Direct transfer from the emergency department or external institution to ICU (i.e. no hospitalization on the general ward)
* Known allergies to components of the smartwatch
* Rejection of ICU transfer in the patient decree
Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients

The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).

This study aims to investigate the physical changes in patients undergoing pulmonary endarterectomy (PET). It will observe alterations in physical performance, lung function, and muscle strength during the postoperative period. This study, observational and prospective, will include individuals aged ≥18 scheduled, evaluating them preoperatively, post-intensive care unit discharge, before hospital discharge and after six months . Assessments involve tests like the Six-minute walk test, Short Physical Performance Battery, One-minute sit-to-stand test, manovacuometry, dynamometry, spirometry and Clinical Frailty Scale to identify frailty and measure muscle and lung function. The study also aims to explore predictive variables for functional loss during hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Both genders
* Elective pulmonary endarterectomy surgery
* Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.

Exclusion Criteria:

* Reoperation for any reason
* Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.