cyrilzakka/clinical-trials huggingface dataset:
A Test of the Investigational SEM Scanner

The objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population.. In order to better understand the data this non-invasive scanner provides a collection of data/readings is required to be collected in a certain population. This will help with clinical interpretation of the numbers and readings this device will provide.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are 18 years of age or older.
* Subject or health care proxy is willing and able to provide informed consent for enrollment.
* Subject is agreeable to having skin assessments, blanchability tests, and SEM Scanner readings performed daily at all anatomical sites for a duration of five (5) days, with photography as needed.
* Subject is admitted to an intensive Care Unit (ICU) and has an anticipated ICU course of 48 hours or greater.
* Subject is not Comfort Measures Only (CMO).
* Subject is anticipated to be bedridden for ore than 6 hours per day.
* All four (4) of the subject's anatomical sites in question (sternum, sacrum, left heel and right heel) are accessible for scanning (e.g., no cast or medical device present such that heels are not accessible).

Exclusion Criteria:

* Subject has broken skin or scar tissue at the sternum, sacrum, left heel or right heel.
* Subjects for whom the physical act of performing the inspections and measurements required in this study are contra-indicated, as determined by the principal investigator or attending physician.
* Subjects or legal representatives who are unable to understand the aims and objectives of the trial.
* Presence of any condition(s) which seriously compromise(s) the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
* Subject is pregnant.
* Subject is incarcerated.
Added Value of Cone Beam CT Guidance to Electromagnetic Navigation Bronchoscopy for the Diagnosis of Pulmonary Nodule.

A monocentric prospective and randomized trial aiming to compare the diagnostic yield and safety of electromagnetical-guided bronchoscopy (ENB) procedures coupled to trans-bronchial lung cryobiopsies for the diagnosis of pulmonary nodule when performed either in a "standard" bronchoscopy suite or in a hybrid room with CBCT guidance and the use of the CrossCountry technique as required.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary nodule of maximum 30mm of largest diameter
* Nodules can be either solid or subsolid (including GGO) without evidence of loco-regional or distant metastasis that could be biopsied, and no evidence for an infectious underlying disease.
* A multidisciplinary discussion is performed for each case before considering its inclusion in the study in order to validate the indication of ENB-guided biopsy. Of note, any other endoscopic or trans-thoracic procedure should be tried before considering ENB if it could achieve the diagnosis according to the investigator's judgment.

Exclusion Criteria:

* Patient eligible for a direct surgical resection of the nodule
* Other exclusion criteria are a higher risk of bleeding (platelets count lower than 80,000/mm³, a systolic pulmonary arterial pressure (sPAP) higher than 45 mmHg at transthoracic ultrasonography, prothrombin time international normalized ratio - INR \>1.5, activated partial thromboplastin time - APTT \>35, uninterrupted anti-coagulant/anti-aggregant therapy), and the presence of any contraindication to general anesthesia as determined by the principal investigator (significant cardiac comorbidities, hypercapnia, severe hypoxia...).

No strict limits for inclusion were applied regarding diffusing capacity for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in 1 second (FEV1).
An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B

This study is an open-label, 2-Part (Single Ascending Dose \[Part 1\] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). EPI-003 is a liver-targeted antiviral therapeutic for intravenous (IV) injection that is capable of precise epigenetic modifications of the HBV genome without causing mutations in the gene sequence itself.


Eligibility Criteria:
Inclusion Criteria:

1. Be between 18 and 65 years of age, inclusive, at the time of signing the informed consent form;
2. Confirmed diagnosis of CHB;
3. Received a stable dose of NA therapy for ≥ 6 months prior to screening and plan to continue receiving the same dose for the duration of the study

Exclusion Criteria:

1. Confirmed diagnosis of liver cancer or cirrhosis;
2. Combination of other major diseases; 3 Pregnant or lactating females.
Performance of Next-X in Alveolar Ridge Preservation

The goal of this case series study is to evaluate the clinical and histological outcomes of a protocol for managing hopeless teeth, focusing on alveolar preservation and subsequent dental implant placement. The study will also assess the long-term success of prosthetic reconstruction. The main questions it aims to answer are:

* How effective is the use of biomaterials for alveolar preservation in maintaining bone structure and quality?
* What are the histological characteristics of the alveolar bone after biomaterial application?
* How successful are dental implants and prosthetic reconstructions in restored sites over a 1-year follow-up period?

Participants will:

1. Undergo extraction of hopeless teeth using an atraumatic protocol.
2. Receive alveolar preservation treatment with biomaterials immediately after extraction.
3. Provide a bone biopsy for histological processing before implant placement.
4. Undergo dental implant placement and prosthetic reconstruction of the lost tooth.
5. Attend follow-up appointments over a 1-year period for clinical and radiographic evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 80 years of age.
* Requirement for single-rooted tooth extraction due to reasons such as caries, fractures, restorative issues, endodontic complications (e.g., root fracture, instrument fracture), orthodontic needs, or prosthetic considerations.
* Presence of at least one neighboring tooth adjacent to the extraction site.
* Maintaining adequate oral hygiene, indicated by bleeding on probing \<20% and plaque index \<20%.
* Presence of at least 50% of the buccal bone plate.
* Classification of patients as ASA I or II status according to the American Society of Anesthesiologists Classification.

Exclusion Criteria:

* All smokers, including smoking alternatives.
* Heavy drinker (\> 60 g of alcohol per day as a mean).
* Uncontrolled metabolic disorders e.g., diabetes mellitus, osteomalacia, thyroid disorder, severe renal or hepatic disorder.
* Prolonged corticosteroid therapy.
* Immunological impairment diseases.
* History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
* General contraindications for dental and/or surgical treatment (including patients who take anticoagulants or antiresorptives).
* Disease or condition affecting bone metabolism.
* Women of child-bearing age, not using a highly effective method of birth control.
* Pregnancy or breast feeding.
* Previous and concurrent medication affecting sinus healing in general (e.g., topical steroids, large doses of anti-inflammatory drugs).
* Acute or chronic oral infection or uncontrolled periodontal disease.
* Crestal bone defects at the implantation site, which require additional bone augmentation around the neck of the implant.
* Allergy to collagen.
* Participation in an investigational device or drug clinical trial within the last six month.
Serum Clozapine and Cognition

This study aim to investigate the relationship between serum levels of clozapine and cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine monotherapy. The hypothesis is that higher serum levels of clozapine are associated with cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine are studied. The design is cross-sectional.


Eligibility Criteria:
Inclusion Criteria:

* Treated with clozapine for minimum 6 months.
* Fixed dosage of clozapine last month before inclusion.

Exclusion Criteria:

* Substance misuse.
* Depression (Calgary Depression score ≥7).
* Somatic disease that interfere with cognitive performance.
* Treatment with benzodiazepines (half-lives \>15 hours not allowed up 14 days prior inclusion and during study. Half-lives \< 15 hours not allowed 3 days prior cognitive testing).
* Electroconvulsive therapy.
* Treatment with other antipsychotics.
* Withdrawal of informed consent.
* Compulsory measures.
* Treatment with anticholinergics except for atropine drops administered sublingually.
* Changes in use of tobacco last month before inclusion.
Noninvasive Physiologic Sensors to Assess Depression

This project aims to use sensors to monitor physiological signals, sleep patterns, vocal characteristics, activity, location and phone usage in study patients with depression who are receiving standard treatment (compared with healthy controls).


Eligibility Criteria:
Inclusion Criteria:

Patients with Depression (n=40):

1. Adults (ages 18-75),
2. Able to read, understand, and provide written informed consent in English,
3. Meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks, according to the M.I.N.I (Mini International Neuropsychiatric Interview),
4. Hamilton Depression Rating Scale (HDRS) total score ≥ 18,
5. Engaged in or willing to be referred for clinical care for depression treatment as usual (antidepressants and/or psychotherapy),
6. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
7. Must own a working Android smartphone (Android 2.3+) and use it regularly,
8. Must own a windows PC (or tablet) or a Mac computer (or laptop),
9. Must have access to Internet service every day.

Healthy Controls (n=10):

1. Adults (ages 18-75),
2. Able to read, understand, and provide written informed consent in English,
3. Not meet criteria for past or current psychiatric illness, excluding specific phobias, as measured by the M.I.N.I.,
4. Not have a first-degree relative with known major psychiatric illness including Major Depressive Disorder, Bipolar Disorder, Psychotic Disorder or Substance Use Disorder,
5. Must have measurable skin conductance/electrodermal activity (as assessed at the screening visit),
6. Must own a working Android smartphone (Android 2.3+) and use it regularly,
7. Must own a windows PC (or tablet) or a Mac computer (or laptop),
8. Must have access to Internet service every day.

Exclusion Criteria (for all subjects):

1. Active drug or alcohol use disorder in the past 3 months,
2. History of psychosis,
3. History of mania or hypomania,
4. Epilepsy or history of seizures,
5. Untreated hypothyroidism,
6. Unstable medical disease,
7. Cognitive impairment that would impede adherence to study procedures,
8. Acute suicide or homicide risk,
9. Current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy,
10. Concurrent participation in other research studies,
11. Cannot comprehend or communicate in English,
12. Lack of working smartphone or lack of daily access to Internet service,
13. Inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and
14. Inability or unwilling to, at minimum, wear the physiological sensor (E4) bands, fill out the surveys, and record a weekly diary.
Colchicine for Acute Coronary Syndromes

Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the specified combined endpoint from 16% to 7-8% at a 2-years follow-up.

Multicenter, double-blind randomized trial to evaluate the efficacy of low dose colchicine (0.5mg once daily for 2 years) to reduce the incidence of subsequent overall mortality, new acute coronary syndromes, and ischemic stroke in patients admitted for an acute coronary syndrome.

Eligibility Criteria:
Inclusion Criteria:

* \>18years
* Acute coronary syndrome (unstable angina or acute myocardial infarction)
* Life expectancy\> 2 years
* Absence of contraindications to colchicine

Exclusion Criteria:

* Colchicine treatment for any cause
* Severe liver disease
* Renal insufficiency with creatinine\>150mmol/l or creatinine clearance\<30ml/min/1.73m2
* Known cancer
* Chronic inflammatory bowel disease
* treatment with cyclosporine
* allergy or hypersensitivity to colchicine
* pregnancy or lactating woman or woman with childbearing potential without valid contraception
Body Awareness Therapy for People With Stroke

Affected balance capacity is common after a stroke due to paresis and sensory disturbances. The affected balance capacity may cause walking disturbances, falls and decreased mobility. Balance may be improved by physical therapy. A possible method for balance training is body awareness therapy, that was introduced in Sweden by Jacques Dropsy and Gertrud Roxendal. Earlier body awareness therapy was mostly used in psychiatric care but in the recent years the method has been used for people with long-tern pain, amputations and multiple sclerosis. Body awareness therapy includes exercises in lying, sitting and standing. Focus of the exercises are awareness of one´s movement behaviour, breathing patterns, resources and limitations. Postural control is an essential part in the exercises. Body awareness therapy could be used for people with stroke as a way to improve postural control. The aim of this study is to investigate if balance training using body awareness therapy can improve balance and walking in people after stroke. The interventions consists of body awareness therapy once a week for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed stroke more than 6 months ago. Walking capacity of 100 meter with or without assistive device.

Exclusion Criteria:

* Medical or cognitive impairment that prohibits participating in the intervention.
A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects

This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject between 18 and 55 years of age, both inclusive,
* creatinine clearance ≥80 mL/minute (Cockcroft-Gault method).

Exclusion Criteria:

1. Clinically relevant pathology or any other systemic disorder/major surgeries that in the opinion of the investigator would confound the subject's participation and follow-up in the clinical study.
2. Drug or food allergy.
Bare Metal Stents and Drug Eluting Stents in Patients Who Underwent Blood Transfusion

Retrospective cohort study of Korean National Healthcare Insurance Database. To investigate clinical outcomes of bare metal stents versus drug eluting stents in patients who underwent periprocedural red blood cell transfusion.

A Korean nationwide, multi-center, retrospective observational cohort study.

The receipt of red blood cell transfusion is at high risk of cardiac events or death. But little is know regarding the comparative outcomes of BMS and DES implantation in patients who underwent periprocedural red blood cell transfusion.

Longitudinal data is collected from administrative claims in the national health insurance services of Korea. All Korean data(N=500,591) undergoing PCI from 2006 to 2015 is extracted. BMS or DES Patients(N=28,322) who received periprocedural red blood cell transfusion is investigate. Clinical outcomes until December 31, 2017 is investigate.

Primary endpoint is a time to the first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, or stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patients with percutaneous coronary intervention from 2006 to 2015
* Patients with the implantation of BMS or DES
* Patients with the receipt of periprocedural red blood cell transfusion

Exclusion Criteria:

* Patients without any of stent implantation
Deep Brain Stimulation Effects in Dystonia

Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. We aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. We will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming. We are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care.

The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series. The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series

Eligibility Criteria:
Inclusion Criteria:

* Patient gives an informed consent.
* Patient is over 18 years of age.
* Having a diagnosis of a primary dystonia confirmed by a trained movement disorders neurologist;
* Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;

Exclusion Criteria:

* Having alternative diagnoses to a primary dystonic syndrome;
* Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease);
* Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
* History of prior resectivebrain surgery (e.g. tumor resection);
* Not being a DBS candidate;
* Selection of alternative targets to conventional GPi;
* Receiving unilateral implants
* Having a higher surgical risk that precludes patient from having standard intraoperative mapping.
Exploring the Efficacy of Assistive Artificial Intelligence for Ultrasound Guided Regional Anesthesia in Residency Training

The purpose of this study is to investigate the efficacy of a novel artificial intelligence (AI) device designed to assist in Ultrasound guided regional anesthesia (ScanNav Anatomy Peripheral Nerve Block; ScanNav), in the teaching and training of anesthesiology residents in the subspecialty of regional anesthesia.

Ultrasound-guided regional anesthesia (UGRA) relies on the precise acquisition and interpretation of ultrasound images. The necessary skills to attain this is dependent on the knowledge of the underlying anatomy. Notwithstanding, even experienced anesthesiologists can find this challenging, especially in the setting of anatomical variation, obesity and other potential confounders. This study aims to clarify if The ScanNav, a novel artificial intelligence device designed to assist in UGRA, when utilized with trainees, improves their uptake and training. We also aim to see the relationships of how it enhances teaching and training of residents by experienced regional anesthesia providers.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include any anesthesia resident with no prior experience with UGRA.

Exclusion Criteria:

* Exclusion criteria include any anesthesia resident who has undergone the regional elective service prior to the inception of the study.
Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems

RATIONALE: Voriconazole and caspofungin acetate may control invasive fungal infections in patients who have weakened immune systems.

PURPOSE: This phase II trial is studying how well giving voriconazole together with caspofungin acetate works in treating invasive fungal infections in patients with weakened immune systems.

OBJECTIVES:

Primary

* Determine the 12-week complete and partial response rate in immunocompromised patients with invasive fungal infections treated with voriconazole and caspofungin acetate.

Secondary

* Determine the 12-week survival rate in patients treated with this regimen.
* Determine the safety of this regimen in these patients.

OUTLINE: Patients receive voriconazole orally or IV over 1 hour twice daily and caspofungin acetate IV over 1 hour once daily on days 1-84. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of probable or definite invasive fungal infection with 1 of the following organisms:

  * Aspergillus species
  * Fusarium species
  * Scedosporium species (Pseudallescheria boydii)
  * Other dematiaceous molds
* The following diagnosis are not allowed:

  * Zygomycetes (Mucor or Rhizopus species)
  * Chronic aspergillosis
  * Aspergilloma
  * Allergic bronchopulmonary aspergillosis
* Must be immunocompromised

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* At least 72 hours

Hematopoietic

* Not specified

Hepatic

* AST \< 5 times upper limit of normal (ULN)
* Bilirubin \< 5 times ULN
* Alkaline phosphatase \< 5 times ULN
* No Child-Pugh class C cirrhosis

Renal

* Creatinine clearance ≥ 50 mL/min

Pulmonary

* No mechanical ventilation

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No hypersensitivity to azoles, caspofungin acetate, or their components
* No history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* More than 14 days since prior therapeutic antifungal therapy of ≥ 1 week duration
* More than 14 days since prior and no concurrent administration of any of the following medications:

  * Terfenadine
  * Astemizole
  * Cisapride
  * Pimozide
  * Quinidine
  * Sirolimus
  * Rifampin
  * Carbamazepine
  * Long-acting barbiturates
  * Rifabutin
  * Ergot alkaloids (i.e., ergotamine and dihydroergotamine)