cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Remote Measures and Assessments in Deep Brain Stimulation for Parkinson's Disease (FoRMA-DBS)

This is an observational pilot study to assess the feasibility of remote functional assessments of gait, balance, and functional mobility via a telemedicine platform enabled via the Abbott Infinity devices. The clinical care of the participant will not be changed based on the remote functional assessments.

This is a single-center, non-randomized pilot observational study to explore the feasibility and tolerability of remotely assessing gait speed, functional mobility and balance measures in patients with Parkinson's disease experiencing medication-refractory tremor, motor complications and/or dyskinesias undergoing initiation of deep brain stimulation therapy. This study explores the feasibility of remotely performing and collecting functional assessments of gait, balance and mobility in the setting of programming deep brain stimulation (DBS).

Ten participants who are deemed surgical candidates for receiving DBS for Parkinson's disease under standard of clinical care processes (neuropsychological testing, neurology consultation and neurosurgery consultation) and have opted for the Abbott DBS system will be enrolled in the study and undergo the pre-surgical and post-surgical visits. A pre-operative in-clinic visit will take place approximately 28 days (day -42) prior to surgical DBS electrode lead implantation. An at-home assessment will take place within 14 days (day -28) of this baseline visit, still prior to surgical DBS electrode lead implantation. Participants will receive care as usual including their first post-operative clinic visit for initial programming (day 28), just like standard of care for DBS patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with with Parkinson's disease, as confirmed by the treating investigator, providing written consent to the clinical study
* Participants have been determined by the treating investigator as candidates for DBS
* Participants who have opted to have DBS with the remote-programming capable platform
* Have internet connection at home or wherever participants will be receiving care remotely and be able to participate in telemedicine visits and remote programming

Exclusion Criteria:

* Has already had prior surgical lesioning or deep brain stimulation therapy
* Meets criteria for Parkinson's disease dementia in the opinion of the treating investigator
* Does not have capacity for consent as judged by the treating investigator
* Scores less than 24 on the Montreal Cognitive Assessment (MoCA) at standard of care DBS screening, indicating, at least, mild cognitive impairment
Fibromyalgia and Sleep Disorder Treatment

This longitudinal study will investigate impact of improved sleep quality on chronic pain, fibromyalgia and how the disrupted sleep pattern alters the neuroenvironment.

The main aim of this study is to evaluate the interaction between pain and sleep, both directly by comparing outcome measures of pain and sleep, and out of one inflammatory perspective using proteomics analyzes. Currently, there is a need for studies that highlight both the above-mentioned interaction and how the inflammatory response in the central nervous system as well as in the systemic circulation is involved. The cohort in existing study (FINE study) is already being used to find associations between these, but as it is a cross-sectional study, the design cannot determinate the causality. The implementation of a longitudinal study where sleep is the single parameter that is modified would add an invaluable scientific basis for the assessment of this complex interplay. Because FINE study also has measurements of both systemic as central immunoactivity, the scientific value becomes very high, and can potentially be helpfull in understanding what happens to pain when sleep is affected, and which immune mediators that are relevant in that dynamic. If it turns out that the treatment of sleep disorders is effective from a pain perspective, it would in addition bring a whole new line of treatment options in fibromyalgia, and emphasize the importance of implementation a proper sleep analysis in the investigation phase for this patient group.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia according to 1990 and 2016 ACR (American College of Rheumatology criteria)
* Included in FINE study
* Sleep disorder

Exclusion Criteria:

* Other autoimmune or neuroinflammatory diseases than FM.
* Other dominating pain conditions other than FM (e.g., severe pain due to osteoarthritis, disc herniations etc).
* Severe somatic or psychiatric diseases that would preclude participation or influence results (e.g., cancer, infectious diseases etc).
* Pregnancy.
* Inability to speak and understand Swedish.
* Treatment with anticoagulants.
* High intracranial pressure.
* Ongoing infections.
* Hemophilia.
Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

The objectives of this study are:

* To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
* To compare the goblet cell count following application between the intranasal and extranasal applications
* To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications

In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:

* Active intranasal device application
* Active extranasal device application

Eligibility Criteria:
Inclusion Criteria:

* Bilateral dry eyes
* Capable of providing written informed consent

Exclusion Criteria:

* Chronic or recurring epistaxis (nosebleeds)
* Blood coagulation disorder
* Uncontrolled or poorly controlled diabetes
* Heart or pulmonary disease
* Females who are pregnant, planning a pregnancy or nursing
Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpful in detecting this pain in ICU patients. Remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage.

The purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (BIS) variations during bronchoalveolar lavage.

It is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients.

The hypothesis is that BIS can study analgesia in sedated patient.

Eligibility Criteria:
Inclusion Criteria:

* Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion Criteria:

* Pace maker
* Neurologic illness
* Hemodynamic instability
* Hypothermia
Assessing the Precision of Convolutional Neural Networks for Dental Age Estimation From Panoramic Radiographs

The aim of this study is to assess the accuracy of a convolutional neural network in dental age estimation from digital panoramic radiographs. The reference standard will be the chronological age of the patient.

Willems method is a dental age estimation technique modiﬁed from Demirjian method by creating new tables from which a maturity score is directly expressed in years.

Panoramic radiographs of all participants will be taken with their informed consent, then they will be numbered and coded. Chronological age for each participant will be calculated by subtracting date of birth from date of radiograph and the real age will be blinded from the researcher (The chronological age is the ground truth). All panoramic radiographs will be examined twice by the main author to determine the dental age according to Willems method.

The seven mandibular left teeth excluding the third molar will be scored as '0' for absence of calcification, and 'A' to 'H', depending on the stage of calcification. Each letter corresponds to a score which is the dental age fraction using tables for boys and girls. Summing the scores for the seven left mandibular teeth directly will result in the estimated dental age. The dental radiologist estimation accurancy will be compared to the ground truth (first index test).

The second index test which will also be compared to the ground truth is the CNN model. To prepare the dataset for the CNN model, a rigorous preprocessing procedure will be followed. This will involve resizing the images to the desired dimensions, segmenting the teeth parts to be included in the image, and applying data augmentation techniques to enhance the quality and quantity of the dataset. The dataset will then be split into training and testing sets using a 20:80 ratio, which will be carefully selected based on the expected number of samples. Also the accuracy of the model will be assessed compared to the ground truth (the chronological ages).

Eligibility Criteria:
Inclusion Criteria:

* Presence of all mandibular left permanent teeth (except third molars)
* Clearly visible root development
* No systemic disease
* No history of root canal therapy or extraction
* No related diseases affecting mandibular development such as cysts or tumors.

Exclusion Criteria:

* Patients with premature birth
* Facial asymmetry
* Congenital anomalies
* History of trauma or surgery in dentofacial region
Cocaine Effects in Humans: Physiology and Behavior - 1

The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users.


Eligibility Criteria:
Please contact site for information.
A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
* Previous treatment with an anthracycline and a taxane in any setting
* Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months

Exclusion Criteria:

* History of inflammatory carcinoma if there is no other measurable disease
* More than 2 chemotherapy agents in the advanced disease setting
* Brain metastases
Vaginal Cuff Closure in Robotic Hysterectomy

The purpose of this study is to evaluate the impact of implementing different types of suturing materials and techniques of vaginal cuff closure in robotic assisted laparoscopic hysterectomy on cost, operative time and post operative surgical outcomes.

Robotic assisted laparoscopic surgery is the fastest growing new modality in gynecologic surgery. Surgeons are adapting it to perform both benign and oncologic gynecologic procedures. Therefore, the fastest growing robotic procedure in the united states is hysterectomy.

The literature in laparoscopic hysterectomy, both robotic and non-robotic, reports a complication of vaginal closure disruption after hysterectomy higher than with abdominal surgery. Reasons hypothesized for this phenomenon include colpotomy (vaginal incision) technique, vaginal closure technique, and types of suture. At present, no further follow up studies have been done to test some of these hypothesis. In light of the rapid adoption of this approach to hysterectomy, more data on this issue will help the physician in counseling patients regarding complications, as well as helping surgeons choose materials and techniques in their hysterectomies which will diminish the chance for this unfortunate complication, which causes pain, hospitalization and excess morbidity after the original surgery.

Additionally, a parallel development of newer suturing materials, the so-called "barbed" self-anchoring sutures, typically fabricated from monofilament materials, have been reported used in laparoscopic hysterectomies in case series. The relative contribution of theses newer materials to the rates of cuff disruption is unknown.

The protocol proposes testing the null hypothesis that different suture materials and methods of closure do not cause a significant difference in the rates of vaginal cuff disruption after robotic assisted laparoscopic total hysterectomy.

Study design is a prospective randomized controlled trial. Patients will be blindly randomized to one of the 3 closure techniques using 3 different materials. Technique and material by necessity can not be blinded to the surgeon. Otherwise, standard surgical technique will be used. Followup in 2 and 6 weeks for clinical assessment will be performed. To asses the long term of cuff disruption, a 12 month interview will be also conducted. Data points will include operative time for closure, postoperative pain at 2 and 6 weeks, postoperative pain with urination/voiding at 2 and 6 weeks, spotting, bleeding and /or frank vaginal disruption documented at 2 and 6 weeks, and pain and presence of dyspareunia at 12 months will be assessed.

Cost associated with cuff closure will be calculated by addition of OR time and material cost.

Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for robotic assisted laparoscopic hysterectomy

Exclusion Criteria:

* Patients who will not consent.
* Hysterectomy due to malignant conditions.
Evaluation on the Effectiveness and Safety of RuiXin-CoronaryAI for Diagnosis of Coronary Artery Stenosis

With the emergence of advanced technology to date in the artificial intelligence (AI), computer aided diagnosis has gradually gained its popularity in the field of healthcare. Particularly, in the clinical practice of coronary artery disease diagnosis, the application of AI could be of great implication in alleviating the shortage of medical sources. To evaluate the effectiveness and safety of the AI-based coronary CT angiographic analysis software (RuiXin-CoronaryAI) for diagnosis of coronary artery stenosis, a retrospective, multi-center, cross-over designed, blinded, sensitivity superiority and specificity non-inferiority clinical trial will be conducted.

Patients ≥18 years old with suspected or known coronary artery disease who underwent CCTA will be included. CCTA images of subjects should be of good quality up to the DICOM 3.0 standards, obtained by CT scan with ≥64-slices. The subjects with unqualified CTA will be excluded. CCTA images will be analyzed in three methods (3 groups). Control group: CCTA images will be visually evaluated by physicians. Experiment group: CCTA images will be evaluated by physicians using RuiXin-CoronaryAI. Reference group: CCTA images will be visually evaluated by cardiologists with at least 10 years experiences, and the conclusions they offer will be used as golden standard. Primary outcomes are diagnostic sensitivity and specificity of RuiXin-CoronaryAI and coronary CTA for diagnosis of ischemia on a per-vessel basis. The effectiveness of RuiXin-CoronaryAI for diagnosis of coronary artery stenosis will be conducted by testing superiority of diagnostic sensitivity and non-inferiority of specificity.

Eligibility Criteria:
Inclusion Criteria:

1. layer thickness of CCTA images should be less than 1mm, image quality should be up to DICOM 3.0 standards;
2. vessels should be clearly developed, contrast medium ought to be well filled, the average of CT value of aortic root cavity should be between 325-600HU in CCTA image;
3. remodeling of vessels should be intact, including coronary artery and branches, without missed or inaccurate slices;
4. CCTA image should be obtained from single- or dual-source computed tomography (CT) scanners with a minimum of 64 detector rows.

Exclusion Criteria:

1. CCTA image is of poor quality due to motion artifact, severe calcification, metal coverage, noise, poor contrast medium injection and other variables influencing the diagnosis of stenosis;
2. previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
3. anomalous origin of coronary artery;
4. other non-atherosclerosis-related coronary diseases like coronary artery fistula, aneurysm, coronary artery ectasia, arteritis coronaria, etc.;
5. repeated enrollment;
6. other conditions not suitable for enrollment.
The VERIFY Study: An Observational Study Called VERIFY to Learn More About the Use of Vericiguat in People With Chronic Heart Failure With Reduced Ejection Fraction

This is an observational study in which the health data of people with chronic heart failure with reduced ejection fraction (HFrEF) are collected using administrative claims data.

In observational studies, only observations are made and participants do not receive any advice or changes to healthcare.

Chronic HFrEF is a longterm condition that occurs when the heart is weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen which the body requires to function properly. The common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death.

Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result, the heart is able to pump better.

Vericiguat was approved for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. There is limited information available about the use of vericiguat for the treatment of HFrEF under realworld conditions.

The main purpose of this study is to collect information about the characteristics of people with HFrEF, who are on vericiguat in addition to at least one standard treatment. Researchers will collect information about participants' basic characteristics, including their age, gender, other health conditions they may have, and the medicines they may be taking.

The data will come from administrative claims data for people in the United States of America who were diagnosed with HFrEF between January 2020 and June 2022.

In this study, only available data from routine care is collected. No visits or tests are required as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* ≥18-years old and have at least one year of continous enrollment in the HV database.
* Have proven or presumed HFrEF
* Have received ≥1 GDMTs for HFrEF
* All patients will be required to have continuous enrollment in the HealthVerity data set during the pre-index date (baseline period) of at least 90-days.
Radioprotective Light-weight Caps in the Interventional Cardiology Setting

The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.

The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.

For more information please contact Dr. Raul Herrera, MD, Director Baptist Cardiac and Vascular Institute Baptist Hospital of Miami.

Eligibility Criteria:
Inclusion Criteria:

* Interventional Cardiologist practicing in Baptist Cardiac \& Vascular Institute
* cardiac procedure requiring C-arm fluoroscopy

Exclusion Criteria:

* Interventional Neuroradiologists and Interventional Radiologists will not be included in this study.
Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia. The subjects will be given 3 day dosing regiment of the fixed-dose combination of Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction data will be evaluated on Day 28 as primary endpoint.

After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.

Eligibility Criteria:
Inclusion Criteria:

* Primigravidae and secundigravidae pregnant women at \>=14 and \<=30 weeks of gestational age (confirmed by ultrasound examination).
* Evidence of asymptomatic parasitemia with Plasmodium falciparum monoinfection (confirmed by microscopy) with parasite counts in the range of 80 100,000/uL on thick blood smears.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if a subject is \<18 years of age) has been informed of all pertinent aspects of the study and that all questions by the subject have been sufficiently answered. Assent will be obtained from subjects \<18 years of age.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Age \<16 years old or \>35 years old.
* Multiple gestations (more than one fetus) as per the ultrasound results at screening.
* Clinical symptoms of malaria.
* Hemoglobin \<8 g/dL (measured at baseline).
* Any condition requiring hospitalization or evidence of severe concomitant infection at time of presentation.
* Use of antimalarial drugs in previous 4 weeks.
* History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability.
* Known allergy to the study drugs (AZ, CQ, and SP) or to any macrolides or sulphonamides.
* Requirement to use medication during the study that might interfere with the evaluation of the study drug of AZ or CQ or is contra indicated during pregnancy per package inserts.
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
* Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
* Known severe sickle cell (SS) disease or sickle hemoglobin C (SC) anemia.
* Known family history of prolonged QT syndrome, serious ventricular arrhythmia, or sudden cardiac death.