cyrilzakka/clinical-trials huggingface dataset:
Examining Interactions Between PALS and Caregivers

The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and their caregivers.

The question is, What are the effects of communicative interaction on verbal communication in people with ALS when they interact with their caregivers and does this change over time?

Participants will read words and sentences while they are interacting with their caregivers.

PALS and Caregivers will participate in two sets (pre-test and post-test) of interactive tasks two weeks apart. Over two weeks, they will complete the collaborative word-matching task ten times (once every weekday for an average of 10 mins/day) on their own.

The study is designed to examine two things. First, to examine the speech produced by PALS with familiar interlocutors. Second, to examine the changes in speech production as a function of collaborative practice.

Plans for Assignment - This is a single group study in which all participants will engage in the same tasks.

Delivery of Intervention: Using tablets and audio recording devices provided to them, participants will complete this task in the comfort of their home. Study protocols will be explained via videoconferencing by experimenters. Produced speech will be recorded using solid-state audio recorders as well as remotely through the video conferencing software.

Adequacy of Sample size. Assuming medium effect sizes (Cohen's f = 0.3) based on our pilot data, for 80% power at an alpha of .05, the investigators will require 76 speakers. The investigators propose n =76 PALS and their caregivers (total 152) in order to account for speech variability that is common for PALS.

Adequacy of Analyses. The proposed statistical analyses (Generalized mixed effects regressions) are standard and will be used to analyze the effect of the intervention on the outcome measures described below. Severity of condition (for PALS) will be included in the analyses and by-subject slopes and intercepts will be used to account for variability across participants.

Eligibility Criteria:
Inclusion Criteria:

Speakers with amyotrophic lateral sclerosis (ALS) (PALS-people with ALS)

* diagnosis of ALS following the revised EL Escorial criteria
* no history of other neurological conditions (e.g., stroke)
* no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)
* detectable speech disturbance according to the ALS Functional Rating Scale-Revised (ALSFRS-R)
* the ability to produce single words
* being a native speaker of American English (AE).

Caregivers

* being a caregiver of a participant with ALS
* being a native speaker of American English (AE).

Exclusion Criteria:

- None - if volunteer meets the inclusion criteria, then they will be enrolled
Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

This is a Phase 1/2, first-in-human, open label, multicenter study to assess safety and tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV as monotherapy and in combination with pembrolizumab in patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck, cervical, anal, vulvar, or penile cancer.


Eligibility Criteria:
Inclusion Criteria - All Patients:

* Male or female patients ≥18 years of age
* Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
* At least 1 measurable lesion according to RECIST 1.1
* Must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Screening and on Cycle 2 Day 8 (+/- 2 days)
* Patients must agree to venous access for leukapheresis and be willing to have a central line inserted if venous access is an issue
* Adequate organ function and bone marrow reserve performed within 14 days prior to leukapheresis

Inclusion Criteria - Part 2:

• Patients must not have been treated with immune check-point inhibitors

Exclusion Criteria - All Patients:

* Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis.
* Systemic treatment with either corticosteroids (\>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to leukapheresis
* Patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months prior to leukapheresis
* Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor
* Patients with \>Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except Grade 2 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
* Known HIV infection, active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
* Has known active central nervous system metastases
* Have active interstitial lung disease and any history of myocarditis
* Major surgery within 2 weeks of leukapheresis

Exclusion Criteria - Part 1B:

* Known hypersensitivity to pembrolizumab
* History of any Grade 3 immune-related AE (irAE) from prior immunotherapy

Exclusion Criteria - Part 2:

• Prior treatment with an immune check-point inhibitor
Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants

This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at 2, 6 and 12 months after surgery. Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).


Eligibility Criteria:
Inclusion Criteria:

* completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses.
* sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm)
* no evidence of systemic or psychic pathology that might contraindicate the implant treatment.

Exclusion Criteria:

* Those in which oral surgery or cognitive evaluations are contraindicated
A Pilot Proof of Concept, Randomized Controlled, Single-Center Study of a Decision Aid Tool for Older Patients Considering LHC as Treatment for NSTEMI

This study will be a single-center, prospective, un-blinded, randomized controlled trial evaluating a decision aid tool for older patients considering left heart catheterization (LHC) as treatment for non-ST elevation myocardial infarction (NSTEMI). The study population is 50 total inpatients (25 per study arm) with NSTEMI eligible for elective LHC. The first arm is the control group that will receive standard of care, while the second arm will have access to the decision aid and shared-decision making conversation with one of the co-investigators. Baseline characteristics and surveys/questionnaire data will be collected after study intervention (as applicable), and prior to final decision regarding LHC. Statistical analyses will be conducted on the primary endpoint, decisional conflict score, as well as on various secondary endpoints.

A single-center, prospective, un-blinded, randomized controlled trial. Primary objective: To pilot a coronary revascularization decision aid in older adults with NSTEMI who are candidates for elective LHC in order to determine its effectiveness in lowering decisional conflict by the decisional conflict scale (DCS).

Secondary objectives: To determine decision aid feasibility by measuring time of administration and percentage of patients agreeing to use. Also, to assess efficacy of the decision aid in decreasing patient feelings of anxiety and depression (by the Hospital Anxiety and Depression Scale), increasing decision self-efficacy (by the Ottawa Decision Self-Efficacy Scale), and increasing medical knowledge.

Eligibility Criteria:
Inclusion Criteria:

* Must be admitted to the hospital, and there must be clinical suspicion for type I NSTEMI
* Must be eligible for non-urgent revascularization
* Must have capacity to consent for the study based on the judgment of the study investigators
* Must speak English

Exclusion Criteria:

* Does not meet all of the inclusion criteria listed above
* Has significant vision or hearing impairment that prohibits use of the decision aid
* Unable to read
* Has a clinical diagnosis of dementia and/or severe cognitive impairment documented in the electronic medical record
Ambisome in Liver Transplant Patients

In this study we are trying to find out the amount of a drug called Ambisome in the liver, the blood, the bile and the fatty tissues of the body. This drug is approved for treatment of infections caused by fungus and is known to be effective against most of the fungal infections, which can happen after liver transplantation. By taking small pieces (less than quarter of a teaspoon) of liver and fat during the liver transplant operation, we can measure how much of the drug is concentrated in the liver. After that, we will measure the level of the drug in the blood and in the bile that comes out of a small tube which is inserted into the bile tube as a routine in all liver transplant patients. These measurements will be taken daily for a week and then weekly for another 3 weeks.

We are inviting you to take part in this study in order to increase our knowledge of the behavior of this drug so that we can find the most effective treatment to prevent fungal infections in liver transplant patients.

Fungal infections continue to be a source of serious morbidity and mortality in liver transplant patients. Liposomal Amphotericin B (AmBisome ®) has been shown in animals to be concentrated in the liver, lungs and leukocytes. It also has a long half-like making it a potentially attractive drug for prophylaxis in liver transplantation (OLT).

We propose to administer a single (5mg/kg) dose of AmBisome ® following reperfusion of the new liver. Liver, subcutaneous fat, blood and bile samples will be analyzed for AMB levels 1-2 hours after drug administration. Blood and bile, and body fluid samples will be sequentially analyzed for 3 weeks post transplant. This will be done in 50 consecutive patients. The incidence of fungal infections and adverse effects will be monitored for three months.

Persistent AMB levels in blood bile and ascites, if found, will provide a good rationale for AmBisome ® prophylaxis for fungal infections in outpatients.

Eligibility Criteria:
Inclusion Criteria:

* All adult liver transplant recipients receiving cadaveric liver transplants

Exclusion Criteria:

* Patients with choledocho-jejunostomy reconstruction of the biliary tree.
* Children less than 18 years of age
* Patients with known allergy to Amphotericin B.
Development of a Tissue-Based & Cell Free DNA Next-Generation Sequencing Workflow

1. Develop a Next-Generation Sequencing (NGS) workflow for mutation profiling of formalin-fixed paraffin-embedded (FFPE) tissue and cell-free DNA (cfDNA) specimens.
2. Calculate the proportion of cases in a test series of B-cell non-Hodgkin Lymphomas (BNHL) with somatic mutations or immunoglobulin heavy chain (IGH) gene rearrangements common to both FPPE and cfDNA specimens.
3. Determine if certain types of BNHL are more likely to have mutation profiles common to both FFPE \& corresponding cfDNA ("FFPE-cfDNA dyads")
4. Determine if specific mutations or mutation profiles in FFPE or cfDNA specimens (or both) are of prognostic value after a clinical follow-up of 2 years from the time of diagnosis.

Patients with newly diagnosed B cell NHL will be identified. Samples will be cored from their diagnostic FFPE blocks and assayed to find lymphoma specific variants and immunoglobulin heavy chain gene rearrangements. Blood samples collected at baseline will be compared to see if variants and rearrangements can be detected in tumor specific DNA based on previous studies. Participant data will be collected, and clinical outcomes will be assessed to determine effect of mutation profiles on outcomes over 2 year follow up.

Blood samples will be prospectively collected at scheduled follow up and if primary objectives of this study are met, will be assessed for presence of cfDNA and impact of variation on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of B cell NHL
* Willing to have blood collected at timepoints of regularly scheduled follow up
* Formalin fixed paraffin embedded (FFPE) diagnostic specimen sufficient for further testing

Exclusion Criteria:

* Unwilling or unable to participate in follow up
Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition

The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.

Several studies reported the relationship between plasma phytosterol concentrations and parenteral nutrition-associated cholestasis (PNAC). Information on plasma phytosterols half-lives in very-low-birth-weight (VLBW) preterm infants on lipid parenteral nutrition (PN) are lacking. In a prospective cohort study, plasma phytosterols (campesterol, stigmasterol and sitosterol) of VLBW preterm infants on routine PN will be measured by gas chromatography-mass spectrometry (GC-MS) during PN administration and after only lipid stopping. Plasma phytosterols half-lives will be calculated from the monoexponential decay curves. Blood samples will be weekly collected from 1st to 7th week of life during routine metabolic tolerance analysis or gas-analysis in order to avoid burden of additional phlebotomy. Samples will be collected in ethylenediaminetetraacetic acid-tubes and immediately centrifugated. Plasma will be stored in pyrogallol added-tubes at -20°C until analysis. Saponification reaction will be done using 5-alpha-cholestane as internal standard.

Eligibility Criteria:
Inclusion Criteria:

* 24 weeks \< gestational age \< 32 weeks;
* 500 g ≤ birth weight \< 1250 g;
* parenteral nutrition with soy oil-based lipid emulsions from the first hours of life;
* parental consent.

Exclusion Criteria:

* length of parenteral nutrition \> 24 days;
* severe malformations;
* inborn errors of metabolism;
* severe congenital sepsis;
* liver dysfunctions.
Cross-training Effect of Whole-body Vibration

This study evaluates whether an increase in the ipsilateral knee flexor muscle strength transfers to the contralateral knee extensors which are not exposed to vibration, when unilateral-isolated whole body vibration (WBV) is applied to the lower extremity. In the half of volunteers the right leg were exposed vibration, while in the other half the right leg were exposed sham vibration. Muscle strength were measured with the Cybex® (Massachusetts, USA) extremity-testing system.

This study was included 40 healthy volunteers. The change in the quadriceps muscle strength after 20 session of WBV exercises was evaluated this study. In the WBV group, 20 sessions of unilateral lower extremity vibration exercises were performed with the Whole Body Vibration (WBV) device. WBV was applied when the subjects are in the semi-squat position. WBV was implemented with Powerplate® Pro5 (PowerPlate® International Ltd, London, United Kingdom). During 20 sessions, the WBV amplitude and vibration time were increased gradually. In the first session, the subjects were do a 30-second, 30-35, 40- and 45-Hz low-amplitude WBV while the knee and hip joint were in 30 degrees of flexion (in the semi-squat position); 10-second rest period between vibration applications were applied. A total duration of WBV was be two minutes. In the 20th session, the subjects were given a 60-second, 30-, 35-, 40- and 45-Hz high-amplitude WBV while the knee and hip joint were in 45 degrees of flexion; 10-second rest period between vibration applications were applied. A total duration of WBV was eight minutes. During WBV, the left lower extremity was in the knee-hip flexion position but was not exposed the vibration.

The same experimental protocol was applied to the isometric exercise (control) group. Unlike the experimental group, sham vibration was applied to the control group. Before and after 20 session-exercise, both knee extensor isokinetic muscle strength was measured.

Eligibility Criteria:
Inclusion Criteria:

* Men with ages between 20-50 years
* Being healthy
* Being volunteer
* Right-sided dominant

Exclusion Criteria:

* Non-cooperative subject
Preterm Neonates Brain Ultrasound With CEUS and Elastography

The aim of the study is to investigate levels of brain perfusion and elasticity in preterm neonates when they reach the estimated due date and to compare the data with magnetic resonance imaging at term. Contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography will be used to evaluate the state of brain perfusion with ultrasound. Different appropriate imaging sequences will be used regarding MRI, including asl-perfusion. Neonates recruited from the Neonatal Intensive Care Unit (NICU) of Turku University Hospital will be recruited.

SonoVue (sulphur hexafluoride) is a contrast agent composed of micro bubbles. It increases echogenicity of the ultrasound thus enhancing the visualisation of vessels and giving better insights into tissue perfusion. The use of sulphur hexafluoride has been approved by FDA and it has been in off-label use in Europe for years. SonoVue is thought to be especially useful for children, because it can enhance the diagnostic capabilities of ultrasound and the examination can be performed without radiation or sedation.

Elastography is a method to investigate the elasticity of a tissue by tracking the shear waves generated by the ultrasound beam. Also this method has been used in Europe and America for years.

The aim of this study is to examine cerebral hemodynamics in preterm neonates reaching term age, using ultrasound of the brain, contrast enhanced ultrasound (CEUS) and ultrasound-guided shear-wave elastography (US-SWE). The brain ultrasound, CEUS and US-SWE to preterm babies is planned to take place while having a clinically appointed brain magnetic resonance imaging at about term. Total recruitment for the study is 100 infants in total. The recruitment period will be up to seven years if needed.

The injections of SonoVue will be administered through pre-existing venous cannulas. The examination will be done in addition to the MR-imaging, after the parental consent has been given. The ultrasound examination altogether is estimated to take about 20 minutes per day. Safety monitoring period is conducted after the injection. CEUS data will be analysed with proper software. US-SWE will be measured repeatedly on both brain hemispheres and on different areas to validate the measurements. Ultrasound data will be evaluated comparing preterm neonates with and without MRI-proven brain pathology and comparing the ultrasound-achieved data to magnetic resonance imaging.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates attending brain MR-imaging at term

Exclusion Criteria:

* Pre-known genetic disease
* Difficult congenital malformations that need surgical treatment
* Central nervous system tumors
* Weight less than 2,5 kg during examination
* Medical history of SonoVue hypersensitivity
* Uncontrolled systemic hypertension
* Systolic pulmonary artery pressure \> 90 mmHg
* Unstable cardiovascular state
Patient Education and Use of Post Operative Pain Medication in Ambulatory Hand Surgery: a Randomized Controlled Trial

There is a current opioid epidemic in the United States partially fueled by excess prescribing practices after surgery. The objective of this study is to decrease the amount of opioids needed after ambulatory hand surgery. In this randomized control trial, patients will be randomized into a patient education group and into a control group. The education group will be provided with a pre-operative video detailing proper indications for opioid use after hand surgery, alternative pain management strategies to try before using prescription opioid medications, and side effects associated with opioid use. Patients will also receive information on the current opioid epidemic. Patients will be reminded of the information given pre-operatively after surgery in the post-anesthesia care unit. The control group will not receive pre-operative education and will only receive standard of care post-operative counseling by nursing in the post-anesthesia care unit. All patients will be given a pain log, pain medication diary and participate in phone/email surveys to determine number of opioid pills taken, pain levels, and satisfaction with surgery. The investigators hypothesize that the education group will have decreased opioid intake and increased patient satisfaction compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* English Speaking: must be able to communicate over the phone or by email to perform questionnaires
* Primary elective ambulatory hand surgery (bony or soft tissue)

Bony: Scaphoidectomy/ligament reconstruction tendon interposition (LRTI), Arthrodesis, Arthroplasty Soft Tissue: Carpal tunnel release (CTR), Trigger Finger (TF), DeQuervain's (DQ), Cyst removal, Cubital tunnel, Dupuytren's, tendon transfer, arthroscopy of wrist or elbow

Exclusion Criteria:

* Disability or preop pain in ipsilateral upper extremity from a secondary condition not related to the study procedure
* Allergy or inability to consume oxycodone, Percocet or Vicodin due to a particular health state
* Current Substance Abuse
* HSS employees