cyrilzakka/clinical-trials huggingface dataset:
Mechanical Load on the Shoulders While Carrying a Backpack- Towards a Knowledge-Based Backpack Design

Soldiers and recreational backpackers are often required to carry heavy loads on their body during military operations or hiking. Despite the advances in backpack design, the loads carried by soldiers still impose an extreme physiological strain (soft tissue deformation) which frequently results in discomfort, pain,musculoskeletal injuries, and loss sensorimotor function.

In the current study, characterization of the pressures, evaluation of the deformations of the soft tissues, specifically the fat, muscles, Brachial plexus and subclavian vessels applied on the shoulder while sitting with a heavy backpack will performed. The data acquired in the current trials will be used for development of a finite element (FE) 3D shoulder model. The purpose is to better understand the mechanical loads that are being transferred to the underlying tissue below the shoulder straps during walking/marching with a backpack. During the 2nd phase of this project, data collected during this research will be used to develop gear that will alleviate the strain on the shoulders, prevent injury, and enhance performance.

Hypothesis

* High focal strain (hot-spots) on the shoulder tissue that are observed with the pressure mapping will be observed also in the MR scans.
* The strain at those hot-spots can be reduced by personal-geometry adjusted straps.

Volunteers

Five young (18-30 yrs), healthy, and fit males will participate in this study.

Trials design

1. MR Scans- The scan will be performed for analysis of personal shoulder anatomy, and will be used for developing a 3D FE model. The sagittal view will be used to develop the 3D model. The coronal and axial sectional views will be used to assess the deformations applied on the shoulder tissue. The scan will then be repeated while carrying a 25 kg standard commercial backpack while sitting in the same position, for the assessment of shoulder girdle tissues deformations. Time estimation for each scan is 40 min (80 min total). The subjects are not required to carry the backpack prior to those scans.
2. Static pressure measurement- each volunteer will be asked to sit for 30 seconds while carrying the 25 kg backpack. During this session, pressure will be measured using a pressure mapping pad (Sensor Products Inc., USA) placed between the shoulder strap and the underlying tissue.

The maximal total participation time of each volunteer will be 2 hours total (inside and outside the MR).

Data acquired in the current trials will be used for the development of a FE (finite element) 3D shoulder model. MR scans will be utilized for composing geometry and for the boundary conditions assessment (strain magnitude). Pressure measurements will be used as boundary conditions (stress magnitude).

MR scans and pressure measurements will be performed in the Sheba medical center facilities.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 yrs
* healthy
* fit
* males

Exclusion Criteria:

* contraindications for MRI
Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures

Spinal orthoses have been used in the treatment of non-operative thoracic and lumbar fractures with much success. However, there has been increasing questioning as to wether or not the orthotics are necessary to have a good overall outcome. Being fitted for and acquiring braces are associated with great expense and increased hospital stays. The purpose of this study is to determine wether or not braces are required for good outcome post thoracic or lumbar fracture.

Several tens of patient's per year come to the Emergency Department with thoracolumbar spine compression and burst fractures that are not indicated for surgical fixation. Currently, these patients are treated non-operatively through brace wear which is either custom made for the patient or is off-the-shelf pending location of the fracture and surgeon preference. All braces are through the currently contracted orthotics company. As they are non stocked in house, waiting for the brace requires the patients to remain on "strict spine precautions" (flat bed rest in a Miami J collar, no pillows behind the head, and logrolls for turning) for anywhere from 24-48 hours. No only is this incredibly uncomfortable for the patient, it is also extending their hospital stay for at least one day and, sometimes, up to three as they wait for the brace and have it adjusted to fit appropriately. The patient's all have to then wait to work with physical therapy and occupational therapy and, finally, have upright spine films taken in the brace. The braces tend to be very uncomfortably and constricting for patient's and significantly inhibit their daily lives. The investigators are proposing that these fractures can be treated without needing bracewear and will have equivalent to superior outcomes than results while wearing the brace.

Eligibility Criteria:
Inclusion Criteria:

* Any acute, stable thoracic or lumbar compression or burst fracture appropriate for non-operative care

Exclusion Criteria:

* neurological deficit, pregnant, incarcerated, non-English speaking, previous spinal surgery, additional lower extremity injury affecting weight bearing, younger than 18 years of age
Computer Assisted Instruction Weight Management for Low Literacy Populations

To develop and evaluate a computer assisted instruction (CAI) weight management program in an adult population with low literacy at Sheehan Memorial Hospital's Family Care Center (FCC), an outpatient clinic serving the inner city of Buffalo, New York.

BACKGROUND:

This was the first study in patient care informatics in which nutrient analysis methodology was used on a day-to-day basis to motivate low literate individuals to improve their food choice behavior and physical activity. The deliverables of this investigation included revised and enhanced software, professional documentation, and a participant workbook. These materials were designed so that they could be integrated into any risk factor reduction program for low literacy populations.

DESIGN NARRATIVE:

The CAI featured voice recognition, giant cursor movement, and a graphics-based environment using pictures to facilitate an exceptionally easy to use and understand software program and booklet. The voice recognition technology was linked with compact disk read only memory (CD ROM) to visually display food choices and physical activities for ease of recording data by the individual. The software was formatted so that health professionals could select preference levels which corresponded to the motivational level of the individual. The four-session CAI intervention had two planned maintenance sessions. The output was personalized and in color. It was designed to identify problematic foods in the diet, improve food selections, and increase physical activity. Stars were printed for adherence to individual goals.

One hundred and fifty (150) men and 150 women, between age 20 and age 44, with a reading level of 8th grade or less, who were between 20 percent and 40 percent over their ideal body weight, were randomly assigned to three groups. The design compared a control group without the intervention, a group experiencing the CAI intervention and hands-on computer use, and a group experiencing the intervention but not the CAI component or computer use. All groups were pretested, posttested, and follow-up tested at six months and twelve months following baseline. The primary outcome measures were weight loss, nutrient intake, and physical activity. Data were analyzed using a two-way analysis of covariance and appropriate t-tests.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Safety and Anti-Tumor Study of Oral EPI-506 for Patients With Metastatic Castration-Resistant Prostate Cancer

The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In Part I, patients will participate in single, multiple, and long-term dosing periods using EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design, dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after their initial twelve weeks. Additional patients may be enrolled at any safe dose level prior to or concurrent with enrolling patients in Part II.

In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in each cohort) will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the Prostate
* Metastatic Disease with at least one lesion on bone scan and/or soft tissue on CT/MRI
* Demonstrated progression on abiraterone and/or enzalutamide
* Demonstrated PSA progression within 12 weeks of study participation
* Castrate testosterone levels at screening with continued Luteinizing hormone-releasing hormone (LHRH) therapy
* Eastern Cooperative Oncology Group (ECOG) score between 0-1
* Asymptomatic or mildly symptomatic

Exclusion Criteria:

* Candidates for cytotoxic chemotherapy
* Received more than one line of chemotherapy
* Received more than one treatment course of enzalutamide or abiraterone
* Inadequate washout of prohibited hormonally active agents or other prior treatments for prostate cancer (PCa)
* Known intra-cerebral disease or brain mets
* Spinal cord compression within 6 months
* Prior treatment with investigative androgen receptor (AR) agents
Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents

To compare the proportion of rheumatoid arthritis (RA) patients prescribed opioids, benzodiazepines, and antidepressants before versus after starting each of the following biologics: abatacept, infliximab, etanercept, adalimumab, utilizing an administrative claims database.


Eligibility Criteria:
Inclusion Criteria:

* ICD 9 diagnosis RA 714.0
* Documented first biologic prescription ("index" prescription) for abatacept, infliximab, etanercept, or adalimumab
* Continuous therapy (gap between scripts no greater than 150% days supply) for minimum 6 months from index
* Prescription claims data available for 6 months before and 12 months after index biologic prescription
* Continuous eligibility for 6 months before and 12 months after index biologic prescription

Exclusion Criteria:

* Prescription claims for another biologic during the observation period (including rituximab and anakinra)
* Prescriptions not continuous for at least 6 months
Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation

This study is a prospective randomized trial examining the effect of topically combined antifibrinolytics (Tranexamic acid) with local anesthetics in all electively created surgical wound beds in hand surgery to provide long term pain relief and decrease the use of postoperative narcotics.

The aim of the study is to provide long term pain relief and decrease the use of postoperative narcotics. All treatments are applied topically to the surgical bed prior to closure of the skin. Each of the drugs used in this study are Food and Drug Administration (FDA) approved and routinely used for pain relief. However, the route of administration of the drugs and addition of tranexamic acid or aminocaproic acid is considered off-label (outside of the FDA-approved indications) and therefore investigational.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Any patient undergoing elective hand surgery

Exclusion Criteria:

* Any patient with a traumatic open wound (only surgically created wounds will be included)
* History of chronic pain
* History of narcotic addiction
* History of recreational drug dependency
* History of psychiatric pathology
* Allergy to local anesthetics, recombinant human thrombin or tranexamic acid
* Any patient receiving a supra/infraclavicular block for anesthesia
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

Primary objective:

To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD.

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo.

To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD.


Eligibility Criteria:
Inclusion Criteria:

* Age 12 to 17.
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
* History of AD for ≥1 year.
* History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
* AD involvement of ≥10% body surface area at screening and baseline.
* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

Exclusion Criteria:

* Active dermatologic conditions that may confound the diagnosis of AD.
* Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
* Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
* Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents.
* Active skin infection within 1 week prior to randomisation.
* Clinically significant infection within 4 weeks prior to randomisation.
* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
* Tuberculosis requiring treatment within the 12 months prior to screening.
* Known primary immunodeficiency disorder.
AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer

The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

Due to the hidden onset and rapid progression of pancreatic cancer, most patients are already locally advanced or have distant metastasis at the time of diagnosis and lose the opportunity for surgery. Even among operable patients, about 50% will have recurrence and metastasis one year after surgery. Therefore, more and more evidence supports neoadjuvant therapy for patients with high risk factors for resectable pancreatic cancer, and conversion therapy followed by surgery for patients with borderline resectable and locally advanced pancreatic cancer. Therefore, the objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years；
2. Eastern Cooperative Oncology Group (ECOG) score of 0-1;
3. Pancreatic cancer confirmed by histology or cytology;
4. Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan;
5. Hematological indexes: Neutrophil count \>= 1.5 x 10\^9/L Hemoglobin \>= 10g / dl Platelet count \>= 100 x 10\^9/L; Biochemical indicators: Total bilirubin \<= 1.5 x upper limit of normal value (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 1.5 x ULN; Creatinine clearance rate \>= 60ml / min.
6. Participants of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test;
7. Signed informed consent;
8. Follow the protocol and follow-up procedures.

Exclusion Criteria:

1. Have received systematic anti-tumor treatment.
2. Previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment).
3. Active bacterial or fungal infection (\> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0).
4. Human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group.
5. Autoimmune diseases or immune defects who are treated with immunosuppressive drugs.
6. Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group.
7. Drug abuse, clinical or psychological or social factors make informed consent or research implementation affected.
8. Allergic to programmed cell death protein-1 (PD-1) monoclonal antibody immunotherapy drugs.
A Smartphone Intervention With Telemedicine Support for Management of Post-traumatic Stress Disorder: A Randomized Trial

This study tests whether people receiving clinician support to use a mobile application on their smartphone can manage their post-traumatic stress disorder (PTSD) symptoms better than those who do not. Half of the participants will receive the clinician supported smartphone application intervention and the other half will remain on the waiting list.


Eligibility Criteria:
Inclusion Criteria:

* on the waiting list for the Ontario Shores traumatic stress clinic;
* score ≥ 31 on the PCL-5
* have access to a smartphone or tablet to which they are willing to download the app.

Exclusion Criteria:

* active suicidal ideation
Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)

The primary objective of this study is to assess the number of patients preferring the methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment based on a questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age between 18 and 75 years
* Rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria 1987 or ACR/European Liga Against Rheumatology (EULAR)2010
* Disease activity score (DAS) 28 \> 2.6

Main Exclusion Criteria:

* Prior or other current subcutaneous treatment with self-injection
* Prior or concomitant treatment with biologics
* Contraindications to MTX treatment
* History or diagnosis of a dermatological disease at the injection site
* Women with child-bearing potential who do not use a highly effective method of contraception or men who have a partner with child-bearing potential and do not use a contraception during the study and at least 6 months thereafter.
System Accuracy Evaluation of Karajishi Contour and Karajishi TS Blood Glucose Monitoring Systems Following ISO 15197:2013

The study consists of 2 parts:

The objective of part 1 of this study is the performance of a short evaluation of system accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure that the Karajishi meters are fully functioning, assure and document the accuracy of the comparison method, evaluate and validate the processes and procedures of the study methodology. The objective of part 2 of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated.

This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer: Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
* For provoked blood glucose excursions due to insulin dose adjustment: Male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy.
* Minimum age of 18 years
* Signed informed consent form
* Legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
* Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* Incapability of giving informed consent
* \< 18 years
* Legally incompetent
* Accommodated in an institution (e.g. psychiatric clinic)
* Language barriers potentially compromising an adequate compliance with study procedures
* Dependent from investigator or sponsor
* For provoked blood glucose excursions 50 - 80 mg/dl:
* Coronary heart disease
* Condition after myocardial infarction
* Cerebral incidence
* Peripheral arterial occlusive disease
* Hypoglycemia unawareness