cyrilzakka/clinical-trials huggingface dataset:
Redesigning Patient Handling Tasks to Prevent Nursing Back Injuries

This study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. Nurses have one of the highest incidences of work related back injuries of any profession. Over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful.

Background:

This study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. Nurses have one of the highest incidences of work related back injuries of any profession. Over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful.

Objectives:

The goal of this study is to reduce the incidence and severity of occupational musculoskeletal injuries in nursing through the redesign of stressful patient handling tasks. This study addresses three objectives: 1) conduct a quantitative, biomechanically based, ergonomic evaluation of the eleven "at risk" tasks in nursing practice; 2) redesign the techniques or equipment needed to perform these tasks safely or with reduced risk of musculoskeletal injury; and 3) conduct laboratory- based assessment of the biomechanical benefit of the proposed intervention strategies.

Methods:

Using a randomized experimental design with a control group, ten "at risk" tasks will be evaluated. The sample included 160 experienced nursing staff. Data were collected using: 1) Caregiver Data Form and Anthropometry Data Sheet; 2) 3-D Electromagnetic Tracking System; 3) EMG; and 4) modified Borg Scale for Perceived Comfort. Include: caregiver characteristics, joint torque, spinal forces, spinal tolerance limit and damage load limit, erector spinae surface EMG, joint angles, percent of population capable of performing each task by gender, velocity of lift, reach, heart rate, and perceived comfort.

Status:

This project is complete.

Eligibility Criteria:
Inclusion Criteria:

Subjects included RNs, LPNs, and Nas with a minimum of 6 months experience and a job description that included a minimum of 80% direct patient care responsibilities. Subjects were required to be injury free for at least one year, as evidenced by a brief orthopedic examination and interview. The orthopedic evaluation included an examination of posture, gait, range of motion, sensory deficits, muscle exam, and straight leg raise. We excluded subjects with self-report of injury or any positive finding of back musculoskeletal disorders within the past 12 months.

Exclusion Criteria:
Pediatric Endotracheal Intubation During Resuscitation

Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway. The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR). These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. The aim of the study was to compare time and success rates of different available video laryngoscopes and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
ImmunoPET Imaging of Pancreatic Cancer

Pancreatic cancer remains one of the most aggressive cancer types. Target-specific targeted therapy is an attractive therapeutic alternative for the treatment of patients with a wide range of cancers, including pancreatic cancer. Companion diagnostic technique is critical for the success of targeted therapies. SHR-A1921 is a TROP2-directed antibody-drug-conjugate (ADC) approved for several clinical trials for advanced solid tumors. SHR1920 is the humanized anti-Trop2 monoclonal antibody (hIgG1) of SHR-A1921. Radio-labeling SHR1920 with radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of SHR-A1921 distribution in cancer patients. Performing a \[89Zr\]Zr-DFO-SHR1920 PET scan before treatment with SHR-A1921 can evaluate tracer uptake in the primary and metastatic tumor lesions and normal organ distribution. CLND18.2 is another potential therapeutic target for pancreatic cancer. Target-specific immunoPET imaging may help identify patients more likely to benefit from targeted therapy.

Enrolled patients with pancreatic cancer will undergo whole-body \[89Zr\]Zr-DFO-SHR1920 immunoPET/CT scans at 0,1, 3, 5, or 7 days after tracer injection (1-3 mCi). Uptake of \[89Zr\]Zr-DFO-SHR1920 in tumor and normal organs/tissues will be scored visually and quantitatively. For immunoPET imaging with 18F or 68Ga-labeled 3A12 (a nanobody targeting CLDN18.2), immunoPET/CT scan will be performed 1h after tracer injection (0.05-0.1 mCi/kg).

Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of pancreatic cancer or suspected pancreatic cancer by diagnostic imaging.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Known or suspected hypersensitivity to SHR1920, DFO/RESCA/NOTA, 89Zr/18F or 68Ga or any of the excipients.
* Pregnancy
Validation and Assessment of Patient Adherence to Opioids for Cancer Pain Using MMAS 8 Pain Clinic

This study aims at finding degree of adherence of patients to their chronic pain medication prescriptions containing opioid e.g. Morphine, using Morisky Medication Adherence Scale 8, self- reported questionnaire. Also relationship of various demographic, disease related and opioid related factors to medication adherence.

After institutional review board approval, a Pilot study including 30 patients will be conducted to validate Morisky Medication Adherence Scale 8 to validate the questionnaire for cross cultural variation. The data collected will be analyzed and result will be submitted to institutional review board for approval to conduct the parent study. Following the above approval, all adult patients , more than 18 yrs. of age, who are on a strong opioid for their chronic cancer pain, taken prescription from pain clinic at least once in past, who are able to understand and communicate Hindi will be invited to participate in the study. Each patient will be verbally asked about their medication and same will be confirmed by their previous medical records. An informed written consent will be obtained. Data will be collected by PI or co-investigator after obtaining written consent at Pain clinic(general and private) of Tata Memorial Hospital. Fund for purchasing the copyright to use the Hindi translation of Morisky Medication Adherence Scale 8, was provided by the department of Anesthesia Account, Tata Memorial Hospital, after due permission obtained from, Director Tata Memorial Center and Head of the department of Anesthesiology, critical care and pain, Tata Memorial Center. The precise scoring and permission to use the Hindi translation of the scale has been obtained from the developer. For income we will be considering private and general category of the patients respectively.Data will be analyzed using International Business machines software package for statistical analysis version 20.0.Pilot study data will be analyzed applying tests as internal consistency (Cronbach's alfa), Test retest variability and factor analysis.For parent study in the uni-variate analysis all variables listed above will consecutively tested for significant associations with ''good adherence'' as the outcome variable. Chi-square tests and Student's t-tests will used for categorical and continuous variables, respectively. All variables will be unconditionally entered into a binary logistic multi variate analysis. All p values #0.05 will regarded as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. All adult patients \> 18 yrs. of age
2. Patients suffering from chronic pain of any type and severity 3. On opioid i.e. Morphine, taken prescription at least once 4. Who can understand and communicate Hindi

Exclusion Criteria:

1. Refusal of consent
2. Paediatric patients
3. Patients who cannot understand or communicate Hindi
Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)

The specific aims of the 5-year study are to: 1) describe the nature and extent of substance use and sexual risk behaviors in a sample of 500 sexually active, substance using, not-in-treatment men who have sex with men (MSM) in urban South Florida (Miami/Ft. Lauderdale); 2) identify the independent covariates of baseline substance abuse and sexual risks; 3) evaluate, through random assignment of participants, the relative effectiveness of two intervention conditions in reducing sexual risks and substance use, as measured at 3-, 6-, and 12-month follow-up assessments: a) an innovative five-session risk reduction intervention derived from psychological empowerment theory titled Project GOAL; and, b) an enhanced community standard-of-care HIV counseling Comparison Condition.

Although recent meta-analyses of the HIV prevention intervention literature have demonstrated that behavioral interventions reduce sexual risk-taking among men who have sex with men (MSM), interventions for not-in-treatment substance using MSM are lacking. Consequently, and based upon overwhelming evidence that substance use is a primary driver of HIV infection among urban MSM, public health authorities have identified the development of efficacious interventions for substance using MSM as a concern of the highest priority. The proposed study aims to test a new intervention based upon psychological empowerment theory that, in preliminary field tests, produced high levels of acceptability and participation, as well as large reductions in sexual risks and substance use, among a sample of ethnically-diverse, high risk, substance using, HIV+ and -negative MSM. The intervention to be tested is based upon a theory of MSM health risk behaviors that posits that urban gay "fast lane" subcultures present risk environments - including lack of integration with the larger society, normative hypersexuality and substance use, homophobia, sexual competitiveness, and an emphasis on entertainment and escapism - that become problematic for a sizable minority of MSM who live in them.

The proposed project responds directly to the calls by public health authorities for the development of efficacious risk reduction interventions for substance using MSM. South Florida consistently ranks in the top three MSAs nationwide in HIV and AIDS incidence and prevalence. South Florida is also a well-known migration point for MSM of extraordinarily diverse backgrounds with high rates of non-injection drug use. This setting provides an excellent context for testing an innovative intervention among high risk substance using MSM who are in need of HIV prevention services.

Eligibility Criteria:
Inclusion Criteria:

* ongoing substance use and ongoing unprotected anal intercourse with men

Exclusion Criteria:

* past twelve month participation in HIV prevention intervention or drug treatment; no current working telephone number and residential address; no intention to remain in in South Florida for next 12 months; newly diagnosed with HIV infection in the past 6 months
Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen

The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.

This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years
* Voluntarily signed informed consent form
* BMI ≤ 35 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Cardiovascular diseases
* Implanted defibrillators, implanted neurostimulators
* Electronic implants
* Disturbance of temperature or pain perception
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Malignant tumor
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contageous skin disease
* Elevated body temperature
* Pregnancy
* Breastfeeding
* Injured or otherwise impaired muscles
* Scars, open lesions and wounds at the treatment area
* Basedow's disease
* Previous liposuction in the treatment area in the last six months
* Abdominal wall diastasis
* Unstable weight within the last 6 months
* Previous body contouring treatments in the abdomen area in the last three months
Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.

The purpose of this research is to evaluate the efficacy and safety of Robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (MA) use disorders.

Based on artificial intelligence technology, face recognition technology, virtual reality technology to develop an available Robot-assisted rehabilitation intelligent system. Then, using this intelligent system as a new way of Psychotherapy to provide treatment for methamphetamine patients, and compare it with traditional treatment to verify the efficacy and safety of Robot-assisted rehabilitation intelligent system in Chinese methamphetamine patients.

Eligibility Criteria:
Inclusion Criteria:

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders;
* Education level equal or more than 9 years;
* Have normal or corrected-to-normal vision;
* Have normal or corrected-to-normal hearing;
* Less than 3 months before last drug use;

Exclusion Criteria:

* Current substance use (except nicotine or caffeine);
* History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions;
* Intelligence quotient less than 70.
Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin

The standard CXL technique involves removal of the epithelium to enable riboflavin to penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of riboflavin is one of approach for riboflavin impregnation.

In this study, the investigators compared the results of standard corneal crosslinking (CXL) and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.


Eligibility Criteria:
Inclusion Criteria:

* Documented progressive KC (by Pentacam and/or corneal topography imaging).
* A clear central cornea.
* A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
* Minimal Snellen corrected distance visual acuity of ≥ 0.4.
* Patient age of ≥ 18 years.

Exclusion Criteria:

* Corneal scarring.
* History of epithelial healing problems.
* History or presence of ocular infection (such as herpes keratitis)
* Pregnancy and/or breastfeeding.
Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter

The purpose of this study is to evaluate the efficacy and safety of dutasteride at reducing relapse rates of Acute Urinary Retention (AUR), including reduction in surgical intervention for benign prostatic hyperplasia (BPH), in patients who receive a 6 month treatment of dutasteride (0.5mg once daily) following a single episode of AUR followed by successful Trial Without Catheter compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Able to read, write and understand instructions related to study procedures and able to give written informed consent
* Able to swallow and retain oral medication
* Had a single, spontaneous episode of AUR related to BPH with a drained volume of between 500 and 1500ml
* Had a successful TWOC (defined as successful if the patient returns to satisfactory voiding within the first 24 hours after catheter removal without re-catheterisation) following 2 - 3 days treatment with alpha blocker (preferably alfuzosin 10mg OD) pre TWOC followed by up to seven days treatment with alpha blocker (preferably alfuzosin 10mg OD) post TWOC.
* Able to be randomised within 7 days of successful TWOC

Exclusion Criteria:

* Prostate volume (PV) of less than 30cc and greater than 80cc measured via Trans Rectal Ultrasound (TRUS) either at time of hospitalisation or as part of the screening / randomisation visit
* Previous episode of AUR prior to the current episode
* AUR not related to BPH i.e. postoperative retention following major abdominal / pelvis surgery
* Previous prostate or urethral surgery
* Previous positive prostate biopsy
* Any cause other than BPH that may result in urinary symptoms or changes in flow rates.
* Any unstable co-existing medical condition
* Previous 5-ARI use
* Previous alpha blocker treatment other than the study mandated 2 - 3 days pre and up to 7 days post TWOC period with alpha blocker (preferably alfuzosin 10mg OD)
* Use of prohibited meds (e.g. 5ARI's, anabolic steroids including testosterone, drugs with antiandrogenic properties)
* Liver enzymes (ALT, AST, ALP) at time of hospitalisation / screening visit greater than 2 x ULN or bilirubin at time of hospitalisation / screening visit greater than 1.5 x ULN.
* Serum creatinine at time of hospitalisation / screening visit greater than 1.5 x ULN
* Treatment with any other investigational product within 30 days prior to the first dose of study medication
* History or current evidence of alcohol or drug abuse within the last 12 months
* Prostate Specific Antigen (PSA) greater than 20ng/ml
* Use of suprapubic catheterisation after failed urethral catheterisation
* Neurogenic bladder dysfunction, confirmed or suspected, irrespective of etiology
* Isolated bladder neck disease
* Acute or chronic prostatitis
* Confirmed or suspected urethral stricture
* Known bladder stones
* Clot retention secondary to haematuria of any cause
* Patient unwilling to use a condom during sexual intercourse
Safety and Efficacy of Using PK Morcellator With Pneumoliner Containment Hysterectomy

The study is designed to evaluate the safety of performing in-bag morcellation of uterus tissues during laparoscopic hysterectomy (LSH or TLH). Pre- and perimenopausal women, aged 35-50 undergoing laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH)


Eligibility Criteria:
Inclusion Criteria:

* Pre- and Peri-menopausal woman patient age 35-50 years
* Women with fibroids and indication for laparoscopic hysterectomy at which a morcellators for cutting and extraction of tissue is required.
* Normal Pap test result in the last year
* Hemoglobin level of 10.0 g/dL or more at the time of treatment
* Subject able to comprehend and give informed consent for participation in this study
* Signed informed consent form

Exclusion Criteria:

* Patient is not considered suitable for a laparoscopic hysterectomy procedure
* Women with:
* Known or suspected gynecologic malignancy
* Known cervical dysplasia
* Postmenopausal women
* Undiagnosed vaginal bleeding
* Abdominal wall thickness is larger than 10 cm
* Atypical hyperplasia or malignancy in preoperative endometrial biopsy.
* Known cognitive disorder
* HIV or any other immunosuppressive disorder
* Liver disease
* Renal failure (Serum creatinine above 2.5 dL/ml)
* Cardiopulmonary disease contraindicating laparoscopic surgery
* History or evidence of gynecologic malignancy within the past five years
* Pace maker, internal defibrillator/cardio converter
* Impaired coagulation parameters
* Previous extensive pelvic surgery
* Psychological/psychiatric disease
* Contraindications to anesthesia or abdominal surgery.
* Concurrent participation in any other clinical study
Myofascial Release and Kinesio Taping on Autonomic Nervous System in Low Back Pain

The purpose of this current randomized clinical trial is to determine the effects of myofascial soft tissue release and kinesio taping on disability, pain, quality of life, autonomic nervous system and oxidative stress indicators in chronic low back pain.

Design: Randomized Clinical Trial. Objective: to determine the effects of myofascial soft tissue release and kinesio taping on pain, disability, quality of life, and autonomic nervous system indicators.

Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups.

Intervention: For 10-week, the group 1 will undergo treatment comprising a myofascial soft tissue release protocol (1/week) and the group 2 will recieve a kinesio taping treatment (1/week).

Main Outcome Measures: Intensity of pain, disability, quality of life, biochemical stimation intertitial fluid, body mass indicators, hormonal indicators, indicators of autonomic nevous system, and indicators of oxidative stress will be collected in both groups at baseline, 10 weeks and 15 weeks after the last intervention. Baseline demographic and clinical variables will be examined between both groups with an independent Student t-test for continuous data. Separate 2x3 model ANOVA with time (baseline, 10 weeks and 15 weeks) as the within-subjects factor, group will be to determine the effects of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Score ≥ 4 on the Roland Morris Disability Questionnaire.
* Low Back Pain for ≥ 3 months.
* Not undergoing another physical therapy treatment.

Exclusion Criteria:

* Disease of the central or peripheral nervous system.
* Having previously undergone manual therapy.
* Contraindication to low back manual therapy.
* A history of spinal surgery.
* Treatment with corticosteroid in the past two weeks.
* Clinical sign of radiculopathy
* Presence of Stenosis