cyrilzakka/clinical-trials huggingface dataset:
Effect of Core Stability Exercises and Russian Electrical Stimulation in Non-specific Low Back Pain

Brief Summary: Low back pain (LBP) is an important public health problem due to the increasing world population and aging. In chronic LBP, exercise therapy is among the first-line treatments. Core stabilization exercises (CSE), one of the motor control exercises, focus on the activation and control of the deep spinal muscles. Recently, some studies have shown that Russian electrical stimulation alone or combined with exercise can provide contraction in deep stabilizer muscles and significantly reduce pain in patients with LBP


Eligibility Criteria:
Inclusion Criteria:

* The duration of the disease is more than 3 months with pain scores greater than four in the VAS disability score of 19% or greater as evident from the modified oswestry disability.

Exclusion Criteria:

* Neurological or musculoskeletal diseases that affect lumbar spine (e.g: lumbar spondylosis, spondylolisthesis, and lumbar disc injuries)
* women during pregnancy and lactation.
* History of lumbar spine surgery.
* Signs of lumbar radiculopathy or myelopathy.
* Signs of serious pathology (e.g., malignancy, inflammatory disorders, infection
Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF.

Since 2007, RUTF has been the recommended treatment for SAM. RUTF is not conducive to the growth of bacteria because of the low moisture content, does not require cooking, and has led to greater recovery rates than liquid milk formulations in direct comparisons. One expected benefit of the RUTF-P is improved outcomes due to the higher levels of essential fatty acids.

The essential fatty acid profile (i.e., the level of omega-3 and omega-6 fatty acids) of RUTF-P may have important implications for cognitive development of children, especially infants, with SAM who consume these foods as their sole dietary source for several weeks. In particular, an excess of omega-6 fatty acids (from sources such as peanut and corn oil) and a minimum of omega-3 fatty acids (from sources like flax) may fail to support optimal cognitive development and neural function.

In this prospective, double-blinded, randomized controlled clinical effectiveness trial, we will compare two RUTF products in the treatment of SAM to test the effects of the two different RUTF products on essential fatty acid status.

Eligibility Criteria:
Inclusion Criteria:

* kwashiorkor and/or marasmus
* 6-59 months of age
* lives in local area near enrollment site

Exclusion Criteria:

* recent (\<4 months) therapeutic feeding for moderate or severe acute malnutrition
* chronic medical condition (eg, Down syndrome, other congenital syndrome, chronic heart disease) that may make feeding and growth difficult (not to include HIV or TB)
* caretaker refusal of 2 blood draws
* ineligibility for outpatient therapy (ie, severe illness or anorexia requiring inpatient therapy)
* caretaker expresses plans to move away from local area of clinic, making followup difficult
Aflibercept Injection Into the Vitreous Body of the Eye: Study to Learn More About Patient Relevant Outcomes, Real World Treatment Patterns and How Well the Treatment Works for Patients Suffering From Abnormal Growth of New Blood Vessels Under the Retina.

In this clinical study researchers want to gain a deeper understanding of treatment consistence under real world conditions over the course of 24 months of Aflibercept injections into the eye for patients suffering from abnormal growth of new blood vessels under the retina (neovascular age-related macular degeneration). The study aims to identify potential reasons that may allow classification of non-consistence as patient or physician driven. They want to describe treatment effectiveness (how well the treatment works) and associations between treatment effectiveness, non-consistence and patient relevant outcomes, such as vision specific quality of life and treatment satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neovascular age-related macular degeneration
* Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice or current treatment with IVT-AFL (all prior anti-VEGF treatments must have been applied by the participating study site)
* No participation in an investigational program with interventions outside of routine clinical practice
* No contra-indications according to the local marketing authorization/ Summary of Product Characteristics (SmPC)
* Ability and willingness to participate in telephone interviews

Exclusion Criteria:

* Any prior therapy with intravitreal steroids in the study eye.
* Concomitant therapy (except nutritional supplements) with any other agent to treat nAMD in the study eye
* Any prior transpupillary thermotherapy, photodynamic therapy, macular rotation/ translocation or macular laser in the study eye or
* Structural damage to the center of the macula in either eye
* Any other condition expected to permanently limit visual acuity outcomes over the course of the study
Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Children With Unilateral Cerebral Palsy

This study evaluates the therapeutic effects of constraint-induced movement therapy (CIMT) with home-based hand-arm bimanual intensive therapy (H-HABIT) with unilateral cerebral palsy. Half of the participants will receive CIMT and H-HABIT and others will only receive CIMT.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 12 years
* MACS level 1-3
* Diagnosed with unilateral CP due to central nervous system lesions

Exclusion Criteria:

* Severe cognitive dysfunction that rendered them unable to perform simple tasks (e.g., reaching, grasping
* Untreated seizures
* Visual or auditory problems interfering with treatment
* Prior history of musculoskeletal disorders.
* MACS level 4-5
Applying Neuromodulation to Accelerate Training Effects

This study seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills.

This study uses noninvasive electrical stimulation delivered through seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills.

Eligibility Criteria:
Inclusion Criteria:

People may participate in the experiment if they have normal or corrected vision, are in good health, and are at least 18 years old.

Exclusion Criteria:

People will be screened and excluded from participation if they are currently ill or if they report any history of seizures, if they lack the capacity to consent or appear to lack capacity to consent, if they have participated in previous thinking skills training or brain stimulation, or if they are currently taking certain substances/medications that might change thinking skills.
Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients

The goal of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with C. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. The ultimate goal is to conduct an appropriately-powered RCT to determine the optimal method for reducing C difficile infection in colonized patients.

In this study, patients will be screened for C. difficile colonization

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of 18 years of age or older identified as asymptomatic carriers of C. difficile (i.e. not meeting case definition of C. difficile infection, see below)
* Started on systemic (oral or intravenous) antibiotics for any (presumed) bacterial infection
* Patient must have vitals (heart rate, blood pressure, temperature), estimated creatinine clearance (using the Chronic Kidney Disease Epidemiology equation (CKD-Epi)) and a complete blood count available within 24 hours of enrolment

Exclusion Criteria:

* On a course of systemic antibiotics that had been started more than 72 hours ago (as current evidence suggests that the earlier probiotics are started, the more efficacious they are)
* Patient with C. difficile, i.e. presence of diarrhea (three or more loose or watery stools within 24 hours), or fevers or hypotension from C. difficile infection
* Any patients with contra-indications to probiotics or vancomycin:

  * Immunosuppressed (primary or acquired immunodeficiency, including AIDS (defined as AIDS defining condition or cluster of differentiation 4 (CD4) nadir of \<200/ul), hematologic malignancies, long-term systemic corticosteroid treatment, active treatment with chemotherapeutic agents or biologicals, autoimmune diseases, nephrotic syndrome)
  * Structural heart disease (e.g. atrial septal defect, ventricular septal defect)
  * Gastroesophageal or compromised gut integrity (e.g. short gut syndrome, intestinal injury or dysfunction, inflammatory bowel diseases including current or past history of Crohn's disease and ulcerative colitis)
  * Patients on systemic aminoglycosides, ethacrynic acid, polymixin B, or colistin.
  * Prior or current hearing loss
  * Female patients with known pregnancy or who are planning to get pregnant, or who are breastfeeding
  * Patients with end-stage renal diseases defined as an estimated glomerular filtration rate of \<15ml/min, or absence of a current estimated creatinine clearance
  * History of an allergic reaction to one of the study drugs, or sensitivity to milk
* Patients started on probiotics or oral vancomycin while in hospital
Divestment for Artery-involved Pancreatic Cancer

Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. For artery-involved pancreatic cancer (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. Yet due to the potential screening effect of this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery divestment for the treatment of ai-PC firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. This study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival.

Subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.

Overall mortality at one year after randomization will be the primary endpoint. Other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT\&MRI scan and tumor markers;
2. Age \> 18 year and \<80 year;
3. Agree to participate in the study with signed informed consent.

Exclusion Criteria:

1. Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI;
2. Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy;
3. Focal vessel narrowing or contour irregularity revealed by radiology examinations;
4. Economic situations cannot afford designed treatment.
Intravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal Function

Computer tomography (CT) is the primary imaging option for acute abdominal pain in adults. Intravenous (IV) contrast media is used to improve the CT quality. In patients with impaired renal function, post-contrast acute kidney injury (PC-AKI) has remained a significant concern. Modern retrospective studies have shown no association between worsened baseline renal function and IV-contrast CT. However, no randomised controlled trial has been done to conclude this. The INCARO (INtravenous Contrast computed tomography versus native computed tomography in patients with acute Abdomen and impaired Renal functiOn) trial is a multicentre, open-label, parallel group, superiority, individually randomised controlled trial comparing IV-contrast enhanced CT to native CT in patients with impaired renal function. Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2 are included in the study. The primary outcome is a composite outcome of all-cause mortality or renal replacement therapy within 90 days from CT.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* eGFR less than 15 or more than 45 ml/min/1.73 m2
* Renal replacement therapy within 30 days prior enrolment
* CT with IV contrast less than 72 hours prior enrolment
* Suspicion of vascular occlusion, dissection or bleeding (i.e. need for IV-contrast)
* CT needed without IV-contrast to detect or rule out ureteral stone
* IV contrast allergy
* Inability to give written consent.
Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome

The purpose of this study is to determine whether HemaMax is safe and well tolerated to support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated with the hematopoietic syndrome of acute radiation syndrome.

This is a phase 2 single dose, randomized, double-blind, placebo-controlled, multi center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HemaMax™ (rHuIL-12) in healthy adult male and female subjects considered representative of U.S. population.

Eligibility Criteria:
Inclusion Criteria:

Male and Female healthy subjects who have signed the informed consent form must meet all of the following criteria

* ≥18 to ≤75 years of age
* Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2
* Normal ECG, vital signs and laboratory test results
* Use of effective birth control method and abstinence from sex
* Negative pregnancy test and drug screen

Exclusion Criteria:

Subjects with any of the following characteristics will be considered ineligible:

* History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease
* Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB)
* Drug or alcohol addiction
* History of clinically significant allergy of any kind
* Prior use of IL-12 or HemaMax
* Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months
Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.


Eligibility Criteria:
Inclusion Criteria:

* Patients of any gender, aged 50 to 80 years
* Signed informed consent form
* Healthy eyes besides cataract
* Assured follow-up examinations
* Stable corneal conditions within the last 12 months
* Corneal astigmatism less than 1D
* Implantation into the capsular bag by injector

Exclusion Criteria:

* Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
* Pseudophakia
* Cornea guttata; keratoplasty
* Irregular astigmatism (e.g. Keratoconus)
* Corneal scarring
* Diabetic retinopathy
* Aniridia
* Amblyopia
* Amotio operation; anamnesis with vitreous surgery
* Pseudoexfoliation Syndrome; Uveitis
* Previous intraocular and corneal surgery
* Intraocular tumours; endotamponade
* Glaucoma or IOP higher than 24mmHg
* Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to \> 0.3 logMAR
* Need for a dioptre out of the range of +16.0D to +26.0D
* Inability to achieve secure lens placement in the capsular bag
* Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
* Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis
* Pregnancy or lactation period for female patients
Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria

Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.

The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring catheters.

Urinary tract infection (UTI) is the most common healthcare associated infection (HAI) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the United States, of which 75% are associated with indwelling urinary catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs.

The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring catheters for more than 72 hours. This study will also evaluate the efficacy in reducing bacteriuria of the Accuryn silver fabricated silicone catheters.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (age ≥ 18)
2. Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent
3. Indication for a urinary bladder catheter (or one currently in place)
4. Expected urinary catheter requirement ≥ 72 hours
5. No current urinary tract infection
6. No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours

Exclusion Criteria:

1. Inability to receive a urinary bladder catheter
2. Chronic suprapubic catheter in place
3. Expected survival \< 72 hours
4. Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery
5. Surgery of the genitourinary tract in the past 6 months prior to admission
6. Deemed unfit for the protocol by the investigator for any reason
MOVIDA 1 Ter - Evaluation of the Cobas® Plasma Separation Card in the Field in Vietnam

In low- and middle-income countries, viral load (VL) monitoring of patients living with HIV and followed on antiretroviral therapy (ART) in remote settings is still scarce. Barriers to VL monitoring are essentially the limited access to a laboratory able to perform this measurement, its cost, as well as the lack of human and material resources. Blood sampling using dried blood spots (DBS), which has been validated and is immediately available, could overcome these barriers. With DBS, transfer and conservation of samples are simplified enabling access to VL monitoring to patients seeking care in sites far from laboratory facilities. Use of DBS also offers the advantage not to require extensive investments.

To guide decision makers in the implementation of strategies to scale-up HIV VL monitoring in remote settings, field evaluations of DBS in routine conditions are needed. It is in this context that we propose this field evaluation of the Cobas® plasma separation card in Vietnam

In Vietnam, in 2018, HIV prevalence was estimated at 0.3% among adults and the estimated proportion of PLHIV on ART was 65%, however the HIV epidemic is essentially concentrated in people who inject drugs, men who have sex with men and sex workers.

As of today, routine HIV VL monitoring is not yet available in remote settings in Vietnam. Despite an initiative we conducted and that documented the feasibility of DBS use in remote settings, and although no genuine roll-out of POC machines is yet observed in the field, the Ministry of Health of Vietnam has not yet decided to scale-up HIV VL monitoring using DBS. More field evaluations are needed to convince the Ministry of Health that DBS can effectively be used to scale-up HIV VL monitoring.

The aim of the present study is to evaluate the sensitivity and specificity of HIV VL measurement using the cobas® plasma separation card (PSC) against plasma at the threshold of 1000 copies/mL (threshold currently used to define failure in Vietnam, following the WHO guidelines).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* HIV-1 infected adults
* Willing to participate to the study by giving his/her consent

Exclusion Criteria:

* None
Air Suspension Biodegradable Patient Transport Pad

On the one hand, transferring patient from bed to bed is usually handling by the manual lifting of several staffs or utilizing bedsheet, slide sheet , shovel-style stretcher or other devices to move and lift patients. Whatever, there are some advantages using these devices.

On the other hand, nurses are among the professionals at the highest risk for musculoskeletal disorders. The Bureau of Labor Statistics has shown that overexertion in manual lifting was the main event or exposure leading to injury or illness involving time away from work. Excessive weights, awkward postures, and repetitive motions are some of the known risk factors that contribute to sprains/strains and back injuries. During the process of patient transferring , it refers to the above risk factors for health-care workers. It recommended that using appropriate assistive equipment can reduce the injuries. If staff is safe, patients are safer.

The research team has designed and produced a new transport assistive devices-- biodegradable and air-suspending transfer mattress, which was precisely controlled by gas flow and based on ergonomics. And then apply it to the clinic in order to find whether it's benefit for patients and nursing staff.

It is a randomized controlled trial design.

Research design：randomized controlled trials. Computer generated random numbers. The patients were randomly divided into three groups, ① transfer patients by air-suspending mattress, ② transfer patients by slide board, ③ transfer patients by bedsheets.

Participants: passive patient with transports needs, such as CT/ MRI examination etc. The sample size estimation was according to the formula of multiple parallel design. The main outcome measure was the perceived exertion.

Eligibility Criteria:
Inclusion Criteria:

* Passive patient with transfer requirements, such as CT/ MRI examination , transfer from one department to another etc；Patients or their family signed an informed consent.

Exclusion Criteria:

* The patients weighted over 150kg and have spine fracture ；age\< 15 years old.