cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Monitoring: Impact on Patient Management and Outcomes

Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery.

In skilled nursing facilities (SNFs) and assisted living facilities (ALFs), managing patient health presents considerable hurdles in accurately identifying and responding to deteriorating conditions. The intricacies of care within these settings are compounded by a high patient-to-healthcare provider ratio, often leading to infrequent vital sign checks with significant time gaps between assessments. This monitoring gap may result in overlooking early signs of health decline, potentially causing adverse patient outcomes. A February 2014 report by the Office of Inspector General (OIG) underscored this issue, revealing that around 22% of Medicare beneficiaries experienced adverse events during their stays in SNFs, with an additional 11% facing temporary harm events. Notably, 59% of these incidents were considered preventable, largely due to insufficient patient monitoring, care delays, and substandard treatment. In response to these challenges, Turtle Shell Technologies (TST) Private Limited has developed Dozee Pro NX, an innovative system tailored to improve patient monitoring in these healthcare settings. This system employs non-invasive sensors to continuously monitor crucial parameters such as heart rate, respiration rate, blood pressure, temperature, and SpO2. Distinguished from traditional patient monitoring devices, Dozee Pro Nx offers advanced functionalities, including customizable notifications to alert healthcare providers of vital sign deterioration, thereby enabling prompt intervention. The primary objective of this clinical study is to evaluate the potential impact of the Dozee Pro Nx system on patient outcomes, healthcare practitioner efficiency, and overall healthcare costs. This investigation aims to ascertain whether the implementation of this advanced monitoring technology can effectively address the identified gaps in patient care within SNFs and ALFs, ultimately leading to improved health outcomes and enhanced care delivery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Weight between 40kg-120kgs

Exclusion Criteria:

* Terminal illness with a life expectancy of less than 1 month.
* Have any condition that could interfere with the subject's ability to lie flat or stable on the bed
* Needs the use of equipment whose operation can interfere with Investigation System operations
* Patients planned to be transferred from the facility within 72 hours
* Prisoners
* Pregnant
Desensitization of Renal Transplant Candidates

Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.

Pre-formed HLA antibodies prevent renal transplantation because of the risk of hyperacute rejection. We propose a prospective study evaluating the efficacy of Enteric Coated Mycophenolate Sodium (Myfortic) in decreasing the titers of anti-HLA alloantibodies in patients awaiting kidney transplantation. Myfortic is an immunosuppressant that inhibits the proliferation of B and T cells by blocking the enzyme inosine monophosphate dehydrogenase. We will attempt to determine whether a 6-week course of Myfortic adequately decreases the antibody reactivity to a level compatible with transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients on the deceased donor kidney transplant waiting list with panel reactive antibodies \>50% and living donor waiting list patients who have a history of a positive crossmatch (donor-specific antibodies) will be eligible for the study.

Exclusion Criteria:

* Any subjects not meeting the Inclusion Criteria
* Subjects unable to attend weekly clinic visits for six weeks
* Inability to tolerate Myfortic
A Multicenter Pediatric Deep Brain Stimulation Registry

There is limited data on outcomes for children who have undergone deep brain stimulation (DBS) for movement disorders, and individual centers performing this surgery often lack sufficient cases to power research studies adequately. This study aims to develop a multicenter pediatric DBS registry that allows multiple sites to share clinical pediatric DBS data. The primary goals are to enable large-scale, well-powered analyses of the safety and efficacy of DBS in the pediatric population and to further explore and refine DBS as a therapeutic option for children with dystonia and other hyperkinetic movement disorders. Given the current scarcity of evidence available to clinicians, this centralized multicenter repository of clinical data is critical for addressing key research questions and improving clinical practice for pediatric DBS.

The use of deep brain stimulation (DBS) has expanded to include multiple conditions in children including dystonia, epilepsy, Tourette syndrome and mood disorders. Despite its growing application, DBS remains a low-volume procedure in most pediatric centers, which limits opportunities for large-scale research studies. To overcome this challenge, an international data-sharing platform is essential for advancing knowledge about DBS in pediatric patients, particularly concerning surgical techniques and patient outcomes across various conditions.

This study aims to establish a multicenter pediatric DBS registry. With limited data on pediatric DBS outcomes and a small number of cases at individual centers, there is a need for a comprehensive registry to enable large-scale, well-powered analyses of DBS safety and effectiveness. The primary goals of this study are to:

* Establish and implement a multi-center pediatric DBS registry
* Facilitate large-scale analyses of DBS safety and effectiveness in children
* Refine DBS as a treatment option for dystonia and other hyperkinetic movement disorders in children.

Secondary objectives include:

* Identifying which patients benefit most from DBS
* Determining clinical variables that influence DBS responsiveness
* Identifying optimal implant sites for specific conditions
* Understanding the long-term effects of DBS in children
* Assessing the impact of DBS on the quality of life in pediatric patients

The study will involve both prospective and retrospective data collection from pediatric DBS patients.

Eligibility Criteria:
Inclusion Criteria:

* Female or male patients between ages of 0-18 years.
* Having received or scheduled to receive DBS for any neurological movement disorder.
* Parents or legal guardians are able to provide written consent for prospective enrollment.
Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment

Researchers are studying ways to predict if cancer patients are at risk for poor nutrition during their chemotherapy treatment. They hope to identify children with nutrition problems early in treatment. This may help prevent weight loss and other nutrition problems later in treatment.

The PEDSGA is a newly developed nutrition tool that includes a training manual that be used to teach health care professionals to identify at-risk patients by doing a nutrition physical exam. The PEDSGA also includes questions that the patient/caregiver answers regarding appetite, recent treatment, and activity level. This method of screening is new and may be able to identify at-risk patients better than the standard method. This study will use both methods and evaluate the two, in hope of determining which method works best to identify at-risk patients.

Eligibility Criteria:
Inclusion Criteria:

* St. Jude Children's Research Hospital patient between 2 and 16 years of age who is actively receiving treatment for a hematologic or solid tumor malignancy
* Patient is not admitted to the transplant service
* Patient is able to read English or Spanish
Efficacy of a Fibrin Sealant in Burn Surgery

The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation.

Burn patients require extensive split-thickness skin grafting operations. These operations necessitate excision of burn wounds and the procurement of autografts. Both of these result in bleeding open wounds. Fibrin sealants may be of benefit in three aspects of burn surgery:

1. as a hemostatic agent on excised burns,
2. as a hemostatic agent on donor sites, and
3. as a method of fixation of skin grafts to wounds.

Skin grafts are routinely secured with surgical staples. Patients with large burns will commonly have hundreds, even thousands of staples used during the course of their care. Problems associated with the use of surgical staples include:

1. discomfort upon removal and
2. staples become deeply embedded in the tissue.

If effective in securing skin grafts, fibrin glue would directly benefit burn patients by decreasing the number of staples required, and thereby decreasing the number of retained staples. Fibrin sealant is produced from human fibrinogen and human thrombin from pooled plasma that is virally inactivated by a two-stage heating process.

Subjects will serve as their own control. They will have an area of their wound treated with the fibrin sealant and another area treated with the standard of care. Both areas will be compared for hemostasis, skin graft fixation, wound healing, and cosmetic outcome.

Eligibility Criteria:
Inclusion Criteria:

* Requires skin grafting of an acute or reconstructive burn wound.

Exclusion Criteria:

* Active disseminated intravascular coagulation (DIC) or known hypersensitivity to bovine protein.
Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects

This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
* Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.

Exclusion Criteria:

* Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
* Subjects who had any corneal refractive surgery in the study eye.
* Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
* Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
* Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
* Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
* Subjects who are monocular.
D-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)

The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer (NSCLC).

60 patients with stage Ⅲb～Ⅳ NSCLC will be randomly divided into group A（receive D-CIK treatment and chemotherapy) or group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).

Eligibility Criteria:
Inclusion Criteria:

* The patient who have singed the informed consent;
* Histologically confirmed with NSCLC at stage Ⅲb～Ⅳ;
* Expected survival time is more than 2 month;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.

Exclusion Criteria:

* Hemoglobin\<8.0 g/dL,White blood cell \<3 x 10\^9/L;Platelet count \<75 x 10\^9/L; ALT, AST, BUN and Cr more than normal limits on 3.0 times;
* Known or suspected allergy to the investigational agent or any agent given in association with this trial;
* Pregnant or lactating patients;
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
* Patients who are suffering from serious autoimmune disease;
* Patients who had used long time or are using immunosuppressant;
* Patients who had active infection;
* Patients who are suffering from serious organ dysfunction;
* Patients who are suffering from other cancer;
* Other situations that the researchers considered unsuitable for this study.
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection

To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the two-year survival after transplantation, the interaction between HCV and HIV after transplantation, the influence of HIV on HCV recurrence after transplantation, the interaction between immunosuppressive and antiretroviral drugs in particular anti-proteases, immunological follow-up and quality of life of these patients

Until recently, HIV infection was considered as a contraindication for liver transplantation. A dramatic improvement in survival of HIV patients have been observed since the advent of new antiviral treatments against HIV including antiproteases. However an important proportion of patients with HCV-HIV coinfection are suffering from life-threatening liver disease due to HCV infection. Liver transplantation may be considered in this particular group of patients.

The ideal timing for the indication of liver transplantation during HIV disease and during the course of HCV liver disease needs to be defined. Liver transplantation in this particular group of patients raised several questions : a) the role of HIV infection on prevalence and severity of HCV recurrence after transplantation ; b) the role of liver transplantation and immunosuppression on HIV disease ; c) drug interactions between immunosuppressive agents and antiproteases ; d) immunological follow-up and quality of life of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Coinfection HIV-HVC
* Indication of liver transplantation for severe hepatopathy with life threatening:repetitive ascitis or infection of ascitis or icterus or decreased of prothrombin index under 50 percent or digestive haemorrhage by portal hypertension uncontrolled

Exclusion Criteria:

* Toxicomania
* Alcohol consumer (over 30g per day)
* AgHBs positive
* hepatocarcinoma over 5 cm or 3 nodules
* CD4 below 200/mm3
* Viral load below 400 cp
* HIV stade C
Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol.

This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years
2. History of type 2 diabetes mellitus for at least 3 months
3. Prior therapy with dietary management, oral agents, or insulin
4. Non child-bearing potential or a negative urine pregnancy test
5. Initial blood glucose in ER \> 200 mg/dl

Exclusion Criteria:

1. Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
2. Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention.
3. History of current drug or alcohol abuse.
4. History of current mental illness
5. Inability to give informed consent
6. Female patients who are pregnant or are breast feeding
7. Patients who have clinically significant liver disease with AST/ALT (aspartate transaminase/alanine transaminase) \> 3 times the upper range of normal
8. Patients currently treated with dialysis
Quantitative Requirements of Docosahexaenoic Acid for Neural Function in Children With Phenylketonuria

Patients with phenylketonuria (PKU) have an inborn error in the metabolism of the amino acid phenylalanine (Phe) and thus must follow a strictly controlled protein-restricted diet from early infancy. This protein-restricted diet is devoid of natural dietary sources of n-3 long chain polyunsaturated fatty acids (LC-PUFA), such as eggs, meat, milk or fish. Therefore, blood concentrations of n-3 LC-PUFA, especially of docosahexaenoic acid (DHA) are reduced in PKU children compared to healthy controls. DHA availability is considered important for optimal neurological function. Previous studies have shown that neural function of PKU children is improved by high dose supplementation of fish oil providing DHA, as shown by significant improvements of both visual evoked potential latencies and of fine motor skills and coordination, but no dose response relationship has been established so far.

This multicentric double-blind randomized trial aims at determining quantitative DHA requirements for optimal neural function in PKU children. Patients with classical PKU from several major treatment centers in Europe will be randomized to receive between 0 and 8 mg of DHA per kg body weight daily for a duration of 6 months. Biochemical (fatty acid composition of plasma phospholipids, lipoprotein metabolism and metabolic profiles), and functional testing (visual evoked potentials, fine motor skills, cognitive function and markers of immune function) will be performed at baseline and after 6 months. Intake per kg body weight will be related to outcome parameters and thus a possible dose response relationship will be defined. The results from this study are expected to contribute to the improvement of the diet of PKU patients, but they also have the potential to help defining quantitative DHA needs of healthy children.

The primary hypothesis is that supplementation with DHA improves visual function in children with PKU.


Eligibility Criteria:
Inclusion Criteria:

* Children with classical PKU, who have been diagnosed and treated from the newborn period onwards
* Classical PKU must have been established by a baseline plasma phenylalanine (PHE) level \>1200 µmol/L or detection of underlying mutations
* Children are clinically healthy besides classical PKU
* Good metabolic control (a minimum of 2 Phe-values during the last 6 months are needed with average Phe values being below 480 µmol/L in the last 6 months)
* No n-3 LC-PUFA supplementation for at least 6 months before enrolment
* Written informed consent of parents exists

Exclusion Criteria:

* Severe neurological symptoms
* History of neurological disease
* Children are unable to take DHA-capsules regularly
* Acute illness, especially infections at the time of clinical examination/testing
* Children with weight/height over the 97th percentile or below the 3rd percentile
* Known hypersensitivity to fish oil products
A Clinical Investigation of the M2a- Taper™ Hip System

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- Taper™ Hip System


Eligibility Criteria:
Inclusion Criteria:

* Patients having primary cemented or cementless total hip replacement for non-inflammatory degenerative joint disease (NIDJD), or any of its composite diagnoses of:

  1. Osteoarthritis,
  2. Avascular Necrosis,
  3. Traumatic arthritis,
  4. Subcapital fracture,
  5. Legg Perthes,
  6. Slipped Capital Epiphysis,
  7. Fracture of the pelvis,
  8. Diastrophic Variant
* Patients with full skeletal maturity.
* Patients undergoing unilateral total hip arthroplasty or bilateral total hip arthroplasty, either staged or simultaneously.
* Patients of all races and gender.
* Patients who are able to follow postoperative care instructions.
* Patients who are able and willing to return for follow-up evaluations.
* Patients have a preoperative total Harris Hip Score less than 70 with at least moderate pain.

Exclusion Criteria

* Patients diagnosed with inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematous, pigmented villonodular synovitis, juvenile rheumatoid arthritis and other arthritic processes of inflammatory or autoimmune etiology.
* Patients less than 18 years.
* Patients with the presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
* Patients with previous Girdlestone procedures.
* Patients with above the knee amputation of the contralateral and/or ipsilateral leg.
* Patients with osteoporosis, or marked bone loss which would preclude proper fixation of the prosthesis.
* Patients who are pregnant.
* Patients with an active or suspected infection in or around the hip.
* Patients with Parkinson's disease.
* Patients with vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb.
* Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue which would prelude stability of the prosthesis.
* Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
* Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless total hip replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
* Patients with previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome, e.g., Paget's disease, Charcot's disease, severe osteoporosis compromising bone stock (Dorr type C bone).
* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
* Patients with a "fused" hip.
* Patients who have had a total hip arthroplasty on the contralateral hip within the last year.
STAMP: Sharing and Talking About My Preferences

The purpose of this study is to examine the effect of an individually transtheoretical model (TTM) tailored intervention on the completion of advance care planning (ACP) behaviors.

This will be a randomized controlled trial examining the effect of an individually TTM-tailored intervention on the proportion of middle-age and older persons recruited from primary care practices who complete four ACP behaviors (completion of a living will, assignment of a health care proxy, and communication with loved ones and with their clinician about views on quality versus quantity of life) over six months, compared with usual care.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be community-dwelling persons with an upcoming primary care visit in the study's practice settings.

Exclusion Criteria:

* Severe hearing impairment, defined as being unable to participate in a telephone conversation.
* Severe visual impairment, defined as being unable to read large-print materials.
* Moderate to severe cognitive impairment, defined as either a diagnosis of dementia and/or short-term recall of \<2/3 objects at 2 minutes.
* Primary language other than English.
* Having completed all of the four ACP behaviors that are the focus of this study.