cyrilzakka/clinical-trials huggingface dataset:
Developing a Risk Assessment System of Multidrug-resistant Organisms Infection

1. A retrospective analysis was performed to determine the prevalence of multidrug- resistant organisms infection in ICU from October 2017 to October 2019.
2. Non-MDRO patients were selected by random sampling in a ratio of 1:1 to the final MDRO group during the same period , and select the risk factors of infection with multi-drug resistant bacteria by comparing the two groups.
3. Randomly select 30% of the sample size as the validation set, and the remaining 70% for the training set to establish a model. Using multi-factor Logistic regression, decision tree classification, artificial neural network, support vector machine, Bayesian network Method to establish risk assessment system for multidrug-resistant organisms infection respectively.Using validation set data to calculate the area under the ROC curve (AUC) and sensitivity, specificity of models and comparing the prediction accuracy of several models. Finally, choose a more suitable risk assessment system for multidrug-resistant organisms infection.
4. Predict the patient's infection risk level according to the best risk assessment system and develop a low-to-high intervention plan.


Eligibility Criteria:
Inclusion Criteria：

* Duration of ICU admission ≥ 48h
* no less than 18 years old

Exclusion Criteria:

* Patients with MDRO infection at the time of admission
* Lack of case data
* MDRO colonized patients
Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.

OBJECTIVES:

* Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2.
* Assess the toxicity associated with this treatment.

OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited.

Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed renal cell carcinoma (RCC) that is metastatic or recurrent

  * No central nervous system or major nerve involvement
  * No more than 25% estimated hepatic replacement by tumor on CT or MRI
* Measurable disease required

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 80%-100%

Life expectancy:

* Greater than 3 months

Hematopoietic:

* Platelet count at least 80,000/mm3

Hepatic:

* Bilirubin normal
* AST and ALT no greater than 3 times normal

Renal:

* Creatinine normal

Cardiovascular:

* Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG)

Pulmonary:

* FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray)

Other:

* No sites of ongoing bleeding
* No HIV antibody or AIDS
* No hepatitis B antigen
* No systemic infection
* No requirement for steroids
* No psychiatric disease that precludes informed consent or safe administration of immunotherapy
* No second malignancy except:

  * Basal cell carcinoma
  * In situ cervical cancer
  * Other cancer provided all evaluable lesions are documented RCC
* No pregnant or nursing women
* Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior interleukin-2 therapy

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 28 days since therapy for RCC
Does tDCS is Effective in the Prophylactic Treatment of Migraine

Migraine has been described as one of the most common neurological diseases, with high social and economic impact. Despite the high prevalence, the pathophysiology of migraine is still unknown, several studies have been developed in order to advance the understanding of the pathophysiological mechanisms of the disease which are not yet entirely elucidated. The aim of this study is to observe the effects of transcranial direct current stimulation (tDCS), applied in the visual cortex, on neurophysiological and clinical measures (frequency, intensity, duration of attacks and severity of pain) in migraine patients.


Eligibility Criteria:
Inclusion criteria for migraine patients:

* Age must be between 18 to 40 years
* Gender: male and female
* Diagnosis must meet the 2004 IHS criteria for migraine without aura and migraine with aura
* Duration of the disease must be at least 12 months
* Patients had no preventative medication consistently for at least six months prior to study initiation.

Inclusion criteria for healthy individuals

* Age must be between 18 to 40 years
* Gender: male and female
* Individuals who have not filed headache crisis in the last year assessed according to the 2004 IHS criteria

Exclusion criteria

* Pregnant woman
* Individuals with clinical evidence of brain injury
* Metallic implant head
* Pacemaker
* History of seizure and chronic pain associated with other pathologies
Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness

This study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness

This prospective study included 31 patients who underwent slanted lateral rectus muscle recession for intermittent exotropia with convergence weakness. Measurements of preoperative and postoperative deviation angle, stereopsis was performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more
* Patients with follow up duration greater than 6 months

Exclusion Criteria:

* Patients with previous ocular or strabismus surgery
* Patients with ocular or neurologic pathologic conditions
* Follow up duration less than 6 months
Assessing Feasibility of Prolonged Repetitive Near Infrared Light Stimulation in Early to Mid-Stage Dementia

This study will gather data to see if infrared and near infrared light frequency can increase the activity of brain cells and provide support for the cell's ability to repair and protect themselves against further damage.

Research suggests that impaired regional cerebral blood flow (rCBF) \[flow of blood in certain parts of the brain\] plays an important role in dementia. Infrared and near infrared light frequency has been shown to increase the activity of brain cells and provide support for the cell's ability to repair and protect themselves against further damage. This study will evaluate the effects of repeated brief exposure to near infrared light stimulation twice a day on subjects that have problems such as attention span, working memory, strategies of learning and remembering, planning, organizing, self-monitoring, inhibition and flexible thinking for an 8 week period.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50-85 years with an independently provided diagnosis of dementia, probable Alzheimer's type.
* Dementia symptoms not greater than early to mid-stage dementia
* Generally healthy as indicated by recent physical examination within the last 6 months
* If labs are available within the last 6 months, renal function, hepatic function, cardiac function should be normal

Exclusion Criteria:

* Diagnosed actively growing intracranial pathology (tumors etc.)
* Misusing illegal substances or alcohol
* Previous history of stroke
* History of aggression or violence
* History of major psychiatric illness
* No underlying CNS pathology (confined to tumor, epilepsy only)
User Study of an Investigational Blood Glucose Monitoring System

This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes
* 18 years of age and older
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Previously participated in a study using this investigational system
* Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
* Pregnancy
* Hemophilia or any other bleeding disorder
* Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
* A condition which, in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
The Clinical Utility of Overtube Use at the Time of Endoscopy

Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease® spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical, Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are to evaluate the efficiency of an overtube system for visualization of small bowel. The hypothesis is that this will permit more complete and efficient evaluation of the small intestine.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 18 years.
2. Have an indication for enteroscopy as determined by the patient's physicians. These indications include, but are not limited to, obscure gastrointestinal bleeding, malabsorption, suspected small bowel tumor, small bowel strictures, small bowel ulceration, and abnormal imaging of the small bowel.
3. Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida, as medically indicated.
4. Subject must be able to give informed consent.

Exclusion Criteria:

1. Platelets \< 75,000.
2. INR \> 1.6.
3. NSAIDS within 48 hours of procedure.
4. Pregnancy.
5. Esophageal stricture.
6. Inability to give informed consent.
A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics

This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each period, participants will receive once daily injections of stable dose LY2605541 or insulin glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats and sugars. Participants will continue to use meal time insulin throughout the study. Healthy participants will also enroll in the study. They will not receive any study medication.


Eligibility Criteria:
Inclusion Criteria:

Type 1 Diabetics:

- T1DM for more than 1 year with Hemoglobin A1c (HbA1c) of less than 9.5%

All Participants:

* Otherwise fit and healthy
* Non smoker

Exclusion Criteria:

Type 1 Diabetics:

* Taking medication or supplements other than insulin to control diabetes
* Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia

All Participants:

- Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids
Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty

The aim of this research is to confirm the effectiveness of remimazolam in preventing delirium during recovery from anesthesia in adult patients who have undergone one of the rhinological surgeries (septoplasty, rhinoseptoplasty or functional endoscopic sinus surgery).

Patients aged 18-65, ASA classification I-II will be anesthetized with balanced anesthesia maintained with sevoflurane and will be randomized into two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline solution.

The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be the postoperative pain level, the length of stay in the recovery room, the presence of unwanted events in the recovery room, and the presence of postoperative mood changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for rhinoplasty, rhinoseptoplasty or FESS
* ASA I or II

Exclusion Criteria:

* pregnancy
* patients treated with psychiatric medication (in the time of operation or 6 months prior to operation)
CO2 Laser Phototherapy for Management of Mature Burn Scars

Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

Laser phototherapy has gained growing acceptance and popularity for management of burn scars. The most commonly used laser is the Carbon Dioxide (CO2) Laser. At this institution, the investigator has used CO2 for management of Burn Scars since 2012. While the existing literature and the investigator's anecdotal experience thus far has been positive overall, there is no conclusive evidence to support that CO2 does indeed improve the quality of mature burn scars

The primary objective of this study is to evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 to 21
* Patients with mature burn scars that are at least two years old from burn injury and that have not previously undergone CO2 laser therapy for scar revision.
* Scars in all body areas with the exception of face, genitals or hands will be considered eligible for the study
* Entry into this study is open to pediatric patients of both genders.
* Entry into this study is open to pediatric patients of all ethnic backgrounds.
* Entry into this study is open to females of childbearing potential with a negative urine or serum pregnancy test

Exclusion Criteria:

* Patients with scars less than 2 years old
* Patients with contraindications to laser treatment (i.e.: active acne infections/ treatment with isotretinoin, active Zoster infection)
* Patients receiving other forms of scar revision therapy such as other laser types, steroid injections, or surgical excisions.
Rehabilitation in Patients With Human Lymphotropic Virus Type I

In our times, it is known that approximately 5% of patients seropositive for HTLV-1 may desengage a frame with several neurological disorders, which is called myelopathy associated with HTLV-1, characterized for gait, decreased dynamic balance and limitation of walking independence the use of walkers, crutches as in wheelchairs. This evolution of the disease is based, above all, on muscle changes, such as inflammation of the muscles, which contributes to the attenuation of muscle capacity . In addition, muscle changes caused by HTLV-1 also affect the respiratory muscles, causing a change in respiratory mechanics, which can impair alveolar ventilation and, therefore, the development of a restorative respiratory disorder, reducing total lung capacity. Therefore, it is perceived the importance of offering planned rehabilitation according to the global assessment of the health status of these patients, considering their influence on activities of daily living.The focus of this study is on the weekly respiratory muscle training, as assessed by mensuration maximal inspiratory pressure, showed significant results in improving lung capacity and in this way promoting the prevention of pulmonary complications. Therefore, the protocol proposed by the present study includes respiratory muscular training plus resistance exercise, assessing the impact on both the strength muscular respiratory to as peripheral muscles, through the palmar pressure test and consequent enhancement of quality life and functionality of these patients. Furthermore, it will be possible to contribute to the knowledge of society and the scientific community about this theme, which is still very small in the world literature.


Eligibility Criteria:
Inclusion Criteria:

* Seropositive carriers for HTLV-1 with PET

Exclusion Criteria:

* lung diseases
* heart disease
* arterial hypertension
* cognitive impairments
REM (Risk Of Endometrial Malignancy)

The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.

Objective: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help physician are needed, in order to triage patients into high and low risk of endometrial cancer (EC). The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.Women, between 45 and 80 years, diagnosed with ultrasound endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical, ultrasound and laboratory features were taken into account. Logistic regression algorithm was utilized to categorize patients into low and high risk groups for EC.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 45 and 80 years;
2. Eastern Cooperative Oncology Group performance status 0-2 according to World Health Organization (WHO) criteria;
3. informed consent obtained from the patients.

Exclusion Criteria:

1. abnormal cardiac, haematological, renal, respiratory and/or hepatic functions;
2. presence of a previous malignancy;
3. presence of concomitant adnexal masses.
Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

This is a prospective, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of olaparib versus enzalutamide or abiraterone in subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have a qualifying tumor mutation in one of 15 genes involved in the homologous recombination repair (HRR) pathway. Subjects will be divided into two cohorts based on HRR gene mutation status.

Approximately 340 subjects will be randomized 2:1 (olaparib : investigator choice of enzalutamide or abiraterone acetate) into the trial.

Eligibility Criteria:
Inclusion criteria

1. Histologically confirmed diagnosis of prostate cancer.
2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
3. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
4. Ongoing therapy with LHRH analog or bilateral orchiectomy.
5. Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
6. Qualifying HRR mutation in tumor tissue.

Exclusion criteria

1. Any previous treatment with PARP inhibitor, including olaparib.
2. Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose \> 5 years prior to randomization.
3. Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥5 years.
4. Subjects with known brain metastases.
Amsterdam Stool Scale: Usefulness in Clinical Setting

The aim of this study is to assess interobserver and intraobserver variability of the Amsterdam Stool Scale in clinical practice. After passing a stool by the child participating in the study it will be assessed using the Amsterdam Stool Scale independently by one of the parents and the medical doctor. At the same time a parent will take 2 photos that will be independently evaluated by another doctor.

INTRODUCTION:

Description of stool appearance is important in clinical practice. Parents are often asked to evaluate stool of their child. At present parents also take more frequently photos using smartphone camera when they are concerned with child's stool appearance and show it to their doctors. To make stool evaluation easier there have been stool form scales created. One of this is Amsterdam Stool Scale that enables stool assessment of children who are not yet toilet trained. This scale facilitates to describe amount, consistency and color of the stool.

AIM:

To assess interobserver and intraobserver variability of the Amsterdam Stool Scale in clinical practice.

METHODS:

After passing a stool by the child participating in the study, within a short-time interval (\<5 min), the stool will be assessed independently by one of the parents and the medical doctor. At the same time a parent will take 2 photos with phone camera. The photographs then will be independently evaluated by another doctor who will be unaware of both the "in vivo" stool appraisal and child condition.

STATISTICAL ANALYSIS:

Then the interobserver (between a parent, the doctor and the doctor assessing photograph) variability will be evaluated by calculating the kappa (κ) statistics for nominal data for the stool consistency, amount and color separately.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-18 months of age
* Lack of ability to use the toilet

Exclusion Criteria:

* Lack of parental consent to participate in the study
* Parental inability to understand the study procedures