cyrilzakka/clinical-trials huggingface dataset:
Detection of Bloodstream Pathogens in Hematological Malignancies

* To identify the common bacterial and fungal species causing fungemia and bacteremia in hematological malignancies.
* To identify sensitivity pattern for causative microbes.
* Compare culture on ordinary media with Vitek2 (automated microbial identification system) and multiplex polymerase chain reaction (PCR )

Sepsis is a global health problem and an estimated 17 million cases of sepsis occur each year in the world .The early initiation of appropriate antibiotic therapy is determinant for the prognosis and survival of patients with bloodstream infections . Infections in patients suffering from hematological malignancies are a frequent problem, leading to higher mortality and morbidity, increased costs of health care and prolonged duration of hospitalization. Common among these infections are those involving the bloodstream. In febrile neutropenic patients, the attack rate of bloodstream infection was reported to be between 11 and 38% . Hematological malignancies by themselves or by their therapeutic strategies, put patients at risk for infections. Wide use of antibiotics and prophylactic agents in such patients has led to the development of resistance. The general term fungemia describes the presence of a fungal species in the blood while term bacteremia describes the presence of bacterial species in the blood A positive culture may indicate a widespread infection or commonly, the infection of an intravenous catheter .Fungal microbes are abundant in nature and are frequent colonizers on human mucosal surfaces. However, under conditions of impaired immune responses or a break in host barriers, fungi are able to invade normally sterile areas of the human body, where they can cause severe infections that are difficult to recognize and treat and are often ultimately lethal .Indeed, recent epidemiological data show that invasive fungal infections (IFIs) are frequently encountered in clinical practice, with the most common offenders, being Candida spp. and Aspergillus spp. In order to effectively eliminate these infections, early diagnosis and species identification are of paramount importance. Traditional diagnostic methods such as blood culture is still considered the gold standard .Indeed ,novel molecular and non molecular techniques have been developed and currently under clinical evaluation . The VITEK 2 is an automated microbial identification system that utilizing growth-based technology. With its colorimetric reagent cards, the VITEK 2 offers a state of the art technology platform for phenotypic identification methods. The application of the multiplex polymerase chain reaction PCR method in the diagnosis of bloodstream infections is designed to reduce the time for identification of the microorganisms grown from the positive samples to 24-48 hours, as pathogens are identified directly from a positive blood sample

Eligibility Criteria:
Inclusion Criteria:

* hematological malignancy patients on chemotherapy associated with fever

Exclusion Criteria:

* Age below 18 years old
Contrast-Enhanced Ultrasound for the Prediction of Bile Duct Cancer Response to Radioembolization Treatment

This phase II trial tests whether contrast-enhanced ultrasound can predict the response of bile duct cancer to targeted radiotherapy (radioembolization treatment). Contrast-enhanced ultrasound uses gas microbubbles that may provide enhancement on ultrasound. It is also possible to pop these microbubbles using ultrasound imaging. Tumors that experience popping of these microbubbles may be easier to kill with radiotherapies. Therefore, this trial may also help doctors see if ultrasound-triggered microbubble popping can improve bile duct cancer response to radiotherapy. Another purpose of this trial is to test if the pressure inside the tumor estimated through ultrasound can be used to predict the tumor response to radiotherapy.

PRIMARY OBJECTIVE:

I. To determine the ability of quantitative volumetric contrast-enhanced ultrasound (CEUS) to predict non-hepatocellular carcinoma (HCC) tumor response to transarterial radioembolization (TARE) prior to therapy.

SECONDARY OBJECTIVES:

I. To characterize the safety and preliminary efficacy of using localized ultrasound contrast agent (UCA) inertial cavitation to improve ICC response to radioembolization.

II. To determine if CEUS estimated tumor perfusion and residual vascularity 7-14 days post treatment can predict ICC response to radioembolization.

III. To evaluate tumoral response using the patient's 1 month magnetic resonance imaging (MRI) (obtained clinically) and determine the accuracy of MR or computed tomography (CT) tumor evaluation at this earlier time point.

EXPLORATORY OBJECTIVE:

I. To examine the utility of subharmonic aided pressure estimation (SHAPE) to noninvasively monitor tumoral interstitial fluid pressure (IFP) and provide an early biomarker of radiotherapy response.

OUTLINE:

Patients receive perflutren protein-type A microspheres intravenously (IV) over 10 minutes and undergo ultrasound at 1 month before TARE, 1-4 hours, 1 week, and 2 weeks post-TARE.

After completion of study, patients are followed for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Be scheduled for sub-lobar radioembolization therapy of a previously untreated intrahepatic cholangiocarcinoma greater than 1 cm but small enough to be fully visualized in the ultrasound three-dimensional (3D) volume (approximately 6 cm maximum diameter, but depth dependent)
* Be at least 18 years of age
* Be medically stable
* If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam
* Have signed Informed Consent to participate in the study

Exclusion Criteria:

* Females who are pregnant or nursing
* Patients with recent cerebral hemorrhage
* Patients with known sensitivities to albumin, blood, or blood products
* Patients with known hypersensitivity to perflutren
* Patients with known congenital heart defects
* Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
* Patients with bilirubin levels \> 2 mg/dL
Telemonitoring Device in Managing Outpatient Care of Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia After Intensive Chemotherapy

This randomized pilot clinical trial studies a home telemonitoring device in managing the care of patients with myelodysplastic syndrome or acute myeloid leukemia after they are discharged from the hospital following chemotherapy. After treatment and hospital discharge, patients typically need extensive care to deal with the side effects of chemotherapy, keep up with medications, and obtain medical assistance. A home telemonitoring device would allow patients to monitor vital signs, symptoms, and use of medications, communicate with healthcare providers, and access educational material. A telemonitoring device may allow patients to be managed more effectively than standard outpatient care after being discharged from the hospital.

PRIMARY OBJECTIVES:

I. To determine the feasibility of home telemonitoring for adult patients following intensive induction, re-induction/salvage, or consolidation chemotherapy for myelodysplastic syndrome (MDS) or non-acute promyelocytic leukemia (APL) acute myeloid leukemia (AML).

SECONDARY OBJECTIVES:

I. To estimate the impact of the telemonitoring intervention on mortality, duration of hospital stay, use of emergency services, visits to primary care physicians and to specialists, home visits, and telephone calls ("health care resource utilization").

II. To evaluate the telemonitoring procedure in economic terms compared to usual care through a cost-effectiveness analysis.

III. To estimate the impact on the quality of life of study participating.

IV. To assess the degree of satisfaction of the patients/caregivers and health care professionals with the telemonitoring intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (CONTROL): Patients receive standard outpatient supportive care after completion of chemotherapy.

ARM II (INTERVENTION): Patients receive standard outpatient supportive care as in Arm I and use the home telemonitoring device for the duration of chemotherapy-induced cytopenia (up to 3-4 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MDS or AML other than APL with t(15;17)(q22;q12), (promyelocytic leukemia\[PML\]/retinoic acid receptor \[RAR\]), or variants according to the 2008 World Health Organization (WHO) classification
* Patient is currently undergoing AML-like intensive induction, re-induction/salvage, or consolidation chemotherapy, or planned to start such therapy within 1 week
* Willingness to have close follow-up and treatment at the Clinic at the Seattle Cancer Care Alliance (SCCA) or at a local facility; typically, patients will be seen at least 3 times per week as per standard practice, including at least once weekly at the SCCA
* Permanent or temporary housing available within a 60 minute (min) commute from the SCCA
* Available caregiver
* Willingness and ability to use the telemonitoring device
* Provision of written informed consent

Exclusion Criteria:

* Cognitive impairment
Confinement and Spondyloarthritis Treatment

Evaluate the impact of confinement on treatment use in spondyloarthritis. Study hypothesis that with the confinement, subjects will stop their treatment. The main objective is to study the impact of confinement on treatment. And secondly to look for for specific psychological profile linked to the interruption of the treatment. the study population consists of patients with spondyloarthritis and belonging to a patient association (ACS). All patients over 18 are included. A mailing questionnaire will be send to all patients. data on diseases activity and treatment will be collected


Eligibility Criteria:
Inclusion Criteria:

* spondyloarthritis,
* age over 18 ans
* treatment by NSAID or biological treatment to be part of the patient association "ACS" (action contre les spondylarthropathies).
The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes

To study the effects of crocin supplement in patients with type 2 diabetes, 50 patients will be randomly allocated to placebo group and 2 tablets of crocin for 12 weeks. At the first and the end of the intervention, lipid profiles, blood pressure, blood sugar, inflammatory and anthropometric factors will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

Age of 40 to 65 years type 2 diabetes: and body mass index range of 18.5 to 30 kg/m2

Exclusion Criteria:

pregnancy or lactation A history of Cardiovascular disease, Pulmonary disease, Renal disease
HepHospital: A Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease

This research study is evaluating a program that entails home-based care for people with advanced liver disease.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ≥ 18 years old with a diagnosis of cirrhosis based on histology, radiology, and/or elastography
2. Admitted for symptomatic ascites
3. Receiving their outpatient hepatology and/or primary care at MGH
4. Hemodynamically stable during the first 24 hours of hospital admission
5. Must have telephone or internet/wifi access
6. Residing within the designated geographic area for MGH Home Hospital Service

Exclusion Criteria:

1. Have \> grade 1 hepatic encephalopathy
2. The presence of asterixis
3. Have a current diagnosis of hepatic encephalopathy on medical therapy and do not have a caregiver at home
4. Have uncontrolled neuropsychiatric or neurodegenerative illness prohibiting informed consent
5. Are admitted to the intensive care unit
6. Have refractory ascites or are on dialysis
7. Current admission for acute portal vein thrombosis, GI bleeding, or alcohol-related hepatitis
8. Have a history of solid organ transplantation of any organ
9. Reside within a long-term care or rehabilitation facility
10. Undomiciled
11. In police custody
12. Require more than the assistance of one person to reach a bedside commode
13. Require routine administration of controlled substances
14. Those deemed ineligible based on the MGH Home Hospital, inpatient medicine or hepatology clinician evaluation
The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients

Tertiary care IBS patients will be recruited for a prospective low FODMAP intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different FODMAP groups administered as powder, to be added to the strict FODMAP exclusion phase. During the screening phase of two weeks, baseline data regarding psychological, nutritional, microbial, and genetics will be collected. Predictors of treatment response (a 50-point drop on the IBS-severity scoring system (IBS-SSS) during the strict FODMAP exclusion phase of 6 weeks) will be studied with linear mixed models.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for the study if all of the following criteria are met:

  1. Patients with irritable bowel syndrome as per Rome IV diagnostic criteria
* Symptom characteristics of IBS according to Rome IV criteria 2. Patients must provide witnessed written informed consent prior to any study procedures being performed 3. Patients aged between 18 and 70 years inclusive 4. Male or female patients

Exclusion Criteria:

* Patients are excluded from the study if any of the following criteria are met:

  1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
  2. Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
  3. Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)
  4. Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
  5. Females who are pregnant or lactating are excluded from the study.
Randomized Controlled Trial on the Treatment Effects of Melatonin and Light Therapy on Delayed Sleep Phase Syndrome

In this study the investigators will examine the effects of melatonin and light therapy on delayed sleep phase syndrome in adolescents 16 up to 20 years old. 60 subjects will be randomized into four different groups; melatonin + light therapy (N=15), melatonin + placebo light (N=15), placebo + light therapy (N=15) and placebo + placebo light. This is a double-blinded treatment and the participants will receive this treatment for 2 weeks. Then they will be re-randomized into two groups; full treatment with light therapy + melatonin (N=30) and no treatment (N=30) for 3 months unblinded. The investigators will test the subjects pre-treatment, post 2 week treatment and after 3 months.

Delayed sleep phase syndrome (DSPS) is a circadian rhythm sleep disorder where the sleep-wake rhythm is significantly delayed according to the environmental demands. Hence, the symptoms consist of major difficulties falling asleep and problems awakening in due time and patients often experience work- and school related impairments (The International Classification of Sleep Disorders: Diagnostic and Coding manual, 2005). However, correct diagnosis is often not made and the treatment offered is, accordingly, often inadequate. DSPS normally develops in interplay between dysfunctional habits/behaviour and biological vulnerability.

Bright light therapy and administration of exogenous melatonin comprise the most common interventions. Timed bright light has been shown to effectively phase advance the rhythm (Rosenthal et al., 1990), but no standardized guidelines regarding the duration, intensity or timing of light exposure have been established. Compliance to the treatment is often poor because it involves structuring the daily schedule, which may be hard for the relevant age group. Similarly, administration of melatonin in the evening has been shown to phase advance the rhythm (Lewy et al., 1998; Mundey, Benloucif, Harsanyi, Dubocovich, \& Zee, 2005), but a standardized approach for dose, duration and timing is lacking.

It is important to establish effective treatment guidelines for delayed sleep phase syndrome. Large scale studies on the effects of melatonin and bright light treatment in randomized placebo-controlled designs are needed. In a clinical trial we aim to investigate the efficacy of bright light and melatonin treatment using a 4 armed randomized placebo controlled design.

Eligibility Criteria:
Inclusion Criteria:

* 16-25 years old
* lives in the Bergen area
* has Delayed Sleep Phase Disorder

Exclusion Criteria:

* pregnant or nursing women
* other sleep disorders (i.e. sleep apnoea or PLMS)
* moderate to serious psychiatric disease
* use of psychopharmacological medicines
* in psychotherapeutic treatment
Assessment of Kidney Function for Drug Dosage Adjustments in Critically Ill Patients

The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill patients. In control group, colistin maintenance dosage will be decided using serum creatinine based eGFR (in ml/min). In study group, colistin maintenance dosage will be decided using 4hr CrCl.

1. Screening periods (From 'informed consents' to 'randomization')

   * Check of inclusion/exclusion criteria ② Measurement of 4hr CrCl \& eGFR in ml/min

     * calculation of maintenance dose ③ Baseline characteristics \& laboratory findings ④ Randomization
2. Colistin dosage Loading dose : 5 x body weight (not exceeding 300mg) Maintenance dose (after 12 hours from loading dose)

   : 2.5 x (\[1.5 x GFR\] + 30) (divided doses every 12hours), GFR in ml/min

   During the study period, daily morning serm creatinine levels are measured. Whenever serum creatinine concentration changes by more than 10% compared with baseline, 4hr CrCl will be mearued. At the every time of 4hr CrCl measurements, colistin dose wil be modified according to new GFR values (4hr CrCl in study group, eGFR in control group)
3. Blood sampling for Colistin trough level measurement Peripheral blood will be sampled twice between 72 hrs and 144 hours after loading dose, just before colistin infusion. The samples were collected in heparined tubes and centrifuged at 4 °C within 1 hr of collection. The resulting plasma was stored at - 70°C . And two values will be averaged out.
4. End of randomization (7 days after colistin initiation) ① Nephrotoxicity ② Treatment outcome microbiological outcome: eradication / no eradication clinical outcome: complete response / partial response / treatment failure

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged over 18
2. Patients in intensive care unit received colistin for the microbiologically documented cases associated with carbapenem-resistant gram negative bacilli.

Exclusion Criteria:

1. Patients who received colistin empirically.
2. Patients who received renal replacement therapy due to acute kidney injury or end-stage renal disease
3. Patients whose urine output was less than 0.5cc/kg/hr for 6 hrs
4. Patients who underwent hematopoietic stem cell transplantation
5. Patients who disagree with this study.
Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors

1. To determine the outcome of patients with potentially resectable superior sulcus tumors of non-small cell histology treated by surgery followed by accelerated radiation therapy and chemotherapy.
2. To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures.

Eligible (surgically resectable and medically operable) patients will have surgery followed by radiation therapy, given twice daily, for 5 weeks if margins are negative and for 5-1/2 weeks for positive margins. Grossly positive margins can be treated by brachytherapy followed by external radiotherapy.

Concomitant chemotherapy consisting of cisplatin given intravenously on days 1 and 8, and etoposide taken by mouth 30-60 minutes prior to each radiotherapy treatment x the first 10 days. The cycle will be repeated start day 29.

If the patients are considered to have no evidence of disease in one month after completion of chemotherapy, optional prophylactic radiotherapy to the brain will be give in 10 fractions once daily for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. No previous treatment.
2. Tumor must be resectable.
3. \>/= 18 and \</= 70 years of age.
4. Zubrod performance status \</= or higher performance status if based only on pain.
5. Must have adequate bone marrow, liver and renal function as defined in 3.6.

Exclusion Criteria:

1. Cytological or histological proof of N3 disease.
2. Evidence of metastatic disease to distant sites.
3. Patients with impending cord compression will be ineligible.
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

Eligibility Criteria:
Inclusion Criteria:

* Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
* No more than 3 previous anti-myeloma regimens
* No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
* Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).

Exclusion Criteria:

* Prior development of disease progression during high-dose dexamethasone containing therapy.
* Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed
* Laboratory abnormalities: Platelet count less than 75,000/mm cubed
* Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL
* Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase \[AST\]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase \[ALT\])greater than 3.0 x upper limit of normal
* Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL
* Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.
* Known hypersensitivity to thalidomide or dexamethasone.
* Development of a desquamating rash while taking thalidomide.