cyrilzakka/clinical-trials huggingface dataset:
Effects of Nonpharmacological Interventions in Sleep Quality, Anxiety, and Delirium for Patients of Adult Intensive Care Units

This study will investigate the effect of nonpharmacological intervention in sleep quality, anxiety and delirium among adult ICU patients.

Background: Due to the intensive care unit (ICU) noisy environment, nearly 66% critically ill patientsseem to suffer from poor sleep quality, which can easily lead to complications, such as anxiety, delirium, prolong hospital stay, and even increased mortality.

Objective: This study will investigate the effect of nonpharmacological intervention in sleep quality, anxiety and delirium among adult ICU patients.

Methods: The design of this study is a randomized experimental study recruiting 154 patients from five adult ICUs in a teaching hospital located in the central southern Taiwan. The experimental group (n=77, nonpharmacological intervention, and the control group (n=77, routine care). The nonpharmacological intervention involves listening of 30 mins ocean wave music, aromatherapy of lavender essential oil, and eye masks and earplugs. Research measurement tools, including demographic data, physiological index questionnaire, Richards-Campbell sleep scale (RCSQ), Chinese Visin-style sleep scale, Chinese State -Trait Anxiety Inventory-1, visual analogue scale for anxiety, which will be measured five times, before intervention (T1), every 9AM for three days (T2, T3, T4), and ICU transferring day (T5). SPSS 26.0 will be used to analyze data by using descriptive statistics, chi-square test, pearson correlation, independent t-test, paired t-test, ANOVA, generalized estimating equation (GEE).

Eligibility Criteria:
Inclusion Criteria:

* Conscious and able to speak or write (GCS ≥ 11)
* Hemodynamically stable
* Normal hearing and able to communicate in a low voice
* Stay in ICU for more than 24 hours
* Aged over 18 years.

Exclusion Criteria:

* Pre-existing insomnia diagnosis with long-term reliance on sleep medication,
* Sleep-related medical history such as sleep apnea
* Shift work prior to hospitalization
* Diagnosis of alcohol abuse or schizophrenia
* End-of-life or terminal conditions
* Allergy to essential oils
* Exclusion of dementia
Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine

The investigators want to find out whether a recently introduced combination of two blood pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering effect than a single active substance. In addition the investigators want to find out whether there is a difference in the changes in blood pressure over the course of a day depending on the time when the medications are taken (in the morning or at night). Male and female patients over 18 years of age may participate.

Investigation of changes in blood pressure after six weeks therapy with a fixed combination of 40 mg olmesartan and 10 mg amlodipine compared to a monotherapy with 32 mg candesartan. Investigation of changes in dipping-profile after a further six weeks of therapy with the fixed combination when time of intake is switched from morning to evening.

Eligibility Criteria:
Inclusion Criteria:

* essential hypertension, i. e. systolic OPM \>=140 mmHg at screening and \>=160 mmHg after two weeks wash-out

Exclusion Criteria:

* systolic office bp \> 180 mm Hg at screening visit

  * known hypertensive retinopathy GIII or IV
  * recent (\< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
  * type I diabetes or poorly controlled (HbA1c \>= 8) type II diabetes
  * chronic heart failure NYHA III or IV
  * prior stroke or TIA
  * creatinine clearance \< 60 ml/min or condition after kidney transplant
  * moderately or severely impaired liver function (ALT or AST or bilirubin more than double normal value)
  * women of childbearing potential without highly effective contraception, pregnant or breastfeeding women
  * concomitant therapy with lithium
  * hemodynamically relevant mitral or aortic valve stenosis (\>= II°) or hypertrophic obstructive cardiomyopathy
  * concomitant therapy with strong CYP3A4 inhibitors or inductors
  * african patients
  * concomitant severe psychiatric condition that might impair proper intake of study medication
  * life expectancy \< 6 months
  * night shift workers
  * known other mandatory indication for treatment with antihypertensive medications
Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy

The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of three different induction regimens (Ven+AZA vs DA/IA 3+7 vs DA/IA 2+5+VEN). A total of 90 patients will be enrolled in this study and segregated into thress groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the study and voluntarily sign informed consent.
2. Age: 60\~75 years old, gender unlimited.
3. Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.
4. Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2.
5. Fit for intensive chemotherapy.
6. The function of main organs should meet the following standards before treatment: Kidney: serum creatinine ≤ 2× upper limit of normal range (ULN); Liver: total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5× ULN; Heart: myocardial enzymes ≤ 2× ULN and normal ejection fraction by cardiac color doppler ultrasound

Exclusion Criteria:

1. Patients with acute promyelocytic leukemia
2. Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene
3. Patients with BCR::ABL fusion gene
4. Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before.
5. Patients with concurrent malignant tumors requiring treatment
6. Patients with active heart disease defined as one or more of the following: (1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA\> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range.
7. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with progressive small cell lung cancer (SCLC).

OBJECTIVES:

Primary

* Determine the targeting, tissue distribution, and pharmacokinetics of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).

Secondary

* Determine the immunogenicity of of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
* Determine tumor response of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
* Determine the safety of tof monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).

OUTLINE: This is an open-label, pilot study.

Patients received monoclonal antibody hu3S193 (mAb hu3S193) intravenously (IV) over 30 minutes on day 1 of weeks 1-4. Patients also received indium-111 (111In) radiolabeled hu3S193 IV over 30 minutes on day 1 of weeks 1 and 4 and then underwent gamma camera imaging. Treatment continued in the absence of disease progression or unacceptable toxicity.

Patients were followed at 1 and 4 weeks, every 3 months for 1 year, and then every 6-12 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

Small cell lung cancer, pathologically confirmed. Measurable disease, including at least one lesion measuring ≥ 2 cm that has not been previously irradiated.

Progression of disease after one, two, or three prior chemotherapy regimens. At least 4 weeks since the last chemotherapy or radiation treatment. Karnofsky performance status ≥ 70% (ECOG 0 or 1).

The following laboratory results within the last 2 weeks prior to study day 1:

White Blood Cell Count (WBC) ≥ 3,500/mm3; Platelet count ≥ 100 x 10\^9/L; Serum creatinine ≤ 2.0 mg/dL; Serum bilirubin ≤ 2.0 mg/dL; International normalized ratio (INR) ≤ 1.3; Women of childbearing potential with confirmed negative quantitative serum HCG on the day of administration of study agent.

Negative stool guaiac test (read by laboratory). Tumor tissue positive for Lewis Y expression.

Exclusion Criteria:

Clinically significant cardiac disease (New York Heart Association Class III/IV).

Uncontrolled brain or leptomeningeal metastases. GI bleed within the preceding 6 months. Patients with history of receiving mouse monoclonal antibody. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.

Women who are pregnant or breast-feeding.
Live Classical Music and the Response to the Disease and Its Evolution in Patients With Chronic Renal Failure

People are most vulnerable to anxiety when faced with life-threatening situations such as illness, medical treatments and surgeries. When a person becomes ill, he and his family must face a series of changes in their life habits, must cope with admissions, aggressive treatments and endure physical pain. These changes can generate an unfavorable state of mind to face the disease, which sometimes worsens the previous clinical situation. The direct effect of music has been studied in different pathologies during the last years.

The proposed research sought to provide information on the influence of classical music listened to live and in situ in the hospital, and the response to the disease and its evolution, in patients with chronic renal failure. For this purpose, the effect of live music performances in hemodialysis rooms was analyzed and changes in the patients' mood and quality of life were observed. Changes in vital sign recording were also observed, all of which were assessed before and after the interventions. Finally, we checked if there were any changes in the variables described as confounders (KT/V-Albumin-Hemoglobin-Blood Pressure-Consumption of psychotropic drugs and analgesics), which could be attributable to listening to music.To test the effect in patients with chronic renal failure, live classical music was listened to in the hospital, as an adjuvant to treatment during haemodialysis processes. Ninety patients participated in 2 groups, the intervention group that listened to music during haemodialysis sessions and the control group that continued with their usual treatment. Changes in anxiety and mood were analyzed by means of the quality of life questionnaire (HAD) and quality of life by spheres with the KDQOL-SF questionnaire, before and after the intervention in both groups.

To test the effect in patients with chronic renal failure, live classical music was listened to in the hospital, as an adjuvant to treatment during haemodialysis processes. Ninety patients participated in 2 groups, the intervention group that listened to music during haemodialysis sessions and the control group that continued with their usual treatment. Changes in anxiety and mood were analyzed by means of the quality of life questionnaire (HAD) and quality of life by spheres with the KDQOL-SF questionnaire, before and after the intervention in both groups.


Eligibility Criteria:
Inclusion criteria:

* Patients over 18 years of age.
* Signed informed consent.
* To be more than 3 months in the chronic HD program.

Exclusion criteria:

* Inability to listen to music.
* Inability to answer the surveys.
* Failure to sign informed consent to participate.
* under 18 years of age.
* hospital admissions for more than 4 weeks or in the last two weeks of the intervention.
In-Home Sensor Monitoring of Older Adults With Cancer

The investigators propose a pilot study of monitoring a sample of 6 older patients receiving active cancer treatment over a period of 6 months with in-home sensor monitors installed and maintained by Foresite Healthcare. The investigators also propose exploring the beliefs and attitudes of those who are not willing to allow in-home sensor monitoring by asking them to complete a brief survey related to in-home sensor monitoring. The investigators hypothesize that patients will find the equipment acceptable and unintrusive, that changes in home-monitored patient parameters will precede clinical events and that patient trajectories will be more fully characterized with the in home sensors.


Eligibility Criteria:
Inclusion Criteria:

Arm A:

* Age ≥ 65
* Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents OR will begin systemic therapy within the next 4 weeks.
* Estimated life expectancy \>1 year
* Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
* Willing to have sensors installed in 1-2 primary living areas (e.g. living room and bedroom)
* Continuous home internet connection
* Able to understand and willing to sign an IRB-approved written informed consent document

Arm B:

* Age ≥ 65
* Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents OR will begin systemic therapy within the next 4 weeks.
* Estimated life expectancy \>1 year
* Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
* Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria:

Arm A:

* Inability to read and understand English
* Only receiving hormonal agents (e.g. anti-estrogen or anti-androgen)
* Lives in institutional setting where instrumental activities of daily living are completed for patient by paid staff

Arm B:

* Inability to read and understand English
* Only receiving hormonal agents (e.g. anti-estrogen or anti-androgen)
* Lives in institutional setting where instrumental activities of daily living are completed for patient by paid staff
Endogenous Modulation of Pain and Stretch Tolerance

This study investigates the role of two endogenous inhibitory mechanisms; exercise-induced hypoalgesia (EIH) and a conditioning painful stimulus (CPM) on passive joint range of motion, passive resistive torque and pain sensitivity. The study is a randomized, repeated-measures cross-over study.

The increase in range of motion following stretching is related to changes in the tolerance to stretch. The mechanistic relationships behind these changes in subject sensation are however unknown but could be related to endogenous modulation of pain.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility for participation included the absence of any pain or other conditions that might affect the somatosensory system.

Exclusion Criteria:

* Substance abuse, History of neurological or mental disabilities, Lack of ability to comply with instructions, Delayed onset of muscle soreness.
Integrative Parenteral Nutrition in Cancer Patients

Although it is demonstrated that nutritional support can improve clinical outcomes, the literature shows that approximately 50% of cancer patients are not able to meet their estimated energy requirements. Recent clinical studies suggest that a supplementary support for parenteral nutrition (PN) could significantly help to improve the nutritional status of malnourished cancer patients.

International guidelines recommend the use of PN in malnourished, hypophagic, non-surgical cancer patients if enteral nutrition is not feasible and in patients affected by severe iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated for more than 7 days. However, there are no studies on the effects of integrative PN in hospitalized, malnourished, hypophagic, non-surgical cancer patients.

Recent studies have reported on the validity of bioelectrical impedance vector analysis in monitoring the body composition of patients receiving nutritional support. Particularly, phase angle proved to be a superior prognostic marker than other nutritional screening tools.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer (head-neck, lung, gastrointestinal, pancreas, biliary tract, haematology).
* Nutritional Risk Screening 2002 score ≥3.
* Expected duration of parenteral nutrition ≥7 days
* Availability to planned measurements
* Contraindication to enteral nutrition support
* Written informed consent

Exclusion Criteria:

* Age \< 18 years
* Ongoing artificial nutrition before hospitalization
* Eastern Cooperative Oncology Group performance status \>2
Microwave Radiometry Thermometry for the Diagnosis of Critical Limb Ischemia in Diabetic Patients

Diagnosis of vascular involvement in diabetic foot disease remains challenging. Differential diagnosis between pure neuropathic or neuro-ischemic diabetic foot requires a combination of clinical examination, medical history and ankle-brachial index (ABI) measurement, which is considered the "gold standard" non-invasive modality for limb ischemia diagnosis. However, in diabetic patients with suspected arterial ischemia resulting in tissue loss (critical limb ischemia; CLI), false negative ABI results are frequent due to Monckeberg medial sclerosis producing incompressible vessels, while clinical signs are subjective and not accurate in posing definite diagnosis of CLI.

The investigators conducted a proof of concept study of the feasibility of microwave radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue loss.

This is a prospective, multi-centre, trial designed to investigate the he feasibility and efficacy of microwave radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue loss. The study included 80 patients, equally divided in four groups. Group N: normal subjects; group DN: diabetic patients with verified neuropathic ulcers without vascular involvement; group DC: diabetic patients with CLI and group NDC: non-diabetic patients with CLI. All patients underwent MWR with the RTM -01-RES device (University of Bolton, UK) to record the mean internal tissue temperature of the foot. MWR is based on the principle that the intensity of radiation is proportional to tissue temperature. The specific device is not commercially available and has been developed to detect temperatures from internal tissues at microwave frequencies. Foot temperature measurements were performed as near as possible at the site of ulceration in patients of groups DN, DC and NDC and in various sites in subjects of control group N.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from both insulin and not insulin dependent diabetes mellitus.
* Critical limb ischemia verified by both clinical examination, haemodynamic tests and digital subtraction angiography.

Exclusion Criteria:

* Uncertainty regarding the absence of peripheral arterial disease in groups N and DN.
* Uncertainty regarding the diagnosis of critical limb ischemia for patients in groups DC and NDC.
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of UC established at least 3 months prior to Day 1
* Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
* Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
* Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
* Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
* Use of highly effective contraception as defined by the protocol
* Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

* A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
* Prior or planned surgery for UC
* Past or present ileostomy or colostomy
* Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
* Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
* Any prior treatment with rituximab
* Any treatment with tofacitinib during screening
* Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
* Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
* Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
* History of recurrent opportunistic infections and/or severe disseminated viral infections
* History of organ transplant
* Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
* Received a live attenuated vaccine within 4 weeks prior to Day 1