cyrilzakka/clinical-trials huggingface dataset:
Effect of Digital Health Coaching Program on Self-efficacy and Patient Reported Outcomes of Patients With Newly Diagnosed Acute Myeloid Leukemia or Chronic Lymphocytic Leukemia

This trial studies the effect of a digital health coaching program on self-efficacy and patient reported outcomes of patients with acute myeloid leukemia or chronic lymphocytic leukemia that is newly diagnosed. A digital health coaching program may help leukemia patients report information about their health while receiving treatment, which may lead to improvement in overall health.

PRIMARY OBJECTIVE:

I. To evaluate the effect of digital health coaching on self-efficacy among two cohorts of individuals with acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), respectively, as measured by the Cancer Behavior Inventory (CBI version \[v.\] 3).

SECONDARY OBJECTIVES:

I. To evaluate the relationship between self-efficacy and patient reported outcomes among individuals with and without digital health coaching, specifically:

Ia. The physiologic and psychosocial outcomes of individuals with AML and CLL as measured by the Functional Assessment of Cancer Therapy-Leukemia Questionnaire (FACT-Leu).

Ib. The symptom experience of individuals with AML and CLL as measured by the MD Anderson Symptom Inventory (MDASI).

Ic. The financial toxicity of individuals with AML and CLL as measured by the Comprehensive Score for Financial Toxicity (COST).

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive the PACK Health digital health coaching program over 3 months consisting of communication initiated by either the PACK Health coach or the patient through either text, e-mail, or phone call, to provide education and support related to a specific topic such as fatigue, nutrition, or exercise.

GROUP II: Patients receive standard of care support services consisting of a telephone triage line that patients may call when experiencing physical or psychological concerns, or with any other questions related to their disease or treatment.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, speak and consent in English
* Individuals newly diagnosed with either acute myelogenous (AML) or chronic lymphocytic leukemia (CLL), defined as within three months of diagnosis
* Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments
* Individuals with a prior history of myelodysplastic syndrome (MDS) will be allowed to enroll

Exclusion Criteria:

* Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
* Individuals who have undergone treatment for previous diagnoses of leukemia
* Individuals for whom there is documentation of inability to provide consent in the medical record
Clinical Study of SARS in Children

Severe acute Respiratory Syndrome (SARS) is an emerging infectious disease. It is caused by a novel SARS-associated coronavirus. According to the epidemiological data, it is highly infectious by intimate contact, respiratory secretion, or direct contact with infectious body fluid. By June 1, 2003, Center for Disease Control Taiwan, R.O.C reported 677 probable SARS cases. Among them, 93.2% (631/677) were more than 20 years old. Only 6.8% (46/677) were under 20 years old. Usually the major hosts of respiratory viruses are children, but evidence up to now shows that SARS is mainly a disease of adults. The data of clinical presentation and epidemiological prevalence in teenage group and children are lacking. Therefore, this project is aimed at the children and teenager among 1 month to eighteen years old. Seroepidemiology of SARS-CoV infection in children would be investigated. Patients who admitted to pediatric wards or visited ER and received blood sampling due to the need of clinical diagnosis/management would be enrolled. After the necessary laboratory examinations were done, the remaining serum would be collected and tested for anti-SARS-CoV IgG by ELISA.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 1 month to 18 years old
* Received blood sampling during admission or at emergency department due to the need of clinical diagnosis/management

Exclusion Criteria:

-
Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal

This is a prospective randomized double-blind controlled trial assessing the benefits of intramuscular ketorolac before or immediately after office ureteral stent removal.

Patients who are undergoing cystoscopy with ureteral stent removal at the University of Texas Southwestern Medical Center and have no contraindications to receiving ketorolac will be eligible. Patients will be randomized to receive either a 1 mL injection of ketorolac tromethamine or 1 mL injection of normal saline (0.9%) as the control arm. Ketorolac is a member of the pyrrolo-pyrrole group of non steroid anti inflammatory drugs. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. The peak analgesic effect occurs within 2-3 hours. If no contraindications exist, ketorolac can be safely given to patients of any age in the 30 mg intramuscular formulation if given as a one time dose according to the package insert.

Normal saline contains 0.9% of Sodium chloride in each mL. Like ketorolac, it is a clear solution and given that there are no major side effects of normal saline it is a good control for our study. It is packaged in a single dose vial that contains 100 mL. It is preservative free and stored at room temperature (20-25°C). Local pain at the injection site may occur, temporarily.

The investigators will specifically look at pain scores before and after stent removal as well as narcotic medication use, telephone calls and/or emergency room visits for pain. Based on the rate of renal colic from our quality improvement project and prior work, the investigators calculated the maximum number of local subjects to be consented for this study to be n=116 (see biostatistics section). The study is expected to last 6 months.

Eligibility Criteria:
Inclusion Criteria:

* patients 18 to 79 who have undergone a cystoscopy with indwelling double-J ureteral stent placement at Clements University Hospital and are presenting to the office for cystoscopy and stent removal.

Exclusion Criteria:

* eGFR \<50
* any active or history of peptic ulcer disease or GI bleeding
* Bleeding disorder, suspected of confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis
* Concurrent use of Aspirin 325mg, wafarin, rivaroxaban, apixaban, clopidogrel, or heparin
* Allergic reaction to NSAIDs
* Concurrent use of other NSAIDs within 24 hours
* Pregnancy (ketorolac contraindicated in this population)
* Recent myocardial infarction (MI)
Hand Acceleration Time Assessment With Ultrasound Doppler

Chronic upper limb ischemia syndrome is uncommon compared to lower limb ischemia, with several potential causes (e.g., arteriosclerosis, compressive syndromes, arteritis, connective tissue diseases, trauma, and thrombosis). Many patients with upper limb ischemia remain asymptomatic due to arterial collateral vascularization.

Given the wide variety of potential causes for upper limb ischemia, the diagnosis may require different technical approaches. Doppler ultrasound is a non-invasive, accessible, non-radiating technique that provides direct arterial imaging, yielding valuable information on arterial anatomy and hemodynamics.

Some authors have described the reliability of the arterial duplex ultrasound for lower limb assessment using the pedal acceleration time (PAT). The PAT provides real-time hemodynamic physiological information on the entire limb. The acceleration time (AT) is an ultrasound parameter which measures the time elapsed (in milliseconds, ms) from the beginning of the arterial Doppler waveform until the systolic peak, evaluating the morphology of the arterial waveform in real time. In a healthy individual, this time should be short (between 40 - 100 milliseconds), displaying a triphasic waveform with a systolic acceleration, a sudden diastolic fall, and a subsequent anterograde flow at the end of diastole. A more damped wave suggests proximal stenosis and the acceleration time has been correlated to different degrees of foot ischemia.

Notably, the AT parameter has also been studied in other territories, such as the carotid and pulmonary arteries, coronary arteries, and the aorta. Hand acceleration time (HAT) has also been described very recently as a potential tool to assess hemodialysis access-induced ischemia, cardiogenic shock, and subclavian iatrogenic ischemic lesion. However, the HAT has not yet been properly characterized or validated. Our working hypothesis is that the HAT is a useful diagnostic tool for chronic upper limb ischemia.


Eligibility Criteria:
Inclusion Criteria (healthy volunteers):

* Healthy adult volunteers (≥ 18 years of age).
* No evidence of upper limb arterial disease.
* Who sign the written informed consent.

Exclusion Criteria (healthy volunteers):

* Healthy volunteers unable (at the investigator discretion) to understand or comply with any study-related procedure.
* Healthy volunteers who refuse to participate.
* Those presenting cardiovascular risk factors (e.g., hypertension, diabetes mellitus, dyslipidemia).

Inclusion Criteria (upper limb ischemia patients):

* Adult patients (≥ 18 years of age) with a known diagnosis of chronic upper limb ischemia.
* Who sign the written informed consent.

Exclusion Criteria (upper limb ischemia patients):

* Patients unable (at the investigator discretion) to understand or comply with any study-related procedure.
* Patients who refuse to participate.
Testosterone for Penile Rehabilitation After Radical Prostatectomy

The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Subjects will be randomized (like flipping a coin) to one of two groups. One group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.

Subjects will begin drug treatment 3 months after the initial screening visit and will take study drug for 3 months only. Participation will end at the end of the 6-month visit.

There was only one patient who began treatment with the study drug. After blind was broken, it was noted that he received placebo Testim and Viagra.

Eligibility Criteria:
Inclusion Criteria:

* Males, 18 years of age or older, with low testosterone levels.
* Must have undergone a bilateral nerve sparing radical prostatectomy.
* Nadir PSA (Prostate-Specific Antigen) values should be less than 0.01 ng/ml on two consecutive occasions separated by 4 weeks at the start of treatment.
* Must give informed consent.
* Must be willing to complete follow-up visits.

Exclusion Criteria:

* Testosterone level greater than 300 ng/ dl
* Hemoglobin level greater than 18 ng/dl.
* Positive surgical margins or evidence of residual prostate cancer after surgery.
* Clinically suspected advanced disease or actual evidence of metastatic prostate cancer.
* Primary Gleason Grade greater than 3 or secondary Gleason Grade greater than 4 in the final pathologic specimen will be excluded.
* Taking nitrates or with contraindications to the use of Viagra or androgen therapy will be excluded.
* Known hypersensitivity to any component of the tablet will be excluded.
Sevoflurane in Subarachnoidal Haemorrhage

Feasibility and safety of short term application of sevoflurane in patients with SAH treated with aneurysm coiling or clipping in the setting of a neurointensive care unit.

After admission to the ICU, before the coiling / clipping intervention has been performed, the patients are screened for eligibility. When the patients are coming back to the ICU, after successful aneurysm coiling or clipping, data of artificial ventilation, systemic and other cerebral parameters will be collected continuously by online monitoring, starting at baseline and stopping at discharge of the ICU. Sevoflurane will be vaporized and administrated by the MIRUS™System directly to the inspiratory part of the ventilation circuit for the next 4 hours. In the following 14 days of the stay on the ICU, standard monitoring parameters, the appearance of vasospasm and brain oedema will be recorded. Besides the continuous online monitoring, laboratory assessment will be performed daily. At day 7±2 and day 14±2 after bleeding a MRI or CT examination will be performed, according to the clinical condition of the patient, to detect secondary brain injuries, as ischemia or brain oedema. At ICU discharge, the neurological outcome will be assesses applying GOS.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex aged 18-85 years
* Patients with severe aneurysmal SAH, Hunt/Hess 3 to 5.
* The ruptured aneurysm is successfully excluded with coiling or clipping
* Sedation and mechanical ventilation necessary due to the clinical situation
* ICP monitoring in use due to the clinical situation
* ICP \< 20mmHg without medical treatment
* Systolic blood pressure values (BP syst) \> 120 mmHg with no need for catecholamines
* Female patients of childbearing potential with negative pre-treatment serum pregnancy test
* Informed consent obtained

Exclusion Criteria:

* Significant kidney disease, defined as plasma creatinine \>120 µmol/l
* Significant liver disease, defined as Aspartate-Aminotransferase (AST) \>200 U/l
* Significant elongation of the QTc interval: female \< 470 msec/ male \< 450 msec; based on 'Bazett's Formula'
* History of epilepsia and/ or occurring seizures with aneurysm rupture
* Pneumocephalus after surgery excluded by CT scan performed immediately after clipping
* History of allergic disorders
* History for, or relatives with a history for malignant hyperthermia
* History or signs for neuromuscular disease
* Pre-existing disability
* Patients participating in an interventional clinical trial within the last 30 days before start of treatment
Correlation Between Postoperative Cognitive Dysfunction and Telomere Length in Patients With Non-cardiac Surgery

To study on the Postoperative Cognitive Dysfunction: Correlations With Leukocyte telomere length。


Eligibility Criteria:
Inclusion Criteria:

* Non-cardiac surgery patients;

  * Age is greater than or equal to 65 years old;

    * Han Nationality, mother tongue is chinese;

      ④The MMSE score:Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;

      ⑤The Geriatric Depression Scale (GDS) grade 1 or 2;

      ⑥The important function without serious heart, brain, liver, kidney, lung and other organs;
      * The ASA class I or II;

        * The people signed informed consent.

Exclusion Criteria:

* The diagnosis of neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.; ②Had severe head and face disease, trauma history or history of surgery;

  * Had a history of influenza in 3 weeks; ④The serious body disease and tobacco, wine and other substance abuse history; ⑤The presence of malignant tumor with shorter survival disease.
Ultrasound Beams as an Adjunct to Reperfusion Therapy in STEMI

Successfully perfused STEMI patients will receive routine transthoracic echocardiography qid for 4 days or placebo. Myocardial function and infarct size will be evaluated at 3 and 6 months.

Patients who had acute STEMI and successfully reperfused by either thrombolytic therapy or primary angioplasty and stenting will be included this study.

A basal routine echocardiography will be obtained in all patients after reperfusion therapy. Thereafter, patients will be divided into two groups: 1.Treatment group will receive transthoracic echocardiography using Philips HD11 XE ® for 30 minutes qid for 4 days. 2. Placebo group will have the same Philips HD11 XE ® echo transducer applied for the same time and duration on their chest but with the ultrasound turned-off. Detailed left and right ventricle function as well as performance index and stress-strain imaging will be obtained and analyzed at 3 and 6 months.

Eligibility Criteria:
Inclusion criteria:

-Patients presenting within 12 hours of their first ST- elevation myocardial infarction that is successfully reperfused; and completed baseline echocardiographic evaluation and accepted participation in the study

Exclusion criteria:

Patients:

* With prior ST- elevation myocardial infarction
* Patients presenting \>12hrs
* Not successfully reperfused
* Not completed baseline ECHO evaluation,
* Not accepting participation in the study
Pre-biotics and Probiotics for Constipation in Parkinson's Disease

Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have been investigated and are now available for the management of constipation in PD. Preliminary data have suggested that probiotics could be help improving bowel habits but high-quality randomized trials are required in this area. Therefore, the investigators designed a randomized trial to evaluate whether the use of a fermented milk containing multiple probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of constipation according to Roma III criteria
* complete bowel movements per week \<3
* total bowel movements per week \<6
* written informed consent

Exclusion Criteria:

* report of loose (mushy) or watery stool in the absence of laxative use
* ongoing artificial nutrition
* lactose intolerance
* chronic inflammatory bowel disease
* previous abdominal surgery
* use of anti-cholinergics
* use of antibiotics in the 6 weeks before baseline visit
* Radio- chemotherapy
* Cognitive decline (Mini Mental State Examination \<27)
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.

This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* breast cancer;
* bone metastases;
* mean worst pain score \>=4 during 3 day baseline period;
* stable dose of analgesics over a 3 day baseline period;
* adequate renal function.

Exclusion Criteria:

* bisphosphonate treatment within 3 weeks of study enrollment;
* a change in antineoplastic treatment within 6 weeks of study enrollment;
* bone radiation within 2 weeks of study enrollment;
* active infection.
The Role of IGRA in Screening and Monitoring for TB During Anti TNF Therapy in Patients With IMID

Hong Kong is a region of intermediate TB burden, and the reactivation of latent TB in IMID patients treated with anti-TNF can be a serious problem. This study aims to investigate the role of IGRA in screening for latent TB in IBD patients and control subjects. In part II of the study, patients of other immune-mediated inflammatory diseases (IMID) will also be included to investigate the role of serial interferon-gamma release assays (IGRA) for the diagnosis of tuberculosis (TB) infection in patients with immune-mediated inflammatory diseases (IMID) treated with biologics

The incidence of inflammatory bowel disease is rising in Hong Kong. Anti-tumor necrosis factor alpha (anti-TNF)-α is effective and increasingly being used for the treatment of patients with refractory disease and complicated disease behaviour. The reactivation of latent tuberculosis (TB) is a well-recognised complication associated with the use of anti-TNF therapy, and most cases occurred in endemic regions. Hong Kong is a region of intermediate TB burden, and the reactivation of latent TB in IMID patients treated with anti-TNF can be a serious problem. Screening has been shown to reduce the incidence of TB, but it remains unclear whether monitoring during anti-TNF therapy is effective. Despite reported efficacy with the current screening strategy, active TB developed in up to 11.4% of patients receiving anti-TNF therapy. There is therefore an urgent need for better disease monitoring and prevention, particularly in regions where TB is endemic.

Part I of this study aims to investigate the role of IGRA in screening for latent TB in IBD patients and control subjects. Part II of this study is a prospective study of serial interferon-gamma release assays (IGRA) for the diagnosis of tuberculosis (TB) infection in patients with immune-mediated inflammatory diseases (IMID) treated with biologics

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 years or older
* patients with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) for at least 3 months defined by histology or radiology

Exclusion Criteria:

* Patients with a previous history of TB
* Patients with a positive IGRA or CXR suggesting latent tuberculosis prior to commencement of therapy
A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

This is a phase 2a study evaluating the safety and tolerability of multiple ascending doses of GFB-887 in patients with diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD).

Approximately 125 patients will be enrolled in this study across the United States. Patients with DN and FSGS/TR-MCD will be randomized in 3 ascending dose cohorts to receive either GFB-887 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* All patients:

  1. Male or female 18-75 years of age, of any race, at the time of signing informed consent.
  2. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at Screening.
  3. Currently receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
* For DN patients:

  1. Diagnosis of type 2 diabetes with glycated hemoglobin (HbA1c) level ≤11% at Screening.
  2. UACR ≥ 150 mg/g.
* For FSGS/TR-MCD patients:

  1. Diagnosis of FSGS based on either biopsy or genetic testing or TR-MCD based on biopsy.
  2. UPCR ≥ 1.0 g/g.

Exclusion Criteria:

* All patients:

  1. Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease.
  2. History of malignancy, unless in remission for at least 5 years other than adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer not expected to require treatment over the course of the study.
  3. History of any organ or bone marrow transplant, including kidney grafts.
  4. History of alcoholism or drug/chemical abuse within 12 months prior to Screening.
* For DN patients:

  1. Renal disease that requires immunosuppressive therapy (currently, or in the past).
  2. Body mass index (BMI) \>45 kg/m2.
* For FSGS/TR-MCD patients:

  1. Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors.
  2. Body mass index (BMI) \>40 kg/m2.
  3. Known history of severe or chronic hepatobiliary disease.