cyrilzakka/clinical-trials huggingface dataset:
RCT of Automated Telephone Outreach to Improve Colorectal Cancer Screening

This large randomized controlled trial is testing the effectiveness of automated telephone outreach with speech recognition to improve rates of screening for colorectal cancer. The hypothesis is that the intervention improves rates of screening overall and specifically rates of colonoscopy.

Colorectal cancer (CRC) is the second leading cause of cancer-related mortality in the United States. Despite widespread dissemination of evidence-based guidelines recommending CRC screening, a large proportion of eligible individuals do not undergo screening. A variety of interventions have been tested to increase screening in primary care, but there remains an urgent imperative to develop and evaluate cost-effective and widely applicable approaches to promoting screening. In March 2005, Harvard Pilgrim Health Care, a large non-profit HMO in New England, carried out an internally funded program to increase CRC screening. The HMO randomized 80,000 members aged 50 to 64 years to receive automated telephone outreach with speech recognition or usual care. The intervention entailed the telephone engagement of members in a dialogue with a computer-programmed, responsive human voice about the importance of CRC screening, the options for undergoing screening, and encouragement to follow-up with their primary care physicians. The present study involves a 12-month follow-up of all eligible members randomized to intervention or usual care in March 2005, with assessment of the effect of the intervention on rates of CRC screening. This study has important implications for increasing CRC screening. With health plans expanding efforts to screen large populations for CRC and other malignancies, automated telephone outreach with speech recognition can reach large numbers of individuals with educational and reminder messages. It is important to know whether these efforts to promote screening are effective in overcoming known disparities in screening for CRC. If proven effective and cost-effective, this technology has the potential for widespread adoption and population-wide improvements in CRC screening and other prevention-related behaviors, with the ultimate public health goal of reducing the burden of suffering attributable to cancer and its complications.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-64 at baseline
* Continuous enrollment in health plan

Exclusion Criteria:

* Prior request for exclusion from research or quality improvement
* No telephone number on file
* Enrolled in other telephone-based outreach program of the health plan
* Share household with another eligible member
* Evidence of colorectal cancer or polyps at baseline
* Evidence of prior screening at baseline such that screening is not due at time of intervention
A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis

The overall objective of the study is to assess the effectiveness of switching from immediate-release prednisone (conventional) therapy to delayed-release prednisone (RAYOS) in patients with moderately to severely active Rheumatoid Arthritis (RA), managed according to standard of care in clinical practice settings.

Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone and followed for approximately 12 weeks.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and in general good health (Investigator discretion) with a recent stable medical history other than related to RA disease activity
* RA diagnosis is ≥ 6 months according to ACR and/or EULAR classification criteria for diagnosis of active RA
* Morning stiffness duration of at least 45 minutes at study entry
* RA disease activity as defined by DAS28 of ≥ 3.2 at study entry
* Currently receiving conventional immediate-release prednisone ≥ 2.5 milligram (mg) every morning and previously agreed to switch to RAYOS
* Willing and able to sign an Informed Consent Form (ICF)

Exclusion Criteria:

* Patient is unwilling to participate in the non-interventional study
Liposomal Doxorubicin in Treating Patients With Advanced Stomach Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced stomach cancer.

OBJECTIVES: I. Determine overall survival, time to disease progression, objective reponse rate, safety profile, and quality of life in patients with inoperable gastric adenocarcinoma when treated with doxorubicin HCl liposome.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour every 4 weeks. Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding disease may continue therapy past the 6 courses until documented disease progression. Quality of life is assessed prior to every treatment course. All patients are followed at 1 month. Patients with stable or responding disease are then followed every 3 months until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced gastric adenocarcinoma, including adenocarcinoma of the esophagogastric junction Evaluable disease No CNS involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin normal AST or ALT less than 3 times upper limit of normal (ULN) (5 times ULN if documented liver metastases) Renal: Creatinine less than 1.5 times ULN Cardiovascular: LVEF normal No history of New York Heart Association class II-IV heart disease with congestive heart failure No unstable cardiovascular disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior primary cancer within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No hypersensitivity to anthracycline therapy No history of severe hypersensitivity reactions to products containing Chremophor EL (e.g., cyclosporine or teniposide for injection concentrate) No other significant medical disorder (e.g., active uncontrolled infection) that would preclude study treatment

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to less than 1/3 of hematopoietic sites and recovered Surgery: Not specified Other: At least 30 days since other prior investigational agents
Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial

This is a Phase 2 multicenter randomized (2:1), placebo-controlled trial to evaluate early signs of efficacy of allogeneic, umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in patients with COVID-19 and Acute Respiratory Distress Syndrome (ARDS).

Randomized participants (N=54) will receive 3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs) or blinded placebo. The MSC product will be provided as 2.5 million cells/ml suspended in PlasmaLyte A containing 5% Human Albumin. The appearance-matched placebo product contains the same excipients, PlasmaLyte A and 5% Human Albumin, as the UC-MSCs.


Eligibility Criteria:
Inclusion Criteria:

* Age of ≥18 years
* Laboratory-confirmed SARS-CoV-2 infection during the current admission
* On invasive, non-invasive mechanical ventilation (NIV) (PEEP ≥5 cmH20) or high-flow nasal canula (HFNC) oxygen therapy (minimum total flow rate of 40 lpm)
* ARDS (onset \<96h) as per the international consensus definition (P/F ratio \< 300 with PEEP ≥5cm H20 or on HFNC), not due primarily to cardiac causes.

Exclusion Criteria:

* No consent/inability to obtain consent
* Rockwood Clinical Frailty Score \> 4
* Moribund patient not expected to survive 24 hours
* Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
* Currently receiving extracorporeal life support
* Pregnant or lactating
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Moderate to severe chronic liver disease (Childs-Pugh Score \> 12)
* Severe chronic respiratory disease with a baseline PaCO2 \> 50 mm Hg or the use of home oxygen
* Documented deep venous thrombosis or pulmonary embolism within the preceding 3 months
* Inability/contra-indications to receiving local standard of care thromboprophylaxis
* Chronic immunosuppression (any chronic immunotherapy including daily oral steroid use \>6months)
* Known HIV, Hep B/C positive, or active tuberculosis
* Multisystem shock (SOFA score change from baseline of \>2 in \>2 systems)
* Patient, surrogate, or physician not committed to full support including intubation (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
Effect of Immersion Level on Respiratory Function of Spinal Cord Injury Patients During Balneotherapy

Balneotherapy is a physiotherapy technique which allows patients to work out in a weightless environment and which is often used in patients with spinal cord injury. In normal subjects, water immersion generates a reduction in lung volumes. The effects of water immersion on the respiratory function of spinal cord injury patient (who are liable to present a respiratory failure secondary to paralysis) are not well known. They could be deleterious (by majoring respiratory failure)or beneficial (by mimicking the effect of a corset and improving respiratory function). Therefore, we are planning to study the effect of different water immersion levels on the respiratory function of spinal cord injury patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patient
* complete tetraplegia from spinal cord injury
* initial spinal cord injury at leat 3 months before study

Exclusion Criteria:

* contra indication to a balneotherapy session (bed-sore, skin infection or irritation, urinary or fecal incontinency, tracheostomy, ongoing infection)
* unstable respiratory state (patient free of respiratory infection or encumbrance)
* refusal to participate to the protocol
* pregnancy
Yoga to Improve Physical Function and Maximal Walking Distance Among Patients With Peripheral Arterial Disease

The investigators propose to pilot test a six-week yoga program among adults with peripheral arterial disease (PAD). Participants (n=50) will be randomized to a six-week yoga intervention (n=25) or wait-list control (n=25). The yoga intervention will include a weekly yoga class currently used among cardiac rehab patients at the University of Michigan Health System, together with home-based practice sessions. Participants will perform treadmill testing at baseline and 6 weeks to assess walking capacity. The primary outcomes of interest include 1) acceptability of the program by participants, 2) feasibility of recruitment, 3) change in maximal walking distance, 4) change in claudication symptoms, and 5) change in health-related quality of life (HRQOL). The investigators expect this will inform us on the acceptability and feasibility of a larger proposal examining yoga in PAD patients. These data will also inform on the effect size in maximal walking, and HRQOL, which will be used to estimate the sample size needed for a larger R01 level proposal.

Study hypotheses:

Hypothesis 1: Participants will find the yoga program acceptable with low drop-out rates (\<15%), excellent attendance (\>80% classes attended), and good completion of the home-based practice sessions (self-report \>80% completed).

Hypothesis 2: The yoga intervention will be feasible for a larger study based on numbers of potential participants approached, and those who consent to participate vs. those who do not.

Hypothesis 3: Increases in maximal walking distance and pain-free walking distance (from baseline to 6 weeks) will be greater in the participants randomized to the yoga intervention compared to the control group.

Hypothesis 4: Self-reported claudication symptoms will be reduced to a greater degree (at 6 weeks) among participants randomized to the yoga intervention compared to the control group.

Hypothesis 5: Increases in HRQOL (from baseline to 6 weeks) will be greater in the participants randomized to the yoga intervention compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 40
* Diagnosis of lower extremity PAD (defined as a documented ankle-brachial index of \< 0.9)
* Do less than 150 minutes of exercise per week
* Competent to give informed consent

Exclusion Criteria:

* Life expectancy under 1 year
* Pregnancy
* Co-morbidities which limit physical activity to a severe degree (unable to walk at least a block)
* Signs of critical limb ischemia and/or planned revascularization in the next 12-months
* Recent CVD event (\< 3 months) including stroke/transient ischemic attack (TIA), myocardial infarction (MI), unstable angina (UA), percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG), or severe valve disease, congenital heart disease, complex arrhythmias (untreated), NYHA class III-IV heart failure
* Recent or current enrollment in formal exercise or yoga program
* Psychiatric disorder, which limits subjects ability to follow the study protocol
* Current substance abuse
* Non-English speaking
Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC

The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.

The purpose of this Expanded Access Program is to provide investigational ALK inhibitor, neladalkib (NVL-655), for eligible patients with ALK-positive locally advanced or metastatic NSCLC (ALK+ NSCLC) who have previously received lorlatinib or a second-generation ALK tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement or activating ALK mutation.
3. Previously received lorlatinib or received at least one second-generation ALK TKI and is either not eligible for or does not have access to lorlatinib, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
4. Enrollment in a clinical trial of neladalkib is not possible.
5. Adequate organ function and bone marrow reserve.

Exclusion Criteria:

1. Prior receipt of neladalkib.
2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
3. Ongoing anti-cancer therapy.
Versi Retriever Approving Trial in Japan

This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.

This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.

60 cases will be enrolled and 90 days follow up need. Primary endpoint is favorable clinical outcome, mRS 0-2. Secondary endpoint are mortality in 90days, immediate successful recanalization, TICI 2b-3, symptomatic intracranial hemorrhage, and any adverse event related to device and or procedure.

Eligibility Criteria:
Inclusion Criteria:

* acute onset neurological sympto m related to occluded vessel
* within 8 hours from onset to tre atment or within 24 hours from onset to treatment with imaging diagnosis
* contra-indication or failed to int ravenous rt-PA
* accessible occlusion at ICA, MC A, VA, BA, PCA
* 5-30 of NIHSS
* 0-2 of mRS before onset
* obtain documented informed co ntent

Exclusion Criteria:

* following condition; arterial diss ection, engird, inaccessible turtuousity, difficult access by 50% or m ore stenosis, acute intracranial hemorrhage, space occuping lesion or brain tumor, major early ischemic change in brain
* occlude 2 major vessel territory
* allege for contrast media,
* abnormal PTT/APTT within 4 h ours intravenous heparin
* hemorrhagic tendency or 3 or more INR with Warfarin administration
* 30000cc or less of Platelet
* 50mg/dL or less of blood sugar
* uncontrolled blood pressure, 185mmHg or more at systolic, 110m mHg or more at diastolic
* 90days or less life expancy
* pregnant or lactating
* join another trial of medicine or medical device
* ineligible for trial
Metabolic Determinants of Cardiac Function

Assessment of cardiac energy metabolism in patients with impaired glucose tolerance

Insulin resistance, hepatocellular lipids (HCL) and plasma concentrations of free fatty acids (FFA) are predictors of heart failure, the leading cause of mortality in patients suffering from type 2 diabetes mellitus (T2DM). Epidemiological data suggest that diabetic cardiomyopathy (DC) presents as ventricular dysfunction in patients with T2DM independent of coronary artery disease. The underlying cellular mechanisms are poorly understood. Reduced mitochondrial activity and insulin resistance of skeletal muscle relates to liver steatosis, possibly due to higher substrate flux to the liver. High oxidation rates in the liver result in oxidative stress, damage of mitochondria and apoptosis. The investigators hypothesize that (i) HCL and impaired liver energy metabolism correlate with ventricular dysfunction, (ii) impaired glucose uptake and mitochondrial capacity in skeletal muscle relates to enhanced oxidative capacity, oxidative stress and lipid deposition in heart tissue (iii) reduced myocardial oxidative capacity limits recovery of myocardial function in patients with acute heart failure.

The investigators aim to assess (i) liver energy metabolism and heart function, (ii) respiration and lipid metabolites in skeletal muscle and heart tissue in humans with advanced heart failure and (iii) the prognostic impact of these factors in humans with acute heart failure.

This study will improve the understanding of mechanisms underlying the development of DC and the identification of patients at risk for poor outcome in heart failure.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 20 and ≤85 years
* myocardial biopsy for medical reason

Exclusion Criteria:

* acute infection
* autoimmune disease
* pregnancy
* cancer
Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms

The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin alone or in combination with solifenacin for the treatment in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms of frequency and urgency related to benign prostatic hyperplasia for at least 3 months
* I-PSS(S) score of ≥ 12
* Maximum flow rate (Qmax) of 4 to15 mL/sec
* Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary
* Benign digital rectal examination (DRE) result

Exclusion Criteria:

* Clinically significant outflow obstruction
* Significant post void residue volume (PVR \>100ml)
* Prostate specific antigen (PSA) ≥10 ng/mL
* Previous or planned prostate surgery, including transurethral resection of the prostate (TURP)
* Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months
* Patient with a neurological cause for abnormal detrusor activity
* Patients with urinary tract infection, chronic inflammation, bladder stones, bladder neck, sclerosis, urethral stricture, prostatic cancer, severe vesical diverticulum
* Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
* Patients with any other complication which may cause voiding dysfunction
* Patients with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorder, orthostatic hypotension, or senile dementia
* Patients receiving any medication therapy for LUTS/BPH 2 weeks prior to the study
* Use of drugs to treat incontinence currently
* Hypersensitivity to tamsulosin and/or solifenacin or to any component of the formulation
* Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
* Patients had taken any investigational drug in the previous 3 months prior to this study
Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment

The purpose of this study is to develop and test a new magnetic resonance imaging (MRI) technique to see if it can be used to tell the difference between tumor growth from worsening of cancer and growth from the effects of treatment in participants who have brain tumors treated with radiation therapy called stereotactic radiosurgery (SRS).


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers \[for Study Aim 1 (SA1) and Study Aim 2 (SA2)\] will be entered into the study if they meet the following criteria:

* Age ≥ 18 years
* Able to understand and give informed consent
* No known cancer diagnosis

Patients \[for Study Aim 1 (SA1)\] will be entered into the study if they meet the following criteria:

* Age ≥ 18 years
* Able to understand and give informed consent
* At least one untreated brain metastasis \> 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)

Patients \[for Study Aim 3 (SA3)\] will be entered into the study if they meet the following criteria:

* Age ≥ 18 years
* Able to understand and give informed consent
* At least one untreated brain metastasis \> 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)
* Planned SRS treatment

Exclusion Criteria:

Healthy volunteers (SA1 \& SA2) and patients (SA1 \& SA3) exclusion criteria:

* Pregnant or breastfeeding women
* Pre-existing medical conditions, including the likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
* Age \< 18 years