cyrilzakka/clinical-trials huggingface dataset:
Evaluating the EAPOC-COPD System

The EAPOC-COPD study is a stepped wedge cluster randomized controlled trial (SW-RCT) designed to evaluate the effectiveness of the Evidence at the Point-of-Care for COPD (EAPOC-COPD) system, a digital clinical decision support system (CDSS) integrated into primary care electronic medical records (EMRs). The system aims to improve COPD management by providing personalized pharmacotherapy recommendations, symptom and risk assessments, and self-management action plans, based on patient-reported data.

Study Design:

Six primary care sites in Ontario, Canada will transition from usual care to EAPOC-COPD-supported care in a staggered manner over 56 weeks. Each site will serve as its own control during the pre-intervention period.

Primary Objective:

To assess the impact of EAPOC-COPD on guideline-aligned pharmacotherapy optimization for COPD, measured by the proportion of patients with medication escalation.

Secondary Objectives:

Evaluate improvements in symptom/risk assessments (mMRC, CAT), COPD action plan delivery, influenza vaccination, smoking cessation support provision, pulmonary rehabilitation referrals, and COPD symptom burden

Process Measures:

Study investigators will also measure provider and patient uptake, satisfaction, and system feasibility will be assessed through EMR data audits, patient/provider surveys, and system usage analytics

Population:

All prescribers at the six primary care sites (physicians and nurse practitioners) will be eligible. The study will involve patients with physician-diagnosed COPD, identified through EMR searches.

Data Collection:

Clinical outcomes will be obtained through chart reviews and data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN), where available. Patient-reported outcomes will be captured via questionnaires through the patient app/portal.

Sample Size:

An estimated 1860 COPD patients will be seen during the study. With an expected baseline medication escalation rate of 13%, the study is powered to detect an 8% absolute increase (assuming an Intra Class Correlation (ICC) =0.1).

Analysis:

A generalized linear mixed model (GLMM) will assess primary and secondary outcomes, accounting for time trends, clustering, and the stepped roll out.

Significance:

This trial will generate real-world evidence on the effectiveness of a point-of-care digital tool in closing COPD care gaps, with potential for large-scale primary care implementation.


Eligibility Criteria:
Inclusion Criteria:

* Providers working at clinical site currently using IT infrastructure that allows for integration of EAPOC-COPD
* Providers caring for patients with COPD

Exclusion Criteria:

* Unwilling to use EAPOC-COPD system
Common Genetic Variation and Type 2 Diabetes

Type 2 diabetes is a common metabolic disorder arising from a complex interaction between genetic predisposition and the environment. The development of this disorder is preceded by impaired glucose tolerance and elevated fasting glucose which also carry adverse cardiovascular risk. To date a few common genetic variants have been reliably associated with predisposition to type 2 diabetes. However, it is uncertain how these genes interact to alter insulin secretion and insulin action prior to the development of type 2 diabetes. We propose to utilize an established population-based cohort to determine how common genetic variants associated with type 2 diabetes alter the response to an oral glucose challenge in people without overt type 2 diabetes. This will enable us to understand how common variants alone or in combination alter whole-body glucose physiology and predispose to type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Fasting blood glucose \< 126mg/dL

Exclusion Criteria:

* Fasting blood glucose \> 126mg/dL
CLIC1 in Patients Presenting PD

In this study, mononuclear cells, particularly monocytes, were collected from the peripheral blood of elderly patients who underwent orthopedic hip surgery under spinal anesthesia. We then observe the accumulation of chloride intracellular channel 1 (CLIC1), particularly the characteristic accumulation morphology and its function. The purpose of this study is to compare whether there is a difference in the degree and form of cytoplasmic CLIC1 accumulation between the elderly group with postoperative delirium (PD) and the elderly group without postoperative delirium. We'll also confirm whether this is appropriate as a predictor of postoperative delirium. In addition, we will establish a control group for the non-elderly group to check the difference due to aging itself.


Eligibility Criteria:
Inclusion Criteria:

Male or female patients aged 65 years or older who are scheduled to undergo surgery for an orthopedic hip fracture under spinal anesthesia

Exclusion Criteria:

* Patients who are unconscious
* Patients who are unable to communicate
* Alzheimer
* Parkinson Disease
* Conversion to general anesthesia
Therapeutic Neuroscience Education in Individuals With Fibromyalgia

The aim of this study was to investigate the effects of Therapeutic Neuroscience Education (TNE) in individuals with Fibromyalgia (FM). The study included 25 females with FM, randomly separated into two groups as the intervention group (Clinical Pilates Exercises+TNE, n=11) and the control group (Clinical Pilates Exercises, n=14).


Eligibility Criteria:
Inclusion Criteria:

* age between 18-65 years,
* female gender,
* a VAS of at least 40mm to report the pain intensity of the last week,
* having been diagnosed with FM for at least 1 year to present a range of somatic and cognitive symptoms in addition to widespread pain,
* using a fixed dose of medication for at least the past 6 months (serotonin noradrenaline reuptake inhibitors \[Ex, duloxetine, milnacipran\]; alpha 2-delta receptor ligand \[Ex, pregabalin\]; gabapentinoids).

Exclusion Criteria:

* the presence of another disease which may affect the physical condition,
* cognitive impairment at a level preventing cooperation,
* being pregnant,
* inability to understand or speak Turkish,
* concurrent autoimmune or inflammatory disease,
* the presence of a central nervous system disease (eg multiple sclerosis, Parkinson's disease),
* serious psychiatric conditions (eg, psychotic disorders) that would prevent participation,
* participation in a rehabilitation program in the past year,
* have been exercising regularly for 6 months,
* not participating in at least 75% of treatments.
Study of ACE-536 in Healthy Postmenopausal Women

The purpose of this study is to find out whether ACE-536 can be safely given to patients. This study will also look to see if ACE-536 increases red blood cells, the cells that carry oxygen in the body.


Eligibility Criteria:
Key Inclusion Criteria:

* Postmenopausal women
* Body Mass Index (BMI) of 20 - 32 kg/m2.

Key Exclusion Criteria:

* History of hypertension
* Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit, Aranesp, etc.) within 6 months prior to Day 1
* History of clinically significant cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other disease
* Surgery within 3 months (other than minor cosmetic surgery or minor dental procedures)
* Subject has received treatment with another investigational drug, or approved therapy for investigational use within 1 month prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Day 1, whichever is longer
Intraoperative Imagery of Breast Cancer With Folate-FITC (EC17)

Breast cancer is the most common cancer and the second cause of cancer mortality in women. There are approximately 200,000 new cases of breast cancer a year. Classically, breast cancers are divided into two groups, invasive and non-invasive. A mainstay of the treatment of both of these types is surgical resection not only for therapeutic purposes but also for diagnostic purposes. Breast conserving therapy includes surgical lumpectomy and post-operative radiation. However, despite best surgical practices, when patients undergo BCT anywhere from 20 - 40% of these patients have margins positive for cancer. This leads to increased rates of reoperation which are quoted to be as high as 30% and increased local recurrences.

There is an over expression of folate receptors located on the surface of many human carcinoma nodules.Specifically for breast cancer up to 33% of all breast cancers over express the folate receptor.

Folate-fluorescein isothiocyanate, or folate-FITC, also identified as EC-17, targets folate receptors over expressed in certain cancers such as breast cancer, and could help in better identifying the margins of the cancer thereby achieving negative margins.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients 18 years of age and older
2. Patients presenting with breast cancer presumed to be resectable by lumpectomy and/or mastectomy on pre-operative assessment
3. Good operative candidate
4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
2. Patients with a history of anaphylactic reactions to Folate-FITC or insects
3. At-risk patient populations

   1. "People who would be easily lost to follow up (ex: People who are homeless or alcohol dependent)
   2. Patients unable to participate in the consent process (children and neonates).
A Study of Galunisertib in Participants With Myelodysplastic Syndromes

The purpose of this study is to investigate the effect of the study drug known as galunisertib in participants with myelodysplastic syndromes (MDS). Participants with different degrees of disease (very low, low, and intermediate risk) will be studied. The study treatment is expected to last about 6 months for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MDS based on the World Health Organization (WHO) criteria
* Participants with 5q deletions are allowed only if they have failed or are intolerant of lenalidomide treatment
* Participants must have a Revised International Prognostic Scoring System (IPSS-R) category of very low-, low-, or intermediate-risk disease
* In the 8 weeks prior to registration, participants in phase 2 should have anemia with Hb ≤10.0 g/dL (based on the average of 2 baseline measurements and untransfused for at least 1 week) with or without red blood cell (RBC) transfusion dependence confirmed for a minimum of 8 weeks before enrollment
* For phase 3, participants should have anemia with RBC transfusion dependence confirmed within 8 weeks before enrollment
* Performance status ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria:

* No history of moderate or severe cardiac disease
* No prior history of acute myeloid leukemia (AML)
Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* opioid naïve (or less than 4 vicodin equiv/day)
* 18-70 years old
* candidate for opioid therapy for nonmalignant pain.

Exclusion Criteria:

* history of substance abuse or severe psychiatric disease
* use of medications for the treatment of neuropathic pain as these may alter tolerance or hyperalgesia
* neurological conditions interfering with experimental pain testing, e.g. severe peripheral neuropathy
Tongue Image Database and Diagnostic Model for Digestive Tract Disease Diagnosis

The tongue images of patients with gastrointestinal diseases and healthy people will be collected and the tongue image database will be established. Through deep learning and artificial intelligence, early screening models of various gastrointestinal tumors based on tongue images were constructed.


Eligibility Criteria:
Inclusion Criteria:

1. Be older than 18 years old;
2. Clinical or pathological diagnosis of Digestive tract diseases;
3. Patients before receiving surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy and other treatment measures；
4. The patient had no tongue disease
5. Patients understand and are willing to sign written informed consent.

Exclusion Criteria:

1. Patients unable to complete the process as required (mental disorder or poor compliance, etc.);
2. The patient or guardian is unwilling to participate in this study;
3. Combined with other serious systemic diseases (heart failure, renal failure,hematopoietic system disease or Uncontrollable acute infection);
Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.

A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism, secondary hyperparathyroidism and cardiovascular calcification in prevalent haemodialysis patients. And the long term safety of the 1.25 mmol/L calcium dialysate was also considered.

There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.

Phase 2 (intervention phase). Each subject will be randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.

All patients recruited from these centers who met the inclusion criteria were randomly allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36 months.

Calcium carbonate was mainly used as the phosphate binder. Active vitamin D metabolite, calcitriol (Rocaltrol, Hoffmann La Roche, and Basel, Switzerland) was given as to control the secondary hyperparathyroidism. The doses of these agents were adjusted according to the serum calcium level, serum phosphate level, calcium-phosphorus product and serum iPTH level, which were recommended by the K/DOQI Guidelines 6.3b and 8B. Aluminum hydroxide might be introduced as a phosphate binder for no more than 4 weeks in addition to calcium carbonate and dietary restriction when serum phosphate level could not get a good control (serum P level≥1.78 mmol/L, lasting above 4 weeks). A non- calcium-containing phosphate binder could be administered for 1\~2 weeks in patients with hypercalcaemia during the observation. At the time of the study, non-calcium, non-aluminum based phosphate binders as well as calcium acetate were not available in our country.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to sign an informed consent
* Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
* Secondary hyperparathyroidism defined as serum intact parathyroid hormone (iPTH) \> 150 pg/mL, hypercalcemia defined as serum Ca \> 2.2 mmol/L and /or calcium phosphate product ≥55mg2/dl2

Exclusion Criteria:

* Inability or unwillingness to sign the informed consent
* Cardiac arrhythmia
* Serious renal osteopathy
* Oral active vitamin D and/or calcium carbonate intolerance
* Poor compliance or unwillingness to meet the scheme demands raised by the investigators
* Patients who had undergone percutaneous ethanol injection therapy or parathyroidectomy for secondary hyperparathyroidism
* Patients who had previously been treated and/or were being treated with glucocorticoid, which affects bone metabolism.
Greek NIS Spiolto ELLACTO

Open-label observational study: including COPD patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations


Eligibility Criteria:
Inclusion Criteria:

* Therapeutic indication before entering the enrollment face is patients diagnosed with COPD requiring a combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and guidelines, COPD GOLD 2017 groups B to D
* Female and male patients ≥40 years of age
* Treatment with Spiolto ® Respimat® acc. to SmPC and at the discretion of the physician
* Written informed consent prior to participation

Exclusion Criteria:

* Patients with contraindications according to Spiolto® Respimat® SmPC
* Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 weeks or patients already on a combination of LAMA and LABA therapy; either as a fixed combination product or as separate components Note: Patients previously treated with LABA or LAMA (with or without ICS) are eligible to be included in the study
* Patients continuing LABA-ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
* Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
* Pregnancy and lactation
* Patients currently listed for lung transplantation
* Current participation in any clinical trial or any other non-interventional study of a drug or device
New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.

The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Master Umbrella Clinical Investigation will be comprised of several sub-investigations, which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.

This is a feasibility, prospective, multi-center, single-subject, repeated-measures clinical investigation in experienced adult cochlear implant users. The Master Umbrella design will enable the execution of a series of sub-investigations in the same user population, with the goal to evaluate a range of speech enhancement pre-processing algorithms in separate sub-investigations. The primary objectives for each sub-investigation will be consistent with the master umbrella investigation, with secondary and exploratory objectives selected based on the algorithm to be investigated. Secondary and exploratory objectives will be described in the sub-investigation documentation.

Eligibility Criteria:
Inclusion Criteria:

* User of an approved Nucleus cochlear implant.
* User of the ACE (Advanced Combination Encoder) sound processing strategy.
* Aged 18 years or older (no upper age limit).
* Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.\*
* Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
* Willing and able to provide written informed consent.
* ≥3 months post cochlear implant activation

Exclusion Criteria:

* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* Investigator site personnel directly affiliated with this study and/or the investigator's immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.

Purpose:

Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination.

Phase II: Determine the complete remission rate (CR+CRp)

Eligibility Criteria:
Inclusion Criteria:

1. Morphologic evidence of acute myeloid leukemia in first relapse.
2. Phase I: 18 years or older, Phase II: 50 years or older

Exclusion Criteria:

1. Prior treatment with zosuquidar
2. Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
3. History of stem cell transplant
Effects of Coenzyme Q10 Supplement on Cardiovascular Risk Factors in Subjects at High Risk of Metabolic Syndrome

This study aims to evaluate the ameliorating effect of coenzyme Q10 supplementation on cardiovascular risk factors in high risk population for metabolic syndrome, including blood lipid metabolism, insulin resistance, blood pressure regulation, platelet function, endothelial function, cardiorespiratory fitness and muscle function.


Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome or high-risk groups with metabolic syndrome are defined as subjects with metabolic syndrome according to the International Diabetes Federation (IDF) Chinese Adult Criteria, and high-risk groups are defined as those who meet at least two MetS risk factors. The specific criteria are as follows:

  1. Aged 30-90 years old;
  2. Two or more of following are acceptable:

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  1. Abdominal obesity (central obesity): waist circumference \>=90 cm for men and \>=80cm for women;
  2. Hyperglycemia: fasting blood glucose ≥ 5.6mmol/L or taking hypoglycemic drugs;
  3. Hypertension: systolic blood pressure \>=130mmHg and (or) diastolic blood pressure \>=85mmHg or taking blood pressure medications;
  4. Fasting TG\>=1.70mmol/L or taking antihyperlipidemic drug;
  5. Fasting HDL-C\<1.04 mmol/L for men, \<1.29 mmol/L for women or taking antihyperlipidemic drug; 3) Sign informed consent and insist on participating in the research.

Exclusion Criteria:

* 1) Take drugs/dietary supplements, such as aspirin, fish oil and etc., that affect platelet function in recently six months; 2) blood system disease or infection; 3) Blood pressure \>=160/100mmHg; 4) Low platelet count (whole blood platelet\<100 x 10\^9/mL); 5) Abnormal hemoglobin (male \<120g/L, female \<110g/L); 6) Low hematocrit (male \<40%, female \<37%); 7) Prothrombin time (PT) is outside the normal reference range; 8) Pregnant women or nursing mothers; 9) Abnormal menstrual cycle, taking birth control pills or hormone replacement therapy; 10) Gastric ulcer, liver or kidney dysfunction.