cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with type II diabetes mellitus aged 19 years or older
2. Patients who had taken DA5221-B1 and DA5221-B2(or another DPP-4 inhibitor is allowed) combination therapy at the same dose for at least 8 weeks prior to the screening visit
3. Patients with fasting plasma glucose≤270mg/dL at the screening visit
4. Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit
5. Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion Criteria:

1. Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
2. Patients with a medical history of New York Heart Association(NYHA) class III\~IV heart failure or with congestive heart failure, acute and unstable heart failure
3. Patients with severe infectious disease or severe traumatic systemic disorders
4. Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
5. Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption
Learning Health for Pediatric Complex Care Integration (PCCI)

The study team will conduct a mixed methods evaluation of the implementation of an evidence-based clinical program -- the Pediatric Complex Care Integration (PCCI) program - for improvement of care integration for children and youth with special healthcare needs (CYSHCN) and children with medical complexity (CMC). The PCCI program is not a discrete intervention itself; rather it is a health system-initiated program that will be implemented as a new standard of care for eligible patients with the intention of improving quality of care, implemented by clinical teams within Duke Health.


Eligibility Criteria:
* Inclusion criteria for children and parents/caregivers:

  * Patients up to 20 years old or under at the time of the monthly data pull or clinical team recommendation (for participation in the PCCI clinical program; no minors under 18 years old will be directly surveyed)
  * Adult parents/caregivers of participating children (for participation in interviews and quantitative parent-reported surveys) \*For human-centered design interviews, PCCI program participation is not required
  * Primary care attributed to Duke Pediatrics Primary Care - Roxboro Road clinic
  * High level of medical complexity: CSHCN (level 2 PMCA) or CMC (level 3 PMCA)
  * High risk for future healthcare utilization - may be defined by provider/care team determination, EHR data-based risk prediction model (exempt IRB Pro00104983, Developing a Model to Predict Risk for Healthcare Utilization by Children with Chronic Conditions), or any other way in which the clinical team determines a patient is "high risk" as part of their standard practice/care.
* Exclusion criteria for children and parents/caregivers: children/parents will be excluded if they meet the below criteria:

  * Unable to provide informed consent
  * Non-English or Spanish speaking parent/caregiver or young adult patient
* Inclusion criteria for clinical staff and providers (participation in interviews and quantitative staff/provider-reported surveys):

  * Currently employed by Duke Health
  * Primary site of work at participating primary care clinic site or central DUHS PHMO
Gait Recovery After Stroke

The purpose of this observational study is to track the recovery of stance duration symmetry during the first 6 months after stroke using wearable sensors and explore the influence of stroke specific factors (time since stroke, stroke type, location and paretic side).

Gait impairments can limit the ability to perform daily activities and increase the risk of falls in stroke survivors. Although rehabilitation improves walking in people with stroke, it is unclear whether the improvement relies on compensatory strategies or can be further improved to achieve normal or closer to normal performance.

Stance duration symmetry is an ideal measure of gait recovery in stroke survivors as it indicates the paretic sides capacity to control body weight and maintain balance during walking. Measuring stance duration symmetry may, therefore, be useful for monitoring gait recovery and could be considered as one of key goals in stroke rehabilitation.

Understanding the mechanisms of gait recovery in people with stroke is, therefore, essential for designing treatment program, setting realistic goals and appropriate timing for promoted intervention according to their stroke characteristics.

Our plan is to track changes in the symmetry of stance duration of hemiplegic patients during the first 6 months after stroke attached at the following time points: 1) at recruitment (within 2 weeks after of stroke), 2) 4th weeks (1 month) after stroke, 3) 12th weeks (3 months) after stroke, and 4) 26th weeks (6 months) after stroke. Two wearable accelerometers (the ActivPAL4+, PAL technology, Glasgow, UK) directly to the skin of both anterior thighs using sticky pads for 4 days (24 hours) period. Demographic (age and gender) and relevant clinical data (10-meter walk test, Modified Rivermead Mobility Index (RMI), stroke type, paretic side) will also be recorded as factors to explain gait symmetry.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or older
* diagnosis of a first occurrence of stroke by consultant stroke physician
* Medically stable
* referred for rehabilitation
* functional ambulatory category of 1 and over

Exclusion Criteria:

* acute skin condition
* transient ischemic stroke
* comorbidities that may interfere with walking function, such as Parkinson's disease or lower limb amputation
* severe communication impairments or delirium
Neurofeedback Intervention for Preclinical Alzheimer's Disease

Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective pharmacologic therapy for this disease. Electroencephalogram-based neurofeedback is considered as a potentially treatment strategy. In this project, the investigators aim to investigate the effectiveness of neurofeedback therapy on cognition for individuals with subjective cognitive decline (SCD). Participants will receive electroencephalogram-based neurofeedback therapy once a day for successive five days. Then, the investigators will evaluate the changes of memory function between baseline and post-therapy visits.

Currently, there has been no effective therapy for Alzheimer's disease (AD). Electroencephalogram-based neurofeedback is now considered as a potentially intervention and may positively affect cognitive function for patients with AD. However, there are few existing studies involving the role of neurofeedback on cognition for subjective cognitive decline (SCD).

Fifty participants with SCD will be recruited in this clinical trial. At baseline, neuropsychological tests are conducted. Participants will receive electroencephalogram-based neurofeedback therapy once a day for successive five days. After that, the investigators will evaluate the changes of memory measures, which is the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* 50-79 years old, right-handed and Mandarin-speaking subjects;
* self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event;
* normal age-adjusted, gender-adjusted and education-adjusted performance on standardised cognitive tests;
* concerns (worries) associated with memory complaint;
* failure to meet the criteria for MCI or dementia

Exclusion Criteria:

* a history of stroke;
* major depression (Hamilton Depression Rating Scale score \> 24 points);
* other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
* cognitive impairment caused by traumatic brain injury;
* systemic diseases, such as thyroid dysfunction, syphilis and HIV;
* a history of psychosis or congenital mental growth retardation.
Effect of Lymph Node Ratio in Gastric Cancer to Determine Recurrence Rate After Curative Resection

D2 gastrectomy is standard treatment of early gastric cancer in Japan but in other countries there is still some discord, especially in Europe and North America. Although the quantity of metastasis cancer in lymph node defines survival regardless of which country the patient is treated, the total number of lymph nodes harvested is an important factor to predict accurate staging and/or D2 gastrectomy. Both of the number total lymph nodes and the metastasis lymph node status in gastric cancer are important factors to decide each prognosis. This study evaluated the correlation between total lymph nodes retrieved and metastasis node by lymph node ratio (LNR) status to determine the recurrence rate after curative resection of gastric

A retrospective chart review was made of all patients who presented with gastric cancer after curative surgery resection from January 1, 1995 to December 31, 2016 in Ramathibodi Hospital.Data of metastasis node by lymph node ratio (LNR) were evaluated. The total of lymph node less than 15 and more than 15 were evaluated. The Kaplan-Meier curve estimates recurrence survival (Log-rank test). The p-value \< 0.05 is statistically significant.

OBJECTIVE :

The outcome of this study was evaluated lymph node ratio (LNR) status that determined by the ratio of total lymph node metastasis and the total lymph node which retrieved after performed the curative surgery and lymphadenectomy of gastric cancer. The correlation of LNR and prognosis of recurrence and survival of gastric cancer patients were evaluated and reported in this study.

Eligibility Criteria:
Inclusion Criteria:

* Gastric cancer after curative surgery resection
* No received neoadjuvant therapy
* Patients have tissues confirmed by Pathology
* Staging used esophagogastroduodenoscopy (EGD) or imaging, including ultrasonography, Computer Tomography (CT) or Magnetic Resonance Imaging (MRI
* Surgery was performed for curative intent and D2 lymphadenectomy and according from Japanese guideline for gastric cancer

Exclusion Criteria:

* Distant metastasis during surgery
Nutrition and Exercise Intervention Study

The purpose of the present study was to clarify the effects of increase in physical activity on incidence and surrogate marker of cardiovascular diseases. The working hypothesis of the present study was that the physical activity to satisfy the Japanese guideline of Ministry of Health, Labour and Welfare is effective for the primary prevention of the lifestyle-related disease.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Ages 30-64 years old

Exclusion Criteria:

* During treatment of any diseases
* Two or more metabolic risk factors
Health Coaching to Empowering Hospitalised Chronic Heart Failure Patients

Aims: To evaluate the preliminary efficacy of Health Coaching in empowering hospitalised chronic heart failure patients.

Methods: pre-post quasi-experimental pilot study was carried out with 59 patients, allocated into the pre-intervention group (N=29) and post-intervention group (N=30) in a cardiology ward of a hospital. The intervention consisted of the knowledge traslation acquired on health coaching by the nurses of the cardiology unit to their care activity with CHF patients. The Patient empowerment in long-term conditions Questionnaire was used to measure heart failure patients: Attitude and sense of control; Shared and informed decision-making; and Information seeking and peer sharing, on two occasions: T1, pre-intervention, and T2, after completion of the intervention.

Data collection:

Data collection was carried out by two members of the research team, who were not directly involved in the care of the patients, at two points in time: T1, pre-intervention, and T2, post-intervention. Two questionnaires were used for data collection:

1. Patient empowerment questionnaire for patients with chronic illness (Garcimartin et al. 2019): validated instrument in Spain with good psychometric properties, excellent Cronbach's alpha (\>0.9) and moderate interclass correlation coefficient (0.47). It consists of 47 items and 3 dimensions: 1) Positive attitude and sense of control (21 items); 2) Shared and informed decision-making (13 items); and 3) Information seeking and sharing among peers (13 items). Response options for each item are scored on a 5-point Likert-type scale (1 strongly disagree and 5 strongly agree). The overall score for each patient ranges from 47 (worst empowerment) to 235 (best empowerment).
2. Questionnaire to collect sociodemographic and clinical variables: sex, age, educational level, marital status, employment status, hospital stay, Charlson index, 10-year survival, functional class (I-IV; according to NYHA), time of diagnosis and admissions in recent months.

Ethical considerations:

This study conformed to the principles set out in the Declaration of Helsinki and was approved by the centre's board and by the Research Ethics Committee (code 2019.066). Data custody complied with Organic Law 3/2018 on data protection (LOPDE). Informed consents were given to all participants. They were informed verbally and in writing about their free participation, the confidentiality and anonymity of the data and its use for scientific purposes. Nobody declined to participate or withdrew at any point of the study.

Eligibility Criteria:
Inclusion Criteria:

1) ≥18 years old; (2) at any stage of their disease (I-IV), according to the New York Heart Association Functional Class (NYHA) classification; (3) who had been admitted for more than 3 days; (4) whose level of consciousness was normal and whose state of health allowed them to complete the questionnaire; (5) who spoke and understood Spanish and; (6) who signed the informed consent form.

Exclusion Criteria: Patients with cognitive impairment or unable to answer the questionnaire.
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.

Eligibility Criteria:
Inclusion Criteria:

* All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)

Exclusion Criteria:

* Patients not administered XALKORI in spite of enrolled.
Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection

Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. The related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. Because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Child-pugh A-B
* Primary hepatocellular carcinoma of the left liver lobe
* Tumor size ≤5cm in diameter
* KPS≥60

Exclusion Criteria:

* Significant abnormal liver function
* Significant abnormal Heart function
* Significant abnormal lung function
* Significant abnormal kidney function
Fungal Resistance in Dermatophyte Infection

The aim of the study is to compare the efficiency of broth microdilution versus disk diffusion method for antifungal drug susceptibility testing of the most used drugs in dermatophytosis treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed clinically with dermatophytosis, any age group and any sex

Exclusion Criteria:

* Patients under either Local or systemic antifungal treatment
Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients

The purpose of this study is to compare preference of the patients, efficacy of preparation, and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid in patients with inactive ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years old
* ulcerative colitis patients without symptoms for at least 1 year
* ulcerative colitis patients who undergo colonoscopy for surveillance

Exclusion Criteria:

* subjects who had abdominal surgery
* pregnant or breast feeding
Tai Chi/Qigong Exercise Persistence Among Residents of Senior Housing

This randomized field trial uses a self-report daily exercise log to answer the research question: Does frequency of instruction influence tai chi/qigong home practice exercise persistence among residents of Senior housing?


Eligibility Criteria:
Inclusion Criteria:

* Resident of Senior housing,
* Ability to engage in mild exercise
* Vision sufficient to view TV medium
* Willingness to engage in tai chi/qigong training and practice.

Exclusion Criteria:

* Unable to provide informed consent
* Unable to attend initial training session
Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer


Eligibility Criteria:
Inclusion Criteria:

- Age ≥18 years and age ≤75 years. ECOG score 0-1. Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer

Adequate bone marrow and organ function:

Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study.

Signed informed consent. Ability to comply with the study protocol and follow-up.

Exclusion Criteria:

1. Received antitumor chemotherapy, radiation therapy, and immunotherapy prior to first treatment.
2. Patients with comorbid severe pancreatic portal hypertension, which may cause a higher risk of bleeding with subsequent injection therapy;
3. Patients with prior or concomitant history of other tumors (except basal cell carcinoma of the skin, cervical cancer in situ).
4. Serious uncontrolled medical conditions that may interfere with the subject's ability to receive treatment as specified in the protocol, including, but not limited to, positive HIV test, active tuberculosis, and DNA copy number of HBV \>103/ml;
5. Uncontrollable comorbidities, including, but not limited to, active bacterial, viral, tuberculosis, or fungal infection, symptomatic congestive heart failure, unstable angina, and cardiac arrhythmia.
6. Patients with autoimmune disease or immunodeficiency treated with immunosuppressive drugs;
7. Pregnant or lactating women;
8. Those who may be allergic to the study drug or any of its excipients;
9. Preoperative ultrasound evaluation of patients with small tumor size, location near or behind major blood vessels, and various other factors that may result in a low success rate of intra-tumoral viral injection under ultrasound and a high rate of post-injection complications;
10. Substance abuse or those who are unable to undergo immunization or lysosomal viral therapy due to clinical, psychological, or social factors.
11. Any uncertainty that affects patient safety or compliance.
MK0462 in Treatment of Migraine With Recurrence (MK0462-022)

A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo.

The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.


Eligibility Criteria:
Inclusion Criteria:

* Patient had at least a 6-month history of migraine, with or without aura
* Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
* Patient was judged to be in good health, apart from migraine

Exclusion Criteria:

* Patient was pregnant or a nursing mother
* Patient had abused drugs or alcohol within 12 months prior to entering the study
* Patient had a history of cardiovascular disease
* Patient had clinically significant ECG abnormality
* Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
* Patient received treatment with an investigational device or compound within 30 days of the study start
* Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
* Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
* Patient had prior exposure to rizatriptan