cyrilzakka/clinical-trials huggingface dataset:
Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial

Eligibility Criteria:
Inclusion Criteria:

* Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
* Clinical diagnosis of moderate renal impairment

Exclusion Criteria:

* AST and /or ALT \> 3.0 times the upper limit of normal
* Serum total bilirubin \> 1.5 times ULN
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

For local relapse not amenable to reasonable curative surgery or for those with metastatic chordoma, chemotherapy is recognised as inactive. The major study drug is the small molecular tyrosine kinase inhibitors targeted at the stem cell factor receptor (KIT) and the platelet-derived growth factor receptors (PDGFRA and PDGFRB), eg. imatinib. Anlotinib is a novel tyrosine kinase inhibitor targeting both at VEGFR-2, -3 and PDGFRA and PDGFRB with high affinity, which also showed broad antitumor activity against EGFR and so on. Thus this multicenter, two-armed phase II trial of PKUPH-sarcoma 05 intended to investigate the efficacy and safety of anlotinib versus imatinib on advanced chordoma.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older;
* histologically proven metastatic or locally advanced chordoma, reviewed by the Pathology Committee of Peking University People's Hospital;
* not amenable to curative-intent surgery;
* measurable with computed tomography scan or magnetic resonance imaging, per RECIST, version 1.1.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG)30 performance status more than 2 ;
* life expectancy less than 12 weeks;
* with severe or uncontrolled medical disorders (≥grade 2 of Common Terminology Criteria for Adverse Events version 4.03 \[CTCAE version 4.03\]) that could jeopardise the outcomes of the study, for example, cardiac clinical symptom or disease with LVEF (left ventricular ejection fraction) \<50%, hypertension that could not be well controlled through antihypertensive drugs and so on;
* weight loss of 20% or more before illness;
* brain or leptomeningeal metastasis;
* surgical procedure or radiotherapy within 4 weeks of enrollment;
* active gastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
* proteinuria or hematuria;
* denutrition with albuminemia less than 25 g/L;
* pregnant or breastfeeding status;
* other malignancy, positive HBV/HCV/HIV serology;
* known allergy to the experimental agents;
* had ever used anti-angiogenesis TKIs.
The Relationship Between Belief, Expectation, and Adherence to Therapy During COVID-19 Pandemic

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* \[question
* \[question Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items \].

If there is a comparison group: Researchers will compare insert groups \] to see if insert effects


Eligibility Criteria:
Inclusion Criteria:

* all patients diagnosed with ischaemic heart disease established by angiography;
* reaching the age of majority;
* score \>= 26 on the Montreal Cognitive Assessment (MoCA) test (Nasreddine et al., 2005).

Exclusion Criteria:

* presence of comorbidity with other pathologies in an active or advanced phase; -patients with a prognosis to be defined;
* pregnancy;
* participants with neurological pathologies that significantly impair their cognitive functions (e.g. advanced Parkinson's disease; Alzheimer's dementia...cardiac arrest with hypoxic damage);
* participants with cognitive impairments that compromise comprehension and sharing of the contents of the questions, detected through the administration of the Montreal Cognitive Assessment (MoCA) test (Nasreddine et al., 2005).
Lung Cancer Patients and Parent-child Interaction Experience and Process

Type of study: The goal of this observational study is to explore the relationship between patients with advanced lung cancer and their parent-child interactions during the treatment process, and to understand the impact of the degree of self-differentiation of parents with advanced lung cancer on the physical and mental health of their children. The main questions it aims to answer are:

1. To explore the post-illness adjustment process of patients with advanced lung cancer and the changes in the parent-child relationship among adolescents.
2. To explore the changes in demographic factors-self-belief, mental health, and self-efficacy among patients with advanced lung cancer-and the parent-child relationship among adolescents.
3. Explore the family resilience of patients with advanced lung cancer - family peer relationships, and the interaction between parent-child relationships among adolescents.

This study explores the relationship between late-stage lung cancer patients and their parent-child interactions during the treatment process, and understands the impact of the degree of self-differentiation of parents with late-stage lung cancer on their children's physical and mental health.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced lung cancer aged 40 to 64 years (mid-adulthood).
2. There are lung cancer patients in the family who are teenagers aged 10 to 19 years old.
3. Those who voluntarily participate in this study.
4. Voluntary participants can express themselves orally and in handwriting.

Exclusion Criteria:

1. Single lung cancer patients over 65 years old.
2. Lung cancer patients under 40 years old.
3. Patients diagnosed with early-stage lung cancer.
4. Those who have cognitive impairment and are unable to understand the problem.
5. Those who are unable to express and respond to questions.
Dexmedetomidine Plus Low Dose Morphine Versus Standard Dose of Morphine in PCA in Children .

The treatment of perioperative pain in children has been a topic of great interest to pediatricians, pediatric surgeons, and anesthesiologists for many years. Opioids are the most common analgesics used to manage acute postoperative pain in children and adults

Patient-controlled analgesia (PCA) permits patients to self-administer small doses of opioid analgesics intravenously or subcutaneously at frequent intervals. PCA is used in the management of moderate-to-severe pain. Patient-controlled analgesia (PCA) is now used in children as young as 5 yr for the treatment of postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

1. ASA I \& II of both sex.
2. Age between 8 and 12 years.
3. Patients scheduled for exploration surgery under general anesthesia.

Exclusion Criteria:

1. Parents refused to give consent.
2. Patients with history of allergy to morphine or dexmedetomidine.
3. Mental disorders.
4. Unsuitability for extubation.
5. Comorbidities as cardiac, pulmonary and obstructive sleep apnea.
6. children with chronic opioid use for \> 3 monthes
Dialysis Adequacy in Nutritional Status in Hemodialysis Patients

Assess nutrition status in hemodialysis patients and effect adequacy of hemodialysis on it.

Effect of dialysis adequacy and nutritional status in patients' quality of life.

Patients with end-stage renal disease (ESRD) are unable to sustain life without hemodialysis. So, adequacy of hemodialysis is the main treatment for this patient.

Adequacy of hemodialysis can be appeared on patient clinically by improve Quality of life and life expectancy, increase appetite and weight gain, control blood pressure, no bone disease, control of acidosis and anemia, Relief of uremic symptoms as nausea, vomiting, fatigue, anorexia, weight loss, muscle cramps, pruritus, or changes in mental status.

Malnutrition is a major issue in patients undergoing hemodialysis and is observed in approximately 20% - 70% of this group. Malnutrition is a serious predictive factor for mortality and morbidity accompanied by an increase in the rate of hospitalization, less physical activity, lower quality of life.

An imbalance between energy and protein gain and food metabolism, metabolic acidosis, dietary restrictions, anorexia and poor appetite, protein and nutrient loss during dialysis, underlying diseases, such as cardiovascular problems, infection, poor nutrition management, inadequate dialysis, etc. are among influencing factors on the nutrition of hemodialysis patients.

Among patients undergoing hemodialysis, 6% to 8% suffer from severe malnutrition and 30% - 65% from mild malnutrition. The results of some studies have shown that one of the important causes of malnutrition is low dialysis adequacy in patients undergoing hemodialysis.

Malnutrition is associated with an increase in morbidity, a decrease in functional capacity, and a greater number and duration of hospital admissions, all of which may cause a low health-related quality of life (QOL) and impact patients' emotional, physical, and psychosocial health.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in regular haemodialysis .
2. patients above 18 years

Exclusion Criteria:

1. Patients with thyroid illness.
2. Patients with acute infection.
3. Patients with major surgeries.
4. Patients with malignancy.
5. Patients with liver cirrhosis.
6. patient with inflammatory bowel diseases.
A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)

This is a Phase I study. This study is the first time that a new experimental drug called 18FFluoroglutamine, or F-Glutamine, is being used in people. F-Glutamine is a drug designed to be used with PET scanners that can 'see' where F-Glutamine goes in the body, after its injected. PET scanners are one of the kinds of scanners you normally find in a hospital radiology department. The researchers have found that tumors in animals absorb F-Glutamine. The researchers believe that scans with F-Glutamine might be able to find tumors in patients.

This first in-human study is being done to see how long F-Glutamine lasts in the blood, when it is given to people in tiny amounts by an injection, and to see where F-Glutamine goes in the body. If the results of this trial are good, then the study doctors plan to use F-Glutamine in another trial to see if scans with F-Glutamine are better for finding tumors compared to the standard types of scans that doctors use.


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of histologically-confirmed solid malignancy and/or lymphoma (histology confirmed by MSKCC Department of Pathology.) Disease measurable or evaluable as defined by RECIST 1.1 or other tumor response criteria from an MSKCC IRB-approved clinical research protocol. NOTE: Study patients do not need to be participating in an MSKCC approved clinical trial prior to study recruitment.
* Age between 21-90
* Negative serum pregnancy test for female patients of childbearing age and potential (as defined by MSKCC Standards \& Guidelines), from assays obtained \<2 weeks prior to study enrollment. Patients will be advised against having unprotected sexual intercourse from the time of the negative serum pregnancy test until after completing their participation in the study.

Exclusion Criteria:

* Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of \[18F\] 4-L-Fluoroglutamine (2S,4R) injection and blood draws.)
* Breast-feeding
* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
* Hepatic: from assays obtained \<2 weeks prior to study enrollment For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay.
* Bilirubin \> 1.5 x (ULN)
* AST/ALT \>2.5 x ULN
* Albumin \< 3 g/dl
* GGT \> 2.5 x ULN IF Alkaline phosphatase \> 2.5 x ULN.
* Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min, from assays obtained \<2 weeks prior to study enrollment
* Acute major illness (e.g., unstable cardiovascular condition, etc.)
CHInese Medicine NeuroAid Efficacy on Stroke Recovery

CHIMES is a double blind, placebo controlled, randomized, multicenter study to test the hypothesis that NeuroAid is superior to placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity.

Stroke is a major cause of death and disability. Previous clinical studies performed in China have shown that NeuroAiD increase stroke patients'recovery in terms of neurological disability and functional outcome{Chen et al,2009}and thus may be beneficial as part of a post-stroke rehabilitation programme.

In the CHIMES study,we seek to test the hypothesis that NeuroAiD is superior to a placebo in reducing neurological deficit and improving functional outcome in patients recruited within 72 h after the ischemic stroke with intermediate range of severity {6\<_NIHSS\<_14}.More details of the study protocol have recently been published {Venketasubramanian et al,2009}.

Eligibility Criteria:
Inclusion Criteria:

* Subject is aged 18 years old and above (for Singapore 21 years and above as this is the legal age of consent)
* Subject is on anti-platelet therapy
* Subject is presented a pre-stroke Modified Rankin Scale inferior or equal to 1
* Female subject is eligible to participate in the trial if she is of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post menopausal)
* Subject or his/her legally acceptable representative is willing to provide written informed consent
* Subject is presented with cerebral infarction with compatible imaging at Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI)
* Time window is less than 72 hours after symptoms onset
* Subject with cerebral infarction with intermediate severity range: 6 ≤ NIHSS ≤ 14

Exclusion Criteria:

* Subjects deemed unstable by investigator after thrombolysis treatment
* Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
* Subject has a rapidly improving neurological deficit
* Subject has definite indication for full-dose or long-term anticoagulation therapy
* Subject has other significant non-ischemic brain lesion which could affect function disability
* Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine \> 200 μmol/L, if known), cirrhosis, severe dementia or psychosis
* Subject has participated in another clinical trial within the last three months
In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program.

Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: an in-person Wellness Session and an at-home cooking experience using ingredients provided at the Wellness Session.

The study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. Investigators hypothesize that after the program, participants' diets will be higher in quality than before.

Eligibility Criteria:
Inclusion Criteria for adolescent participants:

* 12-18 years of age
* self-identify as Black or African American
* have obesity (\>=95th percentile BMI)

Exclusion Criteria for adolescent participants:

* pregnant or within 3 months postpartum.
* participated in a formal weight management program within 6 months prior to study.
* currently taking medications or diagnosed with a condition known to influence metabolism, physical activity ability, or cognitive function.
* have previously undergone bariatric surgery.
* have type 2 diabetes.
* unable to speak English or have developmental conditions that interfere with ability to communicate.

Inclusion Criteria for caregiver participants:

* 18 years or older.
* proficiency in speaking English.
* live in the same household as the adolescent who will also be enrolled.
* prepares the majority (\>50%) of meals in the household.

Exclusion Criteria for caregiver participants:

* pregnant or within 3 months postpartum.
* unable to speak English or have developmental conditions that interfere with ability to communicate.
Laparoscopy-Assisted Transanal Endoscopy Rectosigmoid Resection for Rectal Cancer

Transanal Endoscopic Rectosigmoid Resection with Laparoscopic Assistance was developed at Massachusetts General Hospital and performed successfully to remove cancer of the lower rectum. Based on the outcomes, the research doctors believe that this investigational surgery may be as safe and effective as standard laparoscopic or open surgery performed to remove rectal cancer, may facilitate the operation and reduce the size of the abdominal incisions. In this research study, the investigators are looking to see if this investigational procedure is a safe and effective approach to remove rectal cancer of the mid and lower rectum.

Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. At the end of the procedure, the rectum will be removed though the anus, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven adenocarcinoma of the rectum
* Eligible to undergo standard open or laparoscopic low anterior resection with a temporary diverting stoma
* Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI
* Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI
* Rectal cancer located 4-12 cm from the anal verge
* ECOG performance status 2 or less

Exclusion Criteria:

* Metastasis
* Obstructing rectal cancer
* Synchronous colon cancer
* T3 rectal cancer not treated preoperatively with full-course chemoradiation
* Pregnant or breast-feeding
* Receiving any other study agents
* Fecal incontinence
* History of prior colorectal cancer
* History of inflammatory bowel disease
* History of pelvic radiation
* Prior pelvic surgery or multiple abdominal procedures
* BMI \> 30
* Large uterine fibroids
* Uncontrolled intercurrent illness
* Other malignancies diagnosed within the previous year, except basal cell cancer
Evaluating XPERIENCE™ Advanced Surgical Irrigation

A prospective, multi-center, double-arm, parallel, interventional, randomized, controlled clinical trial to assess the rate of periprosthetic joint infection (PJI) in patients undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA) or hip resurfacing (HR) with XPERIENCE™ (XP) Advanced Surgical Irrigation versus dilute Betadine (DB).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 years or older
2. Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumatic arthritis to the affected joint.
3. Primary TKA, THA, and HR
4. Subjects receiving both cemented or uncemented orthopaedic implants
5. Willing and able to sign written consent, follow study protocol and attend follow-up

Exclusion Criteria:

1. Inability or refusal to sign informed consent form
2. Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
3. Prior arthroplasty procedure to the affected joint
4. Procedures involving solid HA implants
5. Oncologic diagnosis to the affected joint.
6. Non-TKA, THA or HR prosthesis (i.e., hemiarthroplasty, unicompartmental arthroplasty etc.)
7. Allergy to any of the components of XP Advanced Surgical Irrigation
8. Allergy to iodine
9. Presence of concurrent active infection, primary immunodeficiency, history of uncontrolled HIV (CD4 count \<200 cells/uL), treatment with immunomodulatory medications for malignancy or autoimmune disease (with exception to inflammatory arthritis), chronic glucocorticosteroid use (≥20 mg of prednisone daily for at least 1 month with another cause of immunosuppression), and solid organ and/or bone marrow transplantation.
10. History of septic arthritis to the affected joint within two years of surgery(1).
11. History of steroid injection to the affected joint within the three months preceding surgery.
12. Simultaneous bilateral total joint arthroplasty
The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function

Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades. AVS is independently associated with atheroclerosis risk factors and clinically apparent CV disease indicating that the degeneration of the aortic valve may represent an atheroclerosis-like process involving both, the aortic valve as well as the vascular system, respectivel. It is still unknown whether the endothelial function is affected as an manifestation of the atherosclerotic process, changes in the driving mechanical forces as WSS downstream of the valve, or other factors beyond physical pressure effects.

The investigators hypothesized that altered haemodynamics may at least partly be responsible for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI) affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as markers of endothelial integrity.


Eligibility Criteria:
Inclusion Criteria:

* aortic valve stenosis
* screened for TAVI
* written informed consent

Exclusion Criteria:

* no written informed consent
* Patients with acute infections (CRP\> 0.5 mg / dL)
* Patients with Atrial Fibrillation
* Patients with inflammatory and malignant diseases