cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Diabetes Self-Management Consultant Care

The purpose of this study is to find out if Self-Management Consultant (SMC) intervention will be more effective than usual care in improving blood glucose control and diabetes-related quality of life for adults with type 2 diabetes.

This study is designed to compare the effectiveness of a diabetes Self-Management Consultant (SMC) intervention for adults with type 2 diabetes with unsatisfactory glucose control (i.e., HbA1c ≥ 8%--the value chosen as "high risk" by the Diabetes Quality Improvement Project which is an initiative of the Health Care Financing Administration, the American Diabetes Association, and the Foundation for Accountability) to a control group selected using the same criteria. The SMC intervention will be implemented and evaluated in two different health care systems serving two distinct populations of patients with diabetes. After signing the Informed Consent document, subjects will be randomized to the SMC intervention or a control group. All subjects in the study will complete a baseline assessment of their diabetes care and health status.

Subjects randomized to the SMC intervention will have an individual meeting with the SMC to review and refine a self-management plan based on the subject's priorities and goals. These subjects will receive individual follow-up and support during the year, through monthly phone calls and an annual meeting with the SMC and their primary care physician. Subjects randomized to the control group will receive usual care following their baseline and their 12-, 24-, and 36-month assessments. Unlike most nurse-manager studies, the SMC's interactions with patient care will use a theory-based behavioral approach with which we have extensive experience. The study is designed to evaluate the effectiveness of the SMC intervention compared to usual care.

All records will be handled confidentially. Lab results and personal data will be linked by a research specific identifier code.

Eligibility Criteria:
Inclusion Criteria:

* Adults over age 21 diagnosed with type 2 diabetes for at least one year.

Exclusion Criteria:

* Patients under psychiatric care
* Currently pregnant
* Those who have not been diagnosed with type 2 diabetes
Bunionectomy Study (0000-063)

We are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS) medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if this model is useful to study other drugs for the treatment of acute pain. The other drugs being tested in this study are pregabalin and naproxen sodium. These drugs are approved for use by the Food and Drug Administration (FDA). This study is designed to test whether these two drugs are effective in treating pain after a bunionectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a man or woman between 18 and 65 years of age
* For Women of Child-bearing potential: woman who is currently not pregnant not nursing and who is willing to use a medically acceptable method of birth control from the time after the screening visit until completion of the follow-up visit
* Patient is scheduled to have a bunionectomy
* Patient must be willing to stay at the study site throughout the 48-hour observation period following surgery and is willing to complete a 2-week follow up
* Patient is capable of operating a Patient Controlled Analgesia device

Exclusion Criteria:

* Patient is being treated for a disease and has not been on a stable dose of medication for at least 2 weeks prior to surgery
* Patient has used or intends to use any of the medications that are prohibited by the protocol, which could interfere with the evaluation of the study drugs
* Patient has an estimated creatinine clearance of \< or = 60 mL per min
* Patient has a history of drug abuse or dependence, or patient has a positive urine drug screen
* Patient has a condition that prevents clear communication concerning pain perception (such as diabetic neuropathy, peripheral neuropathy, etc.)
BiodEgradable Soaked Amiodarone PaTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery

The primary objective of the present prospective, randomized, double blind, controlled study is to assess whether the application of 2 oxidized regenerated cellulose (SurgicelTM FibrillarTM) patches soaked with amiodarone hydrochloride over the anterior wall of the left atrium and the lateral wall of the right atrium results in a reduction in the incidence of POAF


Eligibility Criteria:
Inclusion Criteria:

* All patients who are candidates for elective cardiac surgery trough complete sternotomy with indications of coronary artery disease (both off-pump and on-pump), aortic valve disease, mitral valve disease, tricuspid valve disease, and ascending aorta disease, whether as an isolated pathology or in combination

Exclusion Criteria:

* patients with a clinical history of atrial or ventricular arrhythmia of any nature and duration, patients undergoing reoperation, patients with emergency surgical indications due to acute myocardial infarction or cardiogenic shock, patients with thyroid disfunction, patients with HOCM and those with pacemakers or ICDs
An Efficacy and Safety Study of shRNA-modified CD34+ Cells in HIV-infected Patients.

The purpose of the study is to evaluate the efficacy and safety of autologous CD34+ cells that stably express multiplexed shRNA to treat HIV infection.

CD34+ cells will be isolated from mobilized PBMC of HIV patients. The cells will be lentivirally transduced with multiplexed shRNAs in the same vector that target CCR5 and HIV genome. Such modified cells will be infused back to the patients who have received bulsufan preconditioning before infusion. The patients will then be evaluated for efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) from 18 - 25; body weight ≥50kg.
* Diagnosis of HIV infections/AIDS based on "Diagnostic Criteria for HIV/AIDS" WS 293-2008.
* No antiretroviral therapy (ART) in the past 6 weeks and refuse to receive ART.
* CD4 T cell count ≥350/μl.
* No plan for pregnancy in the near future and agree to practice non-drug based contraception.
* Voluntary to participate in the study, comply with the study design to complete all monitory measurements, and agree to sign the study agreement.

Exclusion Criteria:

* Existence of infections/opportunistic tumors.
* Mutations in the shRNA target sequences.
* White blood cell count \<3x10\^9/L, neutrophil count \<1.5x10\^9/L, hemoglobin \<110g/L, platelet count \<100x10\^9/L.
* Liver diseases (HBV, chronic HCV infection, congenital liver metabolic disease), abnormal liver functions (test value 2x above normal).
* Kidney deficiency (Creatinine level above the upper limit of normal levels).
* Severe chronic disease, metabolic disease (e.g., diabetes), neurological and psychiatric diseases.
* History of pancreatitis.
* Women in pregnancy, lactating or at reproductive age who do not practice contraception.
* Allergy to agents or drugs used in the study.
* Verified or suspected abuse of alcohol and drugs.
* Participated in other clinical trials within 3 months.
* Based on investigator's assessment, those who are unfit for the study (e.g., general weakness, poor compliance with study design).
* Personal or family history of tumors.
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis

This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either sex, 14-65 years of age;
2. Diagnosis of systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997);
3. Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class V, III +V, IV+V;
4. LN (Class IV+V): proteinuria \> 1g/24hr or Scr \> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \> 5 white blood cell count (WBC) /high power field (hpf)(excluding infection ), \> 5 red blood cell count (RBC)/hpf;
5. LN (Class V or III +V ): proteinuria \> 2g/24hr or Scr \> 1.3 mg/dl;
6. Provision of written informed consent by subject or guardian

Exclusion Criteria:

1. Inability or unwillingness to provide written informed consent
2. Usage of immunosuppression therapy (MMF, Cyclophosphamide (CTX), Cyclosporine A (CysA), methotrexate (MTX) ect) for more than 1 week within 1 month or Pulse intravenous MP treatment prior to recruitment
3. Scr \> 4mg/dl (354umol/L)
4. Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin
5. Lupus encephalopathy
6. Diagnosed diabetes mellitus (DM); Malignant tumors (except fully cured basal cell carcinoma)
7. History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study
8. Any Active systemic infection or history of serious infection within one month of entry
9. known infection with HIV, hepatitis B, or hepatitis C
10. Known hypersensitivity or contraindication to tacrolimus, corticosteroids
11. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening
12. Pregnancy, nursing or use of a non-reliable method of contraception.
Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.

The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches.

An arthroscopic rotator cuff repair is nowadays mostly implemented in order to restore function and reduce or eliminate pain. The primary objective of this randomized controlled trial is to demonstrate, in patients 60 years or older with a large rotator cuff tear, that biological or synthetic patch augmen-tation in arthroscopic rotator cuff repair results in decreased rate of retear 24 months post-operatively compared to re-pair without patch augmentation.

Eligibility Criteria:
Inclusion Criteria:

* Rotator cuff tear \> 2 cm in the sagittal plane involving the supraspinatus tendon as well as at least the superior 1/3 of the infraspinatus tendon
* Indicated for surgical reconstruction by arthroscopy
* Patient aged 60 years and over
* Consenting participation in this study by signing the Informed Consent form

Exclusion Criteria:

* Osteoarthritis (grade ≥ 2 after Samilson \& Prieto)
* Advanced fatty infiltration of the rotator cuff muscles (Goutallier grade III or IV)
* Tear of the subscapularis \> Typ 1 Lafosse (partial tears of superior 1/3 of the tendon)
* Irreparable tear of the supraspinatus
* General medical contraindication to surgery
* Known hypersensitivity to the materials used
* Revision operations
* Open reconstruction
* Tendon transfer necessary (latissimus dorsi or pectoralis major)
* Any disease process that would preclude accurate evaluation including:

  * Systemic arthritis, rheumatoid arthritis, diabetes (insulin dependent), acute or chronic infection, abnormal bone metabolism, tumour / malignoma, psychiatric disorder
  * Inadequate blood flow or neuromuscular disease in the affected arm
* Recent history of substance abuse
* Legal incompetence
* German language barrier to complete the questionnaires or
* Participation in any other medical device or medicinal product study that could influence the results of the present study
RLC Followed by CR-CHOP in Elderly Patients with Newly-diagnosed DEL

This is a prospective, single-arm, multicenter clinical study to evaluate the efficacy and safety of chidamide, rituximab combined with lenalidomide sequential immunochemotherapy in the treatment of newly diagnosed elderly double-expressor diffuse large B-cell lymphoma.

It is divided into 4 stages: screening period, induction therapy period, immunochemotherapy period and maintenance therapy period. The screening period was 28 days before the first dose. Introduction treatment period: Enrolled subjects received RLC regimen every 21 days for a cycle of 2 cycles. Immunochemotherapy phase: CR-miniCHOP regimen was administered after the completion of the introduction therapy phase. Every 21 days for a cycle, treatment for 4 cycles. Patients who achieved CR with induction therapy entered the maintenance treatment period, receiving 20 mg of chidamide d1,4,8,11 recommended 8 cycles. Patients who did not achieve CR were discontinued from the study and treated at the discretion of their physician.

Eligibility Criteria:
Inclusion Criteria:

* 1. Untreated DLBCL patients confirmed by histopathology 2. Immunohistochemistry showed positive expression of MYC and BCL2 protein (double expressor lymphoma, MYC≥40%, BCL2≥50%) 3. age over 70 years old or age ≥65 years old and ECOG score ≥2 points, both male and female 4. Having at least one evaluable lesion, defined as having at least one lymphadenopathy with a maximum diameter \> 1.5 cm, or at least one extranodal lesion with a maximum diameter \> 1.0 cm, and at least two vertical diameters that can be accurately measured.

  5. ECOG PS≤3 6. Expected survival time ≥3 months 7. voluntary participation in clinical research; Fully understand and understand the study and sign the informed consent; Willingness to follow and ability to complete all research steps.

Exclusion Criteria:

* 1. The pathological subtypes were PCNSL, PMBCL, EBV-positive DLBCL and HGBL 2. Hemophagocytic syndrome accompanied the diagnosis 3. Central nervous system involvement is secondary to lymphoma 4. Are participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study 5. HIV infection 6. Major surgery was performed within 28 days prior to study start 7. Any active infection that required systematic anti-infective therapy developed within 14 days prior to study initiation 8. The patients considered by the investigator to be unsuitable for participating in this study
The Burden of Access in Duchenne Muscular Dystrophy in the US

This study is being conducted to determine if DMD patients / families and healthcare providers experience burdens related to access, and if so, to identify them, and to determine life impacts to the patient, if any, of these burdens. Data from healthcare providers will be collected by an online survey and from patients/families by one on one telephone interview.

Patient/Parent Portion

In this non-interventional study, DMD patients / parents of DMD patients will be interviewed to gather qualitative input, in the patient's voice, regarding challenges associated with access to medications, services and medical equipment, and how these burdens impact quality of life.

Healthcare Provider Portion

In this non-interventional study, healthcare providers who see patients with DMD and who deal with insurance issues on behalf of DMD patients will participate in an online survey designed to determine the burden associated with access to medications, services and medical equipment.

Eligibility Criteria:
Inclusion Criteria:

Patient/Parent interviews

* Patients residing in the US who have been diagnosed with DMD who are age 18 years or older, or the parent / legal guardian of a person of any age who has been diagnosed with DMD,
* Have provide "Proof of DMD" to ensure that they are impacted by the disease,
* Who have provided sufficient information in the RSVP process to determine their functional status; ambulatory, transitional or non-ambulatory,
* State that they are the person who deals with insurance issues for the affected patient and,
* Who are able to understand and consent to participation in the study

Healthcare Provider survey

* Healthcare providers (physicians, nurse practitioners, and physician assistants) currently involved in the care of patients with DMD
* Are currently practicing in the US,
* Who have provided sufficient information in the survey screening to determine that they currently care for DMD patients,
* State that they and/or persons on their staff interface with insurance companies for DMD patients related to access to medications, services and/or medical equipment and,
* Who are able to understand and consent to participation in the study

Exclusion Criteria:

* There are no stated exclusion criteria in this study. Study population must meet all inclusion criteria in order to be deemed eligible to participate.
A Retrospective EGFR Mutation Status Study in Chinese NSCLC Patients Using Paired Plasma and Tissue Samples

EGFR mutations plays an essential role in EGFR-TKIs treatment. However, for some patients, tissue samples are not available. The purpose of this study is to determine whether blood sample is feasible for EGFR mutation detection.For late stage NSCLC, we hypothesis plasma sample is an alternative for detecting EGFR mutations.


Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer
* Available plasma and pathologically confirmed tissue slices(pre-chemo and pre-radio therapy)
* Informed Consent

Exclusion Criteria:

* N/A
Azacitidine and Homoharringtonine in JMML

Juvenile myelomonocytic leukemia (JMML) has a poor prognosis in general, with hematopoietic stem cell transplant (HSCT) remaining the standard of care for cure. Azacitidine and homoharringtonine, which exhibited a anticancer mechanism and has been widely used in patients with relapse/refractory acute myeloid leukemia (AML). However, the efficacy of these agents has not been elucidated in children with JMML. The primary objective is to assess the treatment effect on response rate in this subject population.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed JMML, with PB and BM confirming diagnosis prior to informed consent signature, with one of the following:

  1. somatic mutation in PTPN11
  2. somatic mutation in KRAS
  3. somatic mutation in NRAS and HbF % \> 5x normal value for age
  4. clinical diagnosis of neurofibromatosis Type 1.

Exclusion Criteria:

* 1. Any condition that would prevent the subject from participating in the study.

  2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if participated in the study.

  3. Any condition that confounds the ability to interpret data from the study.
The Effect of a Mind-body Exercise Program on Aspects of Attention in Individuals With Anxiety

Mind-body exercises is a non-pharmacological intervention to mental health and can improve interoceptive capacity. Interoceptive is linked to the process of sensory information within the body playing an important role in behavior. Consequently, interoceptive can be modulated by mind-body training through sustained attention to breathing signals, certainty of movements, and also related to activation of brain processes. The present study aimed to evaluation the effect of mind-body in interoceptive capacity in individuals with anxiety. An anamnesis will be performed with demographic data, as well as questions about medications and physical and mental health history. After that, subjects will be randomized into an intervention (one session of mind-body exercises) where they will be asked to sit in a comfortable armchair and remain in a comfortable posture with their eyes closed. A meditation will be guided by an audio through headphones. The audio will last 15 minutes with an initial invitation to centering (full attention to the state of the body and the breath, bringing the attention to the present moment), followed by a body scan considering the seven dimensions of interoceptive capacity (noticing, not being distracted, not worrying, attentional regulation, emotional awareness, self-regulation, and trust) and the passive control group (waiting room), after the intervention the same cognitive tests will be reapplied. Then, the groups will be switched for a crossover analysis.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of anxiety
* must be able to understand procedures

Exclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease
Shake It Up: Lipidomics of Lipoproteins and Diet

The purpose of this research is to understand how dietary fat is related to cardiovascular disease (CVD). This study tests the effect of different dietary fats on the level of fat in the blood and the particles that transport fat in the blood. The researchers want to know if these particles change after eating meals made with different fats.

The overall objective of this work is to discover how the lipidomic composition of postprandial lipoproteins responds to dietary fats of differing fatty acid composition by comparing meals rich in saturated fatty acid (SFA) (from dairy cream) versus polyunsaturated fatty acids (PUFA) (from soybean oil). The information derived from these studies will provide mechanistic insight into postprandial lipid metabolism and will support efforts to identify optimal dietary oil intakes for people.

Eligibility Criteria:
Inclusion Criteria:

* Normal to overweight (BMI 18.0-29.9 kg/m\^2
* Willing to comply with the demands of the experimental protocol

Exclusion Criteria:

* Inability to provide consent
* Have fasting blood glucose \<60 mg/dL or \>126 mg/dL
* Have fasting blood cholesterol \>300 mg/dL
* Have fasting blood triglyceride \<100 mg/dL or \>300 mg/dL
* Have uncontrolled hypertension (blood pressure \>140/90 mm Hg)
* Take prescription medications for blood sugar or lipid management or anti-inflammatory steroids (e.g. cortisone)
* Over the counter use of supplements (fish oil, flax, plant sterol or sterol esters) and unwilling to discontinue use for 6 weeks prior to study initiation
* Have a history of an eating disorder, unusual dietary pattern (extreme nutrient or food group restriction; erratic meals due to shift work, etc.)
* Have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes
* Have cancer
* Use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes/vaping in the past 6 weeks
* Have alcohol, anabolic steroids, or other substance abuse issues
* Consume more than 3 alcoholic drinks/week
* Are lactose intolerant or have an allergy to dairy foods