cyrilzakka/clinical-trials huggingface dataset:
Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone

Having a diagnosis of schizophrenia or bipolar disorder and being treated with certain of the newer antipsychotics are risk factors for development of diabetes. Subjects with these risk factors plus obesity and/or family history of diabetes who agree to study participation will undergo an oral glucose tolerance test. If the oral glucose tolerance test demonstrates that the subject is pre-diabetic (elevated glucose levels, but below the diabetic range), he/she will have his/her insulin resistance level measured, prior to random assignment to either stay on current antipsychotic medication or switch to ziprasidone. Insulin resistance will be measured again after four months. The primary hypothesis is that insulin resistance will decrease in those switched to ziprasidone relative to those continuing on their same antipsychotic medication.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder
* BMI\>29.9 or family history of diabetes and/or abdominal circumference greater than 88 cm in women or 102 cm in men
* Pre-diabetic oral glucose tolerance test
* Current treatment with olanzapine, risperidone, paliperidone, or quetiapine, or combination of these
* Willing to switch to ziprasidone
* No psychiatric hospitalizations in past three months and judged by treating clinician to be suitable for antipsychotic medication switch
* Able to give informed consent to study

Exclusion Criteria:

* Judged to be currently suicidal, homicidal, or unable to cooperate with treatment
* Unstable serious medical illness
* Current use of drugs that interfere with glucose and fat metabolism (sulfonylureas, metformin, thiazolidinediones). The use of "statins" and fibrates will be allowed ONLY if stable dose for past 3 months.
* Current diagnosis of diabetes
* Fasting blood glucose \>125 mg/dl
A Study of Second-line Treatment With Apatinib After TACE in Advanced Hepatocellular Carcinoma Patients

This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in treating advanced hepatocellular carcinoma. The primary endpoint is progression-free survival (PFS), 3-month PFS, 6-month PFS and 1-year PFS.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologic or cytologic diagnosis of hepatocellular carcinoma
* Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment
* The previous chemotherapy and the present trial registration must be at least 2 weeks apart. And they must have recovered from any toxicity of a previous chemotherapy
* Patients with Child Pugh Class A \& B disease are eligible for the study
* Patients with Barcelona Clinic Liver Cancer stage B or C are eligible for the study
* Eastern Cooperative Oncology Group performance score (PS): 0-2
* Life expectancy of at least 12 weeks
* Hepatitis B virus DNA\<2000 IU/ml
* Adequate organ function meeting the following:

  * Bone marrow: absolute neutrophil count ≥1.5×109/L (1500/mm3); platelet ≥ 75×109/L; hemoglobin ≥9 g/dL
  * Liver: Serum bilirubin ≤ 1.5 ×ULN, AST and ALT ≤ 5 ×ULN, ALB ≥ 29 g/L
  * Kidney: Cr ≤1.5 ×upper limit of normal
* Within 7 days prior to the start of therapy, women of child-bearing potential must undergo a pregnancy test, which must be negative; men of child-bearing potential: contraceptive measures must be adopted during treatment and within 8 weeks afterward
* Subjects who understand and voluntarily signed a written informed consent form

Exclusion Criteria:

* Previous locoregional therapy within 4 weeks prior to enrollment
* Diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma
* History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
* Prepared for liver transplantation
* Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)
* A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence
* Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
* Patients with central nervous system metastases or brain metastasis
* Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia
* Pregnant or lactating women
* Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment
Trial of Cyclosporine in the Acute Phase of Leber Hereditary Optic Neuropathy

The Leber Hereditary Optic Neuropathy is a genetic disorder caused by maternal transmission of mitochondrial DesoxiroboNucleid Acid mutations. It is manifested by a rapidly progressive blindness, profound, due to atrophic optic nerve. The visual loss is primarily unilateral bilateralisation taking place in the vast majority of cases in weeks or months. The neuro-cardio-protective properties of cyclosporine (and its analogs specifically targeting the anti-apoptotic mechanisms) are particularly promising.

The investigators hypothesis is that cyclosporine may limit apoptosis during the acute phase of the disease process and would limit the loss of visual acuity and improve the visual prognosis of these patients.


Eligibility Criteria:
Inclusion Criteria:

* patient with the mutation confirmed by molecular analysis
* patient with a recent loss of monocular vision (≤ 6 months)
* voluntarily Patient Consent

Exclusion Criteria:

* patient who have not given their written and informed consent signed
* against indication of cyclosporine
* no drug compliance to previous inclusion
* no national health insurance affiliation
* pregnant women or lactating
* women who could become pregnant during the study period and with no contraception
* private patients of their liberty by judicial or administrative decision, or patients under supervision
Intervention to Promote Advance Care Planning for Older Adults in the Emergency Department

There is an urgent need to increase advance care planning among older adults in order to ensure that patients receive care of the end of life that is consistent with their values and preferences. Emergency departments (EDs) provide an opportunity to reach a large proportion of older adults who have not yet completed advance care planning at a time when they are likely to recognize the need for such planning. The purpose of this pilot is to examine the potential of a video-supported intervention initiated during the emergency department visit to promote advance care planning.

The overarching goal of this project is to understand the impact of an ED-initiated intervention on the promotion of advance care planning (ACP) among older adults. Participants are given either a short informational handout on the process and choices involved in ACP or watch a 6-minute video about ACP. The video describes cardiopulmonary resuscitation (CPR), breathing tube placement, and mechanical breathing support in addition to the general process of ACP. Following the video, patients in the intervention will also have an email sent to their primary care provider. The email will inform the primary care provider that the patient has watched a video about ACP, include a brief synopsis of the video, and provide instructions as to how to document the patient's preferences in the hospital's electronic health record in a way that will be accessible to other providers. Outcomes will include documentation of end-of-life care preferences in the electronic health records and patient-reported conversation with their provider as well as conversations with loved ones.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Ability to communicate in English
* Age 65-79 years with a serious medical illness: (1) Established diagnosis of metastatic cancer, advanced heart failure, chronic obstructive lung disease, end stage liver disease, end stage renal disease, (2) Unable to walk or requires human assistance with walking, (3) Two hospitalizations within the last 6 months
* Age 80 years or older

Exclusion Criteria:

* Critically ill (emergency severity index = 1)
* Cognitively impaired based on Six Item Screener \< 4 or lack the capacity to consent
* Currently enrolled in hospice or comfort care program
* No working phone number
* Non English speaker
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.

PRIMARY OBJECTIVES: I. Test the effects of the Family Caregiver Palliative Care Intervention (FCPCI) on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on caregiver burden and caregiving skills preparedness as compared to family caregivers in the control group.

II. Test the effects of the FCPCI on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on quality of life (QOL) and psychological distress as compared to family caregivers in the control group.

SECONDARY OBJECTIVES: I. Describe family caregivers' self-care behavior, comparing the experimental and control groups.

II. Describe family caregivers' resource use, comparing the experimental and control groups.

III. Identify subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics.

IV. Describe family caregivers' satisfaction with the FCPCI.

V. Describe caregiver out-of-pocket costs and the cost of the intervention.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive FCPCI with an advanced practice nurse (APN), comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months.

ARM II: Participants receive usual care

Eligibility Criteria:
Inclusion Criteria:

* Primary family caregivers of cancer patients with gastrointestinal (colorectal, pancreatic, gastric), gynecologic, urinary or lung cancers who are entering the City of Hope for treatment or follow-up
* Primary family caregivers of cancer patients who are diagnosed with stage II-IV disease
* Primary family caregivers of cancer patients with \> 6 months prognosis
* Living within a 50 mile radius of the City of Hope
Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis

The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic Lateral Sclerosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of definite Motor Neuron Disease/amyotrophic lateral sclerosis.
* Age 18-80 years

Exclusion Criteria:

* HIV/HBV/HCV
* Malignancies
* Bleeding tendencies
* Pneumonia
* Renal failure
* Severe liver dysfunction
* Severe anemia \[hb \< 8\]
* Any bone marrow disorder
* Space occupying lesion in brain
* Pregnancy and lactation
* Other acute medical conditions/infections such as respiratory infection and pyrexia
* left ventricular ejection fraction \< 25%
* Patient on artificial ventilatory support
Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy

Cardiac resynchronization therapy with pacemaker alone, or in combination with a cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS duration 6 months after cardiac resynchronization therapy. Such phenomenon is called reverse electrical remodeling of native conduction. Retrospective analysis showed that reverse electrical remodeling of the native conduction after at least 6 months of CRT is associated with decreased rate of ventricular arrhythmias and better survival. This study is designed to study reverse electrical remodeling prospectively.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing implantation of a CRT-D

Exclusion Criteria:

* age \< 18 y
* pregnancy or planned pregnancy
Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis (The SARA Study)

Rheumatoid arthritis (RA) is an autoimmune disease that causes long-term inflammation of the joints and occasionally, other body tissues. The purpose of this study is to evaluate two different types of cognitive behavioral therapy (CBT) in reducing RA disease activity and improving mental health of adults with RA.

Symptoms of RA include swelling, pain, stiffness, and redness in the joints. Over time, joint deformity, joint destruction, and loss of function can occur. Even simple tasks of daily living can become difficult to manage for people with RA. Current treatment aims to improve symptoms, but there is currently no cure for the disease. Dealing with the long-term pain and the unpredictability of RA can cause symptoms of depression, which is common among people with RA, especially early in the disease. Improving coping skills and minimizing emotional stress may help improve the overall health of people with RA. CBT is a form of psychotherapy that emphasizes the important role of thinking in how we feel and what we do. This type of therapy emphasizes that people can change the way they think to feel or act better even if the situation does not change. The purpose of this study is to evaluate two different types of CBT that focus on stress, pain, and depression responses in reducing disease activity and improving mental health of adults with RA.

This study will last about 15 months. Initially, all participants will fill out a diary report about their symptoms for a total of 30 days. Half of the study participants will undergo a 2- to 3-hour lab session that will include blood collection, vital signs measurements, joint exams, questionnaires, and an interview about symptoms and medical history. All participants will then be randomly assigned to one of the following three groups:

* People in Group 1 will participate in CBT for Pain (CBT-P), which will focus on altering thought processes as a way to cope more effectively with pain.
* People in Group 2 will participate in Mindfulness Medication for Emotion Regulation (MM-ER), a type of CBT that focuses on being more aware of one's emotions and regulating them.
* Group 3 participants will serve as controls and receive educational information on the causes of, course of, and treatment for RA.

Participants in all three groups will attend 2-hour weekly sessions of their treatment for 8 weeks. After treatment, all participants will undergo a 2- to 3-hour lab session that will include blood collection, vital signs measurements, joint exams, questionnaires, and an interview about symptoms and medical history. Participants will also fill out another daily diary report about their symptoms for 30 days. A follow-up questionnaire will be mailed to participants 6 months following the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA

Exclusion Criteria:

* Currently taking cyclical estrogen replacement therapy
* Diagnosis of lupus
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents

The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.

The study design is a single arm treatment (all patients assigned to receive etravirine), open label (patients will know the identity of the treatments they are receiving) safety and antiviral activity of Etravirine (TMC125) in treatment-experienced, HIV infected children and adolescents 6 to 17 years of age. Etravirine is a new drug belonging to the NNRTI (a non-nucleoside reverse transcriptase inhibitor) drug class that slows down the growth of the human immunodeficiency virus (HIV). This drug has been tested for safety and effectiveness in adults, however, there is no data on the drug's long-term safety and antiviral activity in children and adolescents. This study will last for a maximum of 48 weeks. A total of 100 ptients will receive etravirine tablets based on body weight and an investigator selected optimized background regimen (OBR) of at least 2 antiretrovirals (ARVs), consisting of a boosted protease inhibitor (PI) and nucleoside reverse transcriptase inhibitor(s) (NRTI\[s\]). Use of enfuvirtide is optional. Safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* Body weight according to age within the 10-90th percentile of CDC growth chart
* On steady antiretroviral therapy regimen for at least 8 weeks at screening and willing to remain on that regimen until baseline
* HIV viral load of 1,000 copies/ml or greater at study entry
* Parent or legal guardian willing to provide informed consent, if necessary

Exclusion Criteria:

* The Key Exclusion Criteria are: Evidence of resistance to etravirinel Any grade 3 or 4 toxicity (More information available in the protocol)
* Use of disallowed concomitant therapy (specified in the protocol)
* Currently active AIDS defining illness (category C)
* Active hepatitis A, B or C virus infection
* Any clinically significant diseases or findings that, in the opinion of the investigator, would interfere with the study
* Receipt of any ARV or non-ARV investigational medication or investigational vaccine within 30 days prior to screening
* History of clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125)
Family Participation in Bangladesh Hospital Care

This mixed methods study aims to understand family care participation in the adult medicine wards of Chattogram Medical College Hospital, Bangladesh. The main questions it aims to answer, from the perspective of the patient, family caregiver, nurse, doctor, ward assistant, and hospital administrator, are:

1. What is the role of the family caregiver in hospital care?
2. What is the perceived effect of family participation in hospital care?
3. What are the barriers and facilitators experienced in family participation?
4. What are suggestions for family participation interventions?

These questions will be answered with three study arms:

1. A prospective observational cohort (population: patients and family caregivers)
2. A time and motion study (population: nurses and doctors)
3. Interviews and focus group discussions (population: patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators)


Eligibility Criteria:
Prospective Observational Cohort

* Inclusion Criteria

  * Population
  * Patient: Admitted to the ward (in-patient)
  * Family caregiver: caregiver providing care at the bedside of the patient on the ward
  * Environment: Admitted to medicine wards 13, 14 or 16 of Chattogram Medical College Hospital
  * Admission time: Admitted in the last 48 hours
  * Adult: ≥18 years
* Exclusion criteria

  * Admission time: Planned discharge or transfer within the first 24 hours of admission
  * Child: \<18 years
  * Previously enrolled in this study arm
  * No consent given

Time and Motion

* Inclusion Criteria

  * Population: Nurses and doctors
  * Environment: Working in the medicine wards 13, 14 or 16 of Chattogram Medical College Hospital
* Exclusion Criteria

  * Population: \<6 months work experience on wards 13, 14 or 16 of CMCH
  * Previously enrolled in this study arm
  * No consent given

Qualitative (interviews and focus group discussions)

* Inclusion Criteria

  * Population
  * Patient: Admitted to the ward (in-patient)
  * Family caregiver: Caregiver providing care at the bedside of the patient on the ward
  * Health workers: Nurses, doctors and ward assistants
  * Hospital administrator: Managers and professors
  * Environment
  * Patient: Admitted to medicine wards 13, 14 or 16 of CMCH
  * Family caregiver: Caring for their relative on wards 13, 14 or 16 of CMCH
  * Health worker: Working on wards 13, 14 or 16 of CMCH
  * Hospital administrator: Responsible for care delivery on wards 13, 14 or 16 of CMCH
* Exclusion Criteria

  * Population
  * Patient: Unconscious or unable to participate in a conversation
  * Family caregiver: Unable to leave the patient for reasons of safety
  * Health worker: \<6 months of work experience on wards 13, 14 or 16 of CMCH
  * Hospital administrator: \&amp;lt;6 months in a management role for wards 13, 14 or 16 of CMCH
  * Admission time
  * Patient: Admitted \<48 hours
  * Family caregiver: \<8 cumulative hours present at patient bedside in last 48 hours
  * Child: \<18 years
  * Previously enrolled in this study arm
  * No consent given
Difference in the Estimation of Prognosis

Objectives:

Primary Objective:

The primary objective is to identify the difference in the estimation of prognosis of advanced cancer patients between medical oncologists, gynecological oncologists, and palliative care physicians

The goal of this research study is to identify the difference in the estimation of prognosis of advanced cancer patients between medical or gynecological oncologists, and palliative care physicians. Up to 140 patients will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Medical oncologists or gynecological who referred patients to the palliative care team; Palliative Care physicians to whom the patients were referred; Patients with locally advanced, metastatic, or, not curable cancer.
2. 18 years old or older

Exclusion Criteria:

N/A