cyrilzakka/clinical-trials huggingface dataset:
Patient Perspectives Medicaid Title XIX Sterilization Consent Form

The goal of this survey and interview study is to learn about patient experience consenting for permanent contraception using the Medicaid Title XIX Sterilization Consent form. The main questions it aims to answer are:

* To explore patient perspectives on and understanding of the current consenting process for obtaining permanent contraception as it relates to the Medicaid Title XIX Sterilization consent form.
* To explore patient experience with the current consenting process, and thoughts regarding the ideal consenting process including how it would differ from the one currently in place, if at all.

Participants will complete a 10-15 minute survey and be offered participation in an in-depth one-on-one interview.

The United States has a long history of coerced sterilization which was influenced by the eugenics and population control movements of the early and mid-20th century, respectively. The Medicaid Title XIX Sterilization Consent Form was created in response to these forced sterilizations to protect patients, but in recent years there have been questions regarding whether these forms are instead creating barriers to care for already marginalized populations. Prior studies demonstrated decreased rates of completion of postpartum permanent contraception requests secondary to invalid consent forms and negative attitudes among OBGYNs, including concerns regarding the ethics behind the forms. To date, there is very limited literature exploring patient perspectives. This will be a mixed methods study in which bilingual surveys will be distributed via REDCap to patients seeking permanent contraception at Columbia University affiliated OBGYN practices and complete in-depth interviews exploring patient experiences consenting for permanent contraception, and what an ideal consenting process might look like to them.

Eligibility Criteria:
Inclusion Criteria:

* Seeking permanent contraception procedure through a Columbia University practice
* English or Spanish speaking
* Completed the Medicaid Title XIX Consent Form

Exclusion Criteria:

-Currently pregnant and seeking immediate postpartum permanent contraception
Biomarkers of Response in Blood and Tumor Tissue Samples From Patients With Unresectable Stage IV Squamous Cell Cancer of the Head and Neck Previously Treated With Cetuximab, Cisplatin, and Radiation Therapy

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.

PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck previously treated with cetuximab, cisplatin, and radiation therapy.

OBJECTIVES:

Primary

* To expand upon the list of molecular correlates indicated in clinical trial ECOG-E3303, including EGFR expression, EGFR phosphorylation, map kinase, AKT, and STAT3.
* To correlate the status or expression level of each biomarker with clinical outcome (response, progression-free survival, overall survival).

OUTLINE: Archived tumor and blood specimens are analyzed for human papilloma virus and p16 status; EGFR gene amplification; levels of ERCC1, XPF, and c-Met proteins; expression and activation of several signaling pathways including PI3 kinase gene and mTOR; levels of ErbB2, ErbB3, P70S6 kinase, S6 , and Akt; expression of amphiregulin (AR), TGF-alpha (TGF-α), heparin-binding EGF-like growth factor (HB-EGF), EGF, epiregulin and c-Met ligand, and hepatocyte growth factor by fluorescence in situ hybridization (FISH), automated in situ quantitative measurements of protein analysis (AQUA), IHC, PCR, and ELISA.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of squamous cell carcinoma of the head and neck

  * Stage IV disease
  * Unresectable disease
* Treated with cetuximab, cisplatin, and radiotherapy on clinical trial ECOG-E3303
* Archived blood and tumor tissue samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study

Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive surgery in certain situations. They offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations. In addition, pIOLs have been shown to provide better retinal image magnification and higher contrast sensitivity compared to laser in situ keratomileusis, regardless of whether the myopia is low or high.


Eligibility Criteria:
Inclusion Criteria:

* myopia of more than 6 diopter

Exclusion Criteria:

* unstable refraction
* unstable refraction
Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy

: Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and induces pathological signaling within cardiomyocytes resulting in progressive cardiac failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and increases the risk of arrhythmias. But today patient treatment and prognosis is based on ejection fraction quantification, QRS duration, and symptoms.

Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared with normal value, is of prognostic value in patient with dilated cardiomyopathies under optimal treatment.

Methods: 330 patients are planned to be included and followed for 2 years


Eligibility Criteria:
Inclusion Criteria:

* patient with dilated cardiomyopathy and typical symptoms of cardiac insufficiency at the time of the diagnosis: oedemas of lower limbs, dyspnoea, asthenia.
* and of a reduction in the fraction of ventricular ejection left (awkward) 45 % measured in echocardiography ( modified Simpson biplane) and associated with a volume télédiastolic volume superior to the normal in echocardiography: \> 90ml / m2 ( modified Simpson biplane).

Exclusion Criteria:

* Patients to whom the dysfunction VG is secondary or in a secondary overload of pressures in a HTA or a severe valvulopathie is in a coronary infringement(achievement), proved by histories of infarct or gestures(movements) of revascularisation (bypass(decking), stent) and or coronary hurts at least bi tronculaires significant the severity of which can explain the ventriculaire failure.
Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects

This is a single center, double-blind, placebo and positive-controlled, randomized, partial 6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401 (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is able to give legal informed consent and understand the requirements of the study and communicate with the investigator in the local spoken language.
2. The subject is willing to comply with the study requirements (eg, all dietary, exercise, tobacco, and alcohol restrictions) and provide their written informed consent to participate in the study.
3. The subject is a man or woman, 18 to 50 years of age, inclusive.
4. The subject has a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
5. The subject has skin type I to IV (very light to olive).
6. The subject is in a good health as determined by medical history, ECG, vital signs, physical examination, and clinical laboratory tests.
7. Female subjects of childbearing potential must have a negative serum β-human chorionic gonadotropin (hCG) test (at screening) and check-in and be willing and able to use one of the protocol-specified double-barrier methods of birth control.
8. The subject is able to complete the screening process within 4 weeks prior to study drug administration.

Exclusion Criteria:

1. The subject has a cognitive performance outside of reference values at screening.
2. The subject smokes, is a tobacco user, currently uses nicotine products.
3. The subject has a known hypersensitivity to donepezil, modafinil, irdabisant, or one of the excipients, or has any significant food or drug allergies.
4. The subject is a female who is pregnant or lactating.
5. The subject has an intraocular pressure greater than 22 mm Hg.
6. The subject is suffering from, or has a clinically significant history of one or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), or a history of any illness that, in the opinion of the investigator, might pose additional risk to the subject by participation in the study or confound the results of the study.
7. The subject has a laboratory abnormality judged by the investigator as clinically significant, or measurements outside of the defined range

   * Other exclusion criteria apply; please contact the investigator for more information.
Prospective Observational Study of Disease Progression in Chronic Hepatitis C

The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* All these patients had a definite history of regular plasma donations with repeated blood cell re-transfusions.
* The Hepatitis C Virus antibody was positive.
* All patients did not receive interferon therapy before being recruited.

Exclusion Criteria:

* Patients with evidences for other forms of liver diseases.
* The coinfection with hepatitis B virus or other virus.
Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease

The primary purpose of the study is to assess whether SAM-531, an investigational drug, is safe and well tolerated, compared with placebo (a medically inactive substance), in subjects with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria

1. Signed and dated written informed consent obtained from the subject or the subject's legally authorized representative (LAR) or next of kin (if applicable), in accordance with the local regulations. The subject's caregiver must also consent to participate in the study.
2. Diagnosis of probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
3. Men and postmenopausal or surgically sterile women aged from 50 to 90 inclusive. Postmenopausal women must have had 12 months of spontaneous amenorrhea. Surgically sterile women are defined as having a hysterectomy, bilateral ovariectomy \[oophorectomy\], or bilateral tubal ligation. Men who are sexually active will need to agree to use a form of contraception that is satisfactory as per the investigator.
4. Able to participate in all scheduled evaluations with a high probability of completing all required procedures and neuropsychological tests.

Exclusion Criteria

1. Significant neurological disease other than Alzheimer's disease, which may affect cognition (eg, epilepsy, Parkinson disease).
2. Current diagnosis of a major depressive disorder or other major psychiatric symptom according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Version (DSM-IV-TR).
3. Current clinically significant systemic illness, which is likely to deteriorate or affect the subject's safety, influence cognitive assessment or ability to complete the study.
4. Any clinically important deviation from normal limits in physical and neurological examination, vital signs, on electrocardiogram (ECG) or clinical laboratory test results that could compromise the study or be detrimental to the subject.
Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault

Females who have been sexually abused anally, have a disturbed anorectal motility. They have an increased resting pressure at the lower part of the anal canal. When their rectum is suddenly distended, they tend not to have an initially increased pressure in the anal canal, and the recto-anal inhibitory reflex is markedly decreased amplitude which is caused by reflex contraction of the pelvic floor during the relaxation of the internal anal sphincter.

The cause of fecal incontinence after sexual abuse is the improper functioning of anal sphincter muscles, as a result of their damage and/or neurological changes including the disturbance perception of sensory stimuli from the anal canal. Biofeedback therapy using visual and verbal feedback techniques has emerged as an useful option in managing fecal incontinence and levator ani syndrome. The goal of biofeedback training is to improve bowel function by restoring a normal pattern of defecation.

Eligibility Criteria:
Inclusion Criteria:

* absent anal reflex,
* skin trifles around the anus,
* funnel shaped anus
* medically stable and able to follow instructions

Exclusion Criteria:

* sexual transmitted disease
* any medical condition that affect the anus potentially such as Crohn's disease,
* severe chronic constipation,
* myotonic dystrophy
Hepatitis C in Severe Mental Disorders: Nursing Programme

It has been described in the scientific literature that people diagnosed with serious mental disorders, such as psychosis and schizophrenia, have difficulties to access medical treatments for their physical illnesses, which produces excess mortality in this population.

This project will consist of three different parts. The first will be the detection and accurate diagnosis of hepatitis C (HCV) in the population diagnosed with a severe mental disorder (SMD). It will find the prevalence of people with infection who have not been diagnosed, as well as that of people diagnosed but who have not completed treatment. Likewise, the characteristics of the sample obtained and the risk factors associated with positive cases will be analyzed.

The second part of the study will consist of comparing the effectiveness of an individualized monitoring programme (NURSE-NAVIGATION PROGRAMME), carried out by the specialist mental health nurse, during the treatment of hepatitis C versus the usual health care.

In order to fulfill these first two objectives, a Clinical Pathway will be opened in which the Microbiology, Gastroenterology, Pharmacy and Mental Health services of the Regional University Hospital of Malaga will participate.

The third objective of the project will be to study how the presence of Hepatitis C influences psychotic symptoms, mainly negative ones, changes in daily functioning and changes in quality of life . For these purposes we will use the PANSS scale, a Quality of Life scale (the Life Skill Profile) and the Euroqol5D Health Questionaire before treatment and after verifying the effective cure of HCV.

A third and final evaluation with all the study variables will be carried out 6 months after starting the treatment. In addition, the disappearance of the viral load and, therefore, the patient's cure will be determined with a new blood test.

The objective of this study is to compare the effectiveness of a nurse-navigation program developed by specialist nurses on mental health, for patients with HCV and SMD, against the usual standard care, regarding the detection of the disease, facilitation of access and adherence to treatment, guides through the healthcare system, and cure from HCV.

The null hypothesis that this study will test is that there are no differences in the HCV cure rate in SMD subjects who receive the nurse-navigation model versus those who receive usual care. Additionally, a second hypothesis will be tested regarding to the differences in the adherence to HCV treatment.

Eligibility Criteria:
Inclusion Criteria:

* Severe mental disorder
* Hepatitis C positive with viral load

Exclusion Criteria:

* Patients who have contraindicated HCV treatment for any reason
* Patients in a clear situation of psychopathological decompensation (until recovery)
* Patients does not agree to participate
Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial

The purpose of this study is to determine the effects of low-dose aspirin for the primary prevention of vascular events in patients with type 2 diabetes in Japan.

There is a worldwide epidemic of diabetes and the number of individuals with diabetes is set to increase further. As individuals with diabetes are at high risk of accelerated atherosclerosis and thrombotic vascular events, the significant proportion of the cardiovascular disease burden is projected to be among this population. JPAD is a multicenter study with a prospective randomized open, blinded end-point (PROBE) design. The doses administered are aspirin 81 mg/day or 100 mg/day, the latter being enteric-coated Aspirin.

The primary objective was to compare the effect of aspirin on atherosclerotic events including cardiovascular events, cerebral vascular event, and other vascular events.

We also analyze hemorrhagic events in this RCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients have type 2 diabetes mellitus (30 or more years old and 85 years old or less).
* Patients give their informed consent to participate.

Exclusion Criteria:

* Patient has electrocardiographic changes, including ischemic ST-segment depression, ST-segment elevation, or pathologic Q waves.
* Patient has fixed ischemic heart disease, utilizing coronary angiography.
* Patient has cerebral vascular disease, including cerebral infarction, past hemorrhage, and experience of transient ischemic attack.
* Patient has arteriosclerotic disease, which needs internal medicine and/or surgical medical treatment.
* Patient has already taken the following anti-platelet or anti-thrombotic medicine: aspirin, ticlopidine, cilostazol, dipyridamole, trapidil, warfarin, and argatroban.
* Patient has severe gastric and/or duodenal ulcer.
* Patient has severe liver dysfunction.
* Patient has severe renal dysfunction.
* Patient has allergy for aspirin.
* Patient has atrial fibrillation.
* Pregnancy or the possible case of pregnancy.
A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients

This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety.

A multicentre, randomized, open label, two parallel group study The patients will be randomized to MR4 group or Prograf® group. The treatment period is 3 months( 12 weeks).Patients randomized to MR4 group who complete 3 months treatment period will continue to use MR4 until MR4 commercial available or authority notification.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent with the date of the patient must be obtained
2. Patient is the recipient of a liver transplant from 6 to 24 months prior to enrollment
3. Patient is currently receiving Prograf or Prograf + MMF based immunosuppressive therapy
4. At screening the liver and kidney function of patient is stable (defined as Serum creatinine is normal and ALT or AST is \<= 2 times the upper value of normal range)
5. Patient has the stable whole blood trough level concentration of Prograf (defined as tacrolimus trough concentrations of 2-10ng/ml measured 14 days prior to enrollment), and is clinically stable in the opinion of the investigator

Exclusion Criteria:

1. Patient has received an organ transplant other than a kidney
2. Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy
3. Patient is currently receiving other immunosuppressant therapy, eg. sirolimus
4. Patient with liver recurrent cancer, or metastasis, or other cancer
5. Patient has any unstable medical condition that could interfere with the study objectives
6. Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to enrollment
7. Patient is allergic macrolide antibiotics or tacrolimus
8. Patient has psychiatric disorder, in the opinion of the investigator, may invalidate communication with the investigator
9. Patient is currently receiving any medications, which is know to alter the CYP450 3A enzyme system (including grapefruit juice)
Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)

The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).


Eligibility Criteria:
Inclusion Criteria:

* Men or women age between 30 and 75 with Type 2 diabetes mellitus who are treated with pioglitazone or rosiglitazone
* Additionally, patients must have an LDL-C \>100 mg/dL at Visit 1 or prior to initiation of statin therapy

Exclusion Criteria:

* Patients taking sliding scale insulin, selected lipid lowering medications, oral anticoagulants and cyclical sex hormones
* Patients with heart disease, kidney disease, liver disease, uncontrolled high blood pressure, and insulin dependent diabetes