cyrilzakka/clinical-trials huggingface dataset:
A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan

This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 years of age or older
* Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection
* Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment

Exclusion Criteria:

* Patients enrolled in any clinical trials at any time
* Overlapping use of nivolumab and ipilimumab
Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C

RATIONALE: Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup.

PURPOSE: Genetic trial to determine whether different forms of the UGT1A1 gene are related to the body's ability to break down drugs and to the gastrointestinal side effects seen in patients previously treated with flavopiridol.

OBJECTIVES:

* Determine the relationship between UGT1A1 genotypes and drug pharmacokinetics and occurrence of gastrointestinal toxicity in cancer patients previously treated with flavopiridol on protocol NCI-97-C-0171C.

OUTLINE: Genomic DNA from pre-existing samples of serum or plasma from each patient is analyzed for UGT1A1 gene by polymerase chain reaction and DNA sequencing. Results are then analyzed for a possible association between UGT1A1 genotypic variation and susceptibility to flavopiridol.

Patients do not receive the results of the genetic testing, and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cancer patients previously treated with flavopiridol on protocol NCI-97-C-0171C

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Study of Hand Therapy 3 to 24 Months After Stroke

The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.

Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

* 3 to 24 months post stroke
* Able to extend wrist and fingers at least 10 degrees
* Functional hearing and vision
* Able to follow instructions
* Lives at home, not institution
* Stable medications for 3 months

Exclusion Criteria:

* Excessive cognitive impairments
* Taking/Receiving medicines/shots to make arm/hand less stiff
* Severe pain in the impaired arm
* Stroke was more than 24 months ago
Vessel Injury in Relation With Strut Thickness Assessed by OCT

The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.

Thinner struts produce less arterial injury after stent implantation.The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness. Vessel injury after stent implantation will be evaluated with optical coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex ISAR 50 microns and Biomatrix 120 microns) will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of \>50% de novo stenosis located in native coronary vessels

Exclusion Criteria:

* Target lesion located in the left main stem
* STEMI
* Restenosis
* Cardiogenic shock
* Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance
* Known allergy to the study medications (probucol, sirolimus, zotarolimus)
* Pregnancy (present, suspected, or planned)
Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening

Approximately half of the patients receiving treatment for chronic hepatitis C virus (HCV) infection in the United States have advanced liver disease. Patients with advanced fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are clinically cured of HCV continue to have an elevated risk of developing hepatocellular carcinoma (HCC). According to guidelines from several professional societies and from the American Association for the Study of Liver Diseases (AASLD), in particular, patients with advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening has risen dramatically in recent years due to the confluence of three factors: Increased screening for HCV, which has allowed more people to realize that they have this often "silent" infection; the availability of safe and highly effective direct acting antiviral drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to achieve an SVR; and the long duration of HCV infection in many patients, which has allowed enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in the era of DAAs and to promote HCC screening, the objective of this study is to conduct a randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC screening between patients randomized to either personalized patient navigation or automated reminders (e.g. electronic or mailed). Both interventions represent improved care over current standard of care (no patient navigation or automated reminders). There is no evidence to suggest one intervention is better than the other. Healthcare providers who agree to participate in the study will be contacted to confirm the liver disease status of their patients and during the clinical trial the providers of patients in both arms of the trial will be sent reminders about the need to schedule patients for screening visits.


Eligibility Criteria:
Inclusion Criteria:

* ≥21 years old
* history of HCV infection treated in 2011 or after with direct acting antiviral therapy
* achieved ≥SVR-12 as defined as no detectable virus 12 weeks or longer after the cessation of therapy
* FIB-4 ≥3.25
* no history of HCC prior to treatment
* HCV provider deems a subject eligible for HCC surveillance according to AASLD criteria
* able to understand and speak English
* willing to sign the informed consent
* have a working phone number or e-mail to reach them
* no history of liver transplantation.
What is the Effect of Aerobic Exercise on Depression in Geriatric Individuals Diagnosed With Depression?

This study was planned to examine the effect of aerobic exercises on depression in geriatric individuals with a diagnosis of depression.

In this study 67 ± 5 years of age averaged and by the physician in geriatric depression diagnosis was placed 38 sedentary geriatric subjects were included. Meet the inclusion criteria geriatric individuals information, vital signs (pulse,"beats /min", blood pressure, " mmHg ", respiration number, respiratory rate,) was recorded. Depression levels, Depression Outcome Scale- KOFDSS to and quality of life is Quality of Life Survey -EUROHIS WHO-QOL) were evaluated. 6-week, 4 days a week aerobic exercise program was applied to geriatric individuals. As aerobic exercise which included the heating and cooling cycle was started the first week and 120 minutes, 160 minutes weekend out and gradually the intensity was given as an exercise program to be increasing. Individuals from the 6-week program were re-evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 65-75 years of age a in range, geriatric depression diagnosed with and willing to participate in the study is when individuals were included in the study.

Exclusion Criteria:

* Having geriatric psychiatric disorders other than depression, not being able to ride a bike for any reason, have contraindications for exercise, inability to adapt to exercise, not volunteering to participate
Hydra Registry - Italy Experience

Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.

Hydra-IT is a multicenter observational study conducted across different centres in Italy. The primary objective of the study is to evaluate the safety and efficacy of transcatheter aortic valve implantation and clinical outcome in patients treated with Hydra device. Secondary objective is to evaluate the long term (up to 5 years) effectiveness and the quality of treatment using Hydra device. Patients with severe stenosis symptomatic of the native aortic valve or bioprosthesis in a degenerated aortic position will be included in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team
* Ability to understand and provide informed consent for inclusion in the study

Exclusion Criteria:

* Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis.
* Refusal by the patient to participate in the study
* High probability of non-adherence to required follow-ups
Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation

Lung transplantation (LT) is now an established treatment option for patients with a wide variety of end-stage lung diseases- aims to improve quality of life and survival. Pulmonary rehabilitation (PR) is widely recognized as an important component of care of patients with chronic obstructive pulmonary disease (COPD), it improves dyspnea, exercise tolerance, quality of life, and reduces healthcare resource utilization.

The goal of pulmonary rehabilitation following lung transplantation is to enhance the physiological and functional benefits resulting from surgery. Inspiratory muscle Training (IMT) is defined as any intervention with the goal of training the inspiratory muscles. IMT can improve inspiratory muscles strength, endurance and exercise capacity in adults with COPD. IMT provides additional benefits to patients undergoing PR program and is worthwhile even in patients who have already undergone a general exercise reconditioning (GER) program. IMT will provide additional benefits (together or without) PR to patients following lung transplantation. No formal guidelines exist regarding the optimal methods of exercise training component of pulmonary rehabilitation for patients recovering from lung transplantation. This study will evaluate the unique influence of IMT in Patients Following Lung Transplantation.

The post lung transplant patients will participate in a rehabilitation program for 6 months. Participants in the proposed study will belong to one of four intervention groups:

1. Conventional or regular pulmonary rehabilitation program alone(an exercise program that consist 3 main components: aerobic conditioning, resistance training, and flexibility exercises).
2. Very low load IMT(sham IMT) alone.
3. Conventional or regular pulmonary rehabilitation program + Targeted inspiratory resistive or threshold IMT.
4. Targeted inspiratory resistive or threshold IMT alone.

Eligibility Criteria:
Inclusion Criteria:

* Post lung transplant patients attending the pulmonary Institute , will be invited to participate,They will be co-operative and able to perform spirometry; and other lung tests.
* Patients will be stable clinically,for at least one month,the patients will be all new to an IMT program.

Exclusion Criteria:

* Patients with cardiac disease,poor compliance,or requirement of supplemental oxygen.
Improving Help-seeking for Depression Care in Nepal

Depression is a serious public health concern worldwide due to its high prevalence rate and significant emotional and financial burden on individuals, their families, and society. There is a substantial gap between the number of people in need of treatment for depression and those who actually receive it. The recent World Health Organization (WHO) World Mental Health Survey revealed that 86.3% of people with anxiety, mood, or substance disorders in lower-middle-income countries did not receive any treatment in the past 12 months. This study aims to evaluate a community-based intervention to address demand-side barriers by improving mental health literacy, dispelling myths and misconceptions about depression, changing negative attitudes towards depression care, and promoting help-seeking behavior.

It is estimated that more than 300 million people worldwide are experiencing depression, which is about 4.4% of the world's population. Despite the availability of evidence-based treatment, it is reported that 86.3% of people with anxiety, mood, or substance disorders in lower-middle-income countries received no treatment in the past 12 months. Among people who receive treatment for depression, only one out of 27 persons receive minimally adequate treatment in low- and middle-income countries (LMICs). Despite being the major contributor to the overall global burden of disease, depression receives less or no health priority in many LMICs, where more than 80% of people with depression reside.

This study will take place in two municipalities in Morang district, eastern Nepal. Female Community Health Volunteers will administer the intervention to individuals identified with depression using the locally developed and validated Community Informant Detection Tool (CIDT). Participants who receive the intervention will be followed up after one month to evaluate their help-seeking behavior (primary outcome) and after three months to assess treatment adherence, a secondary objective of the study. The study will assess the effects and interactions of four intervention components (information on depression, available treatments, stigma and myths, and life transformation experiences) on the primary outcome of help-seeking behavior and secondary outcomes such as treatment adherence. The severity of depression symptoms will be assessed using the validated PHQ-9, and knowledge and attitudes toward depression will be evaluated to assess mediation effects.

Eligibility Criteria:
Inclusion Criteria:

* being an adult aged 18 or older residing in Kanepokhari Rural Municipality or Patharisanischare Municipality,
* those detected through the CIDT
* providing consent for participation
* being proficient in speaking and understanding Nepali

Exclusion Criteria:

* people with already receiving mental health services
* having severe mental illness\]
* participants below the age of 18 years,
* participants outside of Kanepokhari and Pathari-sanischare Municipality
Metabolic Effects of a Low Carbohydrate Versus a Standard Diet in Morbidly Obese With Prediabetes

To investigate the metabolic effects of a low carbohydrate versus energy-matched standard diet in morbidly obese individuals with prediabetes awaiting bariatric surgery.

The metabolic benefits of calorie restriction in obese people with or without impaired glycaemia are well-established. The impact of diet composition, however, remains poorly understood. Hepatic lipid content strongly correlates with hepatic insulin resistance, which is a key feature of the pre-diabetic state. The investigators hypothesize that a low carbohydrate diet compared to an energy-matched standard diet in morbidly obese patients with prediabetes scheduled for bariatric surgery results in greater reduction in liver fat.

Eligibility Criteria:
Inclusion Criteria:

* Female and male subjects aged 18 years or older
* BMI \>35 kg/m2 awaiting bariatric surgery
* Pre-diabetes according to American Diabetes Association criteria (HbA1c 5.7%-6.4%)
* Capacity to give informed consent and adhere to study procedures

Exclusion Criteria:

* Excess alcohol consumption (\> 3 units/day for men, \> 2 units/day for women)
* Moderate to severe kidney disease
* Nephrolithiasis
* Pregnancy/breastfeeding
* Current participation in another clinical trial
* Claustrophobia
* MRI-contraindications (pacemaker/defibrillator, neurostimulator, drug pump, cochlear implant, heart valve/vascular clips, shunt valve)
Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy

The purposes of the study are to identify 1) the patient (demographic and clinical) and health care system factors predictive of immediate and late postoperative adverse outcomes in children undergoing tonsillectomy. 2) Evaluate the preoperative use of the sleep questionnaire to identify children at risk for immediate and late postoperative adverse outcomes in children undergoing tonsillectomy.

Currently, children are scheduled to go home or stay in the hospital depending on expert consensus and institutional guidelines. The investigators preliminary experience (Dr. Sadhasivam PI: IRB No. 2008-0848) with the pharmocogenetic study, studying the phenotypic and genotypic influences of pain and use of opioids in patients undergoing tonsillectomy indicates that a significant number of patients scheduled as outpatients experience prolonged recovery phases in the PACU, some of whom are admitted or re-admitted following discharge. The identification of those factors that are, predictive of adverse events in tonsillectomy patients and the development of a prototype prediction model in this single-center study to support clinical decision-making. The rationale of this project is that developing a model to predict postoperative adverse events will not only lead to improved clinical outcomes and enhance patient safety, but also reduce family psychosocial distress associated with unanticipated hospital visits or re-admission, while reducing the burden on the health care system.

Eligibility Criteria:
Inclusion Criteria:

* Children 0-17 years of age
* Children scheduled for tonsillectomy or adeno-tonsillectomy
* ASA I, II, or III

Exclusion Criteria:

* ASA IV and V
Preoperative Patient Education Via Animated Videos to Improve Patient Satisfaction and Reduce Complications in Head and Neck Surgery

This randomized control trial will compare traditional patient education methods (pamphlets, clinical visits) to the implementation of an innovated patient education platform. The purpose of the project is to determine whether the use of this animation based patient education platform prior to undergoing surgery will lead to improved patient satisfaction and quality of life.

Hypothesis/Study question:

Does the implementation of an animation based patient education platform prior to undergoing surgery lead to improved patient satisfaction and quality of life?

Study objectives:

Help address patient gaps in understanding, reduce learning barriers in order for patients to make informed decisions, improve behaviors, and better partner with their health providers to attain optimal health outcomes

Methodology / Study design:

Patients will receive access to the patient education platform during the clinical visit in which they receive their diagnosis, and will be asked if they wish to enroll in the study consisting of completing questionnaires before and after their surgical procedure. Questions will inquire on levels of anxiety, patient satisfaction, knowledge retention, and platform feedback.

Eligibility Criteria:
Inclusion Criteria:

* Individuals having any of the following surgical procedure at the Jewish General Hospital over the next 12 months: head and neck cancer resection with or without reconstruction, excision of parotid lesion, thyroidectomy, parathyroidectomy, laryngectomy, or trans-oral robotic resection.

Exclusion Criteria:

* Individuals who are undergoing a surgical procedure not included in the ones listed above, or those who are having revision surgery or have previously had surgery in the otolaryngology, head and neck surgery department.
UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA \< LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).

Limit of Quantitation (LOQ)

Ribonucleic acid (RNA)

End of Treatment (EOT)

Triple Direct Acting Antivirals (3DAA)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Males and females, ≥ 20 years of age
* Subjects chronically infected with HCV GT-1
* HCV RNA viral load of ≥ 100,000 IU/mL

Exclusion Criteria:

* Hepatocellular carcinoma
* Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
* Severe or uncontrollable complication
SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation

The purpose of this study is to determine if simvastatin improves development and behavior in patients with Smith Lemli-Opitz syndrome (SLOS) receiving dietary cholesterol supplementation.

Patients with SLOS receiving dietary cholesterol supplementation are given simvastatin, a drug that decreases the activity/expression of HMG-CoA reductase, an enzyme that controls the first step of the cholesterol synthesis pathway, reduces the accumulation of toxic 7-dehydrocholesterol (immediate metabolic precursor of cholesterol) and improve neurocognitive and behavioral outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 1 years old
* Subject has confirmed diagnosis of Smith-Lemli-Opitz Syndrome
* Subject is currently receiving cholesterol supplementation

Exclusion Criteria:

* Subjects too ill to travel to the study site
* Subjects who are unable to safely undergo study procedures
* Pregnant women