cyrilzakka/clinical-trials huggingface dataset:
A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase

This phase II study is a single-arm, two-stage, multicentre study to determine the clinical activity of lapatinib in combination with pemetrexed in patients with Non-Small Cell Lung Cancer (NSCLC) who have received one prior cytotoxic chemotherapy regimen. There will be a short safety run in portion of the study to determine the optimal treatment regimen (OTR) for the combination, since these two drugs have not previously been used together.

Approximately 27 patients will be enrolled into the first stage of the study and if sufficient responses are seen an additional 27 patients will be enrolled into the second stage giving an overall evaluable patient number of 54. Patients will be treated with pemetrexed plus lapatinib at the determined OTR to disease progression, death or withdrawal from the study treatment for any reason.

Safety and efficacy assessments will be performed on all patients at 6-week intervals, as well as at the end of treatment. Patients withdrawn from study treatment with stable disease will be assessed every 6 weeks until progression. Thereafter, patients will be followed for survival at approximately 12-week intervals until death or to a maximum of 5 years after last patient is enrolled, whichever comes first.


Eligibility Criteria:
INCLUSION CRITERIA:

* Signed informed consent;
* Patients must be 18 years old;
* Subjects must have stage IIIB or IV NSCLC .
* Recurrent or persistent NSCLC following one previous line of cytotoxic chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
* Life expectancy of 12 weeks;
* Have adequate organ function baseline laboratory values for inclusion;

EXCLUSION CRITERIA:

* History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
* Known history of or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or antiseizure medication for = 3 months prior to study enrollment.
* Peripheral neuropathy of grade 3 or higher;
* Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
* Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a 5FU prodrug.
Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome

The goal of this study is to begin to test whether or not pioglitazone, an FDA approved medication used to treat high blood sugar, may be safe and effective in treating Major Depressive Disorder (MDD) in patients with comorbid Metabolic Syndrome (METSYN).


Eligibility Criteria:
Inclusion Criteria:

* Be male or female between the ages of 18 and 70
* DSM-IV diagnosis of major depressive disorder
* Currently depressed as confirmed by the MINI-Plus at the screening visit
* Quick Inventory of Depressive Symptomatology-Self-Report(QIDS-SR) score \> 11 at study baseline
* Meets criteria for the metabolic syndrome as defined by the NCEP ATP III criteria

Exclusion Criteria:

* Pregnancy or breast feeding
* Unstable or inadequately treated medical illness as judged by the investigator
* Severe personality disorder
* Serious suicidal risk as judged by the investigator or having a score \> 2 on item 18 of the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) scale
* Known history of intolerance or hypersensitivity to pioglitazone
* Treatment with pioglitazone in the 3 months prior to randomization
* Currently taking an antidiabetic/glucose-lowering agent. Antidiabetic agents that are prohibited include insulin, rosiglitazone, metformin, sitagliptin, sulfonylureas (e.g. glyburide, glipizide, glimepiride), non-sulfonylurea secretagogues (e.g. repaglinide, nateglinide), incretins (e.g. exenatide), and α-glucosidase inhibitors (e.g. acarbose, miglitol).
* Diagnosed with dementia
* Diagnosed with heart failure
* Transaminase elevation \>2.5 times the upper limit of normal
* Presence of renal impairment
Effect of Self-Foot Massage on Diabetic Individuals

The aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes.

Diabetes mellitus (DM) is the most important metabolic disease that can affect almost every organ system in the body. Although diabetes causes many macrovascular and microvascular complications, one of the rare microvascular complications is peripheral neuropathy. One of the common complementary and integrative applications in the management of diabetic peripheral neuropathy is foot massage. The aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes. Individuals participating in the study will be divided into intervention and control groups. The individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. There will be no additional application other than routine to the control group, data collection forms will be applied and recorded at the beginning of the study and at the end of four weeks. In the collection of data, "Individual Description Form, Visuel Analog Scale- (VAS), DN4 Pain Questionnaire and General Comfort Questionnaire- Short form" will be used. In addition, peripheral skin temperature will be measured with a skin thermometer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or above,
* Having been diagnosed with type 2 diabetes at least 6 months ago,
* HbA1c level\> 6.5%,
* Being able to do personal care for personal hygiene management,
* No peripheral circulation problems,
* Do not have any problems such as speech or hearing that prevent communication,
* Physical and cognitive health levels are suitable for answering the data collection form,
* Agreeing to participate in the research,
* It is planned to include patients who can speak and understand Turkish.

Exclusion Criteria:

* Individuals with other health problems that may cause peripheral neuropathy (chemotherapy, neurological, etc.),
* Patients with organ damage (gangrene or foot / finger amputation) due to diabetes mellitus or any other reason, malignancy, tuberculosis, asthma, or any contagious disease,
* Individuals with a history of disease that may cause changes in peripheral skin temperature (Raynaud's disease, etc.)
* Who do not agree to participate in the research,
* Speaking and hearing impairments that interfere with the collection
eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System

Conduct a rigorous formative evaluation of the initial deployment of the Annie texting system across several pilot test sites and from these findings, develop and test an augmented implementation strategy to facilitate more rapid adoption of Annie across VA.

The investigators examined patient and provider experiences with VA's automated text messaging system, named "Annie". The investigators aimed to describe early experiences using Annie and subsequently pilot and evaluate an augmented implementation strategy to improve implementation of the system. Then, seven new facilities implemented Annie. The investigators focused on specialty clinics serving patients with hepatitis-C virus (HCV). Working in collaboration with clinical team members and other Office of Connected Care stakeholders, the investigators developed a texting protocol for Veterans with HCV that included motivational messages, medication and lab appointment reminders. This protocol was made available to the seven new facilities. Four facilities were randomized to serve as intervention sites to receive augmented implementation strategy. These facilities had regular facilitation calls, a site visit to assist with implementation, and were given the toolkit, in addition to receiving usual implementation assistance, described below. An additional three comparison sites received usual implementation of Annie only, which involves an orientation/training meeting and the option of attending twice-monthly Annie clinical adoption calls run by the Office of Connected Care. Two control sites did not receive Annie. The investigators conducted a mixed-methods evaluation including pre and post patient and provider surveys and semi-structured interviews, medical chart abstraction, and process measure analysis. The investigators collected data on patient and clinician experiences with the Annie system, including usability, clinical workflow fit, and clinical benefits such as improved HCV medication adherence and rates of appropriately timed lab tests.

Eligibility Criteria:
Inclusion Criteria:

* Starting HCV treatment at a VA clinic
* Have access/ability to text messaging

Exclusion Criteria:

* Not being treating for HCV
* No access/ability to use a cell phone
Genomic Predictors of Papillary Microcarcinoma Disease Progression

The study is being done to answer the following question: What are the specific clinical and molecular features that will help us predict which small thyroid cancers are likely to grow and be problematic?

Therefore, the purpose of this study is to identify specific clinical and molecular characteristics that are predictive of tumor progression in small thyroid cancers.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven papillary thyroid cancer (or suspicious for papillary thyroid cancer) confirmed by MSKCC cytopathologist.
* Being followed with active surveillance at MSKCC
* Biopsied index nodule less than or equal to 2 cm in maximum dimension
* Thyroid and neck US performed and interpreted by a MSKCC radiologist within 6 months prior to study entry.

Exclusion Criteria:

* Biopsied index nodule greater than 2 cm in any dimension
* Age less than 18 yrs old
Treatment of Whiplash Associated Disorders by APOS Kit

The purpose of this study is to compare two techniques for treating patients with Whiplash Associated Disorders, in relation to: disability, balance, cervical pain and cervical range of motion.

The hypothesis: The APOS kit treatment is more effective than the short wave therapy.


Eligibility Criteria:
Inclusion Criteria:Cervical pain, Motor vehicle accident a week prior to cervical pain, age above 16, ability to walk independently, signed inform consent, insured in "Clalit health services" Exclusion Criteria: Inability to walk independently, age 16 or less, not signed an inform consent, WAD grade 4, past treatment for WAD, pregnancy, pacemaker, cancer.

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Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer

In lung cancer, ensartinib is effective in improving the prognosis of ALK positive /MET exon 14 skipping patients. However, patients with ALK positive /MET14 exon skipping non-lung cancer solid tumors have limited treatment options in the absence of standard treatment. We hope to bring a new effective and safe treatment option to these patients more efficiently.


Eligibility Criteria:
Inclusion Criteria:

* Advanced/metastatic solid tumors other than primary lung cancer
* Alk-positive or MET14 exon skipping mutation by IHC\\FISH\\NGS\\RT-PCR
* Have no standard treatment after MDT discussion, or could not tolerate the standard treatment, or the patient refused the standard treatment
* Adequate liver and kidney function
* Adequate bone marrow function
* ECOG PS 0-3
* Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided

Exclusion Criteria:

* Active viral, bacterial, or fungal infection detected 2 weeks before enrollment
* Pregnancy or lactation
* receiving medications or herbal supplements with potent inducers of CYP3A4 (at least 3 weeks prior)
* Any severe or uncontrolled systemic illness, including uncontrolled Hypertension and active bleeding, any nonadherence that the investigator considered to be detrimental to study participation or adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV)
* Ineligible cardiac function
* Interstitial lung disease, drug-induced interstitial lung disease, previous history of radiation pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease
* Lack of adequate bone marrow reserve or organ function
A Treatment Protocol for Expanded Access Administration of Prometic Plasminogen Due to Closure of Clinical Trial

The clinical trial is no longer enrolling and is currently closing and Prometic will continue to provide Plasminogen (Human) under a treatment protocol to subjects in the United States (US) with hypoplasminogenemia requiring plasminogen replacement therapy who completed the End of Study visit in the following Prometic-sponsored clinical trials: 2002C011G, 2002C013G, 2002C016G, 2002C017G and 2002C019G.

US adult and pediatric subjects with hypoplasminogenemia requiring plasminogen replacement therapy who completed the End of Study visit in the following Prometic-sponsored clinical studies: 2002C011G, 2002C013G, 2002C016G, 2002C017G and 2002C019G will continue to receive their repeat-dose study of Plasminogen (Human) under a treatment protocol. Approximately, 15 subjects will be enrolled in the treatment protocol under an expanded access to continue to receive Plasminogen (Human) at a dose of 6.6 mg/kg as a 10 to 30-minute intravenous (IV) infusion at site visits or at home by either the subject or caregiver at the same frequency as in their prior Prometic-sponsored clinical study. Subjects or caregivers may be trained for study drug administration as deemed appropriate by the Investigator. Dosing frequency will be adjusted by the Investigator based on clinical response and plasminogen activity trough levels.

Subjects who completed the End of Study visit in studies 2002C011G, 2002C013G, 2002C016G, 2002C017G and 2002C019G and signed informed consent (and assent, if applicable) for the present study will be enrolled in this study; this visit will be designated as Day 1 of the present study. Subjects will return to their study site every 26 weeks, or more often as determined by the Investigator, for safety assessments and measurements of plasminogen activity trough levels at the Investigator's discretion.

Treatment with Plasminogen (Human) will continue until the product has been approved and is commercially available or discontinued at any time by the Sponsor or at the discretion of the Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all the criteria below to participate in this study:

  1. The subject or the subject's caregiver has provided informed consent (as well as assent by subjects with ages dictated by local Investigational Review Board \[IRB\] guidelines).
  2. Subject has a diagnosis of hypoplasminogenemia requiring replacement therapy with Plasminogen (Human).
  3. Subject has completed the End of Study visit at a United States site in the following Prometic-sponsored clinical studies: 2002C011G, 2002C013G, 2002C016G, 2002C017G and 2002C019G.
  4. Female and male subject agrees to use contraceptive methods from Day 1 through 14 days after last dose of study treatment (unless documented as biologically or surgically sterile \[e.g., postmenopausal, vasectomized\]), or has not reached reproductive age.

Exclusion Criteria:

* Subjects who are pregnant and/or lactating are excluded from participating in the study.
Imaging the Vesicular Acetylcholine Transporter Using 18F-FEOBV PET in Parkinsons Disease

Patients with Parkinson's disease (PD) often display symptoms, such as constipation, due to denervation of the cholinergic nerves in the gut. It has been hypothesized that PD initiates in the gut years prior to diagnosis. To gain a detailed understanding of the early stages of PD, techniques for quantification of cholinergic nerves are needed. The PET tracer 18F-FEOBV binds specifically to the vesicular acetylcholine transporter, situated in presynaptic cholinergic nerve terminals. The investigators will investigate 18F-FEOBV uptake in the brain and internal organs of 15 patients with moderate-stage PD and compare to 15 healthy controls. Furthermore, findings are correlated to validated clinical tests of the autonomic nervous system. The aim is to validate 18F-FEOBV PET/CT as a clinical imaging modality to diagnose parasympathetic denervation in PD.


Eligibility Criteria:
Inclusion Criteria:

* Parkinsons disease, disease duration \> 4 years, Hoehn \& Yahr stage 2-3

Exclusion Criteria:

* Significant neurological diseases (e.g. stroke, tumor)
* Significant psychiatric disease
* Previous major surgery on thoracic and/or abdominal organs
* Significant medical disease (e.g. heart- or liver failure)
* Inflammatory bowel disease
* Gluten intolerance
* Diabetes
* Magnetic Resonance (MR) contraindications (metal in body, claustrophobia)
* Allergy to CT-contrast fluid
* Pacemaker
* Any current or previous cancer involving internal organs
* Peripheral neuropathy (except Parkinsons disease related)
To Develop and Introduce Into Polyclinic Practice a Register of Patients with Experience of Myocardial Infarction and Acute Cerebrovascular Disease

This is a retrospective observational study using the methodology of creating medical registries. The expected number of patients included in the registry is about 2000 patients with myocardial infarction and/or ACVD of any duration and concomitant non-cardiac diseases of therapeutic profile in pilot healthcare organizations for any reason during 2019-2022 based on the source medical records data.

The implementation of the task results will improve the efficiency of secondary and tertiary prevention of diseases of the circulatory system - pathology that makes the greatest contribution to the main medical-demographic and socio-economic losses of the state by determining the number of groups with the highest risk of death in outpatient and polyclinic institutions among patients after myocardial infarction, ACVD, living in the Republic of Belarus, to create programs of additional measures to reduce morbidity and mortality of the population based on a comparison of register data and official statistical forms, which will ultimately affect the reduction in the incidence of non-fatal recurrent cardiovascular events in individuals after AMI, ACVD and / or their combination of any duration in the range of 0.2-1% of the indicators determined during the study.

Eligibility Criteria:
Inclusion Criteria:

1. All patients who applied to the pilot ambulatory health care organizations between 2019-2022 in order to identify and "look for" patients after acute cardiovascular event, but who were not monitored for that event for various reasons (statute of limitations, refusal, relocation, etc.);
2. All patients discharged from hospitals with a final diagnosis of AMI/ACVD, assigned territorially to the pilot polyclinics in the period 2019-2022.
3. Presence of a history of AMI and/or ACVD;
4. Age 18 years and older.

Exclusion Criteria:

* No
Efficacy of a Structured, Dimension-based, STI in De-compensated Personality-disorder, Hospitalized, Patients

The assessment of the efficacy of a structured, dimension-based, STI (Short Term Intervention) in de-compensated Personality-disorder, hospitalized, patients

The current study attempts to design a short-term intervention aimed at stabilizing decompensate personality disorder patients in hospitalization. The study is structured as a pilot study, thus will enroll 20 patients only. Patients, upon being hospitalized and after signing the consent to participate in the study, will be randomized to two groups: The first will be treated by the novel, LOOP, concept' the other will be TAU, as routinely done with PersDis patients in the investigators facility. The outcome parameters will be changes in series of questionnaires filled upon being enrolled and at the end of the intervention. Another outcome parameter will be readmission rates in the post-intervention period (3 months).

The LOOP conceptualizes the psyche by a three-dimension structure: the space (the potential of experiencing, the "place" where the investigators experiences occur), the content (the experiences themselves; action, thoughts, feelings, experiences and being) and the order (the relationship between the various contents). The LOOP intervene with these three dimensions by a structures scheme, aimed at allowing the patient to quickly reclaim the responsibility on his psyche, stabilize and initiate long-term rehabilitation processes.

Eligibility Criteria:
Inclusion Criteria:

* Cluster 2 diagnosis
* No suicide attemts 1 month prior to admission
* Regularly treated
* An active support system
* No urgent need for Rx changes

Exclusion Criteria:

* Drug abuse
* An active Axis 1 diagnosis that requires change in Rx
* Unable to read/write fluently
Assessment of a Modified Minimally Invasive Esophagectomy

This is a retrospective case series of a novel fully minimally invasive esophagectomy procedure for patients with primary esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* patient with primary esophageal cancer of any cell type
* underwent the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center by one of the study author-surgeons

Exclusion Criteria:

* non-elective procedure
* less than 90 days of post-discharge follow-up