cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES:

* Determine the response rate and duration of response to mitomycin, vinorelbine, and cisplatin plus tretinoin in patients with stage IIIB or IV non-small cell lung cancer.
* Determine the toxicity of this treatment regimen in these patients.
* Determine survival of these patients with this treatment regimen.

OUTLINE: Patients receive tretinoin orally twice daily for 4 days starting days 1 and 8; cisplatin IV over 2 hours and vinorelbine IV on days 1 and 8; and mitomycin IV (courses 1 and 3) on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: At total of 15-46 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage IIIB or IV non-small cell lung cancer
* Measurable disease
* No brain metastases

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute granulocyte count greater than 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 2 times upper limit of normal (ULN)
* AST and ALT less than 2.5 times ULN (unless attributed to liver metastases)

Renal:

* Creatinine no greater than 1.5 mg/dL AND/OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No myocardial infarction within past 6 months
* No congestive heart failure
* No uncontrolled arrhythmia

Other:

* No other concurrent or prior malignancy within past 5 years except localized basal cell or squamous cell skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy with clearly progressive disease
* Concurrent palliative radiotherapy allowed if no evidence of disease progression

Surgery:

* Not specified
Correction Study of R744 in Renal Anemia Patients on Hemodialysis

This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been receiving hemodialysis more than 1 time a week
* Patients aged ≥ 20 years at the time of obtaining consent
* After starting of hemodialysis, patients who have not received rHuEPO preparation
* After starting of hemodialysis, patients whose value of Hb concentrations determined before the first hemodialysis during the last week prior to the registration has been \< 10.0 g/dL

Exclusion Criteria:

* Patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmHg on more than 1/3 of the determining occasions after starting of hemodialysis during the last week before registration)
* Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification)
* Female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure during the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug
* Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
* Patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom)
* Patients hypersensitive to a rHuEPO preparation
* Patients with malignant tumor (including hemic malignant tumor), severe infection, systemic hemic disease (osteomyelodysplasia syndrome, hemoglobinopathy, etc.), hemolytic anemia or apparent hemorrhagic lesion such as digestive tract hemorrhage
* Patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration
* Patients who have received another investigational drug within 12 weeks before registration
* Patients who have received R744 before registration
* Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L before registration
* Patients who have received erythrocyte transfusion within 16 weeks before registration
* Patients for whom a surgical operation involved with heavy bleeding is planned during the study period
* In addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator
Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease

The morbidity of recurrence of focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) after transplant is well-recognized and include contemporary reduction in quality of life, edema, early graft loss and mortality. Efforts to understand its mechanisms and improve its treatment have been limited by small sample sizes in single center studies and misclassification in registry studies. Recent advances in the understanding of the mechanisms of FSGS in the native kidney has reinvigorated the scientific community to develop a collaborative community to advance research into the epidemiology, mechanisms, interventions, and outcomes.

The purpose of RESOLVE is to gather a group of people with FSGS and MCD that have had or will have a kidney transplant to create a bank of information and biospecimens so researchers can more effectively study these diseases.

RESOLVE is a multicenter, observational cohort study to examine the post-transplant course of patients with FSGS and MCD across the lifespan. The study is designed to collect both retrospective and prospective data as well as biospecimens and patient reported information. With multiple enrollment options, the study will allow investigators to define the incidence and prevalence of FSGS recurrence, describe the post-transplant course of patients with FSGS and MCD across the lifespan, and develop a biorepository to support future translational research studies to explore relevant disease mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Retrospective non-consented participant group had a transplant from the year 2000 and onward.
* Diagnosis of FSGS or MCD in the native kidney (prior to transplant).

Exclusion Criteria:

* Pathologic diagnosis other than FSGS or MCD
* FSGS or MCD secondary to a known disorder (e.g. lupus nephritis, Immunoglobulin A (IgA) nephropathy, malignancy)
Open Label Study of BAY1082439 in Patients With Advanced Cancer

The purpose of this study is to determine the safety, tolerability and the pharmacokinetics of BAY1082439


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable

  * Expansion phase only: Subjects with histologically or cytologically confirmed, locally advanced or metastatic endometrial cancer or breast cancer or iNHL, who are refractory to or have exhausted all available therapies
* International normalized ratio (INR) and partial thromboplastin time (PTT) \<1.5 x ULN \[Subjects on anticoagulation with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.\] For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care
* Measurable or evaluable disease
* Life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* History of cardiac disease: congestive heart failure \> New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months prior to the first dose of study drug), myocardial infarction within the past 6 months prior to the first dose of study drug, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
* History of diabetes mellitus or gestational diabetes mellitus
* Fasting blood glucose level \>125 mg/dL or HbA1c 7% at screening
* Active clinically serious infections \> Grade 2
* History of organ allograft
* Seizure disorder requiring therapy (such as steroids or anti-epileptics)
Incentivizing Reflection and Output in Exercise

This study will test whether incentivizing post-workout activities (i.e., reflecting on workouts) is more effective than incentivizing actual workouts. This study has two conditions: reflection condition (with incentives for reflecting on workouts) vs. output (with incentives for working out). The focus of the incentives will be reinforced by three text messages per week and weekly emails.

Gym members register online to participate in a 28-day workout program. Upon registration, participants are assigned to one of two conditions (a condition that incentivizes reflecting on workouts or a condition that incentivizes workouts). Upon registration, participants are prompted to create a workout schedule and are given advice that reflecting on workouts can help build exercise habits. Over the 28-day intervention period, participants receive text message reminders prior to their scheduled workouts and emails reminding them of their schedules. In both conditions, participants receive points every day that they go to the gym, which can be redeemed for a gift card after the intervention period. In the reflection condition, participants can receive bonus points for responding to each of three text messages each week asking about them to reflect on their gym visits. In the output condition, participants receive the same text messages, but receive bonus points for their first three workouts each week, rather than for responding to text messages.

Eligibility Criteria:
Inclusion Criteria:

* 24 Hour Fitness member

Exclusion Criteria:

-
Rheumatoid Arthritis Coping Enhancement

This study will test an enhanced lifestyle behavioral weight management program that integrates pain coping strategies with a lifestyle intervention that we expect to enhance obese RA patient's ability to cope with pain-related weight challenges. In the proposed study, up to 120 obese (RA-BMI \> 28) rheumatoid arthritis patients will be consented in order to randomly assign 80 patients to one of two conditions: 1) an Enhanced Lifestyle Weight Management protocol or 2) standard care control. Patients randomized to the Enhanced Lifestyle Weight Management condition will participate in a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors will be integrated into a lifestyle behavioral weight loss intervention.


Eligibility Criteria:
Inclusion Criteria:

* had RA for at least one year
* were 18 to 85 years of age
* were obese according to established RA obesity criteria (RA-BMI \> 28)
* had experienced RA pain in the last two weeks.

Exclusion Criteria:

* Subjects were excluded if they 1) have a significant rheumatic disorder other than RA or another organic disease that would significantly affect functioning (e.g., COPD, cancer)
* had a significant medical condition that would expose them to increased risk of a significantly adverse experience during the course of the study (e.g., a recent myocardial infarction)
* they were already involved in a regular exercise program and/or pain coping skills training program
* they had an abnormal cardiac response to exercise such as exercise-induced VT, abnormal blood pressure response, etc.,
* are pregnant at enrollment or at the initiation of intervention
* are younger than 18 years of age or older than 85 years of age
* are known or judged by the physician to be cognitively impaired (dementia, retardation, psychosis)
Molecular Epidemiology of Myocardial Infarction and Stroke in Older Adults - Ancillary to CHS

To investigation the association of thrombosis and inflammation genes with sub-clinical cardiovascular disease and with incident myocardial infarction and stroke in older adults.

DESIGN NARRATIVE:

The study represents a collaborative effort among investigators of the Cardiovascular Health Research Unit, Department of Genome Sciences at the University of Washington (UW), and the multi-center Cardiovascular Health Study (CHS), including the CHS Blood Laboratory at the University of Vermont. The study links advances in thrombosis and inflammation biology, large-scale human genomics, and population and statistical genetics, with the unique resources of CHS, a large, bi-racial cohort of older adults. In older men and women without clinically apparent vascular disease, carotid intimal-medial thickness or IMT (a measure of subclinical atherosclerosis), C-reactive protein (a sensitive marker of inflammation), and D-dimer (a global marker of activation of the hemostatic system) predict subsequent clinical events such as myocardial infarction (MI) and stroke. While the therapeutic benefits of thrombolytic therapy and aspirin suggest a major role for clotting and inflammation in the etiology of coronary disease and stroke, the genetic determinants of these risk factors, which are also influenced by traditional lifestyle risk factors such as smoking and obesity, remain largely unexplored in older adults. The setting for this study is the Cardiovascular Health Study, a cohort study of 5888 older adults designed to assess risk factors for stroke and coronary disease. Data on traditional risk factors, on measures of subclinical disease, and cardiovascular events are available to the ancillary study. By integrating recent clinical and experimental data on age-related and vascular bed-specific regulation of blood coagulation, and incorporating complete human genomic DNA sequence variation data from the NHLBI-funded UW Program for Genomic Applications, the investigators will evaluate thoroughly the association of thrombosis and inflammation genes with (1) carotid IMT, CRP, and D-dimer levels measured at baseline and (2) incident MI and stroke in adults \>65 years old followed for up to 12 years.

Eligibility Criteria:
No eligibility criteria
US Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System in patients with advanced upper lobe predominant emphysema.

Background:

Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.

Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung. This provides room within the chest to allow the remaining healthier portions of the lung to function better.

Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of advanced upper lobe emphysema
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy to relieve symptoms (inhaled beta agonist \& inhaled anticholinergic)
* pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 \< 45% predicted \& experiencing \< 30% or 300 mL improvement using bronchodilator; total lung capacity \> 110% predicted; residual volume \> 150% predicted)
* 6 Minute Walk Distance \>/= 150 m

Exclusion Criteria:

* alpha-1 protease inhibitor deficiency
* homogeneous emphysema
* tobacco use within 4 months of initial visit
* body mass index \< 15 kg/m2 or\> 35 kg/m2
* clinically significant asthma, chronic bronchitis or bronchiectasis
* allergy or sensitivity to procedural components
* pregnant, lactating or unwilling to use birth control if required
* prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endotracheal valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
* history of renal infarction or renal failure
Convenience Sample Data Collection for INVSENSOR00045

This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.


Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 1 month of age
* Gestational age greater than 23 weeks
* Weight less than or equal to 5 kg
* Subjects with standard of care arterial blood sampling line already in place

Exclusion Criteria:

* Subjects with underdeveloped skin
* Subjects with abnormalities at the planned application sites that would interfere with system measurements
* Subjects with known allergic reactions to foam/rubber products and adhesive tape
* Subjects with axillary arterial lines
* Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator
The Effect of the Hand Massage A Women Undergoing Brachytherapy

Background Gynecologic cancers are among the ten most common cancers among women. During brachytherapy, women can have pain and situational anxiety due to the treatment.

Methods This parallel-group randomized controlled study evaluated the effect of the hand massage practiced using baby oil, with lavender oil, on reducing operational pain and situational anxiety in women with brachytherapy. The study was completed with 36 patients. The treatment group included 18 patients, and the control group had 18. The data were collected through patient information form, visual analog scale, and state anxiety inventory. Before the brachytherapy, three sessions of hand massages, each lasting 10 minutes (5 minutes for each hand), were performed using baby oil with lavender. Data collection forms were repeated after each session. The control group received routine treatment. p\<0.05 was accepted as significant.

Therefore, the impact of hand massage applied with lavender baby oil on women with gynecologic cancer having brachytherapy for three sessions on the pain and state anxiety experienced during the intervention was evaluated in this study.

Eligibility Criteria:
Inclusion Criteria:

* verbal communication
* to be at the age of 18 and above
* to be diagnosed with gynecologic cancer and receive BT three days a week regularly
* to be aware that she has a gynecologic cancer disease and to be a volunteer to participate in the study

Exclusion Criteria:

* the patients who had metastasis, bleeding or coagulation disorder
* received complementary and integrated treatment
* had edema or lesion on hand, had a psychiatric disease
* had communication problems
* did not want to have a massage
* were under general anesthesia during the intervention
Development and Application of Accurate Detection Technology Based on Multimodal Data of Breast Cancer Comobid Depression

This study is a prospective, observational clinical research aimed at establishing a multimodal database encompassing clinical information and gut microbiome data from a sample of over 1,000 breast cancer patients comorbid with depression. The research involves collecting cohort sample information from breast cancer patients with comorbid depression, as well as fecal, blood, and saliva specimens for metagenomic sequencing, untargeted metabolite detection, and cortisol level analysis, respectively. Based on the collected multimodal data, diagnostic, efficacy prediction, and prognostic survival prediction models for breast cancer with comorbid depression will be developed. Additionally, a precision prediction cloud platform will be designed and deployed to support data upload, model prediction, and result visualization.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed primary breast cancer; Aged 18-80 years; No prior history of malignancy other than breast cancer; Awareness of their breast cancer diagnosis; Karnofsky Performance Status (KPS) score \>70; Willing to provide blood, fecal, and saliva samples with signed informed consent.

Exclusion Criteria:

* Physician-diagnosed mental disorders before or after breast cancer diagnosis; Severe chronic somatic diseases (e.g., central nervous system disorders, severe head trauma, substance abuse/dependence, intellectual disability, diabetes, gynecological diseases, cardiovascular diseases, thyroid disorders, etc.); Presence of two or more primary malignancies of different tissue origins; Central nervous system (CNS) metastasis of breast cancer; Clinically diagnosed digestive system diseases (e.g., enteritis, gastritis); Use of antidepressant or anxiolytic therapy during the study; Use of medications that alter gut function or metabolism during the study; Pregnant or lactating women; Radiotherapy or chemotherapy within the past 21 days; Use of antibiotics, probiotics, prebiotics, or synbiotics within 3 months prior to the study; Other reasons deemed unsuitable for participation by investigators.