cyrilzakka/clinical-trials huggingface dataset:
Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Female, aged 18-75 years;
2. Primary breast cancer diagnosed histopathologically;
3. Adjuvant chemotherapy regimens include liposomal doxorubicin;
4. ECoG PS score: 0-1 points;
5. Left ventricular ejection fraction (LVEF) ≥ 55%;
6. Estimated survival ≥ 6 months;
7. Major organ function is normal, i.e. meets the following criteria:

   ① And white blood cells ≥ 4.0 × 10 9 / L, neutrophil count (ANC) ≥ 1.5 × 10 9 /L；② Platelets ≥ 100 × 10 9 /L；③ And hemoglobin ≥ 10 g / dl; ④ Serum creatinine ≤ 1.5 × ⑤ the upper limit of normal (ULN) Mmol / L and aspartate transaminase (AST) ≤ 2.5

   × ULN；⑥ Alanine transaminase (ALT) ≤ 2.5 × ULN；⑦ Total bilirubin ≤ 1.5 × ULN；⑧ Serum creatinine ≤ 1.5 × ULN；
8. Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up.

Exclusion Criteria:

1. Pregnant, lactating patients;
2. Breast cancer has been found to have distant metastasis;
3. Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;
4. Those with severe infection or active peptic ulcer requiring treatment;
5. Allergic to chemotherapy drugs;
6. Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;
7. Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;
8. Patients who are participating in other clinical trials or within a month.
Reducing Eating Disorder Risk Factors

The purpose of this study is to determine whether a web-based program is effective in reducing the incidence of eating disorders in college women who are at high risk for developing an eating disorder.

Female college students who use unhealthy weight control methods and have body image concerns may be at risk for developing an eating disorder. Developing and evaluating interventions to reduce eating disorders in high-risk populations is of great public health importance.

Participants are randomly assigned to either join a web-based risk-reduction program or receive no intervention. The 9-week risk-reduction program focuses on reducing body image and weight/shape concerns, identifying the risks of eating disorders, and increasing healthy weight regulation practices. The program includes weekly readings, writing assignments, and participation in a moderated electronic discussion group. Changes in body mass index (BMI) and the occurrence of major stressors and psychiatric events are assessed to determine their impact on the incidence of eating disorders. One-year incidence of eating disorders is determined by a diagnostic interview, and follow up may continue for up to 2.5 years.

Eligibility Criteria:
Inclusion Criteria:

* College students at risk for developing an eating disorder

Exclusion Criteria:

* Suicidal or other severe psychopathology
* Alcohol or drug abuse
* Body mass index (BMI) \< 18 or \> 32
* Current diagnosis of anorexia nervosa, binge eating disorder, or bulimia nervosa and have been in treatment within the past 6 months
Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization

The purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood flow to the lower limb(s).

Negative pressure wound therapy consists of a closed, sealed system that produces negative pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is maintained by connecting suction tubes to a vacuum pump and waste collector.

The investigators objectives are to determine whether there will be any reduction in surgical site infection and this potential reduction will influence length of hospital stay, emergency room visits, antibiotic use and need for re-operation.

The study is a non-blinded randomized control trial. The study examines the effect on wound healing and surgical site infection using negative pressure wound therapy compared to standard dressing in high-risk patients (BMI \> 30, previous femoral cut-down). The investigators expected to find a lower surgical site infection rate in patients using the NPWT device.

Patients after giving informed consent will be randomized to receive either NPWT or standard wound therapy following tier lower-limb revascularization operative. Both will be applied under sterile conditions immediately post-operatively. The intervention will be left for 4-7 days depending on the discharge date and the standard dressing will be removed on post-operative day two.

The data will be analyzed with an intention to treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35
* Previous femoral exposure
* Undergoing lower-limb revascularization

Exclusion Criteria:

* Cannot obtain seal
* Non-primary wound closure
* Pre-existing infection
* Endovascular repair
Study of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

Estimation of the Maximum tolerated dose (MTD) and/or Recommended dose (RD) of LDK378 as a single agent when administered orally to Japanese patients with tumors characterized by genetic alterations in anaplastic lymphoma kinase (ALK)


Eligibility Criteria:
Inclusion Criteria:

* Patients with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
* Only patients with tumors characterized by genetic alterations in ALK. For non-small cell lung cancer (NSCLC), an ALK translocation must be detected by Fluorescent in situ hybridization (FISH) in ≥15% of tumor cells. Local site documented results on ALK alteration are acceptable for enrollment of the patients. Central confirmation of local results is not required.

  --Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2
* Adequate organ function
* Dose-expansion part: Patients must have NSCLC that has progressed since prior therapy with alectinib. Alectinib must have been the only prior ALK inhibitor received by the patient prior to trial entry.

Exclusion Criteria:

* Patients with symptomatic Central Nerve System (CNS) metastases who are neurologically unstable or require increasing doses of steroids to control their CNS disease
* Patients with unresolved nausea, vomiting or diarrhea \> Common Terminology Criteria for Adverse Events (CTCAE) grade 1
* Other concurrent severe and/or uncontrolled medical conditions
* Patients who have been treated with chemotherapy or biologic therapy or other investigational agent \< 2 weeks prior to starting the daily dosing of the study drug for compounds with a half-life ≤ 3 days, and \< 4 weeks prior to starting the daily dosing of the study drug for compounds with a prolonged half-life (\< 6 weeks for patients that received nitrosoureas or mitomycin-C)
* Unresolved toxicity greater than CTCAE grade 1 or unstable toxicity from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia), or incomplete recovery from previous surgery, unless agreed by Novartis and the Principal Investigator and documented
* Patients who have received radiotherapy to lung within 4 weeks prior to starting the daily dosing of the study drug or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites radiotherapy to a large volume (including whole brain radiotherapy) \< 2 weeks prior to starting the daily dosing of the study drug, and patients who have received radiotherapy to a small volume (including stereotactic radiotherapy to the CNS) \< 3 days prior to starting the study drug.

Other protocol-defined inclusion/exclusion criteria may apply.
Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention

The IMMERGE registry is an observational, international multicentric study, including patients underwent IMPELLA implantation in the participating centers both for cardiogenic shock and high-risk PCI. Only IMPELLA CP, 5.0 and 5.5 devices will be included. Consecutive patients with CS and CHIPs implanted with Impella® CP, 5.0 and 5.5 with at least 6 months of follow-up completed will be enrolled in the registry. Baseline clinical and echocardiographic variables, peri-procedural haemodynamic parameters, laboratoristic findings and complications, together with follow-up outcomes data will be recorded in a dedicated database.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 18 years-old with CS or CHIPs
* Impella® device implanted (CP, 5, 5.5)

Exclusion Criteria:

* Age \< 18 years
* No Impella implanted
Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery

Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population.

The aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery.

Preoperative transthoracic echocardiography (TTE) is conducted in 100 individuals. Biventricular function (i.e. systolic and diastolic properties), left ventricular filling pressures and level of venous return are assessed by TTE.

Moreover high-sensitive troponine I and Nt-proBNP, ECG are collected. Multiple echocardiographic parameters will be studied for feasibility in terms of preoperative assessment of the heart.

Eligibility Criteria:
Inclusion Criteria:

* body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

Exclusion Criteria:

* Not signed consent.
DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia

The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation is critical for learning and memory. Individuals with Alzheimer's disease (AD) have fewer NMDA receptors in the frontal cortex and hippocampus than controls. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2) placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function and clinical symptoms in patients with BPSD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable Alzheimer's disease or probable vascular dementia
* For patients with vascular dementia, the post-stroke period must be more than 3 months
* Mini-Mental State scores between 5-26
* Clinical Dementia Rating score equal to or greater than 1
* Behavioral Pathology in Alzheimer's Disease Rating Scale score equal to or greater than 2

Exclusion Criteria:

* Current substance abuse or history of substance dependence in the past 6 months
* Other major psychiatric diagnoses, such as schizophrenia, major depressive disorder, bipolar disorder and mental retardation etc.
* Serious medical or neurological illness other than Alzheimer's disease/vascular dementia and other secondary dementia
First in Human Trial of TAS266 in Patients With Advanced Solid Tumors

This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of solid tumors
* 18 years or older
* ECOG performance status of 0, 1 or 2
* Adequate bone marrow, hepatic and renal function
* Obtained written informed consent

Exclusion Criteria:

* Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met.
* Major surgery within 4 weeks before study treatment
* Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations
* Impaired cardiac functions
* Previous hepatitis viral infection such as hepatitis B or hepatitis C
* Diagnosis of HIV infection
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort Study

This study evaluates the efficacy and safety of routine medical treatments of digital ulcers in patients with systemic sclerosis in a prospective cohort study.

Systemic sclerosis (SSc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. SSc manifests by fibrosis of skin and internal organs. Although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in SSc.

A hallmark feature of SSc is the presence of Raynaud phenomenon (RP) that is caused by reversible vasoconstriction of digital arteries triggered by exposure to cold or emotional stress. In up to 33-43% of SSc patients, the ischemia can progress to digital ulcers (DUs), which are often associated not only with pain but also with severe limitation in the daily activity, anxiety and depression among others. In severe cases, RP can be complicated by superinfection or gangrene, requiring surgical amputation.

The mainstay treatment of RP is restoration of the decreased blood flow using calcium channel blocker, protstanoids, phosphodiesterse V inhibitor, and endothelin receptor blocker. However, the efficacy and safety of those medications in RP-associated ulcers have not been definitive, especially in Korean patients with SSc. In addition, it remains unknown whether Korean SSc patients respond better to a treatment over others.

Study aims include

1. To establish a new prospective cohort of SSc patients with DU in Korea..
2. To investigate the current situation of SSc patients in Korea.
3. To investigate and compare the efficacy and safety of current medical treatments of DU in SSc patients in Korea

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* SSc diagnosis according to 1980 or 2013 ACR classification criteria
* 1 or more active DU
* Patients who start or change medical treatment for DU
* Patients who are willing to participate

Exclusion Criteria:

* Pregnancy or active breast feeding
* Patients with life expectancy \< 6 months
The Salty Gut: Effects of High Dietary Salt Intake on the Gut Microbiota

Gut microbiota has a role in cardiovascular disease and recent findings in rodents show dietary salt can negatively alter gut microbiota composition. High salt intake is a risk factor for cardiovascular disease. Americans consume dietary salt in excess of Dietary Guidelines and American Heart Association recommendations. The objective of this project is to investigate the influence of high dietary salt consumption on the gut microbiota composition in men and women.

Gut microbiota composition and function has an important role in host physiology. In general, gut microbial diversity is positively correlated with health status. Recent evidence confirms the role of gut dysbiosis in cardiovascular disease. Americans consume 50% more salt than the amount recommended by the Dietary Guidelines and 130% more than recommended by the American Heart Association. Excess salt intake is considered a modifiable risk factor for cardiovascular disease. Changes in the gut microbiota composition followed by immune system activation is reported with high salt intake in animals. In particular, abundance of proinflammatory T helper 17 (Th17) cells increases with excess salt consumption. In contrast, T regulatory (Treg) cells oppose Th17 cell action and may aid in reducing inflammation associated with high salt intake, a hypothesis that has not yet been tested in humans. Only one preliminary study assessed changes in gut bacterial composition with high salt intake in humans, when only men were recruited. The study also found an increase in Th17 cell abundance. Thus, the objective of this study is to investigate the influence of high salt intake on the gut microbiota diversity and Th17 and Treg cell abundance in men and women.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* normal blood pressure

Exclusion Criteria:

* hypertension
* cardiovascular disease
* renal disease
* diabetes
* cancer
* current use of anti-inflammatory agents, glucocorticoids or other immune regulating medications, or certain anti-depressants
* history of intestinal surgery
* inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder
* antibiotic use in the past 3 months
* prebiotic, probiotic, or antioxidant supplementation in the past 3 months
* ≥10 lbs weight gain or loss in the past 6 months
* use of tobacco products
* highly trained endurance athletes
* current pregnancy or lactation
Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms

Background: research show that cognitive behavioral therapy (CBT) is effective inreducing bulimia nervosa (BN) and binge eating disorder's (BED) symptoms. Today, with the development of technology there are efforts being made for developinga treatment to these eating disorders threw the media, most of these attempts are based on the CBT method. The size of the effect that CBT given threw the internet has on BN and BED is still not entirely clear. Research presented today are mostly based on treatments that were given threw email or Skypeor an automatic self- help stage program. These researches show heterogenic results about the effect it had on eating disorders. In this research we aim to investigate the effect size that a CBT treatment threw a smartphone application that combines a clinician online reply and an automatic feedback in addition to astandard ones a week clinic treatment has on BN and BED symptoms frequency.

Methods: Our aim is to make a research using an application that treats that offers an automatic and human therapist and dietitian reply threw a similar application that is suited for them. A selected 40 BN or sub-threshold BN or BED patients, men and women ages 18-60 ,that will turn to the "Sheba eating disorder medical center" will include the research. Half of the participants will receive aCBT treatment threw a smartphone application along with astandardclinical treatment that includes ones a week session with a therapist and ones a week session with a dietitian and the other half will receive a standardclinic treatment alone. We will test the eating disorder symptoms using eating disorders questionnaires at the starting point, at the end of a six months treatment and six months after finishing the treatment.

Importance: This research will allow testing the need and benefit that a personal and direct patient- therapist connection has over a standardones a week meeting connection format. In addition, treating with a web application in the future might have a benefit of saving time spent on getting to the clinic, will allow to shorten the time of the session in the clinic and will save cost of the face to face treatment.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of binge eating disorder
* clinical diagnosis of bulimia
* smrtphone owner
* english speaker

Exclusion Criteria:

* clinical diagnosis of type 1 diabetes
* clinical diagnosis of other axis 1 psychological problems
* pregnancy
* clinical diagnosis of celiac disease
Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1% to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 years and older
* Subjects with healthy skin as determined by the clinical grader.

Exclusion Criteria:

* Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions.
* Subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study
* Subjects with known allergy to one of the components of the study drugs (refer to the package insert for Differin® Cream 0.1% and the investigator's brochure for Differin® Lotion 0.1%)
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment.
* Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids.
* Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
* Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated.
* Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis

This study measures circulating, misfolded ATTR oligomers in asymptomatic ATTRm amyloidosis genetic carriers longitudinally over five years.

Recent advances in genetic testing have allowed for pathogenic mutation identification in family members of affected individuals prior to onset of symptoms. While the presence of mutation and the corresponding TTR kinetic stability have been directly linked to disease development, the molecular drivers of tissue specific degeneration have not been defined. We hypothesize that soluble misfolded TTR oligomer species may be circulating within the blood of these patients possibly years prior to amyloid deposition and could serve as an early biomarker and/or driver for disease development. In this line, The Scripps Research Institute has developed a peptide-based probe that specifically labels and integrates into misfolded TTR oligomers allowing the relative circulating concentration in the bloodstream to be determined. Longitudinal monitoring of untreated, asymptomatic TTR amyloid genetic carriers utilizing the Scripps probe is likely to provide novel insight into early disease progression. We also plan to utilize the Scripps probe to monitor disease progression in TTR amyloid genetic carriers currently undergoing treatment by observing how treatments affect the circulating misfolded TTR oligomers. Through enhanced understanding of early disease progression and treatment efficacy, our hope is to limit amyloid accumulation in cardiac and nerve tissue and delay the development of the invariably fatal TTR amyloid cardiomyopathy/neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known hereditary ATTR amyloidosis genetic mutations as identified by genetic testing.

Exclusion Criteria:

* Patients with ATTR amyloidosis identified as wild-type.