cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer

The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer

Recent clinical data has demonstrated that even in heavily pretreated patients with trastuzumab-refractory HER-2 positive breast cancer, targeting HER2 is efficacious.

IPI-504 is an HSP90 inhibitor and is chemically related to 17-AAG and it has been studied in a clinical trial in combination with trastuzamab and a response rate of 26% (7/27) was demonstrated in patients with pretreated, HER2-positive breast cancer. These data provide a strong scientific rationale for clinical testing of IPI-504 plus trastuzumab in patients with pretreated, locally advanced or metastatic HER2-positive breast cancer

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced/metastatic breast cancer.
* HER2-expressing primary or metastatic tumor
* Two prior regimens with HER2. Trastuzumab must have been given. No limit to prior therapies
* Measurable disease with RECIST 1.1
* Clinical progression
* LVEF WNL
* ECOG 0 or 1
* Last dose of chemotherapy, radiotherapy, surgery, ablative therapy, tyrosine kinase inhibitor, ≥2 weeks
* Administration of biological therapy ≥4 weeks
* Last dose of trastuzumab must be ≥1, or ≥3 weeks prior to start, if previously administered on an every 3 week schedule.
* Resolution of toxic effects to baseline or Grade 1, except alopecia (NCI CTCAE Version 3.0
* Organ and marrow function:

  * Hemoglobin ≥8.0 g/dL
  * ANC ≥1200/µL
  * Platelets ≥75,000 /µL
  * ALT and AST ≤ 1.5 x ULN
  * Alkaline phosphatase ≤2.5 x ULN, or ≤3.0 x ULN if secondary to liver metastases.
  * Serum bilirubin WNL
  * Serum albumin ≥3.0 g/dL
  * PT, PTT ≤1.5 x ULN
  * Serum creatinine ≤1.5 x ULN
* Negative pregnancy test

Exclusion Criteria:

* Prior treatment with Hsp90 inhibitor.
* Grade 4 AE secondary to trastuzumab. Grade 3/4 infusion reactions or Grade 3/4 symptomatic heart failure
* Medication/food that is a CYP3A inhibitor or inducer.
* Hx 6 months: cardiac disease - acute coronary syndrome or unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, cirrhotic liver disease, cerebrovascular accident or significant co-morbid condition
* Grade 3 or 4 hemorrhagic event within 6 months.
* HIV positivity
* Baseline QT corrected, QTcF \>470 ms
* Sinus bradycardia \<50 bpm Secondary to pharmacologic therapy may enroll if stopping therapy normalizes heart rate.
* Malignancies within 3 years other than non-melanomatous skin cancers, non-muscle-invasive bladder cancer and carcinoma in situ of cervix.
* Active keratitis or keratoconjunctivitis
* Active brain metastasis (e.g., requiring therapy with steroids or radiation therapy; or with intracranial progression 4 weeks after the completion of radiation therapy) uncontrolled seizure disorder, ongoing spinal cord compression, or carcinomatous meningitis. If clinically stable brain metastasis (previously treated or untreated)are present pt is eligible.
Perioperative Pediatric Blood Transfusion Therapy

The present retrospective study analyses perioperative haemotherapy in children and adolescents at the University Hospital Frankfurt.

In the center of the analyses are the perioperative consumption of transfused red cell concentrates, platelet concentrates and frozen fresh plasma in children and adolescents. The distribution by subject area is also examined, demographic distribution and indicators on transfusion. With the introduction of the Patient Blood Management for adults at the University Hospital in 2013 have become potentially also result in changes in transfusion practice in children, which should also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents \<18 years
* Hospital admission
* Operation

Exclusion Criteria:

- none
Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients

This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female who over 19 years old
* Moderate to Severe Dry Eye Disease Patients
* Must meet all criteria listed below at least in one eye or both eyes. TCSS (National eye institute (NEI) scale)≥ 4 Schirmer test(without anesthesia) ≤ 10mm in 5 mins Tear break-up time ≤ 6 secs
* Written informed consent to participate in the trial

Exclusion Criteria:

* Those who have clinically significant eye disease not related to dry eye syndrome
* Those who have medical history with intraocular surgery 12months before screening visit
* Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
* Participation in other studies within 4weeks of screening visit
The China Valvular Heart Disease Study

This is a observational、multicenter, prospective cohort study for adults with significant VHD. The purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with VHD；also to set up registration system of adult VHD in China, to build a database of Chinese adult VHD, to establish a web-based international standard data acquisition system for VHD and a multicenter clinical research platform. The results of the study will provide a basis for the future national health policy for prevention and treatment of adult VHD.


Eligibility Criteria:
Inclusion Criteria:

* patients over 60 years old meet one of the following conditions.

  1. moderate or above valvular heart disease as defined by echocardiography: （1）aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg, （2）aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （3）mitral stenosis, moderate or above, or valve area ≤1.5cm2, （4）mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （5）tricuspid stenosis, moderate or above, or valve area ≤1.0cm2, （6）tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2, （7）pulmonic stenosis, moderate or above, or maximal jet velocity \>4m/sec, （8）pulmonic regurgitation, moderate or above,
  2. or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
  3. or diagnosis of endocarditis as assessed by Duke criteria.

Exclusion Criteria:

* Patients cannot be followed up for any reasons. Patients have been enrolled in this study.
Analysis of Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium

Painful bladder syndrome (PBS)/interstitial cystitis (IC) may be due to the actions of nitric oxide (NO) in the bladder tissue. NO is a gaseous substance with a very short half-life, synthesized by a group of NO-synthase-enzymes in many tissues.

The goal of this study is to illuminate bladder tissue production of NO in individuals with PBS and healthy individuals, by quantification of NO and NO-enzyme expression by different molecular biological methods.


Eligibility Criteria:
Inclusion Criteria:

* PBS/IC according to International Continence Society (ICS)
* Cystoscopy with bladder distension and deep biopsies within last 5 years
* Cystometry within last 5 years
* Normal urine culture within last month

Inclusion Criteria (for control group):

* Benign non-invasive bladder disease
* No PBS/IC
* Normal urine culture
* No functional bladder disease of known nature (ex. infravesical obstruction)

Exclusion Criteria:

* Age under 18 years
* Inability to understand instructions
* Pregnancy and lactation
Superoxide Dismutase (SOD) as Antioxidant Treatment OF Age Related Macular Degeneration (ARMD)

INTRODUCTION:

Acting directly on the anti-radical enzyme chain, the superoxide dismutase (SOD), a major enzyme of the anti-oxidant system, provides an alternative of the antioxidants treatment in ARMD. Its synthesis depends on the cellular oxygenated reactive species, and leads to the conversion of the superoxide ion (O2-) into hydrogen peroxide (H2O2). This compound is the cell watch guard continuously regulating a free radicals' detoxifying chain. Subsequently, by increasing the production of H2O2, the administration of SOD can trigger endogenous/internal antioxidant mechanisms.

Oral administration of SOD is possible in its galenic form, Glisodine. The purpose of this study was to evaluate the protective effect of SOD on the bilateralization of the disease.


Eligibility Criteria:
Inclusion Criteria:

* unilateral neo-vascular ARMD

Exclusion Criteria:

* other pathology
Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections

Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock therapy for CLABSI prophylaxis in adult patients on PN.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (ages 18-80) on PN with silicone-based central venous catheters

Exclusion Criteria:

* Weight ≤ 50 kg
* Allergy/hypersensitivity/intolerance to ethanol or heparin
* Pregnancy or breastfeeding
* Patient taking metronidazole, disulfiram, or isoniazid
* History of alcohol abuse
* History of heparin-induced thrombocytopenia (HIT) or have an active hypocoagulable state
Repurposing Riluzole for Cancer-Related Cognitive Impairment: a Pilot Trial

This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels of breast cancer survivors with cancer related cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients diagnosed with breast cancer
* Past exposure to chemotherapy, radiotherapy, surgery and/or other breast cancer interventions. There is no minimum treatment time to be considered eligible.
* Washout of 30 days from investigational interventions is required if the patient was previously treated in a research study. There is no washout required from placebo investigational interventions. Washout for conventional interventions is up to the discretion of the Investigator, if the conventional intervention is not planned to be concurrently administered with riluzole/placebo.
* ≥18 years of age
* Perceived by patient or investigator that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment
* Able to provide informed consent.
* Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires.
* Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes.

Note: Patients who have visual impairment or have degenerative conditions (e.g. Parkinsons's disease, etc.) can still participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.

Exclusion Criteria:

* Presence of brain metastasis
* Unwilling to undergo neuropsychological assessments necessary for the study.
* Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy.

  a. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.
* History of suspected hypersensitivity to riluzole or to any of its excipients.
* Patients taking or planned to take medications/substances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole.
* Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN)
* Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.
Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.

To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable based dietary supplement (BioResponse-DIM®), is associated with the regression of cervical dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the tolerability of daily DIM supplementation

Eligibility Criteria:
Inclusion Criteria:

* Non pregnant women greater than or equal to 18 years of age able to consent
* CIN II or III confirmed by histology
* Karnofsky performance status \>= 80
* No prior treatment for dysplasia in the past 4 months

Exclusion Criteria:

* Incompletely visible lesion
* Diethylstilbestrol (DES) exposure
* HIV seropositive
Effects of Wholegrains on Children's Health (KORN)

KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.

The purpose of KORN is to investigate the effects of wholegrain oat and rye intake on cardiometabolic health in slightly overweight 8-13-year-old children. Moreover, KORN aims to investigate effects on body weight and body composition, inflammatory markers, gastrointestinal wellbeing and cognitive function and explore the potential underlying mechanisms through assessment of changes in the children's gut microbiota as well as potential genotype-dependent and sex-specific effects.

The study has a randomized controlled cross-over design. In two 8-week dietary periods the children will receive grain products (cereals, breads, pasta etc) with either high or low content of wholegrain from oat and rye in random order. Measurements and biological sampling will be performed at 0, 8 and 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls 8-13 years of age
* Be overweight i.e. have a parent-reported BMI of at least +1 standard deviation above the median according to the age and sex-standardized Danish growth curves
* Be healthy
* Like grain products and eat them daily
* Speak Danish in order to understand the study procedures
* At least one parent must read and speak Danish, in order to be properly informed about the study procedures
* Parents must have freezer capacity for 2 weeks bread provision

Exclusion Criteria:

* Allergy or intolerance to the study foods, including gluten
* Use of dietary fiber supplements (e.g. HUSK) or probiotic supplements
* Dieting or on a special diet
* Serious chronic illnesses and diseases that may interfere with study outcomes
* Use of medication that may affect study outcomes, including use of antibiotics the last month
* Concomitant participation in other studies involving dietary supplements, drugs or blood sampling
* Living in a household with another participating child
Photobiomodulation in Salivary Production of Patients With Xerostomy

Xerostomia is a quantitative and qualitative alteration of saliva, a symptom present in individuals who make continuous use of medications to control chronic diseases, including hypertension. Difficulties in mastication, swallowing, phonation and palate are present, besides oral burning syndrome, periodontal disease, root caries and bad breath that will interfere in the quality of life, making it difficult to socialize in society. Currently, the methods presented for treatment of xerostomia are palliative, so their use does not consist of an effective treatment. The objective of this study is to evaluate the efficacy of photobiomodulation in the production of saliva in patients with xerostomia induced by antihypertensive drugs. The method consists in the application of the low intensity laser in the three pairs of salivary glands - parotid, submandibular and sublingual. The parameters that will be used are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2. The control group will have a simulation of the application of the laser, with the device turned off. Because it is an infrared light, it is invisible and this will not induce the patient to notice that the device is turned off. In the group that receives the photobiomodulation the device will have its timer turned off, to avoid the perception of sound difference. At the end of the sessions, a sample of saliva will be collected, which will be compared to the initial sample.


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients using antihypertensive drugs who present xerostomia;
* Hospitalized in the high-stay unit of the Mandaqui Hospital Complex;
* Patients who sign the free and informed consent form.

Exclusion Criteria:

* Patients with cancer in the oral region;
* Patients receiving radiation therapy;
* Patients with Sjögren's Syndrome;
* Diabetics and those with any type of photosensitivity.
Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

Periprocedural anxiety is a common problem for patients who undergo interventional pain procedures. Virtual Reality (VR) is an immersive experience that has gained acceptance in the medical field as a tool for reducing anxiety and pain for patients.Research Aim:

To evaluate the effect of immersive virtual reality (VR) on periprocedural anxiety related to therapeutic cervical epidural steroid injections (ESI).

The investigators hypothesize that immersive virtual reality will result in a clinically meaningful anxiety reduction, defined as the proportion of participants with \> 50% reduction in Numeric Rating Scale (NRS) anxiety scores when compared to participants in the non-treatment group who will have standard preprocedural waiting time conditions in clinic, but no VR experience. Similarly, the investigators hypothesize a significant reduction in objective sympathetic tone as measured by skin sympathetic nerve activity (SKNA).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old at day of enrollment
* Neck pain patient deemed to be a candidate for pain control treatment with interventional fluoroscopically guided cervical epidural steroid injection as determined by their pain medicine provider based on history, physical exam, and radiographic findings
* Willingness to undergo pre-procedural intervention of VR viewing experience or equivalent pre-procedural wait time
* No history of prior epidural steroid injections
* Did not receive sedatives prior to or during procedure

Exclusion Criteria:

* Refusal / inability to participate or provide consent
* Contraindications to injection (anticoagulated states, allergy to components of injection, local infection at injection site, current infectious process or treatment of antibiotics for current infection)
* Uncontrolled anxiety disorder or untreated/inadequately treated psychiatric disorder
* History of Alzheimer's, dementia, or cognitive dysfunction
* Patient currently taking benzodiazepines
* Severe motion sickness
* Seizure disorder
* Vision loss
* Non-English speaking patients
Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes

Patients with type 1 diabetes are at increased risk of vascular complications both in the micro- and macrocirculation. Hyperglycemia plays a major role in the development of these vascular complications, but other factors such increased platelet adhesion and aggregation, elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin generation, dyslipidemia and endothelial dysfunction may contribute.

Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and vasculature that are independent of their lipid-lowering properties.

The aim of the present study was to investigated the effects of intensive LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia. Furthermore, the effects of atorvastatin therapy on skin microvascular function was also investigated.


Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes
* level of plasma LDL-cholesterol \>2.5mmol/L and/or total cholesterol \>4.5mmol/L

Exclusion Criteria:

* History of macrovascular events
Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants

The aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production.


Eligibility Criteria:
Inclusion Criteria:

* Nursing mothers of infants born less than 34th week

Exclusion Criteria:

* Sick mothers
* Take medication forbidden during nursing