cyrilzakka/clinical-trials huggingface dataset:
Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer

The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor \[ER\], progesterone receptor \[PR\], Human Epidermal Growth Factor Receptor 2 \[HER2\] negative) locally advanced non-resectable and/or metastatic breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced non-resectable and/or metastatic breast cancer
* Prior adjuvant or neoadjuvant anthracycline-based chemotherapy

Exclusion Criteria:

* Tumors that are fluorescence in situ hybridization test (FISH) positive or immunohistochemistry (IHC) 3+
* Neuropathy \> Grade 1
* Prior systemic therapy for metastatic disease
Top Down Versus Step Up Strategies in Crohn's Disease

The study prospectively compares two treatment algorithms for newly diagnosed Crohn's disease: one 'aggressive' treatment with early introduction of immunomodulators and biologicals and one 'standard treatment' with corticosteroids and only later introduction of immunosuppressives and biologicals if disease activity requires that.

This two year open-label randomized trial compares the early use of combined immunosuppression to conventional management in patients with active Crohn's disease who have not previously received glucocorticoids, antimetabolites, or infliximab. Patients assigned to combined immunosuppression receive azathioprine and 3 infusions of 5 milligrams per kilogram of body weight of infliximab at weeks 0, 2, and 6. Retreatment with infliximab and, if ultimately necessary, corticosteroids are used to control disease activity. Patients assigned to conventional management receive corticosteroids followed, in sequence, by azathioprine and infliximab. The primary outcome measure is remission without corticosteroids and without bowel resection at weeks 26 and 52.

Eligibility Criteria:
Inclusion Criteria:

* age 16 - 75 years
* diagnosis of Crohn's disease within the past 4 years
* no previous treatment with corticosteroids, antimetabolites, or biologic agents.
* Active Crohn's disease, defined by a Crohn's Disease Activity Index (CDAI)20 score of greater than 200 points for a minimum of 2 weeks prior to randomization.

Exclusion Criteria:

* immediate need for surgery
* symptomatic stenosis or ileal/colonic strictures with prestenotic dilatation;
* signs, symptoms or laboratory tests indicating severe, medical disease;
* documented chronic infection
* a positive stool culture for pathogens
* a positive tuberculin test or a chest radiograph consistent with tuberculosis.
* malignancy
* allergy to murine proteins
* pregnancy
* substance abuse
Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis

The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* history of ocular allergies and a positive skin test reaction to perennial allergens within the past 24 months and a history of chronic eye irritation
* visual acuity score ≥ 0.60 (EDTS)
* negative urine pregnancy test for female patients, and use of adequate birth control throughout the study period.

Exclusion Criteria:

* active ocular infection; preauricular lymphadenopathy or ocular condition that could affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3 months; history of asthma, pregnancy or nursing
* contraindications or known allergies to the study drug(s)
A Study of Apatinib in Patients With Advanced Hepatocellular Carcinoma

This phase II trial will be studying how well Apatinib working in patients with Hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologic confirmed advanced hepatocellular carcinoma
* Patients who are unable to or unwilling to undergo surgery or interventional procedures via hepatic artery, or patients who have relapsed/progressed after surgery or interventional procedure via hepatic artery for ≥ 4 weeks and are unable to use sorafenib.
* Life expectancy of more than 12 weeks.
* ECOG performance scale 0 - 2.
* Child -Pugh score A，BCLC stage B or C.
* At least one therapy naïve measurable lesion (larger than 10 mm in diameter by spiral CT scan, conforming to RECIST 1.1).
* Have not received systemic chemotherapy or molecular targeted therapy. At least 4 weeks must have elapsed for patients who have previously underwent radiotherapy or surgery, and all the adverse drug reactions (ADRs) or wounds have completely healed. At least 6 months must have elapsed for patients who have received adjuvant chemotherapy.
* Adequate organ functions (hemoglobin≥ 90g/L ,platelets ≥80 × 109/L, neutrophil≥ 1.5 × 109/L, albumin ≥ 29 g/L, Plasma creatinine ≤ 1.5 × ULN , ALT and AST\< 5 × ULN; TBIL ≤ 1.5 × ULN.
* Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma; other malignancies previously or currently, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
* Dysphagia, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption.
* Evidence of CNS metastasis.
* Subjects with hypertension which cannot be well controlled by antihypertensives; grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmia, and cardiac insufficiency grades III to IV according to NYHA criteria; cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) of \< 50%.
* Subjects with abnormal coagulation functions, and the tendency of bleeding or those who are currently treated by a thrombolytic or anticoagulant therapy.
* Definite concern of gastrointestinal hemorrhage, and history of gastrointestinal hemorrhage within 6 months.
* Patients with symptomatic ascites requiring therapeutic paracentesis or drainage, or with a Child-Pugh score of ≥ 2.
A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A

The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* requesting non-hormonal intrauterine contraception
* able to return for ultrasound in 6-8 weeks

Exclusion Criteria:

* History of recent pelvic inflammatory disease
* Known anemia
* Dysfunctional uterine bleeding
* Malignancy or suspected malignant disease of female inner or outer genitalia
* Known intolerance or allergy to copper and/or copper IUDs
* Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
* Pregnancy
Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris

The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.

The objective of this study is to evaluate the tolerability, safety and efficacy of once daily application of NVN1000 Topical Gel for 8 weeks in comparison with its vehicle in subjects with moderate to severe acne.

Eligibility Criteria:
Inclusion Criteria:

* Baseline IGA score of moderate (3) or severe (4)
* Minimum of 20 but no more than 40 facial inflammatory lesions
* Minimum of 20 but not more than 60 facial non-inflammatory lesions
* No more than 2 facial nodules

Exclusion Criteria:

* Dermatological conditions on the face that could interfere with clinical evaluations
* Underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
* History of experiencing significant burning or stinging when applying any facial treatment
* Female subjects, if they are pregnant,nursing mothers, or planning to become pregnant during the study
* Have used estrogens or oral contraceptives for less than 90 days immediately preceding the Baseline visit, discontinued use of estrogens or oral contraceptives less than 90 days prior to Baseline,or planning to begin or discontinue use of this therapy during the treatment period
* Have used medications and/or vitamins which are reported to exacerbate acne during the 180 days immediately preceding the Baseline visit
* Use concomitantly over-the-counter (OTC) products that contain ingredients such as benzoyl peroxide,salicylic acid,alpha-hydroxy acid,retinol or glycolic acids
* Have not undergone the specified washouts for topical preparations,systemic medications and procedures noted in the protocol
The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble

A controlled clinical study comparing the effect of topical aqueous suppressants on intraocular gas duration.

A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration following Scleral Buckling and Pneumatic Retinopexy

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Have undergone eye surgery including scleral buckling or pneumatic retinopexy for treatment of retinal detachment other condition at the discretion of the investigator.

Exclusion Criteria:

* Prior surgery to treat glaucoma.
* Current use of glaucoma eye drops.
* Absence of a lens in the eye or presence of a lens implant in front of the iris (colored part of your eye).
* Allergy or contraindication to any of the glaucoma drops being used in this study (e.g., sulfa allergy, asthma, chronic obstructive pulmonary disease (bronchitis or emphysema), slow heart rate).
Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy

Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths globally and survivors suffer from long term neurological disability and impairment. Although many neuroprotective strategies appeared promising in animal models, most of them were not feasible and effective in human newborns. However, hypothermia was reported not to be effective if introduced beyond and thus should be introduced within 6 hrs after birth.Applying this selection criterion naturally would deprive many patients of the opportunity of hypothermia treatment.

Hypoxic-ischemic encephalopathy of the newborn infant remains a significant socio-economic health problem worldwide. Moderate to severe HIE of newborn infants is associated with a high rate of death or long-term disabilities. Historically, treatment has been purely supportive including stabilizing cardio-respiratory functions and treating convulsions. Recent multi-center trials assessing the effects of hypothermia demonstrated improved outcome in term neonates with moderate hypoxic-ischemic encephalopathy (HIE). However, hypothermia was not effective beyond 6 hrs after brain injury. The aim of this study was to investigate whether systemic hypothermia induced up to 10 hrs after birth would improve the neurodevelopmental outcome at 18 months in infants with moderate or severe HIE.

Eligibility Criteria:
Inclusion Criteria:

1. Gestation age ≥37 weeks and body weight \>2500g.
2. with one of the following factors:

   1. Apgar score\<5 at 5min;
   2. Assisted respiration \>3min due to respiratory distress;
   3. pH≤7.1 of cord or arterial blood within 60min after birth;
   4. clinical manifestation of encephalopathy during the first 10 hrs of life.

Exclusion Criteria:

1. Major congenital abnormalities;
2. Head trauma or skull fracture causing major intracranial hemorrhage;
3. Mild HIE;
4. Financial problems of the parents;
5. Lack of permanent address;
6. Postnatal age \> 10 hrs
Mastery Learning in Communication Skills

The goal of this study is to determine whether mastery learning in communication skills can improve skills in a simulated environment and have translational improvements in outcomes. The main questions it aims to answer are: 1. Does mastery learning improve skills in the simulation laboratory? 2. Does mastery learning improve clinical skills as seen by milestone performance? and 3 Does mastery learning improve burnout levels? The study is a multi-institutional randomized controlled trial of anesthesiology residents from five different residency programs. Participants will be randomized to mastery training in communication skills and standard of care, which is vicarious learning. Researchers will compare these two groups to see if mastery learning improves skills and translational outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Anesthesiology residents rotating at Ann and Robert H. Lurie Children's Hospital of Chicago

Exclusion Criteria:

* Participant refusal
* Study participants who have already undergone the mastery learning in difficult conversations course.
Radiation Therapy as Palliative Treatment of GIST

Gastrointestinal stromal tumors (GISTs) are generally considered resistant to radiation, but no prospective trials addressing efficacy and tolerability of radiation therapy have been carried out. Limited clinical experience suggests that selected GIST patients may benefit from palliative radiation therapy. The purpose of this prospective, non-randomized, multicenter study is to evaluate efficacy and safety of palliative radiation therapy in GIST patients who have progressive GIST during or after tyrosine kinase inhibitor therapy.

Radiation therapy planning must be based on computerized tomography (CT). External beam radiation must be used. Both 3D and IMRT plans are acceptable. The cumulative radiation dose may range from 30 to 40 Gy as administered in 1.8 to 2.0 Gy fractions, 5 fractions per week. The dose is specified as defined by the ICRU (International Commission on Radiation Units and Measurements) report 50. Response is evaluated using CT 6 and 12 weeks after irradiation. Adverse effects are evaluated using the Common Terminology Criteria for Adverse Effects (CTCAE)version 3.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified GIST.
* Metastatic or locally advanced, inoperable disease.
* Adequate systemic treatment has been administered.
* One or more growing GIST metastasis present during of after TKI therapy.
* The target lesion(s) is measurable.
* A written informed consent

Exclusion Criteria:

* WHO performance status is 4.
* Estimated life-expectancy less than 3 months.
* Radiation planning target volume greater than 3 dm3.
* Unmeasurable target lesion. Bone and brain metastases are not accepted target lesions.
* Radiation therapy cannot be delivered (e.g. active infection or restlessness.)
* Pregnancy.
* Systemic GIST treatment with unknown efficacy.
* Copies of CT images cannot be sent for central review.
Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b

This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.


Eligibility Criteria:
Inclusion Criteria:

* Infants of either sex, aged 2 - 4 months
* In good health as determined by:

  * medical history
  * physical examination
  * clinical judgment of the investigator;
* Available for all visits scheduled in the study and able to comply with all study regulations
* For whom written informed consent has been obtained from at least one parent or legal guardian

Exclusion Criteria:

* Parent or legal guardian is unwilling or unable to give written informed consent to participate in study
* Infants who have received any other Haemophilus influenzae type b immunization dose before
* Infants who presented a previous disease potentially related to Haemophilus influenzae type b
* Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease
* Premature (before 37th week of gestation) or birth weight less than 2500 g
* History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
* Fever ≥ 38.0 °C (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment
* Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease
* Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
* Subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder
* Subjects with a clinically significant genetic anomaly
* Treatment with corticosteroids or other immunosuppressive drugs
* Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
* Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
* Participation in any other investigational trial simultaneously
* Planned surgery during the study period
* Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective
Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.

Currently, the gold standard to obtain bioavailable testosterone results is radioimmunoassay (RIA). However, this assay requires specific equipment.

Giton in 2006 proposed an optimized calculation of the Vermeulen equation, the results of which seem to be well correlated with those obtained by RIA.

The aim of this study is to determine if the bioavailable testosterone levels determined by both methods are similar in order to replace the usual RIA assay of bioavailable testosterone by this calculation.


Eligibility Criteria:
Inclusion Criteria:

* Every men and women aged between 18 and 90 can be included

Exclusion Criteria:

* insufficient sample
* sample not send for RIA
Hypoglycemia Prediction Model

Our goal for this Learning Healthcare System Demonstration Project is to reduce the rate of inpatient hypoglycemia. Hypoglycemia can result in longer lengths of stay and increased morbidity and mortality (ie falls and cardiovascular or cerebral events).

The group at Washington University (WSL) developed a predictive hypoglycemia risk score. Using current glucose, body weight, creatinine clearance, insulin type and dosing, and oral diabetic therapy, they identified patients at high risk for hypoglycemia and then provided in-person education to the providers of these patients. This resulted in a 68% reduction in severe hypoglycemia (blood glucose \< 40 mg/dL). This approach required significant personnel hours and is difficult to replicate in other systems.

The investigators will implement an EHR-based intervention at UCSF to predict which patients are at high risk of inpatient hypoglycemia and take action to prevent the hypoglycemic event. In real time, all adult (non OB) patients with a glucose \< 90, and a high risk of future hypoglycemia (based on the WSL formula) will be identified. Patients will be randomly assigned to intervention or no intervention (current standard care). The intervention will consist of an automated provider alert with recommendations on what adjustments could be made to avoid a potentially serious hypoglycemic event.

The outcomes that will be measured include: 1) reductions in serious hypoglycemic events, 2) monitor the changes made by providers as a result of alerts in order to study provider behavior and identify future areas of intervention, and 3) provider satisfaction with the alert system.


Eligibility Criteria:
Inclusion Criteria:

* All adult inpatients having glucoses measured (point of care)

Exclusion Criteria:

* adults admitted to obstetrics
Self-Reported Exercise Behavior and Short-Term Patient Outcomes in Women Undergoing Radiation Treatment for Operable Breast Cancer

Using an observational prospective design, potential subjects will be identified and screened for eligibility via medical record review of breast cancer patients scheduled for radiation therapy at Duke Radiation Oncology Clinic. Subjects who agree to participate will be asked to complete study questionaires prior to the start of radiation therapy and again during the last week of therapy.

Exercise behavior will be defined as patient reported mean total minutes (frequency x duration) of mild, moderate, and vigorous-intensity physical exercise per week over the past month at baseline (prior to enrollment in the study). In addition we will collect patient reported mean total minutes per week of mild, moderate, and vigorous-intensity physical exercise over the course of radiation therapy.Baseline characteristics including demographic data (age, education, employment) as well as BMI, waist to hip ratio, and health comorbidities (including smoking status, cardiovascular disease, and diabetes) will also be collected. BMI and health comorbidities will be extracted from the chart. Patient-Reported Outcomes will include QOL, fatigue, depression, pain and sleep. QOL will be assessed using the Functional Assessment of Cancer Therapy (FACT) scale developed for the assessment of patient symptoms and QOL in cancer patients. Fatigue will be assessed using the 13-item FACT-fatigue scale for the assessment of fatigue in cancer patients.Skin toxicity will be defined as radiation dermatitis, pruritus, and pain.

Lymphedema will be assessed by measuring limb girth. Measurements will be taken by first marking both limbs while patient is lying supine, starting at the ulnar styloid at 5cm intervals on the length of the arms. The diameter of the limb will then be measured at these markings. Based on these measurements, the affected limb will be compared to the unaffected limb. Range of motion will be defined as reduced abduction compared to the contralateral shoulder . All measurements will be taken with a goniometer.

Eligibility Criteria:
Inclusion Criteria:

* Women with a biopsy-proven diagnosis of ductal carcinoma in situ or invasive breast carcinoma
* Definitive radiation treatment planned to the chest and/or regional nodes
* 18 years of age or older
* Signed study-specific informed consent

Exclusion Criteria:

* Significant mental disorders making informed consent difficult or mental impairment leading to inability to cooperate
* Karnofsky Performance Status (KPS) \< 70%