cyrilzakka/clinical-trials huggingface dataset:
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* HER2 positive breast cancer with locally recurrent or metastatic lesions;
* eligible for chemotherapy;
* baseline LVEF \>=50%.

Exclusion Criteria:

* previous chemotherapy for metastatic or locally recurrent breast cancer;
* previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
* other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
* clinically significant cardiovascular disease;
* chronic daily treatment with aspirin (\>325mg/day) or clopidogrel (\>75mg/day).
Effect of Cross-linked Hyaluronic Acid Filler Versus Botulinum Toxin Type A (Botox) in Management of Gummy Smile

A smile is supposed to express one's feelings and expressions, for that there has been an awakening concern for the appearance of gummy smile. Gummy smile is the appearance of about 2mm or more of the gingiva during smiling. It may affect the quality of life of individuals affecting their self-esteem; patients desire to look good not only while resting but while dynamically expressing themselves too. Variable factors contribute to this gingival display whether skeletal, dental or muscular. Variable treatment modalities are done solely or in adjunction to each other for the treatment of gummy smile including both surgical or nonsurgical procedures.

In patients not preferring surgical correction of gummy smile, botulinum toxin injection type A can be a helpful solution for reduction of peri-oral muscular hypermobility. A characteristic feature of botulinum toxin is the need for the re-injection in short intervals of time to yield better lasting effects. The use of cross-linked hyaluronic acid dermal fillers when used to myomodulate the peri-oral muscles give more immediate results and reduces the need for re-injection at shorter intervals.

Botulinum toxin type A, a toxin produced by the bacteria Clostridium botulinum, has been widely used in different therapeutic and cosmetic applications in dentistry. Amongst its important applications is the treatment of gummy smile by reducing the hypermobility of the peri-oral muscles through chemical denervation. Botox elicits temporary results and requires re-injection at certain time points. It is a safe, suitable, transient solution for patients not willing to undergo any surgical intervention to manage their gummy smile. Another approach for the non invasive treatment of muscular hypermobility is the injection of cross linked hyaluronic acid filler. Once the filler is injected, it typically occupies space that lessens the muscle movement limiting its hypermobility. Instant Smile enhancement is observed upon injection of cross-linked hyaluronic acid fillers and no need to repeat the injection at closer periods of time. Hyaluronic acid fillers are non-permanent fillers that are degradable by hyaluronidase and cross linking renders them more resistant to enzymatic degradation thus lasting longer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with excessive gingival display ranging from 3-8mm due to hypermobile lip.
* Age ranges from 18 years or above.

Exclusion Criteria:

* Excessive gingival display due to other etiological factors.
* Patients allergic to botox or hyaluronic acid fillers.
* Patients with any medical condition that contraindicates botox or hyaluronic acid filler injection.
* Patients previously injected with permanent fillers.
* Pregnancy.
* Breastfeeding females.
* Patients with active inflammatory or infectious disease at intended site of injection.
A Clinical Trial to Compare the Efficacy and Safety of a Combination Therapy of Ezetimibe and Rosuvastatin Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients (I-ROSETTE Study)

A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.


Eligibility Criteria:
Inclusion Criteria:

1. 19 \~ 79 years old
2. Patients who confirmed hypercholesterolemia.
3. Patients who requiring drug therapy according to NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Visit2.
4. Patients with Triglyceride\< 400 at Visit 2.
5. Patients who have a wash-out period over 4 weeks for other drugs that can affect lipid profile.(Patients who have lipid regulators should have washout period over six weeks)
6. Patients who agreed to participate in the trial

Exclusion Criteria:

1. Patients who have a history of myopathy or rhabdomyolysis by statin treatment or hypersensitivity to statin HMG CoA(3-hydroxy-3-methylglutaryl-coenzyme) reductase inhibitors) or ezetimibe.
2. A heavy alcohol consumer. (alcohol \> 25 units/week)
3. Patients with severe renal disease. (creatinine ≥ 2.0 mg/dL)
4. Patients with active liver disease and AST(aspartate transaminase) or ALT(alanine transaminase) \> 2 times of upper limit of normal range.
5. Patients with CPK(creatine phosphokinase) \> 2 x upper limit of normal range.
6. Patients who have a endocrine or metabolic diseases known to affect the serum phospholipid or lipoprotein.
7. Patients with HIV(human immunodeficiency virus positive.
8. Patients who have a acute arteriopathy.
9. Patients with uncontrolled hypertension.
10. Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
11. Patients who have a drugs absorption disorder by gastrointestinal surgery or gastrointestinal disorder.
12. Patients with tumor.
13. Patients who have hormonal therapy.
14. Pregnancy or breastfeeding patients who don't agree to use adequate contraception.
15. Patients who are judged unsuitable to participate in this study by investigator.
16. Patients taking other clinical trial drugs within 30 days from the time of visit for screening.
Comparison of Walking Parameters Between Idiopathic Toe Walking and Independent Walking Diparetic Cerebral Palsy

The aim of the observational study is to compare static, kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait Analysis method, and to enable the early diagnosis of DCP and ITW. Male and female cases aged between 3-18 years will be included. This study will be carried out at Acıbadem Altunizade Hospital.

It is an observational study. The aim of the observational study is to compare static, kinematic and kinetic parameters with normal gait parameters in cases with Idiopathic toe walking (ITW) and Diparetic Cerebral Palsy (DCP) who have Gross Motor Function Classification System 1 level with the 3D Gait Analysis method, and to enable the early diagnosis of DCP and ITW. Male and female cases aged between 3-18 years will be included. This study will be carried out at Acıbadem Altunizade Hospital. 51 cases will be included in our study. These cases will be divided into three groups. The first group will consist of patients diagnosed with idioaptic toe walking (n:17), the second group will be composed of diparetic cerebral palsy (n:15) with independent ambulation, and the third group will be the control group (n:19). First, the demographic information of the cases will be recorded. With 3D walking analysis, kinetic, kinematic and static data will be collected. The analysis of the obtained data will be done with Polygon Software (Vicon, Oxford, UK). Evaluated kinetic, kinematic and static parameters will be compared between three groups.

Is the lower extremity compensation of children with diparetic cerebral palsy who can walk independently more than children with idiopathic toe walking?

Eligibility Criteria:
Inclusion Criteria:

* Voluntary consent from family
* Diagnosed with idiopathic toe walking and spastic diparesis between the ages of 3-18.
* Cases with GMFCS 1
* The patients who applied to the healthy children's clinic, showed typical development, did not have any musculoskeletal and neurological problems, and wished to voluntarily participate in the study were included in the control group.

Exclusion Criteria:

* Refusing to participate in the study
* Under the age of 3 and over the age of 18
* Not at GMFCS 1 level
* Cases who did not have any orthopedic problems other than accompanying toe walking were excluded from the study.
A Timeline Study of Alcohol Use and Its Relationship to Insomnia

This study is an epidemiological and descriptive study of the lifetime relationship of insomnia to alcohol problems.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be between the ages of 18-70, may be male or female, and from any ethnic background.
* Individuals must have the capacity to give IRB-approved study consent.
* Subjects must at least have a lifetime history of being heavy alcohol drinkers (i.e., drinks approximately 21 alcoholic drinks or more per week). Alternatively, subjects are eligible if they meet criteria for a lifetime history of either alcohol dependence or alcohol abuse. Overall, a subject must meet at least one of these alcohol criteria: a lifetime history of heavy drinking, alcohol abuse or alcohol dependence.
* Subjects must have a complaint of chronic insomnia, reporting either six or less hours TST, on average at least three times per week.

Exclusion Criteria

* Potential subjects with a lifetime diagnosis of Bipolar Affective Disorder, Schizophrenia, Borderline Personality Disorder, dementia of any type, or epilepsy will not be admitted to the study.
* Subjects will be excluded with a diagnosis of any other substance dependence syndrome other than alcohol dependence, nicotine dependence, and/or caffeine dependence. However, individuals may have a history of episodic abuse of cannabis, cocaine, sedatives/hypnotics and opiates, amphetamines, and hallucinogens. Also, subjects may be on prescription benzodiazepine or related sedative/hypnotic therapy.
* Any condition or treatment of a condition that is likely to confound the experimental design or the results will be prohibited by the PI.
The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

The objective of this study is not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

1. healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5\~25)
2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
3. Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results(clinical laboratory test, 12-lead GCG etc)

Exclusion Criteria:

1. Subject who is hypersensitive to components contained in YH4808 or this drug
2. Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
3. Subject who has history of surgical operation or diseases related to gastrointestinal symptom (e.g. Crohn's disease, ulcer etc except appendectomy or simple for hernia)
4. Other exclusions apply
NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma

This pilot clinical trial studies the side effects of NovoTTF-200A device in treating patients with newly diagnosed high risk oligodendroglioma. NovoTTF-200A device is a portable battery operated device which produces tumor treating (TT)Fields in the body by means of surface electrodes placed on the skin. TTFields are very low intensity, intermediate frequency electric fields that may slow the growth of tumor cells in patients with high risk oligodendroglioma.

PRIMARY OBJECTIVES:

I. To describe the safety and tolerability of the TTFields treatment in patients with newly diagnosed high risk oligodendroglioma following standard of care treatment.

SECONDARY OBJECTIVES:

I. To estimate the proportion of patients who tolerated 75% of treatment goal at months 6, 12, 24.

II. To estimate the progression free survival time. III. To assess quality of life. IV. To assess whether or not there is a correlation between genomics and the efficacy of the TTFields treatment.

OUTLINE:

Beginning 4-8 weeks after standard of care treatment, patients wear NovoTTF-200A device over 18 hours daily (QD). Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2 months and then monthly thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed oligodendroglioma (oligo) (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification
* Surgically sub-total or unresectable tumors, i.e. in insula, including but not limited to the insula and received standard of care (SOC) radiation
* Historical pathological tissue evidence of high risk oligo (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification
* 1p and 19q deletion status known
* IDH 1 \& 2 mutations status known
* MGMT status known
* Karnofsky equal or greater than 70
* Life expectancy at least 3 months
* Participants of childbearing age must use effective contraception

  * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    * Has not undergone a hysterectomy or bilateral oophorectomy; or
    * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Actively participating in another clinical treatment trial
* Tumor progression after radiation
* Pregnant
* Has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain
* Documented clinically significant cardiac arrhythmias
* Infra-tentorial tumor
Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis

This is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia.

Patients with RMS receiving Ocrelizumab or Ofatumumab will be recruited to measure the time spend for Healthcare Providers (HCP) (neurologist, nurse and hospital pharmacist) on preparing, administering the medication and following up with the patient.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of 18 or more years of age.
* Patients with confirmed diagnosis of RMS (CIS, RRMS or aSPMS) following 2017 McDonnald criteria.
* Patients currently prescribed with Ocrelizumab or Ofatumumab to treat MS according to the Summary of Product Characteristics (SmPC). The decision must be based on patient disease and taken before the decision of inviting the patient to participate in this study.
* Patients literate in English.
* Patients must provide informed consent to participate in the study.

Exclusion Criteria:

* Patients currently participating in any other RMS clinical trial.
The Relationship Between the SPI and the Postop ED

Surgical plethysmography index (SPI) is a device that can noninvasively monitor the balance between the nociception and ant-nociception using pulse photoplethysmographic amplitude (PPGA) and heart rate obtained through an oxygen saturation measuring device. SPI has recently been studied as a useful tool to monitor the stress response of patients due to surgery or anesthesia and to guide the appropriate use of analgesics/anesthetics. However, these SPI devices have been developed for adults and have not been studied in pediatric patients with relatively high heart rates, and no direct effects on post-operative arousal excitability have been reported.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 2-7 years with an American Society of Anaesthesiologists physical status (ASA PS) of 1 or 2, who were planned to undergo ophthalmology surgery requiring general anesthesia.

Exclusion Criteria:

* ASA PS 3 or 4
* Presence of developmental delays or neurological diseases
* History of allergies or contraindications to the use of ketamine (increased intracranial pressure, open-globe injury, or a psychiatric or seizure disorder)
* treatment with beta-receptor blockers, beta-receptor agonists or any other drug suspected to interact with the sympathovagal balance
* diseases with impairment of sensitivity (diabetes, polyneuropathy, peripheral arterial obstructive disease et etc)
* pacemaker therapy
* dermal diseases with the affection of the forearm/hand
Hemodynamic Effects of Intermittent Pneumatic Compression for Sports

The aim of this randomized crossover trial is to assess the hemodynamic effects caused by the use of 2 distinct intermittent pneumatic compression protocols on athletes.

The main questions it aims to answer are:

* Does intermittent pneumatic compression enhance athletes blood flow?
* If yes, what pressure is better to cause this enhancement?


Eligibility Criteria:
Inclusion Criteria:

* male gender
* healthy
* competing in soccer of track and field for at least two years
* not have performed any physical activity on the data collection day

Exclusion Criteria:

* more than one risk factor for thromboembolism (e.g., use of tobacco, varicose veins)
* injured athletes
Methylprednisolone After Split-course Chemoradiotherapy For Bulky Local Advanced None-small Cell Lung Cancer

This Phase II randomized controlled study is to determine the efficacy of the preventively use of methylprednisolone after split-course chemoradiotherapy (CCRT) in locally advanced non-small cell lung cancer with bulky tumor.

This study is to determine the efficacy of the preventively use of methylprednisolone after split-course chemoradiotherapy(CCRT) in locally advanced non-small cell lung cancer with bulky tumor.

All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy, with one-month break. In the experimental arm, patients were treated with methylprednisolone after the first course of radiation, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days,then 16mg for 7 days, and 8 mg for the last 7 days. Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of NSCLC.
* Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

  * Unresectable phase IIIA(N2) and IIIB lung cancer confirmed by PET/CT, CT or MRI.
  * Whole lung V20\>=35% when giving 60Gy which is the minimum dose of radical irradiation.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Previously treated with chemotherapy or treatment-naive
* No previous chest radiotherapy, immunotherapy or biotherapy
* Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
* Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
* Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
* FEV1 \>0.8 L
* CB6 within normal limits
* patients and their family signed the informed consents

Exclusion Criteria:

* Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
* Contraindication for chemotherapy
* Malignant pleural or pericardial effusion.
* Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
* Women who has the probability of pregnancy without contraception
* Tendency of hemorrhage
* In other clinical trials within 30 days
* Addicted in drugs or alcohol, AIDS patients
* Uncontrollable seizure or psychotic patients without self-control ability
* Severe allergy or idiosyncrasy
* Not suitable for this study judged by researchers
Study to Understand Novel Biomarkers in Researching Dementia

The purpose of this study is to determine the relationships between amyloid, tau, and neurodegeneration biomarkers in the blood and the presence of Alzheimer's disease (AD) pathology, clinical cognitive decline, and diagnosis. We aim to understand how well blood-based biomarkers can diagnose and predict Alzheimer's disease, which will help to further develop and validate blood tests for the disease.

All participants who are eligible and provide informed consent will complete an initial study visit, which includes a research blood collection and cognitive assessments. Depending on the results of the cognitive assessments, participants will complete follow-up visits annually or biennially for additional cognitive testing, research blood collections, and potential clinical testing for Alzheimer's disease as determined by the participant's medical provider.

Eligibility Criteria:
Inclusion Criteria:

* At least 60 years of age
* 80% of the newly enrolled clinic-based cohort will have symptoms of forgetfulness, mild cognitive impairment, mild dementia, or Alzheimer's disease as determined by their medical chart and/or provider
* All SEABIRD participants will be invited to participate regardless of their cognitive status

Exclusion Criteria:

* Unable to perform one or more basic activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment
* Uncontrolled hepatitis B, hepatitis C, or HIV at time of blood collection
* Taking a disease-modifying drug for AD at time of enrollment
* Blood transfusion in the last three months
* Unwilling or unable to participate in all study activities