cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer

This study is randomized phase III trial designed to assess whether (preoperative) neoadjuvant chemotherapy followed by surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (experimental treatment) improves 3-year disease-free survival, compared to surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (standard treatment) in stage IB, IIA, IIB and T3N1 non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven NSCLC patients
* All patients must have:Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, Chest CT and PET-CT
* 18 year of ages or older
* ECOG performance status 0-1
* Uni-dimensionally measurable lesion by RECIST criteria
* No prior chemotherapy or radiotherapy for NSCLC
* Pre-operative FEV1 ≥ 2.0 L evaluated within 28 days
* Adequate bone marrow function: Hb \> 9.0 g/dL, WBC ≥ 4,000/μL, platelet count ≥ 100,000/μL
* Adequate liver and renal function: Total bilirubin \< 2 x ULN, AST/ALT \< 3 x ULN, serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min
* Written informed consent

Exclusion Criteria:

* Superior sulcus tumor
* Prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer at least 5 years
* Uncontrolled systemic illness such as DM, CHF, unstable angina or arrhythmia
* Recent myocardial infarction within 6 months
* Patients with post-obstructive pneumonia or serious infection
* Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method.)
* Patients with psychological problem
Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea

The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients
* Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.

Exclusion Criteria:

* Off-label use of Daklinza and Sunvepra
* Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information
Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRA•CER) (Study P04736)

The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care in preventing heart attack and stroke.

The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.


Eligibility Criteria:
Inclusion Criteria:

Men and women at least 18 years old with current clinical manifestation of non-ST-segment-elevation myocardial infarction (heart attack) according to the following three criteria:

* current symptoms of cardiac ischemia (chest pain leading to cardiac ischemia or heart attack)

AND

* either of the following:

  * concurrent elevation of troponin I or T, or of creatine kinase - myocardial band (CK-MB) to a level above the upper limit of normal, OR
  * concurrent appropriate electrocardiographic evidence

AND

* any one (or more) of the following:

  * age \>= 55 years
  * documented history of prior heart attack or coronary revascularization (eg, angioplasty \[PCI\], coronary artery replacement \[CABG\])
  * diabetes (documented use of insulin or oral hypoglycemic\[s\])
  * documented history of peripheral arterial disease

Exclusion Criteria:

* history of intracranial hemorrhage or of central nervous system (CNS) surgery, tumor, or aneurysm
* any bleeding disorder or abnormality
* sustained severe hypertension or valvular heart disease
* current or recent platelet count \<100,000 mm\^3
* planned or ongoing treatment with a blood thinning medication
* pregnancy
* any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study
Effects of Acute High Intensity Exercise Training on Cardiac Function in Type II Diabetes

It is known from research that long-term exercise exposure in type 2 diabetes had positive effects. However, the effect of acute exercise in a patient group with already reduced cardiac function is not known.

In this study, the impact of acute exhaustive high intensity interval training on cardiac function will be investigated in type 2 diabetes patients.

One single session of exhaustive high intensity interval exercise training is expected to lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the right ventricle of the heart is expected to be more affected than the left ventricle.


Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes

Exclusion Criteria:

-
A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.

This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced and/or metastatic solid tumor malignancy;
* measurable or evaluable disease;
* ECOG performance status 0 or 1.

Exclusion Criteria:

* prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
* prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
* major surgery within 28 days of first receipt of study drug.
Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE

The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent
* Clinical and laboratory diagnosis of Hereditary Angioedema Type I or II
* An average angioedema attack frequency of 1/week
* Acceptable birth control measures

Key Exclusion Criteria:

* Concurrent use of defined treatments for prophylaxis
* Pregnancy or breast-feeding
* Clinically significant medical condition, laboratory abnormality or medical history
Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department

This study is designed to evaluate the predictive value of heart rate variability on medial outcome in patients admitted to the intensive care department


Eligibility Criteria:
Inclusion Criteria:

* adults admitted to ICU

Exclusion Criteria:

* rhythm other then sinus
* presence of cardiac pacemaker
Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty

Younger hip patients often need revision of their hip replacement due to wear and loosening. Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces in metal may reduce the wear, increase the longevity of the implant and give an improved function. The possible downside is that these concepts releases metal debris to the body. The investigators wish to see if the newer interventions are a clinical improvement compared to standard. The investigators also wish to investigate the extent of metal released to the body and any effect on the immune system. Finally the investigators wish to investigate the stability of these new implants and their ability to preserve the bone around the implant.

The investigators hypothesis is:

That the metal on metal articulations will not have better clinical outcomes than standard The resurfacing implant is expected to preserve the bone of the upper femoral bone. The implants are expected to be stabile within the first year.


Eligibility Criteria:
Inclusion Criteria:

* Primary hip osteoarthritis
* Secondary osteoarthritis due to mild dysplasia
* Age from 40 to 65 years

Exclusion Criteria:

* Dysplasia with CE angle \< 25 degrees on the AP projection
* Severe femoral head deformation
* Reduced femoral neck length
* Leg length discrepancy more than 1 cm
* Need for restoration of offset
* Deformation after fractures or earlier osteotomies
* A previous hip arthroplasty
* Inflammatory arthritis
* Endocrinological disease with bone metabolic manifestations
* Renal disease
* Malignant disease
* Neuro/muscular or vascular diseases of the affected leg
* Osteoporosis
* Use of opioid pain killers due to other diseases
* High dose corticosteroids
* Obese with BMI \> 35
* Pregnant or planning to be
* Ppresented problems that would prevent completing our follow-up program
Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B

The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule


Eligibility Criteria:
Inclusion Criteria:

* Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems
* Have a normal gestational age (≥ 37 weeks); birth weight \> 2.5 kg
* There is no congenital disease detected through interview and clinical examination
* Already had or not yet received Hepatitis B vaccination at birth
* Do not have dermatological diseases such as eczema, allergies
* Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures

Exclusion Criteria:

* Already vaccinated with DTP vaccine
* Have an acute infection at the time of study vaccination
* Contraindications to Quinvaxem
* Receiving treatment with systemic corticosteroids
* Currently participating in another clinical trial
* In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth
* Parents intend to move to another location during the study (the next 12 months)
The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients

Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines.

It is not well known if a stratification based on the grade of BOO and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. In our study, we investigated possible differences in treatment outcome between patients with and without BOO, and with or without proper contractility who are treated with alfuzosin. So we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH patients by the grade of BOO and/or bladder contractility.

1. Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility
2. Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity \& frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
* Patients satisfying all of the following:
* Moderate to severe LUTS :
* international prostate symptom score (IPSS)≥ 8
* An enlarged prostate (≥25 mL)
* Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

* Post voided residual urine ≥ 200 mL
* Patients performing catheterization
* Urinary tract infection patients
* Patients taking 5 alpha reductase inhibitor
* Known hypersensitivity to alfuzosin
* History of postural hypotension or syncope
* Hypertension patients treated with other alpha1-blockers
* Patients newly taking anticholinergic medication within 1 month
* Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
* Renal insufficiency (s-Cr ≥ 2mg/dL)
* Unstable angina pectoris
* Uninvestigated hematuria
* Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
* Interstitial cystitis patients
* Severe concomitant condition threatening life.
* Patient who is unable to make voiding diary
* Bladder or prostate cancer patients
* Patients receiving prostate or bladder surgery
Improving Measurement and Treatment of Post-stroke Neglect

This study examines how to best assess and treat post-stroke neglect. This study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. This study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure.

It is very common for stroke survivors to have difficulty attending to one side of their body or space (neglect). Stroke survivors with neglect not only demonstrate impairments in attention but they also experience motor impairment. These individuals also have an imbalance in excitation in the brain. This study will examine the preliminary effects of non-invasive brain stimulation (transcranial direct current stimulation, tDCS) combined with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with neglect following stroke. The investigators will examine the effects of the intervention on brain excitability, upper extremity motor impairment, and attentional impairment. This study will also examine assessment of neglect. There are many clinical assessments designed to assess neglect; however, it is unknown whether items from some of the most commonly used assessments are able to effectively measure neglect or whether items from these assessments can be combined. Clinicians rely on clinical assessments to inform treatment and document patient progress. Therefore, it is important that investigators more closely examine these existing assessments.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke 3 months post stroke.
* Fugl-Meyer Upper Extremity (FMA-Upper Extremity) score between 20-56/60
* Inducible motor evoked potential (MEP) of the abductor pollicis brevis (APB) on the paretic stimulation (TMS)
* Demonstrate the presence of unilateral neglect (Virtual Reality Lateralized Attention Test score \<18)

Exclusion Criteria:

* History of cortical hemorrhagic stroke
* Presence of any MRI, TMS, tDCS risk factors including:

  * history of seizures
  * history of brain tumor
  * hardware in skull or spine (e.g. coils, clips)
  * implantable medical device (e.g. pacemaker)
  * metal in body (not compatible with MRI)
  * pregnancy
* Severe spasticity (Modified Ashworth Scale score 3)
* Severe aphasia or cognitive impairment limiting participants' comprehension (National Institutes of Health Stroke Scale Level of Consciousness Commands Item score 1 or Best Language Item score 2)
* Unable to travel to UE Motor Function Laboratory at the Center for Rehabilitation Research in Neurological Conditions (a collaborative, MOU approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study
Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial

To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy

To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy

Eligibility Criteria:
Inclusion Criteria:

1. Subjects greater than 18 years of age
2. Fulfilling the latest classification criteria for axial spondyloarthropathy
3. Active spondylitis as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of more than 4 despite treatment with non-steroid anti-inflammatory drugs for more than 3 months

Exclusion Criteria:

1. Major surgery (including joint surgery) within 8 weeks prior to study entry
2. History of treatment with anti-tumor necrosis factor agents or any investigational therapies within 12 months of study entry
3. Immunization with a live/attenuated vaccine within 4 weeks prior to study entry
4. Active current bacterial, viral, fungal, mycobacterial or other infections at study entry
5. Chronic hepatitis B or hepatitis C carriers
6. History of malignancies, including solid tumors and hemic malignancies
7. History of congestive heart failure
8. History of demyelinating disorders
9. History of peripheral neuropathy
10. Pregnant women or lactating mothers
11. Baseline liver parenchymal enzymes elevated to more than 2 times normal
12. Absolute lymphocyte count less than 500/mm3
13. Serum creatinine level of more than 200umol/L
Body Composition & REE Responses to Bariatric Surgery

The aim of this study is to measure important components of weight change in patients who underwent bariatric surgery on measures of fat mass and its distribution and fat-free mass (FFM) (bone mineral density, skeletal muscle, and specific organs) at 60 months (T60) and 84 months (T84) post-surgery, and to compare compartment sizes with stable weight controls.

Consenting, eligible patients previously enrolled in the ancillary study, "Longitudinal Assessment of Bariatric Surgery" (LABS), from Weill Cornell and the University of Pittsburgh will undergo the following measures: total body water by deuterium dilution (fat and fat-free mass (FFM)), extracellular water by sodium bromide tracer, body density by the BodPod, whole-body magnetic resonance imaging (MRI) (adipose tissue and its distribution; skeletal muscle mass; mass of liver, kidneys, heart, and brain), dual energy-X-ray absorptiometry (femur bone mineral density (BMD), total body fat, fat-free mass, and bone mineral content), and resting energy expenditure (REE). MRI will describe body composition changes at the tissue/organ level and adipose tissue distribution allowing us to address questions of biological and clinical importance including the body composition changes' influences on REE. The specific aims are to: 1) measure important components of weight change in patients who underwent bariatric surgery on measures of fat mass and its distribution and FFM (including bone mineral density, skeletal muscle, and specific organs) at T60 and T84 months following surgery, and also to compare compartment sizes with those seen in stable weight controls; 2) measure the amount of change in REE at T60 and T84 compared to T0, following weight loss induced by bariatric surgery and to determine its relation to changes in body composition compartments, and its duration over the follow-up period. Secondary research questions relate to changes in cardiac structure and function, physical activity associations with skeletal muscle changes, and adipose tissue depot changes as predictors of cardiometabolic parameters (glucose metabolism and serum lipid composition). Subjects will be women and men (n=100) equally distributed between the New York and Pittsburgh sites.

Eligibility Criteria:
* Had to have been enrolled in the ancillary study prior to having bariatric surgery
* Are able to come to the laboratory for testing.
Machine Learning Predicts Survival and Mutations in Ovarian Metastases of Colorectal Cancer

The study aimed to develop and validate models to predict survival outcome and key mutations in patients with ovarian metastases of colorectal cancer, as well as to compare the differential gene expression between long-survival group and short-survival group.

The investigator performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict survival outcome and key mutations from multimodality data in patients with ovarian metastases of colorectal cancer. Secondly, the investigator aimed to compare the differential gene expression between long-survival group and short-survival group.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal cancer
* Unilateral or bilateral ovarian masses confirmed by peroperative imaging examination
* Patient requiring resection of their ovarian and/or peritoneal carcinomatosis
* 18 ≤ Age ≤ 85
* World Health Organization performance status ≤ 1
* Life expectancy \> 12 weeks
* Adequate haematological, liver and renal function
* Patient information and signature of the informed consent form before the start of any treatment procedures

Exclusion Criteria:

* Ovarian metastases of origin other than colorectal
* Primary ovarian tumor
* Clinical data missing