cyrilzakka/clinical-trials huggingface dataset:
A Study of MRG002 in Treatment of Advanced HER-2 Positive Breast Cancer Patients

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2 positive breast cancer with liver metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign the informed consent form and follow the requirements specified in the protocol.
2. Aged 18 to 75 (including 18 and 75), both genders; Life expectancy ≥ 12 weeks;
3. The score of ECOG for performance status is 0 or 1
4. Patients with HER2-positive breast cancer confirmed by central laboratory and with evidence of liver metastasis by imaging;
5. Archival or biopsy tumor specimens should be provided (primary or metastatic) for HER2 testing;
6. Patients must have measurable lesions according to the Response Criteria in Solid Tumors (RECISTv1.1);
7. Organ functions must meet the basic requirements.
8. Patients of childbearing potential are willing to take effective contraceptive measures from the time of signing the informed consent form to 6 months after last administration of the study drug.

Exclusion Criteria:

1. Previous history of other primary malignancies;
2. Presence of peripheral neuropathy ≥ grade 2 (according to CTCAE V5.0);
3. Previously received antibody-drug conjugates, investigational drugs, anti-tumor vaccines or drugs, endocrine therapy for breast cancer, radiotherapy, CYP3A4 inhibitors or inducers, anthracyclines and other treatments;
4. Central nervous system metastasis and/or neoplastic meningitis;
5. History of decompensated cirrhosis, or liver metastases with a single lesion ≥ 10 cm in longest diameter;
6. Pleural or peritoneal effusion with combined clinical symptoms, which seriously endangers the life safety of subjects or urgently requires clinical treatment; Or pericardial effusion with combined clinical symptoms;
7. Any serious or uncontrolled systemic disease judged by the investigator;
8. Uncontrolled cardiac disease;
9. Evidence of active infection;
10. Pulmonary embolism or deep venous thrombosis within 3 months prior to study treatment;
11. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary dysfuction, symptomatic bronchospasm, etc.;
12. Patients with active autoimmune disease or a history of autoimmune diseases who are receiving immunosuppressive agents or systemic hormone therapy, and are still using them within 2 weeks prior to enrollment;
13. History of hypersensitivity to any component of MRG002 or known history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;
14. Uncontrolled tumor-related bone pain or urgent spinal cord compression;
15. Other conditions inappropriate for participation in this study, as deemed by the investigator.
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.

Influenza and pneumonia are the fifth leading cause of death in the United States, the leading cause of vaccine preventable death, and the leading cause of infection related deaths among nursing home residents(Nace, Drinka et al.2010). Each year, an estimated 36,000 individuals die from seasonal influenza and over 90% of these deaths occur among older adults, primarily the frail older adults residing in LTC settings(Fiore,Uyeki et al. 2010).Vaccination is the most effective means of preventing influenza (Nichol and Treanor 2006). Despite increasing success in immunizing LTC residents though, outbreaks continue to occur annually with case fatality rates ranging between 5-55% (Nace 2008). Older adults have a reduced response to influenza vaccination, in part due to age related immunosenescence (Keitel, Atmar et al. 1121; Skowronski, Tweed et al. 2008). It is widely recognized that more effective vaccine options are needed for frail older adults. One option is to increase the hemagglutinin (HA) dose in influenza vaccines in an effort to increase antibodies to hemagglutinin. To date, no studies have evaluated the effectiveness of the HDIV among LTC residents.

Eligibility Criteria:
Inclusion Criteria:

* Residents of one of the participating LTC sites
* 65 years or older at the time of consent
* require assistance in two or more Instrumental Activities of Daily Living and/or one or more Activities of Daily Living as identified by facility staff

Exclusion Criteria:

* Age less than 65 years
* Life expectancy less than 6 months
* History of allergic reaction to influenza vaccine, its components, or eggs
* History of severe allergic reaction to latex
* History of Guillian-Barre Syndrome
* Actively undergoing chemotherapy
* Actively undergoing radiation therapy
* Use of prednisone (or other steroid) at prednisone-equivalent dosages of 10mg or higher within the past 14 days
* Serious current immunosuppression or immunosuppression expected in the next 6 weeks
* Any condition that, in the opinion of the investigator,might interfere with the evaluation of study objectives
Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer

Techniques to improve pregnancy and delivery rates in IVF cycles have focused not only on the embryos transferred, but also the conditions in the uterus at the time of transfer and implantation. Prior studies have shown that embryos secrete human chorionic gonadotropin (hCG) prior to implantation. However, in IVF cycles, the embryos have limited time to secrete hCG before implantation must occur because embryos are placed into the uterus rather than traveling there from the fallopian tubes. Recent studies have shown that the introduction of hCG into the uterus prior to embryo transfer may make the uterus more receptive to implantation. These studies involved day 3 embryos and the investigators are seeking to evaluate the potential benefits of hCG on implantation rates of blastocysts (day 5 or day 6 embryos).

The purpose of this study is to determine whether infusion of human chorionic gonadotropin (hCG) into the uterus immediately prior to embryo transfer results in increased implantation rates.

The entire IVF cycle, fresh or frozen, will be conducted per routine. All laboratory culture conditions will be per routine. In fresh and frozen IVF cycles, an embryo transfer will be performed per routine.

At the time of embryo transfer, participants will be randomly assigned to either the control group or the hCG group. Patients in the hCG group will have a mock embryo transfer with 20µL of transfer media including 500IU of hCG. Patients in the control group will have a mock embryo transfer with 20µL of transfer media.

All post-transfer care and pregnancy monitoring will be identical and per routine protocol.


Eligibility Criteria:
Inclusion Criteria:

* all patients 43 years old or under undergoing fresh or frozen IVF cycles are eligible to participate

Exclusion Criteria:

* patients greater than 43 years old
* patinets currently participating in any other research studies
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2

This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).


Eligibility Criteria:
Inclusion Criteria:

* Meets ICSD-3 criteria for IH or Narcolepsy Type 2 and not undergoing pharmacologic treatment for the condition
* Usual nightly total sleep at least 6 hours as single major rest period without naps
* Epworth Sleepiness Scale of 10 or greater
* Males or females age 18 to 65 years

Exclusion Criteria:

* Any disorder causing hypersomnia other than IH or Narcolepsy Type 2
* Usual bedtime later than midnight
* Seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years
* Beck Depression Inventory score greater than 19
* Beck Anxiety Inventory score greater than 15
* Significant history of or current suicidal ideation or behavior
* BMI less than 18 kg/m2 or greater than 39 kg/m2
* Positive toxicology screen or breathalyzer test
* Clinically significant abnormal findings on safety assessments
* Any significant medical or psychiatric disease or any condition that would put the patient at risk by participating in the study
Smartphone Addiction in Relation to Trunk Position Sense, Fatigue and Insomnia in Adolescences

The aim of the study is to evaluate the relationship between smartphone addiction and trunk position sense, insomnia and fatigue in adolescents. Sample size will be determined after a pilot study conducted on a small sample of adolescents. Digital goniometer will be used to evaluate trunk position sense, insomnia severity index will be used to evaluate insomnia severity and fatigue will be measured by fatigue severity scale.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents with age between 17 and 18 years old.
* BMI between 16.4 and 24.8 kg/m2
* Smartphone addiction scale (short version) higher than 33
* Smartphone users of 4-5 inches screen size smartphones, weighing 140-160 grams and dimensions less than 159\*79\*9 mm.

Exclusion Criteria:

* Visual or hearing defects.
* Congenital abnormalities.
* Neurological abnormalities
* Musculoskeletal abnormalities
Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure

Statin therapy has been shown to efficiently reduce mortality in patients with coronary artery disease and myocardial infarction, partially as a result of the lipid-lowering properties of statins. However, especially the pleiotropic effects of statins, e.g. their anti-inflammatory and anti-oxidative properties, might be of interest in the treatment of patients with chronic heart failure that are limited in their exercise capacity due to alterations of the skeletal muscle and peripheral endothelial dysfunction.

Aim of this trial is therefore to assess the effects of three months of rosuvastatin treatment on markers of inflammation and oxidative stress in the skeletal muscle and the blood, on postnatal vasculogenesis, and endothelial function of the radial artery in patients with severe chronic heart failure.

A total of 40 patients with severe chronic heart failure are prospectively randomized to either 3 months of rosuvastatin or placebo treatment.

Before and after the intervention period maximal exercise capacity is measured by ergospirometry and endothelial function is determined by high-resolution A-mode ultrasound. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for inflammatory markers, measures of oxidative stress and vasculogenesis. Blood samples are assessed with regard to markers of inflammation and oxidative stress as well.

Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure (NYHA class III or IV)
* peak oxygen uptake \<20 mL/min/kg body weight
* left ventricular ejection fraction \<30 %
* left ventricular end-diastolic diameter \>55 mm
* stable medication within the last 4 weeks

Exclusion Criteria:

* elevated GOT and GPT levels as a sign of hepatic dysfunction
* elevated creatinine levels as a sign of renal dysfunction
* insulin-dependent diabetes mellitus
* arterial hypertension
* muscle disease or elevated CK levels
* treatment with fibrates
* co-treatment with drugs that are metabolized by Cyp3A4
* diseases that disallow a participation in the study
Energy Balance and Breast Cancer Aspects-II

The purpose of this study, the EBBA-II trial, is to determine whether a 12 month exercise program comprised of strength and endurance training among newly diagnosed breast cancer patients undergoing adjuvant therapy, will influence cardiopulmonary function. Secondary aims are to determine whether the 12 month exercise program will influence factors associated with metabolic profile, tumor growth, disease-free survival, overall mortality and breast cancer specific mortality. Furthermore, the effect on QoL parameters, and dietary factors will be assessed and evaluated.

The EBBA (Energy Balance and Breast cancer Aspects)-II study is a randomized clinical 12 month physical activity intervention trial, including female breast cancer patients diagnosed with histologically verified invasive cancer stage I-II or carcinoma in situ (DCIS/LCIS) grade 3.

* Participants are randomized to either control or intervention group 10 days +/- 2 days after surgery. The intervention start 3 weeks after surgery and continue throughout adjuvant treatments given (chemotherapy, radiation, endocrine therapy etc). The intervention group receive a detailed training program based on their own ventilatory maximal oxygen consumption (VO2max) at baseline. They meet for supervised training sessions in groups for 60 minutes x 2/ week during 12 months. In addition, they are informed to exercise at home for at least of total 120 minutes weekly aiming to perform a total of 240 minutes exercise, weekly. The patients in the control group receive standard of care without any restrictions regarding exercise.
* All participants will undergo a series of measurements before surgery, after surgery, 6 months and after the 12 months exercise intervention trial. Clinical measurements will include anthropometric measurements, fasting blood, fecal and urine samples and cardiopulmonary exercise test (CPET). Complete questionnaires (food diary (PFD)/food frequency questionnaires (FFQ), quality of life (QoL)).
* All participants will come to clinical examination and fasting blood sampling after 2, 3, 5 and 10 years follow up.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Newly diagnosed DCIS grade 3 or invasive breast cancer stage I, II, histologically verified.
* All ethnic groups, but participants have to speak and write the Norwegian language.
* Ability to join and maintain an intervention for 12 months

Exclusion Criteria:

* Verified heart disease
* Dysregulated diabetes mellitus or thyroid disorders
* Muscular and skeletal or other disorders excluding regular physical activity performance
* Body Mass Index \>40 kg/m2
* Previous surgical treatment for obesity
* Travel distance \>1.5 hour from home to study site
Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder

The purpose of this study is to assess and optimize the Avation electric stimulation system output and electromyography (EMG) processing to stimulate the tibial nerve in people with chronic Spinal Cord Injury (SCI) who have foot muscle atrophy and edema, both of which may affect proper device operations, to evaluate the safety, feasibility, and effectiveness of Avation Electric Stimulation System for bladder neuromodulation in people with SCI and identify barriers to implementation of the existing Avation Electric Stimulation System to help with developing it towards a new indication for routine care of SCI NB.


Eligibility Criteria:
Inclusion Criteria:

* Injury level above T10.
* Diagnosis of neurogenic bladder (Performing intermittent catheterization).
* English or Spanish Speaker.
* Toe flexion upon tibial nerve stimulation with transcutaneous electric stimulation.
* No adverse events during the Vivally 5-minute trial

Exclusion Criteria:

* Intradetrusor Botulinum Toxin within six months.
* Presence of urinary tract infection (UTI) symptoms.
* Pregnancy or breastfeeding.
* Known allergy to electrode or device materials.
* Known intolerance to leg electric stimulation
* Patient with no smartphone access.
* Pain/discomfort or adverse reaction with the trial of toe flexion.
Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis

There are cells in the skin and blood of humans with chronic moderate to severe plaque psoriasis with specific activities that may determine the effectiveness of treatment. These activities may be described by obtaining samples of skin and blood and analyzing them using a variety of tests.

The final subject in Cohort 1 completed the study on 19-Nov-2013 (LSLV date). Because the study analyses were novel and exploratory, they required extensive analyses by study team and external experts. As a result of this analysis it was determined on 21-July-2014 that the data from Cohort 1 were sufficiently definitive and that enrollment of Cohort 2 would not be justified. Since this decision resulted in the LSLV for Cohort 1 becoming the LSLV for the study, the full data analysis and reporting is not projected to be complete within 12 Months of LSLV. The final analysis and final reporting is planned to be completed on 18-Feb-2015. Results for this data are anticipated to be released in April 2015.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque psoriasis for at least 12 months; in generally good health; on stable dose of non-prohibited medications; able to stop current psoriasis therapy (systemic or topical) for several weeks prior to and during study participation.

Exclusion Criteria:

* Serious underlying disease including viral disorders such as hepatitis or HIV or skin condition that would interfere with skin biopsies or evaluation of psoriasis; conditions that could interfere with drug absorption after oral administration; history of malignancy or auto-immune disease.
* Use of oral or injected corticosteroids (steroids).
Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study

It is generally accepted that physically fit patients cope much better with the stress of surgery and recover faster. Consequently several research studies have tried to increase people's level of fitness before they have surgery. These previous research studies have usually required patients to carry out intense, structured exercise programmes that involve going to a gym. However such programmes are not 'user friendly' especially if people are not used to taking a lot of exercise. In this pilot study we want to test the feasibility of a home based programme that tries to increase patients' level of fitness by gradually increasing the number of steps they walk every day.

Participants will be randomised into one of two groups. One group of participants will be asked to increase their level of activity by gradually walking further (the exercise group) and the other group will carry on with their usual level of activity (the usual activity group) .

Assessments People in both groups will have an assessment on 3 occasions: when they join the study, just before surgery and 3 months after surgery.

This assessment involves:

Walking for 6 minutes up and down a corridor to see how far they can walk. Asking them for some information about their medical history Completing three questionnaires about how they are feeling and their quality of life.

People who are randomised to the exercise group will be advised about how many steps to take based on how they did in the initial walking assessment. The number of days or weeks they will be asked to take a daily walk will depend on how much time there is between them joining the study and the date of their surgery. We think this will be about 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Requiring elective resectional bowel surgery
* Gives consent to participate in the study

Exclusion Criteria:

* Younger than 18 years of age.
* A history of unstable angina/unstable coronary artery disease or a heart attack in the previous month.
* Any heart related disease including but not limited to aortic stenosis, pericarditis or any thromboembolic disease.
* Severe Infections and fever.
* Uncontrolled metabolic diseases.
* Resting heart rate of more than 120 BPM.
* Systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg.
* Recent cerebrovascular accident.
* Pregnancy
* Pre-existing severe physical disability.
* Unwilling to allow their GP to be informed of their participation in the study.
* Not able or unwilling to consent to take part in the study
Evaluation of Intravenous Dalbavancin for Peritonitis

This study evaluates the use of Dalbavancin 1500 mg IV x 1 dose for treating patients with gram positive peritonitis in patients requiring peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

Patients \> 18 years of age actively receiving peritoneal dialysis diagnosed with a gram + peritonitis determined to be a good candidate for dalbavancin treatment by the attending nephrology attending.

Exclusion Criteria:

Patients with contraindications to dalbavancin therapy
Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.

Assessing postoperative pain after ropivacin 0.5% spray in the abdominal cavity during laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Appendectomy or cholecystectomy surgery

Exclusion Criteria:

* Allergy to local anesthetics
* Intolerance to tramadol HCl
* Patient with peritonitis
* Pregnant women
* Surgery without laparoscopy
* Chronic pain before the operation
Association of Midlife Dietary and Lifestyle Factors on Cardiac Functional Changes in the Elderly

The investigators aim to investigate the association of midlife dietary and lifestyle factors on cardiac functional changes in the elderly. The investigators hypothesize that even in those without clinically manifest cardiovascular disease, the extent of underlying abnormalities in cardiovascular structure and function in the elderly would be independently related to midlife dietary and lifestyle factors.

This proposal will investigate how midlife factors in diet and lifestyle affect various aspects of cardiac structure and function related to ageing. The investigators plan to conduct the study among a sub-cohort of 600 participants from the Singapore Chinese Health Study. Comprehensive information on diet and lifestyle factors had been collected at recruitment and updated in two subsequent follow-up interviews. Candidate nutrition-related blood biomarkers such as vitamins D, homocysteine, fatty acids (short, medium and long-chain) and lipids (LDL, HDL, triglycerides) will be analyzed from samples obtained between 1999 and 2004. The investigators will study effects of smoking, alcohol consumption, sleep duration, physical activity and diet on cardiac ageing. The investigators will study overall dietary pattern, intake of specific items such as fatty acids, soy food, coffee and tea beverages, from validated food frequency questionnaires (FFQ), and nutrients from questionnaire information from this cohort previously obtained.

These nutrient and lifestyle factors will be studied individually, and for their joint or interactive effects on cardiac ageing measurements. Quantitative cardiac ageing-related outcome parameters describing cardiac mass, systolic and diastolic function, and vessel distensibility will be examined by cardiac magnetic resonance imaging. Maximum oxygen uptake (VO2 max) will be calculated based on age, gender, waist circumference, resting heart rate, and exercise habits. Body composition will be analysed by a body composition analyser machine onto which subjects stand on.

Eligibility Criteria:
Inclusion Criteria:

* Who were younger than 60 years at recruitment
* Had been interviewed at baseline and at the two follow-up interviews
* Had provided biospecimens for research previously before the age of 65 years (2000-2004)
* Who will be 65 years or older by 2013

Exclusion Criteria:

* Any known history of heart disease or stroke
* Anticipated life expectancy \< 1 year
* Unable to provide written informed consent to participate in the study
* Patients with cancer
* Patients with chronic renal disease
* Any metallic implants