cyrilzakka/clinical-trials huggingface dataset:
Cardiac Toxicity in Medical Treatment of Breast Cancer

This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.

In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HER2 positive breast cancer
* Adjuvant treatment with trastuzumab

Exclusion Criteria:

* Left ventricle ejection fraction (LVEF) \<50%
* Chronic or persistent atrial fibrillation
* History of moderate or severe valvular heart disease.
Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD

In this project, patients with Parkinson's Disease (PD) will be characterized by measuring cognitive and motor function and relation to effect of Levodopa.

Participants will be patients with Parkinson's Disease and healthy controls. It will be investigated if there is a difference between patients with a good measured Levodopa response and with a poor measured response.

The patients with Parkinson's Disease will be included from the outpatient clinic at the Department of Neurology at Bispebjerg Frederiksberg Hospital and healthy controls will be found among relatives or volunteers through research ads.

Patients will be asked to pause dopaminergic medication for 6 half times.Then a baseline examination will be performed in the morning in a non-medicated state (OFF), using Unified Parkinson's disease rating Scale (UPDRS), the MOntreal Cognitive Assessment (MoCA) and computerized cognitive testing. Baseline screening for depression with Beck Depression Inventory (BDI) and for impulsivity with Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP).

An acute levodopa challenge will be performed with patients receiving 200/25 mg dispersible levodopa/benserazide. After an hour UPDRS and cognitive computerized tests are repeated.

This is estimated to take about 3½ hours to complete. In healthy controls a neurological examination, BDI and MoCA will pe performed.

The UPDRS motor test is videotaped. A specialist will later evaluate the motor function blinded.

The participants will be asked to participate in the Bispebjerg Frederiksberg (BFH) BioBank, BFH-2017-114, (ISuite nr.: 05991) at Bispebjerg Frederiksberg Hospital for future research.

An exact calculation of power is difficult to calculate as the project includes a broad range of correlations.

Numeric data will be analysed using the Student's t-test (when normal distribution is met) or Wilcoxon rank sum test (when normal distribution is not met). Binary data will be analysed using the Fishers exact test.

Eligibility Criteria:
Inclusion Criteria:

* Age of minimum 18
* Diagnosis of PD
* Be able to cooperate, understand and participate in the project
* Signed informed consent, including consent to being included in the Biobank

Exclusion Criteria:

* Dementia
* Treatment with anti-dopaminergic medication.
Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan

Ankylosing spondylitis (AS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) are the most common rheumatic diseases dealt with rheumatologists in Taiwan. In previous studies, the 3 diseases all have broad impacts on health-related quality of life of patients and drive enormous economic burden on patients and society. The objective of this study is to compare health-related quality of life and disease-related costs between patients with the 3 different diseases.

We will invite at least 100 patients with AS, RA or SLE respectively who are regularly followed in the outpatient clinic of the Division of Rheumatology at Taichung Veterans General Hospital (VGHTC) to participate in the study. Patients who have cognitive impairment, who are older than 65 years old or younger than 18 years old, who have overlapping syndrome of any 2 of the 3 rheumatic diseases (eg. RA overlapping with SLE) or who have visited rheumatologists in the outpatient clinics at VGHTC for less than 4 times in 2008 will be excluded. Patients who agree to take part will attend a comprehensive clinical examination in the outpatient department. Patients will complete a questionaire including demographic and disease characteristics, and health-related quality of life at the time of survey. The questionaires about disease-related costs will be completed once per quarter throughout 2009. The four questionaires about costs will be given at the time of initial survey and will be returned by returned by mail or in the following outpatient clinics visits every 3 months in 2009.

The result of this study will help patients to realize their own health-related quality of life and disease-related costs and help government in Taiwan to realize the socioeconomic burden of the 3 common rheumatic diseases and to allocate health care resources more properly in the future.


Eligibility Criteria:
Inclusion Criteria:

* AS patients who fit the modified New York criteria (1984)
* RA patients who fit the American College of Rheumatology (ACR) criteria (1987)
* SLE patients who fit the ACR revised criteria for the classification of SLE (1997)

Exclusion Criteria:

* 1. Patients who have cognitive impairment.
* 2. Patients who have overlapping syndrome of any 2 of the 3 rheumatic disease (eg. RA overlapping with SLE).
* 3. Patients who are less than 18 years old or older than 65 years old.
* 4. Patients who visited rheumatologists in the outpatient clinics of the Division of Rheumatology at Taichung Veterans General Hospital for less than 4 times in 2008.
A Study to Test if TEV-48574 is Effective in Relieving Asthma

The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).

The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control.

The duration of participant participation in the study is planned to be up to approximately 30 weeks.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a diagnosis of asthma for at least 12 months prior to the initial screening visit.
* The participant is able to perform technically acceptable and repeatable spirometry, including with a hand-held spirometer, after training
* The participant has had at least one documented clinical asthma exacerbation in the 18 months prior to (but not within 30 days of) the initial screening visit.
* The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years, with no current ecigarette or marijuana use.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* The participant has any concomitant conditions or treatments that could interfere with study conduct.
* The participant is currently pregnant or lactating or is planning to become pregnant during the study.
* The participant has received any live or attenuated vaccine within 15 days of the initial screening visit.

NOTE- Additional criteria apply, please contact the investigator for more information
Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration

Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines.

The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of exudative age-related macular degeneration requiring intravitreal anti-VEGF treatment.
* Patient for whom the last intravitreal injection of anti-VEGF in the eye is strictly more than 3 months
* Signature of informed consent
* Affiliation to the French social security system

Exclusion Criteria:

* Pregnant or nursing patient (a urinary pregnancy test will be performed)
* Systemic treatment with anti-VEGF
* Intravitreal treatment with anti-VEGF for less than 3 months regardless of the treated eye.
* Retinal pathology that can modify the secretion of pro-inflammatory cytokines such as diabetic retinopathy, venous occlusions, intermediate and posterior uveitis.
* Diabetes Mellitus
* High Myopia
* Simultaneous participation in another clinical research protocol in exudative AMD
* Person under guardianship, under curatorship, deprived of liberty
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction

According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient (MAG) \>40 mmHg, and a maximal aortic velocity \>4 m/sec.

Aortic valve replacement (AVR) is recommended (class I indication) in patients with "classical" severe AS who have any symptoms related to aortic valve disease.

In 2007, Hachicha et al. described a particular pattern of severe AS, characterized by an AVA ≤0.6 cm2/m2, low mean pressure aortic gradient (MAG \<40 mmHg), despite the presence of a preserved left ventricular ejection fraction (LVEF ≥50%). This pattern of AS is encountered in nearly 15-25 % of patients who have severe AS. Typically, these patients are elderly subjects, with several comorbidities, a small left ventricular (LV) cavity with pronounced LV concentric remodeling and a restrictive physiology, leading to a decrease in LV stroke volume despite a preserved LVEF. The diagnosis and management of patients with low gradient severe AS and preserved LVEF are often challenging because:

1. the presence of a "true" severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach;
2. the best therapeutic management (AVR versus conservative strategy) of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established.

In very recently updated European guidelines on the management of VHD, symptomatic patients with low gradient and low flow severe AS and preserved LVEF have only a class IIa-level C indication for AVR. No specific indications are given for the management of symptomatic patients with low gradient and normal flow severe AS. This lack of indications is clearly attributed to a gap in knowledge which requires further investigations to be filled up.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Symptomatic and severe AS defined by an effective AVA ≤1 cm² and indexed AVA ≤0.6 cm2/m2
3. LVEF ≥50%
4. MAG \<40 mm Hg (measure confirmed by the multi-window continuous-wave Doppler interrogation and use of Pedoff probe)
5. Confirmation of the presence of severe AS at DSE and MDCT aortic calcium score
6. Feasibility of AVR by surgery or TAVR according to the "heart team"
7. Signature of an informed consent

Exclusion Criteria:

1. Uncontrolled atrial of ventricular arrhythmias
2. Patient having a life expectancy \<1 year, independently from their aortic pathology
3. Coronary artery disease necessitating a percutaneous or surgical revascularisation
4. Presence of a concomitant valve disease needing surgical treatment
5. Patient who are included in another research protocol
6. Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)
Bone Age Determined by Ultrasound (BAUS) in Brazilian Control Children

Aiming to validate the use of bone age determined by ultrasound (BAUS) in Brazilian children, normal control students will be studied. X-Ray bone age (RXBA) and BAUS will be determined in 500 children and adolescents of both genders, with chronological age varying from 6-16 years.

Concordance analysis and the correlation between both BA determination methods will be performed.

Bone age is a valuable method to recognize the maturation status of development and growth. Classical analyses is performed by using the Greulich and Pyle X-Ray measurement. Such analyses have some restrictions such as intra- and inter observer variability, and variable synchronicity of bone maturation.

Bone age determined by ultrasound (BAUS) has been indicated as a fast and reproducible method, allowing decimal BA determination and avoiding the need for X-Ray.

Our aim is to validate the BAUS method in Brazilian normal controls. School students of both genders, with age varying from 6 to 16 years will be included.

Eligibility Criteria:
Inclusion Criteria:

* absence of chronic illness and drug ingestion

Exclusion Criteria:

* any chronic disease or medicine use
* body mass index: \< -2SDS or \> +2SDS
* stature : \< -2SDS or \> +2SDS
β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults

The purpose of this study is to assess the effectiveness and safety of HMB-enriched nutritional supplements for improving muscle mass and muscle function in Chinese adults with obesity during the weight loss process using calorie restriction.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 30-50 years
2. Currently having obesity defined by body mass index (BMI) ≥ 28 kg/m2 (based on measured body weight and height at booking, using validated scales)
3. Having an intention to lost weight via caloric restriction
4. Apparently healthy and able to walk independently
5. Able to eat independently to meet their energy needs
6. Without significant body weight change in the last 6 month (less than 5% change in body weight)
7. Having sedentary habit defined by Sedentary Behavior Research Network
8. Able to collaborate with the research staff.

Exclusion Criteria:

1. Having a history of intolerance to enteral nutrition, food (e.g., lactose intolerance), or being allergic to the components of our HMB-enriched nutritional supplements (e.g., soy or corn);
2. Having any implants (e.g., pacemakers);
3. Current use of other nutritional supplements or drugs that may have an impact on the effectiveness of the intervention (e.g., glucocorticoids, antineoplastic drugs, antituberculosis drugs, sedatives, antipsychotics, muscle relaxants, monoamine oxidase inhibitors, antibiotics) within 3 months prior to enrollment;
4. Secondary obesity caused by diseases (e.g., hypothalamic diseases and hypercortisolism) or drugs (e.g. glucocorticoids, insulin, tricyclic antidepressants);
5. Clinically visible edema;
6. Trauma, surgery, hospitalization, fall, or fracture within 6 months prior to enrollment;
7. Pregnancy, having pregnancy plans, or lactation;
8. Individuals who are participating in other clinical trials; any acute illness (e.g., acute infection, myocardial infarction, arrhythmia, myocarditis, appendicitis, etc.);
9. Swallowing disorders; abnormal thyroid function (including hyperthyroidism and hypothyroidism);
10. Having a history of diabetes, respiratory diseases, cardiovascular diseases, uncontrolled hypertension, kidney diseases, digestive system diseases, renal insufficiency, mental illness, neurological diseases, hematologic diseases, liver diseases (except for fatty liver), chronic infection (e.g., tuberculosis), immune system diseases, joint disorders, any type of tumor;
11. Alcohol consumption over two standard alcoholic beverages (20 g of alcohol/day);
12. Difficulty to comply with the study protocol;
13. Other conditions that indicate the individuals are inappropriate for participation in this study.
Study Evaluating the Safety and Efficacy of Piperacillin/Tazobactam and Ampicillin/Sulbactam in Patients With Diabetic Foot Infections

Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.


Eligibility Criteria:
Inclusion Criteria

* Patients with diabetes mellitus
* Inpatient
* Have 1 or more infected ulcer(s) below the ankle

Exclusion Criteria

* Must not have gangrene or severely impaired arterial supply in your foot
* Must not have a bone infection in the area of your ulcer
* Must not have allergies to penicillins
Evaluation of the SPINNER Device for the Application of Wound Dressing: Treatment of Split Skin Graft Donor Sites

Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW)

The SPINNER is a hand held, portable electro-spinning device that produces personalized in-situ nanofiber dressings for the treatment of external burns and wounds.

The dressing has non-adherence, high absorbance, bacterial protection, easy and pain-free peel characteristics and shows excellent conformability and optimal coverage of the wound.

The objective of this study is to evaluate the safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW) at size of 10-200 cm2.

The study will include five sites in Israel:

Sheba Medical Center, Tel Hashomer RambamMedical Center, Haifa Kaplan Medical Center, Rehovot Souraski Medical Center, Tel Aviv Beilinson Medical Center, Petach Tikva

Study primary endpoints:

1. Dermal Safety
2. Wound healing and time to complete re-epithelialization at 1, 3, 5, 7, 14 and 21 days post operation

Study secondary endpoints:

1. Ease of use
2. Pain assessment at 1, 3, 5, 7, 14 and 21 days post operation
3. Infection assessment from 3 days post operation up to 21 days
4. Device related adverse events of the SPINNER device and wound dressing

Extended exploratory follow up:

Assessment of itching and scarring from wound closure time and up to 12 months follow up

Eligibility Criteria:
Inclusion Criteria:

* The patient is ≥ 18 years old at enrolment. Both genders.
* Patients with donor site wound, size of 10-200 cm2, located in the thigh after partial thickness skin-graft
* The patient is able and willing to comply with study procedures and give written informed consent prior to enrollment in the study

Exclusion Criteria:

* Any known or suspected systemic infection
* Any known sensitivity to components/products used in this study
* Use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation
* Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
* Patients undergoing repeat skin graft harvesting at the same donor site
* Patients with burns of more than 15% TBSA
* Requires immersion hydrotherapy at any time during study participation
* Bleeding disorders
* Skin disorders such as psoriasis, pemphigus, Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), pyoderma gangrenosum and other exfoliative disorders
* Terminal patients
* Soldiers
* Prisoners
* Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
* Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
* Psychiatric patient.
Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

• To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

* Aged between 18-75 years (inclusive).
* Male or female.
* Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless of HBeAg status , HBV DNA ≥2×103 IU/ml
* Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and decompensated, but only Child-Pugh A or B.
* The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study.

Exclusion Criteria:

* Subjects meeting any of the following criteria must not be enrolled in the study

  * Subjects with non-HBV cirrhosis
  * Co-infection with HAV/HCV/HDV/ HIV
  * Subjects who take nucleosides within 6 months
  * Kidney injury due to non-HBV factors
  * Inability to comply with study requirements as determined by the study investigator
  * Patients with very low GFR, who may need dialysis or renal transplantation
Botox Cosmetic and the Young Patient With Glabellar Furrows

The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Fitzpatrick Skin Types I-III
* Between 30 and 50 years of age
* At least moderate severity at maximum frown

Exclusion Criteria:

* Prior botulinum toxin treatment
* Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function
* Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis)
* Allergy or sensitivity to any study component
* Participation in another clinical study within 30 days of the study start date
* Are planning other facial cosmetic procedures during the study period, or are pregnant, breastfeeding, or planning a pregnancy during the study.