cyrilzakka/clinical-trials huggingface dataset:
A Study to Determine Enzalutamide Long-term Safety and Efficacy After Anti-androgen Therapy for CRPC

This is a prospective observational study to evaluate effectiveness and safety of Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to administer Enzalutamide after anti-androgen therapy.

CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and observed the practical treatment. Total research term is for 4 years, consists of 2-year case registration terms and 2-year observational terms.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed prostate cancer.
2. Patients who are receiving or received continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist (medical castration), or both testicles removal by surgery (surgical castration).
3. Castration resistant prostate cancer (CRPC) patients who are observed disease progression after castration treatment and implied the treatment resistant.
4. CRPC patients who conducted anti-androgen alternating therapy as shown below 1) and are observed one or more of disease progression shown as below 2) during or after the therapy and decided to administer enzalutamide.

   Note 1) anti-androgen alternating therapy is defined as the therapy of flutamide administration after bicalutamide.

   Note 2) Disease progression criteria during or after anti-androgen alternating therapy

   ① PSA progression during or after anti-androgen alternating therapy: PSA increased more than 25% compare to the lowest test results after initial dose of anti-androgen alternating therapy (flutamide) and the increasing is more than 2ng/ml.

   ②Confirmed disease progression of soft tissue lesion defined as RECIST v1.1.

   ③Confirmed disease progression of bone lesion defined as 2 or more of new appearance of bone lesion on bone scintigraphy.
5. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Patients who have signed written informed consent to participate in this study

Exclusion Criteria:

1. Patients who is administering or have administration history of enzalutamide, abiraterone, docetaxel or cabazitaxel
2. Patients with history of seizure or predisposing disease of seizure
3. Patients with severe liver dysfunction
4. Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
5. Patients who considered to be inappropriate for the study participation by the investigator
Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS)

This study is a multi-center, open-label study of intravenous (IV) ANX005 in participants with ALS.

In this Phase 2a, multi-center, open label, proof-of-biology study, ANX005 will be administered to participants with ALS.

The study consists of approximately 22 weeks of treatment and approximately 14 weeks of follow-up. All participants will be contacted by phone 6 months after study completion.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of ALS according to the World Federation of Neurology revised EI Escorial criteria.
* Onset of weakness within 3 years prior to Day 1 visit.
* Slow Vital Capacity ≥ 50% of predicted normal adjusted for sex, age, and height (from the sitting position).
* ALS Functional Rating Scale-Revised (ALSFRS-R) ≥ 30 at the Screening visit (Week -2).
* If female, must be postmenopausal, surgically sterilized, or childbearing potential must agree to use highly effective methods of contraception from Screening until 3 months after the last infusion with study medication.
* Males with a woman partner of childbearing potential must agree to use highly effective methods of contraception from Screening until Week until 3 months after the last infusion with study medication.
* Documented history of vaccinations within 5 years prior to Screening visit against encapsulated bacterial pathogens or willing to undergo vaccinations.

Key Exclusion Criteria:

* Clinically significant intercurrent illness, medical condition, or medical history that would jeopardize the safety of the participant, limit participation, or compromise the interpretation of the data derived from the participant.
* Participants with body weight \> 150 kilograms.
* Antinuclear antibodies (ANA) titer ≥ 1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) during the Screening Period.
Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia

Preeclampsia is an important disease that develops during pregnancy and it is one of the main contributors to maternal and fetal complications.

The only known definitive treatment is delivery. Although delivery is always appropriate for the mother, it might not be the best for a very premature neonate.

In cases of non-severe preeclampsia there no benefit delaying delivery beyond 37 weeks. It is also well established that before 34 weeks an expectant management confers perinatal benefit with minimum amount of additional maternal risk. There is then an area of uncertainty between 37 and 37 weeks. This is why in this period it is a clinical need to select high risk patients of complications that will benefit from labor induction, and differentiate them from low risk patients that can be manage expectantly until 37 weeks.

Placental growth factor (PlGF) is an angiogenic factor that is lower in pregnant women with preeclampsia and current evidence shows that it as a predictor of adverse pregnancy outcome and requirement of delivery.

Circulating levels of PIGF at 34 weeks could help to identify those women that may benefit from labor induction and those where delivery can be delayed until 37 weeks with low risk for maternal complications.

BACKGROUND

The current definition of pre-eclampsia is a new onset hypertension (\>140/90mmHg) and proteinuria (\>0'3g per 24 hours) after 20 weeks of gestation. Pre-eclampsia affects 3% to 8% of all pregnancies and it is a leading cause of maternal and neonatal morbidity and mortality.

It has been subclassified by clinical severity in severe and non-severe and by gestational age at the diagnosis in early and late onset pre-eclampsia (\>34 weeks of gestation).

Pre-eclampsia is associated with abnormal placentation and uterine angiogenesis. Pregnant women with preeclampsia show lower circulating levels of placental growth factor (PlGF), a proangiogenic factor related to placental angiogenesis, compared with healthy pregnant women. Moreover evidence has been found regarding the role of PlGF as a predictor of adverse pregnancy outcome and requirement of delivery.

The only definitive treatment of the disease is delivery. In patients with non-severe preeclampsia between 34 and 37 weeks there is no consensus regarding the ideal time of delivery.

AIM: The aim of this study is to assess whether circulating levels of PIGF at 34 weeks could help to identify those women that may benefit from labor induction and those where delivery can be delayed until 37 weeks with low risk for maternal complications.

Eligibility Criteria:
Inclusion Criteria:

* \> or = 18 years
* pregnant women with non-severe preeclampsia
* gestational age between 34 and 36.5 weeks

Exclusion Criteria:

* No exclusion criteria are defined (intention-to-treat analysis)
Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

The number of elderly individuals affected by cardiovascular diseases has been increasing in our country. Garlic (Allium sativum) has been associated with decrease of reactive species of oxygen, hypertension, high cholesterol, platelet aggregation, blood coagulation and especially cardiovascular diseases. The present study evaluated the effects of a garlic supplementation on vascular function and blood pressure in the elderly at cardiometabolic risk. Twenty-eight elderly individuals were submitted to an ingestion of four capsules of an aged garlic extract (KYOLIC® Aged Garlic Extract™). Muscle oxygenation and function were measured 180 min after interventions. Urinary thiosulfate, blood nitrate, nitrite, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at baseline and 180 min after interventions.


Eligibility Criteria:
Inclusion Criteria:

* Cardiometabolic risks
* Cardiovascular diseases

Exclusion Criteria:

* Cancer;
* HIV positive;
* Alcohol or drug abuse within the past 6 months previous the visit 1;
* Garlic allergy;
Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

The primary objectives of the study are:

* To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH)
* To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH

The secondary objectives of the study are:

* To evaluate the effect of evinacumab on lipid parameters in patients with HoFH
* To evaluate the effect of evinacumab on lipid parameters in adolescent patients with HoFH
* To evaluate the potential development of anti-evinacumab antibodies


Eligibility Criteria:
Key Inclusion Criteria:

1. Completion of the parent study in which they participated
2. Able to understand and complete study-related questionnaires

Key Exclusion Criteria:

1. Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient
2. Concomitant medications that have not been stable prior to the baseline visit
3. Adverse event leading to permanent discontinuation from parent study
4. Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study
5. Member of the clinical site study team and/or his/her immediate family
6. Pregnant or breastfeeding women
7. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug
8. Men who are sexually active with women of childbearing potential and are unwilling to use the following forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug: vasectomy with medical assessment of surgical success OR consistent use of a condom.

Note: Other protocol defined Inclusion/Exclusion criteria apply
Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia

The present study is assessing the efficacy and safety of AVE5530 (25mg and 50mg) co-administered with all approved doses of atorvastatin in a double-blind comparison with placebo, AVE5530 alone and atorvastatin alone in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of the association AVE5530+atorvastatin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530+atorvastatin on other lipid parameters will be assessed as secondary objectives

The study will include a 2 week pre-randomization placebo lead-in phase. There will be a 12- week double-blind treatment period for both components AVE5530 and atorvastatin, followed by a 40-week period with maintenance of double-blind design for AVE5530 component and open label for atorvastatin component transitioning at 20 mg for all patients with subsequent titration, if necessary, based on regular LDL-cholesterol monitoring. The treatment period can be variably extended up to approximately 18 months with double-blind for AVE5530 component and open-label for atorvastatin.

Eligibility Criteria:
Inclusion Criteria:

* Adults with high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy

Exclusion Criteria:

* LDL-C levels \> 250 mg/dL (6.48 mmol/L)
* Triglycerides levels \> 350mg/dL (3.95 mmol/L)
* Conditions / situations such as:

  * presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels
  * Active liver disease
  * High estimated risk of Coronary Heart Disease
  * Recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
  * Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive
* Pregnant or breast-feeding women,
* Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product
* Hypersensitivity to any component of atorvastatin
* Concurrent administration of Cytochrome P450 3A4 inhibitors (e.g. cyclosporine, erythromycin, clarithromycin, and azole antifungals) should be avoided as increasing the risk of myopathy with atorvastatin

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Weight Management for Adolescents With IDD

The goal of this study is to explore the impact of two different diets (conventional vs. enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight across 18 months in overweight and obese adolescents with intellectual and developmental disabilities.

Rates of obesity and obesity related chronic health conditions are higher in adolescents with Intellectual and Developmental Disabilities (IDD) than those in the general population. Many of the negative health consequences observed in obese adults are already present in obese adolescents with IDD.

This study is a 3 group randomized trial to evaluate the intervention delivery system and type of reduced energy diet. The investigators will randomize 123 overweight/obese adolescents with mild to moderate IDD to one of 3 groups for an 18 month trial (6 month weight loss; 12 month weight maintenance):

group 1) Face-To-Face/CD

group 2) Technology delivery/CD

group 3) Technology delivery/eSLD.

All participants will receive a progressive program of physical activity. Participants on the CD diet will be asked to consume a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Participants on the eSLD will consume pre-packaged portion controlled meals with the addition of 5 fruits and vegetables per day.

FTF will meet with a health educator and will track progress using pen and paper records for both physical activity and diet. TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-21 yrs
* Mild (IQ of 74-50) or moderate (IQ 40-49) IDD,
* Of sufficient functional ability to understand directions, communicate preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) through spoken language.
* Overweight or obese (BMI ≥ 85th%ile on CDC growth charts, or waist circumference to height ratio \> 0.5
* Living at home with a parent or guardian.
* Internet access in the home.
* No plans to relocate outside the study area over the next 18 mos
* Physician consent for PA and diet.

Exclusion Criteria:

* Insulin dependent diabetes
* Participation in a weight management program involving diet and PA in the past 6 mos
* Eating disorders, serious food allergies, consuming special diets, aversion to common foods,
* Diagnosis of Prader-Willi Syndrome
* Currently pregnant, planning on/becoming pregnant during the study.
* Unable to participate in moderate to vigorous PA.
Dietary Approach to Stop Hypertension With Sodium (Na) Reduction for Chinese Canadians

The study examined the feasibility of the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC) intervention and its potential effects on blood pressure, health-related quality of life, and health service utilization. Half of participants received usual care while the other half received the DASHNa-CC intervention.

Hypertension has been identified as the most important risk factor for cardiovascular diseases and accounts for a large proportion of stroke, myocardial infarction and heart failure in the Chinese population. While unhealthy diet has been identified as a modifiable risk factor for hypertension, there is a lack of culturally sensitive dietary intervention targeting Chinese Canadians. The 8-week DASHNa-CC intervention incorporated Dietary Approach to Stop Hypertension (DASH) diet, sodium reduction with the food therapy of Traditional Chinese Medicine, and included an intervention manual, two sessions of classroom instruction delivered in Mandarin, and a 20-minute telephone follow-up.

Eligibility Criteria:
Inclusion Criteria:

* were at least 45 years old;
* had a systolic blood pressure 140 to 159 mmHg, or a diastolic blood pressure 90 to 99 mmHg, based on pre-intervention baseline assessment;
* were able to understand (listen) and speak in Mandarin, read and write in Chinese; and
* had access to a telephone.

Exclusion Criteria:

* used antihypertensive medications or other medications that raise or lower blood pressure during the previous three months;
* used TCM or professional TCM counselling to decrease blood pressure during the previous three months;
* used insulin or oral hypoglycemic agents during the previous three months;
* had a history of a cardiovascular event (stroke, myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass surgery, or other arteriosclerotic cardiovascular disease related therapeutic procedure) during the previous three months;
* had a history of congestive heart failure;
* had a cancer diagnosis or treatment during the past two years;
* had special dietary requirements;
* were pregnant, breast feeding, or planned for pregnancy prior to the anticipated end of study;
* were a household member of another DASHNa-CC participant; or
* planned to leave the area prior to the anticipated end of study.
Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus.

II. Evaluate objective disease parameters, including serum complement levels, anti-DNA antibody titers, sedimentation rate, and the systemic lupus activity measure in these patients.

PROTOCOL OUTLINE:

Subcutaneous cytarabine is given for 5 days. Patients are re-treated every 4 weeks for a maximum of 3 courses; those who relapse prior to the second course are re-treated every 3 weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Disease Characteristics

* Clinically documented active systemic lupus erythematosus demonstrating at least 4 revised diagnostic criteria
* Unresponsive to conventional therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), topical corticosteroids, and antimalarials
* Intolerable side effects from corticosteroids or other immunosuppressive drugs Failure on immunosuppressives not required
* No life-threatening disease, e.g.: Lupus cerebritis Rapidly progressive glomerulonephritis

Prior/Concurrent Therapy

* No concurrent other DNA synthesis inhibitors, NSAIDs, and prednisone continued on study

Patient Characteristics

* Hematopoietic: WBC at least 2000; Platelets at least 100,000
* Renal: Creatinine clearance at least 20 mL/min
* Other: No major infection within 2 weeks prior to entry
* Negative pregnancy test required of fertile women
* Effective contraception required of fertile women. Advised for men during and for 75 days after therapy
Safety and Efficacy of the Journey II BCS Total Knee System

Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.

Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Pre-operative and operative assessments collected retrospectively. All postoperative assessments beginning at the 6 month post-operative time point collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee System due to degenerative joint disease
* Subject is willing to sign and date an IRB approved consent form
* Subject is of legal age to consent
* Subject plans to be available through ten (10) years postoperative follow-up
* Subject agrees to follow the study protocol

Exclusion Criteria:

* Subject received the JOURNEY™ II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
* Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
* Subject possesses a contralateral or ipsilateral revision hip arthroplasty
* Subject has ipsilateral hip arthritis resulting in flexion contracture
* At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:

  * Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
  * Contralateral primary total knee or unicondylar knee arthroplasty
* At the time of surgery, subject had an active infection or sepsis (treated or untreated)
* At the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease
* At the time of surgery, subject had conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
* At the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation
* Subject is pregnant or plans to become pregnant during the study
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
* At the time of surgery, subject had a BMI\>40
* At the time of enrollment, subject has a BMI\>40
* Subject is enrolled in another investigational drug, biologic, or device study
* Subject is facing current or impending incarceration