cyrilzakka/clinical-trials huggingface dataset:
Markers of Anthracycline-Related Cardiac Muscle Injury

Anthracycline antibiotics are included in the chemotherapy regimens of approximately 82% of patients with bone cancer and 44% of those with soft tissue sarcoma diagnosed in childhood or adolescence. Impaired cardiac function occurs after treatment with anthracyclines. The frequency of impairment increases with increasing cumulative dose. There are inadequate data regarding the relationship between doxorubicin administration and changes in serum levels of cardiac troponin T (cTn-T) or I (cTn-I), N-terminal (NT) brain natriuretic peptide (BNP), or tissue Doppler imaging parameters.

This non-therapeutic study proposes a prospective, single arm study of serial changes in tissue Doppler imaging parameters, cTn-T and NT-BNP in children and adolescents with malignant bone and soft tissue tumors whose planned chemotherapy includes treatment with ≥ 375 mg/m2 of doxorubicin.

The proposed study will rigorously evaluate the usefulness of serial determinations of tissue Doppler imaging, cTn-T and NT-BNP for very early identification of anthracycline-related myocardial injury. Demonstration that one or more of these markers identifies subclinical myocardial damage and that biomarker or tissue Doppler imaging parameters exhibit a dose-response relationship with cumulative doxorubicin dose would facilitate intervention trials in patients at risk for anthracycline cardiomyopathy.

The primary aim of this proposal is to serially evaluate imaging tests in previously untreated patients with osteosarcoma, Ewing's Sarcoma Family of Tumors(ESFT), rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas whose planned treatment includes a cumulative doxorubicin dose ≥ 375 mg/m2 to determine if serial levels of one or more of these potential markers of cardiac muscle injury obtained prior to each infusion of doxorubicin and at the completion of chemotherapy correlate with increasing cumulative anthracycline exposure.

The secondary aim of the study is to estimate the proportion of patients with decreased (evaluation j - evaluation j+1) peak longitudinal systolic strain (ε) or strain rate (SR), peak radial systolic ε or SR, peak radial systolic myocardial velocity or peak longitudinal systolic myocardial velocity among those who have a shortening fraction (SF) ≥ 29% prior to each infusion of anthracycline. This study will evaluate whether the serum levels of cTn-T and/or NT-BNP will increase following doxorubicin administration. The study will evaluate whether the serum levels of cTn-T and/or NT-BNP will increase with increasing cumulative doxorubicin dose.

Eligibility Criteria:
Inclusion Criteria:

* Between 0 and 21 years of age
* Diagnosis of osteosarcoma, Ewing Sarcoma Family of Tumors, rhabdomyosarcoma, or intermediate or high-risk non-rhabdomyosarcoma soft tissue sarcoma
* Planned treatment includes administration of a cumulative anthracycline dose ≥ 375 mg/m2

Exclusion Criteria:

* Pregnant Females
* Patients with a history of cancer prior to the current malignancy
* Patients whose treatment will include radiation therapy to a volume that will include the heart
A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura

The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of episodic or chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
* Prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months.

Exclusion Criteria:

* Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
* Current use or prior exposure to galcanezumab or another CGRP antibody.
* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
* History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks

To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* A candidate for elective EVAR of an infrarenal aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women

Exclusion Criteria:

* An inability to provide informed consent
* Enrolled in another clinical study
* Concomitant iliac artery ectasia or aneurysm (common iliac artery diameter \>24 mm)
* Patent AAA sac feeding vessels (within the sac) \>4 mm in diameter
* Volume of AAA sac to be filled after stent graft placement \<30 mL or \>135 mL, based on pre-procedure CTA (i.e. aortic flow volume exclusive of stent graft volume)
* Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II Stent Graft, or Endologix Ovation Alto Abdominal Stent Graft System to treat the AAA
* Planned use of the chosen stent graft outside its instructions for use (IFU)
* Planned use of fenestrated or chimney stent grafts
* Study participants in which stent graft placement is abandoned for any reason, and/or in which the investigator decides, during the course of the stent graft placement, that the study procedure may not be appropriate
* Planned use of embolic devices other than the investigational product to embolize the AAA sac
* Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac
* Ruptured, leaking, or mycotic (infected) aneurysm
* Aneurysmal disease of the descending thoracic aorta
* Coagulopathy or uncontrolled bleeding disorder
* Long-term (\>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin K antagonist anticoagulant use
* Serum creatinine level \>2.5 mg/dL;
* Cerebrovascular accident within 3 months prior to the procedure
* Myocardial infarction and/or major heart surgery within 3 months prior to the procedure
* Atrial fibrillation that is not well rate controlled
* Unable or unwilling to comply with study follow-up requirements
* Life expectancy of \<2 years post-procedure
* Known hypersensitivity or contraindication to platinum, iridium, or polyurethane
* A condition that inhibits radiographic visualization during the implantation procedure
* History of allergy to contrast medium that cannot be managed medically
* Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study
* Pregnant or a lactating female. For females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study
* Prisoner or member of other vulnerable population.
A Comparison of Continuous Moderate Training and Reduced High Intensity Interval Training in Obese Young Adults

Exercise is a key component of obesity management. Obese subjects cannot attend or sustain exercise program because of increased general fatigue, dyspnea and muscle fatigue. And they feel more exertion when comparing with normal weight subjects. Reduced-exertion high-intensity interval training (REHIT) is a alternative method to continuous exercise programs. The investigators aimed comparing metabolic effects of REHIT and continuous exercise in young adults, in this study.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-22,
* BMI ≥ 30,
* Female gender,

Exclusion Criteria:

* Smoking history,
* Having any metabolic disease except obesity,
Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease

The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD).

Participants with NAFLD who meet inclusion and exclusion criteria and who give informed written consent, will be randomly assigned to the intervention and control group. Randomization will be done by using a random sequence generator with concealed allocation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years to 60 years
* Body Mass Index (BMI) is 25 kg/m\^2 or more
* Newly diagnosed with NAFLD based on clinical history, ultrasound scan and laboratory values

Exclusion Criteria:

* Any medical condition that will significantly alter the weight eg: hypothyroidism, hyperthyroidism, Cushing disease
* Having moderate/severe depressive disorders or psychotic symptoms and or substance use disorders that would reduce their capacity to give consent and engage in Motivational interview
* Who are on drugs which will affect weight or mood/affect (eg: corticosteroids)
* Pregnancy or expecting to be conceive within the study period
* Having any health conditions that would impede engagement in physical activities
* Having any health conditions that would compromise the ability to follow the recommended dietary behaviors
* Concurrent involvement in another weight loss programme
Bicarbonated Ringer's Solution Versus Lactated Ringer's Solution in Patients With Septic Shock

In this prospective randomized controlled trial, investigators aim to study the effects and safety of bicarbonated Ringer's solution in patients with septic shock compared with lactated ringer's solution, and provide evidence for current fluid resuscitation strategies for septic shock.

Although the latest guidelines recommend crystalloids as the first choice for the patients' fluid resuscitation, it still remains controversial that which crystalloid solution is the best choice. It is reported that balanced crystalloid can result in better outcomes than saline for critically ill patients. However, there are few studies conducted between different crystalloid solutions.

Lactated ringer's solution is the longest-used crystalloid solution. Compared with lactated ringer's solution whose anion is lactate, the anion of bicarbonate ringer's solution is bicarbonate. And lactate needs to be metabolized into bicarbonate through the mitochondria of the liver before it can play an alkalization role. Therefore, in theory, bicarbonate ringer's solution does not need to rely on liver metabolism, the onset time to maintain acid-base balance is shorter, and it may be more suitable for patients with severe acidosis. In patients with septic shock, the incidence of moderate to severe metabolic is increased. Bicarbonate ringer's solution can directly supplement the concentration of bicarbonate, while lactated ringer's solution needs to take time and be metabolized in the liver. Thus, we hypothesize that bicarbonate ringer's solution is more effective for patients with shock and metabolic acidosis than lactated ringer's solution.

Eligibility Criteria:
Inclusion Criteria:

* 1. At the age of 18 to 75;
* 2. Being treated in the ICU;
* 3. Diagnosed as septic shock according tho the definition of Sepsis 3.0 with fluid resuscitation requirement.

Exclusion Criteria:

* 1. Severe hepatic failure;
* 2. Possible brain injury;
* 3. With absolute contraindications for central vena catheterization;
* 4. Ever participated in another clinical trial within 30 days prior enrollment;
* 5. Have corrected metabolic acidosis through alkaline drug application within 24 hours prior to enrollment;
* 6. Hypermagnesemia or hypothyroidism;
* 7. Pregnant of breast-feeding women;
* 8. Considered inevitable death;
* 9. Other situations where investigators think enrollment is not appropriate.
Azacytidine Plus FLAG for Relapsed or Refractory AML

The purpose of this phase 2 study is to test the efficacy of azacytidine given prior to fludarabine, cytarabine, and G-CSF for the treatment of relapsed or refractory acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

1. Age 16 to 60
2. Patients with a diagnosis of relapse or refractory AML (≥ 20% blast in bone marrow).
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
4. Patients must have preserved organ function as defined below:

   * Creatinine ≤ 1.5 mg/dl
   * Total bilirubin ≤ 1.5x upper limit of the normal
   * Alanine aminotransferase (ALT) ≤ 2x upper limit of the normal
   * Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria:

1. Patients with a diagnosis of acute promyelocytic leukemia (AML -M3)
2. Pregnant women
3. Patients previously treated with fludarabine are allowed to participate.
4. Patients with Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)

The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing to limit alcohol intake to 3 or less beverages per day
* Patient agrees to use only acetaminophen/paracetamol for breakthrough pain

Exclusion Criteria:

* Patient has other inflammatory arthritis (e.g. lupus). Patient has had major surgery or donated or lost 1 unit of blood in the last 4 weeks
* Patient has a history of drug or alcohol abuse in the last 2 years
* Patient has had a vaccine (with a live or attenuated virus) in the last two weeks
A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants

The purpose of this study is to assess the extent of availability of drug to the body of four different lazertinib tablet formulations at a single oral dose under fasted conditions in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history (at screening only), vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site in Intervention Period 1
* Body weight not less than 50.0 kilograms (kgs) and body mass index (BMI, weight/height\^2) within the range 19.0-30.0 kg/m\^2 (inclusive) at screening
* All female participants must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-HCG) test at screening and a negative urine pregnancy test on Day -1 of Intervention Period 1
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study intervention
* Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease and interstitial lung disease, diabetes mellitus (with the exception of history of gestational diabetes), hepatic insufficiency, inflammation bowel disease/Crohn's disease, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption or excretion of orally administered drugs
* History of malignancy within 5 years before screening
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, ibuprofen, and stable hormone replacement therapy (in postmenopausal female participants only) within 14 days before the first dose of study intervention is scheduled until completion of the study
* History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
UCLA FOCUS Family Resiliency Training Research Study

The study will examine the effectiveness of an eight session, manualized individual family resiliency training (IFRT) for families with one OEF/OIF/OND veteran in promoting better family communication relating to return to post military life.


Eligibility Criteria:
Inclusion Criteria:

* OEF/OIF/OND Veteran adult family member
* cohabiting with significant other for 6 months or more
* at least one child age 5 to 17 years

Exclusion Criteria:

* active case with Child Protective Services
* conditions or substance use that limits ability to fully participate in the research program
Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women

To assess the effects of a lactoferrin supplemented formula on fetal development , iron metabolism and immunity in healthy pregnant women. One hundred and twenty healthy pregnant women (24\<gestational weeks\<26) are enrolled and randomly assigned to lactoferrin-supplemented formula group (active group) or normal formula group (control group, without lactoferrin supplementation). Subjects allocated in active group consume lactoferrin supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally), while those in control group consume formula without lactoferrin supplementation (\<6mg lactoferrin per 100g formula) according to the same schedule. Routine blood test including hemoglobin and serum ferritin, and food frequency questionnaire-based review and 24h\*3 dietary record are performed every 4 weeks during intervention until delivery. Body weight of newborns are recorded after delivery. The differences in iron deficiency anemia morbility of pregnant women and anthropometric measurements of newborns between groups would be analyzed after completion of this study.


Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women with gestational weeks between 24 and 26;
* with hemoglobin concentration \> 110g / L;
* without indication of abortion;
* without infectious disease or hereditary disease;
* without iron supplementation before enrollment.

Exclusion Criteria:

* with red blood count \<3.5\*10\^12/L，hemoglobin concentration\<110g/L or serum ferritin \<20 μg/L；
* diagnosed with gestational diabetes mellitus;
* enrolled in other intervention study within past 1 month.
New Reference Values for Intracranial Pressure

Intracranial pressure is a cornerstone in neurosurgical care used in a variety of diseases. However currently, doubts regarding normal intracranial pressure exist. Few studies have investigated normal intracranial pressure in truly normal adults. The aim of this study is to investigate intracranial pressure in adults who have normal intracranial pressure physiology.

In this prospective, multicenter, clinical study, the intracranial pressure of 10 adults requiring surgery for an unruptured aneurysm will be investigated. These patients are thought to be normal in terms of intracranial pressure physiology. At the end of their surgery for an aneurysm, a telemetric intracranial pressure monitoring sensor will be implanted. Afterward, intracranial pressure curves will be obtained non-invasively 1., 14., 30 and 90 days after implantation. The intracranial pressure will be investigated in 5 different positions (supine, lumbar, upright sitting, standing and walking). Furthermore, a 24-hour measurement will be performed in their home environment, thus investigating intracranial pressure under daily activities.


Eligibility Criteria:
Inclusion Criteria:

* Above the age of 18
* Requiring surgery for a "cold" (unruptured) aneurysm

Exclusion Criteria:

* Current or previous examination or treatment for hydrocephalus
* Current or previous examination or treatment for idiopathic intracranial hypertension
* Previous operation with insertion of cerebrospinal fluid shunt
* Previous trauma with intracranial hemorrhage
* Global cerebral edema
* Increased infection risks
* Surgical complications during the primary operation
* Unable to understand patient information
Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation

Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?

Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression.

Read-Out: Renal function after 6 months; tolerability; and safety were assessed.

Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?

Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression.

Read-Out: Renal function after 6 months; tolerability; and safety were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplantation (\> 6 months post-operation)
* Renal failure (serum creatinine stably \> 1.7 mg/dl
* Cyclosporine trough blood level \< 110 ng/ml

Exclusion Criteria:

* \< 18 years of age
* Rapamycin intolerability
* Active infection
* Pregnancy, breast feeding
* Major elective surgery planned in study period
* Thrombopenia \< 100,000/ml