cyrilzakka/clinical-trials huggingface dataset:
Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of bryostatin-1 plus cisplatin in treating patients who have recurrent or advanced cancer of the cervix.

OBJECTIVES: I. Determine the safety and efficacy of bryostatin-1 plus cisplatin in patients with recurrent or advanced carcinoma of the cervix. II. Determine the response rate, progression free interval, and duration of survival of these patients when treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive bryostatin-1 IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed until death.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study over 2-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or advanced carcinoma of the cervix not amenable to surgery or radiotherapy Squamous cell OR Adenocarcinoma OR Adenosquamous carcinoma Measurable disease Brain metastases treated with surgery or radiotherapy allowed if no residual symptoms or medications (e.g., anticonvulsants, corticosteroids)

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST/ALT less than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No severe cardiac dysfunction or arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent unstable medical illness, infection, or other significant medical problem No clinically apparent neuropathy, including hearing loss No psychological, familial, sociological, or geographical conditions that may preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior neoadjuvant chemosensitization therapy allowed At least 3 weeks since prior chemotherapy (6 weeks since prior mitomycin or nitrosoureas) and recovered Prior cisplatin therapy allowed No prior chemotherapy for advanced disease Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 2 weeks since prior radiotherapy and recovered Surgery: Prior surgery allowed Other: No concurrent anticonvulsants No concurrent antiarrhythmic medication
Orthopaedic Implant Removal

The necessity of orthopedic implant removal is under intense discussion and even if it is performed as an elective procedure, the risk of complications is present.

Aim of the study is to identify parameters responsible for an increased risk of early post-operative complications after elective aseptic orthopedic implant removal.


Eligibility Criteria:
Inclusion Criteria:

Elective aseptic orthopaedic Implant removal

Exclusion Criteria:

Arthroplasty present infection
Hair Cortisol and Symptoms in Children With Psychopathology During CBT

This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study.


Eligibility Criteria:
Inclusion Criteria:

* symptoms of anxiety or depression
* deficiencies in emotional and behavioral skills impairing functioning
* sufficient social and cognitive skills to participate in group work.

Exclusion Criteria:

* excessive physical aggression
* excessive physical restlessness
* severity of psychiatric symptoms requiring individual psychotherapy (e.g., acute suicidality).
PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions

This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).
* Japanese subjects who have four Japanese grandparents born in Japan.

Exclusion Criteria:

* Confirmed fasting glucose more than 100 mg/dL at Screening and Day 0 in both Cohort A and B.
* Corticosteroid use of more than 5 mg prednisone equivalent per day for more than 6 weeks.
* Evidence or history of clinically significant hematological (including anemia), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)

This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of qualifying vessel (carotid or aortic) plaque inflammation
* Documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk
* Use of a stable dose of statin therapy for at least 6 weeks prior to screening. Patients must be capable of maintaining statin therapy at a current dose level from screening until the last follow-up visit.
* For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to screening and capable of continuing with that dose for the duration of the study

Exclusion Criteria:

* Occurrence of a cardiovascular event \< 6 months prior to screening
* Pregnant, planning to become pregnant during the study, or breastfeeding
* Clinically significant abnormal laboratory values or abnormal ECG or vital signs
* History of anaphylactic reactions
* Newly discovered Type 2 diabetes mellitus (T2DM) (prior to study entry) or medical treatment for T2DM started \< 3 months prior to study entry
* Use of insulin, corticosteroids (oral, rectal, or injectable), or other immunosuppressive medications
* Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C
* Impaired renal function
* History of malignancy within 2 years prior to screening
* Current life-threatening condition other than vascular disease that may prevent a patient from completing the study
* Use of an investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
* Exposure to substantial radiation within 12 months prior to screening
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.

This is a multi-national, multi-center, prospective, non-randomized, open label trial of patients implanted with the study device. A total of up to 20 patients will be implanted with the study device and followed at regular intervals for 1 year and then annually for a total of 5 years post implant.

Eligibility Criteria:
Main Inclusion Criteria:

1. Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
2. WHO Functional Class III or IV symptoms. If WHO Class III, at least 1 High-Risk characteristic or 2 Intermediate-Risk characteristics from the 2015 ESC Guidelines.
3. Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.

Main Exclusion Criteria:

1. Resting oxygen saturation \<90 % without supplemental oxygen corrected for altitude.
2. Mean Right Atrial Pressure \>20 mmHg.
3. Severe restrictive or obstructive lung disease.
4. Evidence of organ dysfunction other than right heart failure.
5. Left ventricular ejection fraction \<40 %.
6. Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum.
7. Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent.
8. Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.
Clopidogrel Efficacy and Acute Coronary Syndromes

The purpose of this study is to compare clopidogrel effectiveness between severe hemodynamically unstable versus stable patients with acute myocardial infarction.

Clopidogrel exists in oral form only. As a prodrug, it has to be metabolized to the active form by cytochrome system in the liver. Both facts could lead to lower efficacy of the drug in hemodynamically unstable patients, where splanchnic and liver hypoperfusion is present. We hypothesised that clopidogrel efficacy is insufficient in patients with acute myocardial infarction and severe hemodynamic instability. Therefore we would like to compare the effect of clopidogrel in unstable STEMI patients on mechanical ventilation with stable STEMI patients.

Eligibility Criteria:
Inclusion Criteria for unstable group:

* acute STEMI
* mechanical ventilation
* the need for catecholamine support.

Inclusion Criteria for stable group:

* acute myocardial infarction

Exclusion Criteria for any:

* previous treatment with clopidogrel
* clopidogrel administration during transport by ambulance
* known intolerance to clopidogrel
* history of thrombocytopenia (\<150,000 platelets/ml)
* pre-existing liver disease
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU

Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor

Dexmedetomidine is in Russian currently approved for sedation only in adults; paediatric experiences in the literature are in the form of small studies and case reports.

Dexmedetomidine may be useful in paediatric patients for sedation in a variety of clinical situations. Based on literature analysis, dexmedetomidine may be potentially used in the intensive care unit in pediatric patients who require sedation, either breath spontaneously or require mechanical ventilation.

Dexmedetomidine is a newer sedative with little safety data in paediatrics, particularly for therapy lasting longer than 48 h. Additional studies in paediatric patients are warranted to further evaluate its safety and efficacy in all age ranges.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 12 to 17 years;
2. Clinical need for prolonged (\>24h) light to moderate sedation in patients with spontaneous or artificial ventilation
3. Negative urine pregnancy test (for female patients);
4. Written informed consent

Exclusion Criteria:

1. Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury; any other disorder where sedation assessment is not reliable due to any neurological conditions;
2. Uncompensated acute circulatory failure;
3. Severe hypotension or hypertension
4. Severe bradycardia or tachycardia
5. A/V-conduction block II-III;
6. Severe hepatic impairment
7. Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data;
8. Use of centrally acting alfa-2 agonists or antagonists in the period less than 5x halflife between drug discontinuation and the time of randomisation;
9. Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
10. Patients receiving sedatives for therapeutic indications (e.g. epilepsy);
11. Patients allergic to dexmedetomidine and rescue medications
12. Hemodialysis and peritoneal dialysis;
13. Those requiring deep sedation or neuromuscular blocking agents;
14. Burn injuries and other injuries requiring regular anaesthesia or surgery;
15. History / family history of malignant hyperthermia;
16. Patients unlikely to be weaned from the ventilator during the study;
17. Patients with early-onset ventilator-associated pneumonia;
18. Any investigational drug within the preceding 30 days;
19. Any other reason which in the investigator's opinion would make it detrimental for the subject to participate in the study.
The Effect of Quinoa on Strength, VO2max and Athletic Performance

Background: Proper nutrition is essential for sports performance. Quinoa is a gluten-free grain rich in macronutrients such as protein, polysaccharides, and fatty acids and consists of many phytochemicals such as carotenoids, flavonoids, saponins, fiber, vitamins, and minerals. Phytochemicals in quinoa act as antioxidant and anti-inflammatory. This will protect against several oxidative stress related diseases.

Objective: Investigate the effect of 50 g of quinoa for four weeks on muscle strength, VO2max and athletic performance among adolescent athletes.

Study design: A Double blinded randomized control trial with pre-test and post-test design.

Methods :32 subjects will be included in this trial. Subjects will be divided randomly into control and experimental group with a 1:1 ratio; the experimental group will receive two cookies that contain 50 grams of quinoa; the control group will receive the same two cookies that but without quinoa. Strength will be assessed by using hand-held dynamometer (HHD). Maximum oxygen uptake capacity (Vo2max) will be assessed by Queen's College step test (QCT). And for evaluating performance: standing long jump test, ball throw test, and agility T-test will be used. Subjects will be asked to take the cookies 1-4 hours before bedtime daily during the study period.

Statistical Analysis: Shapiro wilk test will be performed to check the normality of the data and Levenes test will be performed to check homogeneity of variance. Cohen's d will be used to check the effect size. The level of significance is set to p ≤ 0.05.


Eligibility Criteria:
Inclusion criteria:

1- Healthy adolescent male athletes aged 15 to 18

Exclusion criteria:

1- Use any dietary supplementation, including protein powder, during the study period.

2. Musculoskeletal, neurological, cardiovascular, or systemic disorders which may affect the testing as reported by the participants

3. Biomechanical abnormalities which may affect the testing as reported by the participants

4. Participants psychological disorders

5. Participants on medication which may affect the measurements as reported by the participants

6. Allergic from any recipe ingredients
Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for eligibility for the study. Eligible subjects will be treated with istradefylline at a starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on the Investigator's judgment of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment visit if there are tolerability issues. The istradefylline dose should remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any unscheduled dose adjustment visits. A subject may discontinue from the study at any time.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent;
2. Subjects who completed Study No. 6002-014 inclusive of the 30-day follow-up period;
3. Currently taking levodopa combination (carbidopa/levodopa or benserazide/levodopa) therapy plus at least one adjunctive PD medication;
4. Women of child-bearing potential (WOCBP) must use a reliable method of contraception and have a negative serum pregnancy test at Screening;

Exclusion Criteria:

1. Subjects with less than 70% treatment compliance throughout their enrollment on Study No 6002-014 and or with major protocol deviations in Study No. 6002-014 (subjects who failed to meet any of the inclusion criteria, subjects who met any of the exclusion criteria or subjects who met the criteria for subject withdrawal but who were not withdrawn);
2. Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion;
3. Subject who have had neurosurgical operation for PD;
4. Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers;
5. Subjects who have had a diagnosis of cancer or evidence of continued malignancy within the past three years (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal prostate-specific antigens post resection).
Examination of the Pancreas in New-onset Diabetes

The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer

Compared to the general population, subjects \>50 years of age with new-onset diabetes (DM) are 8-times more likely to have pancreatic cancer (PaC). The likelihood of PaC in new-onset DM is further increased in those who have weight loss or elevated CA19-9. In this study patients with newly diagnosed diabetes will be prospectively identified. Those with weight loss and/or elevated pancreatic cancer marker (CA 19-9) will undergo pancreatic imaging. All subjects will be followed up to 24 months. If successful in identifying surgically removable PaC, this study will fundamentally change our practice and will be a major breakthrough in PaC treatment and research.

Eligibility Criteria:
Patient Characteristics:

--Suspected or definite new-onset diabetes based on recent blood sugar and hemoglobin A1c values

* No acute illness or steroid therapy
* No prior pancreas surgery
A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth

This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents (ages 5-17). Subjects will be randomized to one of two arms: 1) omega-3 fatty acids plus inositol or 2) NAC.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 5-17 years of age.
* Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist \> 180 on the Anxiety/Depression + Aggression + Attention subscales.
* Subjects and their caregivers must be English-speaking, and have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
* Subjects and their caregivers must be willing and able to comply with all study procedures.
* Each subject and his/her parent/guardian must understand the nature of the study. The subject's parent/guardian must sign an informed consent document and the subject must sign an informed assent document.
* Subject must be able to swallow pills.
* Subject must have access to a computer with a camera, speaker, microphone, and internet connection.

Exclusion Criteria:

* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
* Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
* History of bleeding diathesis, including those with von Willebrand disease.
* Uncorrected hypothyroidism or hyperthyroidism.
* History of sensitivity to omega-3 fatty acids, inositol or NAC. A non-responder or history of intolerance to omega-3 fatty acid, inositol or NAC after 2 months of treatment at adequate doses as determined by the clinician.
* Severe allergies or multiple adverse drug reactions.
* Unstable or untreated seizure disorder.
* DSM-IV substance use, abuse or dependence.
* Judged clinically to be at serious suicidal risk or C-SSRS score ≥ 4.
* Current diagnosis of schizophrenia.
* Current diagnosis or symptoms of psychosis.
* IQ \< 70.
* Pregnant or nursing.
Does Transesophageal Echocardiography Along With an Orogastric Tube Improve the Image Quality Intraoperatively?

Image quality of intraoperative transesophageal echocardiography (TEE) tends to get worse during long hours of operations. An orogastric tube (OGT) is often inserted in the beginning of the case, and left there for intermittent suction as needed, or removed before TEE exam to prevent echoic artifacts. However, if left there, the effect of suction might be limited due to unreliable tip position of the OG tube. If removed, stomach will be distended again. We devised the OG tube attached TEE for practical suction and assessed its effect on image quality intraoperatively.

OGT attached TEE probe is used for cardiac and liver transplantation cases. Each case is assigned 3 investigators who are blinded to this study design, We do image quality assessment by two methods; firstly, we categorize image quality as numbers based on each investigator's impression (1: Very bad, 2: bad, 3: acceptable, 4: good, 5: very good) and compare the difference in number before and after suctioning. Secondly, we evaluate consistency intraclass correlation coefficient (ICC) for inter-observer variability using investigator A, B and C. We evaluate absolute-agreement ICC for intra-observer variability using investigator C, who perform analysis for all images twice with a 6 to 8 months interval. This analysis was performed with left ventricular fraction area change using transgastric left ventricular short axis view.

Eligibility Criteria:
Inclusion Criteria:

* adult cardiac surgery or liver transplant surgery

Exclusion Criteria:

* TEE with significant wall motion abnormality or TEE contraindicated patients