cyrilzakka/clinical-trials huggingface dataset:
A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes

This is a Phase I study to determine the effect of GW786034 (pazopanib) on P450 enzymes. This study will help determine which types of drugs may interact with GW786034.


Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of advanced solid tumors.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow, renal, lung, and liver function.
* A female subject must not be pregnant and will agree not to become pregnant during the trial

Exclusion criteria:

* Any major surgery, chemotherapy, hormone therapy, investigational drugs, or radiotherapy within the last 28 days.
* Poorly controlled hypertension.
* Corrected QT (QTc) prolongation defined as a QTc interval greater than or equal to 480 msec and a prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities.
* Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months.
* Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents).

Amiodarone must not have been taken for at least 6 months prior to the administration of the first dose of study drug.

* History of brain metastases.
* Has narrow-angle glaucoma which is a contraindication to midazolam use.
* History of nicotine-containing product (including cigarettes, cigars, nicotine patches) use within the past 6 months.
* A history of bleeding problems.
68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer

The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study is being done because there are unmet medical needs to improve the current ways of detecting prostate cancers before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Biopsy proven adenocarcinoma of the prostate
* Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN guidelines (2.2014) will be included
* Planned radical prostatectomy at MSKCC
* Multiparametric MRI of the pelvis (performed or planned) as routine care

Exclusion Criteria:

* Patients meeting any of the following exclusion criteria will not be eligible for study entry:
* Hematologic

  * Platelets \<75K/mcL
  * ANC \<1.0 K/mcL
* Hepatic laboratory values

  * Bilirubin \>2.0 x ULN (institutional upper limits of normal)
  * AST/ALT \>2.5 x ULN
* Renal laboratory values

  o Creatinine \> 2.0 x ULN
* Claustrophobia interfering with MRI and PET/CT imaging
* Prior pelvic radiation
* Prior androgen deprivation therapy
* Patients deemed not surgical candidates due to prohibitive co-morbidities
Tranylcypromine Treatment of Bipolar Depression

This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective treatment of bipolar depression. New treatments are needed, as there is little evidence that standard antidepressants are effective in treating this condition, and the two antipsychotic medications that have indications for bipolar depression can cause substantial side effects. This study will focus specifically on currently depressed outpatients having a bipolar history for whom at least one standard antidepressant medication was ineffective. Patients will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.


Eligibility Criteria:
Inclusion Criteria:

1. History of Bipolar I, II
2. Currently depressed (major depressive episode or depression NOS)
3. Physically healthy or physically stable (i.e.,No changes in medical interventions in past three months or likely for the next three months)
4. On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer.
5. Prior adequate trial on at least one antidepressant.
6. Able to follow a tyramine-free diet
7. Must speak English

Exclusion Criteria:

1. Current psychosis
2. past psychosis not occurring during an episode of mania or depression
3. prior nonremission to tranylcypromine 60 mg/d (or greater)
4. currently taking effective medication precluded while taking a Monoamine Oxidase Inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor)
5. current (last six months) drug or alcohol abuse or dependence
6. significant suicide risk
7. significant cardiovascular risk
Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure

Evaluation of serial measurement of novel biomarker for diagnosis, prognosis or therapy monitoring in patients presenting with acute decompensated heart failure.

Background: Heart failure (HF) is a chronic and progressive illness resulting from a variety of cardiac causes, including ischemic and valvular heart disease, dilatative cardiomyopathy or hypertension. HF may also develop suddenly, particularly as a complication of acute myocardial infarction or as an acute exacerbation in patients with previously compensated chronic HF. Diagnosis and in-hospital management of HF is often demanding and outcome especially regarding rehospitalizations is impaired. Novel biomarker may be very helpful in assessment of diagnosis, prognosis, and severity of HF as well as for treatment monitoring.

Design: Prospective, multicenter observational study Setting: University Hospital Basel, Kantonsspital Aarau, Kantonsspital Luzern, Kantonsspital Wolhusen Patients: Patients with acute HF not requiring ICU admission

Measurement of serial biomarker (BNP, NT-proBNP, MR-proADM, ST2, hs-cTnI and Copeptin) will be performed at presentation, at 6 hours (h), 12h, 18h, 24h, at 48h, at day 6 and at hospital discharge. Follow- up will be performed at 6 Month, 1 year and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Acute HF
* Informed consent

Exclusion Criteria:

* Cardiogenic shock, ST-elevation myocardial infarction, or other clinical conditions that require immediate ICU admission or urgent PTCA
Exhaled Carbon Monoxide as a Marker of Hemolysis in Sickle Cell Disease- an Exploratory Study

The investigators propose to evaluate etCO in patients with HbSS, HbSC, and HbS-beta thalassemia during routine clinic visits, and longitudinally. Our goal is to know whether etCO differs amongst subjects with different sickle cell syndrome genotypes, and whether it is a stable marker of hemolytic rate, as reflected in routine labs obtained for clinical care (including total hemoglobin, reticulocyte count, lactate dehydrogenase, and, when sampled, total and direct bilirubin). We hope to establish whether this inexpensive and non-invasive test faithfully reflects hemolytic parameters in sickle cell syndromes.

This is an observational study of sickle cell patients with the aim to measure exhaled carbon monoxide levels and to correlate with genotype and standard clinical markers of hemolysis.

Upon enrollment and at each subsequent visit, if acceptable to the patient, each subject will undergo measurement of exhaled carbon monoxide utilizing a hand held carbon monoxide monitor, MicroCO/Smoke check. Subsequent evaluations may be obtained during a routine visit, while hospitalized for a vasocclusive crises (VOC) episode, or when evaluated in the acute care clinic.

The principal study objective is to assess if exhaled carbon monoxide levels are a non-invasive marker of hemolysis in subjects with sickle cell disease (SCD).

The secondary study objective is to assess exhaled carbon monoxide levels serially in subjects with SCD, relative to vasocclusive crises, transfusion requirements, and pain syndromes.

The one inclusion criteria is for all adult sickle patients presenting for follow up at the outpatient sickle cell clinic who are capable of following simple instructions.

The exclusion criteria are a recent (2 week) history of lung infection, asthma, acute chest syndrome, or COPD exacerbation and/or a significant pulmonary dysfunction in the recent (3-6 month) past.

Eligibility Criteria:
Inclusion Criteria:

All adult sickle patients presenting for follow up at the outpatient sickle cell clinic who are capable of following simple instructions.

Exclusion Criteria:

A recent (2 week) history of lung infection, asthma, acute chest syndrome, or COPD exacerbation and/or a significant pulmonary dysfunction in the recent (3-6 month) past.
Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries

Treatment for veterans who have had a traumatic brain injury (TBI) and who are suffering from post traumatic stress syndrome (PTSD) is varied with varied outcomes. Investigators will study PTSD treatment in military Veterans who have suffered traumatic brain injuries. Investigators will use 1 independent specialty treatment centers that utilize a specific novel methodology of PTSD treatments and study the clinical outcomes of veterans who have suffered a TBI with associated post-concussive symptoms and other comorbidities such as PTSD. Investigators hypothesize that the treatment of PTSD will have a significant outcome with neurological physical and vestibular rehabilitation when compared to psychological or psychiatric therapy. This study will use gold standard measurement scales and compare changes in the scales after treatment to evaluate the treatments.

The Department of Defense and the Defense and Veteran's Brain Injury Center estimate that 22% of all combat casualties from conflicts in Iraq and Afghanistan are brain injuries. Patients with TBI often meet criteria for PTSD on screening instruments for TBI and vice versa. No screening instruments available can reliably make the diagnosis of PTSD and the gold standard remains an interview by a skilled clinician using the Clinician-Administered PTSD Scale (CAPS) a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for PTSD. Treatment for veterans who have had a TBI and who are suffering from PTSD is varied with varied outcomes. Investigators propose a Randomized Prospective Clinical Trial of PTSD treatment in military Veterans that have suffered traumatic brain injuries. Investigators will use 2 independent specialty treatment centers that utilize different methodology of PTSD treatments and study the clinical outcomes of veterans who have suffered a TBI with associated post-concussive symptoms and other comorbidities such as PTSD. This study will use a baseline CAPS assessment and investigators will establish cut points and randomize from within those to establish a stratified randomization within groups. Subjects will undergo treatments and an outcome CAPS score will be obtained at the end of treatment as the primary outcome to calculate if there is a change in score that is statistically or clinically significant. Investigators also will utilize secondary outcomes to measure any changes in the scores obtained by these instruments. These instruments and measures such as Computerized Dynamic Posturography and video electronystagmography and saccadometry will be obtained before the initiation of treatment and when treatment is terminated to measure a change in score. All instruments will be used to measure changes in function that are related to changes in PTSD symptomatology and neurological function

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PTSD
* History of Traumatic Brain Injury
* Military veteran of conflict in war zone

Exclusion Criteria:

* Criminal history of violence
Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.

The subjects will use study product twice daily for 8 weeks starting at Visit 1. The recommendation is to consume one serving in the morning and one in the afternoon / evening between meals. The duration of the study for each subject will be approximately 11 weeks, comprising a screening period of max 2 weeks, an intervention period of 8 weeks, and a follow up phone call 1 week after completion of the intervention. A blood sample will be drawn at visit 1 and visit 3.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Identified as at medium or high risk of malnutrition based on:

   1. MUST score ≥ 1 and / or
   2. Being prescribed with ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study
3. In need of 2 servings of ONS/day (400 kcal; 20 gr protein per serving) for at least 8 weeks as determined by the treating healthcare professional.
4. Medically and physically able to consume high energy high protein ONS in the opinion of the Investigator.
5. Willing to maintain dietary habits for the duration of the study.
6. Willing to consume plant based as well as dairy based ONS

Exclusion Criteria:

1. Known allergy to soy, cow's milk protein or to any other ingredients as listed in the study product composition (refer to the product information brochure (PIB) and the appendix of this protocol).
2. Known intolerance to any ingredients as listed in the study product composition (refer to PIB and appendix of this protocol). Subjects with lactose intolerance who use lactase may still be enrolled in the study.
3. Any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intraabdominal sepsis.
4. Active flare of inflammatory bowel disease as defined by Harvey-Bradshaw Index (HBI) \>6 (Crohn's disease) or Simple Clinical Colitis Activity Index (SCCAI) \>5 (ulcerative colitis).
5. Requiring a protein restricted diet as confirmed by a physician, for example chronic kidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate \<30 mL/min/1.73 m2).
6. Requiring enteral nutrition (via tube delivery) or parenteral nutrition.
7. Subjects following a vegan diet.
Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet

A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet

A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet and Viread® tablet in Chronic hepatitis B Patients Subjects will receive either a single oral dose of the test formulation(CKD-390) or a oral dose of the reference formulation(viread).

Eligibility Criteria:
Inclusion Criteria:

1. male or female older than 19 years at the time of screening
2. Patients who have chronic hepatitis B disease are taken Viried for 6 months
3. Patients who show HBV DNA undetected(less than 20 IU/mL)
4. Patients who show positive HBsAg
5. Patients who show positive HBeAg or negative HBeAg
6. Patients who fully understand the clinical trials after in-depth explanation, decided to join the clinical trials by their will and signed inform consent

Exclusion Criteria:

1. Patients who are not taken any anti-viral agents except Viread Tab
2. Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
3. Patients who have seroperitoneum, icterus, hepatic encephalopathy, variceal hemorrhage or Patients with following value at screening

   * total bilirubin \> Upper normal limit x 1.5
   * prothrombin time(INR) \> Upper normal limit x 1.5
   * platelets \< 75,000/ul
   * serum albumin \< 3.0g/dl
4. Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 50ng/mL
5. Patients who show Creatinine Clearance \< 50 mL/min by calculating Cockcroft-Gault equation
6. Patients with disease like heart failure, renal failure, pancreatitis that investigators consider ineligible for this study
7. Patients who have other hepatic diseases like hematochromatosis, Wilson's disease, alcoholic cirrhosis, autoimmune hepatic diseases, α-1 antitrypsin deficit syndrome
8. Patients with genetic disease like Galactose intolerance, lapplactase deficiency, Glucose-galactose malabsorption
9. History of malignant tumor within 5 years
10. Patients who take any other investigational product within 30 days
11. Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial
12. Pregnant, breast-feeding and childbearing age who don't use adequate contraception
13. Patients who receive an organ transplant or bone marrow transplant or are going to received surgury
14. History of allergic reaction to the investigational product
15. Patients that investigators consider ineligible for this study
Proton MR Spectroscopy of Brain Metastases in Evaluation of Treatment Response.

The aim of the study is to investigate the feasibility of in vivo single volume MR spectroscopy in evaluation of treatment response in patients with brain metastases, using 3T MR instrument. In order to optimize and avoid ineffective treatment of patients with brain metastases, in vivo MR spectroscopy can be an useful tool.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of brain metastases

Exclusion Criteria:

* children
* pregnancy
68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.

The investigators recently developed a granzyme B-specific radiotracer named 68Ga-grazytracer. This clinical trial aims to investigate whether granzyme B PET imaging using 68Ga-grazytracer could early identify tumor responses to immune checkpoint inhibitory therapy or CAR-T therapy in subjects with solid tumor and lymphoma. PET/CT imaging of 68Ga-grazytracer will be performed in subjects after immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who were diagnosed with malignant tumors;
2. Patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team;
3. participants who had no prior immunotherapy;
4. participants who had no regional therapy within 3 months;
5. Participants aged ≥18 years.

Exclusion Criteria:

1. participants with a concurrent disease that would impede the treatment regimen;
2. Participants who were unable or unwilling to provide written informed consent.
Effect of a Pre-operative Internet-based Educational Video on Post Operative Opioid Consumption

One of the most challenging issues in modern medicine is the current opioid epidemic. Given the association between opioid use after surgery and the development of opioid addiction, an essential goal of the medical community should be to develop strategies aimed at instructing the safe use of opioids. In addition, instructions on how to use non-opioid painkillers and exercises and techniques to better cope with pain can be used to reduce the patients opioid requirements after surgery. This study aims to evaluate the effect of providing an online educational video presentation to patients prior to surgery. This will be a 30 minute video which will provide the study participants with instructions on how best to use their opioid and non-opioid medication for pain and also teach the study participants exercises and techniques to better cope with their pain. This intervention will be used with a view to reduce the amount of opioids used by patients following hip or knee replacement surgery. Participants will be followed during their immediate phase after surgery to determine how much pain killers the participants have used and at six weeks the participants will be asked to return their unused opioids to see how much the participants have used in total.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be adults (\> 18 years of age) undergoing knee or hip arthroplasty.
* Patients will be ASA 1-3 undergoing elective surgery.
* English speaking patients with internet and computer access at home will be included.
* Patients with pre-existing psychological conditions who receive either pharmaceutical or talk-based therapy will be included.
* Patients must meet a minimum cognitive capacity to understand the instructions for the Opioid Counseling and Pain Coping Skills presentation. This will be assessed by the administration of the Montreal Cognitive Assessment during screening (MoCA), whereby a minimum score of 18 will be required to meet inclusion into the study.

Exclusion Criteria:

* Significant cognitive impairment.
* Chronic pain, long-term opioid therapy
* Renal replacement therapy
* Standing opioid requirements
* Neuropathic pain
* Fractures requiring emergency surgery
* End stage cardiac or respiratory disease
* Severe hepatic dysfunction,
* Patients with severe psychiatric disorders
* Vision loss
* Allergy to local anesthesia.
* Patients who refuse to consent to neuraxial anesthesia and/or peripheral nerve blocks will also be excluded.
Allogeneic CART-33 for Relapsed/Refractory CD33+ AML

The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).

The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* Patient with relapsed and/or refractory CD33 positive acute myeloid leukemia (AML)
* Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Previous treatment with investigational gene or cell therapy medicine products
* CD33 negative leukemia
* Any uncontrolled active medical disorder that would preclude participation as outlined
* Pregnant or lactating women
The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator

The study compares the incidence of pharyngolaryngeal complications in patients managed with either a pressure-limiting strategy using the AES Ultra CPVTM or a standard practice using a LMA, in ambulatory surgery patients.

Recent evidence suggests that reduction of LMA intracuff pressure may decrease the incidence of pharyngolaryngeal symptoms. Yet, pressure manometers are not widely available limiting the application of a strategy of intracuff pressure reduction. The Ultra airway has been designed to provide continuous indication of intracuff pressure and can limit the intracuff pressure to \< 60 cm H2O. This study compares the incidence of pharyngolaryngeal complications in patients managed with either a pressure-limiting strategy using the Ultra or a standard practice using a LMA, in ambulatory surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I-III
* 18 to 65 years of age
* Ambulatory patients scheduled to undergo knee arthroscopy, transurethral resection of bladder tumor, hand, gynecological, general surgical and eye procedures under a short general anesthesia of less than 2 hours
* Spontaneously breathing on the LMA

Exclusion Criteria:

* Reduced mouth opening less than 2.5cm
* Recent history of upper respiratory tract infection and sore throats
* Contraindications of LMA use (Morbid obesity with body mass index greater than 40kg/m2, symptomatic hiatus hernia, esophageal reflux disease)