cyrilzakka/clinical-trials huggingface dataset:
PK of Rivaroxaban in Bariatric Patients - Extension

Aim of this clinical Trial is the assessment of rivaroxaban PK/PD parameters in patients 6-8 months after bariatric surgery

Weight loss after bariatric surgery can putatively alter drug disposition of rivaroxaban. This may be due to an altered intestinal adaptations several months after the surgical procedure. The aim of this clinical trial is to investigate pharmacokinetic and pharmacodynamic parameters after single application of 10 mg rivaroxaban in patients with prior bariatric intervention (Roux-en-y-gastric bypass or sleeve gastrectomy 6-8 months ago). PK/PD parameters will be assessed during 12 hours after application of rivaroxaban.

Eligibility Criteria:
Inclusion Criteria:

* Patient with past elective bariatric surgery (Roux-en-Y gastric bypass surgery or sleeve gastrectomy 6-8 months ago)
* Patient aged 18 years and older
* BMI ≥ 35 kg/m2
* Women of child-bearing age: Willingness of using a double barrier contraception method during the study
* Written, informed consent

Exclusion Criteria:

* Intake of oral anticoagulants (phenprocoumon, acenocoumarol, dabigatran, etexilate, apixaban etc.) 4 weeks prior to inclusion in the study
* Application of parenteral anticoagulants (unfractionated heparin, low molecular weight heparins, heparin derivates (fondaparinux etc.) 4 weeks prior to inclusion in the study
* Pharmacologic platelet inhibition 4 weeks prior to inclusion in the study
* Known coagulation disorders (e.g. Willebrand's disease, haemophilia)
* Evidence for deep vein thrombosis or pulmonary embolism in the personal history or in the history of first degree relatives
* Medical condition that is associated with an increased risk for VTE, i.e. active cancer disease, lupus erythematodes chronic inflammatory bowel disease
* Active, clinically significant bleeding
* Congenital or acquired bleeding disorder
* Uncontrolled severe hypertension
* Active gastrointestinal disease that can potentially lead to bleeding disorder: oesophagitis, gastritis, gastroesophageal reflux disease, chronic inflammatory bowel disease
* Vascular retinopathy
* Bronchiectasis or history of pulmonary bleeding
* Prior stroke or TIA
* Hereditary galactose intolerance, Lapp lactase deficiency, glucose-lactose malabsorption
* Severe renal impairment with a creatinine clearance (GFR) of \< 30ml/min
* Positive pregnancy test, pregnancy or nursing women
* High risk of bleeding (e.g. active ulcerative gastrointestinal disease)
* Known intolerance of the study medication rivaroxaban
* Concomitant treatment with strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, lopinavir, ritonavir, indinavir)
* Concomitant treatment with an P-glycoprotein inhibitor and weak or moderate CYP3A4 inhibitor (e.g. erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine)
De-Implementing Opioids for Dental Extractions

The overarching goal of this project is to de-implement the reliance on opioid analgesics and to implement reliance on non-opioid analgesics to manage postoperative pain following dental extractions. Using a prospective, provider-level, 3-arm cluster randomized trial design, the investigators will compare different strategies to reduce the reliance on opioids and increase the use of alternative pain management approaches utilizing information support tools aimed at both providers and their patients.

The primary objective of this project is to de-implement the use of opioid analgesics for the management of postoperative pain following dental extractions and to implement effective alternative pain management. The investigators propose a cluster-randomized trial design in which dental practitioners will be randomly assigned to 1 of 3 conditions involving different implementation strategies. The first condition, Standard Practice, will serve as a control condition. The second condition will implement a clinical decision support (CDS) tool that will extract patient history and interface with the state prescription drug monitoring program to provide personalized recommendations for analgesic prescribing and offer language for discussing optimal, evidence-based non-opioid pain management with dental extraction patients. The third condition will involve an enhanced version of the CDS (CDS-E) that will also include information regarding optimal, evidence-based, non-opioid pain management delivered directly to the patient both before and following the dental extraction visit. The investigators will examine opioid and non-opioid prescribing data from the electronic health record across study arms as well as other provider- and patient-focused outcomes using mixed methods.

Eligibility Criteria:
PATIENTS

Inclusion Criteria:

* Have a dental extraction of a permanent teeth performed by an eligible HealthPartners provider during the intervention period

Exclusion Criteria:

* Patients who have opted out of research at HealthPartners
* Meet above age criteria
Sleep and Behavior in Children With Cleft Palate

The purpose of this study is to determine whether cleft palate repair increases the risk for obstructive sleep apnea in children and whether sleep apnea could explain learning and behavior difficulties that are often observed.


Eligibility Criteria:
Inclusion Criteria:

* Previous cleft palate repair
* Age 6-15 years

Exclusion Criteria:

* Other condition that impacts the interpretation of PSG or neurobehavioral assessments
* Being treated for sleep apnea with CPAP
Dexmedetomidine and Sufentanil Effect in PCA on Pediatric Patients Undergoing Scoliosis Surgery

The primary purpose of this three-arm single center, randomized, subject and assessor blind, controlled clinical study is to evaluate the effect of dexmedetomidine on patient-controlled intravenous analgesia after pediatric scoliosis orthopedics.

The study is a single center, randomized, subject and assessor blinded, controlled clinical study.

Children who meet the inclusion/exclusion criteria will be evaluated. The patients will use a postoperative analgesic pump which is named as patient-control-analgesia (PCA) until the end of surgery with different dose of drugs. The control group will be set as using sufentanil only (0.05ug/kg/h infusion and 0.05ug/kg bolus). The experimental group will use sufentanil combined with different doses of dexmedetomidine. Low dose of dexmedetomidine PCA formula is 0.05ug/kg/h sufentanil with 0.05ug/kg/h dexmedetomidine infusion and 0.05ug/kg sufentanil with 0.05ug/kg dexmedetomidine bolus. High dose of dexmedetomidine PCA formula is 0.05ug/kg/h sufentanil with 0.1ug/kg/h dexmedetomidine infusion and 0.05ug/kg sufentanil with 0.1ug/kg dexmedetomidine bolus.

Then patients will be followed until they discharge.

The purpose of this trial is to evaluate the effect of of dexmedetomidine on patient-controlled intravenous analgesia after pediatric scoliosis orthopedics.

Eligibility Criteria:
Inclusion Criteria:

* Aged 1-14 years scheduled to receive scoliosis orthopedics under general anesthesia;
* Weight is ±15% of standard weight (standard weight (kg) = height (cm) -100);
* Informed consent signed.

Exclusion Criteria:

* Allergy to dexmedetomidine;
* Obvious abnormalities of heart, lung, liver, renal function and endocrine function;
* Patients who can not cooperate with this trial.
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (axitinib implant) for Intravitreal Injection in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age or older
* Moderately severe to severe NPDR in the study eye defined as: DRSS levels of 47 or 53 as determined by the reading center
* Diabetes type 1 or 2
* BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Exclusion Criteria:

* DME within 6 months involving the center of the macula in the study eye
* Presence of DME threatening the center (within 200 microns) of the macula in the study eye
* OCT CSFT of ≥320 μm in the study eye
Diagnosis and Characterization of Dengue Fever in Children

Dengue virus is an arbovirus transmitted by mosquitoes which causes significant morbidity and mortality among children in tropical regions, especially in resource limited countries. The objective of this protocol is to compare the sensitivity and specificity of clinical gestalt and two rapid antigen tests for dengue virus and to compare the gene expression of leukocytes in distinct dengue fever disease phenotypes module-based RNA microarray technology.

This is a biology protocol with no treatment regimen associated. Blood collection will be drawn from subjects in El Salvador to be tested in an effort to improve detection and test sensitivity and specificity of a dengue NS1 Ag ELISA, dengue NS1 Ag STRIP, and clinical suspicion for the detection of dengue virus infection in children in San Salvador, El Salvador compared to the gold standard, PCR. This protocol will also seek to identify and compare gene transcription patterns characteristics of each dengue virus disease phenotype in children.

Eligibility Criteria:
Inclusion Criteria Part A:

* Age: Greater than or equal to 6 months and less than 13 years
* One of the following; History of fever OR a history of spontaneous or provoked bleeding

Inclusion Criteria Part B:

* Gender: Female
* Age: greater than or equal to 36 months
* Tanner stage less than 2
* One of the following criteria: Classical Dengue Fever, Dengue Hemorrhagic Fever or Dengue Shock Syndrome

Exclusion Criteria for both parts:

* Obvious alternative explanation for the actual illness
* Cellulitis/Abscess
* Osteomyelitis
* Varicella
* Urinary Tract Infection
* Known immunocompromising condition
Study on the Effects of Mutations Under Inherited Retinal Disease in Korean

To develop comprehensive genetic maps of inherited retinal diseases in Korean

* Establishment of comprehensive genetic database in Koreans with inherited retinal diseases including frequently mutated genes, genotype-phenotype correlations, and visual prognosis."

Group/ Cohort Label : Subject with age between 6 months and 65 years who have not receive molecular genetic testing Group / Cohort Description : Consecutive subjects with inherited retinal disease who are willing to do genetic testing using whole exome sequencing (n=265) and whole genome sequencing (n=15) and agree to informed consent of the study

Eligibility Criteria:
Inclusion Criteria:

* Inherited retinal disease
* Age between 4 months and 75 years
* Subject who has clinically confirmed visual impairment including night blindness or photophobia. Subject should meet one of the following criteria
* pigmentary retinopathy in both eyes
* reduced response in photopic or scotopic electroretinogram in both eyes
* photoreceptor degeneration in optical coherence tomography in both eyes

Exclusion Criteria:

* unilateral retinal disease
* Subject who had previously confirmed genetic testing
* Age less than 4 months or more than 75 years
* When congenital infection or trauma are suspicious for the cause of retinal disease
* When age-related macular degeneration, myopic degeneration, autoimmune origin are suspicious for the cause of retinal disease
* No visual impairment or normal electroretinogram (e.g., benign fleck)
* Illiterate subject who can not understand informed consent
* Foreigners
Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients

The overall goal of this study is to identify a safe dose of metformin, in combination with oligomeric procyanidin complex (OPC) for pharmacologic reduction of AGE levels in patients with prostate cancer.

AGEs (advanced glycation endpoints) are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer.
2. Subjects must be receiving ADT with a GnRH agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be \<50ng/dL at enrollment. Subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain \<50ng/dL for the entire duration of study participation. Subjects who have undergone orchiectomy are also eligible.
3. Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows:

   * Hematology parameters: ANC \>1000/mcL, platelets \> 100,000/mcL, Hgb \>8.0gm/dL
   * Renal Function: eGFR of ≥ 45mls/min using Cockkroft and Gault formula (see appendix C).
   * Liver Function: Total bilirubin ≤ULN, AST and ALT \<1.5xULN, Prior radiation therapy allowed
4. Subjects may have diabetes mellitus but must not be taking metformin.
5. Able to swallow and retain oral medication
6. ECOG performance status of 0 - 2
7. Ability to sign written informed consent
8. Testosterone level \<50ng/dL at time of enrollment.
9. Age 18 or older.

Exclusion Criteria:

1. Known allergy to grapes or grape seed
2. Known hypersensitivity or intolerance to metformin.
3. Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as NYHA Class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day).
4. Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed.
5. History of receiving more than 2 classes of ADT.
6. Current use of metformin, or strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine
7. PSA doubling time of \<6 months, measured over the 3 months prior to enrollment.
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer

The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.

This is a open-label, randomized, multicenter Phase 3 study to evaluate ESG401 versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Individuals able to understand and give written informed consent.
* Males or females aged ≥ 18 years ;
* Histologically and/or cytologically confirmed HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy in metastatic settings;
* Patients who are eligible for a chemotherapy regimen in the control group;
* Patients with at least one measurable lesion per RECIST 1.1 criteria;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
* Expected survival ≥ 12 weeks;
* Patients with adequate organ and bone marrow function;
* Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 180 days after the last dose.

Exclusion Criteria:

* Received chemotherapy, targeted therapy, immunotherapy, interventional therapy or other systemic anti-cancer therapie within 4 weeks before the first investigational product administration;
* Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
* Received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
* Prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy, or prior TROP2 targeted therapy, or use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration;
* New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months;
* Uncontrolled systemic bacterial, viral or fungal infections;
* Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases;
* Patients with Primary CNS malignancy；or patients with other malignancies within 3 years prior to the first dose;
* Patients with uncontrollable systemic diseases;
* Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea;
* Subjects with clinically significant cardiovascular disease;
* Human Immunodeficiency Virus (HIV) infection;
* Active hepatitis B or hepatitis C;
* Known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to any investigational drug or excipient ingredient;
* Pregnant or lactating women.
Determination of Protein Requirements in Pregnancy

Protein is an essential part of our diet. It is used to build muscle and body tissue, send signals throughout our body and to support the immune system. Dietary protein is even more crucial during pregnancy as it is needed for healthy growth and development of the baby. There is very minimal data available on how much additional protein is required during pregnancy. Current recommendations are based on older techniques such as nitrogen balance studies of non-pregnant adults and minimally based on pregnancy specific data. There is no scientific information regarding the amount of protein needed during different stages of pregnancy.

The investigators hypothesize that the current recommendations of protein intake during pregnancy are underestimated.

The goal of this study is to measure protein requirement in healthy pregnant women (19-35y)using a more quick and modern technique called the indicator amino acid oxidation technique (IAAO).


Eligibility Criteria:
Inclusion Criteria:Healthy pregnant women

* Singleton pregnancy
* Maternal age 19-35y
* In good health (free of chronic/acute disease,full range of physical mobility)
* Healthy pre-pregnancy body mass index

Exclusion Criteria:Women

* not pregnant
* Pregnant with more than one child
* Singleton pregnancy outside the age range of 19-35y
* Not in good health or have a metabolic, neurological, genetic, or immune disorder, including gestational diabetes or anemia
* smoke or consume alcohol during their pregnancy
* classified as underweight (\<18.5 kg/m2), overweight (25-30 kg/m2) or obese (\>30 kg/m2)
* allergic to eggs and egg protein
* severe nausea/vomiting throughout their pregnancy
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Hodgkin's Lymphoma

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with relapsed or refractory Hodgkin's Lymphoma. Infusions may be administered on an out-patient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Hodgkin's Lymphoma (blood products, growth factor, etc.) are allowed.


Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmation of Hodgkin's Lymphoma.
* Must have measurable disease.
* Evidence of progressive disease following at least one prior line of combination therapy.
* Must have failed, refused, or otherwise not a candidate for stem cell transplant.
* Patient's must have normal organ function.
* Willing to submit to blood sampling for planned PK and PD analyses.
* Ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria:

* No other agents or therapies administered with the intent to treat malignancy.
* Patients with prior exposure to obatoclax.
* Prior allogeneic stem cell transplant if evidence of graft versus host disease, or requirement for steroids or other immunosuppressive therapy.
* Uncontrolled, intercurrent illness.
* Pregnant women and women who are breast feeding.
Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension

This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful information to develop a new fixed dose combination drug.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 20-50 years of age
* Above 55Kg and within ±20% ideal body weight
* Subjects who are in average of 130mmHg ≤ systolic blood pressure (SBP) \< 160mmHg, 80mmHg ≤ diastolic blood pressure (DBP) \< 100mmHg
* Female subject who confirmed non-pregnant status and agree to comply with proper contraception.
* Subjects who wrote informed consent

Exclusion Criteria:

* Subjects who are suspected to have acute disease
* Subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
* Subjects who have gastrointestinal history
* Subjects whose heartrate is less than 60
* Subject who suspected to orthostatic hypotension
* Subjects who have clinically significant allergy disease
* Subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
* Administration of prescription drug within 14 days or over the counter (OTC) drug within 7 days
* Subjects who have past history of drug abuse and positive in drug screening test
* Subjects who donate whole blood within 60 days and platelet within 30days.
* Subjects taking St John's wort or CYP inhibitor and inducer
Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients

The study hypothesis is that the relief of pain in patients with osteoarthritis in the hand can be detected by a form of brain scanning that detects which parts of the brain are activated when pain is felt.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed, post-menopausal female, any race, 50-80 years
* Clinical diagnosis of osteoarthritis of the hand
* Estimated pain in this joint of at least 5 on a scale of 0 to 10

Exclusion Criteria:

* Any patient who smokes more than 5 cigarettes per day
* Patients receiving some anti-depressant drugs unless the dose is stable
* Patients unable to be admitted or lie still in an MRI scanner