cyrilzakka/clinical-trials huggingface dataset:
Lesinurad Interaction Study With Ranitidine

This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of ranitidine on lesinurad.

This study will evaluate the potential effect of ranitidine on the pharmacokinetics of lesinurad. An earlier study demonstrated an effect on lesinurad PK in the presence of both calcium-containing and magnesium- and aluminum-containing antacids. The current study will assess whether raising gastric pH, without the presence of these cations, affects lesinurad PK and PD under the fasted state. If an impact is seen, then the optional second cohort will be conducted under the fed state.

Eligibility Criteria:
Inclusion Criteria:

* body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
* Screening sUA value ≤ 7.0 mg/dL.
* free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject has no clinically relevant abnormalties in vital signs, ECG, physical examination or safety laboratory values per the Investigator's judgment.

Exclusion Criteria:

* history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic renal,urological, or psychiatric disorders.
* history or suspicion of kidney stones.
* undergone major surgery within 3 months prior to Day 1.
* donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
* inadequate venous access or unsuitable veins for repeated venipuncture.
The Impact of Prehabilitation

While numerous studies have assessed the promising impacts of prehabilitation, there is a lack of prehabilitation research within lower socioeconomic patient populations. Often for prehabilitation studies, patients are heavily involved in full scale exercise and nutrition programs weeks before the scheduled procedure. In underserved populations, programs such as these are often not feasible due to lack of transport, resources, and other barriers to healthcare. The investigators seek to evaluate the effectiveness of inexpensive interventions in lower socioeconomic populations.

The investigators hypothesize that barriers to prehabilitation are environmental and that prehabilitation interventions tailored for lower socioeconomic (SES) populations will improve time to discharge, mobility, and in turn, readmission rates.

The participants for this clinical trial will be seen four times: initially at the preoperative surgical clinic (6-8 weeks prior to surgery), 1-2 days preop at a pre-procedure clinic, postoperative in the inpatient setting (as soon as the participant is able to ambulate during their hospital stay), and in the postoperative surgical clinic at the postoperative visit. Patients will be within the general surgery, colorectal, and surgical oncology departments at Boston Medical Center (BMC).

The anticipated sample size is 60 participants (30 in the intervention/prehabilitation arm and 30 in the control/usual care arm). Participants in the intervention arm will participate in a mobility and step tracking intervention aimed at improving postoperative outcomes. The control group will follow routine standard of care at BMC for preoperative and postoperative care.


Eligibility Criteria:
Inclusion Criteria:

* Patients within general surgery, colorectal, and surgical oncology departments at Boston Medical Center.
* English or Spanish speaking
* Able to ambulate without cane, walker, wheelchair
* Surgery scheduled within 4-8 weeks
* Must have cell phone with internet access and text message capabilities
* JH-HLM score of 6

Exclusion Criteria:

* Limited/non readers (less than 5th grade reading level), assessed via comprehension of consent materials
High Nucleotide Meal Consumption in Uric Acid and Metabolic Health

The production of protein rich animal products is associated with a large environmental burden, and with ethical considerations. Additionally, the over-consumption of meat might be associated with detrimental effects to health.

Using mycoprotein, a food ingredient derived from the fermentation of a fungus, as a meat substitute could result in environmental benefits, and could have a role in managing obesity, diabetes and improving metabolic health. However, naturally produced mycoprotein has a high nucleotide content and little is known about the impact of nucleotides in uric acid levels and other health markers.

The aim of this study is to investigate the effect of a meal based on nucleotide rich mycoprotein on uric acid concentrations and other markers of health.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 30

Exclusion Criteria:

* On medication (except contraception)
* Smokers
* Diagnosed with any metabolic or cardiovascular conditions
* BMI \< 18 or \> 30
Trial to Describe the Safety and Immunogenicity of Fluzone®

Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation.

Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation.

Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Participant aged 18 years or older on the day of inclusion.
* Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
* Participant is in good health as assessed by the investigator.
* Participant willing and able to meet protocol requirements.
* Participant willing and able to give informed consent.
* For a woman, inability to bear a child or negative serum/urine pregnancy test.

Exclusion Criteria:

* Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
* An acute illness with or without fever (temperature ≥ 99.5 °F oral) in the 72 hours preceding enrollment in the trial.
* Clinically significant findings in vital signs (including temperature ≥ 99.5 °F oral) on review of systems.
* Self-reported history of severe adverse event to any influenza vaccine.
* Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
* Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 2.
* Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.
* Immunocompromising or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
* Receipt of blood or blood products within the 3 months preceding enrollment in the study.
* Diabetes mellitus requiring pharmacological control.
* Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
* Person deprived of freedom by an administrative or court order (having legal or medical guardian).
* For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial.
* Current alcohol or drug use that may interfere with the subject's ability to comply with trial procedures.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Prior personal history of Guillain-Barré syndrome.
Open Latarjet Techniques Versus Arthroscopic Latarjet Techniques on Anterior Shoulder Instability: The Comparison of Clinical and Radiographic Outcomes

The open Latarjet techniques has benn considered as an effective treatment on anterior shoulder instability.Over the past decade there has been a shift from open to all-arthroscopic technique in many surgeries. The arthroscopic technique may result in less postoperative stiffness and faster rehabilitation. So we hypothesized that the arthroscopic Latarjet techniques would have better clinical and radiographic outcomes than the open Latarjet Techniques on anterior shoulder instability.


Eligibility Criteria:
Inclusion Criteria:

* age older than 15 years
* Traumatic anterior shoulder instability
* Recurrent instability
* Glenoid defects larger than 25%
* Clinical and radiographic data at pre-operation and follow-up

Exclusion Criteria:

* Younger than 18 years
* Non-traumatic shoulder instability
* Primary episode of instability
* Glenoid defects less than 25%
* Previous surgical procedure Incomplete clinical or radiographic data Combination with rotator cuff tear
A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS).

Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

The drug being tested in this study is called soticlestat (TAK-935). Soticlestat administered long-term in pediatric and adult participants who participated in an antecedent soticlestat Phase 3 clinical study will be assessed for additional safety and tolerability data along with efficacy analysis, as well as palatability and acceptability of soticlestat in the pediatric population.

The study will enroll approximately 400 participants.

All participants will receive soticlestat based on their weight in the 2-week Titration Period (for participants who roll over from an antecedent double-blind study). Following the Titration Period, participants will continue to receive the same dose in the Maintenance Period. At the end of maintenance period, the dose will be down-tapered (unless already at the lowest dose) and then stopped. Participants not tolerating minimum dose of 100 mg twice a day (BID) will be discontinued from the study.

This multi-center trial will be conducted worldwide. The overall time to participate in the study will be approximately 4 years, or until the study is stopped at the discretion of the sponsor, or the product is approved and launched. Participants who discontinue study drug treatment before the completion of the study, will continue to be followed per protocol and maintain a daily seizure diary until the final follow-up phone call.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must have:

* Been previously enrolled in a phase 3 soticlestat clinical study.

Exclusion Criteria:

1. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.
2. Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) \>450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF.
3. Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.
To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients

To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.


Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed, solid tumor refractory to standard therapy.
* Tumor for which there is no standard therapy.
* Able to swallow and retain oral medication.
* ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2.
* Provided written informed consent.
* Adequate bone marrow function.
* Serum creatinine is less than or equal to 1.5 mg/dL.
* Calculated creatinine clearance is greater than or equal to 60 ml/min based on Cockcroft and Gault.
* Total bilirubin is greater than or equal to the upper limit of normal of institutional values.
* Aspartate and alanine transaminase is less than or equal to 3 times the upper limit of the institutional values.
* Have a left ventricular ejection fraction (LVEF) greater than or equal to 40% based on electrocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
* Resting oxygen saturations of greater than 90%.

Exclusion criteria:

* Pregnant or lactating female.
* Have malabsorption syndrome, a disease affecting gastrointestinal function.
* Resection of the stomach or small bowel.
* Evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease.
* Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
* Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product.
* Use of anilinoquinazolines, such as gefitinib \[Iressa™\], erlotinib \[Tarceva™\].
* Immediate or delayed hypersensitivity reaction to midazolam or any component of the formulation, including benzyl alcohol (cross-sensitivity with other benzodiazepines may exist).
* Has narrow-angle glaucoma which is a contraindication to midazolam use.
* Has received treatment with any investigational drug in the previous 4 weeks.
* Received chemotherapy, immunotherapy, biologic therapy or hormonal therapy within the past 14 days, with the exception of mitomycin C within the past 6 weeks.
* Currently receiving amiodarone or has received amiodarone in the 6 months prior to screening.
* Is taking regular doses of opiates that in the opinion of the investigator would put the patient at risk of clinically significant respiratory compromise when midazolam is administered.
* Physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
* Has Class II to IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
* Clinically significant electrocardiogram (ECG) abnormality.
* Clinically assessed to have inadequate venous access for protocol-related blood draws.
Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide

Anxiety disorders affect over a quarter of the population, yet very little is known about the variables that predict treatment outcome. The planned study explores whether a patient's response to a physiological test involving inhalation of carbon dioxide predicts their response to exposure therapy.

Anxiety Sensitivity (AS) refers to an individual's fear of experiencing anxiety-related symptoms (e.g., dyspnea or heart palpitations) and is a core construct underlying the initiation and maintenance of pathological anxiety. Recent evidence suggests that reducing AS may be critical for the prevention and treatment of anxiety across diagnostic categories. Exposure therapy, an important component of cognitive behavioral therapy (CBT), is one of the most effective treatments for reducing AS, and has been shown to improve symptoms across a number of different anxiety disorders. Meta-analyses reveal an approximately 50% treatment response rate, with the remaining half of patients showing either no response or dropping out of treatment early. Unfortunately, there is a paucity of research exploring which variables predict treatment outcome and there are currently no tests for predicting which patients would benefit the most from exposure therapy. In this study, participants will complete two sessions of a carbon dioxide (CO2) habituation paradigm, a safe and noninvasive physiological test that entails repeated exposures to single vital capacity inhalations of 20% CO2. Both CO2 testing sessions will be completed within a 72-hour time period. Patients then complete a 10-week group-based exposure therapy to determine whether an individual's degree of habituation to CO2 predicts treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-V diagnosis of an Anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia)
2. Anxiety Sensitivity Index (ASI-3) total score \> 29
3. Overall Anxiety Severity and Impairment Scale (OASIS) score \> 8
4. Between 18-55 years of age
5. Subject must be "treatment-seeking" and willing to enroll in the 10-week group-based Exposure Therapy

Exclusion Criteria:

1. Comorbid Bipolar Disorder, Schizophrenia, Anorexia or Bulimia Nervosa, or Obsessive-Compulsive Disorder
2. Current Substance Use Disorder \> moderate (within the past 6 months)
3. Currently taking a psychotropic medication
4. Currently receiving psychotherapy/counseling for anxiety
5. Currently being treated as an inpatient
6. Active suicidal ideation with intent or plan
7. History of neurological, cardiovascular or respiratory problems (e.g., asthma, severe brain injury)
FLUENCY® PLUS in the Treatment of Peripheral Artery Disease

This is a retrospective, multi-center study to assess the safety and performance by proactively reviewing pre-existing medical records and imaging of patients who had previous placement of FLUENCY® PLUS Vascular Stent Graft in iliac artery vessel(s) between January 2010 and March 2020.

The purpose of this study is to retrospectively collect and analyze data on the FLUENCY® PLUS Vascular Stent Graft to summarize and describe real-world experience, and long-term data regarding its safety and efficacy and to compare these findings with published data on stent-treatment in iliac artery disease. The present study aims to collect clinical data about FLUENCY® treatment of atherosclerotic disease (stenosis, occlusion, dissection) as well as to explore safety and effectiveness data for off-label use in additional indications in the iliac segment that have been described in the scientific literature (vessel rupture, aneurysm).

Eligibility Criteria:
Inclusion Criteria:

* The FLUENCY® PLUS Vascular Stent Graft implantation procedure was for the purpose of lesions in the iliac arteries.
* The FLUENCY® PLUS Vascular Stent Graft was placed between January 2010 and March 2020.
* Male or female ≥ 18 years old at the time of implantation.
* The subject provides written informed consent. The subject may be enrolled without informed consent for anonymous data collection if the responsible Ethics Committee has waived the requirement due to the retrospective study design, and written documentation about this decision is provided to the Investigator and the Sponsor.

Exclusion Criteria:

* The FLUENCY® PLUS Vascular Stent Graft was implanted in an anatomic location other than iliac arteries.
* Absence of a target lesion (i.e. diseased or damaged artery) in the area covered by the FLUENCY® PLUS Vascular Stent Graft.
* Subjects without any existing follow-up information after hospital discharge (This criterion does not apply to subjects who deceased during implantation/prior to discharge).
* The subject was identified with a medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol, or confound the data interpretation.
Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program

This study will test the newly-developed My spinal cord injury (SCI) Toolkit program in two formats - unguided use of the program and use supported by a coach. These two active treatment formats will be compared to treatment as usual (waitlist control) in adults with chronic pain and SCI.

Hypotheses include:

* Treatment adherence, participant satisfaction, and perception of positive change will be high and drop-out rates low for both treatments but will be better in the coached compared to the unguided arm
* In terms of pre- to post-treatment changes in pain interference, coached My SCI Toolkit program will be superior to treatment as usual

All participants will also be asked to complete online surveys at baseline (before being randomized to a group), half-way through the 8-week study period, and after the 8-week study period is over. The surveys are online and can be completed from home. Participants in the unguided and coached programs will also be asked to complete a weekly online survey asking about use of the website in the past week, taking approximately 5 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SCI (all injury levels included);
* Average pain intensity over the past 3 months greater or equal to (≥) 4/10 on 0-10 numerical rating scale
* Fluent in English and able to read English at a 6th grade level
* Access to internet connected device (phone, tablet, computer) and telephone
* Willingness to maintain stable analgesic regimen during study period

Exclusion Criteria:

* Currently in inpatient care or intensive outpatient physical therapy
* Significant cognitive impairment as indicated by scores ≥2 on cognitive screener
Nursing Care Management of External Fixation in Hospitalization: Pin Site Infection Incidence

The incidence of pin site infection is related to the nursing management of external fixation.


Eligibility Criteria:
Inclusion Criteria:

* 18 year old patients

Exclusion Criteria:

* Immune Depression
* Patients who are treated with immunosupressive drugs or steroids
Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum

The aim is to investigate the efficacy of mirtazapine and ondansetron as treatment for hyperemesis gravidarum(HG).

The setup is a double-blind multicenter trial where patients suffering from HG will be randomized to treatment with either mirtazapine, ondansetron or placebo (1:1:1).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained before any trial related procedures are performed
* Female age \>18 years
* Pregnant woman with gestational age between 5+0 and 19+6
* Nausea and vomiting without other obvious reason
* PUQE-24 score ≥13 OR PUQE-24 score ≥7 AND

  1. weight loss \>5% of pre-pregnancy weight and/or
  2. hospitalisation due to nausea and vomiting of pregnancy
* Singleton pregnancy
* The subject must be willing and able to comply with trial protocol

Exclusion Criteria:

* Mola pregnancy, multiple gestation or non-vital pregnancy
* Nausea and vomiting of other aetiology than NVP
* Allergic to selective 5-HT3-receptor antagonists
* Ongoing treatment with antidepressant medication
* Pre-existing diagnosis of chronic kidney disease, diabetes type 1 or 2, significant cardiac disease (incl. long QT syndrome), epilepsy, HIV. In case of other pre-existing conditions subjects might be excluded based on individual assessment by an MD
* Elevated liver enzymes (ALAT\>150 U/l)
* Elevated creatinine (\>100 µmol/l)
* ECG showing long QT-syndrome (QTc \>460msek)
* Weekly alcohol intake \>2 units of alcohol
* Not able to take medicine orally
* Not able to understand spoken and/or written Danish
* Participation in another investigational drug trial within current pregnancy