cyrilzakka/clinical-trials huggingface dataset:
Midodrine Use in Septic Shock

The investigators aim to perform a randomized, double-blind, placebo-controlled trial to investigate the efficacy of midodrine in decreasing time to IV vasopressor liberation in patients with septic shock.

A growing body of literature comprising largely retrospective data seems to support the safety and efficacy of midodrine in the intensive care unit for decreasing IV vasopressor use. The investigators hypothesize that administration of midodrine in the early phase of septic shock in patients with adequate enteral access will result in a significant decrease in time to IV vasopressor liberation (increase in vasopressor-free days), secondarily resulting in decreased central venous catheter dwell times and intensive care unit length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18-89 years old
* Admitted to UVA medical ICU with diagnosis of septic shock.
* Patients requiring at least 5 mcg/min norepinephrine infusion (or equivalent) for blood pressure support for at least 3 hours
* Patients with enteral access established within 12 hours of admission (either able to swallow, or feeding tube in place)

Exclusion Criteria:

* Pregnant females; (due to the potential adverse effects to an unborn child); patients with childbearing potential will have results of pregnancy test checked (which is routinely performed on admission); should the patient have child-bearing potential and the pregnancy status is not checked as part of routine care, such patients will be excluded from the study (i.e. pregnancy testing will not be performed for research purposes)
* Patients \< 18 years
* Prisoners
* Patients already taking midodrine
* Patients with cirrhosis of the liver as defined by either biopsy, imaging findings of cirrhosis AND thrombocytopenia or patients otherwise undergoing liver transplant evaluation
* Patients with Increased intraocular pressure and glaucoma
* Patients with allergy to midodrine
* Non-English speaking patients, due to the narrow time-frame for study enrollment and execution of study protocol, employing interpreters is deemed to be a significant burden on the investigators with potential to hamper study enrollment. Non-english speaking patients are not deemed to be adversely affected by exclusion from study as there is no clear a priori reason why study results would not also apply to non-English speakers.
* Patients without enteral access within 12 hours of initiation of IV vasopressors
* Patients where the attending physician does not clinically intend to target a mean arterial pressure of \> 65 mmHg
* Patients with pheochromocytoma or thyrotoxicosis
* Patients with active bowel ischemia
HemFitBit, an Observational Study of Physical Activity in People With Moderate and Severe Haemophilia A

The study aims to describe physical activity (PA) levels in young people with haemophilia A in Norway compared with non-haemophilia controls, and to identify factors influencing PA. This will be conducted through an observational study measuring PA over 12 weeks. Forty young people with moderate and severe haemophilia A will be enrolled. PA data will be compared to demographically and seasonally matched non-haemophilia controls. PA will be measured using the activity tracker Fitbit Charge 3. A subgroup of participants will also wear the hip-worn accelerometer ActiGraph GTX+BT for seven consecutive days in order to validate the two devices against each other.


Eligibility Criteria:
Inclusion Criteria:

* moderate or severe haemophilia A
* no inhibitor
* on continuous prophylaxis

Exclusion Criteria:

* current inhibitor
Identifying Risk Factors for Developing AKI in Sepsis

A study to evaluate the prevalence of Acute Kidney Injury (AKI) in patients with Diabetic Ketoacidosis (DKA) and sepsis using data collected prospectively to a patient registry. The primary objective is to compare the prevalence of AKI in sepsis and DKA in different age groups in children and investigate the difference in the prevalence of hyperchloremia in the two groups.Secondary objectives are Compare the prevalence of AKI in sepsis and DKA in different age groups in children and investigate the difference in the prevalence of hyperchloremia in the two groups.

It is a descriptive study to report the prevalence ofAcute Kidney Injury ( AKI) in the two cohorts of sepsis and Diabetic Ketoacidosis ( DKA). In addition we aim to evaluate the relation with hyperchloremia. In both groups, attempts will be made to evaluate the association of risk factors such as severity of dehydration/shock and hyperchloremia with AKI in the two groups.

Data will be analysed using SPSS software. Categorical variables will be analysed using Chi-square test and if appropriate, multiple logistic regression analysis. Continuous variable will be analysed with Student's T test and if possible, by linear regression modelling. The differences between the two groups may analysed using Analysis of Variance (ANOVA).

The study will collect anonymous data from 2015 to 2020 from the Paediatric Intensive Care Audit Network (PICANet) database for a tertiary PICU servicing the pediatric population of Wales.This data is submitted prospectively for audit of clinical outcomes of children admitted for paediatric intensive care in the United Kingdom. The study was reviewed by the Institutional Research and Development department and was given exemption for ethics committee review as it does not involve direct patient contact and the data is anonymous. Approval was obtained from the relevant database manager, institutional information governance department as well as the Health Care Research Wales.

Eligibility Criteria:
Inclusion Criteria

* Children under 16 years and admitted to PCCU or wards in the past 5 years
* Diagnosis of DKA or Sepsis/severe bacterial infection/septic shock

DKA - defined as per the British Society for Paediatric Endocrinology and Diabetes (BSPED) guidance. Sepsis is defined based on the International Pediatric Sepsis Consensus Conference guidance (2005)

8.3. Exclusion Criteria

* Any patients identified as above but not able to obtain case notes for any reason.
* Patients with pre-existing kidney conditions
* Patients with inborn errors of metabolism
Mesh Stents Study in ILIAC Complex Lesions (IMS-Study)

The main objective of the IMS-Study is to evaluate the short and long-term safety and efficacy of mesh stent implantation in patients with stenotic iliac disease with complex plaques or lesions containing thrombotic material.

Iliac artery disease may include complex lesions with a vulnerable plaque and containing thrombotic materials. The treatment of these complex plaques is frequently complicated with local, acute occlusion, dissection and distal embolisation.

Studies with a mesh stent in the carotid region have shown a reduced risk of peripheral embolization. The use of mesh stents in iliac arteries can provide similar benefits. The structure of the stents, sizes, and the release system do not require any changes. The study is to assess the usefulness of mesh stents in preventing peripheral embolisation.

Eligibility Criteria:
Inclusion Criteria:

* General Inclusion Criteria (principal):

  * Patients older than 18 years, after Vascular Team evaluation, according to local standards, eligible for Iliac artery
  * Written, informed consent to participate
  * Agreement to attend Protocol required (standard) follow up visits and examinations
* Angiographic Inclusion Criteria (principal):

  * De novo iliac stenosis
  * Stenosis eligible for endovascular treatment per Vascular Team evaluation (according to current standards and guidelines)
  * High-risk morphology stenosis with complex/thrombotic lesions (per 1 independent, experienced operator).

Exclusion Criteria:

* General Exclusion Criteria (principal):

  * Life expectancy \<1 year (e.g., active neoplastic disease).
  * Chronic kidney disease with creatinine \> 3.0 mg/dL.
  * Coagulopathy.
  * Contraindication for decoagulation
  * History of uncontrolled contrast media intolerance
  * Myocardial infarction in 72 hours preceding the stenting procedure (if possible, postponing the procedure)
  * Stroke in 6 weeks preceding the stenting procedure (if possible, postponing the procedure)
  * Pregnancy (positive pregnancy test)
* AngiographicExclusion Criteria (principal):

  * Chronic total occlusion not amenable to re-canalization
  * Stent in the target vessel/lesion
  * Anatomic variants precluding stent implantation
  * Mobile (free-floating) plaque elements in aorta or arteries proximal to the target lesion
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.


Eligibility Criteria:
Inclusion criteria:

* Chronic hepatitis C viral infection
* Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
* HCV genotype 2 or 3
* No previous treatment for hepatitis C infection

Exclusion criteria:

* Evidence of cirrhosis at the time of screening
* Evidence of hepatocellular carcinoma at the time of screening
* Any other cause of relevant liver disease other than HCV
* Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
* Other protocol-defined inclusion/exclusion criteria may apply
Role of Epicardial Adipose Tissue in Coronary Artery Disease

We sight to evaluate whether patients with coronary artery disease (CAD) have more epicardial fat than patients without CAD, which would suggest that epicardial fat may be more than an "innocent bystander" and be actively involved in the disease process. Its role as a modulator of vascular response and myocardial function could potentially lead to new areas of cardiac research. We also sight to evaluate whether epicardial fat from patients with CAD releases more adipokines than subcutaneous fat from these patients which could prompt studies into the differential regulation of adipokine secretion in this tissue. Thus for e.g., the use of thiazolidinediones (glitazones), statins, ARBs or other compounds that can specifically modulate adipokine secretion could be explored to determine their benefit in ameliorating the effects attributable to increased epicardial fat.


Eligibility Criteria:
Inclusion Criteria:

* All patients elegible for elective cardiac surgery are elegible
* Ability to provide written informed consent in accordance with GCP guidelines and local legislations.
* \> 18 years of age

Exclusion Criteria:

* Control patients will not have clinical signs of CAD and will show normal coronary arteries on angiography.
* Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.
Implantable Device for Male Reproductive Sterilization

The study is to evaluate a device for male reproductive sterilization and determine if this device is successful at blocking the sperm.

Ninety subjects from two centers in the United Stated will be followed closely for 24 months.

If you are someone interested in a vasectomy, you may be eligible to participate in this clinical study.

This feasibility study is intended to collect pertinent clinical information on the use of the Shepherd Medical Intra Vas Device (IVD) necessary to support the design of a future pivotal study. The IVD is intended to occlude the vas deferens and thus accomplish male reproductive sterilization and to offer an additional method to vasectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Subject desires to undergo a vasectomy.
2. Freely consents to participate in the Study a
3. Agrees to provide a semen sample at regularized periods for at least 30 months.
4. Willing to use a redundant method of contraception until successful occlusion is confirmed.
5. Agrees to provide follow-up information.
6. Willing and able to understand and agree to follow all aspects of the procedures and Study requirements.
7. At least 18 years of age.

Exclusion Criteria:

1. Has a condition permanently or temporarily making participation in the Study inadvisable.
2. Has a condition permanently or temporarily making a vasectomy inadvisable.
3. Has had a previous successful/unsuccessful vasectomy.
4. Has had an allergic reaction to silicone and/or ethylene.
Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and Digoxin

To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)


Eligibility Criteria:
Inclusion criteria:

* healthy male subjects
* age of 18 to 50 years
* body mass index (BMI) of 18.5 to 29.9 kg/m2
* Subjects must be able to understand and comply with study requirements

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm at screening
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Endobiotics for Phenotyping of Human Cytochrome P450 Enzymes

CYP2D6 metabolizes \~25% of all marketed drugs. There is an important variability in the activity of this enzyme among individuals. The cause of this variability might be environmental, genetic, ethnical or even related to a disease. The administration of a CYP2D6 probe drug (e.g. dextromethorphan) is a good way to characterize CYP2D6 phenotype. Nonetheless, it is relatively invasive and the vulnerable population (e.g. pregnant women) cannot be phenotyped in this manner. Therefore, finding an endogenous substance which is metabolized by CYP2D6 could replace usual phenotyping procedure using a probe drug. This study evaluates the impact of a CYP2D6 inhibitor and of genetic polymorphism on the metabolome of healthy volunteers in order to identify new CYP2D6 biomarkers. To this end, untargeted metabolomics analysis using LC-HRMS will be performed on plasma and urine samples This single-centre open-label clinical trial will include 40 healthy subjects (men and women) between 18 and 65 years. Eligible participants will be assigned to a study group according to their CYP2D6 genotypes: poor metabolizers (PMs) and extensive/ultrarapid metabolizers (EMs-UMs). Two sessions will take place for each subjects.

Session 1: CYP2D6 phenotyping (dextromethorphan 5 mg, single dose) Session 2: idem session 1 with prior uptake of a CYP2D6 inhibitor (paroxetine 10 or 20 mg, one dose a day for 7 days).

In both sessions, urine will be collected up to 24 hours and capillary/venous blood will be sampled before phenotyping for metabolomics analyses. Urine will also be collected for 4 hours after dextromethorphan intake in order to phenotype the CYP2D6 enzyme.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Age 18-65 years
* Body Mass Index (BMI) 18-27
* Understanding of French language and able to give a written inform consent
* CYP2D6 genotype : activity score = 0 (PMs) or activity score ≥ 1 (EMs-UMs)
* Reliable contraception during the whole study, including a barrier method

Exclusion Criteria:

* Participation in any other interventional clinical study within 3 months prior to inclusion
* Pregnant or breastfeeding woman
* Any pathologies, use of drugs or food that may affect CYP activity (based on the 'drug interactions and cytochromes P450' table published by the Service of Clinical Pharmacology and Toxicology, HUG54 and on the investigator's knowledge)
* Regular smokers of ≥ 10 cigarettes/day
* Alcohol intake 2 days prior to session 1 and during paroxetine intake
* Medical history of chronic alcoholism or abuse of psychoactive drugs
* Regular use of psychotropic substances
* Sensitivity to any of the drugs used
* Alteration of hepatic tests (ASAT, ALAT, BILI, GGT) more than 3x normal
* Psychiatric disorders
* Beck Score ≥10 (question related to suicide \>0)
Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

The purpose of this study is to determine whether the use of negative pleural suction in tube thoracostomy is more effective than water seal alone for the treatment of pneumothorax and/or hemothorax in patients with chest trauma.


Eligibility Criteria:
Inclusion Criteria:

* Pneumothorax after penetrating o blunt chest trauma
* Hemothorax after penetrating o blunt chest trauma
* Hemopneumothorax after penetrating o blunt chest trauma
* Require tube thoracostomy

Exclusion Criteria:

* Invasive mechanical ventilation
* Emergent Surgery (thoracoscopy, open thoracotomy)
* Chronic pulmonary diseases (COPD, CRPD)
* Severe traumatic brain injury
* Glasgow coma scale upon arrival \<8/15
A Study of ONO-1110 in Patients With Postherpetic Neuralgia

To evaluate the efficacy and safety of ONO-1110 in Japanese patients with postherpetic neuralgia


Eligibility Criteria:
Inclusion Criteria:

* Japanese (both sexes)
* Age (at the time of informed consent): 18 years and older
* Outpatient
* Patients with persistent pain ≥3 months (90 days) after the onset of herpes zoster
* Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator)

Exclusion Criteria:

* Patients who previously underwent neurodestruction or neurosurgical therapy for PHN
* Patients with pain other than PHN that may affect assessments in this study
* Patients with any skin condition related to the site of herpes zoster that may affect assessments in this study
* Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
* Patients with concurrent psychiatric diseases that may affect assessments in this study
A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Study PCYC-1112-CA is a randomized, multicenter, open-label, phase 3 study of the Bruton's Tyrosine Kinase (BTK) inhibitor Ibrutinib (PCI-32765) versus Ofatumumab in patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

Patients randomized to the ofatumumab arm may be considered to receive next subsequent therapy with ibrutinib.

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0-1.
* Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.
* Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.
* Must have received at least one prior therapy for CLL/SLL.
* Considered not appropriate for treatment or retreatment with purine analog based therapy.
* Measurable nodal disease by CT.
* Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study.

Exclusion Criteria:

* Known CNS lymphoma or leukemia.
* No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug.
* Any history of Richter's transformation or prolymphocytic leukemia.
* Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP).
* Prior exposure to ofatumumab or to ibrutinib.
* Prior autologous transplant within 6 months prior to first dose of study drug.
* Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.
* History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
* Serologic status reflecting active hepatitis B or C infection.
* Unable to swallow capsules or disease significantly affecting gastrointestinal function.
* Uncontrolled active systemic fungal, bacterial, viral, or other infection.
* History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
* Requires anticoagulation with warfarin.