cyrilzakka/clinical-trials huggingface dataset:
LUKS-Leads Registry on Long-term Performance of ICD Leads

All patients having an implantable cardiac defibrillator (ICD) implanted and having follow-up at the Cantonal Hospital Lucerne (LUKS), the investigator center, are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.

All patients having an ICD implanted and having follow-up at the investigators center are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.

The following parameters will be measured during regular clinical controls: electronic impedances, threshold values, sensing values, battery performance, inadequate/adequate shock release und software problems

Eligibility Criteria:
Inclusion Criteria:

* all patients being implanted with a Defibrillator lead from 2006 onwards

Exclusion Criteria:

* documented refusal of data collection for scientific purposes
Understanding Pain Perception in Osteoarthritis

Osteoarthritis (OA)is a painful and disabling disease, predicted to be the fourth largest cause of disability worldwide by 2020. It commonly affects the hip or knee ultimately resulting in total joint replacement. In order to assess disease progression and plan surgery, x-rays are taken as part of routine practice. However x-rays provide limited information about formation of substructures and changes occurring during progression of disease. The proposed study aims to invite patients with OA of the hip or knee to participate in detailed examinations of their pain and their painful joint through interviews, blood and urine samples taken, MRI magnetic resonance imaging)and donating their waste tissue after joint surgery (all of old joint). Informed patient consent will be sought in all cases.

The patient will be asked for permission for a clinician to access their notes for information relevant to the research, including full medical history, their sex and date of birth. Tissue obtained from joint replacement surgery at St. George's Hospital and transferred to St.George's, University of London where it will be prepared for various experiments including looking at the genes and proteins in people with osteoarthritis. The blood and urine samples will also be taken to St. George's, University of London, and prepared for studies on the genes and proteins in people with osteoarthritis. All samples provided will be anonymised with no patient details on the samples and stored in locked freezers, in locked labs. at St.George's, University of London.

Eligibility Criteria:
Inclusion criteria:

Inclusion Criteria for OA patients:

Study participant will be recruited from rheumatology outpatient clinics and primary care:

1. fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
2. male or female,
3. symptomatic knee pain
4. on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
5. participants between 35 and 90 who will be undergoing knee replacement surgery or arthroscopy for osteoarthritis or knee surgery for fractured tibia/femur/fibula with osteoarthritis

Inclusion criteria for Early OA Patients

Study participant will be recruited from rheumatology outpatient clinics and primary care:

1. fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
2. male or female,
3. symptomatic knee pain
4. on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
5. Participants between 35 and 90 who have osteoarthritis but will not be undergoing knee surgery

Inclusion criteria for Healthy control subjects

1. Participants aged between 35 and 90 who do not have knee pain or osteoarthritis as a comparator group
Estimation of Autonomic Nervous System Modulation by Pulse Plethysmographic Analysis

Novel pulse plethysmography-derived indexes has been proposed as a tool to measure autonomic nervous system modulation in anaesthetized and awake patients, but nowadays a physiologic validation is lacking. We aim to examine the effects of sympathetic stimulation on pulse plethysmographic amplitude (PPGA), autonomic nervous system state (ANSS) and autonomic nervous system state index (ANSSi).

It has been supposed that indexes derived from pulse plethysmographic analysis -the autonomic nervous system state (ANSS) and ANSS index (ANSSi)- may be useful tools to measure the autonomic nervous system (ANS) activity but, to date, physiologic experimental evidences are lacking.

Traditionally,it is widely accepted that ANS modulation and the baro-reflex control can be non-invasively studied through heart rate variability (HRV) and systolic variability analyses.

The aim of this study is to assess if PPGA-derived indexes are able to detect changes of ANS system modulation directed to heart and vessels.

Changes in position of patients lead to changes in the balance of the ANS. One of the most used manoeuver to stimulate ANS is head-up tilt (HUT). Tilt causes pooling of blood toward lower body and reduces the venous return to the heart. These activation of ANS leads to an increase of heart rate and peripheral vascular resistance aiming to maintain arterial pressure near to the level preceding the challenge (baro-reflex control).

Methods: we study the effects of sympathetic stimulation on ANSS and ANSSi induced with two different tilt at 45 and 90 degrees angles. We compare the ANSS and ANSSi with HRV analysis and baro-reflex control analysis. We plan to study 7 volunteers to detect a difference of 30 (standard deviation of 15) between the mean of ANSS and ANSSi at baseline and during tilt, with a power of 80% and alfa error of 5%.

Eligibility Criteria:
Inclusion Criteria:

* adult healthy humans (american society of anesthesiologists class I)
* age between 25 and 35 years old
* no assumption of any drug, beverages containing caffeine or alcohol during the previous 24 hours
* fasting 3 hours before the study protocol

Exclusion Criteria:

* american society of anesthesiologists class \>1
* age \<25 or \>35 years
* pregnancy
* accidental discover of non sinus cardiac rhythm or ectopic beats \>5%
Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis

The goal of this clinical trial is to learn if ultrasonication-mediated microbubbles dressing works to treat hand arthritis in adults. It will also learn about the safety of ultrasonication-mediated microbubbles dressing. The main questions it aims to answer are:

Does ultrasonication-mediated microbubbles dressing increase the therapeutic efficacy of piroxicam gel for hand arthritis?

Researchers will compare "ultrasonication-mediated microbubbles dressing + piroxicam gel " to "ultrasonication + piroxicam gel" and "piroxicam gel alone" to see if ultrasonication-mediated microbubbles dressing works to treat hand arthritis.

Participants will:

Take "ultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7) ", "ultrasonication (day 1,3,5) + piroxicam gel (day 2.4.6.7)", and "piroxicam gel alone (day 1-7)" for 1 week.

Visit the clinic on day 1 and day 8 for checkups and tests Keep a diary of their symptoms


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hand arthritis
* Have at least three symptomatic joints over wrist, metacarpophalangeal joints, and interphalangeal joints

Exclusion Criteria:

* Infectious arthritis
* Acute gout
Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma

The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 18 years and \<=70 years of age.
* at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence.
* tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis.
* Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
* No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
* Hb ≥90g/L,white blood cell count ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
* Patients who can understand this trial and have signed information consent

Exclusion Criteria:

* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
* Patients with other diseases which may affect the treatment mentioned.
* Patients with a medical history of other malignant tumors.
* Subjects participating in other clinical trials.
* liver function:Child C.
* no pathological evidence of hepatocellular carcinoma.
Rates of Apnea in Patients Undergoing Vitreoretinal Surgery

The purpose of this study is to determine if apnea (the stopping of breathing) occurs in patients undergoing undergoing monitored anesthesia care (MAC) for vitreoretinal surgery

Patients undergoing vitreoretinal surgery will be monitored during the procedure to determine if they stop breathing. This study is observational in nature and no interventions will be made.

Eligibility Criteria:
Inclusion Criteria:

* patients having vitreoretinal surgery under monitored anesthesia care

Exclusion Criteria:

* patients having vitreoretinal surgery without monitored anesthesia care
Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.

The study is designed to compare renal toxicity of Iodixanol and Iopromide after coronary angiography or percutaneous coronary intervention (PCI) in patient with Chronic Kidney Disease, considering original renal function and adequate hydration. The risk of varying degree of renal impairment, changes of serum Cys C level will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Provides written Informed Consent and is willing to comply with protocol requirements
* Is referred for cardiac angiography, with or without PCI
* Has a documented predose serum creatinine level of 1.5～3.5 mg/dl for men and 1.3～3.0 mg/dl for women
* Serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment)

Exclusion Criteria:

* Has a history of hypersensitivity to iodine-containing compounds
* Has end-stage renal disease
* Has kidney transplantation
* Has creatinine clearance rates \>60 ml/min in last 3 months
* Has acute coronary syndrome with heart failure(above class II in accordance with Killip or class III in accordance with the classification of the New York Heart Association (NYHA)) and shock
* Patients with cancer
* Has diabetes with serious complications, other kidney organs
* Patients with serious blood system disease
* Heart failure \[class III\~Ⅳ in accordance with the classification of the New York Heart Association (NYHA) and (or) pulmonary edema\]
* Patients with hepatic insufficiency\[3 times as ALT and (or) AST normal reference value limit\]
* Has received an iodinated contrast agent within 14 days prior to the administration of the study agent
* Is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent
* Has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months
* Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure
* Patients with hypotension \[(SBP\<80 mmHg for over 1h and needing Medication or intraaortic balloon counterpulsation(IABP) \]
* Uncontrolled condition of hyperthyroidism
* pregnancy or lactation
* Is planned to receive the drugs without permission in this protocol
* Participating in another intervention research study in last 3 months
* legally incapacitated or limitations
* Any other conditions not suitable to be enrollment
Evaluation of Tracheal Pressure During CPAP

This trial evaluates tracheal pressure values in intubated intensive care unit patients during continuous positive airway pressure without any ventilatory support, automatic tube compensation and assisted spontaneous breathing.

Aim of this trial is to investigate if there are any significant differences between airway and tracheal pressure values during continuous positive airway pressure (CPAP) ventilation. For this purpose, a tracheal pressure measurement catheter is inserted into the tracheal tube and the obtained values are compared with the corresponding airway pressure measured on the ventilator. To further evaluate the impact of mild respiratory support automatic tube compensation and assisted spontaneous breathing with 4 cmH2O will be applied and measured pressure values compared as well.

We hypothesize that tracheal pressure will be significantly lower than airway pressure values during inspiration, which represents the primary outcome measure. Secondary outcome parameters include comparison of expiratory and mean pressure values of airway and tracheal pressure. Additionally, effects of mild respiratory support will be evaluated as well.

Measurement of inspiratory tracheal pressure might allow to calculate the pressure drop between the airway pressure at the Y-piece of the ventilator and the pressure at the trachea. Currently it is not known, if this pressure drop is significant during CPAP, which represents the rationale to perform this pilot study. In a second step it would be possible to determine if the recorded pressure drop can be used as a surrogate parameter for the respiratory drive in terms of a risk assessment for the development of patient self-inflected lung injury.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥ 18 years
* Intubated patient during CPAP without pressure support
* Informed consent

Exclusion Criteria:

* Female subjects known to be pregnant
* Known participation in another clinical trial
* Critical pulmonary state (paO2/FiO2 ratio \<100)
A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin

The primary purpose of this study is to determine whether the treatment with AZD9668 will affect the metabolism and effect of Warfarin.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent (including genotyping screening sample for CYP2C9 and VKORC1) prior to any study specific procedures
* Subjects must be willing to use a barrier method of contraception, unless their partners are post-menopausal or surgically sterile, or if a female partner is of childbearing potential the subject must use a barrier method of contraception (condom) and the partner must use accepted contraceptive methods (oral contraceptive, implant, long term injectable contraceptive or intrauterine device), from first dose of IP (warfarin and AZD9668) until 3 months after last dose of IP (warfarin and AZD9668)
* Have a body mass index between 19 and 30 kg/m2 (inclusive) and a weight between 50 and 100 kg (inclusive)
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1.

Exclusion Criteria:

* Any clinically significant disease or disorder
* Subject predicted to have high sensitivity to warfarin based on CYP2C9 and VKORC1 genotypes
* Any clinically relevant abnormal findings in physical examination
Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)

This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C) more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM with inadequate glycemic control on acarbose monotherapy.

The study includes an 8-week antihyperglycemic agent (AHA) wash-off period\* (which includes a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment period. All participants will receive open-label acarbose at a minimum dose of 50 mg three times daily (t.i.d.) during the run-in and treatment periods.

\*: Wash-off only applicable to patients who were on acarbose and another AHA.

Eligibility Criteria:
Inclusion Criteria:

* has T2DM and is on acarbose alone at a stable dose of at least 50 mg t.i.d.(three times a day) for at least 10 weeks or on acarbose at a stable dose of at least 50 mg t.i.d. (three times a day) for at least 10 weeks in combination with another antihyperglycemic agent (AHA)
* is at least 18 years of age (for participants in India: between 18 and 65 years of age)
* male or female who is unlikely to conceive (not of reproductive potential, or agrees to remain abstinent or use \[or have partner use\] acceptable birth control if of reproductive potential)

Exclusion Criteria:

* has a history of type 1 diabetes mellitus
* use of thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, or insulin
* has the following cardiovascular disorders: acute coronary syndrome; new or worsening symptoms of coronary heart disease; coronary artery intervention; stroke or transient ischemic neurological disorder
* has liver or kidney disease
* has cancer or any clinically significant disease or disorder as judged by the Investigator
The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients

The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years to 75 years
* Subjects requiring treatment for a clinical diagnosis of cervical dystonia
* Willing to provide written informed consent before any study-related procedures.

Exclusion Criteria:

* Patients with pure anterocollis
* Patients with an anaphlyactic response history to botulinum toxin type A.
* Patients who have been treated with botulinum toxin type A within 3 month.
* Females who are pregnant, planning pregnancy, unable to use contraception or lactating.
* Any medical condition that may put the subject at increased risk with exposure to botulinum toxin at the discrimination of investigators.
Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation

we compared the effect of 3 different kinds of liquids (water, Oral Rehydration Salt 3 and white granulated sugar water) intake in Vasovagal Reaction After Whole Blood Donation

Vasovagal reaction is the most common type of blood donation reaction. The main cause of this reaction is the decrease of blood volume. Therefore, fluid supplement before blood donation has been proved to be effective in preventing the vagal reaction after blood donation. It was proved that isotonic (sugar \& salt) drink intake before blood donation had a significant effect on reducing vasovagal reaction.

However, in 2002, WHO recommended the new reduced osmolarity rehydration formula with better taste. Oral Rehydration Salt 3 has been produced according to WHO formula with standard ingredient and easy to prepare. In addition, in Guangdong culture, sugar water is regarded as a tonic, more easily accepted. So, the aim of our study was to compare the effects of 500 ml water with Oral Rehydration Salt 3, white granulated sugar and conventional recommended water intake prior to blood donation on blood donation reaction after whole blood donation, in order to understand the effect of different liquid supplement on blood donation reaction and the willingness of blood donation again.

Eligibility Criteria:
Inclusion Criteria:All blood donors donated whole blood in Guangzhou Blood Center during study.

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Exclusion Criteria:Blood donors who were deferral by blood screening result and other situations.

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Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing

The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer.

The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer. Once selected for the study and with full informed consent, patients will have a blood draw to allow the detection of cancer-related genomic alterations that are detectable within the blood sample. These results will be compared to results obtained from genomic profiling via standard tissue biopsy taken as part of routine care to help determine whether such 'liquid biopsies' can be used to guide treatments in future patients. The results of the liquid biopsy will not be used to guide treatment decisions in study participants.

In addition there is data-collection of treatments received for non small cell lung cancer and the response to these treatments during the first 6 months post tissue and blood analysis, though no additional visits or procedures are required for the patient beyond the initial blood draw.

Eligibility Criteria:
Inclusion Criteria:

* Written, signed and dated informed consent to participate in the study must be given by the patient in accordance with 21 CFR Part 312, the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6, and applicable regulations, before completing any study-related procedures.
* Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
* Arms A and B: Patients intended to initiate first-line treatment according to standard guidelines. Note, a patient is eligible to receive sterotactic radiosurgery (no whole-brain radiotherapy). Arm C: Patients who are at a second-line treatment setting or greater may participate. Note, a patient may be included if they have metastatic brain lesions. Arms A, B, C: If enrolled in a treatment clinical trial, patients may also enroll in this study if all eligibility criteria are met.
* Arm A only: Patients intended to initiate first-line treatment according to standard guidelines who plan to have or have had a recent tumor tissue biopsy taken for molecular profiling as part of their standard of care.
* Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions.

Exclusion Criteria:

* Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy (Arms A and B)
* Patients who have any other prior metastatic or current second primary cancer (Arms A and B)
* Patient who has a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.