cyrilzakka/clinical-trials huggingface dataset:
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

The purpose of this Pilot feasibility study is to find out the effect of different behavioral treatments along with different duration of a drug called varenicline, on smoking behavior and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that has been shown to help people quit smoking.

Following the initial telephone screening, eligible participants will be scheduled for a screening evaluation session.

Following the screening evaluation, participants who pass the medical screening and meet all other inclusion criteria will be scheduled for their first assessment and then randomized to receive standard varenicline (SV), extended varenicline (EV), or extended varenicline plus facilitated extinction (EV + FE). The randomization list will be generated by the study statistician. It will be stratified by gender and will employ a variable block randomization that will guarantee that the arms are balanced when a given block is filled.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Smoke at least 10 cigarettes daily for the past year
* Expired-air carbon monoxide (CO) \> 8 ppm
* Medically eligible to receive varenicline
* Score at least a 5 on the Contemplation Ladder (Biener \& Abrams 1991), a measure of motivation to quit smoking.

Exclusion Criteria:

* Are pregnant or lactating
* Have renal dysfunction
* Have a history of seizures
* Are medically at risk in the judgment of the study physician
* Have ever used varenicline
* Have used other smoking cessation medications within the past three months
* Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders)
* Have substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview \[MINI\]; Sheehan et al 2015).
* We must limit the number of participants from the same street address to 1.
Quality of Life With TESTIM®

The present non-interventional study is to document the testosterone levels in patients with clinical symptoms such as loss of sexual desire indicating hypogonadism (testosterone deficiency syndrome). During testosterone replacement therapy with TESTIM®, the changes in the quality of life - especially with respect to motivation, activity and fatigue - of hypogonadal patients will be documented and correlated with the testosterone levels during the course of therapy.


Eligibility Criteria:
Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent

Exclusion Criteria:

* contraindications according to SPC
An Observational Cohort Study to Assess the Postop Activity of Colorectal Patients Undergoing Elective Surgery (PHYSPAL)

All participants will have a physical activity monitor placed onto the right thigh in the midline which will start collecting data at midnight on the first postoperative day. This will continue until discharge or day 7, whichever is earlier. This is a non-invasive measure of activity and can discriminate between whether a patient is lying, sitting, standing or walking. There is no control group.

Recruited patients from the colorectal clinic at the Royal Derby Hospital will be invited to be included in the study, and can either attend the University of Nottingham, Centre Of Metabolism, Ageing \& Physiology (COMAP) research group unit at the Royal Derby Hospital Centre or discuss the trial in detail over the phone after which a consent form will be sent to them (either by post or email). If they agree to inclusion in the study the consent form will be brought with them to be completed on the day of surgery. On the morning of surgery they will have their consent recorded and the activPAL™ accelerometer applied to the anterior thigh.

The activPAL™ is a non-invasive physical monitor that records periods spent, lying, walking and engaging in more strenuous activity. This will remain in situ for 7 days, or until discharge, whichever comes first. The investigators will ask participants to complete a short diary to note down any times the monitor is removed and the time of sleep and waking. After removal - the data is uploaded (it does not include any person-identifiable data) for analysis using software on a local computer in the COMAP unit. After discharge, they will have 2 x telephone calls and/or emails at day 10 and at day 28 to follow up from the research team to monitor progress for the next 30 days. If they develop any complications including readmission data within that time period, this will be collected from the participants' notes along with demographic data and postoperative pathology and recorded. Complications will be graded as per the Clavien-Dindo Classification system.

On postoperative day 3, day 5 and day 7 (if still an inpatient) they will also be asked to complete the Hospital Anxiety and Depression Scale (HADS) paper questionnaire. Just prior to discharge, they will complete the discharge questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and over
* Clinical diagnosis of colorectal cancer due to undergo surgical resection with curative intent
* Must be able to give informed consent

Exclusion Criteria:

* Lacking capacity to consent
* Undergoing emergency surgery
* Undergoing defunctioning surgery prior to neoadjuvant treatment
* Undergoing surgery with palliative intent
Different Reperfusion Timing and Ventricular Arrhythmias in STEMI Patients

The aim of this study was to investigate the association between different reperfusion timing and ventricular arrhythmias (VAs) to provide evidence for clinical decision-making for patients with ST-segment elevation myocardial infarction (STEMI). All the participants included in the study were diagnosed with STEMI according to the 4th universal definition of myocardial infarction, with a follow-up of 1, 6, 12 months, respectively. Symptom onset-to-reperfusion timing (SO2RT) and 24h-dynamic electrocardiogram parameters were recorded to compare different SO2RT and VAs during 3 follow-up visits.

It is Class I recommendation that STEMI require emergency revascularization with no delay. However, arrhythmias after acute myocardial infarction (AMI), particularly VAs, also occur in the early post-MI phase, leading to increased mortality. Previous studies have shown benefits of late reperfusion to electrical stability. The aim of this study was to investigate the association between different reperfusion timing and VAs to provide evidence for clinical decision-making for STEMI. In this multicenter, prospective, observational study, STEMI participants from July 2019 to December 2020 confirmed according to the 4th universal definition of myocardial infarction were enrolled, with a follow-up of 1, 6, 12 months, respectively. SO2RT was defined as the time interval between symptom onset and reperfusion timing which referred to the timing when coronary angiography showed Thrombolysis In Myocardial Infarction (TIMI) blood flow level 2\~3 immediately after percutaneous coronary intervention (PCI). The primary end point was VAs on 24h-dynamic electrocardiogram. Secondary outcomes included a composite of death from coronary heart disease, fetal of non-fetal ischemic stroke, revascularization, or chest pain requiring readmission.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients undergoing coronary angiography and PCI;
* can complete 3 follow-up visits well.

Exclusion Criteria:

* without PCI;
* undergoing thrombolytic therapy;
* mental diseases;
* renal failure;
* stroke sequelae;
* tumor and a history of revascularization.
Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study

The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart failure biomarker and changes in physical function quality of life, stress and anxiety.

This is a randomized, double-blind (patients and physicians), placebo controlled multi-center study to evaluate the effect of ertugliflozin 5mg once daily (p.o.) for 52 weeks on the ventricular arrhythmic burden and markers of physical and mental well-being as well as biomarker for Heart Failure with reduced Ejection Fraction (HFrEF) and heart failure with mid-range ejection fraction (HFmrEF) patients with ICD±CRT therapy. The study will be conducted in 8 experienced sites in Austria with an aim to enrol 402 patients to evaluate the overall study hypothesis.

Therefore, three study visits will be carried out (baseline, 1-year follow-up visit and a telephone visit 4 weeks after visit 2). As part of the two on-site study visits, study-specific measures, a blood sample and an echocardiographic examination will be performed. The trial is completed by a telephone visit 4 weeks after the second on-site visit (week 52).

It is anticipated that the study will run for 30 months.

Eligibility Criteria:
Inclusion Criteria:

1. HFrEF or HFmrEF, and ICD±CRT therapy \> 3 months
2. at least 10 documented VT episodes (either nsVT or sVT ± ICD treatment) within the last 12 months plus:

   * nt-proBNP \> 500pg/mL or
   * Left-ventricular Ejection Fraction (LV-EF) \< 35% or
   * hospitalization for heart failure within the last 12 months or
   * \> 100 nsVTs within the last 12 months
   * \> 1 sVT/VF within the last 12 months
3. Informed consent has to be given in written form.
4. estimated glomerular filtration rate (eGFR) \> 30 ml/min/1.73m2
5. Blood pressure before first drug dosing: blood pressure systolic \> 100 mmHg
6. Blood pressure before first drug dosing: blood pressure diastolic \> 60 mmHg

Exclusion Criteria:

1. Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
2. Ongoing ventricular arrhythmia
3. Known allergy to SGLT-2 inhibitors
4. Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors
5. \>1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea
6. Planned catheter ablation for ventricular arrhythmia
7. Planned explantation of ICD, or planned up/downgrade to/from CRT-D device
8. Existing therapy with SGLT-2 inhibitors
Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with primary or secondary SjS according to the 2002 American European Consensus Group (AECG) classification
* Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI) ≥ 5
* Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or anti-SSB)

Key Exclusion Criteria:

* Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD) (prior bDMARD treatment allowed with appropriate washout as per study protocol)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Predictive Markers of the Effects of Opioid Therapy

The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by developing an implementable clinical computerised decision support system based on individual patient characteristics.

The investigators hypothesize that successful pain control with opioids can be predicted before treatment initiation with advanced data analyses of data originating from pre-treatment EEG, QST and pain-related catastrophic thinking.

The primary objective of this study is the identification of markers that can be used to individualize treatment recommendations, i.e. to reliably predict the response of pain to opioids.

Markers are selected among the most promising data and machine-learning methods are used for the prediction. This includes determining the associations between a battery of selected pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in opioid naïve chronic pain patients, including indication and responder identification.

The key secondary objectives are as follows: to investigate pre-treatment clinical predictive markers as predictors of opioid treatment efficacy and effectiveness in terms of the following:

* Pain intensity and unpleasantness
* Use of rescue analgesics
* Physical functioning
* Global improvement and satisfaction with treatment


Eligibility Criteria:
Inclusion Criteria:

* Pain duration ≥ 3 months.
* Minimum baseline pain intensity ≥ 4 on a 0-10 numerical rating scale (over the past week).
* Maximum baseline pain intensity \< 9 on a 0-10 numerical rating scale (over the past week).
* Prescribed opioid treatment (ATC: N02)
* Anticipated to stay on prescribed opioid treatment throughout the study, i.e. \>14 days.
* Anticipated to stay on any concomitant non-opioid treatment throughout the study, i.e. \>14 days.
* Subject may be male or female, age \>18 years old.
* Is willing and able to comply with study procedures as judged by the site investigator.
* Subject has voluntarily signed and dated the study-specific informed consent form, approved by an Independent Ethics Committee, after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent form must be signed before any study-specific procedures are performed.

Exclusion Criteria:

* Has a mental incapacity or language barriers precluding adequate understanding of study procedures.
* Is considered by the site investigator unsuitable to participate in the study for any other reason, for instance due to a significant serious underlying condition.
* Recently received opioids on a daily basis (within the last 10 weeks).
* Current alcohol or substance abuse, according to the site investigator's medical judgement.
* Is anticipated to undergo a painful procedure(s) (e.g. surgery) during the study, which can interfere with the experience of the chronic pain condition for which the subject is to receive opioids.
GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice.

In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).

Please see Brief Summary section.

Eligibility Criteria:
Key Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR status must be known)
3. Brain metastasis from breast cancer with or without prior WBRT
4. At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0 cm in the longest diameter) by Gd-MRI of the brain \< 14 days prior to first dose (Metastatic brain lesions previously treated with SRS may not be target or non-target lesions)
5. Patients must be neurologically stable: On stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose
6. KPS ≥ 70%
7. Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose

Key Exclusion Criteria:

1. NCI CTCAE v4.0 Grade ≥ 2 neuropathy
2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
3. Known leptomeningeal disease
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

* Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality.
* Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals.
* Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection.
* Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection.
* Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children.
* Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.

Herpesvirus infections may lead to severe disease with a high risk of complications and mortality in hematopoietic stem cell transplant (HSCT) recipients, or in patients receiving high-intensity chemotherapy for hematological malignancies. That risk is mainly associated with the worldwide prevalence of herpes simplex virus 1 (HSV-1) that increases consistently with age. In particular, the majority of adult leukemia patients are HSV seropositive, while allogeneic HSCT recipients had post-transplant HSV reactivation. It is worth noting that in the first post-transplant year, symptomatic varicella-zoster virus (VZV) reactivation has a rate of 13% - 55% in adult recipients. Similar percentages of children receiving HSCT had VZV reactivation, being also possible a disseminated infection in 10% of children. However, thanks to antiviral prophylaxis in seropositive HSCT recipients, the rate of infection has significantly dropped.

Among the drugs most used for treatment and prophylaxis of HSV/VZV infections among children who are HSCT recipients or undergo a high-intensity chemotherapy, acyclovir represents the drug of choice. Although its role in preventing and treating herpes virus infections, the pharmacokinetics of acyclovir is highly variable, especially in patients in intensive care units, in those who have organ dysfunction, or in children. In particular, information about the optimal use of acyclovir in children with malignancies is limited.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Hematological malignancies
* HSCT recipients who require ACV prophylaxis or treatment for HSV-VZV infection or
* Children undergoing high-intensity antineoplastic chemotherapy who need ACV treatment.
* Intravenous or oral ACV dosing
* Active/available a therapeutic drug monitoring (TDM) protocol for ACV
* Informed consent signed by patient's parents

Exclusion Criteria:

* lack of signed informed consent
* lack of TDM for ACV
* unavailable patient's demographic characteristics
The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery

Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment.

An increasing number of studies are being published on the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery, showing promising results.

Therefore, we propose conducting a multicenter, randomized controlled trial to investigate the potential use of quantitative assessment of near-infrared fluorescence imaging with indocyanine green (ICG) to prevent anastomotic leaks during colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old
* ECOG status 0-2
* Written informed consent
* histologically confirmed neoplasms malignant of the colon (caecum, ascending, transverse, descending, sigmoid)
* Scheduled for colorectal resection with primary anastomosis

Exclusion Criteria:

* Pregnancy or breast feeding
* Colon obstruction, perforation or bleeding complicating the tumor
* Medical contraindications for surgical treatment
* Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
Prospective Cohort Study on Prognosis of Patients With Hepatitis B/C

Hepatitis B (HBV) and hepatitis C (HCV) are prevalent all over the world, which seriously threatens public health. In 2016, the World Health Organization(WHO) put forward the goal of eliminating the threat of viral hepatitis to public health by 2030. However, at present, the diagnosis rate and treatment rate of chronic HBV and HCV in China are still far from the goal put forward by WHO. Therefore, for China, the elimination of viral hepatitis is still a public health problem that needs a long time to face.

This study aims to screen and follow up HBV and HCV patients in Danzhou City, Hainan Province, so as to understand the epidemiological characteristics and long-term prognosis of HBV/HCV patients.

Hepatitis B (HBV) and hepatitis C (HCV) are prevalent all over the world, which seriously threatens public health. According to the survey, there are about 93 million chronic HBV infected people and 10 million chronic HCV infected people in China, accounting for 36.19% and 14.08% of the global HBV and HCV infected people respectively. Chronic HBV and HCV infection is the main cause of liver cirrhosis and liver cancer, which places a great burden on the national economy.

In 2016, the World Health Organization(WHO) put forward the goal of eliminating the threat of viral hepatitis to public health by 2030, including 90% diagnosis rate, 80% treatment rate and 90% cure rate of viral hepatitis, in order to reduce 65% of viral hepatitis related deaths and reduce the disease burden. However, at present, the diagnosis rate of chronic HBV in China is 18.7%, the treatment rate is 10.8%, the diagnosis rate of chronic HCV is 30%, and the treatment rate is 9%, which are still far from the goal put forward by WHO. Therefore, for China, the elimination of viral hepatitis is still a public health problem that needs a long time to face.

This study aims to screen and follow up HBV and HCV patients in Danzhou City, Hainan Province, so as to understand the epidemiological characteristics and long-term prognosis of HBV/HCV patients.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg/HBV DNA positive
* or anti-HCV/HCV RNA positive

Exclusion Criteria:

* patients who refused to participate in the study.