cyrilzakka/clinical-trials huggingface dataset:
Intubating Condition After Magnesium Pre-treatment

Magnesium had an inhibitory effect on neuromuscular transmission and caused a decrease in muscle fiber membrane excitability. It reduces the amount of acetylcholine that is released at the motor nerve terminal by decreasing the calcium conductance of presynaptic voltage-dependent calcium channels. After pre-treatment with magnesium, an increased speed of onset and a prolongation of the recovery period of neuromuscular blockade have been observed with other non-depolarizing neuromuscular blocking agent (NMBA) such as atracurium, vecuronium and rocuronium. Rocuronium is the currently preferred NMBA used as an alternative to succinylcholine for rapid tracheal intubation. As an alternative to succinylcholine, high doses of NMBA have been tested for rapid sequence intubation. This excessively high dose of rocuronium, however, prolongs the duration of the neuromuscular block and this may not be warranted in every surgical setting.

The reduction of onset time of rocuronium by magnesium pre-treatment can make intubation condition more rapid and much better clinically. It will thus be interesting to compare intubation conditions of a standard intubation dose of rocuronium after magnesium pre-treatment with high dose of rocuronium or standard dose of rocuronium.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing operation under general anesthesia
* American Society of Anesthesiologist physical status I or II
* 20-65 year old male or female

Exclusion Criteria:

* hepatic or renal dysfunction
* respiratory or cardiovascular dysfunction
* neurologic disorder
* neuromuscular disease
* pregnancy
* body mass index (BMI) \>30 kg/m2 or \<16.5 kg/m2
* anticipated difficult airway
* higher magnesium level than normal range in preoperative evaluation
* chronic medication with calcium channel blocker or magnesium
* history of known allergy to magnesium sulphate or any other study drugs
Nurse-led Smoking Cessation With Further Follow-up in Lifestyle Centres - a Randomized Pilot Study

The purpose of this randomized controlled pilot study is to test whether an in-hospital nurse-led smoking cessation intervention increases the refferal rate to healty life-centers in the municipalities. We will also describe the proportion who succeed in quitting smoking between the intervention group and the control group and obtain new knowledge about the patient and system factors of importance for participation to healty life-centers and for successful and unsuccessful smoking cessation.


Eligibility Criteria:
Inclusion Criteria (all):

* Age\> 18 years and smokes at least 1 cigarette daily
* Hospitalized with a cardiovascular event (i.e. myocardial infarction, heart failure, unstable or stable angina, achyarrhythmias, bradyarrhythmias, carotid stenosis or claudication with need for peripheral revascularization)
* Sign informed consent and is expected to participate according to ICH / GCP

Exclusion Criteria (none of these):

* Does not meet the criteria to participate in the pilot project, i.e. patients who do not usually live or work in the Vestre Viken catchment area
* Chronic renal failure stage 4 or known allergic reaction to varenicline

  . Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical
* Lack of Norwegian and English knowledge
* Short life expectancy (\<12 months)
Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.

Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA \< 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with \< HBV DNA 60 IU/mL level and HBeAg positive status.

Exclusion Criteria:

* Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
* Subjects should have ALT \< 10 x ULN, and no evidence of hepatocellular carcinoma.
* Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
* Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.
A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer

The main objectives of this study are:

* To determine the recommended dose (RD) of FPA144 in participants with gastric or gastroesophageal cancer (hereafter referred to as gastric cancer)
* To evaluate the safety of escalating doses of FPA144 in participants with gastric cancer
* To characterize the pharmacokinetic (PK) profile of single and multiple doses of intravenously administered FPA144 in participants with gastric cancer


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma that is locally recurrent or metastatic and has progressed following standard treatment or is not appropriate for standard treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Adequate hematological, liver and kidney function. Measurable or non-measurable disease
* Archival tumor tissue for determination of FGFR2 status

Key Exclusion Criteria:

* Untreated or symptomatic central nervous system (CNS) metastases
* Clinically significant cardiac disease
* Peripheral sensory neuropathy \>/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
* Active infection requiring systemic treatment
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
* Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
* Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
* Known positivity for human epidermal growth factor receptor 2 (HER2)
* Women who are pregnant or breastfeeding
Epigenetic Regulation of Human Adipose Tissue Distribution

The purpose of this study is to collect data to help researchers better understand the different ways that women or men store fat (apple shape versus pear shape).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years inclusive;
* BMI 23-35 kg/m2 inclusive;
* HbA1C \<6.0%;
* Weight stable (± 3 kg) during the 3 months prior to enrollment;
* Women must be \> 9 months post-partum;
* Able to provide written, informed consent.

Exclusion Criteria:

* Postmenopausal women
* Women with an oophorectomy
* Fasting plasma glucose \> 126 mg/dL, or diagnosis with Type 2 Diabetes (T2DM)
* Untreated or symptomatic thyroid disease.
* Aminotransferase or aspartate aminotransferase \> 3x upper limit of laboratory reference range, or known diagnosis of liver disease.
* Creatinine \> 2x upper limit of laboratory reference range, or known diagnosis of kidney disease.
* Uncontrolled hypertension (BP \> 140 systolic or \> 90 diastolic)
* New onset (\<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy.
* History of drug or alcohol abuse (\> 3 drinks per day) within the last 5 years, or psychiatric disease prohibiting adherence to study protocol. Current drug use may be determine by plasma or urine drug screens.
* History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
* History of organ transplant.
* Myocardial Infarction within the last 6 months.
* Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for biopsy and testing procedures.
* History of HIV, active Hepatitis B or C or tuberculosis
* Presence of clinically significant abnormalities on EKG.
* Current smokers (smoking within the past 3 months).
* Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (eg. growth hormone therapy, glucocorticoids \[steroids\], etc.)
* Other chronic or acute illness that might affect study results / interpretation in the opinion of the clinical
* Other items related to procedural risk (outlined below) such as bleeding disorder, claustrophobia, etc.
* Elevated high sensitivity c-reactive protein or known active infection.
* There are some implants which are MR compatible (safe) but would cause artifacts which could obscure our ability to measure an organ, e.g. full braces may negate the ability to measure brain size.
The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation

Sperm DNA fragmentation (SDF) serves as a marker for chromatin and DNA damage in sperm. Assessing sperm DNA integrity is crucial in male fertility evaluation since high levels of SDF are associated with a greater number of adverse reproductive outcomes, including an increased risk of miscarriage and birth defects.

Recent research suggests that advanced paternal age (APA) may lead to DNA damage in sperm, however the precise age at which this risk becomes apparent has not yet been clearly defined, necessitating the identification of the point in time at which high SDF levels occur. With the help of this knowledge, male infertility can be diagnosed with greater accuracy, and infertile couples can receive appropriate care.


Eligibility Criteria:
Inclusion Criteria:

* Male of at least 18 years of age
A Study of Baricitinib in Healthy Participants

The purposes of this study are to determine:

* If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms.
* How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.
* The safety and tolerability of baricitinib.

The study has two parts. Individuals will participate in only one part.

Participants will be admitted to the clinical research unit (CRU) and will be discharged from the CRU following the completion of 3 overnight stays.

Each part of this study will last from 8-10 days, not including screening. Follow-up will occur 7 to 14 days after the last dose of baricitinib.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Women not of child-bearing potential
* Have a body mass index (BMI) of 18.5 to 29.9 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion Criteria:

* Have received live vaccine(s) within 3 months of screening, or intend to during the study
* Have a current or recent history (less than \[\<\] 30 days prior to screening and/or \<45 days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
Safety of Riluzole in Patients With Acute Spinal Cord Injury

The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).

The primary aim of the study is to develop acute care safety and pharmacokinetic profiles of riluzole in patients who have sustained a acute traumatic spinal cord injury. Secondary objectives are to conduct exploratory analyses of functional outcomes for purposes of planning a subsequent Phase II randomized study of the efficiency of Riluzole for the treatment of acute traumatic spinal cord injury.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years and less than or equal to 70 years;
* Willing to give written informed consent to participate in the study. The informed consent may require legally authorized representative to sign if arm/hand function is compromised.
* No other life-threatening injury
* Spinal cord injury at the neurologic level from C4 to T12
* ASIA Impairment Scale level A, B or C
* No cognitive impairment which would preclude an informed consent (including moderate or severe traumatic brain injury)
* Less than 12 hours since injury

Exclusion Criteria:

* Equal or more than 12 hours since injury
* Hypersensitivity to riluzole or any of its components
* Unable to receive riluzole orally or via nasogastric tube
* History of liver or kidney disease (e.g. Hepatitis A, B or C, Cirrhosis, etc.)
* Has a recent history of regular substance abuse (illicit drugs, alcohol)
* Unconscious
* Penetrating spinal cord injury
* Pregnancy as established by urine pregnancy test
* Breastfeeding
* Life expectancy less than 12 months
* Is currently involved in another therapeutic SCI research study that precludes or complicates participation in this study (e.g. study of another therapeutic drug aiming for spinal cord injury recovery, any study that substantially interferes with the follow -up schedule (f/u) schedule, or any high risk study that complicates evaluation of safety outcomes. Types of studies that would not preclude participation are e.g. behavioral adaptation studies, mental health interventions)
* Has a mental disorder or other illness, which in the view of the site investigator, would preclude accurate evaluation (e.g. schizophrenia, severe cognitive disability, Parkinson disease)
* Unable to commit to the follow-up schedule
* Is a prisoner
* Unable to converse, read or write English at the elementary school level
Evaluation of GvHD Damage on Medullary Mesenchymal Stem Cells

Spontaneous, multicenter, prospective, non-pharmacological study. At the diagnosis of acute or chronic GvHD after HSCT, bone marrow cells will be analysed for MSC content and properties. Bone marrow aspirate will be performed according to usual clinical practise


Eligibility Criteria:
Inclusion Criteria:

* Patients (children and adults) developing acute or chronic GvHD after HSCT.
* Age 6 months- month-99 years,
* Landsky-Karnofsky\> 70%,
* Acute or chronic GvHD needing further immunosuppressive treatment.

Exclusion Criteria:

* Anything not included in the inclusion criteria.
Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors.

Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

Part 1 only:

- Subjects with a histological diagnosis of advanced cancer (solid tumors or central nervous system \[CNS\] tumors) with disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available (histological confirmation waived for brain stem gliomas and optic pathway tumors)

Part 2 only:

* Subjects with histologically confirmed diagnosis of refractory or relapsed: Neuroblastoma, High-grade gliomas: glioblastoma multiforme, anaplastic astrocytomas, and other high-grade gliomas (histological confirmation waived for brain stem gliomas), Rhabdomyosarcoma.
* Measurable disease (for subjects with neuroblastoma, evaluable disease as determined by a positive metaiodobenzylguanidine (MIBG) scan will also be permitted).

Exclusion Criteria:

Exclusion Criteria:

* Subjects receiving enzyme-inducing anticonvulsants.
* Pulmonary hypertension or pneumonitis
* Active infection or serious intercurrent illness
* Other exclusions apply
Can Psychotherapy Reduce Sickness Absence?

The purpose of this study is to examine if psychotherapy can reduce sickness absence.

Sickness absence due to psychiatric problems is considered a growing problem in Norway. Little research is done to examine if psychotherapy can reduce sickness absence. Since 2007 there is a government sponsored program in Norway (Raskere tilbake) aimed at reducing sickness absence. This study examines if psychotherapy within this program, delivered at an out-patient clinic, actually reduces sickness absence. Levels of absenteeism is measured before, after and 6 months after treatment. This is a quasi-experimental study, where the treatment-group will be compared with a statistical group in the general population, that is socio-demographical similar and has similar history of sickness absence but haven't been to treatment. Changes in levels of symptoms and quality of life will also be measured. The participants will be asked to describe their working environment, and this will be related to outcome-measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving psychotherapy at Lovisenberg DPS/Raskere Tilbake

Exclusion Criteria:

-
Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis

The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.

Background: Crohn's disease (CD) is a chronic inflammatory disorder of the bowel that is characterized by periods of clinical remission alternating with periods of recurrence. Persistent inflammation is believed to lead to progressive bowel damage that, over time, will manifest in the development of strictures, fistulae, and abscesses. The recent development of the Lemann index allows us to precisely assess digestive damage in CD. The aim of the present study is to evaluate digestive damage and associated predictive factors in CD 5 to 10 years after diagnosis.

Methods: Prospective, multicenter, international, transversal, observational study. Patients who completed the RAPID trial (evaluating the benefits on the course of CD of an early prescription of azathioprine compared with conventional step-care therapy) will be eligible. Digestive damage will be assessed using methods described in the Lemann index protocol, dependent on CD location (abdominal MRI obligatory). The total duration of study participation for 1patient will be ≤4 months.

Aims: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients over 18 years old
* Active or Inactive Crohn's Disease
* Previously enrolled in RAPID clinical trial

Exclusion Criteria:

* Pregnant or nursing woman
* Patient with a contraindication or who decline to have study exams (MRI and endoscopy)
* Other medical or psychiatric or serious chronic conditions or according to the physician's discretion that could affect the patient's cooperation or the capacity to follow study procedures.
Diagnostic Performance of a Convolutional Neural Network for Diminutive Colorectal Polyp Recognition

Rationale: Diminutive colorectal polyps (1-5mm in size) have a high prevalence and very low risk of harbouring cancer. Current practice is to send all these polyps for histopathological assessment by the pathologist. If an endoscopist would be able to correctly predict the histology of these diminutive polyps during colonoscopy, histopathological examination could be omitted and practise could become more time- and cost-effective. Studies have shown that prediction of histology by the endoscopist remains dependent on training and experience and varies greatly between endoscopists, even after systematic training. Computer aided diagnosis (CAD) based on convolutional neural networks (CNN) may facilitate endoscopists in diminutive polyp differentiation. Up to date, studies comparing the diagnostic performance of CAD-CNN to a group of endoscopists performing optical diagnosis during real-time colonoscopy are lacking.

Objective: To develop a CAD-CNN system that is able to differentiate diminutive polyps during colonoscopy with high accuracy and to compare the performance of this system to a group of endoscopist performing optical diagnosis, with the histopathology as the gold standard.

Study design: Multicentre, prospective, observational trial. Study population: Consecutive patients who undergo screening colonoscopy (phase 2)

Main study parameters/endpoints: The accuracy of optical diagnosis of diminutive colorectal polyps (1-5mm) by CAD-CNN system compared with the accuracy of the endoscopists. Histopathology is used as the gold standard.


Eligibility Criteria:
Phase 1A -

- Patients with one polyp subtype (based on histology)

Phase 1B Patients older than 18 years that underwent colonoscopy in one of the participating centres.

Phase 2:- Validation CAD-CNN system

Inclusion Criteria:

All patients older than 18 years old undergoing screenings colonoscopy in one of the participating centres.

Exclusion Criteria:

* Diagnosis of inflammatory bowel disease, Lynch syndrome or (serrated) polyposis syndrome.
* Boston Bowel Preparation Scale (BBPS) \<2 in one of the colon segments
* Patients who are unwilling or unable to give informed consent
An Open-label Pharmacokinetic Study of TS-172 in Patients on Hemodialysis

A phase 1, open-label, pharmacokinetic study of TS-172 in patients on hemodialysis


Eligibility Criteria:
Inclusion Criteria:

1. Japanese male patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to the screening test
2. Patients aged \>= 18 and \< 75 years at the time of obtaining informed consent

Exclusion Criteria:

1. Patients with gastric or intestinal ulceration or a history of them within the past year prior to the date of initiation of treatment, or patients with inflammatory bowel disease or irritable bowel syndrome, or a history of these within the past 5 years prior to the date of initiation of treatment
2. Patients scheduled for renal transplantation, home hemodialysis or change of dialysis facility (transfer or temporary dialysis at other hospital) during the study period
3. Patients who frequently experience diarrhea (defined as Bristol Stool Scale score of 6 or higher)