cyrilzakka/clinical-trials huggingface dataset:
Factors Determining Oxygen Wash in During Pre-oxygenation

Earlier studies has shown a correlation between older age and longer time for the rise in the end-tidal O2 concentration during pre-oxygenation. In this study the investigators aim to analyse this correlation more closely and investigate if the arterial partial pressure of oxygen (PaO2) as measured before the start of pre-oxygenation, with the patient breathing air, is a better predictor than age for estimating the time necessary for achieving the goal of pre-oxygenation.

Before induction of general anaesthesia pre-oxygenation is a recommended procedure to enhance the time available for solving a problem with the airway or intubation during induction. This can be accomplished by letting the patient breath normal tidal volumes with 100% oxygen for 3 to 5 minutes during pre-oxygenation. If there is airway closure during tidal volume breathing, pre-oxygenation needs longer time to achieve a maximum effect. Airway closure increases with advanced age and a few earlier studies has also shown a correlation between older age and longer time for the rise in the end-tidal O2 concentration during pre-oxygenation.

Pre-oxygenation is a strongly recommended safety procedure before starting anaesthesia but has at least one major side affect: it is the main reason for the development of atelectasis in the lungs during anaesthesia. Atelectasis impairs oxygenation during anaesthesia and probably increase the risk for postoperative pulmonary complications.

Postoperative complications are more common with advanced age and it is important to understand the mechanisms and risk factors involved.

In this study, the investigators hypothesise that the PaO2 as measured before the start of pre-oxygenation, with the patient breathing air, is a better predictor than age for estimating the time necessary for achieving the goal of pre-oxygenation. If this assumption is correct it might have implication for how pre-oxygenation should be adjusted with advancing age.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for general anaesthesia in American Society of Anesthesiology (ASA) physical status classification grade I-III.
* Body mass index over 18.5 and less than 30 kg/m2
* Peripheral oxygen saturation 92% or more on air.

Exclusion Criteria:

* ASA IV.
* Patients with active smoking and former smokers with a history of smoking more than 6 pack-years.
* Chronic obstructive lung disease.
* Bloodgas with PaO2 ≤ 8 kilopascal (kPa) or PaCO2 ≥ 6.5 kPa.
* Continuous positive airway pressure treatment at night.
* Heart failure or angina pectoris.
* Hemoglobin value less than 100 g/L.
* Pregnancy.
* Any neuromuscular or neurologic illness reducing ventilatory capacity.
* Any endocrine disease influencing basic metabolic demand.
* Not possible to achieve a tight mask seal.
* Patient unable to follow instructions.
Mindfulness and Psychological Inflexibility

This study aimed to examine whether mindfulness skills training can help to reduce experiential avoidance and anxiety level. This study investigated whether the training delivery methods (audio-guided mindfulness exercise or virtual reality-based mindfulness exercise) differ in terms of changing general experiential avoidance and anxiety symptoms.

The experimental design (randomized trial) was used in this study. Data were collected through convenience sampling. After obtaining ethical approval fromEthics Committee of the Bahçeşehir Cyprus University, participants were invited to participate in the study via advertisements posted in the university building. Recruited participants were randomly assigned to the experimental group or control group. All participants will be provided with an informed consent form which provided information about participant's right and data management. Participants in the experimental group completed mindfulness exercise on Virtual Reality (VR) system where they listened to an audio track (guide for the exercise) and saw calming nature scenes (e.g., views on the beach) whereas those in the control group completed mindfulness exercise by listening to the (same) audio track only. Each mindfulness session took approximately 15 mins. In total, four sessions were completed in two weeks (2 sessions per week). After obtaining informed consent, the participants completed a survey pack that included valid and reliable measurement scales (mindfulness skills \[The Cognitive and Affective Mindfulness Scale - Revised\], experiential avoidance \[Acceptance and Action Questionnaire-II\], and anxiety symptoms \[Generalized Anxiety Disorder Scale\]) at two-time points (i.e., pre-test \[before intervention\], and post-test \[after 4 sessions/when sessions were completed\], At the end of the study, the participants were provided with a debrief form.

Eligibility Criteria:
Inclusion Criteria:

* age of 18 and above,
* ability to read, and/or understand English

Exclusion Criteria:

* Participants who regularly practice mindfulness exercise were excluded form the analyses
Entecavir to TAF Switch

A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B


Eligibility Criteria:
Inclusion Criteria:

* Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
* Maintained on Entecavir for a minimum of 48 weeks
* Viral suppression (HBV DNA \<20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
* Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.

Exclusion Criteria:

* Subjects with known poor or non-compliance
* Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
* Pregnant women and those who wish to become pregnant during the course of the study.
Survey of Cabozantinib Tablets Used To Treat People With Hepatocellular Carcinoma

This study is a survey in Japan of Cabozantinib tablets used to treat Japanese people with a type of liver cancer called hepatocellular carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with hepatocellular carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 12 months.


Eligibility Criteria:
Inclusion Criteria:

Participants with unresectable hepatocellular carcinoma that has progressed after cancer chemotherapy (Regardless of previous treatment history)

Exclusion Criteria:

Participants who has a history of hypersensitivity to any component of cabozantinib.
The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks

Thyroid gland surgery is one of the most commonly performed operations for either benign or malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be treated with NSAIDs or opioids. However, Opioids have many well-known undesirable effects, including postoperative nausea and vomiting, which are frequent after this type of procedure.

Regional techniques of anesthesia may help to decrease post-operative pain and reduce systemic analgesic requirement. Classically, the cervical plexus is considered to have two distributions, the superficial cutaneous and the deep motor nerves.

Anatomically, the thyroid gland has an inner true capsule which is thin and adheres closely to the thyroidal tissue \[Fancy et al., 2010\]. External to this is a false capsule formed by the middle layer of the deep cervical fascia, which splits anterolaterally to ensheathe the thyroid gland, thus forming the thyroid sheath \[Bliss et al., 2000\]. In this fashion, the potential space called the capsule-sheath space is formed. It contains also loose connective tissue, blood vessels, nerves and parathyroid gland. Anesthetic deposited in this space would block the surface of thyroid gland and permeate directly into the parenchyma producing effective local anesthesia for thyroid surgical procedures. It is supposed also to involve autonomic nerve block of the thyroid gland \[Fliers et al., 2010\]. Additionally, a subcutaneous injection along the sternocleidomastoid muscle (SCM) would also enhance effective local anesthesia for the initial skin incision and further contribute to a more ideal working environment for the surgeon. Therefore, anesthetic technique termed ultrasound-guided capsule-sheath space block (CSSB) combined with anterior cervical cutaneous nerves block (CCNB) for thyroidectomy is done \[Wang et al., 2015\] .

Our hypothesis is that a combination of simple dual techniques including superficial cutaneous block to provide sensory blockade, and surgeon mediated capsular block may afford autonomic thyroid blockade. In comparison, ultrasound guided intermediate cervical plexus block may provide these blocks but using a machine and deep penetration possibly involving unwanted blocks for phrenic and recurrent laryngeal nerves. So, if the simple safe technique can provide the same intra and postoperative anesthetic conditions it will be preferred.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status grade I and grade II.
* Euthyroidism after thyroid function tests

Exclusion Criteria:

* Patient refusal.
* Thyroid gland more than 5 cm size.
* Retrosternal extension.
* Planned block neck dissection.
* Neuromuscular diseases
* Hematological diseases.
* Bleeding diseases.
* Coagulation abnormality.
* Psychiatric diseases.
* Drug abuse.
* Local skin infection
* sepsis at site of the block.
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2.
* Known diaphragmatic motion abnormalities
* major respiratory disease.
* Previous history of cervical surgery.
Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel Obstruction

Small bowel obstruction is a common reason for surgical admission. Most common reason for small bowel obstruction is adhesions, which account up to 70-80 % of small bowel obstructions. Large proportion of adhesive small bowel obstructions may be treated nonoperatively, but up to 50-60% may need surgical intervention. Current golden standard for surgical intervention is open adhesiolysis. Recently, retrospective studies have provided encouraging results of laparoscopic adhesiolysis for small bowel obstructions. However, no prospective randomized trials have been carried out and retrospective series carries a high risk for patient selection and bias. Although in general laparoscopy has been associated with shortened hospital stay, less pain and reduced mortality, laparoscopic adhesiolysis for small bowel obstruction has been reported to cause iatrogenic small bowel lesions up to 7% of patients. Aim of the study is to compare open adhesiolysis to laparoscopic adhesiolysis. The investigators hypothesis is that laparoscopic adhesiolysis is safe, will shorten the hospital stay, and reduce mortality compared to open approach.


Eligibility Criteria:
Inclusion Criteria:

* All patients with clinical and computed tomography-diagnosed adhesive small bowel obstruction AND
* Obstruction is not relieved by conservative methods (nasogastric tube, NPO) including Gastrografin is not passed to colon within 8 hours (48-hour conservative treatment without Gastrografin® is allowed if Gastrografin® is contraindicated (e.g. allergy) or not available)

Exclusion Criteria:

* Strong suspicion of strangulation or clinical peritonitis thus indicating an urgent operative intervention
* Earlier confirmed or strongly suspected peritoneal carcinosis
* Earlier confirmed wide diffuse adhesions of abdominal cavity
* Earlier open surgery for endometriosis
* Earlier generalized diffuse peritonitis (not including local peritonitis such as appendicitis)
* Active abdominal malignancy or remission less than 10 years
* Earlier abdominal region radiotherapy
* Earlier obesity surgery
* 3 or more earlier open abdominal operations (not including caesarean section(s))
* Suspicion of other cause for obstruction than adhesions in CT-scan
* Earlier abdominal surgical operation within 30 days
* Earlier surgical operation for aorta or iliac vessels performed through laparotomy
* Crohn's disease
* Anesthesiological contraindication for laparoscopy
* Missing informed consent
* Age less than 18 years or over 95 years
* Pregnancy
* Patient living in institutional care (such as health centre ward), not including retirement homes
* Over 1 week of hospital stay directly prior surgical consultation
Use of eHealth in Communication With Patients About Prenatal Diagnosis

The research aims at generating new knowledge about ways to inform pregnant women about prenatal screening for Downs syndrome.

The overall purpose of this project is to increase pregnant women's knowledge of prenatal screening for Downs syndrome, and thereby an option to make an informed choice. The project is planned as a research into whether the use of an eHealth solution (in this project an interactive website) may be an appropriate intervention for pregnant women.

Prenatal screening and diagnosis is testing for diseases or rare conditions in the fetus before birth. The aim is to assist the pregnant women to make their own decisions, and neutral and adequate counseling is a prerequisite during prenatal diagnosis. To make an informed choice, the pregnant women must be informed about the benefits and potential disadvantages of prenatal diagnosis and with this background be able to make a comprehensive evaluation, where ethical values will have a high impact.

The overall purpose of this project is to increase pregnant women's knowledge of prenatal screening for Downs syndrome, and thereby an option to make an informed choice. The project is planned as a research into whether the use of an eHealth solution (in this project an interactive website) may be an appropriate intervention for pregnant women.

Methods:

Part one consists of an identification of the problem

Part two consists of developing a website with relevant information about prenatal screening for Downs syndrome.

Part three is an effect measurement. The effect of the intervention is measured through a randomized controlled trail in which the essentials of the measurement will be the pregnant women's knowledge and behavior in relation to prenatal diagnosis. Twice 300 pregnant women will be included in the project.

Results:

The research aims at generating new knowledge about ways to inform pregnant women about prenatal diagnosis and prenatal screening. The expected results are:

* Higher knowledge about prenatal diagnosis for the pregnant women.
* Less difficulty in making an informed choice for the coming parents.
* Easy access to high quality information.
* Equity in access to high quality information.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women participating in screening for Downs syndorme

Exclusion Criteria:

* Respondents who do not speak, read and understand Danish.
* Respondents who have opted out of health care services and prenatal diagnosis.
* Reespondenter who do not wish to participate.
* Respondents under 18 years.
* Respondents with a strong suspicion of threatening abortion
* Respondents whom are vulnerable
* Respondents with a late referral
Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension

High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is more common during months where UVB radiation from the sun is absent, and vitamin D has been associated with high blood pressure. This study will evaluate the effect of vitamin D replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Well-regulated arterial hypertension
* Office blood pressure \> 120/70 mmHg

Exclusion Criteria:

* Pregnancy or nursing
* Cancer
* Alcohol abuse
* Continuous glucocorticoid or NSAID treatment
* 24-hour blood pressure \> 150/95 mmHg
* Hypercalcemia
Time-Restricted Eating and Bipolar Disorder

This is a pilot trial to examine the acceptability and feasibility of time-restricted eating as an adjunct to medication treatment for bipolar disorder.

Time-restricted eating (TRE) is a way of scheduling food intake that has been shown to improve circadian rhythms in animals and humans. TRE is based on animal and human science that shows that the timing of eating powerfully influences diurnal rhythms. Animal research has shown that feeding during sleep periods leads to a surge of norepinephrine, cortisol, wakefulness, and activity. Drawing on this, over a decade of studies have examined the impact of experimentally randomizing mice to time-restricted feeding during wake hours (vs. 24-hour ad libitum feeding). Importantly, caloric intake and other facets of diet were yoked for strict control. A consistent finding is that TRE had powerful benefits for circadian and metabolic indicators across studies,and more recent data also shows benefit for animal longevity.

Here, the investigators' goal is to extend this work to bipolar disorder (BD). More specifically, the investigators will gather data to examine the acceptability and feasibility of TRE among those who self-identify with bipolar disorder and who experience some problems with sleep, circadian rhythms, or schedules. The investigators will gather measures of mania, depression, sleep, and QOL, to provide preliminary evidence of change on these dimensions.

Eligibility Criteria:
Inclusion Criteria:

* adults diagnosed with bipolar disorder and currently receiving medical care for their bipolar disorder.
* Experiencing schedule/sleep or circadian problem in the past 3 months
* Medication regimens stable for past month
* Adequate English language skills for taking part in the program.
* Living in California.

Exclusion Criteria:

* Cognitive deficits (Screening OMC Test)
* Current: psychosis, (hypo)mania, major depressive episode, substance/alcohol use disorders, eating disorder diagnoses or acute suicidal risk (MINI interview; see DSM5 TRE screening)
* High scores (\> 5) on the Screening Eating Disorder Examination Questionnaire
* Current shift work
* \>5 kg weight change within 3 months
* Pregnancy
* Breastfeeding
* Uncorrected hypo or hyperthyroidism

  \* diabetes type 1
* Gastrointestinal conditions impairing nutrient absorption
* Medications contraindicated for fasting, including clozapine, glucose-lowering medications, diabetes-related injections, requiring food early morning or late evening, corticosteroids.
Evaluation of a 28-day Fermented Milk Product Consumption Twice Daily as Compared to a Non-fermented Milk Product on Intestinal Gas Production in Healthy Subjects High Dihydrogen Producers

The purpose of this study is to assess the effect of a 28-day fermented milk product consumption twice daily on intestinal gas production of dihydrogen (H2) and methane (CH4) in healthy subjects high H2 producers.


Eligibility Criteria:
Inclusion Criteria:

* Subject with body mass index (BMI) between 18.0 and 30.0 kg/m2 (bounds excluded)
* Subjects having a high dihydrogen (H2) production as defined by a fasting exhaled level of H2 in breath at 10 parts per million (ppm) or more.
* Women of childbearing potential must be using a medically approved method of contraception OR women must be postmenopausal for at least 12 months prior to study entry

Exclusion Criteria:

* Subject with functional gastrointestinal disorder according to ROME III criteria (Functional Bowel Disorders/FBD module, Functional Dyspepsia/FD module, Irritable Bowel Syndrome/IBS module)
* Subject with gastrointestinal disorders according to investigator's medical assessment
* Subject taking drugs that might modify gastrointestinal function
* Subject with severe disease as assessed by the investigator (ex: cancer, severe heart disease, kidney disease, neurological disease or psychiatric disease, immunodeficiency disorder)
Glassy Trial for Effects of Wearing Glasses

Randomized trial testing 6 forms of a communication summarizing the results of a recent study (about the effects of wearing glasses on reducing covid infection risk).

The goal of the trial is to test the effect of different language options to describe uncertainty, and of including the margin of error around the main result.

The study is designed as a proof-of-concept exercise to develop and test a communication meant to summarize the results of a recent randomized trial examining the effects of wearing glasses on the chance of developing COVID-19.

The objectives of the randomized trial are:

* To compare the effects of three ways of communicating the overall uncertainty of the effects of wearing glasses to reduce the chance of getting COVID and
* To compare the effects of including the margin of error (confidence interval) compared to not including it.

Researchers will conduct an online, parallel group, individually randomized, pragmatic trial using a 3x2 factorial design, ie, 3 uncertainly language options (GRADE language, colloquial language or none 2 options for the statistical margin of error for the main results (margin of error language or none).

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old
* literate in English or Norwegian
* currently residing in Norway or the United States

Exclusion Criteria:

* individuals who regularly wear any kind of glasses (i.e., prescription or sunglasses) all or most of the time