cyrilzakka/clinical-trials huggingface dataset:
Nicotine Replacement Provided at a Tertiary Care Hospital

The purpose of this study is to show that a patient-centered survey asking about smoking habits, with the option for nicotine replacement therapy (NRT) will increase the prescription rates among health care providers (HCP). The investigators also believe that this intervention can also lead to increased referrals to smoking cessation clinics and ultimately increase rates of smoking cessation.

Since the past decade, there has been an increased awareness of the effects of smoking of general health. In 2000, 18.1% of all US deaths were related to tobacco use. Multiple trials have proven that providing nicotine-replacement therapies to help smoking cessation were efficacious with various types of populations. However, smoking has not been eradicated in North America and was associated with a 3.1 million YPLL (years of potential life lost), along with 96.8 billion in productivity losses in the US4.

We are carrying out a study of 200 inpatients on a general medicine ward to attempt to improve prescription rates of nicotine replacement therapy (NRT) and smoking cessation. Our goal is to use a patient centred approach to determine which patients would benefit from NRT and which patients would be in the contemplative stage of smoking cessation. We will want to look at whether a simple, short survey taken by patients can encourage the health care provider (HCP) to provide more NRT and more referrals to a smoking cessation clinic. We hope that this tool will improve the ability of HCP to provide optimal, comprehensive care. The study's findings should help to guide future practices for hospitalized smokers.

Currently, standard treatment involves NRT being prescribed completely at the discretion of the physician. This occasionally involves a discussion with the patient regarding their preferences, but more often is a unilateral decision made by the health care provider. Additionally, we believe that this method misses a lot of potential patients who may benefit from this therapy but are otherwise not identified. We will not be using a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the general medicine ward
* Currently smoking (or quit within the last two weeks)
* 18 years and over
* Able to read in the English language or have a translator present

Exclusion Criteria:

* Non-smokers
* Pregnant or actively trying to conceive
* Recent acute coronary syndrome (within 1 month)
* Active temporo-mandibular joint disease
* Currently on NRT
* Allergy to nicotine
* Acute delirium/chronic dementia
* Inability to complete survey secondary to language/educational issues (if no translator present)
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent

To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB

Patients with the following conditions would be recruited for drainage under EUS guidance with the new lumen apposing FCSEMS

* Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or 10 mm)
* Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)
* Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)
* Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)
* Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary approach (the diameter of the CBD \> 10 mm) (SPAXUS 8 or 10 mm)

Outcome paramaters include technical and clinical success, adverse events.

Eligibility Criteria:
Inclusion Criteria:

Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study.

* Pancreatobiliary diseases that are eligible for EUS-guided transenteric drainage
* The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
* Target lesion that is accessible through the transenteric approach
* The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
* The patient who is willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures
* The patients should not have any unacceptable conditions (e.g., physiological, familyism, social, geographical) for medical follow-up and adaptation of the study.

Exclusion Criteria:

Patient presenting with any of the following will not be included in the study.

* Inaccessible to EUS-guided approach
* Bleeding tendency: International normalized ratio (INR) of prothrombin time \< 1.5 or platelet conunt \< 60,000/mm3
* Patients with Disseminated Intravascular Coagulation syndrome(DIC)
* Patients who have been taking medicines that can cause hemorrhage (e.g., Aspirin, Wafarin etc.)
* Patients with other serious disease or medical condition
* Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
* Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects

To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 to 55 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]²

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy or intolerance to metformin or other similar acting agents
* Prior exposure to metformin within 3 months of study drug administration
* Estimated creatinine clearance (Clcr) of \< 80ml/min using the Cockcroft Gault formula
COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology

Prospective cohort study of COVID-19 infection among children in Norway.

This nation-wide, prospective cohort study of COVID-19 infection addresses three main issues: 1) Epidemiological risk factors; 2) Natural history (including immunological mechanisms and long term effects) and 3) Support of infection prevention. Also, the study focuses solely on children.

Children (0-18 years of age) admitted to hospital with suspected COVID-19 are eligible (Fig. 1). Those with confirmed COVID-19 serve as cases, whereas those with non-COVID-19 serve as controls; both groups will be followed prospectively for 6 months. Three objectives/Work Packages (WPs) are defined:

* In WP1, the investigators will investigate risk factors for severe outcome of the acute infection; potential risk factors include sex, age, comorbidities, initial clinical findings, infectious load, and genetic markers.
* In WP2, the investigators will investigate the immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.
* In WP3, the investigators will investigate the prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue

Eligibility Criteria:
Inclusion Criteria:

Suspected covid-19 infection and age 0-18 years

Exclusion Criteria:

Age \>18 years
Optic Nerve Sheath Diameter, Carotid Duplex and Transcranial Duplex as a Prognostic Factor

Optic nerve sheath diameter (ONSD) had been proved to be associated with increased intracranial pressure and can be used as one of the prognostic factors in cardiac arrest patients. It is simple, quick and can be measured repeatedly. Carotid duplex and transcranial duplex(TCD) provide rapid, noninvasive, real-time measures of cerebrovascular function. It can be used to assess the vascular territory by measuring blood flow, and to evaluate factors include brain perfusion, plaque morphology, and patency of intracranial collaterals. Hence, it could act as a crucial role in neuroprognosis in post-arrest patients. In this study, the investigator aimed to analyze the ONSD diameters, ONSD/external transverse diameter (ETD) ratio, carotid duplex and transcaranial duplex parameters in different stages of post-cardiac arrest care, demographic characteristics and resuscitation information with the neurological outcome of post-cardiac arrest patients. The ONSD diameter, and ONSD/ETD ratio were compared with age-, and sex-matched normal volunteers.

Prediction of the neurological outcome in resuscitated post-cardiac arrest patients is important to tailor appropriate management plans. Brain imaging, electrophysiological evaluations, biomarkers all take part in neuroprognosis in cardiac arrest patients, however, these modalities are more expensive or not suitable to repeat in a short time. Optic nerve sheath diameter (ONSD) had been proved to be associated with increased intracranial pressure2 and can be used as one of the prognostic factors in cardiac arrest patients. It is simple, quick and can be measured repeatedly. Carotid duplex and transcranial duplex(TCD) provide rapid, noninvasive, real-time measures of cerebrovascular function. It can be used to assess the vascular territory by measuring blood flow, and to evaluate factors include brain perfusion, plaque morphology, and patency of intracranial collaterals.

Hence, it could act as a crucial role in neuroprognosis in post-arrest patients. In this study, the investigator aimed to analyze the ONSD diameters, ONSD/ETD ratio, carotid duplex and transcaranial duplex parameters in different stages of post-cardiac arrest care, demographic characteristics and resuscitation information with the neurological outcome of post-cardiac arrest patients.

Eligibility Criteria:
Inclusion Criteria:

. Non-traumatic cardiac arrest adult patients achieving return of spontaneous circulation after resuscitation

Exclusion Criteria:

* traumatic cardiac arrests
* non-traumatic arrest patients without return of spontaneous circulation after resuscitation
Comparison of Bag-Valve-Guedel Adaptor to Common Face Mask for the Ventilation of Bearded Men

Ventilation of a bearded patient with the commonly used face mask has low efficiency because of difficulties to achieve a tight seal around the mouth and nose.

The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the need for a face mask.

Ventilating a patient using a bag valve and a face mask is not easy to perform, especially for a long period of time, and mandates experience and strength by the care giver. The need for a tight seal around the mouth and nose is a major challenge especially if the patient has a beard. Nevertheless, the face mask is the only approved respiratory support that medics and other basic care givers are allowed to use in the out-of-the-hospital setting, and only physicians and paramedics are allowed to use more advanced techniques, providing a definite airways. Thus, despite its lower effectiveness, the bag valve mask technique is the most commonly used in the field

The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the need for a face mask.

Study Design: Prospective, randomized, controlled. The volunteers will be asked randomly assigned to breathe through the BVGA/Face mask followed by the same protocol with the Face-mask/BVGA: 5 minutes room air, 5 minutes 100% oxygen, and 5 minutes room air again. The BVGAs/face masks well be connected to a standard operating room ventilation machines, and cardiopulmonary parameters will be monitored and documented.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males more than 18 years of age.
2. 22 with beards, 3 without beards.

Exclusion Criteria:

1. Presence of facial fractures or injuries.
2. Claustrophobia.
3. Respiratory diseases.
4. Severe illness such as cardiac or neurological diseases.
Daily Iron vs Every-other-day Iron for Pediatric Patients With IDA

Iron Deficiency Anemia (IDA) is a prevalent global health issue affecting a significant proportion of the population, including children. While daily oral iron supplementation is a common approach to treat IDA, concerns regarding side effects and compliance have led to exploration of alternative dosing schedules, such as every-other-day. This study aims to investigate the efficacy and safety of daily versus every other day oral iron supplementation in the management of IDA in pediatric patients.

This is a prospective open-label randomized controlled study. Patients will be randomized into two groups, one group (investigational) will receive oral iron every other day (every 48 hours) and the control group will be prescribed daily oral iron. Data will be collected prospectively including compliance assessment, side effect profile, hemoglobin (CBC), iron stores, hepcidin levels and other monitoring as relevant for best patient care.

At the time of enrollment and following randomization patients will commence treatment with oral iron. Duration of treatment will be 3 months. Laboratory monitoring will also commence at the time of enrollment along with ongoing evaluation of signs and symptoms of anemia, side effects of oral iron therapy, compliance with oral iron therapy. Duration of monitoring will be 6 months.

A medication diary will be provided to all subjects of each group to track their intake of their oral iron supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Iron Deficiency Anemia
* Pediatric patients (1-18 years of age) without regard of gender, race, ethnicity nor language.
* Able and willing to take oral iron (tablet or liquid).

Exclusion Criteria:

* Pregnant or lactating patients
* Known allergies or intolerance to oral iron formulations
* Concomitant chronic medical conditions affecting iron metabolism
* Short gut syndrome
* Celiac disease
* Inflammatory bowel disease
* Cancer
* Chronic kidney disease
* Blood transfusions in the past 3 months
* IV iron administration in the past 3 months
* Oral iron supplementation in the past 2 weeks
The Effect of Blood Donation on Hematological and Iron Indices and Detection of Autologous Blood Transfusion

Blood donations is a essential and crucial in the clinic. Normal biological variation of relevant biomarkers and hormones before the donation of 450 mL whole blood as well as the expected alterations in systemic levels of plasma iron indices and RBC measures up to 4 weeks after donation in healthy, non-anemic, young men and women is investigated

Likewise, the possibilities for detecting autologous blood transfusion is investigated.

Blood donations is a essential and crucial in the clinic. A whole blood donation results in the loss of 450-525 mL whole blood in eight to ten minutes and is known to reduce body iron stores with 200-265 mg iron depending on the donor's age, hematocrit and sex and accounts for 25% of average tissue iron stores in men and up to 75% in women.In the present study, the investigators aimed at thoroughly evaluate normal biological variation of relevant biomarkers and hormones before the donation of 450 mL whole blood as well as the expected alterations in systemic levels of plasma iron indices and red blood cell measures up to 4 weeks after donation in healthy, non-anemic, young men and women

Likewise, doping in sport is a major problem concerning both the health of the athletes and the integrity of sports. Despite major improvements in anti-doping work in recent years, it is still impossible to test for all existing and future doping strategies, such as manipulation with blood oxygen carrying capacity. A well-known doping strategy is autologous blood transfusion (ABT), and at present, the detection of ABT is a challenge for anti-doping authorities. The hypotheses for this study are that 1) ret% and abnormal blood profile score (ABPS) have higher sensitivity to micro-dose ABT compared to current variables in the Athlete Biological Passport (ABP); 2) The plasma concentration of hepcidin and erythroferrone (ERFE) is sensitive to micro-dose ABT; 3) Gender-specific variations in hematologic variables affect the interpretation of the athlete's biological passport.

Eligibility Criteria:
Inclusion Criteria:

* Relative maximum oxygen uptake (VO2-max) of at least 55 ml O2/min/kg for male participants and 50 ml O2/min/kg for female participants

Exclusion Criteria:

* Age
* Insufficient fitness level
* Blood donation 3 months prior to enrollment
* Altitude exposure 2 months before enrollment
* Hypertension
A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants

This will be a Phase I, 2-part, open-label, non-randomized study to investigate the safety, tolerability, and pharmacokinetics (PK) of a multiple-dosing regimen of risdiplam (Part 1) and the effect of risdiplam on the PK of midazolam (Part 2) following oral administration in healthy adult male and female participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants as defined by the Investigator
* A body mass index (BMI) of 18.0 to 32.0 kg/m2
* Use of adequate contraception methods during the treatment period and until 4 months after last study drug administration. Males must refrain from donating sperm during this same period
* Willingness and ability to complete all aspects of the study

Exclusion Criteria:

* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study
* History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs
* Surgical history of the GI tract affecting gastric motility or altering the GI tract
* History or presence of clinically significant ECG abnormalities or cardiovascular disease
* History of malignancy in the past 5 years
* Positive result on human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B virus, or hepatitis C virus
* Donation of blood or blood products for transfusion
* Participation in an investigational drug medicinal product or medical device study within 90 days prior to Screening
* Any clinically significant history of hypersensitivity or allergic reactions
* History of hypersensitivity to midazolam or any other benzodiazepine or its formulation ingredients

For Part 2 participants:

- History of acute angle glaucoma
Obstetric Pain Management for Women With Opioid Use Disorder (QUEST)

This is a mixed methods longitudinal observational study to assess patient and provider perspectives on pain and pain management among pregnant women with opiate use disorder (OUD). The findings from this study will inform patient-centered approaches to pain management. Themes surrounding mothers' pain/recovery experiences that correlate with quantified pain and analgesia endpoints will be identified. Findings will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with OUD.

A fine understanding of the attitudes and beliefs about pain and its management for patients with opioid use disorder is currently lacking. These psychological aspects of pain and analgesia are expected to have significant effects on nociception, pain experience, analgesic efficacy, and opioid requirements and its subsequent risks for relapse/treatment noncompliance. There is also have little understanding of provider-held attitudes and beliefs which can influence pain and its treatment for this population.

The findings from this study will inform patient-centered approaches to pain management for obstetric patients with OUD. They will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with OUD. This work will find new patient-centered endpoints for this special population that may be currently overlooked with existing standard pain assessments.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are 18 years of age or older
* History of opioid use disorder, on medication assisted therapy
* Currently in their third trimester

Exclusion Criteria:

* Unable to participate in informed consent discussions
* Unable to give informed consent for any reason
* Not fluent in English (surveys are validated in English language)
* Unable to participate fully in all study procedures for any reason
Low Field Magnetic Stimulation (LFMS) in Mood Disorders: 6 Treatments

To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods.

The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain brain regions.

Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects MUST be significantly depressed, currently.
2. Subjects must not have serious physical illnesses, neurological diseases or dementias.
3. Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed.
4. Subject must have a Ham-D score \> 17, YMRS score \< 7 (bipolar subjects only), and a MADRS score \> 18.
5. Subjects must be capable of providing informed consent.
6. Subjects must have an established residence and phone.
7. Subjects may be medicated or unmedicated.

Exclusion Criteria:

1. Dangerous or active suicidal ideation.
2. Pregnant or planning on becoming pregnant.
3. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
4. Mixed mood state or rapid cycling.
5. Presence of a pacemaker, neurostimulator, or metal in head or neck.