cyrilzakka/clinical-trials huggingface dataset:
Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation

Globally, we are approaching 1 million surgical procedures each day. Tracheal intubation is the mainstay of securing the patient's airway and breathing during general anaesthesia. Approximately 100.000 tracheal intubations are performed annually in Denmark. Airway management remains the primary reason for anaesthesia-related morbidity and mortality. It has been traditionally accepted that best tracheal intubation conditions are obtained by paralysing the patient's muscles, including vocal cords, using a neuromuscular blocking agent (NMBA) such as rocuronium. However, using NBMA may increase the risk of pulmonary complications, intra-operative awareness, in which the patient is paralysed but awake during surgery, anaphylaxis, and re-intubation. In addition, there is a risk of residual neuromuscular blockade postoperatively. In the US, prolonged ventilation and unplanned intubation are the top two most costly perioperative complications. An alternative to NMBA is a large dose of opioids to depress laryngeal reflexes during intubation. The most commonly used non-NMBA modality includes bolus administration of remifentanil. However, remifentanil may cause bradycardia and hypotension. Even short periods of hypotension have been shown to increase the risk of myocardial injury and other serious adverse events such as renal failure, delirium, and even mortality.

Evidence also indicates that intubation conditions using only opioids to facilitate intubation, including remifentanil, are inferior to NMBA. However, these trials are underpowered to assess effects on patient-important outcomes and are mostly at high risk of bias. A recent trial has suggested that remifentanil intubation conditions may not be very different. Almost all existing research comparing NMBA to opioids has focused on intubation conditions for direct laryngoscopy using a conventional Macintosh laryngoscopy blade. In recent years, the implementation and availability of the video laryngoscope have grown exponentially and become universal. The video laryngoscope has vastly improved the ease of tracheal intubation, and the number of failed intubations has decreased by two-thirds in Denmark, where a rapid implementation of the video laryngoscope took place. However, limited evidence exists on whether NMBA improves intubation conditions compared to remifentanil when performing video laryngoscope-assisted tracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years
* Undergoing general anaesthesia requiring oro-tracheal intubation

Exclusion Criteria:

* Neuromuscular disease that may interfere with neuromuscular monitoring
* Awake intubation
* Rapid sequence induction
* Known allergies or contraindications to rocuronium or remifentanil
* Patients who do not understand Danish or English or are unable to give informed consent.
* Oral, pharyngeal, and laryngeal surgery
* Surgical indication for the use of a nerve stimulator
Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease

The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged more than 18 years
2. Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohn's disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis)
3. Weight above 50 kg
4. Hb \<12 g/dL (7.45 mmol/L)
5. Transferrin saturation (TfS) \<20%
6. Life expectancy beyond 12 months by investigator's judgment
7. Willingness to participate after informed consent -

Exclusion Criteria:

1. Anaemia predominantly caused by other factors than iron deficiency anaemia
2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate)
4. Known hypersensitivity to any excipients in the investigational drug products
5. Subjects with a history of multiple allergies
6. Active Intestinal Tuberculosis
7. Active intestinal amoebic infections
8. Decompensated liver cirrhosis and hepatitis (Alanine Aminotransferase (ALT) \> 3 times upper limit normal)
9. History of immunocompromise and/or history of Hepatitis B and/or C
10. Acute infections (assessed by clinical judgment), supported by white blood cells (WBC) and C-reactive protein (CRP))
11. Rheumatoid arthritis with symptoms or signs of active joint inflammation
12. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches)
13. Extensive active bleeding necessitating blood transfusion
14. Planned elective surgery during the study
15. Participation in any other clinical study within 3 months prior to screening
16. Untreated B12 or folate deficiency
17. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit
18. Erythropoietin treatment within 4 weeks prior to screening visit
19. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. Example: Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus
The Chronic Pain Incidence After Elective and Urgent Cesarean Sections

The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain.

The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain. Patients aged between 18 - 45 years whose underwent urgent or elective cesarean section will be invited to participate in the study. Preoperatively in operating theatre, patients will be asked to complete the pain catastrophizing scale (PCS) questionnaire. In postoperative 6 months after discharge, patients will be called by an investigator who is blind to the study to evaluate the presence of chronic pain. Patients will be asked to grade the pain that they suffer using a numeric rating scale for the intensity of pain.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 - 45 years of age
* underwent elective or urgent cesarean section

Exclusion Criteria:

* not willing to participate in the study
* can not reach by phone
* use of anti-psychotic or anti-depressant drugs
Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy

The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 to August 2011 using either Alyte Y-mesh or Restorelle Y-mesh

Exclusion Criteria:

* Refusal to participate in our long-term outcome study
The Safety And Efficacy Of Maintenance Therapy With CP-690,550

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI\<150) at Week 8.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
* Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI\<150) in Study A3921083.
* Women of childbearing potential must test negative for pregnancy prior to study enrolment.

Exclusion Criteria:

* Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
* Subjects likely to require any type of surgery during the study period.
* Fecal culture/toxin assay indicating presence of pathogenic infection.
Visuospatial and Affective Abilities in Parkinson Disease

The aim of the study is to investigate whether prismatic adaptation (AP), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG).


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old;
* Right-handed;
* Diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria (Lyon and Pahwa, 2011);
* Hoehn and Yahr Stadium (Hoehn and Yahr, 1996) \<2,5;
* Stable pharmacological treatment (dopaminergic therapy: dopamine agonists and Levo-dopa) in the last 6 weeks.

Exclusion Criteria:

* - Sensory-motor deficits that can hinder neuropsychological assessment;
* Visual system disorders (blindness, glaucoma);
* Atypical parkinsonisms;
* PD with dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association).
The Study in Outpatient Medicine Using Nudges to Improve Sleep

The goal of this clinical trial is to learn if electronic health record (EHR) nudges (changes to the EHR that do not restrict freedom of choice or alter incentives) can reduce Z-drug prescribing in primary care clinics for patients with insomnia. The main questions it aims to answer are:

1. Can Z-drug prescribing be reduced by setting the dispense quantity default of new Z-drug orders in the EHR to 10 pills with 0 refills?
2. Can Z-drug prescribing be reduced by an EHR alert that suggests clinicians remove a Z-drug and/or add an evidence-based behavioral treatment for insomnia, followed by a request to justify their reasoning if the suggestion is not followed?
3. Does combining these two nudges reduce Z-drug prescribing?

Researchers will compare each nudge individually and in combination to an guideline education control group to see if each nudge (separately and in combination) can reduce Z-drug prescribing.

Clinician-participants will:

1. Complete an introductory educational module about treating insomnia and relevant EHR changes.
2. Complete their routine patient visits.
3. Either experience EHR changes when prescribing Z-drugs, including a Z-drug dispense quantity default of 10 pills for new orders, a prompt to remove or justify Z-drug orders, both, or neither.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient primary care clinician at Northwestern Medicine

Exclusion Criteria:

* Clinician participated in pilot study
* Clinician-investigator for this trial
* Visit involves patient with ICD-10 F31.X diagnosis code (bipolar disorder) present in the last year or on active problem list
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS

The goal of this interventional Randomized clinical is to compare the effect of Metformin alone, Cabergoline alone and Metformin and Cabergoline in combination in a sample of Iraqi female patients with polycystic ovary syndrome. The main questions to answer are:

1. What are the effects of the tested regimens on Body mass index (BMI)?
2. What are the effects of the tested regimens on hormonal status?
3. What are the effects of the tested regimens on uterine artery resistive index ?
4. What are the effects of the tested regimens on some inflammatory markers?

Participants will be separated into two groups:

1. Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration.
2. Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week).
3. Group 3 (MD): 25 Pateins, Received metformin 500 mg per oral twice daily for 90 days duration and Dostinex (Pergolin) as 0.5 mg per oral (single dose per/week).

Researchers will compare Group 1 (M), Group 2 (D), Group 3 (MD) to observe the effect of the tested treatment regimens on Body Mass Index, Hormonal status, uterine artery resistive index, and some inflammatory markers that are IL-18, Anti-GAD Antibody and GnRH Antibody.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 40 years
* Diagnosed with Polycystic Ovarian Syndrome based on Rotterdam criteria
* Body Mass Index (BMI) \< 40 Kg/m²

Exclusion Criteria:

* Age less than 18 years or more than 40 years
* Co-morbid conditions including (diabetes mellitus, essential hypertension, and thyroid disease)
* Patients planning for conception.
* Body Mass Index \> 40 Kg/m²
Unhealthy Alcohol Drinking and Anesthetic Requirement in Women

Unhealthy alcohol drinking is negatively influencing health of people and costing a large number of annual finance via "secondhand" effects. Additionally, unhealthy alcohol use covers a spectrum that is associated with varying degrees of risk to health. The investigators hypothesized that unhealthy alcohol drinking resulted in significant increase in anesthetic requirement during general anesthesia. This investigation would clarify the association between unhealthy alcohol use and the intraoperative consumption of anesthetics, and provide clinical evidence for preoperative assessment with respect to the alcohol drinking habit.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* Chinese
* 19-45yr
* Undergoing general anesthesia

Exclusion Criteria:

* A history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
* Participants younger than 18yr，older than 45yr or pregnancy was eliminated.
* Those who were not willing to or could not finish the whole study at any time.
Evaluating a Community-Based Exercise Intervention With Adults Living With HIV: An Interrupted Time Series Study

The primary aim of this research is to evaluate a community-based exercise (CBE) intervention for adults living with HIV within the community with the goal of reducing disability and enhancing health (cardiopulmonary, strength, weight and body composition, and neurocognitive outcomes) and contextual factor outcomes (social support, stigma, mastery, coping) for adults living with HIV.

Investigators will use the RE-AIM Framework to evaluate the community-based exercise (CBE) intervention. The RE-AIM Framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational-levels in order to promote uptake, transferability and ultimately enhance the public health impact of health promotion interventions.

Specific study objectives are: 1) To determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults with HIV participate in a CBE intervention; 2) To assess the effect of a CBE intervention on disability and health outcomes and intrinsic and extrinsic factor outcomes for people living with HIV; 3) To assess engagement in CBE for adults with HIV over time (adherence, level of physical activity); and 4) To evaluate the process (strengths and challenges; feasibility; accessibility, long term sustainability) of implementing a CBE intervention within the community from the perspective of recreation providers (fitness instructors; managers) and people living with HIV.

Investigators will conduct a prospective longitudinal study using mixed methods to evaluate a CBE intervention in the community with people living with HIV. They will use an interrupted time series (ITS) design in combination with qualitative interviews to assess outcomes at baseline (pre-testing phase), during (intervention phase) and after the CBE intervention (post-testing phase) to evaluate the short- and long-term effect of CBE.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older) living with HIV in Toronto who consider themselves medically stable and safe to engage in exercise and who are willing to participate in a 22 month study involving a 14 month CBE intervention at the YMCA.

Exclusion Criteria:

* Not applicable.
The Impact of Liver Cirrhosis on Outcomes in Trauma Patients

Given that there are only a few studies on the effects of cirrhosis on trauma patients and none have addressed the impact cirrhosis has on the incidence of infections, it is important that we study this to determine the mortality in cirrhotic trauma patients and ascertain the incidence of infectious complications in these patients. We hypothesize that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.

There have been a select few studies addressing the effects of cirrhosis on trauma patients. These studies show an increase in morbidity and mortality. However, there is limitation in the depth and breadth of analysis. The primary aim of this study is to determine the mortality rates in cirrhotic trauma patients with a secondary end-point being the determination of the incidence of infections associated with these patients.

Given that there are only a few studies on the effects of cirrhosis on trauma patients and none have addressed the impact cirrhosis has on the incidence of infections, it is important that we study this to determine the mortality in cirrhotic trauma patients and ascertain the incidence of infectious complications in these patients. PI hypothesizes that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic trauma patients in the United States within 2010-2018
* Patients ≥ 18 years old

Exclusion Criteria:

* Patients less than 18 years old
ACT MALI: Treatment of Malaria Based on Combination Therapies

Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia


Eligibility Criteria:
Inclusion Criteria:

* Body weight \> 5kg
* Residence in the investigator site area for the duration of the trial
* Axillary temperature ≥ 37,5°C at Day 0
* Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood

Exclusion Criteria:

* Danger signs or signs of severe malaria
* Other severe illnesses
* Allergy to one of the drugs
* Pregnant women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study of Gastric Motility in Eosinophilic Gastritis

Purpose:

The study is a cross-sectional observational study designed to determine if eosinophilic gastritis (EG) results in gastric motility impairment.

Hypothesis:

Gastric dysfunction occurs in the natural history of EG but is underdiagnosed due, in part, to contraindications to the use of the standard meals used in gastric emptying studies.


Eligibility Criteria:
Inclusion Criteria:

* Eosinophilic gastritis (EG) defined as at least one endoscopy with histopathologic evidence of ≥ 30 eosinophils in 5 or more high powered fields (hpf's) with associated symptoms of EG.
* Patient reported symptoms starting at least one year or more prior to screening consistent with a diagnosis of EG: nausea, vomiting, early satiety, abdominal pain/bloating, regurgitation, diarrhea.
* Symptoms suggestive of a possible gastric motility disorder during the 60 days prior to screening including: nausea, vomiting, early satiety, post-prandial feeling of fullness or bloating.
* Tolerance and willingness to consume the oatmeal meal in this study.

Exclusion Criteria:

* Diagnosis of eosinophilic enteritis.
* Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
* Known disorders associated with eosinophilic gastrointestinal (GI) diseases (e.g., D 816 V Kit+ systemic mastocytosis, Marfan syndrome or Loey's Dietz Syndrome).
* Known inflammatory or autoimmune disorders associated with gastric dysmotility such as systemic sclerosis, lupus or eosinophilic fasciitis.
* Uncontrolled diabetes or known diabetic complications of gastroparesis, neuropathy or nephropathy.
* Taking opioid agents in the 2 weeks prior to screening and throughout the study.
* History of strictures in the small bowel or stomach (e.g., pyloric stenosis) or gastric surgeries or procedures such as pyloromyotomy, pyloric dilation, pyloric resection, vagotomy, bariatric surgery or post-Nissen fundoplication or antrectomy with Billroth I, Billroth II or Roux-en-Y gastrojejunostomy.
* Past or current medical problems or findings such as: advanced liver disease (Child's B or C), acute or chronic renal disease (serum creatinine \> 3 mg/dL), neurologic disease (e.g., dysautonomia), achalasia and adrenal insufficiency.
COVID-19 and Intestinal Microbiota in Children

SARS-CoV-2 is the causative agent of the COVID-19 pandemic. It appears to cause only mild to moderate upper respiratory symptoms in children, in addition to gastrointestinal symptoms resulting from its penetration into intestinal cells. Viral respiratory infections are often accompanied by a change in the composition of the gut microbiota (GM). Additionally, intestinal metabolites and integrity appear to be altered. This work aims to study the composition of the GM of Lebanese children, currently (n=14) and previously (n=33) infected with SARS-CoV-2 and to compare it to pre-pandemic controls (n=39). Furthermore, the correlation between the composition of the GM and the intestinal homeostasis are evaluated. Clinical data and stool samples were collected from children aged 1 month to 12 years. The bacterial profile is determined by quantitative PCR and 16S rRNA sequencing. Levels of secretory immunoglobulin A (sIgA), fecal calprotectin, beta defensin type 2 (hBD-2), short-chain fatty acids (SCFAs), tryptophan derivatives, and bile acids are also evaluated. Given the well-established relationship between the GM and the immune system, the results of this study could serve as a potential basis for the implementation of personalized nutrition and biotic supplementations aimed at restoring the host-microbiota symbiosis, pointing to the prevention and treatment of COVID-19


Eligibility Criteria:
Inclusion Criteria:

* Within age limits
* positive PCR

Exclusion Criteria:

* metabolic disorders, hepatic disorders, immunodeficiency, allergy, autoimmune diseases, IBD, food intolerance, antibiotic administration within 3 months, pro and prebiotic administration within 3 months
Facilitation of NGT Insertion

Insertion of a nasogastric tube (NGT) in anesthetized patients can be a disappointing experience. Many techniques have been explained to improve success rate along with increasing safety, such as forward displacement of the larynx, tube rigidity improvement methods, pushing it down directly through pharynx or using a guide tube. Failure of insertion under general anesthesia reached 50% in some publications


Eligibility Criteria:
Inclusion Criteria:

* all surgicl patients needing NGT insertion

Exclusion Criteria:

* refusal coagulopathy ASA more than 2