cyrilzakka/clinical-trials huggingface dataset:
Comparing Ease of Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery

This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.

Manual in-line stabilisation is used to immobilise the neck during endotracheal intubation in patients undergoing cervical spine surgery to prevent secondary spinal cord damage. This makes visualisation of the glottis difficult with conventional laryngoscopy which can be overcome with videolaryngoscope. CMAC Videolaryngoscope has the conventional blade (C blade) and the highly angulated D blade which was introduced to aid in difficult airway. This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.

Methodology: After Institutional Ethics Committee approval and obtaining informed consent, 68 patients undergoing elective cervical spine surgery were randomised into 2 groups - C (intubated with C blade) or D (intubated with D blade) (n=34 each) by computer generated randomisation. After induction of general anaesthesia, manual in-line stabilisation of the cervical spine was achieved and intubation was attempted by experienced anaesthesiologist with the C blade or D blade according to the group. The time taken for successful intubation, time taken for optimum glottic visualisation, the number of attempts, additional manouvres required for successful intubation and the incidence of complications were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA (American Society of Anaesthesiology) grade one and two,
* aged 18 years and older,
* Patients with mouth opening more than two and a half fingers (inter-incisor distance \>3cm)

Exclusion Criteria:

* Patients who were unwilling to be a part of the study,
* patients with any oral pathology, hiatus hernia, pregnant women,
* patients with severe systemic diseases
Impact of Rotational Atherectomy on Coronary Microcirculation

The purpose of this observational study is to compare the impact of rotational atherectomy to conventional stenting and to investigate how it may affect coronary microcirculation in patients with calcified coronary artery lesions and stable CAD.

The study's objectives are to:

* investigate the impact of rotational atherectomy on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction;
* investigate the impact of conventional stenting on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction; and
* compare the impact of both percutaneuos coronary interventions on coronary microvascular dysfunction.

Patients with calcified lesions will be enrolled prospectively and will have serial invasive and non-invasive microvascular testing prior to and after rotational atherectomy or conventional stenting.

Rotational atherectomy (RA) is a medical procedure used to treat patients with severe atherosclerosis, a condition that causes plaque buildup within the artery walls, resulting in narrowing of the blood vessels and decreased blood flow to the heart. RA is a technique that involves breaking up and removing plaque from the artery with a small, high-speed rotating burr.

However, RA is not without risks. One of the major risks associated with RA is the potential damage to the artery wall and surrounding tissue. This can lead to complications such as bleeding, blood clots, or injury to the heart or other organs. Additionally, the high-speed rotation of the burr can generate heat, which may damage the artery wall or cause the release of harmful particles into the bloodstream.

Another hypothesized risk of RA is its impact on microcirculation, which refers to the smallest blood vessels in the body. RA can cause disruption to these vessels, leading to a decrease in blood flow and potentially causing damage to tissues and organs that depend on them.

The purpose of this study is to look into the effect of rotational atherectomy on coronary microcirculation.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with stable coronary artery calcified lesion requiring Percutaneous coronary intervention

Exclusion Criteria:

* patients with a history of old myocardial infarction or history of coronary artery bypass grafting (CABG) or Percutaneous coronary intervention PCI
* Patients with signs of chronic infection, prolong usage of corticosteroids or compromised immune system
* patients had contraindication of adenosine triphosphate (ATP);
* had a history of liver or renal function dysfunction
* Patients with dementia
* Patients being referred to CABG
* unable to provide informed consent;
* had pregnancy or life span \< 1 year.
* Presence of sever structural valvular heart disease
* Presence of significant left main disease
* Unability to measure the index of microcirculatory resistance due to (death or retraction from the study ...etc)
* Inability to perform successful PCI
Colonisation Efficacy of Oral Probiotic Fast Melt Powder

To evaluate the colonisation efficacy (i.e. ability of the probiotic bacteria to remain in your mouth) of a fast melt powder that quickly dissolves in the mouth. The fast melt powder will contain a Streptococcus salivarius probiotic and the study is to be done in healthy adults.

This is a double-blind, randomized controlled study with no cross over to evaluate the colonization efficacy of fast melt powders containing a commercially available probiotic bacterium Streptococcus salivarius K12.

Participants will be randomly assigned to one of the 2 groups consuming Fast Melt powder containing two different doses of Streptococcus salivarius K12 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility Criteria:
Inclusion Criteria:

1. In general good health 18 - 80 years of age.
2. Practice good oral hygiene.

Exclusion Criteria:

1. Have a history of autoimmune disease or are immunocompromised.
2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
3. History of allergy (e.g. dairy).
Biomarker-enhanced ED Disposition Decisions

Patients presenting to emergency departments (ED) with non-specific complaints (NSC) such as "not feeling well", "feeling weak", "being tired", "general deterioration" are a very common and well-known, but poorly studied patient group. The differential diagnosis of NSC is extremely broad ranging from insufficient home care to acute life-threatening conditions. Therefore, the evaluation and diagnostic work-up of these mostly elderly patients with NSC is very time-consuming and not straight-forward. Furthermore, the assessment is complicated by comorbidities, polypharmacy or an altered mental status. For this reason, potentially unnecessary diagnostic efforts are undertaken in order to exclude a serious underlying condition, leading to prolonged throughput times and ED observation unit stays.

On the other hand, the patients' condition might be underestimated by ED physicians, which may result in ineffective, delayed or inadequate disposition, as well as poor patient outcomes. BANC (formerly BAUCAS) is a series of clinical studies with the intention to investigate the usefulness of clinical findings and biomarker levels combined for disposition of patients with non-specific complaints presenting to the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* All adult non-trauma patients with an Emergency Severity Index (ESI) of 2 or 3 are screened for inclusion

Exclusion Criteria:

* patients with specific chief complaints are excluded. Moreover, patients in whom an unambiguous and clear working hypothesis with logical management steps can be established are excluded
Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.

Metastatic spinal cord compression (MSCC) is a serious complication to metastatic cancer and when diagnosed life expectancy is short. Treatment is palliative radiotherapy (RT). Early esophageal toxicity is underreported but can seriously impact quality of life (QoL).

The aim of the ESO-SPARE trial is to investigate if esophagus sparing RT can decrease patient reported esophageal toxicity without compromising ambulatory function or increase other toxicities.

200 patients with MSCC in the thoracic or cervical spine referred for RT will be randomized to either standard or esophagus/pharynx sparing RT. Subsequently participants will be followed with PROM (Patient Reported Outcome Measures) for 9 weeks. PROM-CTCAE questionnaires on upper GI toxicity and pain will be collected daily for 5 weeks and weekly for 4 weeks. Questionnaires evaluating QoL and physical function will be collected weekly for 9 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Histology or cytology proven cancer
* Referred for palliative radiotherapy of the cervical or thoracic vertebra for

  * epidural ingrowth
  * metastatic spinal cord compression
  * metastatic spinal nerve root compression
  * post-operative radiotherapy after decompressive surgery for spinal cord or nerve root compression
* Ability to understand and the willingness to sign a written informed consent document
* Referred for the following dose prescriptions 5 Gy x 5, 5 Gy x 4, 3 Gy x 10, 10 Gy x 1, 8 Gy x 1.
* ≥ 18 years old.

Exclusion Criteria:

- Referred for \> 10 fractions
Secondary Prophylaxis After Variceal Bleeding in Non-Responders

Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.

The present is a prospective, randomized, open label study, in parallel groups, in which the patients with hemorrhage caused by esofagic varices will be randomized in two groups of treatment, after control of acute hemorrhage.

All the patients included will receive standard medical treatment with beta - blockers and endoscopic ligation of the esofagic varices.

The control group will be constituted by the patients assigned to receive endoscopic ligation and nadolol (N).

The experimental group will be constituted by patients assigned to receive treatment according to the hemodynamic response.

All patients included in the experimental group will receive pharmacologic treatment with nadolol combined with Isosorbide Mononitrate (MNI) or Prazosin (PZ).

In both groups it will practice a basal hepatic hemodynamic study in the 4th-5th day after their admitance (after achieve hemodynamic stability for at least 48 h and with hemorrhage controlled) and a second control hepatic hemodynamic study 3-4 weeks after the beginning of the pharmacologic treatment, once adjusted doses.

In the experimental group, the responders to N + MNI will keep on this treatment, but nonrespondent in the hemodynamic study will switch treatment to N + PZ and a third hepatic hemodynamic study will be performed 3 to 4 weeks after the dosage adjustement.

The randomization will be stratified according to the degree of hepatic failure measured by Child-Pugh classification (classes A and B versus C) The design is random to avoid bias in the selection of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Any Patient with endoscopically assessed Variceal Bleeding (esofagic and gastric)
* Cirrhosis
* Patient agreement to be included in the study onsentiment signed

Exclusion Criteria:

* Any associated comorbidity with life expectancy lesser than 6 months
* Patient refusement to be included in the study.
* Pregnancy
* Failure to control acute bleeding
* Previous prophylaxis treatment
Female Sexual Dysfunction, Risks and Outcomes (FSFI)

Many women will likely experience a sexual problem in their lifetimes. The Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking (PRESIDE) study surveyed more than 30,000 U.S. women aged \>18 years regarding sexual function. Results from this study estimated that 12% of women experience a diagnosable sexual disorder that causes personal distress, with lack of sexual desire being the most prevalent. - See more at: http://www.uspharmacist.com/content/d/featured_articles/c/56908/#sthash.LTDkyRlR.dpuf

Standard of care includes completion of a sexual dysfunctional questionnaire at every visit. This study will collect information from the questionnaires and office visit and follow the patient for outcomes of successful or non successful treatment.

The purpose of this study is to collect and analyze data on the characteristics of women who present with sexual dysfunction, to evaluate what risk factors contribute to sexual dysfunction and to evaluate what factors contribute to successful treatment of sexual dysfunction.

Upon a visit to the office participants will complete the Female Sexual Function Index (FSFI), this is standard of care for all patients. Research related procedures include: Review of questionnaires and collecting data from medical records regarding medical history, and treatment outcomes. If a participant does not return to the office for a follow up visit (or final visit) the final questionnaire will be sent by their preference (e-mail, phone, or mail) noted in the consent form.

Participates will also be given the option of participating in a "future storage of data". Future testing will be in the area of female sexual dysfunction. Data will be identified by a code number and only the research staff at Saint Louis University will have access to the data.

Eligibility Criteria:
Inclusion Criteria:

Female 18 to 89 years of age Being treated at the Saint Louis University Clinic for Sexual Dysfunction

Exclusion Criteria:

None

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A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)

A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a cholesterol-enriched test meal.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be otherwise healthy men and women (if not on oral contraceptives or hormone replacement therapy) 18 through 70 years of age with moderately high cholesterol.

Exclusion Criteria:

* Individuals on other lipid-lowering therapy (medicines that lower cholesterol) including statins (within 6 weeks) and fibrates (within 8 weeks) prior to administration of the study drug.
To Explore a Bridging Index for the Effectiveness of the Clinical Trial

To explore a bridging index for the effectiveness of the clinical trial with Nasal Spray Lyophilized Live Attenuated Influenza Vaccine

With a randomized, blind, parallel placebo-controlled design, to screen the susceptible individuals aged 3\~59 years old whose titers of either of Hi antibody level of H1N1, H3N2 or B are not higher than 1:10 prior immunization , in which all persons are to be assigned into the two subgroups (aged 3\~17 and 18\~59 years old) with radio of 1:1, individually. All persons of each age subgroups are to be randomly assigned into the two groups (vaccine or placebo group) with th radio of 2:1 via intranasal injection of one dose of the study vaccine or placebo. The blood samples are to be collected prior immunisation and on the 21st day post immunisation, individually, the nasopharyngeal swab samples are also to be done prior immunisation and on the 10th day and 21st day post immunisation, individually, and the levels of serum HI antibody and mucous sIgA antibody are to be compared between the two groups, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. healthy volunteer aged 3\~59 years old；
2. no vaccination with any influenza vaccine within the past year；
3. no catching any influenza or flu like symptoms （axillary temperature ≥ 38℃， accompanied by cough or sore throat ）；
4. influenza susceptible individual（any serum Hi antibody level of H1N1, H3N2 and B≦1:10）；
5. with informed consent obtained from the volunteer and / or guardian；
6. willing of volunteers and / or guardians to comply with the requirements of the clinical trial protocol.

Exclusion Criteria:

1. Known allergy individual to any ingredient of this product, including egg protein, subsidiary material and/or gentamycin sulfate;
2. patients with acute disease, severe chronic disease, acute attack of chronic disease and/or fever (axillary temperature ≥ 37.3℃ on the day of immunisation);
3. pregnancy (enquire);
4. patients with Leigh syndrome treated with aspirin or aspirin containing drugs;
5. patients with immunodeficiency or receiving immunosuppressive therapy;
6. patients with uncontrolled epilepsy and other progressive nervous system diseases, with a history of Guillain Barre syndrome;
7. patients with rhinitis or other nasal abnormalities judged by clinicians that may affect vaccination or sample collection;
8. accept any immunoglobulin and / or any blood products within 3 months, or plan to use them during the study (until post immunization blood sample collection);
9. .taking anti influenza drugs in the past 48 hours;
10. .any situation that the researchers believe may affect the study.
Pilot Study of Health Information Technology for Chronic Kidney Disease Management

Researchers now know that treating chronic kidney disease (CKD) in its early stages can prevent dialysis and reduce heart problems that go along with kidney disease. Computerized tools may help primary care doctors to diagnose the disease earlier and computer reminders may help doctors to prescribe the best treatments. In this project the investigators will test computer reminders in primary care clinics to see if they improve treatment of early chronic kidney disease and to see if it can promote referral to nephrology.

The investigators are conducting a randomized trial to determine the effect of a health information technology (HIT) application to calculate risk progression of end stage renal disease (ESRD). The primary outcome is the completion of the necessary tests for the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) for CKD patients in primary care. Secondary outcomes will include nephrology referrals, doubling of serum creatinine, initiation of hemodialysis, and primary care provider (PCP) satisfaction. In the analysis, all patients over the age of 18 who have a visit with one of physicians involved in the trial during the intervention period will be eligible and patients with stage 3-5 CKD will be included. Physicians are the subjects in this study, as the intervention is a behavioral intervention for physicians. The physicians' patients will not actively be recruited and will only indirectly be affected by the study. The application creates blocks of patient appointments for each physician and randomly assigns patients to intervention and control arms within these blocks.

Eligibility Criteria:
Inclusion Criteria:

* patients who are 18 years or older
* patients of primary care providers who are included in the study
* patients with CKD (defined as two estimated glomerular filtration rate (GFR) values under 60 mL/min per 1.73 m\^2 90 days apart)

Exclusion Criteria:

* patients without CKD (defined as two GFR values under 60 mL/min per 1.73 m\^2 90 days apart)
* patients under the age of 18
Combining Primary and Secondary Prevention for Reduction of Excessive Weight Gain in School

The main objective is to evaluate the effects of a multicomponent, school-based intervention combining change in nutritional behaviors with after school physical activity activities in reducing the excessive weight gain in schoolchildren.

Specific objectives are:

- evaluate the effect of the program on: change in nutritional behaviors, such as reducing sugar sweetened beverages and cookies intake reduction of time spent in sedentary activities gains in school performance and cognition outcomes the amount of daily physical activity on the percentage of body fat, changes in biochemical markers and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

Both prevention programs:

* 6th and 7th grades students
* consent form signed by parents / tutors

Secondary prevention program:

- overweight and obese children

Exclusion Criteria:

* pregnant girls
Study of 23ME-01473 in Patients With Advanced Solid Malignancies

This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies.

This study includes a dose escalation portion to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) to evaluate the clinical activity of 23ME-01473 and further evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with solid malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Phase 1: Adults ≥ 18 years of age
2. Phase 1: Histologically-diagnosed locally advanced (unresectable), or metastatic carcinoma or sarcoma that has progressed after standard therapy for the specific tumor type.
3. Adults 18+: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
4. Life expectancy ≥ 12 weeks
5. Phase 1: Participants with evaluable disease are eligible regardless of tumor type, RECIST 1.1 can be used to assess disease progression.

Exclusion Criteria:

1. Females who are pregnant (positive serum pregnancy test within 7 days prior to study drug administration) or breastfeeding.
2. Immune-Related Medical History

   1. Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years
   2. Receipt of systemic immunosuppressive therapy (e.g. steroids) within 4 weeks prior to the start of study drug administration
   3. History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, non-infectious pneumonia that required steroids, or evidence of active, non-infectious pneumonitis
   4. History of Grade ≥ 3 immune-mediated toxicity
3. Prior allogeneic or autologous bone marrow transplant, or other solid organ transplant
4. History of a positive test for:

   1. Hepatitis C virus (HCV) infection, except for those who have completed curative therapy for HCV and have undetectable HCV RNA
   2. Hepatitis B virus (HBV) infection, except for those who are receiving treatment with HBV-active nucleos(t)ide antiviral therapy at the time of study entry and have undetectable HBV DNA
   3. Human Immunodeficiency Virus (HIV) infection, except those who meet the following criteria: CD4+ T cells ≥ 350 cells/μL, no history of Acquired Immunodeficiency Syndrome (AIDS)-defining opportunistic infections, HIV RNA \< 50 copies/mL, and on a stable antiretroviral regimen for at least 3 months
5. Prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is shorter)
6. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free.
7. Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis
8. Recent history (within 6 months) of serious cardiovascular disease